AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON OCTOBER 10, 1997DECEMBER 17, 1999

                                                      REGISTRATION NO. 333-36657333-
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                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                           ---------------
                                
                             AMENDMENT NO. 1     
                                       
                                    TO--------------------------

                                    FORM S-3
                             REGISTRATION STATEMENT
                                     UNDER
                           THE SECURITIES ACT OF 1933
                           -----------------------------------------

                                 ABIOMED, INC.
             (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

DELAWARE                                                04-2743260
     (STATE OR OTHER JURISDICTION OF               (I.R.S. EMPLOYER INCORPORATION                (I.R.S. EMPLOYER IDENTIFICATION NO.)
                   OR ORGANIZATION)
IDENTIFICATION NUMBER)
 
                             33
-------------------------- 22 CHERRY HILL DRIVE DANVERS, MASSACHUSETTS 01923 (978) 777-5410 (ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES) ----------------------------------------- DR. DAVID M. LEDERMAN PRESIDENT AND CHIEF EXECUTIVE OFFICER ABIOMED, INC. 3322 CHERRY HILL DRIVE DANVERS, MASSACHUSETTS 01923 (978) 777-5410 (NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF AGENT FOR SERVICE) ----------------------------------------- COPIES TO: PHILIP J. FLINK, ESQUIRE STEVEN C. BROWNE, ESQUIRE BROWN, RUDNICK, FREED & GESMER TESTA, HURWITZ & THIBEAULT, LLP ONE FINANCIAL CENTER 125 HIGH STREET BOSTON, MASSACHUSETTS 02111 BOSTON, MASSACHUSETTS 02110 (617) 856-8200 (617) 248-7000 --------------- PETER M. ROSENBLUM, ESQ. WILLIAM T. WHELAN, ESQ. FOLEY, HOAG & ELIOT LLP MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. ONE POST OFFICE SQUARE ONE FINANCIAL CENTER BOSTON, MASSACHUSETTS 02109 BOSTON, MASSACHUSETTS 02111 (617) 832-1000 (617) 542-6000
-------------------------- APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as practicable after the effective date of this Registration Statement. If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. [_]/ / If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. [_]/ / - ---------------- . If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [_]/ / - ---------------- . If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [_]/ / If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box. [_]/ / -------------------------- CALCULATION OF REGISTRATION FEE
PROPOSED PROPOSED MAXIMUM AMOUNT MAXIMUM OFFERING AGGREGATE OFFERING AMOUNT OF TITLE OF SHARES TO BE REGISTERED TO BE REGISTERED(1) PRICE PER SHARE(2) PRICE(2) REGISTRATION FEE Common Stock, $.01 par value per share....... 1,725,000 shares $44.563 $76,871,175 $20,294
(1) Includes up to 225,000 shares of common stock which the underwriters have the option to purchase solely to cover over-allotments, if any. See "Underwriting." (2) Estimated solely for the purpose of determining the registration fee pursuant to Rule 457(c) under the Securities Act of 1933. Based upon the average of the high and low price of the common stock as reported on the Nasdaq National Market on December 15, 1999. -------------------------- THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE. - --------------------------------------------------------------------------------------------------------------------------------------------------------------- - --------------------------------------------------------------------------------------------------------------------------------------------------------------- ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ +INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A + +REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE + +SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY + +OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT + +BECOMES EFFECTIVE. THISThe information in this prospectus is not complete and may be changed without notice. ABIOMED may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities, and ABIOMED is not soliciting offers to buy these securities, in any state where the offer or sale of these securities is not permitted. PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR + +THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE + +SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE + +UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF + +ANY SUCH STATE. + ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ SUBJECT TO COMPLETION, DATED OCTOBER 10, 1997(Not Complete) Issued December 17, 1999 1,500,000 SHARES [ABIOMED LOGO APPEARS HERE] 2,400,000 SHARESLOGO] ABIOMED, INC. COMMON STOCK Of the 2,400,000---------------- ABIOMED, Inc. is offering 1,500,000 shares of Common Stock offered hereby, 2,250,000 shares are being offered by ABIOMED, Inc. ("ABIOMED" or the "Company") and 150,000 shares are being offered by the Selling Stockholders. See "Principal and Selling Stockholders."common stock in a firmly underwritten offering. ------------------------ The Company will not receive any of the proceeds from the sale of shares by the Selling Stockholders. On October 9, 1997, the last reported sale price of the Company's Common Stock, as reported on the Nasdaq National Market, was $22.125 per share. See "Price Range of Common Stock." The Company's Common Stockcommon stock is tradedlisted on the Nasdaq National Market under the symbol "ABMD." -----------On December 16, 1999, the last reported sale price of the common stock on the Nasdaq National Market was $48.875 per share. ------------------------ INVESTING IN THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 6. ----------- THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE. - -------------------------------------------------------------------------------- - -----------------------------------------------------------------------------------------------------
UNDERWRITING PROCEEDS TO PRICE TO DISCOUNTS AND PROCEEDS TO SELLING PUBLIC COMMISSIONS COMPANY(1) STOCKHOLDERS - ---------------------------------------------------------------------------------------------Per Share Total --------- ----- Per Share.............. - --------------------------------------------------------------------------------------------- Total (2)..............Offering Price............................................ $ $ Discounts and Commissions to Underwriters................. $ $ Offering Proceeds to ABIOMED.............................. $ $
- -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- (1) Before deducting expenses payable byNeither the Company, estimated at $400,000. (2) The CompanySecurities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense. ABIOMED and one stockholder of ABIOMED have granted the Underwritersunderwriters a 30-day option to purchase up to an additional 360,000225,000 shares of Common Stock solelycommon stock to cover over- allotments, if any. See "Underwriting." If such optionany over-allotments. Banc of America Securities LLC expects to deliver the shares of common stock to investors on , 2000. BANC OF AMERICA SECURITIES LLC SALOMON SMITH BARNEY ---------------- , 2000 ABIOCOR-TM- IMPLANTABLE REPLACEMENT HEART [Illustration of certain components of the AbioCor system positioned on photograph of woman appears here. The following components are labeled: replacement heart, wireless energy transmission system, controller, internal battery and external battery pack.] Illustration of implantable and patient-worn components of the AbioCor Implantable Replacement Heart, which is exercised in full,being developed for patients with end-stage heart failure. [Photograph of AbioCor next to diseased human heart appears here.] Photograph of clinically configured AbioCor, scaled to illustrate size compared to diseased human heart. [Photograph of implantable components of the total Price to Public, Underwriting Discounts and Commissions and Proceeds to Company will be , and , respectively. ----------- The Common Stock is offered by the Underwriters as stated herein, subject to receipt and acceptance by them and subject to their right to reject any order in whole or in part. It is expected that delivery of such shares will be made through the offices of BancAmerica Robertson Stephens, San Francisco, California, on or about , 1997. UBS SECURITIES BANCAMERICA ROBERTSON STEPHENS The date of this Prospectus is , 1997 BVS-5000(R) BI-VENTRICULAR ASSIST SYSTEMAbioCor appears here.] Implantable AbioCor components. THE BVS-5000 PNEUMATIC [PHOTOGRAPHABIOCOR IS IN A PRE-CLINICAL STAGE OF THE ITEMS DESCRIBED CONSOLE WITH TWO SINGLE-USE IN THE CAPTION] BVS BLOOD PUMPS MOUNTED ON A BEDSIDE STAND. THE BVS-5000 PROVIDES A PATIENT'S FAILING HEART WITH FULL CIRCULATORY ASSISTANCE WHILE ALLOWING THE HEART TO REST, HEALDEVELOPMENT AND RECOVER ITS FUNCTION. CERTAIN PERSONS PARTICIPATING IN THIS OFFERING MAY ENGAGE IN TRANSACTIONS THAT STABILIZE, MAINTAINIS NOT APPROVED FOR SALE OR OTHERWISE AFFECT THE PRICE OF THE COMMON STOCK OF THE COMPANY, INCLUDING STABILIZING BIDS, SYNDICATE COVERING TRANSACTIONS AND THE IMPOSITION OF PENALTY BIDS. FOR A DISCUSSION OF THESE ACTIVITIES, SEE "UNDERWRITING." IN CONNECTION WITH THIS OFFERING, CERTAIN UNDERWRITERS AND SELLING GROUP MEMBERS OR THEIR AFFILIATES MAY ENGAGE IN PASSIVE MARKET MAKING TRANSACTIONS IN THE COMMON STOCK ON THE NASDAQ NATIONAL MARKET IN ACCORDANCE WITH RULE 103 OF REGULATION M UNDER THE SECURITIES EXCHANGE ACT OF 1934. SEE "UNDERWRITING." NO DEALER, SALES REPRESENTATIVE OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS IN CONNECTION WITH THIS OFFERING OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS, AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATION MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY, ANY SELLING STOCKHOLDER OR ANY UNDERWRITER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY, ANY SECURITIES OTHER THAN THE REGISTERED SECURITIES TO WHICH IT RELATES OR AN OFFER TO, OR A SOLICITATION OF, ANY PERSONCLINICAL USE IN ANY JURISDICTION IN WHICH SUCH AN OFFER OR SOLICITATION WOULD BE UNLAWFUL. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY OFFER OR SALE MADE HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE HEREOF OR THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENTCOUNTRY. REGULATORY APPROVAL AND COMMERCIALIZATION ARE SUBJECT TO THE DATE HEREOF. ----------------NUMEROUS UNCERTAINTIES AND RISKS. SEE "RISK FACTORS." 2 TABLE OF CONTENTS
PAGE ------------ Summary...............................................................Prospectus Summary.......................................... 4 Risk Factors..........................................................Factors................................................ 6 Use of Proceeds.......................................................Proceeds............................................. 17 Dividend Policy.......................................................Policy............................................. 17 Price Range of Common Stock...........................................Stock................................. 17 Capitalization.............................................. 18 Capitalization........................................................ 19 Selected Consolidated Financial Data.................................. 20Data........................ 19 Management's Discussion and Analysis of Financial Condition and Results of Operations................................................ 21 Business.............................................................. 26 Management............................................................ 40 Certain Transactions.................................................. 43Operations................................. 20 Business.................................................... 27 Management.................................................. 52 Principal and Selling Stockholders.................................... 44Stockholders...................................... 56 Description of Capital Stock.......................................... 45 Underwriting.......................................................... 46Stock................................ 57 Underwriting................................................ 60 Legal Matters......................................................... 50 Experts............................................................... 50 Available Information................................................. 50 Incorporation of Certain Documents by Reference....................... 51Matters............................................... 62 Experts..................................................... 62 Where You Can Find More Information......................... 62 Index to Consolidated Financial Statements............................Statements.................. F-1
---------------- ABIOMED(R), ABIODENT(R) andFORWARD LOOKING STATEMENTS This prospectus, including the ABIOMED logo are registered service marks of the Company. BVS(R), BVS-5000(R) and PerioTemp(R) are registered trademarks of the Company. Angioflex(TM) and Heart Booster(TM) are trademarks of the Company. Halimeter(R) is a registered trademark of Interscan Corporation. This Prospectus alsodocuments incorporated by reference in this prospectus, includes trademarks of companies other than the Company. As used herein, the term "ABIOMED" or the "Company" includes the Company and its consolidated subsidiaries. References to "Common Stock" include "Rights" issuable pursuant to that certain Rights Agreement entered into in August 1997 providing for the delivery of a Right along with each share of Common Stock issued by the Company. See "Description of Capital Stock." 3 SUMMARY This Prospectus containsforward-looking statements. We have based these forward-looking statements which involve riskson our current expectations and uncertainties. The Company'sprojections about future events. Our actual results could differ materially from those anticipateddiscussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements in these documents include, but are not necessarily limited to, those relating to: - our plans to commence initial clinical trials of the AbioCor Implantable Replacement Heart by the end of the year 2000; - our intention to expand the market for our BVS-5000 product; - our ability to obtain and maintain regulatory approval of our products in the U.S. and internationally; - the other competing therapies that may in the future be available to heart failure patients; - our plans to develop and market new products; and - our ability to carry out our strategy. Factors that could cause actual results or conditions to differ from those anticipated by these and other forward-looking statements as a result of certain factors, includinginclude those set forth undermore fully described in the "Risk Factors" section and elsewhere in this Prospectus. The following summary is qualified in its entirety by, and should be read in conjunction with, the detailed information and the Consolidated Financial Statements and Notes thereto appearing elsewhere in this Prospectus.prospectus. We are not obligated to update or revise these forward-looking statements to reflect new events or circumstances. ------------------------ YOU SHOULD RELY ONLY ON THE COMPANYINFORMATION CONTAINED IN THIS PROSPECTUS. WE HAVE NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH DIFFERENT INFORMATION. WE ARE NOT MAKING AN OFFER TO SELL THESE SECURITIES IN ANY JURISDICTION WHERE THE OFFER OR SALE IS NOT PERMITTED. YOU SHOULD ASSUME THAT THE INFORMATION APPEARING IN THIS PROSPECTUS IS ACCURATE AS OF THE DATE ON THE FRONT COVER OF THIS PROSPECTUS ONLY. OUR BUSINESS, FINANCIAL CONDITION, RESULTS OF OPERATIONS AND PROSPECTS MAY HAVE CHANGED SINCE THAT DATE. 3 PROSPECTUS SUMMARY THIS SUMMARY HIGHLIGHTS INFORMATION CONTAINED ELSEWHERE IN THIS PROSPECTUS. YOU SHOULD READ THE ENTIRE PROSPECTUS CAREFULLY, INCLUDING THE "RISK FACTORS" SECTION AND OUR FINANCIAL STATEMENTS AND THE RELATED NOTES CONTAINED HEREIN. UNLESS OTHERWISE INDICATED, THE INFORMATION IN THIS PROSPECTUS ASSUMES THAT THE UNDERWRITERS WILL NOT EXERCISE THEIR OVER-ALLOTMENT OPTION. ABIOMED, Inc. ("ABIOMED" or the "Company")INC. ABIOMED is a leader inleading developer, manufacturer and marketer of medical products designed to safely and effectively assist or replace the researchpumping function of the failing heart. Based on technology that has been developed and developmentrefined over a period of cardiac assistapproximately three decades, we have been developing and are preparing to enter human clinical trials for the AbioCor Implantable Replacement Heart, a battery-powered totally implantable replacement heart replacement technology. The Company developed, manufacturessystem, which we believe will be the first such device for end-stage heart failure patients. We currently manufacture and sellssell the BVS-5000, ("BVS"), a temporary cardiacheart assist device designed to provide a patient's failing heart with full circulatory assistance while allowing the heart to rest, heal and recover its function. The BVS is most frequently used in patients whose hearts fail to immediately recover function following heart surgery. The BVS is the only device that can provide full circulatory assistance approved by the United States Food and Drug Administration ("FDA") as a bridge-to-recovery device, for the treatment of all patients with reversiblefailing but potentially recoverable hearts. We are also engaged in research and development relating to other devices to support the pumping function of the heart. Heart disease is the number one cause of death in the U.S. In 1996, approximately 20 million people in the U.S. were afflicted with heart disease, resulting in over 700,000 deaths. While a number of therapies exist for the treatment of patients in early stages of heart disease, limited therapies exist today for most patients with severe heart failure. The CompanyAbioCor is developing a battery-powered totally implantable artificial heart ("TAH") intended as a permanent replacement device to assume the fullthat will replace a patient's diseased heart and take over its blood pumping function of both the left and right ventricles of the heart. The TAHfunction. It is designed for use by patients with irreparably damaged hearts andwho are at risk of imminent death due to acute myocardial infarction ("AMI"), chronic ischemicheart disease, or some form of end-stage congestive heart failure, but whose other vital organs otherwise remain viable. Among these combined groups,We believe the Company believes thatAbioCor will provide a much-needed treatment option for approximately 60,000125,000 patients per year could benefitin the U.S. for whom there is currently no effective therapy available. The AbioCor has reached an advanced stage of pre-clinical testing, including substantial laboratory and animal testing. We have selected surgical teams from a heart replacement device. The Company is devoting significant resourcesfive leading U.S. medical centers to accelerateperform initial human clinical trials. To date, we have invested more than $40 million in the development of the TAH with the goalAbioCor and, subject to initiatecompleting final testing and securing regulatory approvals, we expect to commence clinical trials offor the TAHAbioCor for certain patient populations by the end of the year 2000. There can be no assuranceWe anticipate that we will sell AbioCor systems, if and when approved by applicable U.S. and international regulatory authorities, for approximately $75,000 to $100,000 each, subject to the Company will be able to successfully complete pre-clinical testingestablishment of the TAH and receive FDA approval to begin clinical trials of the TAH in a timely manner, if at all, or that any market will develop for the TAH. The Company sells the BVS in the United States through direct sales and clinical support teams. Its sales force focuses on sales to new customers, while its clinical support group focuses on training and educating existing customers in order to improve clinical outcomes and increase BVS blood pump usage.reimbursement levels by third-party payors. The BVS is intendeda "bridge-to-recovery" device that can temporarily assume the full pumping function of the heart for use in any hospital performing open-chest cardiac surgery, of which there are more than 900 in the United States. As of September 30, 1997,patients with potentially reversible heart failure. In 1992, the BVS hadbecame the first heart assist device capable of providing full circulatory support to be approved by the the U.S. Food and Drug Administration, known as the FDA. Since fiscal 1995, the BVS has been purchased bya profitable product line. The BVS is the most widely used FDA-approved temporary heart assist device. To date it has been used to support over 2753,000 patients at over 500 medical centers inworldwide. We are pursuing several strategies to continue the United States including manygrowth of the largest centers. The Company believes that its installed base of customers provides an opportunityBVS product line, including implementing new market strategies, developing new products and seeking to expand the indications for reorders ofwhich the single-use BVS blood pumpsmay be used. We believe our experience in developing, manufacturing and selling the BVS will provide us with a competitive advantage in commercializing the AbioCor, as well as a reference base to assist in selling to new accounts. The Company's goal is to be a leader in the development, manufacture and marketing of mechanical cardiac assist and heart replacement devices that address the varying needs of a wide range of patients. The Company is pursuing a variety of strategies to pursue this objective, including accelerating the development of the TAH, increasing market penetration of the BVS, maintaining and enhancing its technological leadership and pursuing strategic relationships to support its research and commercialization efforts. Since the Company's inception, United States government agencies, particularly the National Heart, Lung and Blood Institute ("NHLBI"), have provided significant support to the Company's product development efforts. The Company seeks funding from third parties to support itsother future products. Our focused research and development programsrelated to the AbioCor and generally limits the use of its own funds untilBVS has provided us with the scientific risk is reduced. In addition, the Company intends to pursue collaborative relationshipsproprietary technology, know-how and experience to develop additional products. We believe we are the only company in the world with expertise in the full range of technology to support the pumping function of the heart. We seek to be first to market with high-quality, easy-to-use and commercialize the Company's non- cardiac assist technologies. The Company is a Delaware corporation. The Company's principal offices are located at 33 Cherry Hill Drive, Danvers, Massachusetts 01923. The Company's telephone number is (978) 777-5410 and its fax number is (978) 777-8411.cost- effective technologies for heart failure patients who currently lack adequate therapies. 4 THE OFFERING Common Stock Offeredstock offered by the Company........... 2,250,000ABIOMED.............. 1,500,000 shares Common Stock Offered by the Selling 150,000 shares Stockholders................................. Common Stock Outstandingstock outstanding after the Offering... 10,514,55610,169,867 shares (1)offering................................... Use of Proceeds...............................Proceeds.............................. For funding of clinical trials for the AbioCor, continued research and development, expansion of manufacturing capabilities, international sales and marketing and other general corporate purposes.purposes, including possible acquisitions. See "Use of Proceeds." Nasdaq National Market Symbol.................Symbol................ ABMD
The common stock to be outstanding after this offering is based on the number of shares outstanding as of December 1, 1999 and excludes 1,345,110 shares of common stock reserved for issuance upon the exercise of outstanding stock options at a weighted average exercise price of $11.70 per share. See "Capitalization" and Note 7 to Consolidated Financial Statements. SUMMARY CONSOLIDATED FINANCIAL DATA (in thousands, except per share data)(IN THOUSANDS, EXCEPT PER SHARE DATA) You should read the following summary consolidated financial data in conjunction with our financial statements and accompanying notes and with "Management's Discussion and Analysis of Financial Condition and Results of Operations" included elsewhere in this prospectus.
SIX MONTHS ENDED FISCAL YEAR ENDED MARCH 31, SEPTEMBER 30, ----------------------------------------- -------------- 1993 1994---------------------------------------------------- -------------------- 1995 1996 1997 1996 1997 ------- ------- ------ ------ ------- ------ -------1998 1999 1998 1999 -------- -------- -------- -------- -------- -------- -------- STATEMENT OF OPERATIONS DATA: Revenues: Products..............Total revenues...................................... $ 1,709 $ 4,648 $6,893 $9,725 $12,311 $5,760 $ 9,324 Contracts............. 1,736 2,027 2,337 3,118 4,151 1,754 3,680 ------- ------- ------ ------ ------- ------ ------- Total revenues...... 3,445 6,675 9,230 12,843 16,462 7,514 13,004 Costs and expenses: Cost of products...... 2,042 2,211 3,289 3,921 5,361 2,123 3,438 Research and development (2)...... 2,097 2,431 2,464 3,218 3,833 1,781 3,654 Selling, general and administrative....... 3,803 4,553 4,278 5,741 7,068 3,229 4,970 ------- ------- ------ ------ ------- ------ -------8,729 $11,601 $15,023 $22,446 $22,090 $10,770 $10,520 Total costs and expenses........... 7,942 9,195 10,031 12,880 16,262 7,133 12,062 ------- ------- ------ ------ ------- ------ -------expenses............................ 9,176 11,463 14,282 24,647 29,994 14,522 14,724 Income (loss) from operations............. (4,497) (2,520) (801) (37) 200 381 942 Interest and other income................. 604 537 449 528 535 256 417 ------- ------- ------ ------ ------- ------ -------operations....................... (447) 138 741 (2,201) (7,904) (3,752) (4,204) Income (loss) from continuing operations............ 2 666 1,276 (995) (6,712) (3,025) (3,807) Loss from discontinued operations................... (354) (175) (541) (1,513) -- -- -- Net income (loss)....... $(3,893) $(1,983)................................... $ (352) $ 491 $ 735 $ 637 $ 1,359$(2,508) $(6,712) $(3,025) $(3,807) ======= ======= ====== ====== ======= ====== ======= ======= ======= ======= Income (loss) from continuing operations per diluted share............................................. $ 0.00 $ 0.10 $ 0.18 $ (0.12) $ (0.78) $ (0.35) $ (0.44) Loss from discontinued operations per diluted share............................................. (0.05) (0.03) (0.08) (0.19) -- -- -- ------- ------- ------- ------- ------- ------- ------- Net income (loss) per share..................diluted share................. $ (0.60) $ (0.31) $(0.05)(0.05) $ 0.07 $ 0.10 $ 0.09(0.31) $ 0.17(0.78) $ (0.35) $ (0.44) ======= ======= ====== ====== ======= ============= ======= ======= ======= Weighted average number ofdiluted shares outstanding.. 6,441 6,461outstanding......... 6,512 6,995 7,162 7,196 7,8698,074 8,619 8,599 8,653 ======= ======= ======= ======= ======= ======= =======
AS OF SEPTEMBER 30, 1997 ------------------------1999 ------------------------- ACTUAL AS ADJUSTED (3) ------- --------------------------- ----------- BALANCE SHEET DATA: Cash, cash equivalents and short-term marketable securities.......................................... $24,312 $70,980securities............ $13,661 $82,075 Working capital...................................... 29,109 75,777capital............................................. 18,547 86,961 Total assets......................................... 36,348 83,016 Total stockholders' investment....................... 32,648 79,317assets................................................ 29,659 98,073 Long-term liabilities....................................... 159 159 Stockholders' equity........................................ 23,333 91,747
- -------- (1) Based on the number of shares outstandingThe balance sheet data as of September 30, 1997. Excludes 964,4101999 is adjusted to reflect our sale of 1,500,000 shares of Common Stock reserved for issuance upon the exercise ofcommon stock options outstanding as of September 30, 1997 at a weighted average exercise price of $10.81 per share. See Note 6 to Consolidated Financial Statements. (2) Research and development expenses include certain contract costs. See Note 1(e) to Consolidated Financial Statements. (3) Adjusted to reflect the sale of 2,250,000 shares of Common Stock offered by the Company herebyunder this prospectus at an assumed public offering price of $22.125$48.875 per share and the application of the net proceeds, therefrom after deducting the estimated underwriting discountsfees of the underwriters and commissions andestimated offering expenses payable by the Company.ABIOMED. See "Use of Proceeds" and "Capitalization." Except as otherwise indicated, all information in this Prospectus assumes no exercise of the Underwriters' over-allotment option.We are a Delaware corporation. Our principal offices are located at 22 Cherry Hill Drive, Danvers, Massachusetts 01923. Our telephone number is (978) 777-5410 and our fax number is (978) 777-8411. 5 RISK FACTORS This Prospectus contains forward-looking statementsTHIS OFFERING AND AN INVESTMENT IN OUR COMMON STOCK INVOLVE A HIGH DEGREE OF RISK. YOU SHOULD CONSIDER EACH OF THE RISKS AND UNCERTAINTIES DESCRIBED IN THIS SECTION AND ALL OF THE OTHER INFORMATION IN THIS PROSPECTUS BEFORE DECIDING TO INVEST IN OUR COMMON STOCK. OUR BUSINESS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS COULD BE SEVERELY HARMED BY ANY OF THE FOLLOWING RISKS. THE TRADING PRICE OF OUR COMMON STOCK COULD DECLINE IF ANY OF THESE RISKS AND UNCERTAINTIES DEVELOP INTO ACTUAL EVENTS. YOU MAY LOSE ALL OR PART OF THE MONEY YOU PAID TO BUY OUR COMMON STOCK. OUR FUTURE SUCCESS IS HEAVILY DEPENDENT ON DEVELOPMENT OF THE ABIOCOR. OUR DEVELOPMENT EFFORTS MAY NOT BE SUCCESSFUL. We are currently devoting our principal research and development and regulatory efforts, and significant financial resources, to the development of the AbioCor, an implantable replacement heart system. An implantable replacement heart is a complex medical device and has never been successfully developed or marketed by any company. The development of the AbioCor and other new products, including our AbioBooster and AbioVest heart assist products, presents enormous challenges in a variety of areas, many or all of which involve riskswe may have difficulty in overcoming, including blood compatible surfaces, blood compatible flow, manufacturing techniques, pumping mechanisms, physiological control, energy transfer, anatomical fit and uncertainties. The Company's actual results could differ materially from those anticipatedsurgical techniques. For many years, we and other parties have been attempting to develop a heart replacement device, but, to date, none of these efforts has been successful. We cannot be sure that we will be successful in these forward-looking statements as a result of certain factors, including those set forthour development efforts, and in the following riskevent that we are unable to commercialize the AbioCor, our business and financial condition would be adversely affected. THE MARKETS FOR THE ABIOCOR AND OUR OTHER PRODUCTS UNDER DEVELOPMENT ARE UNPROVEN. Even if the AbioCor or any other of our products are successfully developed and approved by the FDA and corresponding foreign regulatory authorities, they may not enjoy commercial acceptance or success, which would adversely affect our business and results of operations. Several factors could limit our success, including: - Our need to create a market for an implantable replacement heart, and elsewherepossible limited market acceptance among physicians, medical centers, patients and third party payors; - The need for surgeons to develop or be trained in this Prospectus. In additionnew surgical techniques to use our product effectively; - Limitations on the other informationnumber of patients who may have access to physicians and medical centers with adequate training, equipment and personnel to make use of our products; - Limitations inherent in this Prospectus, the following risk factors should be considered carefully in evaluating the Company and its business before purchasing shares of the Common Stock offered hereby. DEPENDENCE ON BVS PRODUCT LINE; EARLY STAGE OF BVS MARKET DEVELOPMENT In the six months ended September 30, 1997first generation devices, and the fiscal year ended March 31, 1997, sales ofpotential failure to develop successive improvements, including increases in service life, which would reduce the BVS and related products and services represented more than ninety percent of the Company's product revenues. The Company believes that its dependence on the BVS product line is likely to continue for at least the next several years, unless and until the Company successfully develops, obtains regulatory approvals for and sells new products. Theaddressable market for the BVS continuesAbioCor; - The lifestyle limitations that patients will have to be inaccept, including traveling with external batteries at all times and potentially avoiding activities such as air travel or diving that involve significant pressure changes; - The timing and amount of reimbursement for these products, if any, by third party payors; - The introduction by other companies of new treatments, products and technologies which compete with our products, and may reduce their market acceptance, or make them obsolete; 6 - The reluctance, due to ethical considerations, of physicians, patients and society as a whole to accept medical devices that replace the early stageheart; and - The reluctance of development. The Company has initially focused its marketing efforts on larger medical centersphysicians, patients and hospitals.society as a whole to accept the finite life and risk of mechanical failure of devices that replace the heart. The commercial success of the BVSAbioCor and other heart assist products will be dependent upon both the Company's ability to sell the BVS to smaller hospitalsrequire acceptance by cardiovascular surgeons and medical centers, which generally have more limited financial resources,interventional and the increase of the use of the BVS at those medical centers and hospitals which have purchased the systems. There can be no assurance that the Company will be successful in marketing the BVS. Advances in medical technology, biotechnology and pharmaceuticals may reduce the size of the potential markets for the Company's products or render those products obsolete. Failure of the Company to expand the market for and use of the BVS would have a material adverse effect on its business, financial condition and results of operations. See "Business--Marketing and Sales." UNCERTAINTY OF PRODUCT DEVELOPMENT AND CLINICAL TRIALS The Company has developed and marketsheart failure cardiologists, a limited number of whom significantly influence medical device selection and purchasing decisions. We may achieve our business objectives only if the AbioCor and our other products are accepted and believes that its future success will in large part be dependent upon its ability to develop and market innovative new products, such as the TAH. The successful development of these products presents enormous challenges. The Company must demonstrate that the TAH,recommended by leading physicians, which is being designedlikely to assume the full pumping functionbe based on a determination by these physicians that our products are safe, cost-effective and represent acceptable methods of both the lefttreatment. Although we have developed relationships with leading cardiac surgeons and right ventriclescardiologists, we cannot assure that these existing relationships and arrangements can be maintained or that new relationships will be established in support of the heart, can operate effectivelyAbioCor and reliably withinour other products. If cardiovascular surgeons and cardiologists do not consider our products to be adequate for the treatment of our target cardiac patient population or if a patient over an extended period. For many years,sufficient number of physicians recommend and use competing products, it would seriously harm our business. PRE-CLINICAL AND CLINICAL TESTING OF OUR NEW PRODUCTS WILL INVOLVE UNCERTAINTIES AND RISKS WHICH COULD DELAY OR PREVENT NEW PRODUCT INTRODUCTIONS, REQUIRE US TO INCUR SUBSTANTIAL ADDITIONAL COSTS OR RESULT IN OUR FAILURE TO BRING OUR PRODUCTS TO MARKET. Prior to commencing clinical trials of the CompanyAbioCor and others have been attemptingour other products under development, we must perform pre-clinical tests which consist of demonstrating performance, durability and reliability through laboratory and animal studies. We could encounter significant delays or other setbacks in pre-clinical testing. Prior to develop products that meet these criteria and have not yet been successful. Before obtaining regulatory approvals in the U.S. and other countries for the commercial saleclinical testing in humans of any of itsthe AbioCor and other products, under development, the Companywe must demonstrate throughin pre-clinical studies and clinical trialstesting that theeach product is safe and effective. Initialhas the potential to be effective in humans for the intended duration of use. We are now conducting pre-clinical testing of the TAH and other products being developed by the Company will be conducted in simulated environments and animal models to demonstrate safety and effectiveness over an extended period of time before they are permitted to be clinically tested in humans. There can be no assurance that the Company will be able to successfully complete pre-clinicalAbioCor. This testing of the TAH or other products being developed by the Company and receive FDA approval to initiate clinical trials of such products in a timely manner, if at all. Moreover, pre- clinical trials may not be predictive of results that will be obtained in clinical trials. Any significantA number of companies in the medical industry have suffered delays, cost overruns and project terminations despite achieving promising results in pre-clinical testing. In the event that we suffer setbacks in the pre-clinical or terminationclinical testing of the AbioCor or other heart assist products, these products may be delayed, require further funding, and possibly may not be brought to market. If we cannot demonstrate through clinical testing on humans that the AbioCor or other new products are safe and effective, we will not be able to obtain regulatory approvals in the U.S. or other countries for the commercial sale of these products. Delays, budget overruns, and project terminations are not uncommon even after promising pre-clinical and clinical trials of the Company's products under development would have a material adverse effect on the Company's business, financial condition and results of operations. Clinical trialsmedical products. We intend to conduct clinical testing for the Company's cardiacAbioCor and other heart assist and heart replacement products will be conducted with critically ill patients, who are critically ill. During the course of treatment,and these patients may die or suffer other adverse medical effectsresults for reasons thatwhich may or may not be related to the product being tested but which can nevertheless affecttested. Those outcomes could seriously delay the completion of clinical trial results. A numbertesting, as could the unavailability of companies in the medical device industry have suffered significant 6 setbacks in advancedsuitable patients for clinical trials, even after promising results in earlier trials. Clinical trialsboth of the Company's TAH and other products under development may be delayed or terminated as a result of many factors, and there can be no assurance that such delays or terminations will not occur. One such factor is the rate of enrollment of patients, which generally varies throughout the course of a clinical trial and which depends on the size of the potential patient population, the number of clinical trial sites, the proximity of the patients to clinical trial sites, the eligibility criteria for the trial and the existence of competitive clinical trials. The Companyare outside our control. We cannot control the rate at which patients present themselves for enrollment, and there can be no assuranceassure that the rate of patient enrollment in our clinical trials will be consistent with the Company'sour expectations or be sufficient to enableallow us to complete our clinical trials offor the Company'sAbioCor or our other products under development to be completed in a timely manner, if at all. Any significant delaysDelays could defer the marketing and commercial sale of our products, require further funding, and possibly result in or terminationfailure to bring the products to market. Development and testing of clinical trials ofdesign changes to the Company'sAbioCor and other products under development is often extensive, expensive and time consuming. Some of the tests for our products may require months or years to perform, and we could be required to begin these tests again if we modify one of 7 our products to correct a problem identified in testing. Even modest changes to certain components of our products can take months or years to complete and test. If results of pre-clinical or clinical testing of the AbioCor or other products under development indicate that design changes are required, such changes could cause serious delays that would have a material adverse effect on the Company's business, financial condition andadversely affect our results of operations. IF WE FAIL TO OBTAIN APPROVAL FROM THE FDA AND FROM FOREIGN REGULATORY AUTHORITIES, WE CANNOT MARKET AND SELL THE ABIOCOR OR OTHER NEW HEART ASSIST PRODUCTS IN THE U.S. AND IN OTHER COUNTRIES. Obtaining required regulatory approvals may take several years to complete and consume substantial capital resources. We cannot assure that the FDA or any other regulatory authority will act quickly or favorably on our requests for product approval, or that the FDA or any other regulatory authority will not require us to provide additional data that we do not currently anticipate in order to obtain product approvals. We cannot apply for FDA approval to market the AbioCor and our other products under development until the product successfully completes its pre-clinical and clinical trials. Several factors could prevent successful completion or cause significant delays of these trials, including an inability to enroll the required number of patients or failure to demonstrate adequately that the product is safe and effective for use in humans. If safety problems develop, the FDA could stop our trials before completion. In addition, we are planning to conduct phased clinical trials for the Company's productAbioCor tailored to specific patient populations with different life expectancies. If we are successful in obtaining FDA approvals for the AbioCor based on this phased approach, the initial approvals are likely to include conditions or limitations to particular indications that would limit the available market for these products. If we are not able to obtain regulatory approvals for use of the AbioCor or our other products under development, willor if the patient populations for which they are approved are not sufficiently broad, the commercial success of these products could be subjectlimited. We intend to numerousmarket the AbioCor and our other risks associated with new product development,products in international markets, including unanticipated delays, expenses, technical problemsthe European Union and Japan. We must obtain separate regulatory approvals in order to market our products in other jurisdictions. The approval process may differ among those jurisdictions and approval in the U.S. or in any other difficulties thatjurisdiction does not ensure approval in other jurisdictions. Obtaining foreign approvals could result in significant delays, difficulties and costs for us, and require additional trials and additional expense. IF WE OBTAIN REGULATORY APPROVAL OF OUR NEW PRODUCTS, THE PRODUCTS WILL BE SUBJECT TO CONTINUING REVIEW AND EXTENSIVE REGULATORY REQUIREMENTS, WHICH COULD AFFECT THE MANUFACTURING AND MARKETING OF OUR PRODUCTS. The FDA continues to review products even after they have received initial approval. If and when the abandonmentFDA approves the AbioCor or substantial change in the design, development and commercialization of these new products. Given the uncertainties inherent with product development and introduction, there can be no assurance that any of the Company'sour other products under development, will demonstrate sufficient safetythe manufacture and efficacy to obtain the requisite regulatory approvals, on a timely basis and within budget, if at all, or that anymarketing of these products will be commercially successful if suchsubject to continuing regulation, including compliance with current Quality Systems Regulations and Good Manufacturing Practices, known as QSR/GMP, adverse event reporting requirements and prohibitions on promoting a product for unapproved uses. We will also be required to obtain additional approvals in the event we significantly modify the design of an approved product or the product's labeling or manufacturing process. Modifications of this type are obtained. See "Business--ABIOMED Productscommon with new products, and Products under Development." ANTICIPATED FUTURE LOSSES The Company plans to use its own resources to fundwe anticipate that the further developmentcurrent first generation of the TAH in amounts significantly in excessAbioCor will undergo a number of changes, refinements and improvements over time. For example, the current configuration of the funding provided underAbioCor's thoracic unit, or "replacement heart," is sized for patients with relatively large chest cavities, and we anticipate that we will need to obtain regulatory approval of thoracic units of other sizes. If we are not able to obtain regulatory approval of modifications to our current and future products, the Company'scommercial success of these products would be limited. We and our third-party suppliers of product components are also subject to inspection and market surveillance by the FDA for QSR/GMP and other requirements. Enforcement actions resulting from 8 failure to comply with government requirements could result in fines, suspensions of approvals, recalls of products, operating restrictions and criminal prosecutions, and affect the manufacture and marketing of our products. The FDA could withdraw a previously approved product from the market upon receipt of newly discovered information, including a failure to comply with regulatory requirements, the occurrence of unanticipated problems with products following approval, or other reasons, which could adversely affect our operating results. THE COST OF DEVELOPING AND MANUFACTURING THE ABIOCOR AND OUR OTHER PLANNED NEW PRODUCTS IS SUBSTANTIAL FOR A COMPANY OF OUR SIZE AND WILL EXERT A STRAIN ON OUR AVAILABLE RESOURCES. In recent years we have significantly increased our research and development contractexpenditures for the TAH withAbioCor, and we expect that this trend will continue in the NHLBI ("TAH Contract"). The Companyfuture. We will also need to make significant expenditures to begin to manufacture and market the AbioCor and our other planned new products in commercial quantities for sale in the U.S. and other countries, if and when we obtain regulatory approval to do so. We cannot be sure that our estimates thatof capital expenditures for the AbioCor and the development of our other new products will be accurate. We could have significant cost overruns, which could reduce our ability to commercialize our products. Any delay or inability to commercialize our products under development could adversely affect our business prospects and results of operations. WE DO NOT OPERATE AT A PROFIT AND DO NOT EXPECT TO BE PROFITABLE FOR SOME TIME. Our total revenues for the TAH, including conductingsix months ended September 30, 1999 and in fiscal 1999 each declined by approximately 2% from the comparable period in the prior year. We had a net loss of $3.8 million for the six months ended September 30, 1999 and a net loss of $6.7 million in fiscal 1999. We are committed to making large expenditures for the AbioCor and, to a lesser extent, other new products, in fiscal 2000 and subsequent fiscal years, which may result in losses in future periods. These expenditures include costs associated with performing pre-clinical and clinical studiestrials for the AbioCor, continuing our research and obtainingdevelopment relating to the AbioCor and other new products, seeking regulatory approvals will require substantial funds. Its spending under the TAH Contract in the quarter ended September 30, 1997 exceeded the amount which the government has currently appropriated for that contract, and the original government appropriation schedule calls for no further appropriations for the TAH Contract until October 1998. There can be no assurance that the government will appropriate any additional amounts under the TAH Contract or anyAbioCor and, if we receive these approvals, commencing commercial manufacturing and marketing of the Company'sAbioCor. The amount of these expenditures is difficult to forecast accurately, and cost overruns may occur. We plan to fund a portion of these expenditures from our limited existing financial resources, revenues from BVS sales, which are variable and uncertain, and development contracts, which may be terminated at any time by the government. We anticipate that we will also need to fund a substantial portion of these expenditures from other government contractssources, such as the proceeds of this offering or other equity and debt financing. We cannot be sure that we will have the necessary funds to develop and commercialize our new products, or that additional funds will be available on a timely basis,commercially acceptable terms, if at all. Even if and when additional amountsIn the event that we are appropriated underunable to obtain the TAH Contract, the Company believes that its total expenses to complete the development of the TAH will significantly exceed the remaining TAH Contract amount. As a result, the Company believes that it is likely that the Company will incur losses, potentially as soon as the quarter ending December 31, 1997. The amount and duration of these losses will depend upon a number of factors, including the Company's ability to increase sales and profitability of its present products,necessary funding to develop and obtain regulatory approvals forcommercialize our products, our business may be adversely affected. OUR OPERATING RESULTS MAY FLUCTUATE UNPREDICTABLY. Our annual and quarterly operating results have fluctuated historically and we expect these fluctuations to continue. Among the factors that may cause our operating results to fluctuate are: - costs we incur in developing and testing the AbioCor and other new products andor product enhancements, and to successfully manufacture and market these new products and enhancements, as well asenhancements; - the timing of regulatory actions, such as product approvals or recalls; - costs we incur in anticipation of future sales, such as inventory purchases, expansion of manufacturing facilities, or establishment of international sales offices; 9 - the timing of customer orders and extentdeliveries, particularly of BVS consoles, which are priced significantly higher than the Company's spending related tosingle-use BVS blood pumps; - competitive changes, such as price changes or new product development andintroductions that we or our competitors may make; - the timing of government appropriations related to our research contracts and grants; and - economic conditions in the Company's NHLBI contracts. See "Usehealth care industry and the state of Proceeds"cost containment efforts, including reimbursement policies. We believe that period-to-period comparisons of our historical and "Management's Discussionfuture results will not necessarily be meaningful, and Analysisthat investors should not rely on them as an indication of Financial Condition and Results of Operations." COMPLEX MANUFACTURING; HIGH-QUALITY REQUIREMENTS The nature of the Company's products requires high-quality manufacturing. The Company's manufacturing and quality testing processes and procedures are highly dependent on the diligence and experience of the Company's personnel.future performance. To the extent we experience the factors described above, our future operating results may not meet the expectations of securities analysts or investors from time to time, which may cause the market price of our common stock to decline. THE BVS PRODUCT LINE, OUR PRINCIPAL PRODUCT AND CURRENT PRIMARY SOURCE OF REVENUES, IS VULNERABLE TO COMPETITIVE PRESSURES, DISRUPTIONS IN SALES, CONTINUING REVIEW AND EXTENSIVE REGULATORY REQUIREMENTS. All of our product revenues to date have come from sales of the BVS line of products. We believe that we will continue to be dependent on our BVS product line for at least the next several years, unless and until we are able to successfully develop, obtain regulatory approval for and sell new products. In the event that a competitor were to introduce new treatments, products and technologies which compete with our products, add new features to their existing products or reduce their prices to make their products more financially attractive to customers, our revenue from our BVS products could decline. For example, in the event of the expansion of technologies which allow heart surgical procedures to be performed without stopping the heart, a reduction in the market for the BVS could potentially result. Further, the BVS is subject to stringent and continuing FDA and other regulatory requirements, including compliance with QSR/GMP, adverse event reporting, prohibitions on promoting the BVS for unapproved uses, and continued inspection and market surveillance by the FDA. If BVS products are recalled or otherwise withdrawn from the market, our revenues would likely decline, which would hurt our business. In addition, variations in the quantity and timing of sales of BVS consoles have a disproportionate effect on our revenues, because the price of the console is substantially greater than the price of our disposable blood pumps. If we cannot maintain and increase our revenues from our BVS product line, our overall business and financial condition could be adversely affected. Revenues from our BVS product line in the six months ended September 30, 1999 declined by 3% from the comparable period in the preceding year, and in fiscal 1999 our BVS revenues increased by 5% from revenues in fiscal 1998. To maintain or increase revenues from sales of our BVS products, we may be required to adopt new sales and marketing strategies, some of which may require expending additional capital resources. The new strategies we may adopt include: - promoting increased use of the BVS by existing customers in order to increase disposable blood pump sales to those customers; - selling the BVS to smaller hospitals and medical centers in the U.S.; - regularly introducing enhancements to the BVS; - expanding sales of our BVS product line in international markets, some of which require separate regulatory approvals; and - seeking new categories of patients to support with the device. 10 In the event that we are unsuccessful in carrying out these new strategies, our revenues may decline. WE MAY NOT BE SUCCESSFUL IN EXPANDING OUR SALES ACTIVITIES INTO INTERNATIONAL MARKETS. We are seeking to expand our international sales of the BVS and prepare for commercialization of the AbioCor by recruiting direct sales and support teams for selected countries in Europe and pursuing regulatory approval of the BVS in Japan. To date we have limited experience in selling the BVS internationally. In fiscal 1999, approximately 3% of our revenues from the BVS product line were derived from international sales. Our international operations will be subject to a number of risks, which may vary from the risks we experience in the U.S., including: - the need to obtain regulatory approvals in foreign countries before our products may be sold or used; - longer sales cycles; - dependence on local distributors; - limited protection of intellectual property rights; - difficulty in collecting accounts receivable; - fluctuations in the values of foreign currencies; and - political and economic instability. If we are unable to effectively expand our sales activities in international markets, our results of operations could be negatively impacted. WE DEPEND ON THIRD PARTY REIMBURSEMENT TO OUR CUSTOMERS FOR MARKET ACCEPTANCE OF OUR PRODUCTS. IF THIRD PARTY PAYORS FAIL TO PROVIDE APPROPRIATE LEVELS OF REIMBURSEMENT FOR PURCHASE AND USE OF OUR PRODUCTS, OUR PROFITABILITY WOULD BE ADVERSELY AFFECTED. Sales of medical products largely depend on the reimbursement of patients' medical expenses by government health care programs and private health insurers. The cost of our BVS system is substantial, and we anticipate that the Company's manufacturing volumes expand orcost of implanting the Company beginsAbioCor in a patient will also be substantial. Without the manufacture of new products, this dependence on personnel will likely increase. In addition, the manufacturefinancial support of the blood contacting surfacesgovernment or third party insurers, the market for our products will be limited. Medical products and devices incorporating new technologies are closely examined by governments and private insurers to determine whether the products and devices will be covered by reimbursement, and if so, the level of reimbursement which may apply. We cannot be sure that third party payors will reimburse sales of our products now under development, or enable us to sell them at profitable prices. We also cannot be sure that third party payors will continue the current level of reimbursement to physicians and medical centers for use of the Company's products requires a high degree of precision. These surfaces are manufactured from polyurethane-based materials. The quality and composition of polyurethane-based products can vary significantly based on numerous factors including humidity, temperature, material content and air flow during the manufacturing process. The Company's products also incorporate plastic components for non-blood contacting surfaces. The Company relies on third-party vendors to provide these components to the Company's specifications. The Company is not able to fully inspect the quality of all vendor supplied components and, therefore, relies on its vendors with respect to the 7 quality of these components. Once the plastic-based components of the Company's products have been assembled, accessibility for inspection is limited. If a defect is detected in as few as one of the Company's products, or in one component of a Company product, it can resultBVS. Any reduction in the recall or restrictionamount of this reimbursement could harm our business. The federal government and private insurers have considered ways to change, and have changed, the manner in which health care services are provided and paid for in the U.S. In the future, it is possible that the government may institute price controls and further limits on saleMedicare and Medicaid spending. These controls and limits could affect the payments we collect from sales of our products. Once assembled, in most cases, the Company's blood contacting components cannot be reworked for human use. The manufacturing lead times for parts and assemblies, particularly the polyurethane-based components, can take many weeks from the date that all materials and components are received by the Company. In addition, vendor lead times for materials and components of the Company's productsInternationally, medical reimbursement systems vary significantly, with lead timessome medical centers having fixed budgets, regardless of levels of patient treatment, and other countries requiring application for, and approval of, government or third party reimbursement. Even if we succeed in bringing our new products to market, uncertainties regarding future health care policy, legislation and regulation, as well as private market practices, could affect our ability to sell our products in commercially acceptable quantities at profitable prices. 11 Prior to approving coverage for new medical devices, most third party payors require evidence that the product has received FDA approval, is not experimental, and is medically necessary for the specific patient. Increasingly, third party payors require evidence that the devices being used are cost-effective. The AbioCor and our other products under development may not meet these or future criteria, which could hurt our ability to market and sell these products. IF WE FAIL TO ACHIEVE AND MAINTAIN THE HIGH MANUFACTURING STANDARDS THAT OUR PRODUCTS REQUIRE OR IF WE ARE UNABLE TO DEVELOP ADDITIONAL MANUFACTURING CAPACITY, WE WILL NOT BE SUCCESSFUL. Our products require precise, high quality manufacturing. Our failure to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, design defects or component failures, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business. We have from time to time voluntarily recalled certain materials and components exceeding sixproducts. In particular, in fiscal 1997 we initiated a voluntary recall of BVS blood pumps when one of our outside suppliers manufactured a limited number of defective components. This recall disrupted our ability to fill orders from certain customers for a period of approximately eight months. The Company isDespite our very high manufacturing standards, we cannot completely eliminate the risk of errors, defects or failures. In addition, we are planning to expand itsmove into a new manufacturing facility for the BVS during the next twelve months. There canin 2000, and this move could disrupt manufacturing of our products. We cannot be no assurancecertain that the products manufactured in the expandednew facility will be manufactured at the same cost and quality as the BVS isand AbioCor are currently being manufactured. In addition, to the extentwe cannot be certain that the Company's products under development have been manufactured, they have been manufactured as prototypes with, at most, pilot-scale production. The Company's products under development are likely to involve additional manufacturing complexities and high quality requirements. There can be no assurance that the Companywe will be able to increase productionobtain ISO 9001 certification of our new facility or approval by regulatory authorities. If we are not able to manufacture the BVS or manufacture future products, if developedin accordance with necessary quality standards, our business and approved, in commercial quantities on a consistent and timely basis, with acceptable cost and quality. The inability to manufacture current and future products in sufficient quantities in a timely manner, and with acceptable cost and quality, would have a material adverse effect on the Company's business, financial condition and results of operations. See "Business--Manufacturing." RISK OF MARKET WITHDRAWAL OR PRODUCT RECALL Complex medical devices, such as the BVS and other of the Company's products under development, can experience performance problems that require review and possible corrective action by the manufacturer. Similar to many other medical device manufacturers, the Company periodically received reports from users of its products relating to performance difficulties they have encountered. The Company expects that it will continue to receive customer reports regarding the performance and use of the BVS. There can be no assurance that component failures, manufacturing errors or design defects that could result in an unsafe condition or injury to the patient will not occur. Certain of these failures or defects have been deemed sufficiently serious by the Company to result in recalls of products associated with certain manufacturing lots or containing certain components, including a recall of certain BVS blood pumps initiated in late 1996. Not all of the products subject to this recall have been returned to the Company. Any product problems could result in market withdrawals or recalls of products, voluntarily or required, which could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, there can be no assurance that a product recall will result in the recovery of all defective products or prevent customers from using these products. The use of a defective product could result in injury to a patient and significant liability to the Company which could have a material adverse effect on its business, financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." FLUCTUATIONS AND UNPREDICTABILITY OF OPERATING RESULTS The Company's annual and quarterly operating results have fluctuated and the Company expects these fluctuations to continue. Significant annual and quarterly fluctuations in the Company's results of operations may be caused by, amongnegatively affected. The AbioCor involves even greater manufacturing complexities than our current product line. The AbioCor must be significantly more durable and meet different standards, which may be more difficult to achieve, than those which apply to our current product, the BVS. If we are unable to manufacture the AbioCor or other factors, the overall state of health carefuture products on a timely basis at acceptable quality and cost containment efforts, economic conditionsand in commercial quantities, or if we experience unanticipated technological problems or delays in production, our business will suffer. The manufacture of our products is and will continue to be complex and costly, requiring a number of separate processes and components. Achieving precision and quality control requires skill and diligence by our personnel. Further, to be successful, we believe we will need to increase our manufacturing capacity. We may experience difficulties in scaling up manufacturing of our new products, including problems related to product yields, quality control and assurance, component and service availability, adequacy of control policies and procedures, and lack of skilled personnel. If we cannot hire, train and retain enough experienced and capable scientific and technical workers, we may not be able to manufacture sufficient quantities of our current or future products at an acceptable cost and on time, which could limit market acceptance of our products or otherwise damage our business. IF OUR SUPPLIERS CANNOT PROVIDE THE COMPONENTS WE REQUIRE, OUR ABILITY TO MANUFACTURE OUR PRODUCTS COULD BE HARMED. We rely on third party suppliers to provide us with certain components used in the Company's markets,BVS, the expenseAbioCor, and timingour other products under development. Relying on third party suppliers makes us vulnerable to component part failures and to interruptions in supply, either of which could impair our ability to conduct clinical tests or to ship our products to our customers on a timely basis. Using third party vendors makes it difficult and sometimes impossible for us to test fully certain components, such as components on circuit boards, maintain quality control, manage inventory and production schedules and control production costs. Vendor lead times to supply us with ordered components vary significantly and can exceed six months or more. Both now and as we expand our manufacturing 12 capacity, we cannot be sure that our suppliers will furnish us with required components when we need them. These factors could make it more difficult for us to effectively and efficiently manufacture our products, and could adversely impact our results of operations. Some suppliers may be the Company's development effortsonly source for a particular component, which makes us vulnerable to cost increases and supply interruptions. Vendors may decide to limit or eliminate sales of certain products to the medical industry due to product liability or other concerns, and we might not be able to find a suitable replacement for those products. Manufacturers of our product enhancement,components may be required to comply with FDA or other regulatory manufacturing regulations and to satisfy regulatory inspections in connection with the timingmanufacture of regulatory actions, the potentialcomponents. If we cannot obtain a necessary component, we may need to recallfind, test and obtain regulatory approval for a replacement component, produce the component ourselves or rework products from time to time, timingredesign the related product, which would cause significant delay and could increase our manufacturing costs. Any of government appropriations related to the Company's research contracts and grants, the timing of or changes in third-party reimbursement policies for the Company's products, the timing of expenditures in anticipation of future sales, variations in the Company's product mix and component costs, the availability of components, the timing of customer orders, adjustments of delivery schedules to accommodate customers, inventory levels of products at customers (including inventory at 8 distributors), changes in the government's funding policies under the Company's existing contracts, pricing and other competitive conditions, and the timing of the announcement, introduction and delivery of new products and product enhancements by the Company and its competitors. Customers may also cancel or reschedule shipments, and production difficultiesthese events could delay shipments. The price for the BVS console is significantly higher than for the single-use blood pumps. As a result, variations in the number and timing of consoles sold have a disproportionate effect on the Company's revenues andadversely impact our results of operations. The Company also believes that BVS sales may be somewhat seasonal, with reduced sales in the summer months, reflecting hospital personnel and physician vacation schedules. Beginning in fiscal 1998, the Company anticipates potentially significant annual and quarterly fluctuations in contract revenues and research and development costs associated with the development of the TAH due to the need for additional government appropriations under the TAH Contract and to increased levels of Company spending. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." MARKETS FOR PRODUCTS UNDER DEVELOPMENT UNPROVEN Most of the Company's products under development, including the TAH, are targeting new and unproven markets. There can be no assurance that the TAH or other products under development by the Company will gain any degree of market acceptance among physicians, medical centers and third party payors, including managed care organizations, even if necessary regulatory approvals and reimbursement are obtained. As a result, it is likely that the Company's evaluation of the potential markets for these products will materially vary with time. In addition, the effective use of these products will likely require development of new surgical techniques by well-trained physicians, which will initially limit the market for the Company's products. Physicians, patients and society as a whole may have ethical concerns or be reluctant to accept medical devices designed to replace the heart. The timing and amount of reimbursement, if any, by third-party payors for the use of these products, if developed, will also have a significant impact on the market for these products. Other companies may also introduce products or technologies which will compete with these products, reduce the market for these products, or render these products obsolete. There can be no assurance that the Company will be able to market successfully any of its products under development, if and when these products are developed. Failure to do so would have a material adverse effect on the Company's business, financial condition and results of operations. See "Business--Marketing and Sales." DEPENDENCE ON KEY PERSONNEL; RISKS ASSOCIATED WITH GROWING NUMBER OF EMPLOYEES The Company is highly dependent on the principal members of its scientific, sales, and management staff, the loss of whose services could have a material adverse effect on the Company's business, financial condition and results of operations. Competition among medical device companies for highly skilled scientific, sales and management personnel is intense. There can be no assurance that the Company will be able to attract and retain all personnel necessary for the development of its business. Failure to do so could have a material adverse effect on its business, financial condition and results of operations. The Company has recently experienced a significant increase in the number of its full-time employees, from 79 at April 1, 1996 to 166 at September 30, 1997. Moreover, the Company intends to continue to add a significant additional number of employees to support its development and expanding manufacturing, marketing and sales efforts. The expansion of the Company's personnel has placed additional demands upon, and may significantly strain, the Company's management, financial systems and other resources. There can be no assurance that the Company will be able to successfully manage its growing number of employees. Failure to do so would have a material adverse effect on the Company's business, financial condition and results of operations.INTENSE COMPETITION AND TECHNOLOGICAL CHANGE Competition in the cardiac assist market is intense and subject toCOULD HARM OUR FINANCIAL PERFORMANCE. Intense competition, rapid technological change and evolving industry requirements and standards. Manystandards in the heart assist markets could decrease demand for our products or make them obsolete. Some of the companies, universities and research organizations developing or marketing cardiac assistcompeting products 9 have substantially greater financial, product development, sales and marketing resources and experience than the Company. Thesewe have. Our competitors maycould commence and complete clinical testing of their products, obtain regulatory approvals and begin commercial-scale manufacturing of their products faster than we are able to for our products. They could develop superior products or products of similar quality at the same or lower prices. Moreover, there can be no assurance that improvements in current or new technologies will not make them technically equivalent or superior to the Company's products inIn addition, to providing cost or other advantages. Other advances in medical technology, biotechnology and pharmaceuticals may reduce the size of the potential markets for the Company's products or render those products obsolete. The BVS is the only device that can provide full circulatory assistance approved by the FDA as a bridge-to-recovery device for the treatment of patients with reversible heart failure. However, the Company is aware of at least one other company, Thoratec Laboratories Corporation, seeking approval of a temporary cardiac assist device to address this market. Approval by the FDA of products that compete directly with the BVS would increase competitive pricing and other pressures and could have a material adverse effect on the Company's business, financial condition and results of operations. The Company is aware of other artificial heart development efforts in the United States, Canada, Europe and Japan. A team comprised of Pennsylvania State University and 3M Corporation, Inc. has been developing a heart replacement device for many years with significant NHLBI support. There are a number of companies, including Thermo Cardiosystems, Inc. and Novacor, a division of Baxter International, Inc., which are developing permanent cardiac assist products, including implantable left ventricular assist devices ("LVADs") and miniaturized rotary ventricular assist devices, that may address markets that overlap with those targeted by the Company's TAH. The Company'sour customers frequentlyoften have limited budgets. As a result, the Company'sConsequently, our products compete against thea broad range of medical devices and therapies for these limited funds. The Company's success will depend in large part upon its ability to enhance its existing products and to develop new products to meet regulatory and customer requirements and to achieve market acceptance. The Company believesWe cannot be sure that important competitive factors with respect to the development and commercialization of its products include the relative speed with which it can develop products, establish clinical utility, complete clinical testing and regulatory approval processes, obtain reimbursement and supply commercial quantities of the product to the market. There can be no assurance that the Companywe will be able to compete effectively and successfully in the markets in which we participate. WE OWN PATENTS, TRADEMARKS, TRADE SECRETS, COPYRIGHTS AND OTHER INTELLECTUAL PROPERTY AND KNOW-HOW THAT WE BELIEVE GIVES US A COMPETITIVE ADVANTAGE. IF WE CANNOT PROTECT OUR INTELLECTUAL PROPERTY, COMPETITION COULD FORCE US TO LOWER OUR PRICES, WHICH COULD HURT OUR PROFITABILITY. Our intellectual property rights are and will continue to be a critical component of our success. A substantial portion of our intellectual property rights relating to the AbioCor and BVS is in the form of trade secrets, rather than patents. In order to preserve certain proprietary information as trade secrets, we are required to restrict disclosure of information intended to constitute trade secrets to third parties. We protect our trade secrets and proprietary knowledge in part through confidentiality agreements with employees, consultants and other parties. Certain of our consultants and third parties with whom we have business relationships may also provide services to other parties in the medical device industry, including companies, universities and research organizations that are developing competing products. In addition, some of our former employees may seek employment with, and become employed by, our competitors. We cannot assure that confidentiality agreements with our employees, consultants and third parties will not be breached, that we will have adequate remedies for any such breach, or that competitionour trade secrets will not become known to or be independently developed by our competitors. The loss of trade secret protection for technologies or know-how relating to the AbioCor or the BVS could adversely affect our business prospects. Our business position will also depend in part on our ability to defend our existing and future patents and rights and conduct our business activities free of infringement claims by third parties. We intend to seek additional patents, but our pending and future patent applications may not be approved, may not give us a competitive advantage, and could be challenged by others. Patent proceedings in the U.S. and in other countries may be expensive and time consuming. In addition, patents issued by foreign countries may afford less protection than is available under U.S. patent law, and may not 13 adequately protect our proprietary information. Our competitors may independently develop proprietary technologies and processes which are the same as or substantially equivalent to ours, or design around our patents. Companies in the medical device industry typically obtain patents and frequently engage in substantial intellectual property litigation. Our products and technologies could infringe on the rights of others. If a third party successfully asserts a claim for infringement against us, we may be liable for substantial damages, unable to sell products using that technology, or would have to seek a license or redesign the related product. These alternatives may be uneconomical or impossible. Patent litigation could be costly, result in product development delays, and divert the efforts and attention of management from our business. We are currently defending a lawsuit that relates to a portion of the energy transmission technology used in the AbioCor. World Heart Corporation and Ottawa Heart Institute Research Corporation filed suit against us in Delaware in January 1998, seeking damages and injunctive relief because they contend that a component of the AbioCor infringes their intellectual property rights. We believe we do not violate any intellectual property rights of the plaintiffs and that we have a material adverse effectstrong defense against this lawsuit, but if we are not successful in the action, we may be required to use or develop alternate energy transmission technology, seek a license from a third party, or modify the design of the AbioCor. We may not be able to develop a reasonable alternative design on a timely, cost effective basis and we may not be able to obtain a license at reasonable cost or on a timely basis. In either case, our failure to win the lawsuit could hurt our ability to develop or market the AbioCor, which would adversely affect our business prospects. IF WE CANNOT ATTRACT AND RETAIN THE MANAGEMENT, SALES AND OTHER PERSONNEL WE NEED, WE WILL NOT BE SUCCESSFUL. We depend heavily on the Company's business, financial condition and results of operations. See "Business--Competition." GOVERNMENT REGULATION Clinical testing, manufacture and salecontributions of the Company's productsprincipal members of our technical, sales and support, regulatory and clinical, operating and administrative management and staff, many of whom would be difficult to replace. Competition for skilled and experienced management, scientific personnel and sales personnel in the medical devices industry is intense. If we lose the services of any of the principal members of our management and staff, or if we are unable to attract and retain qualified personnel in the future, especially scientific and sales personnel, our business could be adversely affected. We expect to grow rapidly if the AbioCor and our other products under development includingadvance through the BVSapproval process. The expansion of personnel and facilities will strain our management and our financial and other resources. If we cannot manage this growth successfully, our business will likely suffer. PRODUCT LIABILITY CLAIMS COULD DAMAGE OUR REPUTATION AND HURT OUR FINANCIAL RESULTS. The clinical use of medical products, even after regulatory approval, pose an inherent risk of product liability. We maintain limited product liability insurance coverage, subject to deductibles and exclusions. We cannot be sure that product liability insurance will be available in the TAH, arefuture or will be subjectavailable on acceptable terms or at reasonable costs, or that such insurance will provide us with adequate coverage against potential liabilities. Claims against us, regardless of their merit or potential outcome, may also hurt our ability to regulation byobtain physician endorsement of our products or expand our business. Many patients using the FDA and corresponding state and foreign regulatory agencies. Noncompliance with applicable requirements canBVS do not survive. There are many factors beyond our control that could result in among other things, fines, injunctions, civil penalties, recall or seizurepatient death, including the condition of products, total or partial suspensionthe patient prior to use of production,the product, the skill and reliability of physicians and hospital personnel using and monitoring the product, and product 14 maintenance by customers. However, the failure of the governmentBVS or other life support products we distribute for clinical test or sale could give rise to grant pre-market clearanceproduct liability claims and negative publicity. The risk of product liability claims could increase as we introduce new products like the AbioCor that are intended to support a patient until the end of life. The AbioCor will have a finite life and could cause unintended complications to other organs and may not be able to successfully support all patients. Its malfunction could give rise to product liability claims whether or pre-market approval for devices, withdrawal of marketing approvals and criminal prosecution. The FDA alsonot it has extended or improved the authority to request repair, replacement or refundquality of the cost of any device manufactured or distributed by the Company. Any devices, includingpatient's life. We cannot be sure that we can obtain liability insurance to cover the BVS, that are manufacturedthe AbioCor or distributed by the Company pursuant to FDA clearances or approvals are subject to pervasive and continuing regulation by the FDA and certain state agencies. Manufacturers of medical devices for marketing in the United States are required to adhere to the FDA's Quality System Regulation and must also comply with Medical Devices Reporting requirements that a firm report to the FDA any incident in which its product may have caused or contributed to a death or serious injury, or in which its product malfunctioned and, if the malfunction were to recur, it would be likely to cause or contribute to a death or serious injury. Labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission. Current FDA enforcement policy prohibits the marketing of approved medical devices for unapproved uses. The Company is subject to routine inspection by the FDA and certain state agencies for compliance with the Quality System Regulation and Medical Device Reporting requirements, as well as other applicable regulations. 10 In addition, the FDA requires that manufacturers of certain devices, including the BVS, conduct postmarket surveillance studies after receiving approval of a Pre-Market Approval ("PMA") application. The primary purpose of required postmarket surveillance is to provide an early warning system to alert the health care community to any potential problems with a device withinnew products at a reasonable timecost. If we have to pay product liability claims in excess of the initial marketing of the device. Postmarket surveillance provides clinical monitoring of the early experiences with the device once it is distributed in the general population under actual conditions of use. The Company is also subject to regulation in each of the foreign countries in which it sells its products. Many of the regulations applicable to the Company's products in these counties are similar to those of the FDA. The Company believes that foreign regulations relating to the manufacture and sale of medical devices are becoming more stringent. The European Union has adopted regulations requiring that medical devices comply with the Medical Device Directive by June 15, 1998, which includes ISO-9001 and CE certification. The Company's BVS currently has German MedGV approval but is not yet certified for ISO-9001 compliance. The Company is working to obtain ISO-9001 and independent CE certification for its BVS facility. There can be no assurance that the Company will obtain such certification in a timely manner, if at all. Unless ISO and CE certification are obtained, the Company's sale of the BVS into the European Union may be restricted. Many manufacturers of medical devices, including the Company, have often relied on foreign markets for the initial commercial introduction of their products. The more stringent foreign regulatory environment could make it more difficult, costly and time consuming for the Company to pursue this strategy for new products. Any FDA, foreign or state regulatory approvals or clearances, once obtained, can be withdrawn or modified. Delay in the Company obtaining, or inability of the Company to obtain and maintain, any necessary United States or foreign clearances or approvals for new or existing products or product enhancements, or cost overruns resulting from these regulatory requirements, would have a material adverse effect on the Company's business,our insurance coverage, our financial condition and results of operations. See "Business--Government Regulation." RELIANCEwill be adversely affected. WE HAVE DEPENDED ON GOVERNMENT CONTRACTS The CompanyTO SUPPORT A SIGNIFICANT PORTION OF OUR BASIC RESEARCH AND DEVELOPMENT. THIS FUNDING MAY NOT CONTINUE. We generally reliesrely on external funding for itsa significant portion of our basic product research and development, primarily throughdevelopment. The primary source of this external funding is government research contracts and grants. SuchWe have obtained this type of funding has been obtained for the initial development of most of the Company'sour current products and products under development. In particular, in September 1996, the Company wasNational Heart, Lung and Blood Institute, or NHLBI, awarded by the NHLBIus a four-year, $8.5 million extension to its TAH Contract, andour AbioCor development contract in September 1995 the Company was awarded1996, and a five-year, $4.3 million contract from the NHLBI for the development of the Company's Heart Booster.AbioBooster in September 1995. As of September 30, 1997, the Company's total backlog of government contracts and grants was $8.7 million. Such contracts and grants are not expected to be sufficient to commercialize the underlying products, and for certain products, including the TAH, the cost of product development in excess1999, we had recognized all of the revenue under the AbioCor development contract value is expected toand all but $1.1 million of the revenue under the AbioBooster contract. We have not determined whether we will seek additional government funding for the AbioCor or the AbioBooster, or new government funding for our other products under development. We cannot assure that any such funding will be significant. The Company's strategy is to continueavailable, if we decide to seek government contracts and grants to support development efforts.it. Funding for the Company'sall our government research and development contracts is subject to government appropriation, and all of these contracts contain provisions which make them terminable at the convenience of the government. There can be no assurance that theThe government will notcould terminate or reduce or delay the funding for any of our contracts at any time. In the Company'sevent that we are not successful in obtaining any new government contracts or further extensions to existing research and development contracts, our financial results could be adversely affected. OUR RIGHTS DISTRIBUTION, CERTIFICATE OF INCORPORATION AND DELAWARE LAW COULD MAKE IT MORE DIFFICULT FOR A THIRD PARTY TO ACQUIRE US AND MAY PREVENT OUR STOCKHOLDERS FROM REALIZING A PREMIUM ON OUR STOCK. Our rights distribution and provisions of our certificate of incorporation and of the Delaware General Corporation Law may make it more difficult for a third party to acquire us, even if doing so would allow our stockholders to receive a premium over the prevailing market price of our stock. Our rights distribution and those provisions of our certificate of incorporation and Delaware law are intended to encourage potential acquirors to negotiate with us and allow our board of directors the opportunity to consider alternative proposals in the interest of maximizing stockholder value. However, such provisions may also discourage acquisition proposals or delay or prevent a change in control, which could negatively affect our stock price. THE MARKET VALUE OF OUR COMMON STOCK COULD VARY SIGNIFICANTLY, BASED ON MARKET PERCEPTIONS OF THE STATUS OF OUR DEVELOPMENT EFFORTS. The perception of securities analysts regarding our product development efforts could significantly affect our stock price. As a result, the market price of our common stock could change substantially when we or our competitors make product announcements, particularly announcements relating to the 15 AbioCor or competing products. Many factors affecting our stock price are industry related and beyond our control. IF WE MAKE ACQUISITIONS, WE COULD ENCOUNTER DIFFICULTIES THAT HARM OUR BUSINESS. We may acquire companies, products or technologies that we believe to be complementary to our business. If we do so, we may have difficulty integrating the acquired personnel, operations, products or technologies. These difficulties may disrupt our ongoing business, distract our management and employees and increase our expenses, which could hurt our business. FUTURE SALES OF OUR COMMON STOCK COULD ADVERSELY AFFECT OUR STOCK PRICE. Future sales of substantial amounts of our common stock in the public market, including the shares covered by this prospectus, or the perception that these sales could occur, could adversely affect the market price of our common stock. As of December 1, 1999, we had outstanding 8,669,867 shares of common stock, plus 1,345,110 shares of common stock reserved for issuance upon exercise of outstanding options. All of the outstanding shares of our common stock are freely saleable except shares held by our affiliates, which are subject to certain limitations on sales. OUR MANAGEMENT WILL HAVE BROAD DISCRETION AS TO THE USE OF PROCEEDS OF THIS OFFERING. Our management will have broad discretion as to how the net proceeds of this offering will be used. Investors will be relying on the judgment of management regarding the application of the proceeds of this offering. The results and effectiveness of the application of the proceeds are uncertain. 16 USE OF PROCEEDS We estimate that the net proceeds to us from the sale of the 1,500,000 shares of common stock we are offering with this prospectus will be approximately $68.4 million, assuming a public offering price of $48.875 per share and after deduction of the estimated underwriting discounts and commissions and estimated offering expenses paid by us. See "Underwriting." We expect to use the net proceeds from this offering for funding of clinical trials for the AbioCor, continued research and development, expansion of our manufacturing capabilities, international sales and marketing and other general corporate purposes, including possible strategic acquisitions of businesses, products or technologies complementary to our business. We do not have any commitments to make any such acquisitions and have not allocated a specific amount of the net proceeds for this purpose. Pending such uses, we plan to invest the net proceeds of the offering in short-term, interest-bearing investment-grade securities. DIVIDEND POLICY We have never declared or paid cash dividends on our capital stock and do not plan to pay any cash dividends in the foreseeable future. Our current policy is to retain all of our earnings to finance future growth. PRICE RANGE OF COMMON STOCK Our common stock is traded on the Nasdaq National Market under the symbol "ABMD." The following table sets forth, for the periods indicated, the high and low sales prices per share of common stock, as reported by the Nasdaq National Market.
High Low Fiscal Year Ended March 31, 1998 ---------- ---------- First Quarter........................................... $16 $ 9 1/2 Second Quarter.......................................... 19 13 1/2 Third Quarter........................................... 23 1/2 15 1/2 Fourth Quarter.......................................... 17 5/8 12 7/8 Fiscal Year Ended March 31, 1999 First Quarter........................................... $17 1/2 $13 3/16 Second Quarter.......................................... 15 1/2 8 1/4 Third Quarter........................................... 11 3/8 7 Fourth Quarter.......................................... 13 3/8 8 1/4 Fiscal Year Ended March 31, 2000 First Quarter........................................... $18 $11 7/8 Second Quarter.......................................... 16 3/4 13 Third Quarter (through December 16, 1999)............... 59 3/8 15 1/4
The last reported sale price of the common stock on the Nasdaq National Market on December 16, 1999 was $48.875 per share. As of December 1, 1999, there were approximately 404 holders of record of our common stock, including multiple beneficial holders at depositories, banks and brokers listed as a single holder in the "street" name of each respective depository, bank or broker. 17 CAPITALIZATION The following table sets forth our capitalization as of September 30, 1999, on an actual basis, and on an as adjusted basis to reflect the receipt of the estimated net proceeds from the sale of 1,500,000 shares of common stock being offered under this prospectus at an assumed public offering price of $48.875 per share, after deducting estimated fees of the underwriters and estimated offering expenses that we will pay. The number of shares issued and outstanding shown in the table below excludes 1,361,385 shares of common stock reserved for issuance upon the exercise of stock options outstanding as of September 30, 1999 at a weighted average exercise price of $11.95 per share. See Note 7 to Consolidated Financial Statements.
AS OF SEPTEMBER 30, 1999 ------------------------ ACTUAL AS ADJUSTED ---------- ----------- (IN THOUSANDS) Long-term liabilities....................................... $ 159 $ 159 Stockholders' equity: Class B Preferred Stock, $.01 par value, 1,000,000 shares authorized; no shares issued and outstanding............ -- -- Common Stock, $.01 par value, 25,000,000 shares authorized; 8,657,742 shares issued and outstanding and 10,157,742 shares issued and outstanding as adjusted.... 87 102 Additional paid-in capital................................ 58,288 126,687 Accumulated deficit....................................... (35,042) (35,042) -------- -------- Total stockholders' equity.............................. 23,333 91,747 -------- -------- Total capitalization.................................. $ 23,492 $ 91,906 ======== ========
18 SELECTED CONSOLIDATED FINANCIAL DATA (IN THOUSANDS, EXCEPT PER SHARE DATA) We derived the consolidated statements of operations data for the fiscal years ended March 31, 1997, 1998 and 1999, and the consolidated balance sheet data as of March 31, 1998 and 1999, from the audited financial statements in this prospectus. Those financial statements were audited by Arthur Andersen LLP, independent public accountants. We derived the consolidated statement of operations data for the fiscal years ended March 31, 1995 and 1996, and the consolidated balance sheet data as of March 31, 1995, 1996 and 1997 from audited financial statements that are not included in this prospectus. We derived the consolidated statement of operations data for the six months ended September 30, 1998 and 1999, and the consolidated balance sheet data as of September 30, 1999 from unaudited financial statements included in this prospectus. These unaudited financial statements have been prepared on the same basis as the audited financial statements and, in our opinion, include all adjustments and reclassifications (consisting only of normal recurring adjustments and reclassifications) necessary to present fairly the financial condition and results of operations for the periods presented. The results for the six months ended September 30, 1999 are not necessarily indicative of the results that may be expected for the full year. You should read this data in conjunction with the financial statements and accompanying notes and with "Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing elsewhere in this prospectus.
SIX MONTHS ENDED FISCAL YEAR ENDED MARCH 31, SEPTEMBER 30, ---------------------------------------------------- ------------------- 1995 1996 1997 1998 1999 1998 1999 -------- -------- -------- -------- -------- -------- -------- STATEMENT OF OPERATIONS DATA: Revenues: Products................................... $6,392 $8,483 $10,872 $17,261 $18,079 $ 7,877 $ 7,615 Contracts.................................. 2,337 3,118 4,151 5,185 4,011 2,893 2,905 ------ ------ ------- ------- ------- ------- ------- Total revenues......................... 8,729 11,601 15,023 22,446 22,090 10,770 10,520 ------ ------ ------- ------- ------- ------- ------- Costs and expenses: Cost of product revenues................... 2,881 3,234 4,427 6,502 6,772 3,000 2,472 Research and development................... 2,464 3,178 3,773 9,091 13,450 6,984 6,842 Selling, general and administrative........ 3,831 5,051 6,082 9,054 9,772 4,538 5,410 ------ ------ ------- ------- ------- ------- ------- Total costs and expenses............... 9,176 11,463 14,282 24,647 29,994 14,522 14,724 ------ ------ ------- ------- ------- ------- ------- Income (loss) from operations................ (447) 138 741 (2,201) (7,904) (3,752) (4,204) Interest and other income, net............... 449 528 535 1,206 1,192 727 397 ------ ------ ------- ------- ------- ------- ------- Income (loss) from continuing operations..... $ 2 $ 666 $ 1,276 $ (995) $(6,712) $(3,025) $(3,807) Loss from discontinued operations............ (354) (175) (541) (1,513) -- -- -- ------ ------ ------- ------- ------- ------- ------- Net income (loss)............................ $ (352) $ 491 $ 735 $(2,508) $(6,712) $(3,025) $(3,807) ====== ====== ======= ======= ======= ======= ======= Income (loss) from continuing operations per diluted share.............................. $ 0.00 $ 0.10 $ 0.18 $ (0.12) $ (0.78) $ (0.35) $ (0.44) Loss from discontinued operations per diluted share.............................. (0.05) (0.03) (0.08) (0.19) -- -- -- ------ ------ ------- ------- ------- ------- ------- Net income (loss) per diluted share.......... $(0.05) $ 0.07 $ 0.10 $ (0.31) $ (0.78) $ (0.35) $ (0.44) ====== ====== ======= ======= ======= ======= ======= Weighted average diluted shares outstanding................................ 6,512 6,995 7,162 8,074 8,619 8,599 8,653 ====== ====== ======= ======= ======= ======= =======
AS OF MARCH 31, AS OF SEPTEMBER 30, ---------------------------------------------------- ------------------- 1995 1996 1997 1998 1999 1999 -------- -------- -------- -------- -------- ------------------- BALANCE SHEET DATA: Cash, cash equivalents and marketable securities................................. $ 4,491 $10,647 $ 9,361 $26,398 $18,181 $13,661 Working capital.............................. 6,341 12,745 12,858 29,284 22,144 18,547 Long-term investments........................ 6,533 -- -- -- -- -- Total assets................................. 14,631 16,066 18,373 38,755 32,982 29,659 Long-term liabilities........................ -- -- -- 64 205 159 Stockholders' equity......................... 13,305 13,945 15,225 33,018 27,072 23,333
For an explanation of the determination of the number of shares outstanding and per share data, see Note 1(h) to Consolidated Financial Statements. We did not declare or pay any cash dividends on our common stock during any of the periods presented. 19 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ALL STATEMENTS, TREND ANALYSIS AND OTHER INFORMATION CONTAINED IN THE FOLLOWING DISCUSSION RELATIVE TO MARKETS FOR OUR PRODUCTS AND TRENDS IN SALES, GROSS PROFIT AND ANTICIPATED EXPENSE LEVELS, AS WELL AS OTHER STATEMENTS, INCLUDING WORDS SUCH AS "MAY," "ANTICIPATE," "BELIEVE," "PLAN," "ESTIMATE," "EXPECT," AND "INTEND" AND OTHER SIMILAR EXPRESSIONS CONSTITUTE FORWARD-LOOKING STATEMENTS. THESE FORWARD-LOOKING STATEMENTS ARE SUBJECT TO BUSINESS AND ECONOMIC RISKS AND UNCERTAINTIES, AND OUR ACTUAL RESULTS OF OPERATIONS MAY DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN "RISK FACTORS" AS WELL AS OTHER RISKS AND UNCERTAINTIES REFERENCED IN THIS PROSPECTUS. OVERVIEW We are a leading developer, manufacturer and marketer of medical products designed to safely and effectively assist or replace the pumping function of the failing heart. We have been developing the AbioCor, a totally implantable, battery-powered, replacement heart which we believe will be the first such device for end-stage heart failure patients. We currently manufacture and sell the BVS, a temporary heart assist device which is the only device approved by the FDA as a bridge-to-recovery device for temporary treatment of all patients with failing but potentially recoverable hearts. Our operating results reflect the dual activities of commercial operations and investments in the research and development of new technologies. The BVS is a temporary heart assist device designed to assume the full pumping function of a patient's failing heart while allowing the heart to rest, heal and recover its function. The BVS consists of a pneumatic drive and control console, single-use external blood pumps and cannulae. All of our product revenues are currently derived from the BVS product line. BVS revenues are split between sales to new customers and reorders from existing customers. Following commercial introduction of the BVS in the U.S., our focus was on obtaining market share beginning with the largest medical centers. As of September 30, 1999, approximately 435 medical centers in the U.S. had purchased the BVS, including over 80% of all major medical centers that perform more than 500 heart surgeries annually. While continuing to seek additional new customers for the BVS, we have shifted our focus to emphasize increasing usage and product reorders by existing customers. Product reorders currently represent approximately half of BVS product revenues. During fiscal 1999 and the six months ended September 30, 1999, no single customer represented more than 5% of product revenues. Research and development is a significant portion of our operations. Our research and development efforts are focused on the development of new products, primarily related to heart assist and heart replacement, and the continued enhancement of the BVS and related technologies. Government contracts and grants have supported a portion of our research and development expenses in recent years. Our government-sponsored research and development contracts and grants generally provide for payment on a cost-plus-fixed-fee basis. We account for revenue under these contracts and grants as work is performed, provided the government has appropriated sufficient funds for the work. Revenues from contract research and development have fluctuated over the last three years and are dependent upon the availability of government contracts and grants to support our research and development efforts, the annual amount of funds that have been appropriated by the government, and the amount of work performed by us. At any time, the government can terminate, reduce or delay the funding for any of our contracts. In addition, we may not be successful in obtaining any new government contracts or further extensions to existing contracts. In fiscal 1998, we began using our own resources to fund the further development of the AbioCor in amounts significantly in excess of the funding provided under the $8.5 million, four-year, AbioCor development contract awarded to us from the NHLBI in 1996. We estimate that the development of 20 the AbioCor, including conducting pre-clinical and clinical trials and obtaining regulatory approvals, will require us to provide substantial additional funding. In fiscal 1999, we incurred $9.7 million in total research and development spending directed at the AbioCor, including $7.7 million, or $0.89 per share, in excess of the amount appropriated under our AbioCor development contract. Excluding these research and development expenses, our income from continuing operations for fiscal 1999 would have been approximately $1.0 million or $0.11 per share. RESULTS OF OPERATIONS The following table shows our statement of operations data expressed as a percentage of total revenues for the periods indicated:
FISCAL YEAR SIX MONTHS ENDED MARCH 31, ENDED SEPTEMBER 30, -------------------------------- -------------------- 1997 1998 1999 1998 1999 -------- -------- -------- -------- -------- Revenues: Products................................... 72.4% 76.9% 81.8% 73.1% 72.4% Contracts.................................. 27.6 23.1 18.2 26.9 27.6 ----- ----- ----- ----- ----- Total revenues........................... 100.0 100.0 100.0 100.0 100.0 ----- ----- ----- ----- ----- Costs and expenses: Cost of product revenues................... 29.5 29.0 30.7 27.9 23.5 Research and development................... 25.1 40.5 60.9 64.8 65.1 Selling, general and administrative........ 40.5 40.3 44.2 42.1 51.4 ----- ----- ----- ----- ----- Total costs and expenses................. 95.1 109.8 135.8 134.8 140.0 ----- ----- ----- ----- ----- Income (loss) from operations................ 4.9 (9.8) (35.8) (34.8) (40.0) Interest and other income, net............... 3.6 5.4 5.4 6.7 3.8 ----- ----- ----- ----- ----- Income (loss) from continuing operations..... 8.5% (4.4)% (30.4)% (28.1)% (36.2)% Loss from discontinued operations............ (3.6) (6.7) -- -- -- ----- ----- ----- ----- ----- Net income (loss)............................ 4.9% (11.2)% (30.4)% (28.1)% (36.2)% ===== ===== ===== ===== =====
SIX MONTHS ENDED SEPTEMBER 30, 1999 AND SEPTEMBER 30, 1998 PRODUCT REVENUES. Product revenues decreased by $0.3 million, or 3%, to $7.6 million in the six months ended September 30, 1999 from $7.9 million in the six months ended September 30, 1998. The decline in product revenues is primarily attributable to a reduction in unit sales of BVS systems sold to new customers partially offset by increased unit sales and increased average selling prices of BVS disposable blood pumps reordered by and sold to existing customers. We believe that the decline in sales to new customers was largely a result of a decision we made at the beginning of the current fiscal year to shift the focus of certain of our sales representatives from sales to new customers to increased support of existing customers in an effort to increase reorders of higher margin BVS blood pumps. Reorders of BVS blood pumps increased by 11% during the six months ended September 30, 1999 as compared to the same period of the prior year. Domestic sales accounted for 97% of total product revenues during the six months ended September 30, 1999, compared to 96% for the same period a year earlier. CONTRACT REVENUES. Contract revenues were $2.9 million during both the six months ended September 30, 1999 and September 30, 1998. Approximately $1.8 million of the contract revenues recognized in both periods was derived from our AbioCor government contract. The remaining $1.1 million in contract revenues recorded during the six months ended September 30, 1999 and September 30, 1998 was primarily derived from our AbioBooster contract and other government grants. 21 We account for contract revenues under our government contracts and grants as work is performed, provided that the government has appropriated sufficient funds for the work. Through September 30, 1999, the government has appropriated all of the $8.5 million AbioCor contract amount, including the $1.8 million appropriated and recognized as contract revenues during the quarter ended June 30, 1999. No amount remains to be recognized under the AbioCor government contract as of September 30, 1999. As of September 30, 1999, our total backlog of research and development contracts and grants was $2.7 million, including $1.1 million for AbioBooster research and development. Funding for our government research and development contracts is subject to government appropriation, and all of these contracts contain provisions that make them terminable at the convenience of the government. ABIOMED retains rights to all technological discoveries and products resulting from these efforts. Due to the nature of our research and development projects and the timing of government appropriations, we believe that we will continue to experience significant quarterly fluctuations in contract revenues. COST OF PRODUCT REVENUES. Cost of product revenues as a percentage of product revenues decreased to 32% in the six months ended September 30, 1999 from 38% in the six months ended September 30, 1998. The majority of this decrease in cost of products sold as a percentage of product revenues was attributable to higher average selling prices for BVS blood pumps during the six months ended September 30, 1999 as compared to the same period of the prior year and to an increase in the proportion of higher margin BVS blood pumps sold relative to lower margin BVS console sales. RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses decreased by $0.1 million, or 2%, to $6.8 million in the six months ended September 30, 1999, from $7.0 million in the six months ended September 30, 1998. Expenditures remained consistent at 65% of total revenues for each interim six month period. During the six months ended September 30, 1999, lower spending for the development of the AbioCor was offset by increased spending on new products and enhancements to the BVS. Research and development expenses during the six months ended September 30, 1999 included $4.7 million of expenses incurred in connection with our development activities for the AbioCor, as compared to $5.2 million for the same period of the prior year. We anticipate that AbioCor expenses will increase in coming fiscal quarters as materials are scheduled to be received in order for us to manufacture AbioCor systems for various testing purposes. SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses increased by $0.9 million, or 19%, to $5.4 million in the six months ended September 30, 1999, from $4.5 million in the six months ended September 30, 1998. Expenditures increased to 51% of total revenues from 42% of total revenues in the same period a year earlier. This increase is primarily attributed to increased selling and marketing expenditures as a result of our implementing new programs designed to improve sales of our disposable blood pumps, and increased legal expenses. INTEREST AND OTHER INCOME. Interest and other income consists primarily of interest earned on our investment balances, net of interest and other expenses. Interest and other income decreased by $0.3 million, or 45%, in the six months ended September 30, 1999 from $0.7 million in the six months ended September 30, 1998. This decrease was primarily attributed to lower average funds available for investment. NET LOSS. Net loss for the six months ended September 30, 1999 was approximately $3.8 million, or $0.44 per diluted share. This compares to a net loss of approximately $3.0 million, or $0.35 per diluted share, for the six months ended September 30, 1998. The losses for both six month periods are primarily attributable to development and pre-clinical testing costs associated with the AbioCor implantable replacement heart. 22 FISCAL YEARS ENDED MARCH 31, 1999 AND MARCH 31, 1998 PRODUCT REVENUES. Product revenues increased by $0.8 million, or 5%, to $18.1 million in fiscal 1999 from $17.3 million in fiscal 1998. This increase in product revenues in fiscal 1999 was primarily attributable to a $1.2 million, or 8%, increase in domestic product revenues. This was derived primarily from increased average selling prices of BVS disposable blood pumps offset by a decrease in international product revenues of $0.4 million. Sales of blood pumps in fiscal 1998 included approximately $1.0 million of reorder pump revenues shipped from backlog. We generally operate with only a limited backlog. Without the effect of the shipment from backlog in 1998, our domestic product revenues increased by $1.8 million, or 16%, in fiscal 1999. Domestic unit sales of BVS blood pumps decreased in fiscal 1999 compared to fiscal 1998 without adjustment for the effect of this backlog but increased if the effect of the backlog is considered. Domestic product revenues included approximately $2.7 million from sales-type leases in fiscal 1999 and $1.3 million in fiscal 1998. International revenues represented 3% of product revenues in fiscal 1999 and 6% in fiscal 1998. CONTRACT REVENUES. Contract revenues decreased by $1.2 million, or 23%, to $4.0 million in fiscal 1999 from $5.2 million in fiscal 1998. This decrease in contract revenues in fiscal 1999 was primarily attributable to the level of government appropriation and work performed by us on Phase II of the AbioCor government contract. We account for contract revenues under our government contracts and grants as work is performed, provided that the government has appropriated sufficient funds for the work. Through March 31, 1999, the government had appropriated $6.7 million of the $8.5 million Phase II AbioCor development contract amount. During fiscal 1999, our expenditures under the AbioCor development contract exceeded the appropriated amount. As a result, in fiscal 1999, we recognized as contract revenues all of the remaining $1.8 million of the $6.7 million appropriated under the AbioCor development contract and used $7.7 million of our own resources to fund AbioCor development. COST OF PRODUCT REVENUES. Cost of product revenues as a percentage of product revenues decreased to 37% in fiscal 1999 from 38% in fiscal 1998. The changes in cost of product revenues as a percentage of product revenues were primarily attributable to increased average selling prices and the mix of products sold. RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses increased by $4.4 million, or 48%, to $13.5 million in fiscal 1999 from $9.1 million in fiscal 1998. This increase is primarily the result of increased expenditures for labor, materials, and professional services related to development and testing of the AbioCor and enhancements to the BVS. We anticipate that our research and development expenses will continue to be significant and may increase as a result of our plans to further develop and test the AbioCor, enhancements to the BVS and other potential new products. SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses increased by $0.7 million, or 8%, to $9.8 million in fiscal 1999 from $9.1 million in fiscal 1998. The increase primarily reflected increased sales expenses, particularly increased personnel and sales commissions, related to the increase in product revenues, as well as additional administrative personnel and legal expenses. INTEREST AND OTHER INCOME. Interest and other income remained consistent at $1.2 million in both fiscal 1999 and fiscal 1998. DISCONTINUED OPERATIONS. Discontinued operations consist of the net revenues, costs and expenses of our dental subsidiary, ABIODENT. In fiscal 1998, we made the decision to shift all of our focus to our core cardiovascular business and to discontinue our dental business. The $1.5 million loss from discontinued operations for the year ended March 31, 1998 represents a loss from dental operations of $0.5 million, or $0.07 per diluted share, and an estimated loss on the disposal of the business, its assets 23 and extinguishment of liabilities of $1.0 million, or $0.12 per diluted share. In fiscal 1999, we incurred costs associated with the discontinuance of operations of $0.4 million, and wrote off remaining net assets totaling $0.3 million. As of March 31, 1999, a reserve of approximately $0.2 million remains as a contingency against additional costs associated with the discontinuation of the dental business. NET LOSS. Net loss for fiscal 1999 was approximately $6.7 million, or $0.78 per diluted share. This compares to a net loss of approximately $2.5 million, or $0.31 per diluted share, for fiscal 1998. The losses for both years are primarily attributable to development and pre-clinical testing costs associated with the AbioCor implantable replacement heart. FISCAL YEARS ENDED MARCH 31, 1998 AND MARCH 31, 1997 PRODUCT REVENUES. Product revenues increased by $6.4 million, or 59%, to $17.3 million in fiscal 1998 from $10.9 million in fiscal 1997. This increase in product revenues in fiscal 1998 was primarily attributable to growing U.S. unit sales of BVS single-use products, including increased blood pump reorders, growing U.S. unit sales of BVS consoles and to increased average selling prices of the BVS single-use products and BVS consoles. The majority of our product revenues in fiscal 1998 and 1997 has been to U.S. customers. International product revenues represented 6% of total product revenues in fiscal 1998 and 7% in fiscal 1997. CONTRACT REVENUES. Contract revenues increased by $1.0 million, or 25%, to $5.2 million in fiscal 1998 from $4.2 million in fiscal 1997. This increase in contract revenues in fiscal 1998 primarily reflected increased activity under the AbioCor government contract. Through March 31, 1998, the government had appropriated $4.9 million of the $8.5 million Phase II AbioCor contract amount. During fiscal 1998, our expenditures under the AbioCor contract exceeded the appropriated amount. As a result, in fiscal 1998, we recognized as contract revenues all of the remaining $3.2 million of the $4.9 million appropriated under the AbioCor contract and used $4.3 million of our own resources to fund AbioCor development. COST OF PRODUCT REVENUES. Cost of product revenues as a percentage of product revenues decreased to 38% in fiscal 1998 from 41% in fiscal 1997. The changes in cost of product revenues as a percentage of product revenues were primarily attributable to the mix of products sold with a higher proportion of product revenues derived from BVS blood pumps in fiscal 1998 as compared to fiscal 1997. The higher fiscal 1997 cost of product revenues as a percentage of product revenues also included costs related to the Company's voluntary recall in fiscal 1997 of certain production lots of disposable BVS blood pumps. RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses increased by $5.3 million, or 141%, to $9.1 million in fiscal 1998 from $3.8 million in fiscal 1997. This increase primarily reflected a higher level of development activity related to the AbioCor. SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses increased by $3.0 million, or 49%, to $9.1 million in fiscal 1998 from $6.1 million in fiscal 1997. This increase primarily reflected increased sales expenses, particularly increased personnel and sales commissions, related to the increase in product revenues, as well as additional administrative personnel and legal expenses. INTEREST AND OTHER INCOME. Interest and other income increased by $0.7 million, or 125%, to $1.2 million in fiscal 1998 from $0.5 million in fiscal 1997. This increase primarily reflects the Company's higher average investment balances. NET LOSS. Net loss for fiscal 1998 was approximately $2.5 million, or $0.31 per diluted share. This compares to net income of approximately $0.7 million, or $0.10 per diluted share, for fiscal 1997. The 24 loss for fiscal 1998 was primarily attributable to research and development costs associated with the AbioCor implantable replacement heart. LIQUIDITY AND CAPITAL RESOURCES We have supported our operations with net revenues from sales of our BVS product line, government contracts and proceeds from our equity financings. As of September 30, 1999, our cash, cash equivalents and short-term marketable securities total $13.7 million. We also have a $3 million line of credit from a bank that expires on October 13, 2000, which bears interest at the bank's prime rate (8.25% at September 30, 1999), and a term loan facility from the same bank, which also bears interest at the bank's prime rate, that permits us to borrow up to $1.2 million through March 31, 2000 for the acquisition of manufacturing equipment and leasehold improvements. Both the line of credit and the term loan facility were entirely available as of September 30, 1999. During the six months ended September 30, 1999, operating activities used $3.4 million of cash. Net cash used by operating activities during this period resulted from a net loss of $3.8 million and increases in accounts receivable, inventory, and prepaid expenses of $0.5 million, $0.7 million and $0.2 million, respectively. It also resulted from decreases in accrued expenses of $0.4 million. These uses of cash were partially offset by increases in accounts payable of $0.9 million and noncash charges for depreciation and amortization of $1.3 million included in the net loss. The increase in inventory is primarily attributable to lower than planned product sales. During fiscal 1999, operating activities used $7.4 million of cash. Net cash used by operating activities in fiscal 1999 reflected a net loss of $6.7 million, including depreciation and amortization expense of $1.4 million, an increase in accounts receivable of approximately $1.1 million, increases in inventory, prepaid expenses and other current assets of approximately $0.6 million each, and a decrease in accounts payable of approximately $1.2 million. These uses of cash were partially offset by an increase in accrued expenses of approximately $1.9 million. The increase in accounts receivable was primarily attributable to increased revenues and extended collection periods for certain accounts. The increase in inventory reflects increased production levels and our decision to increase inventory levels for certain products and component parts. The decrease in accounts payable is primarily attributed to the timing of purchases of direct material and capital equipment for manufacturing, research and development. The increase in accrued expenses reflects timing of payments and increased operating activity throughout ABIOMED, including increased size of payroll and payroll related costs. During the six months ended September 30, 1999, investing activities used $0.8 million of cash. Cash used in these activities included purchases of capital equipment and expenditures for leasehold improvements of $1.2 million. In January 1999, we entered into an operating lease for approximately 80,000 square feet of space in a building addition currently under construction within the same industrial park as our current facilities. We began occupying this facility in fiscal 2000, and we expect to complete our phased move into this facility in fiscal 2001. We plan to use this new facility to expand our headquarters, manufacturing and research and development. In particular, we intend to move all of the manufacturing of our current products to the new facility. We anticipate that we will incur additional costs of approximately $1.0 million for improvements to this new facility, including costs to construct and qualify manufacturing clean rooms and costs for internal information and telephone systems and furniture. These capital expenditures were partially offset by $0.4 million of cash provided from the sale of short-term marketable securities, net of purchases of similar securities. During fiscal 1999, investing activities provided $13.3 million of cash. Net cash provided by investing activities included $14.8 million of sales of short-term marketable securities, net of short-term marketable securities purchased during the year, and $1.6 million of purchases and improvements of property and equipment. 25 During the six months ended September 30, 1999 and during fiscal 1999, financing activities provided $0.1 million and $0.8 million of cash, respectively, related to the exercise of stock options and stock issued under the employee stock purchase plan. Income taxes incurred during each of the periods presented were not material, and we continue to have significant net tax operating loss and tax credit carryforwards. We believe that the net proceeds of this offering, together with our existing resources and our revenue from government contracts and product sales, will be sufficient to fund our planned operations, including the planned increases in our internally funded AbioCor and new BVS development and product extension efforts, for the foreseeable future. However, we may require significant additional funds in order to complete the development, conduct clinical trials, and achieve regulatory approvals of the AbioCor and other products under development over the next several years. We may also need additional funds for possible future strategic acquisitions of businesses, products or technologies complementary to our business. If additional funds are required we may raise such funds from time to time through public or private sales of equity or from borrowings. YEAR 2000 READINESS DISCLOSURE As the year 2000 approaches, it is generally anticipated that computers, software and other equipment utilizing microprocessors may be unable to function properly. We have evaluated this potential issue with respect to our products, our financial and management information systems and our suppliers. With respect to our products, the software controlling the BVS drive console includes internal counters, but the BVS operation is not related in any way to a specific calendar date. Accordingly, we believe that the BVS will not need any repair or modification with regard to the year 2000 issue. With respect to our financial and management information systems, we successfully installed and tested a year 2000 upgrade to our primary system and have completed an assessment of all personal computers and installed applications. All significant systems have been upgraded or replaced where necessary. Expenditures for new personal computers, software applications, and operating systems under our year 2000 plan have amounted to less than $100,000, with no significant costs remaining. We sought assurances of year 2000 compliance from key suppliers and we have increased safety stocks of materials inventory where a prolonged loss of material deliveries would have an adverse impact on our business, financial condition and results of operations. We have also made inquiries to assess key service providers such as financial institutions, our payroll service provider, and our retirement plan administrator as to their year 2000 readiness and have received assurances that the vendors' critical systems have been updated, tested, and found to be compliant. Although we do not expect year 2000 issues to have a material impact on our business or future results of operations, there can be no assurance that there will not be interruptions of operations or other limitations of system functionality or that we may incur significant costs to avoid such interruptions or limitations. To the Companyextent that we can not eliminate all year 2000 issues, the most reasonably likely worst case year 2000 scenario is systemic failures beyond our control, such as a prolonged telecommunications or electrical failure, or a general disruption in supplies and services provided to us which could have a material adverse effect on our business, results of operations and financial condition. 26 BUSINESS OVERVIEW ABIOMED is a leading developer, manufacturer and marketer of medical products designed to safely and effectively assist or replace the pumping function of the failing heart. Based on technology that has been developed and refined over a period of approximately three decades, we have been developing and are preparing to enter human clinical trials for the AbioCor Implantable Replacement Heart, a battery-powered totally implantable replacement heart system, which we believe will be the first such device for end-stage heart failure patients. We currently manufacture and sell the BVS-5000, a temporary heart assist device, which is the only device approved by the U.S. Food and Drug Administration, known as the FDA, for the temporary treatment of all patients with failing but potentially recoverable hearts. We are also engaged in research and development relating to other devices to support the pumping function of the heart. The AbioCor is intended as a replacement device that will replace a patient's diseased heart and take over its blood pumping function. It is designed for use by patients with irreparably damaged hearts who are at risk of imminent death due to heart disease, but whose other vital organs remain viable. We believe the AbioCor will provide a much-needed treatment option for approximately 125,000 patients per year in the U.S. for whom there is currently no effective therapy available. The AbioCor has reached an advanced stage of pre-clinical testing, including substantial laboratory and animal testing. We have selected surgical teams from five leading U.S. medical centers to perform initial human clinical trials. Subject to completing final testing and securing regulatory approvals, we expect to commence clinical trials for the AbioCor for certain patient populations by the end of the year 2000. We anticipate that we will sell AbioCor systems, if and when approved by applicable U.S. and international regulatory authorities, for approximately $75,000 to $100,000 each, subject to the establishment of reimbursement levels by third-party payors. We are committed to the clinical introduction of the AbioCor and, to date, we have invested more than $40 million in its development, including over $20 million in funding from the National Heart, Lung and Blood Institute. In 1997, we decided that the design of the AbioCor demonstrated sufficient functionality and operational performance, through laboratory and animal studies, to warrant accelerated development efforts to bring the product to market. The BVS is a "bridge-to-recovery" device that can temporarily assume the full pumping function of the heart for patients with potentially reversible heart failure. In 1992, the BVS became the first heart assist device capable of providing full circulatory support to be approved by the FDA. The BVS is the most widely used FDA-approved temporary heart assist device, and to date has been used to support over 3,000 patients at over 500 medical centers worldwide. The BVS, which consists of a console and single-use external blood pumps, has been a profitable product line since fiscal 1995. We are pursuing several strategies to continue the growth of the BVS product line, including implementing new market strategies, developing new products and seeking to expand the indications for which the BVS may be used. We believe our experience in developing, manufacturing and selling the BVS will provide us with a competitive advantage in commercializing the AbioCor, as well as other future products. Our focused research and development related to the AbioCor and the BVS has provided us with the proprietary technology, know-how and experience to develop additional products. We believe we are the only company in the world with expertise in the full range of technology to support the pumping function of the heart. We believe that there are many opportunities to apply our expertise to address the needs of heart failure patients. We seek to be first to market with high-quality, easy-to-use and cost-effective technologies for heart failure patients who currently lack adequate therapies. 27 INDUSTRY OVERVIEW THE HUMAN HEART The following diagram illustrates the general structure of the human heart: [DIAGRAM OF THE HUMAN HEART APPEARS HERE, DEPICTING THE LEFT AND RIGHT ATRIA AND THE LEFT AND RIGHT VENTRICLES, THE CORONARY ARTERIES AND THE VALVES OF THE HEART.] The human heart is the central pump for the circulatory system. The heart has four chambers: the left and the right atria and the left and the right ventricles. The two atria serve as the inflow chambers of the heart, collecting blood for delivery to the ventricles. The ventricles are the pumping chambers of the heart, pumping blood to the lungs and the rest of the body. The right ventricle of the heart pumps oxygen-depleted blood returning from the body to the lungs where it is re-oxygenated. The left ventricle receives oxygen-rich blood returning from the lungs and pumps it back to the rest of the body. The chambers of the heart are formed of muscle tissue known as myocardium. The coronary arteries, a specialized network of blood vessels within the heart, provide oxygen and other nutrients to the heart itself. The human heart has four valves that help ensure that blood flows in the proper direction into and out of the ventricles as they are repeatedly filled and then discharged with the pumping of blood. The timing and rate at which the heart beats, referred to as its rhythm, is controlled by electrical impulses in the conduction system of the heart. HEART DISEASE Heart disease is the number one cause of death in the U.S., responsible for more deaths than all forms of cancer combined. In 1996, approximately 20 million people in the U.S. were afflicted with heart disease, resulting in over 700,000 deaths. Illnesses and deaths from heart disease create an immense burden to many individuals and their families. Patients frequently experience extended suffering, and the economic cost is substantial. While a number of therapies exist for the treatment of patients in early stages of heart disease, limited therapies exist today for most patients with severe heart failure. The majority of deaths from heart disease can be attributed to coronary heart disease, or CHD, and congestive heart failure, or CHF. Other types of heart disease include rhythm disorders and diseases of the valves. 28 CHD is a disease of the coronary arteries which affects blood flow to the heart. CHD can lead to a heart attack, technically known as an acute myocardial infarction, caused by insufficient blood flow to the heart and oxygen deprivation, resulting in permanent damage to the heart muscle and, in many cases, death. When CHD leads to a severe heart attack, some patients experience cardiac arrest, which is an acute stoppage of the heart, and sudden death. For other patients, medical personnel typically have a period of hours in which to intervene effectively. Once stabilized by early intervention, a significant number of these patients experience progressive deterioration of heart function, eventually leading to death over a period of days or weeks. CHF is a condition in which the patient's heart cannot provide adequate blood and oxygen flow to meet the needs of the body. CHF develops over time primarily due to excess demand on the heart muscle, and may be caused by a variety of factors, including high blood pressure, problems with the valves of the heart, CHD, infections of the heart muscle or the valves and heart problems present at birth. A progressive deterioration of heart function generally accompanies CHF as the heart becomes swollen and less effective at pumping blood. For most patients with CHF, medical interventions take place over periods of months or years. Medical conditions associated with both CHD and CHF can lead to cardiac arrest. Cardiac arrest is often a result of abnormalities in the heart's electrical conduction system. These abnormalities, known as rhythm disorders, can lead to complications, ranging from unsynchronized contractions and irregular heartbeats to cardiac arrest. Patients who experience cardiac arrest and die are referred to as sudden deaths. Most cardiac arrests that occur outside the hospital result in sudden death. Patients experiencing cardiac arrest generally require initial medical intervention, such as cardiopulmonary resuscitation, commonly known as CPR, and advanced life support, within minutes. In general, heart failure is progressive. While approximately half of all heart failure patients experience sudden death as a result of cardiac arrest, the remaining patients who die from heart failure typically do so in hospitals or long-term care facilities. PREVALENCE AND MORTALITY The number of patients both suffering and dying from heart disease has been rising on an annual basis. In 1996 there were approximately 12 million people with CHD and 4.6 million people with CHF in the U.S., with at least the same incidence outside the U.S. Heart disease resulted in over 700,000 deaths in 1996 in the U.S. Approximately half of all deaths from heart disease were sudden deaths. Of the deaths that did not occur suddenly, approximately 230,000 were associated with CHD and 25,000 with CHF. Current therapies to support these patients are inadequate because they cannot stop the progression of the disease. We believe that a significant number of such CHD and CHF patients could benefit from the AbioCor Implantable Replacement Heart. During 1997 in the U.S., the cost associated with CHD patients was approximately $100 billion and the cost associated with CHF patients was approximately $21 billion. Patients who suffer from heart disease often receive medical treatment for a number of years prior to their deaths. Many late-stage heart failure patients are confined to hospital beds, at a cost that is often greater than $2,000 per day. THERAPIES FOR HEART DISEASE Patients with early- or mid-stage heart disease typically receive treatments such as drug therapies, cardiological interventions, including closed chest procedures and rhythm management therapies, or surgical corrections, such as coronary bypass surgery and valve replacement. For patients with mid-stage and particularly end-stage heart disease, however, these treatments are typically inadequate. Patients with severe heart disease frequently are in need of heart replacement. Because the supply of available donor hearts is limited, with only approximately 2,000 per year available in the U.S., mechanical treatments have been and continue to be developed to extend and improve the lives of these patients. 29 MECHANICAL HEART TREATMENTS Mechanical heart treatments can be divided into two groups of devices: destination therapies, including heart replacement and permanent heart assist, and temporary heart assist. The following table summarizes the principal mechanical heart treatments that are currently in various stages of commercialization or development.
INTENDED PRIMARY PATIENT DURATION OF POPULATIONS SUPPORT CLINICAL STATUS ----------------------- ----------- ----------------------- DESTINATION THERAPY - ----------------------- HEART REPLACEMENT Replacement of End-stage CHD and CHF For life In pre-clinical testing Ventricular Function patients PERMANENT HEART ASSIST Quality of Life Mid-stage CHF patients For life Various stages--none Support not at risk of imminent approved death Ventricular Assist End-stage CHF patients For life In clinical whose diseased hearts trials--none approved can benefit from a ventricular assist device TEMPORARY HEART ASSIST - ------------------------------------------------ BRIDGE-TO-RECOVERY Surgical Origination Patients with Days/Weeks In market complications in connection with heart surgery Cardiology Referrals Patients experiencing Days/Weeks In market viral infections of the heart, or certain heart attacks BRIDGE-TO-TRANSPLANT End-stage heart failure Months In market patients who are candidates for a donor heart STAGING Patients being Days/Weeks Limited market evaluated for use pending longer-term device development of support and patients in destination need of heart support therapies while other therapies are applied
DESTINATION THERAPY. Devices intended to remain in patients for their remaining lives are classified as destination therapies. Destination therapy devices consist of replacement hearts and permanent assist devices, including quality-of-life support devices that provide partial support to the heart. Heart Replacement. The goal of heart replacement, whether with a donor heart or a mechanical device, is to replace the failing human heart with a viable alternative. Patients with irreparably damaged hearts who are facing imminent death due to CHD or severe CHF are potential candidates for heart replacement provided that their other vital organs remain viable. The supply of human donor hearts is currently inadequate to meet the needs of these patients and no mechanical treatment is yet approved for these patients. 30 In the U.S., we believe that approximately 125,000 patients per year might benefit from an implantable replacement heart with an approximately equal number of patients outside the U.S. who might also benefit from an implantable replacement heart. Patients who are likely candidates for an implantable replacement heart are end-stage CHD and CHF patients. In the U.S. in 1996, approximately 470,000 people died of CHD and approximately 44,000 people died of CHF. Because approximately half of these CHD and CHF patients suffered sudden death, which frequently occurs out of the hospital and before medical care can be received, the primary potentially addressable market for a replacement heart in the U.S. consists of approximately 250,000 patients per year. Some of these patients may have other conditions likely to lead to death within a relatively short period of time, or may be of an age at which major surgery is deemed inadvisable, making them unsuitable candidates for a replacement heart. Excluding such patients, we believe that approximately 125,000 CHD and CHF patients per year could benefit from a replacement heart in the U.S. Currently, no life-sustaining treatment is available for these patients except for a limited supply of qualified donor hearts for transplantation, consisting of approximately 2,000 hearts per year in the U.S. In addition, many recipients of heart transplants eventually reject the donor heart and have no other currently available long-term treatment options. In addition to the scarcity of donor hearts, there are various other limitations associated with human heart transplantation. These limitations include incompatibility between recipient patients and their donor hearts and the need for patients to take immuno-suppressant drugs for the remaining term of their lives. Immuno-suppressant drugs are expensive and can increase the patient's exposure to illness. Patients may also require costly care and experience extended periods of illness with impaired quality of life while waiting for a suitable donor heart. As the health of a patient typically deteriorates over a number of hours, days or weeks, many patients will die while waiting for a suitable donor heart. In addition, patients who are awaiting a donor heart generally require extensive tests and hospital time, which result in substantial expense. We believe that a mechanical replacement heart would increase the number of lives saved by mitigating the consequences of the scarcity of available donor hearts. In addition, a significant portion of heart transplant patients must endure a long waiting period before a suitable donor heart is identified, if at all. The development of an implantable mechanical heart could help alleviate this long and difficult wait. Permanent Heart Assist. Permanent assist devices are being developed to supplement the function of the diseased heart or to stop or slow the progression of the disease, while leaving the diseased heart in place. These devices contrast with replacement hearts, which are intended to replace a severely and irreversibly damaged heart. No permanent heart assist device is yet approved by the FDA, but a number of companies are developing permanent heart assist devices, some of which are in clinical trials. Permanent assist devices under development can be grouped into two categories: those that pump blood directly, known as ventricular assist devices or VADs, and less invasive devices that are intended to provide patients with an improved quality of life. The less invasive, quality-of-life devices include those that wrap around the heart, either to help the heart pump blood or to inhibit deterioration of the heart by preventing its further enlargement, and those that attempt to synchronize the actions of the heart ventricles with electrical impulses. We believe that all types of permanent heart assist devices potentially may be used to treat certain CHF patients who are near death as well as those patients who are not at imminent risk of death but whose daily activities are significantly restricted due to their weakened hearts. VADs, the more invasive of the two categories, may prove the most appropriate permanent heart assist devices for certain end-stage CHF patients. Implantable VADs are intended primarily for patients with severe left ventricular failure. We believe that VADs are being primarily developed for CHF patients and that VADs would not be appropriate for long-term support of the majority of heart failure patients, such as those with massive heart damage, severe rhythm disorders, blood clots in the 31 ventricles, severe lung disease, ventricular rupture, chronic right ventricle failure or heart transplant rejection. Heart wrap devices as well as electrical stimulation devices may prove more appropriate than VADs for the larger number of patients with early and mid-stage CHF because they are expected to be less invasive and pose fewer risks. These devices can be referred to as "quality-of-life support devices." We estimate that approximately 200,000 patients per year who are suffering from CHF but who are not at imminent risk of death might benefit from quality-of-life support devices. TEMPORARY HEART ASSIST. Candidates for temporary heart assist devices include patients with severe but potentially reversible heart failure and patients whose hearts need help pumping blood while they await transplantation or other therapies. Temporary heart assist devices typically consist of a specialized pump that is attached to a patient's heart and driven by a console or external battery pack. Such devices are intended to be removed from a patient's body once the patient's heart has had the opportunity to recover its normal function or the heart is replaced. Temporary heart assist devices can be grouped into three categories: Bridge-to-recovery. Bridge-to-recovery devices are used to support the recovery of patients with reversibly failing hearts. These devices are most frequently used to support patients whose hearts do not fully restart following open heart surgery, and who cannot be weaned off the heart-lung machine. Of the patients who experience such complications, approximately 12,000 die each year despite available therapies. Bridge-to-recovery devices temporarily assume the pumping function of the heart, while allowing the heart to rest, heal and recover its normal function. These devices can also be used for patients who have not undergone surgery but whose lives are threatened by viral infections that attack the heart muscle. In addition, bridge-to-recovery devices may prove beneficial to certain patients who have suffered from a recent heart attack. Bridge-to-transplant. Bridge-to-transplant devices are used to support patients who have experienced heart disease and are awaiting heart transplantation. We believe that the market for this category of device may be limited by the availability of qualified donor hearts. Staging. Staging devices are used to support patients before or during application of other therapies and to support patients with failing hearts being transported to other facilities. At present, for reasons of specialized care, patients are transported between medical centers with the assistance of such devices under practice of medicine guidelines. In the future, staging devices may be used to support heart failure patients prior to implantation of a permanent heart assist device or a heart replacement. These devices could help stabilize the patient and provide the medical team with time to better assess the patient's condition before selecting an appropriate therapy. In addition, while bridge-to-recovery devices are approved and used today to assist heart transplant patients when rejection occurs, in the future staging devices may be used with transplant patients who have rejected their donor heart and need life support before receiving a mechanical heart replacement. ABIOMED OVERVIEW ABIOMED is a leading developer, manufacturer and marketer of medical products designed to safely and effectively assist or replace the pumping function of the failing heart. Based on technology that has been developed and refined over a period of approximately three decades, we have been developing and are preparing to enter human clinical trials for the AbioCor Implantable Replacement Heart, a battery-powered totally implantable replacement heart system, which we believe will be the first such device for end-stage heart failure patients. We currently manufacture and sell the BVS-5000, a temporary heart assist device. The BVS is the only device approved by the FDA through its pre-market approval process for the temporary treatment of all patients with failing but potentially recoverable hearts and the most widely used FDA-approved temporary heart assist device. We are also engaged in research and development relating to other devices to support the pumping function of the heart. 32 ABIOMED'S STRATEGY Our goal is to be a leading worldwide provider of medical products that address the needs of a wide range of patients suffering from heart failure and other heart disorders. Our principal emphasis is on the heart assist and heart replacement markets. The following are key elements of our strategy: PERFORM CLINICAL TRIALS AND OBTAIN REGULATORY APPROVAL FOR THE ABIOCOR. We are planning to conduct phased human clinical trials for the AbioCor tailored to patient populations with different life expectancies, beginning with patients with the most severe medical needs and at risk of imminent death. We believe that the nature of the AbioCor and the patient populations that we plan to address initially will allow us to pursue an expedited regulatory review. We are currently performing reliability tests and animal tests of the AbioCor, and we have begun to submit materials to regulatory authorities in support of our plans for clinical trials. Subject to successful completion of final testing and securing regulatory approvals, we anticipate that by the end of 2000 the AbioCor will become the first totally implantable replacement heart to commence human clinical trials. COMMERCIALIZE FIRST TOTALLY IMPLANTABLE REPLACEMENT HEART. We are developing the AbioCor with the goal of providing a treatment option for thousands of patients with irreparable heart damage whose lives cannot be saved with existing medical technology. Our goal is to introduce the AbioCor as soon as possible and to use our clinical experience to regularly improve the product and expand the categories of patients who might benefit from this new technology. We believe that, as the technology matures, permanent heart replacement, and not heart assist devices, will be the preferred therapy for long-term support of the majority of end-stage heart failure patients, who currently have no long-term treatment available if they do not receive one of the limited number of qualified donor hearts available for transplantation. We believe the AbioCor has the potential to provide a cost-effective means of extending the lives of many of these patients and providing them with an improved quality of life. LEVERAGE OUR EXPERIENCE AND INFRASTRUCTURE TO COMMERCIALIZE THE ABIOCOR. In developing, manufacturing and marketing the BVS, we have accumulated significant experience and established an infrastructure that we intend to utilize in obtaining the necessary regulatory approvals and to support the commercialization of the AbioCor. We have experience working with regulatory authorities and leading medical centers and physicians throughout the world to perform clinical trials and obtain regulatory approvals. We have over 10 years of manufacturing experience, and we have obtained ISO 9001 certification for our BVS manufacturing facility. Our sales, clinical support, marketing and field service teams consist of 38 full-time employees, who currently work with over 500 customers worldwide. We believe that our experience and infrastructure position us well to commercialize the AbioCor, as well as other future products and product enhancements. EXPAND MARKETS AND PENETRATION FOR EXISTING BVS PRODUCT LINE. The BVS was the first temporary heart assist device capable of assuming the full pumping function of the heart to be approved by the FDA. The BVS is the most widely used FDA-approved temporary heart assist device. We are pursuing several strategies to continue the growth of the BVS product line, including implementing new market strategies, developing new BVS products and seeking to expand the indications for which the BVS may be used. While we continue our efforts to add new customers, we have increased our marketing focus on expanding BVS usage by existing customers and increasing customer reorders of disposable blood pumps. We are also seeking to expand our international presence and are recruiting direct sales and support teams for selected countries in Europe while pursuing regulatory approval in Japan through a third-party distributor. We are currently developing a number of new devices for the BVS product line, which we expect to introduce over the next several years. Since initial FDA approval, the BVS has twice received approvals for expanded indications for its use, and we are continuing to evaluate additional potential uses of the device to save patients' lives. 33 DEVELOP OR ACQUIRE COMPLEMENTARY PRODUCTS. We believe that we are well positioned to develop new products that are complementary to the AbioCor and BVS. We employ over 100 engineers, physicians, scientists and technicians who are experienced in the development of new products and have a broad range of expertise. We have also developed substantial proprietary technology and know-how as a pioneer in heart assist and heart replacement technology and have been granted a number of patents. This technology and know-how spans a broad range of topics, including expertise in the safe and effective pumping of blood. We believe there is no other company in the world with as much expertise in the full range of technology to support the pumping function of the heart. We also plan to evaluate opportunities to acquire complementary products from third parties, and to license or sell technologies that we are not commercializing. We intend to acquire or develop high quality products which address markets which are complementary to those being targeted by the AbioCor and BVS, products which are best of class and, where possible, products which can be first to market for particular patient needs. PREPAREDNESS FOR INITIAL HUMAN CLINICAL TRIALS Development of the technological foundation for the AbioCor has been a significant focus of ABIOMED since we were founded in 1981. Development and testing of the core technology for the AbioCor was underway prior to our founding. Beginning in 1997, we substantially increased our research and development activities for the AbioCor with the goal of accelerating its development in order to enter clinical trials as early as possible. We decided to significantly increase our investment in the AbioCor after determining that the AbioCor prototypes then produced had shown sufficient functionality through laboratory and animal tests to warrant an accelerated product development effort. The increased spending has been used to build a pilot-scale manufacturing facility, to develop the product from a research-based prototype status to a manufacturable clinical design, to increase system safety and efficacy by making engineering improvements and refinements, to increase operational performance, durability and reliability, to substantially expand laboratory and animal testing of the system, and to begin training of surgical and clinical support teams in selected medical centers for the initial clinical trials. In addition, in late 1996 we began to increase our interaction with regulatory authorities by presenting to them different portions of our developmental status and testing plans. To accomplish these tasks, we have significantly increased the team of engineers, scientists, physicians and technicians working full time on the AbioCor program to more than 70 full-time employees. Our goal is to initiate human clinical trials of the first generation of clinical AbioCor systems by the end of the year 2000. Subject to regulatory approval, we plan to begin initial clinical trials with patients who, despite all available therapies, have extremely high probability of death in the near term due to acute heart failure. Examples of such patients include heart transplant recipients who are rejecting their donor hearts, surgical patients placed on bi-ventricular cardiac assist but whose hearts fail to recover, and hospitalized patients who are facing imminent death following massive heart attacks. We believe that by initially selecting those patients who have no other treatment alternative, we will have the opportunity to obtain regulatory approval to conduct clinical trials based upon the successful completion of ongoing and planned laboratory and animals tests. As we gain clinical experience with the most seriously ill patients and demonstrate clinical efficacy and safety, we expect to continuously enhance the performance range, durability and reliability of AbioCor systems and plan to seek regulatory approval for subsequent generations of the AbioCor for use in increasingly broad patient populations. This regulatory plan is consistent with our experience with the BVS system. Our BVS product, which has now supported thousands of patients, was originally approved by the FDA for post-cardiotomy support on the basis of data from less than half of the approximately 75 patients who were enrolled in the clinical trials and who were suffering life-threatening conditions for which no alternative treatment existed. Our plan for AbioCor clinical trials draws upon our experience with the BVS. 34 STEPS TO INITIAL CLINICAL TRIALS. Prior to the commencement of initial clinical trials for the AbioCor, we must successfully complete the following tasks: MANUFACTURING QUANTITIES OF CLINICAL-CONFIGURED SYSTEMS FOR PRE-CLINICAL TESTING AND FOR CLINICAL TRIALS. Since our pilot AbioCor manufacturing facility became operational in 1997, we have produced more than 100 AbioCor systems and many more individual critical components such as valves and pumping membranes, which have been used for performance evaluation, developmental activities, laboratory reliability testing, and animal implantation tests. We are currently manufacturing more than 50 systems in the configuration intended for use in pre-clinical tests and, subject to regulatory approvals, initial clinical trials. While we plan to continue to produce sufficient quantities of AbioCor systems in our existing facilities to meet our needs for the year 2000, including those needed for initial clinical trials, we are currently building new expanded facilities in anticipation of increased demand. ADDITIONAL PRE-CLINICAL AND ANIMAL TESTS TO DEMONSTRATE DEVICE PREPAREDNESS FOR CLINICAL TRIALS. We have performed component and limited system-level testing of the AbioCor to evaluate operational performance and durability. During 1998, we began formal pre-clinical durability and reliability growth testing of the AbioCor system, consistent with protocols that we believe will be required by regulatory authorities for approval to conduct initial clinical trials. We have also conducted and have continued extensive accelerated testing of the valves and flexing membranes that are critical components of the AbioCor ventricles. Additional tests that remain include completing laboratory performance tests similar to those already conducted using larger numbers of clinical-configured systems for increasing duration. We have conducted approximately 100 animal tests at various stages of development of the AbioCor technology. Approximately half of these were research studies of various configurations and at various stages of development. In the past two years we have implanted AbioCor systems in approximately 40 calves. The most recent series of implants included more than 10 routine tests of the full system as a trial run at one medical center in preparation for similar implantations that we believe will need to be repeated for the same duration but under more formal test protocols consistent with regulatory requirements. The results of these studies in calves have shown that all implanted components are well tolerated and the AbioCor is capable of effectively replacing the heart of a calf. Following AbioCor heart replacement, the calves typically grow normally and perform normal physical functions, including treadmill exercises. Vital physiological parameters typically return to normal pre-operative levels within one week after the implantation. READINESS TRAINING OF THE SELECTED INITIAL MEDICAL CENTERS TO DEMONSTRATE TEAM PREPAREDNESS. In preparation for initial clinical trials, we have selected five U.S. medical centers as initial test sites. Surgical teams from two of these centers have already substantially demonstrated readiness, a third is currently undergoing training, and we plan to schedule the training of the remaining two during the early part of the year 2000. We have also received significant interest from international centers that wish to begin clinical trials. We are in discussions with a number of international centers for this purpose. SUBMISSION OF APPLICATIONS TO THE APPROPRIATE REGULATORY AUTHORITIES. At the end of 1996, we commenced our regulatory interaction process for the AbioCor under the pre-IDE process. We have presented to the FDA key elements of our proposed initial clinical plan, laboratory test protocols, process protocols and materials compatibility evaluation. We expect that this information will become part of the IDE submittal. In addition, we expect that we may be able to use much of the data developed for our IDE application in our corresponding international applications. 35 ABIOMED PRODUCTS AND PRODUCTS UNDER DEVELOPMENT Our current principal products and products under development are the AbioCor, a heart replacement device, the BVS, a temporary heart assist device, and the AbioBooster and AbioVest, which are both permanent heart assist devices. THE ABIOCOR IMPLANTABLE REPLACEMENT HEART. The AbioCor is a battery-powered totally implantable replacement heart system, which we expect will be the first such device to begin human clinical trials. The AbioCor is referred to as totally implantable because it has been designed to operate alternately on internal battery power or portable external battery power, in both cases without wires or any other material penetrating the patient's skin. The AbioCor is referred to as a replacement heart because it has been designed for implantation in the space vacated by the removal of a patient's diseased ventricles, where it will take over the full pumping function of the heart. The AbioCor is intended for use as destination therapy by patients with irreparably damaged hearts who are at risk of imminent death due to CHD or severe CHF but whose other vital organs remain viable. We believe that approximately 125,000 CHD and CHF patients per year could benefit from a replacement heart in the U.S., and an approximately equal number of patients could benefit from a replacement heart each year outside of the U.S. In 1988, we began to receive funding for AbioCor development from the National Heart, Lung and Blood Institute, known as the NHLBI, to support our development, testing and validation of the AbioCor. We have maintained this support by achieving various designated milestones. To date, the NHLBI has provided over $20 million of the more than $40 million that we have invested to date for the development of the AbioCor. DESIGN OF THE ABIOCOR. The following diagram illustrates the principal components of the AbioCor. [DIAGRAM OF THE ABIOCOR SYSTEM IN A PATIENT APPEARS HERE, DEPICTING THORACIC UNIT, RECHARGEABLE IMPLANTABLE BATTERY, IMPLANTABLE CONTROL AND MONITORING DEVICE, TRANSCUTANEOUS ENERGY TRANSFER SYSTEM AND EXTERNAL BATTERY PACK AND MONITORING SYSTEM.] 36 The AbioCor system consists of the following principal components: - A thoracic unit, or "replacement heart," which includes two artificial ventricles with their associated valves and a hydraulic pumping system. The unit weighs approximately two pounds and provides complete blood circulation to the lungs and the rest of the body. The ventricles and their associated valves contain seamless surfaces made of our proprietary blood-contacting material, Angioflex, and specialized geometries which result in flow patterns designed to reduce the risk of blood cell damage and blood clots. Our current configuration of the thoracic unit is sized for patients with relatively large chest cavities. If our testing of this configuration is successful, we plan to develop thoracic units of different sizes to fit other patients. - A rechargeable implantable battery, which allows the AbioCor to operate without any external power supply for limited periods of time. The battery technology in the AbioCor is lithium-based and designed by a third party that has expertise in batteries for medical devices. We have developed a recharging circuit that we believe is considerably more reliable than the recharging circuit employed in most consumer electronics today. - A microprocessor-based implantable electronic device that controls and monitors the thoracic unit and provides radio communication with an external monitor affording patients and caregivers the opportunity for real-time information on its operating status. - An across-the-skin, or transcutaneous, energy transmission system, which eliminates the need for wires penetrating the patient's skin and the inherent associated risks of infection. It transfers the power to operate the AbioCor system and to recharge the implantable battery without tethering the patient to an external drive console. - An external rechargeable battery pack and monitor designed to be worn by the patient. These components supply primary power to the system, allow patient mobility, provide system diagnostic information, and recharge the implanted back-up battery as needed. We anticipate that in the first clinical trials of the AbioCor, the patient may remain under sustained medical supervision and a portable monitoring device will be used in place of the patient-worn external battery pack and monitor. Our AbioCor design is intended both to extend life and to provide patients with a good and productive quality of life. Among the quality-of-life features of AbioCor design are quiet heart valves, elimination of all post-surgical penetration of the skin, elimination of the need for the patient to be tethered to a large external drive console, and expected minimal need for anti-coagulation treatments and immuno-suppression therapies. The AbioCor system is designed for both low maintenance and low patient involvement. We have also created tools and methods intended to make the AbioCor system as easy to implant as possible. These tools include quick-connectors for relatively easy attachment of the AbioCor to the human anatomy and a virtual surgery software tool to allow for the simulated implant of the AbioCor into a three-dimensional software model of the anatomy of a particular patient prior to opening that patient's chest. EVOLUTION OF HEART REPLACEMENT TECHNOLOGY. The development of the AbioCor has included extensive work in the areas of blood compatible surfaces, blood compatible flow, fabrication techniques for seamless blood pumps and valves, advanced pumping mechanisms, physiological control, energy transfer, anatomical fit and surgical techniques. As such, the AbioCor incorporates technology designed to address the clinical limitations experienced by earlier mechanical replacement hearts. One earlier attempt was the Jarvik-7 heart from Symbion, Inc., which was implanted in a small number of patients beginning in 1982. Although much was learned from these pioneering efforts, the technology available at that time would not support a totally implanted system. The Symbion heart required a tube 37 penetrating the skin and a large external console that severely restricted patient mobility. When initially used in patients, there were complications relating to infection, stroke and anatomical fit. In recent years, CardioWest Technologies, Inc. introduced an improved version of the Symbion heart into clinical trials as a bridge-to-transplant device. In the most recently published results, 91 patients had received this mechanical replacement heart worldwide. The majority of these patients have been successfully supported on this device until transplant. The longest implant duration was approximately six months, with an average bridge duration of approximately one month. While the CardioWest device is limited to bridge-to-transplant trials in a hospital setting because it tethers the patients to a large external console, it does provide further evidence that a mechanical heart can be successfully used to replace the human heart in order to extend life. We believe that advances in medical knowledge and technology have permitted us to design the AbioCor to avoid some of the problems that caused earlier replacement hearts to fail. In addition, the miniaturization of electronics and advances in the reliability of electronic systems allow for device controls to be fully implanted today, which eliminates the need for tethering patients to large external control devices. Computer-aided design and virtual surgery tools have allowed us to adapt the design of the AbioCor for human fit and evaluate that fit prior to implantation. PREPARATION FOR CLINICAL TRIALS. In preparation for initial AbioCor clinical trials, we selected the following leading U.S. medical centers as test sites for initial clinical trials: - Brigham and Women's Hospital and the Massachusetts General Hospital, Boston - Hahnemann University Hospital, Philadelphia - Jewish Heart Hospital, Louisville - Texas Heart Institute, Houston - UCLA Medical Center, Los Angeles We have worked with each of these centers for many years in connection with the BVS and believe that each of the centers is well positioned to contribute to the AbioCor clinical trials. We are also in discussions with selected centers outside the U.S. that have expressed interest in participating in international clinical trials. Our goal is to initiate clinical trials of the AbioCor by the end of the year 2000. To achieve this goal, the AbioCor system and its components continue to be tested through a variety of laboratory and animal tests. We are investing significant resources to demonstrate the performance, durability and reliability levels necessary to conduct initial clinical trials. A significant portion of AbioCor testing that we believe is required for initial clinical trials has been completed, however, certain of these tests must be repeated under formal protocols prior to seeking approval to enter clinical trials. In addition, we continue to consult with regulatory authorities, leading medical centers and physicians to define protocols and patient populations for these trials. COMPETITIVE POSITION. We believe that the investment we have made in AbioCor development, including building manufacturing facilities, extensive device testing and regulatory preparations, positions us well to be first to enter clinical trials for, as well as to commercialize, a totally implantable heart replacement device. No such device is clinically or commercially available today. We believe that our closest competitor with an advanced design of a heart replacement device is Pennsylvania State University, in collaboration with third party manufacturers. Pennsylvania State University was the only applicant other than ABIOMED to qualify for the last round of funding from the NHLBI, which was awarded in 1996. To qualify for such funding, both ABIOMED and Pennsylvania State University demonstrated to the satisfaction of NHLBI that the basic design of its system functioned adequately in laboratory and animal models. 38 We will not be able to evaluate fully the competitiveness of the AbioCor with other replacement hearts unless and until each of the products is commercially available. However, we believe that the AbioCor will compete based on clinical outcomes, the quality of life it provides, cost effectiveness, clinical support and customer relationships. For example, we may compete favorably on the basis of cost because we manufacture the valves for the AbioCor at a cost which we believe is considerably below the cost of purchasing the valves from third parties, and because we manufacture all of the blood-contacting surfaces and valves out of our proprietary blood-contacting material, Angioflex. In addition, we believe our design will result in the need for less frequent invasive maintenance than other approaches, resulting in an improved quality of life. We also believe that our experience in regulatory affairs, manufacturing, and the marketing of devices to cardiac surgeons will aid us competitively. We believe there are significant differences that distinguish an implantable replacement heart from a VAD, and that a need exists for both types of devices. We believe that devices being developed for destination therapy must be implantable rather than external to the body in order to address patients' quality-of-life needs. Implantable VADs, referred to as left ventricular assist devices or LVADs, are being developed to attach to a patient's diseased heart and provide pumping support to the left ventricle only. By contrast, the AbioCor will replace the diseased ventricles of the heart and take over the pumping functions of both ventricles. Patients for whom we believe a replacement heart would be preferable to a VAD include those with massive heart damage, severe rhythm disorders, blood clots in the ventricles, severe lung disease, ventricular rupture, chronic right ventricle failure or heart transplant rejection. We also believe that cardiac surgeons will adopt replacement hearts as the preferred technology over LVADs once the reliability of both devices is clinically demonstrated for multiple-year durations. COST EFFECTIVENESS. We believe there is a significant need for cost-effective therapies for heart disease. In the U.S., approximately $100 billion was associated with CHD patients and approximately $21 billion was associated with CHF patients in 1997. A significant proportion of these costs was attributed to hospital support. Patients who suffer from heart disease often receive medical treatment, either in a hospital or at home, for a number of years prior to their deaths. As the lives of these patients are often restricted as a result of their conditions and treatment, they often suffer from a reduced quality of life, including shortness of breath and inability to work. Prior to death, many heart failure patients are confined to bed and require monitoring and other expensive forms of support. Approximately 35% of patients who have CHF are hospitalized one or more times per year. The average length of stay for each hospitalization for a CHF patient is seven to nine days, with cost that often exceeds $2,000 per day. We are developing the AbioCor with the intent to offer a cost-effective treatment for end-stage heart failure patients. In addition, the AbioCor has the potential to allow patients an opportunity to return to productive lives. This would allow the medical system to save money by discharging the patient from the hospital and allowing the person to become productive and lead a reasonably normal life. If the reliability of the AbioCor is clinically demonstrated for multiple-year durations, it has the potential to be considerably less expensive than heart transplantation over a five year period. One reason for this reduced cost is that recipients of a mechanical replacement heart are not expected to need immuno-suppression drugs. The blood and tissue contacting portions of the AbioCor are constructed of inert and biocompatible materials, which typically do not stimulate a patient's immune system. Other cost savings could result because the patient can receive a replacement heart sooner and does not require extensive tests for donor heart compatibility. While recipients of the AbioCor will likely need to purchase new batteries periodically, we anticipate that the annual cost of battery purchases will be significantly less than the cost of immuno-suppression drugs for donor heart recipients. 39 The following table summarizes the approximate average costs incurred by a heart transplant patient over a five-year period, based on data compiled in 1995: AVERAGE 5-YEAR PER-PATIENT COST OF HEART TRANSPLANTATION
TRANSPLANT WITHOUT TRANSPLANT AFTER COST TYPE BRIDGE DEVICE BRIDGE DEVICE - --------- ------------- ---------------- Drugs....................................................... $150,000 $150,000 Hospital, Professional and Laboratory Testing Fees.......... 97,000 242,000 Surgical Operation.......................................... 18,000 41,000 Organ Retrieval and Device Cost............................. 20,000 50,000 -------- -------- TOTAL................................................... $285,000 $483,000
The average cost of a heart transplant over a period of five years is approximately $285,000 without the use of a bridge-to-transplant device and is approximately $483,000 if a bridge-to-transplant device is used. Included in these costs is approximately $150,000 for immuno-suppression drugs and anti-rejection management. These amounts also include hospital, professional and laboratory testing costs of approximately $97,000 for heart transplantation without a bridge-to-transplant device and approximately $285,000 with such a device. These costs reflect extended hospital stays and testing of heart transplant patients required both before and after surgery while waiting for a suitable donor heart and recovering from the transplant surgery. We believe that the costs listed above may have increased in recent years due to increases in the pricing of bridge-to-transplant devices. We also believe that the costs listed above would be reduced if concerns related to recipient compatibility and availability of donor heart supply are mitigated with a mechanical replacement heart. While developing the AbioCor, we introduced the BVS, a temporary heart-assist device, which is currently being sold in the U.S. and international markets. Certain key elements of the technology developed for the AbioCor, such as Angioflex and our tri-leaflet heart valves, have been clinically tested in the BVS and are currently in commercial use. In addition, the BVS has enabled us to develop significant experience in areas such as research and development, manufacturing, regulatory compliance, sales and marketing, and clinical support. We believe our experience with the BVS in these areas will provide us with a competitive advantage in commercializing the AbioCor. THE BVS-5000 TEMPORARY HEART ASSIST DEVICE. The BVS was the first heart assist device capable of assuming the full pumping function of the heart to be approved by the FDA, and is the most widely used heart assist device today, with over 3,000 patients supported to date. It is a bridge-to-recovery device designed to provide a patient's failing heart with full circulatory assistance while allowing the heart to rest, heal and recover its function. The BVS can support the left, right or both ventricles of the heart. The average age of patients supported with the BVS is 52, however the BVS has been used to support patients as young as 9 and as old as 85. The BVS is the only device that the FDA has approved for the temporary treatment of all categories of patients with failing but potentially recoverable hearts. The BVS is most frequently used in patients whose hearts fail to recover function immediately following heart surgery. The FDA approved the BVS through its rigorous pre-market approval process for use with these post-surgical patients in November 1992. In 1996, the FDA approved use of the BVS for all other categories of post-surgical patients with potentially reversible heart failure. In 1997, the FDA approved use of the BVS with patients who had not just undergone surgery, such as patients referred by a cardiologist as a result of viral infections of the heart or certain heart attacks, expanding its use to the temporary treatment of all patients with potentially reversible heart failure. 40 The following diagram illustrates the principal components of the BVS. [DIAGRAM OF BVS ATTACHED TO A PATIENT APPEARS HERE, DEPICTING DRIVE AND CONTROL CONSOLE, EXTERNAL BLOOD PUMPS AND CANNULAE.] The BVS system consists of the following components: - A computer-controlled pneumatic drive and control console, which automatically adjusts the pumping rate, similar to the natural heart; - Single-use external blood pumps, which provide pumping of blood for the left, right or both sides of a patient's heart and are designed to emulate the function of the natural heart; and - Cannulae, which are specially designed tubes used to connect the blood pumps to a patient's heart. The integration of the cannulae, blood pumps and console creates an "external heart" system with the ability to reduce the load on the heart, provide pulsatile blood flow to vital organs and allow the heart muscles time to rest and recover. The BVS is designed to be easy to use and does not require a specially trained technician constantly to monitor or adjust the pumping parameters. The goal of the BVS is to facilitate the recovery of patients' hearts as quickly as possible. Patients who recover under BVS support typically stabilize in a period of less than one week. It generally takes three to five days for the heart muscle to recover its biological energy in a post-cardiotomy patient, and the partial healing of tissue damage frequently associated with post-cardiotomy shock occurs over several days in cases in which the heart is not irreversibly damaged. The BVS, although it is a VAD, 41 serves a different function than bridge-to-transplant devices, which are intended for long-term use by patients awaiting a heart transplant. The BVS is most frequently used to support patients who have undergone open-heart surgery, when the heart cannot be successfully restarted and weaned off the heart-lung machine used in surgery. The BVS can assume the full pumping function of the heart for these patients while reducing certain risks associated with extended support on the heart-lung machine, including bleeding, strokes and blood cell damage. The traditional therapy for these patients has been the combined use of drugs and intra-aortic balloon pumps. Intra-aortic balloon pumps are capable of providing only a small enhancement to the pumping function of a failing heart. Despite the availability of such therapy, approximately 12,000 of these patients die each year, approximately half of whom are over the age of 75. The health of many of the patients who die in this manner deteriorates over a period of weeks with the patient either dying after incurring significant expense, or running the risk of permanent damage to their other organs due to inadequate blood flow. Other categories of patients who can be supported by the BVS include those suffering from viral myocarditis, a viral infection of the heart. For these patients, the BVS assumes the full pumping function of the heart, allowing the patient's immune system to defend against the virus. Other uses of the BVS include supporting patients following failed heart transplants and supporting the right ventricle of a patient's heart in conjunction with the implantation of a device to assist the left ventricle. The BVS is typically used when the patient's chances for survival are small. We are also exploring other potential applications of the BVS, including its use in certain patients who have suffered from a recent heart attack and its use as a staging device to support heart failure patients prior to a permanent heart assist device or heart replacement. Any hospital performing open-chest heart surgery may use the BVS. There are approximately 900 of these hospitals in the U.S. and more than 1,000 such hospitals outside the U.S. Since FDA approval of the BVS, we have primarily focused on sales of the BVS to the largest heart surgery medical centers in the U.S. As of September 30, 1999, approximately 435 medical centers in the U.S. had purchased the BVS, including over 80% of the major U.S. centers that perform more than 500 heart surgeries annually. In marketing the BVS, we are focusing on selling additional consoles and disposable blood pumps to existing customers with significant but less emphasis on adding new customers. Over half of current BVS revenues are derived from sales of BVS single-use blood pumps to existing customers after those customers have used the BVS to support patients. Our U.S. list prices for the BVS system are $64,500 for a BVS console and $12,400 for a BVS single-use blood pump and cannulae set. We are currently seeking to expand our international sales of the BVS and are recruiting direct sales and support teams for selected countries in Europe, while working with a third-party distributor to pursue regulatory approval in Japan. Since the BVS received FDA approval, we have made various improvements to the BVS system, primarily to make it easier to use. We continue to enhance the BVS product line and are developing improved blood pumps, cannulae and consoles. We believe that some of these improvements may permit use of the BVS for additional patient conditions. THE ABIOBOOSTER AND THE ABIOVEST. The AbioBooster is intended as a permanent heart-assist device that will wrap around the heart without direct blood contact and actively help squeeze the heart. We are designing the AbioBooster as a quality-of-life device for use in patients with CHF who are not at imminent risk of death, but whose daily activities are generally restricted due to their weakened hearts. The AbioBooster consists of a flexible artificial plastic "muscle" that can be wrapped around the heart to assist its contraction, thereby increasing blood flow in order to restore quality of life to the patient. The AbioBooster is in research and development, with prototype designs being evaluated and tested in our laboratories and in animals. 42 The AbioVest, which is in an early stage of research, is intended as a permanent implantable device to wrap around the hearts of certain patients with CHF without creating the inherent risks of contacting the patient's flowing blood. The intent of the AbioVest design is to help the heart passively by preventing progressive heart enlargement. OTHER PRODUCTS AND TECHNOLOGIES UNDER DEVELOPMENT. We are using the technology and know-how that we have generated in developing the AbioCor and the BVS to research and develop additional potential cardiovascular products and related technologies. These new products and technologies are in various stages of research and development, and include a variety of specialized implantable and external rotary pumps. We are also developing devices for use in minimally invasive surgery applications such as tissue welding and vascular welding for the repair of small arteries. In addition, research and development activities under our product development programs incorporate certain technologies that have potential as separate spin-off products. Examples include new implantable heart valves, implantable energy transmission systems, implantable monitoring systems for remote transmission and archival of physiological data, diagnostic software for virtual surgery, advanced implantable instrumentation and electronics, and external monitoring systems. MEDICAL AND ETHICAL ADVISORY BOARDS We maintain independent advisory boards for medical and ethical issues, which we consult on a periodic basis. These advisory boards provide guidance to help us develop products that address patient needs and are acceptable to society. Our medical advisory board currently consists of ten physicians, primarily leading cardiac surgeons and cardiologists, who are independent of ABIOMED and are in addition to the physicians being trained at the selected initial clinical sites for the AbioCor. Together, these physicians have a broad range of experience in fields relevant to our products and products under development. We consult with leading experts in the field of medical ethics, and we are in the process of establishing an independent advisory board for ethical issues. We anticipate that our ethics advisory board will consist of five members representing different backgrounds and interests. We expect that this board will be an advocate for patients' interests and will assist us with a number of matters in connection with clinical trials of the AbioCor. For example, we anticipate that the board will participate in the evaluation of patients for inclusion in the initial clinical trials and advise us regarding the bioethical aspects of our regulatory protocols and public disclosures. The board is also expected to interact with the internal review boards of medical centers in conjunction with initial clinical trials and assist us in the review of clinical trial data. We expect that our ethical advisory board will operate under principles and procedures that conform to FDA and European Union requirements. We believe that these advisory boards, together with our own internal resources and the support of leading medical centers and physicians and other third parties with which we collaborate, will continue to assist us in advancing our current products and introducing new products that satisfy patient needs. RESEARCH AND PRODUCT DEVELOPMENT As of December 1, 1999, our research and development staff consisted of 103 professional and technical personnel, including 12 with PhDs or MD/PhDs and 35 engineers, many with advanced degrees, covering disciplines such as electronics, software, reliability testing, fluid mechanics, physics and physiology. Our research and development efforts are focused on the development of new products, primarily related to mechanical heart assist and heart replacement, and the continued enhancement of the BVS and related technologies. Our research and development personnel are also involved in establishing protocols and monitoring test data submissions to the FDA and corresponding foreign regulatory agencies to obtain the necessary clearances and approvals for our products. We are 43 using sophisticated tools, such as three-dimensional computer-aided design systems, and procedures in an effort to permit smooth transition of new products from research to product development to manufacturing. We have substantial expertise in electro-mechanical systems, cardiac physiology and experimental surgery, blood-material interactions, fluid mechanics and hemodynamics, internal and external electronic hardware, software, plastics processing, lasers, and optical physics. We have applied this expertise to address challenges associated with the safe and effective pumping of blood. In 1997, we decided that the design of the AbioCor demonstrated sufficient functionality and operational performance through laboratory and animal studies to warrant accelerated product development efforts to bring the product to clinical use. We expended $13.4 million on research and development during the fiscal year ended March 31, 1999, $9.1 million during the fiscal year ended March 31, 1998 and $3.8 million during the fiscal year ended March 31, 1997. These amounts included $9.7 million in fiscal 1999, $8.5 million in fiscal 1998 and $1.6 million in fiscal 1997 for AbioCor development. Government contracts and grants funded a substantial portion of these expenses, however we have used our own resources to fund research and development expenses not covered by government contracts and grants. Since our inception, U.S. government agencies, particularly the NHLBI, have provided significant support to our product development efforts. The most significant current funding comes from the NHLBI, which supports our development of the AbioCor and AbioBooster. In May 1999, the U.S. government appropriated the final $1.8 million under our current $8.5 million AbioCor development contract. As of September 30, 1999, the backlog of all government contracts and grants was $2.7 million, including $1.1 million related to the AbioBooster. All of our government contracts and grants contain provisions making them terminable for the convenience of the government and are subject to government appropriations. We cannot assure that the government will not terminate, reduce or delay the funding for any of our contracts. In addition, we cannot assure that we will be successful in obtaining any new government contracts or further extensions to existing contracts. ASALES, CLINICAL SUPPORT, MARKETING AND FIELD SERVICE We believe that the sales, clinical support, marketing and field service teams that we have established for the BVS product line and the relationships that we have developed with existing customers will be instrumental not only in continuing to expand BVS usage and sales, but also in launching new products such as the AbioCor. We sell the BVS in the U.S. through direct sales and clinical support teams. As of December 1, 1999, our BVS sales, clinical support, marketing and field service teams in the U.S. included 38 full-time employees. Our sales force focuses on BVS sales to new customers, upgrades of existing customers, and increasingly, expansion of usage by existing customers. Our clinical support group focuses on training and educating new and existing customers in order to improve clinical outcomes and increase BVS blood pump usage. We believe that the efforts of our clinical support group contribute significantly to the number of lives saved by physicians using the BVS as well as usage and reorders of BVS single-use blood pumps. We are increasingly focusing our sales and customer support efforts on increasing BVS usage by existing customers with significant delay or reductionbut less emphasis on adding new customers. Over half of fundingcurrent BVS revenues are derived from sales of BVS single-use blood pumps to existing customers. We believe that our sales and support teams and the reputation and relationships they have helped us develop with our customers will be key assets for the introduction of potential future products such as the AbioCor, BVS product extensions and other products under development. Building on our experience in the Company's government contracts couldU.S., we are working to expand our international sales efforts, both for the BVS and in preparation for the AbioCor. We are working to accomplish this through distributors, including a collaborative arrangement for distribution in Japan, and by selling directly in selected European markets. 44 MANUFACTURING We have over 10 years of experience in the manufacture of the BVS console, BVS blood pumps, certain cannulae and related accessories. As of December 1, 1999, our manufacturing staff consisted of 30 people and our quality assurance staff consisted of 14 people. The manufacture of our BVS blood pumps and consoles includes assembly, testing and quality control. We manufacture key blood-contacting components for the BVS blood pumps, including valves and bladders, from our proprietary Angioflex polymer. We purchase a material adverse effect onmajority of the Company's business, financial conditionraw materials, parts and results of operations. See "Management's Discussion and Analysis of Financial Conditions and Results of Operations" and "Business--ABIOMED Products and Products under Development" and "--Strategic Relationships." 11 DEPENDENCE ON LIMITED SOURCES OF SUPPLY The Company relies on outside vendors to supply certainperipheral components used in the BVS consoles. We both purchase and in its products under development. Certainmanufacture cannulae depending on the size and design of the componentscannulae. Prior to 1999, we purchased all of the cannulae which were used with the BVS. In 1999, we developed the know-how to manufacture our own cannulae using materials purchased from others. Our BVS are supplied by sole source vendors or are custom made formanufacturing facility is ISO-9001 certified and operates under the Company. From time to time, suppliers of certain componentsFDA's current Quality Systems Regulations and Good Manufacturing Practices, known as QSR/GMP. The manufacture of the AbioCor is based on processes that are similar to many of the processes used with the BVS. Prior to 1997, we manufactured AbioCor units one at a time in our research and development facility. In 1997, we constructed a pilot manufacturing facility, which became fully operational in 1998 and has produced all of the more than 100 AbioCor systems manufactured and tested since that time. In October 1999, we commenced construction of new and larger manufacturing facilities for both the AbioCor and the BVS. These new facilities are located in the same approximately 80,000 square foot space that the Company's research and development, sales and marketing and general and administrative group began occupying in 1999 and is in the same industrial park as our current manufacturing facilities. We are scheduled to occupy the new manufacturing areas in 2000, at which time the majority of our operations will be consolidated in one building. We believe that our current manufacturing facilities will permit us to produce sufficient quantities of AbioCor and BVS products until the new facilities are available, including sufficient quantities of the AbioCor for clinical trials. PROPRIETARY RIGHTS, PATENTS AND KNOW-HOW We have indicated that they intenddeveloped significant know-how and proprietary technology, upon which our business depends. To protect our know-how and proprietary technology, we rely on trade secret laws, patents, copyrights, trademarks, and confidentiality agreements and contracts. However, these methods afford only limited protection. Others may independently develop substantially equivalent proprietary information, gain access to discontinue,our trade secrets or have discontinued, makingdisclose such components. In addition, certaintechnology without our approval. A substantial portion of these components are supplied from single sources due to quality considerations, costs or constraints imposed by regulatory authorities. There are relatively few additional sources of supply for such components and establishing additional or replacement suppliers for such components cannot be accomplished quickly and may require FDA approval. In the past, certain suppliers have announced that, due to government regulation or in an effort to reduce potential product liability exposure, they intend to limit or terminate sales of certain productsour intellectual property rights relating to the AbioCor and the BVS is in the form of trade secrets, rather than patents. We protect our trade secrets and proprietary knowledge in part through confidentiality agreements with employees, consultants and other parties. We cannot assure that our trade secrets will not become known to or be independently developed by our competitors. Of our 24 U.S. patents as of December 1, 1999, 4 relate to the AbioCor and 2 relate to the BVS. Of our 21 pending U.S. patent applications as of December 1, 1999, 11 relate to the AbioCor and 1 relates to the BVS. We also own a number of corresponding patents and patent applications in a limited number of foreign countries. Our patents may not provide us with competitive advantages. They may also be challenged by third parties. Our pending or future patent applications may not be approved. The patents of others may render our patents obsolete or otherwise have an adverse effect on our ability to conduct business. Because foreign patents may afford less protection than U.S. patents, they may not adequately protect our proprietary information. The medical industry. There can be no assurance that, if such an interruption weredevice industry is characterized by a large number of patents and by frequent and substantial intellectual property litigation. Our products and technologies could infringe on the 45 proprietary rights of third parties. We are currently involved in litigation relating to occur,technology used in a component of the Company wouldAbioCor. See "--Legal Proceedings." If third parties successfully assert infringement or other claims against us, we may not be able to find suitable alternative supplies at reasonable pricessell our products. In addition, patent or wouldintellectual property disputes or litigation may be ablecostly, result in product development delays, or divert the efforts and attention of our management and technical personnel. If any such disputes or litigation arise, we may seek to obtain requisite regulatory approvals inenter into a timely manner,royalty or licensing arrangement. However, such an arrangement may not be available on commercially acceptable terms, if at all. Similarly,We may decide, in the alternative, to litigate the claims or to design around the patented or otherwise proprietary technology. Some of our products have been developed in part under government contracts that require us to manufacture a substantial portion of the products in the U.S.. The government may obtain certain rights to use or disclose technical data developed under those contracts. We retain the right to obtain patents on any inventions developed under those contracts (subject to a non-exclusive, non-transferable, royalty-free license to the government), provided we follow prescribed procedures. COMPETITION Competition in the heart assist and heart replacement markets is intense and subject to rapid technological change and evolving industry requirements and standards. Many of the companies developing or marketing heart assist products have substantially greater financial, product development, sales and marketing resources and experience than ABIOMED. These competitors may develop superior products or products of similar quality at the same or lower prices. Moreover, improvements in current or new technologies may make them technically equivalent or superior to our products in addition to providing cost or other advantages. Other advances in medical technology, biotechnology and pharmaceuticals may reduce the size of the potential markets for our products or render those products obsolete. No totally implantable replacement heart is commercially or clinically available today. We are aware of other heart replacement device development efforts in the U.S., Canada, Europe and Japan. We believe that our closest competitor with respect to having an advanced design of a heart replacement device is Pennsylvania State University, in collaboration with third party manufacturers. We believe that if and when both the AbioCor and if the Company reachesPennsylvania State University replacement heart are commercially available, the AbioCor will compete based on the quality-of-life it provides, cost effectiveness, clinical testing stagesupport and customer relationships. In addition to the developers of itsimplantable replacement hearts, there are a number of companies, including Thermo Cardiosystems, Inc., Novacor, a division of Baxter International, Inc., and Arrow International, Inc. which are developing permanent heart assist products, under development, itincluding implantable LVADs and miniaturized rotary ventricular assist devices, that may findaddress markets that overlap with certain components become more difficult to source from outside vendorssegments of the markets targeted by AbioCor. AbioCor may compete with those devices for some patient groups, notably patients with severe CHF due to predominant left ventricular heart failure. Thermo Cardiosystems, Inc. has commenced clinical trials under an IDE for PMA approval of LVADs for permanent heart assist. We believe that the product liability risk perceived by those vendors. The Company's inabilityAbioCor, LVADs and other VADs, if developed and proven effective for destination therapy, will generally be used to obtain acceptable components in a timely manner or to find suitable replacements ataddress the needs of different patient populations, with an acceptable cost would have a material adverse effect on the Company's business, financial condition and results of operations. See "Business--Manufacturing." FUTURE CAPITAL NEEDS AND UNCERTAINTY OF ADDITIONAL FUNDING The Company is working on the research and development of several long-term projects and is placing increased emphasis on developmentoverlap for certain segments of the TAH,heart failure population. We believe that there is a need for both implantable LVADs and implantable replacement hearts as destination therapies, and that when both technologies demonstrate the required durability, surgeons will favor replacement hearts. In addition to devices being developed for patients in need of heart replacement, several companies and institutions are investigating xenotransplantation, the transplantation of a heart from another species, as a potential therapy. Most notably, some developers are investigating the use of genetically engineered pig hearts as an alternative source of donor hearts. This technology is still in its 46 formative stage and subject to a number of significant scientific challenges, including controlling elevated immunologic reactions leading to heightened rejection problems between cross-species grafting and concerns for cross-species disease transmission to the recipient and the public at large. We believe that this technology will not achieve practical application for decades, if ever. The BVS is a device that can assume the full pumping function of the heart. The FDA has approved the BVS as a bridge-to-recovery device for the treatment of all patients with potentially reversible heart failure. In May 1998, Thoratec Laboratories Corporation received FDA approval to market their device for postcardiotomy recovery of the natural heart, which will result in significantly increased internally funded researchis one of the primary patient categories addressed by the BVS. The Thoratec device was originally approved for bridge-to-transplant and development expenditures. These costs include costsbridge-to-transplant continues to be the primary use of pre-clinical trials and regulatory approvals. The Company estimatesthe device. We are not aware of any other company that has applied for FDA approval of a device that is directly competitive with the costBVS. Approval by the FDA of developingproducts that compete directly with the TAHBVS could increase competitive pricing and other pressures. We believe that we can compete with such products based on cost, clinical utility and customer relations. Our customers frequently have limited budgets. As a result, our products compete against a broad range of medical devices and other therapies for these limited funds. Our success will be significant. These costs maydepend in large part upon our ability to enhance our existing products, to develop new products to meet regulatory and customer requirements, and to achieve market acceptance. We believe that important competitive factors with respect to the development and commercialization of our products include costs related to pre-clinical andthe relative speed with which we can develop products, establish clinical utility, complete clinical trials and regulatory approvals. The Company estimates that it will require significant additional funds in order to complete the developmentapproval processes, obtain reimbursement, and achieve regulatory approvalssupply commercial quantities of the TAHproduct to the market. THIRD-PARTY REIMBURSEMENT We sell our BVS product and otherintend to sell most of our potential products under development. Generally, estimates of long-term project costs are extremely imprecise and cost overruns are common. As a result, there can be no assurance that the Company will not require significantly more resources to complete the development of the TAH and its other products. The Company plans to fund this effort through a combination of the TAH Contract, proceeds from the offering, existing resources, the possible sales of additional securities and cash flow from sales of its existing products. Even if the Company does not experience cost overruns, there can be no assurance that the Company will be able to obtain sufficient funds to complete the development of the TAH and other products. Moreover, the Company may require additional funds to commence the manufacture and marketing of the TAH or any of the Company's other products under development in commercial quantities, if and when approved or cleared by the regulatory authorities. Failure of the Company to obtain any required additional funding could delay product development and otherwise materially and adversely affect the business of the Company. There can be no assurance that the Company will be able to obtain additional funding on favorable terms, if at all. See "Use of Proceeds" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." DEPENDENCE ON THIRD-PARTY REIMBURSEMENT The Company's BVS product is, and most of its products under development are intended to be, sold to medical institutions. Medical institutions and their physicians typically seek reimbursement for the use of these products from third-party payors, including Medicare, Medicaid, and private health insurers and managed care organizations. As a result, market acceptance of the Company'sour current and proposed products may depend in large part on the extent to which reimbursement is available to medical institutions and their physicians for use of the Company'sour products. TheCoverage and the level of reimbursementpayment provided by United StatesU.S. and foreign third-party payors varies according to a number of factors, including the medical procedure, category, payor, location, outcome and cost. In the 12 United States,U.S., many private health care insurance carriers follow the recommendations of the Health Care FinanceFinancing Administration, ("HCFA"),or HCFA, which establishes guidelines for the reimbursementcoverage of procedures, services and medical equipment and the payment of health care providers treating Medicare and Medicaid patients. Internationally, medicalhealthcare reimbursement systems vary significantly. In certain countries, medical center budgets are fixed regardless of levels of patient treatment. In other countries, such as Japan, reimbursement from government or third party payors must be applied for and approved. As of the date of this Prospectus, under HCFA guidelines,prospectus, the amount that Medicare reimbursesgenerally pays a medical institutionsinstitution for in-patient care of Medicare patients is based on a number of considerations, including a patient's diagnosis regardless of the category of surgical procedures in which the BVS is used and incrementally reimburses physiciansservices that are provided. Physicians however bill separately for the use of the BVS.procedures that they perform. Medicare does not however, currently reimburse medical institutions for the incremental cost of using the BVS above the amount allowed for the reimbursement category of the surgical procedure.BVS. Certain private health insurers and managed care providers provide incremental reimbursement to both the medical institutions and their physicians. The Company is currently petitioning HCFA to assign a higher paying reimbursement category whenever the BVS is used. In October 1995, HCFA established a special "ICD-9" code for the BVS in an effort to more clearly track and evaluate hospital and physician costs associated specifically with the BVS compared to current reimbursement levels, so that HCFA can determine the appropriate category and level of reimbursement. There can be no assurance that HCFA will reassign the BVS to a higher paying category in a timely manner, if at all.47 No reimbursement levels have been established for the Company'sour products under development, including the TAH.AbioCor. Prior to approving coverage for new medical devices, most third-party payors require evidence that the product has received FDA approval, European Union approval, or clearance for marketing, is safe and effective and not experimental or investigational, and is medically necessary and appropriate for the specific patient for whom the product is being used. Increasing numbers of third-party payors require evidence that the procedures in which the products are used, as well as the products themselves, are cost-effective. There can be no assuranceHeart transplantation currently qualifies for reimbursement as does bridge-to-transplant treatment with implantable VADs. Comparatively, we believe that when the AbioCor product reaches maturity, it should cost less over a five-year period than heart transplantation today and provide more ventricular support than VADs. We believe that these factors should benefit the AbioCor when we begin to seek reimbursement for it from third-party payors. However, we cannot assure that the Company'sAbioCor or our other products under development will meet thesethe criteria for coverage and reimbursement or that third-party payors will reimburse physicians and medical institutions for the use of the products or that the level of reimbursement will beat levels sufficient to supportencourage the widespread use of the products. Furthermore, there can be no assurance that third-party payors will continueBecause the AbioCor is an implantable product designed to provideassist patients outside of the hospital environment, the reimbursement for the use of BVSstandards or that such payors will not reduce the current level of reimbursement support for the product. Failure to achieve adequate reimbursement for its current or proposed products would have a material adverse effect on the Company's business, financial condition and results of operations. POTENTIAL INADEQUACY OF PRODUCT LIABILITY INSURANCE The Company's business involves the risk of product liability claims inherent in the manufacture and marketing of life support systems. There are many factors beyond the control of the Company that could result in the failure of the BVS to sustain the life of a patient, the most important of which is the condition of the patient prior to the use of the product. As a result, many of the patients using the BVS do not survive. In addition, the effectiveness of the Company's products could be adversely affected by the reliability of the physicians, nurses and technicians using and monitoring the use of the product, and the maintenance of the product by the Company's customers. The failure of the BVS or any other life support system under development by the Company to save a life could give rise to product liability claims and result in negative publicity that could have a material adverse effect on the Company's business, financial condition and results of operations. The Company currently maintains product liability insurance, subject to certain deductibles and exclusions. There can be no assurance that this insurance will be sufficient to protect the CompanyAbioCor may differ from product liability claims, or that product liability insurance will continue to be available to the Company at a reasonable cost, if at all. The risk of product liability claims against the Company may increase as the Company introduces new products under development, particularly products such as the TAH intended for permanent life support. The TAH will have a finite life and could cause unintended complications to other organs. The eventual failure of the TAH could give rise to product liability claims, regardless of whether the TAH has extended or improved the quality of the patient's life beyond that expected without the use of the TAH. As a result of the additional 13 product liability risks that will be associated with the TAH and other products under development by the Company, there can be no assurance that the Company will be able to secure product liability insurance for these products, when and if developed, or that such insurance will be sufficient to protect the Company at an acceptable cost. The failure of the Company to be able to obtain adequate product liability insurance, if any, for these products could have a material adverse effect on its business, financial condition and results of operations. DEPENDENCE ON PATENTS AND PROPRIETARY RIGHTS The Company's business depends significantly upon its proprietary technology. The Company relies on a combination of trade secret laws, patents, copyrights, trademarks and confidentiality agreements and other contractual provisions to establish, maintain and protect its proprietary rights, all of which afford only limited protection. There can be no assurance that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to the Company's trade secrets or disclose such technology or that the Company can meaningfully protect its trade secrets. The Company has been issued or allowed 22 patents and has pending three patent applications in the United States. The Company has obtained or applied for corresponding patents for certain of these patents and patent applications in a limited number of foreign countries. These patents relate to the BVS and certain of its products under development including the TAH. The Company's United States patents expire at various times from 2003 to 2016. There can be no assurance that the Company's pending patent applications or any future applications will be approved, that any patents will provide the Company with competitive advantages or will not be challenged by third parties, or that the patents of others will not render the Company's patents obsolete or otherwise have an adverse effect on the Company's ability to conduct business. Because foreign patents may afford less protection under foreign law than is available under United States patent law, there can be no assurance that any such patents issued to the Company will adequately protect the Company's proprietary information. Others may have filed and may file patent applications in the future that are similar or identical to those of the Company. To determine the priority of inventions, the Company may have to participate in interference proceedings declared by the United States Patent and Trademark Office or opposition proceedings before a foreign patent office that could result in substantial cost to the Company. No assurance can be given that any such interfering patent or patent application will not have priority over patent applications filed on behalf of the Company or that the Company will prevail in any opposition proceeding. The medical device industry is characterized by a large number of patents and by frequent and substantial intellectual property litigation. There can be no assurance that the Company's products and technologies do not infringe any patents or proprietary rights of third parties. The Company has in the past and may in the future be notified that it may be infringing intellectual property rights possessed by others. Any intellectual property litigation would be costly and could divert the efforts and attention of the Company's management and technical personnel, which could have a material adverse effect on the Company's business, financial condition and results of operations. There can be no assurance that infringement claims will not be asserted in the future or such assertions, if proven to be true, will not prevent the Company from selling its products or materially and adversely affect the Company's business, financial condition and results of operations. If any such claims are asserted against the Company's intellectual property rights, it may seek to enter into a royalty or licensing arrangement. There can be no assurance, however, that a license will be available on reasonable terms, or at all. The Company could decide, in the alternative, to resort to litigation to challenge such claims or to design around the patented technology. Such actions could be costly and would divert the efforts and attention of the Company's management and technical personnel, which would materially and adversely affect the Company's business, financial condition and results of operations. The Company has recently received a letter from a third party alleging that certain technology incorporated into the transcutaneous energy transmission system component of the Company's TAH may infringe the patent or other intellectual property rights of that party. The Company is in the preliminary stages of assessing the allegations, but does not believe that it is infringing any patent or other intellectual 14 property rights of this third party. There can be no assurance that the Company would prevail in the defense of an infringement claim, if made. If infringement of the proprietary rights of the third party were determined to exist, the Company would either be required to use or develop alternative technology or to seek a license of the technology. There can be no assurance that the Company could obtain a license of this technology on a timely basis or on reasonable terms, if at all. In addition, there can be no assurance that the Company could develop or license alternative technology on a timely basis, if at all. As a result, a determination of infringement could have a material adverse affect on the Company's development of the TAH and on its business, financial condition and results of operations. Any patent or intellectual property dispute or litigation could result in product development delays, would be costly, could divert the efforts and attention of the Company's management and technical personnel and could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business--Patents and Proprietary Rights." CONTROL BY MANAGEMENT Upon completion of this offering, the Company's directors, officers and their affiliates will beneficially own approximately 27.2% of the outstanding Common Stock of the Company (as determined in accordance with the rules of the Securities and Exchange Commission). As a result, these stockholders will be able to exert substantial influence over actions requiring stockholder approval, including the election of directors, amendments to the Company's Restated Certificate of Incorporation, mergers, sales of assets or other business acquisitions or dispositions. See "Principal and Selling Stockholders." ANTI-TAKEOVER PROVISIONS; RIGHTS AGREEMENT; ISSUANCE OF PREFERRED STOCK The Company's Restated Certificate of Incorporation ("Certificate of Incorporation") and Amended and Restated By-laws ("By-laws") contain certain provisions that could have the effect of deterring certain mergers, tender offers, proxy contests or other future takeover attempts which holders of some or even a majority of the outstanding stock believe to be in their best interest, and may make removal of management more difficult even if such removal would be deemed to be beneficial to stockholders generally. These provisions could limit the price that certain investors might be willing to pay in the future for shares of the Company's Common Stock. In addition, the Company has adopted a Rights Agreement, pursuant to which the Company has distributed to its stockholders rights to purchase shares of junior participating preferred stock ("Rights Agreement"). Upon certain triggering events, such rights become exercisable to purchase the Company's Common Stock at a price substantially discounted from the then applicable market price of the Company's Common Stock. The Rights Agreement could generally discourage a merger or tender offer involving the securities of the Company that is not approved by the Company's Board of Directors by increasing the cost of effecting any such transaction and, accordingly, could have an adverse impact on stockholders who might want to vote in favor of such merger or participate in such tender offer. In addition, shares of the Company's Class B Preferred Stock ("Preferred Stock") may be issued in the future without further stockholder approval and upon such terms and conditions, and having such rights, privileges and preferences, as the Board of Directors may determine. The rights of the holders of Common Stock will be subject to, and may be adversely affected by, the rights of any holders of Preferred Stock that may be issued in the future. The issuance of Preferred Stock, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or of discouraging a third party from acquiring, a majority of the outstanding voting stock of the Company. The Company has no present plans to issue any shares of Preferred Stock. The Certificate of Incorporation and By-laws impose various procedural and other requirements that could make it more difficult for stockholders to effect certain corporate actions. See "Description of Capital Stock--Anti-takeover Effect of Provisions of the Certificate of Incorporation and By-laws, Rights Distribution and Delaware Law." POSSIBLE VOLATILITY OF SHARE PRICE There has been a history of significant volatility in the market price for shares of the Common Stock and shares of other companies in the medical products and biomedical technology fields. Factors such as the announcement of new products and the achievement of developmental and regulatory milestones by the 15 Company or its competitors have caused and could cause the price of the Common Stock to fluctuate significantly. Moreover, although there has been a public trading market for the Common Stock since 1987, there have been periods of limited trading activity resulting in further volatility of the stock price. Additionally, the spread between the ask and bid prices for the Common Stock on the Nasdaq National Market System has been relatively wide, potentially discouraging investor trades in the Common Stock. Further, in the event that in some future fiscal quarter the Company's revenues were below the expectations of public market analysts and investors, the price of the Common Stock could be materially adversely affected. In addition, stock markets have experienced extreme price and volume trading volatility in recent years. This volatility has had a substantial effect on market prices of securities of many medical technology companies for reasons frequently unrelated or disproportionate to the operating performance of the specific companies. These broad market fluctuations may adversely affect the market price of the Common Stock. See "Price Range of Common Stock." SHARES ELIGIBLE FOR FUTURE SALE Sales of a substantial number of shares of Common Stock in the public market following this offering (pursuant to Rule 144 or otherwise), as well as sales of shares issued upon exercise of employee stock options, could adversely affect the prevailing market price of the Common Stock and impair the Company's ability to raise additional capital through the sale of equity securities. Of the approximately 8,264,556 shares of Common Stock outstanding at September 30, 1997, approximately 5,391,682 shares are eligible for resale in the public market without restriction and approximately 1,474,318 shares are eligible for resale subject to the provisions of Rule 144. The remaining 1,398,556 shares of Common Stock are "restricted securities"devices used solely within the meaning of Rule 144, of which 2,000 shares and 1,396,556 shares will not be eligible for resale until January and July 1998, respectively, the expiration of the one-year holding period under Rule 144, and then only in accordance therewith. In addition, there are 964,410 shares subject to outstanding options, which shares have been registered on Form S-8 and will therefore be subject to resale in the public market either without restriction or subject to the provisions of Rule 144. The holders of 1,396,556 shares of Common Stock have certain registration rights, commencing on July 14, 1998. The Company's executive officers, directors, Genzyme Corporation ("Genzyme") and each of the Selling Stockholders who, in the aggregate hold approximately 2,872,874 shares of Common Stock (2,722,874 shares of Common Stock after the sale of shares of Common Stock by the Selling Stockholders in the offering) have agreed that, for a period of 90 days from the date of this Prospectus, subject to certain limited exceptions, they will not, directly or indirectly, without the prior written consent of BancAmerica Robertson Stephens, sell, offer, contract to sell, pledge, grant any option to purchase or otherwise dispose of any shares of Common Stock or any securities convertible into or exchangeable for, or any rights to purchase or acquire, Common Stock held by them, thereafter acquired by them or which may be deemed to be beneficially owned by them. See "Certain Transactions" and "Underwriting." 16 USE OF PROCEEDS The net proceeds to the Company from the sale of the 2,250,000 shares of Common Stock offered by the Company hereby are estimated to be $46.7 million ($54.2 million if the Underwriters' over-allotment option is exercised in full), assuming an offering price of $22.125 per share and after deducting estimated underwriting discounts and commissions and offering expenses payable by the Company. The Company will not receive any proceeds from the sale of shares of Common Stock by the Selling Stockholders. The Company expects to use the net proceeds from this offering for research and development, expansion of its manufacturing capabilities and other general corporate purposes. In particular, the Company expects that a substantial portion of the net proceeds will be used to support the TAH and other development efforts, although there can be no assurance that the net proceeds will be so used. The Company may also use a portion of the net proceeds for strategic acquisitions of businesses, products or technologies complementary to the Company's business. The Company does not have any commitments to make any such acquisitions and has not allocated a specific amount of the net proceeds for this purpose. Pending such uses, the Company plans to invest the net proceeds of the offering in short-term, interest-bearing investment-grade securities. DIVIDEND POLICY The Company has never declared or paid cash dividends on its capital stock and does not plan to pay any cash dividends in the foreseeable future. The Company's current policy is to retain all of its earnings to finance future growth. 17 PRICE RANGE OF COMMON STOCK The Company's Common Stock is traded on the Nasdaq National Market under the symbol "ABMD." The following table sets forth, for the periods indicated, the high and low sales prices per share of Common Stock, as reported by the Nasdaq National Market.
HIGH LOW ------- ------- FISCAL YEAR ENDED MARCH 31, 1996 First Quarter................................................... $ 9 $ 6 Second Quarter.................................................. 13 1/4 6 7/8 Third Quarter................................................... 16 8 3/4 Fourth Quarter.................................................. 15 1/4 11 1/2 FISCAL YEAR ENDED MARCH 31, 1997 First Quarter................................................... 18 12 1/2 Second Quarter.................................................. 18 1/4 10 1/8 Third Quarter................................................... 18 1/4 11 1/2 Fourth Quarter.................................................. 13 1/4 9 1/2 FISCAL YEAR ENDING MARCH 31, 1998 First Quarter................................................... 16 9 1/2 Second Quarter.................................................. 19 13 1/2 Third Quarter (through October 9, 1997)......................... 23 1/8 16 3/4
The last reported sale price of the Common Stock on the Nasdaq National Market on October 9, 1997 was $22.125 per share. As of September 30, 1997, there were approximately 337 holders of record of the Company's Common Stock, including multiple beneficial holders at depositories, banks and brokers listed as a single holder in the street name of each respective depository, bank or broker. 18 CAPITALIZATION The following table sets forth as of September 30, 1997 the unaudited actual capitalization of the Company, and such capitalization as adjusted to reflect the receipt of the estimated net proceeds from the sale of 2,250,000 shares of Common Stock being offered by the Company hereby at an assumed offering price of $22.125 per share and after deducting estimated underwriting discounts and commissions and offering expenses payable by the Company.
SEPTEMBER 30, 1997 ------------------------ ACTUAL AS ADJUSTED ------------ ----------- (in thousands) Long-term debt....................................... $ -- $ -- ------------ ----------- Stockholders' investment (1): Class B Preferred Stock, $0.01 par value, 1,000,000 shares authorized; no shares issued and outstanding; ..................................... -- -- Common Stock, $.01 par value, 25,000,000 shares authorized; 8,264,556 shares issued and outstanding and 10,514,556 shares issued and outstanding as adjusted........................... 82,646 105,146 Additional paid-in capital......................... 53,221,747 99,867,419 Accumulated deficit................................ (20,655,947) (20,655,947) ------------ ----------- Total stockholders' investment................... 32,648,446 79,316,618 ------------ ----------- Total capitalization........................... $ 32,648,446 $79,316,618 ============ ===========
- -------- (1) Based on the number of shares outstanding as of September 30, 1997. Excludes 964,410 shares of Common Stock reserved for issuance upon the exercise of stock options outstanding as of September 30, 1997 at a weighted average exercise price of $10.81 per share. See Note 6 to Consolidated Financial Statements. 19 SELECTED CONSOLIDATED FINANCIAL DATA The following table contains certain selected consolidated financial data of the Company and is qualified in its entirety by the more detailed Consolidated Financial Statements included elsewhere in this Prospectus. The consolidated statements of operations data for the fiscal years ended March 31, 1995, 1996 and 1997, and the consolidated balance sheet data as of March 31, 1996 and 1997, have been derived from the Consolidated Financial Statements, which statements have been audited by Arthur Andersen LLP, independent public accountants, and are included elsewhere in this Prospectus. The consolidated statement of operations data for the fiscal years ended March 31, 1993 and 1994, and the consolidated balance sheet data as of March 31, 1993, 1994 and 1995 have been derived from the Company's consolidated financial statements, which statements have been audited by Arthur Andersen LLP and are not included in this Prospectus. The consolidated statement of operations data for the six months ended September 30, 1996 and 1997, and the consolidated balance sheet data as of September 30, 1997 have been derived from unaudited Consolidated Financial Statements included elsewhere in this Prospectus. These unaudited financial statements have been prepared on the same basis as the audited financial statements and, in the opinion of management, include all adjustments and reclassifications (consisting only of normal recurring adjustments and reclassifications) necessary to present fairly the financial condition and results of operations for the periods presented. The results for the six months ended September 30, 1997 are not necessarily indicative of the results that may be expected for the full year. This data should be read in conjunction with the Consolidated Financial Statements and "Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing elsewhere herein.
SIX MONTHS ENDED YEAR ENDED MARCH 31, SEPTEMBER 30, ------------------------------------------- ------------- 1993 1994 1995 1996 1997 1996 1997 ------- ------- ------- ------- ------- ------ ------ (in thousands, except per share data) STATEMENT OF OPERATIONS DATA: Revenues: Products.............. $ 1,709 $ 4,648 $ 6,893 $ 9,725 $12,311 $5,760 $9,324 Contracts............. 1,736 2,027 2,337 3,118 4,151 1,754 3,680 ------- ------- ------- ------- ------- ------ ------ Total revenues...... 3,445 6,675 9,230 12,843 16,462 7,514 13,004 Costs and expenses: Cost of products...... 2,042 2,211 3,289 3,921 5,361 2,123 3,438 Research and development (1)...... 2,097 2,431 2,464 3,218 3,833 1,781 3,654 Selling, general and administrative....... 3,803 4,553 4,278 5,741 7,068 3,229 4,970 ------- ------- ------- ------- ------- ------ ------ Total costs and expenses........... 7,942 9,195 10,031 12,880 16,262 7,133 12,062 ------- ------- ------- ------- ------- ------ ------ Income (loss) from operations............. (4,497) (2,520) (801) (37) 200 381 942 Interest and other income................. 604 537 449 528 535 256 417 ------- ------- ------- ------- ------- ------ ------ Net income (loss)....... $(3,893) $(1,983) $ (352) $ 491 $ 735 $ 637 $1,359 ======= ======= ======= ======= ======= ====== ====== Net income (loss) per common and common equivalent share....... $ (0.60) $ (0.31) $ (0.05) $ 0.07 $ 0.10 $ 0.09 $ 0.17 ======= ======= ======= ======= ======= ====== ====== Weighted average number of common and common equivalent shares outstanding............ 6,441 6,461 6,512 6,995 7,162 7,196 7,869
MARCH 31, --------------------------------------- SEPTEMBER 30, 1993 1994 1995 1996 1997 1997 ------- ------- ------- ------- ------- ------------- (in thousands) BALANCE SHEET DATA: Cash, cash equivalents and short-term marketable securities.. $ 9,486 $ 3,067 $ 4,491 $10,647 $ 9,361 $24,312 Working capital......... 10,727 6,043 6,304 12,735 12,850 29,109 Long-term investments... 4,307 7,219 6,533 -- -- -- Total assets............ 17,504 15,426 14,730 16,209 18,547 36,348 Long-term debt.......... 3,820 3,773 -- -- -- -- Total stockholders' investment (2)......... 12,460 10,589 13,305 13,945 15,225 32,648
- ------- (1) Research and development expenses include certain contract costs. See Note 1(e) to Consolidated Financial Statements. (2) No cash dividends on Common Stock were declared or paid during any of the periods presented. 20 MANAGEMENT'S DISCUSSION AND ANALYSIS OFFINANCIAL CONDITION AND RESULTS OF OPERATIONS The following Management's Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements which involve risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth under "Risk Factors" and elsewhere in this Prospectus. OVERVIEW The Company is a leader in the research and development of cardiac assist and heart replacement technology. The Company developed, manufactures and sells the BVS, a temporary cardiac assist device, and is developing a totally implantable artificial heart. The Company's operating results reflect the dual activities of commercial operations and investments in the research and development of new technologies. The BVS is a temporary cardiac assist device designed to provide a patient's failing heart with full circulatory assistance while allowing the heart to rest, heal and recover its function. The BVS is the only device that can provide full circulatory assistance approved by the FDA as a bridge-to-recovery device for the treatment of patients with reversible heart failure. Since fiscal 1994, the first full year of marketing the BVS in the United States, increasing new orders and reorders of the BVS have made product revenues the largest contributor to the Company's revenues. The Company has focused its initial selling efforts of the BVS on the approximately 300 medical centers that perform the most heart surgery procedures, teaching centers and transplant centers. As of September 30, 1997, the BVS had been purchased by over 275 medical centers in the United States, many of which are within the group of medical centers initially targeted. The BVS is comprised of a pneumatic drive and control console, single-use external blood pumps and cannulae. During the six months ended September 30, 1997 and fiscal 1997, revenues from BVS sales represented greater than 90% of the Company's total product revenues with no single customer representing more than 5% of product revenues. Research and development is a significant portion of the Company's operations. The Company's research and development efforts are focused on the development of new products, primarily related to cardiac assist and heart replacement, and the continued enhancement of the BVS and related technologies. The Company's research and development expenses have been primarily attributable to research and development under the Company's government contracts and grants. Revenues from contract research and development and total research and development costs have increased in each of the past three years. The Company's government-sponsored research and development contracts generally provide for payment on a cost-plus-fixed-fee basis. The Company accounts for revenue under these contracts and grants as work is performed, provided that the government has appropriated sufficient funds for the work. There can be no assurance that the government will not terminate, reduce or delay the funding for any of the Company's contracts. In addition, there can be no assurance that the Company will be successful in obtaining any new government contracts or further extensions to existing contracts. The Company plans to use its own resources to fund the further development of the TAH in amounts significantly in excess of the funding provided under the Company's TAH Contract. The Company estimates that the development of the TAH, including conducting pre-clinical and clinical studies and obtaining regulatory approvals, will require substantial funds. As a result, the Company believes that it is likely that the Company will incur losses, potentially as soon as the quarter ending December 31, 1997. There can be no assurance that the Company will be able to develop the TAH, or receive the required regulatory approvals to commence clinical trials on a timely basis or within budget, if at all. The Company has significant net tax operating loss carryforwards and tax credit carryforwards. As a result, income tax expense incurred during the periods presented have not been material. See Note 4 to Consolidated Financial Statements. 21 RESULTS OF OPERATIONS The following table sets forth certain consolidated statements of operations data for the periods indicated as a percentage of total revenues:
SIX MONTHS ENDED YEAR ENDED MARCH 31, SEPTEMBER 30, ----------------------- -------------- 1995 1996 1997 1996 1997 ------ ------ ------ ------ ------ Revenues: Products.................. 74.7% 75.7% 74.8% 76.7% 71.7% Contracts................. 25.3 24.3 25.2 23.3 28.3 ------ ------ ------ ------ ------ Total revenues.......... 100.0 100.0 100.0 100.0 100.0 Costs and expenses: Cost of products.......... 35.6 30.5 32.6 28.2 26.5 Research and development.. 26.7 25.1 23.3 23.7 28.1 Selling, general and administrative........... 46.4 44.7 42.9 43.0 38.2 ------ ------ ------ ------ ------ Total costs and expenses............... 108.7 100.3 98.8 94.9 92.8 ------ ------ ------ ------ ------ Income (loss) from operations................. (8.7) (0.3) 1.2 5.1 7.2 Interest and other income... 4.9 4.1 3.2 3.4 3.2 ------ ------ ------ ------ ------ Net income (loss)........... (3.8)% 3.8% 4.4% 8.5% 10.4% ====== ====== ====== ====== ======
Six Months Ended September 30, 1997 and 1996 Revenues. Total revenues, excluding interest income, increased by 73% to $13.0 million in the six months ended September 30, 1997 from $7.5 million in the six months ended September 30, 1996. This increase was attributable to an increase in both product and contract revenues. Product revenues increased by 62% to $9.3 million in the six months ended September 30, 1997 from $5.8 million in the six months ended September 30, 1996. This increase was primarily attributable to increased unit sales of BVS blood pumps, consoles and related accessories. Product revenues during the six months ended September 30, 1997 included a $640,000 reduction in the Company's backlog for BVS blood pumps. This backlog had primarily resulted from the Company's voluntary recall of certain production lots of single-use BVS blood pumps during the quarter ended December 31, 1996. As of September 30, 1997, the Company's backlog of unshipped customer orders was $370,000. More than 90% of total product revenues in the six months ended September 30, 1997 were derived from domestic sources. Contract revenues increased by 110% to $3.7 million in the six months ended September 30, 1997 from $1.8 million in the six months ended September 30, 1996. This increase primarily reflected increased activity under the Company's TAH Contract. The Company accounts for revenue under its government contracts and grants as work is performed, provided that the government has appropriated sufficient funds for the work. Through September 30, 1997, the government had appropriated $4.9 million of the $8.5 million Phase II TAH Contract amount. The original government appropriation schedule calls for no further appropriation for the TAH Contract until October 1998. This schedule is subject to change at the discretion of the government. During the six months ended September 30, 1997, the Company's expenditures under the TAH Contract exceeded the appropriated amount, resulting in the Company recognizing as revenue all of the remaining $3.2 million balance of the $4.9 million appropriated under the TAH Contract. While the Company currently plans to further increase its expenditures in connection with the development of the TAH, the Company will not recognize any further contract revenues under the TAH Contract until such time as additional funds are appropriated under the TAH Contract, if ever. The Company believes that certain of its costs incurred prior to further appropriations may be reimbursable under the TAH 22 Contract, if and when additional appropriation under the TAH Contract is made. Due to the Company's accelerated TAH development activity and the timing of government appropriations, the Company believes that it will experience significant quarterly fluctuations in contract revenues. The Company also believes that its total expenses to complete the development of the TAH will significantly exceed the remaining $3.6 million TAH Contract amount. As a result, the Company believes that it is likely that the Company will again incur losses, potentially as soon as the quarter ending December 31, 1997. As of September 30, 1997, the Company's total backlog of research and development contracts and grants was $8.7 million, including the remaining $3.6 million under the TAH Contract and $3.0 million for Heart Booster research and development. Funding for the Company's government research and development contracts is subject to government appropriation, and all of these contracts contain provisions which make them terminable at the convenience of the government. Cost of Products. Cost of products sold as a percentage of product revenues remained unchanged at 36.9% for the six months ended September 30, 1997 and 1996. Research and Development Expenses. Research and development expenses increased by 105% to $3.7 million, 28% of total revenues, for the six months ended September 30, 1997, from $1.8 million, 24% of total revenues, for the six months ended September 30, 1996. This increase primarily reflected a higher level of activity under the Company's cost-plus-fixed-fee research and development contracts and grants, particularly the TAH Contract. Research and development expenses during the six months ended September 30, 1997 also included $230,000 of expenses incurred in connection with the Company's development activities for the TAH in excess of the appropriated amounts under the TAH Contract. The Company anticipates that its research and development expenses will increase significantly as a result of its plans to increase its internally funded research and development efforts for TAH. Selling, General and Administrative Expenses. Selling, general and administrative expenses increased by 54% to $5.0 million, 38% of total revenues, for the six months ended September 30, 1997 from $3.2 million, 43% of total revenues, for the six months ended September 30, 1996. The increase in absolute dollars primarily reflected increased sales and marketing expenses, particularly increased personnel and sales commissions, related to the increase in product revenues, as well as additional administrative personnel. The decrease in selling, general and administrative expenses as a percentage of total revenues reflected the Company's higher revenue base to support these increased costs. Interest and Other Income. Interest and other income consists primarily of interest on the Company's investment balances, net of interest and other expenses. Interest income increased by 62% to $417,000, 3% of total revenues, for the six months ended September 30, 1997, from $257,000, 3% of total revenues, for the six months ended September 30, 1996. This increase primarily reflected the interest earned on the Company's higher average investment balances. Fiscal Years Ended March 31, 1997, 1996 and 1995 Revenues. Total revenues, excluding interest income, for fiscal 1997 increased to $16.5 million as compared to $12.8 million in fiscal 1996 and $9.2 million in fiscal 1995, representing increases of 28% and 39% in fiscal 1997 and 1996, respectively. Product revenues increased to $12.3 million in fiscal 1997 from $9.7 million in fiscal 1996, and $6.9 million in fiscal 1995, representing increases of 27% and 41% in fiscal 1997 and fiscal 1996, respectively. These increases were primarily attributable to growing United States unit sales of the BVS consoles and single-use products, including increased blood pump reorders, and to increased average selling prices of BVS consoles and single-use products. The majority of the Company's product revenues in the last three years have been to United States customers. International revenues represented 7%, 9% and 13% of total product revenues in fiscal 1997, 1996 and 1995 respectively. The Company's product revenues from its dental business, ABIODENT, increased in fiscal 1997 but were less than 10% of total product revenues. 23 Contract revenues increased to $4.2 million in fiscal 1997 from $3.1 million in fiscal 1996 and $2.3 million in fiscal 1995, representing increases of 33% in both fiscal 1997 and 1996. These increases are reflective of the increased level of the Company's research and development activities under its government cost reimbursement contracts in each year. The majority of the Company's contract revenues, approximately 59% in fiscal 1997, were recognized in connection with the research and development under the TAH Contract, including amounts paid under Phase I of that contract. Cost of Products. Cost of products represented approximately 44%, 40% and 48% of product revenues for fiscal 1997, 1996 and 1995, respectively. The decrease in gross product margins experienced in fiscal 1997 as compared to fiscal 1996 is primarily attributable to the mix of products sold. The Company generally receives higher margins on the sale of single-use blood pumps than on the sale of consoles. A higher proportion of the Company's revenues was derived from the sale of BVS consoles in fiscal 1997 as compared to fiscal 1996. In addition, the Company's margins in fiscal 1997 were affected by increased costs of production of the single-use blood pumps, including approximately $200,000 in costs related to the Company's voluntary recall during the third quarter of fiscal 1997 of certain production lots of single- use BVS blood pumps. During that quarter, the Company became aware of certain isolated cases where components of its BVS blood pumps exhibited certain abnormalities. In response the Company commenced a product recall for and removed from inventory all blood pumps from the affected production lots. Research and Development Expenses. Cost of research and development increased to approximately $3.8 million, 23.3% of total revenues, in fiscal 1997 compared to $3.2 million, 25.1% of total revenues, and $2.5 million, 26.7% of total revenues, in fiscal 1996 and 1995, respectively. These increases reflect increased activity under research and development contracts and grants, which are billed on a cost-plus-fixed-fee basis. Costs of internal research and development primarily relate to continued engineering support and improvement of existing products as well as regulatory support for all products. Selling, General and Administrative Expenses. Selling, general and administrative expenses increased to $7.1 million, 42.9% of total revenues, in fiscal 1997 from $5.7 million, 44.7% of total revenues, and $4.3 million, 46.4% of total revenues, in fiscal 1996 and fiscal 1995, respectively. These increases primarily reflect increased costs associated with higher product revenues, including the expansion of the United States based sales team and clinical post-sales support personnel. The decreases in selling, general and administrative expenses as a percentage of total revenues in fiscal 1996 and 1997 primarily reflect the Company's higher revenue base to support these increased costs. Interest and Other Income. Interest and other income totaled $540,000, $530,000, and $450,000, for fiscal 1997, 1996 and 1995, respectively. This income primarily represents income earned on short-term investments. LIQUIDITY AND CAPITAL RESOURCES As of September 30, 1997, the Company had $24.3 million in cash and short- term marketable securities. The Company also has a $3.0 million line of credit from a bank that expires in September 1998, and which was entirely available at September 30, 1997. During the six months ended September 30, 1997, operating activities provided $2,000 of cash. Net cash provided by operating activities during the six months ended September 30, 1997 reflected net income of $1.4 million, including depreciation and amortization expense of $440,000, and an increase in accrued expenses of $535,000. These sources of cash were partially offset by an increase in accounts receivable of $2.0 million, a decrease in accounts payable of $156,000, and increases in prepaid expenses and inventory of $220,000 and $30,000, respectively. The increase in the Company's accounts receivable was primarily attributable to the Company's increased sales, including an increase in product revenues attributable to sales-type lease transactions. 24 During the six months ended September 30, 1997, investing activities used $17.0 million of cash. Net cash used by investing activities included $15.9 million of purchases of short-term investments and $1.1 million of purchases and improvements of property and equipment. Although the Company does not currently have significant capital commitments, the Company believes that it will continue to make significant investments over the next several years to support the development and commercialization of its products and the expansion of its manufacturing facility. During the six months ended September 30, 1997, financing activities provided $16.1 million of cash. Net cash provided by financing activities included $16.0 million in net proceeds from the private placement of Common Stock to Genzyme Corporation and certain of the Company's directors in July 1997. The Company believes that its revenues and existing resources, together with the proceeds from the offering, will be sufficient to fund its planned operations, including the planned increase in its internally funded TAH development efforts, for at least through the next twelve months. 25 BUSINESS The Company is a leader in the research and development of cardiac assist and heart replacement technology. The Company developed, manufactures and sells the BVS, a temporary cardiac assist device designed to provide a patient's failing heart with full circulatory assistance while allowing the heart to rest, heal and recover its function. The BVS is most frequently used in patients whose hearts fail to immediately recover function following heart surgery. The BVS is the only device that can provide full circulatory assistance approved by the FDA as a bridge-to-recovery device for the treatment of patients with reversible heart failure. The Company is developing a battery-powered totally implantable artificial heart intended as a permanent replacement device to assume the full pumping function of both the left and right ventricles of the heart. The TAH is designed for use by patients with irreparably damaged hearts and at risk of death due to acute myocardial infarction ("AMI"), chronic ischemic disease or some form of end-stage congestive heart failure, but whose vital organs otherwise remain viable. HEART DISEASE Overview The human heart consists of four chambers, including a left and right ventricle. The left ventricle pumps oxygen rich blood throughout the body. The right ventricle pumps oxygen depleted blood which has been circulated through the body to the lungs where it is re-oxygenated. The heart muscles of the ventricles require an uninterrupted supply of oxygenated blood, which is provided through coronary arteries. Insufficient blood flow to the muscles of the heart, known as ischemia, results in oxygen deprivation and leads to various complications. These complications include reduced cell function and, in more severe cases, permanent damage to the heart muscle, such as AMI. Diseases to the coronary arteries which affect blood flow to the heart are generally classified as coronary heart disease. Congestive heart failure is a condition manifested clinically by an enlarged heart. Congestive heart failure develops over time primarily due to excess demand on the heart muscle caused by a variety of factors, including chronic hypertension (high blood pressure), incompetent valves, coronary heart disease, infections of the heart muscle or the valves and congenital heart problems. Abnormalities in the electrical conduction system regulating the pumping function of the heart, known as rhythm disorders, can also lead to complications. These complications range from ventricular fibrillation (unsynchronized contractions) and arrhythmia (irregular heartbeats) to cardiac arrest. Most cardiac arrests result in sudden death. Prevalence and Mortality In 1994, there were an estimated 13.7 million people with coronary heart disease, 4.8 million people with congestive heart failure, 4.0 million people with rhythm disorders, and 1.4 million people with valvular diseases in the United States. These diseases and conditions resulted in approximately 750,000 deaths in 1995, of which approximately half were sudden deaths. Of the deaths that did not occur suddenly, approximately 110,000, 131,000, and 59,000 were associated with AMI, chronic ischemic disease and congestive heart failure, respectively. Circulatory Support Therapies In general, there are four modalities for the treatment or support of failing ventricles: pharmaceutical therapies, cardiological interventions, surgical corrections, and mechanical cardiac interventions. Pharmaceutical therapies, including diuretics, ACE inhibitors, beta blockers and calcium channel blockers, are commonly the first treatment option. Cardiological interventions, including angioplasty and the use of stents, are minimally invasive procedures that primarily address certain forms of coronary heart disease. Surgical corrections, including coronary bypass surgery and valve replacement, while effective, are a viable alternative only for those patients with enough functional heart muscle to sustain life. Mechanical cardiac 26 interventions involve the use of devices for those patients whose heart muscles are unable to sustain life without cardiac assistance. Mechanical Cardiac Interventions Mechanical cardiac interventions can be divided into three groups of devices: temporary cardiac assist, permanent cardiac assist and heart replacement. Temporary Cardiac Assist. Patients who are candidates for temporary cardiac assist consist of those with severely but reversibly failing hearts and those who need ventricular support to remain alive while they await transplantation. Temporary cardiac devices which are designed to support the recovery of patients with reversibly failing hearts are referred to as "bridge-to- recovery" devices, and those which can support patients awaiting transplantation are referred to as "bridge-to-transplant" devices. Approximately 12,000 patients with potentially recoverable hearts die every year in the United States following heart surgery. Bridge-to-recovery devices can save the lives of many of these patients by temporarily assuming the pumping function of the heart, while allowing the heart to rest, heal and recover its normal function. These devices can also be used for bridge-to- recovery for nonsurgical patients who would otherwise die as a result of certain transient viral infections that attack the heart muscle. Bridge-to- transplant devices are ventricular assist devices ("VADs") used to support a portion of the patients awaiting heart transplants. There are approximately 2,300 heart transplants performed in the United States annually. Permanent Cardiac Assist. Patients with life-impairing or life-threatening heart failure due to permanent muscle damage may require support to either the left or both ventricles. Depending upon the severity of the damage and the nature of the heart's condition, these patients may be helped with permanent assist devices. Permanent assist devices under development can be grouped into two types, those that pump blood directly, such as VADs, and those that wrap around and help contract the heart without direct blood contact. Both types potentially may be used to treat end-stage congestive heart failure patients as well as those patients who are not at imminent risk of death but whose daily activities are generally restricted due to their weakened hearts. In 1995, there were approximately 59,000 deaths in the United States attributable to congestive heart failure. Heart Replacement. Patients with irreparably damaged hearts and at risk of death due to AMI, chronic ischemic disease or some form of end-stage congestive heart failure but whose vital organs otherwise remain viable are candidates for heart replacement. Included among these patients are those with massive heart damage or infection, severe rhythm disorders, prosthetic valves, clots or thrombi in the ventricles, high pulmonary resistance, chronic right ventricle failure and heart transplant rejection. Among these combined groups, the Company believes that approximately 60,000 patients per year could benefit from a heart replacement device. No life-supporting treatment is currently available for these patients except for the approximately 2,300 who receive heart transplants annually in the United States. Currently, available donor hearts are primarily reserved for transplantation of select end-stage congestive heart failure patients because many of these patients are able to survive for the long waiting periods required before a suitably matched donor heart can be found. The Company believes that the development of an artificial heart would increase the number of lives saved by eliminating the scarcity of, and waiting period for, available hearts. ABIOMED PRODUCTS AND PRODUCTS UNDER DEVELOPMENT The Company markets the BVS, which is a temporary cardiac assist device, and is developing the TAH and the Heart Booster, which are replacement and permanent cardiac assist devices, respectively. The BVS-5000 Bi-Ventricular Assist System. The BVS is a temporary cardiac assist device designed to provide a patient's failing heart with full circulatory assistance while allowing the heart to rest, heal and recover its function. The BVS is most frequently used in patients whose hearts fail to immediately recover function following heart surgery. In November 1992, the Company received PMA approval from the FDA for 27 the BVS for this post-surgery therapy. In 1996 and 1997, the FDA approved the use of the BVS for additional indications, expanding its use for the treatment of all patients with reversible heart failure as a bridge-to-recovery device. The BVS is the only device that can provide full circulatory assistance approved by the FDA for the treatment of these patients. The BVS system is comprised of a microprocessor-based pneumatic drive and control console, single-use external blood pumps and cannulae. The BVS console incorporates a closed-loop control system that automatically adjusts the pumping rate, similar to the natural heart. The dual-chamber blood pumps provide complete or partial pumping of blood for the left, right or both sides of a patient's heart and are designed to mimic the function of the natural heart. The BVS blood pumps reduce the risk of damaging blood cells by filling the ventricles passively and continuously by gravity rather than by suction. The cannulae are specially designed tubes used to connect the blood pumps to the heart. The integration of the cannulae, blood pumps and console creates a system with the ability to reduce the load on the heart, provide pulsatile blood flow to vital organs and allow the heart muscles time to rest and recover. Stabilization of patients who recover under BVS support typically occurs in a period of less than one week. The BVS is designed to be simple and easy to use and does not require a specially trained technician to constantly monitor or adjust the pumping parameters, which can reduce hospital operating costs. The following diagram illustrates the BVS. [SCHEMATIC OF PATIENT LYING IN BED ON BVS SUPPORT. COMPONENTS OF THE BVS ARE IDENTIFIED WITH CAPTIONS.] 28 The BVS is intended for use in any hospital performing open-chest cardiac surgery, of which there are more than 900 in the United States. As of September 30, 1997, the BVS had been purchased by over 275 medical centers in the United States including many of the largest centers. Typically, medical centers initially purchase the BVS console, two to four BVS single-use blood pumps, cannulae, training and related accessories. The BVS is capable of supporting the left, right or both ventricles of the heart. In the Company's clinical experience, approximately half of the patients required support to both ventricles of the heart, and therefore the use of two single-use BVS blood pumps. The Company's United States list price for a BVS console, and a blood pump and cannulae set are $59,500 and $6,950, respectively. The Totally Implantable Artificial Heart (TAH). The Company is developing a battery-powered totally implantable artificial heart intended as a permanent replacement device to assume the full pumping function of both the left and right ventricles of the heart. The TAH is designed for use by patients with irreparably damaged hearts and at risk of death due to AMI, chronic ischemic disease or some form of end-stage congestive heart failure but whose vital organs otherwise remain viable. Included among these patients are those with massive heart damage or infection, severe rhythm disorders, prosthetic valves, clots or thrombi in the ventricles, high pulmonary resistance, chronic right ventricle failure and heart transplant rejection. The core technology for the TAH has been under development by the Company since the Company's inception. The Company has completed its feasibility studies of the TAH system and substantially finalized the design of the TAH. The system and individual components have been tested through a variety of laboratory and animal tests. The Company is currently accelerating the development of the TAH and is devoting significant resources towards improving the manufacturing process in order to reach consistency and reliability levels necessary to conduct advanced pre-clinical and clinical trials. The Company's goal is to initiate clinical trials of the TAH by the end of the year 2000. There can be no assurance that the Company will be able to successfully complete pre-clinical testing of the TAH and receive FDA approval to begin clinical trials of the TAH in a timely manner, if at all. Moreover, pre- clinical trials may not be predictive of results that will be obtained in clinical trials. The Company is consulting with regulatory authorities, leading medical centers and physicians to define protocols and patient populations for future clinical trials. The Company has built a new development and pilot-scale manufacturing facility, and has significantly increased the personnel focused on the manufacturability and testing of the TAH. The TAH system is comprised of a thoracic unit, or "replacement heart," a rechargeable battery, a miniaturized electronics package, a transcutaneous energy transmission system, and an external belt-worn battery pack. The thoracic unit includes two artificial ventricles with their associated valves and a hydraulic pumping system. The unit provides complete pumping of the blood to the lungs and throughout the body. The ventricles and their associated valves are being designed and manufactured with seamless surfaces which reduce the risk of damaging blood cells, or creating clots or thrombi. The electronics package automatically adjusts the rate and amount of blood flow to the patient's needs, similar to the natural heart. The implantable rechargeable battery and the transcutaneous energy transmission system eliminate the need for wires penetrating the patient's skin and associated risks of infection. The entire TAH system is being designed to be highly reliable with minimal maintenance and patient involvement. 29 The following diagram illustrates the TAH. [SCHEMATIC OF UPPER TORSO OF PATIENT WITH A TAH IMPLANTED. COMPONENTS OF THE TAH ARE IDENTIFIED WITH CAPTIONS.] Much of the development of the TAH has been funded by the NHLBI. Prior to receiving its most recent $8.5 million TAH Contract extension, the Company demonstrated to the NHLBI that the basic design of the system functioned in laboratory and animal models without significant complications. The Company retains the right to market the resulting TAH without royalty to NHLBI. The Company is responsible for the complete research and development program and has collaborated over the past nine years with the Texas Heart Institute for pre-clinical product testing and evaluation. The Heart Booster. The Company is developing the Heart Booster as a permanent cardiac assist device designed to wrap around and help contract the heart without direct blood contact. The Heart Booster is being designed for use in patients with congestive heart failure who are not at imminent risk of death, but whose daily activities are generally restricted due to their weakened hearts. This device, unlike most devices being developed to pump blood directly, avoids the potential risks of damage to blood cells and formation of clots and thrombi. The Heart Booster consists of a pliant and thin artificial plastic "muscle" that can be wrapped around the heart. This artificial muscle is being developed to mimic the contraction-relaxation characteristics of the heart muscle and provide sufficient contractility. The design goal of the Heart Booster is to restore an acceptable and active quality of life to the patient. The Heart Booster is in an earlier stage of research and development than the TAH and is being developed under a five year, $4.3 million contract from the NHLBI. Columbia Presbyterian Medical Center is collaborating with the Company on this project for pre-clinical testing and evaluation. There can be no assurance that the Company will be successful in developing the Heart Booster. 30 ABIOMED STRATEGY The Company's goal is to be a leader in the development, manufacture and marketing of mechanical cardiac assist and replacement devices that address the varying needs of a wide range of patients.The Company is pursuing the following strategies to achieve this objective. Accelerate Development of the TAH. The Company is devoting significant resources with the goal to be the first to clinically introduce a totally implantable artificial heart. The Company is consulting with regulatory authorities, leading medical centers and physicians to define protocols and patient populations for future clinical trials. The Company has built a new development and pilot-scale manufacturing facility, and has significantly increased the personnel focused on the manufacturability and testing of the TAH. Increase Market Penetration of BVS. The Company has recently increased the size of both its domestic sales force and its clinical support group. Its sales force focuses on BVS sales to new customers, while its clinical support group focuses on training and educating existing customers in order to improve clinical outcomes and increase BVS blood pump usage. As of September 30, 1997, the BVS had been purchased by over 275 medical centers in the United States, including many of the largest centers. The Company believes that its relationships with its customers will facilitate the adoption of the BVS by other medical centers. Maintain and Enhance Technological Leadership. The Company is a leader in the research and development of mechanical cardiac assist and replacement devices. The Company has accumulated substantial proprietary knowledge and has been granted a number of patents relating to the technologies incorporated in these devices. The Company intends to continue to enhance and expand upon its core technical expertise to maintain its leadership and to further develop advanced mechanical cardiac assist and replacement devices. Pursue Strategic Relationships to Support Research and Commercialization Efforts. Many of the Company's products under development, including the TAH, have been funded using government contracts and grants. The Company seeks funding from third parties to support its research and development programs and generally limits the use of its own funds until the scientific risk is reduced. In addition, the Company intends to pursue collaborative relationships to develop and commercialize the Company's non-cardiac assist technologies. MARKETING AND SALES Approximately 900 medical centers in the United States perform heart surgery. The Company has focused its initial BVS selling efforts on teaching and transplant centers as well as the medical centers that perform the most heart surgery procedures. As of September 30, 1997, the BVS had been purchased by over 275 medical centers in the United States, many of which are within the group of medical centers initially targeted. The Company believes that its installed base of customers provides an opportunity for reorders of the single-use BVS blood pumps as well as a reference basehospitals to assist in selling to new accounts. The Company sells the BVS in the United States through direct sales and clinical support teams. As of September 30, 1997, the Company's BVS sales, clinical support, marketing and field service teams included 35 full-time employees. Its sales force focuses on BVS sales to new customers. Its clinical support group focuses on training and educating existing customers in order to improve clinical outcomes and increase BVS blood pump usage. The Company believes the efforts of its clinical support group contribute significantly to increasing the number of lives saved by the BVS and increasing usage and reorders of BVS blood pumps. The Company also believes that its sales and support teams will be key assets for the introduction of potential future products such as the TAH. Building on its experience in the United States, the Company also is working to expand its international sales efforts both through distributors, including a recent collaborative arrangement for distribution in Japan, and by selling directly in select European markets. The Company believes that sales of its BVS may be somewhat seasonal, with reduced sales in the summer months, reflecting hospital personnel and physician vacation schedules. 31 MANUFACTURING The Company manufactures the BVS console, BVS blood pumps and related accessories. The manufacture of BVS consoles consists primarily of assembly, testing and quality control. The Company purchases the majority of the materials, parts and peripheral components used in the BVS consoles. The Company manufactures certain blood contacting components for the BVS blood pumps, including valves and bladders, from its proprietary Angioflex polymer. The nature of the Company's products requires high quality manufacturing. The Company's manufacturing and quality testing processes and procedures are highly dependent on the diligence and experience of the Company's personnel. To the extent that the Company's manufacturing volumes expand or the Company begins the manufacture of new products, this dependence on personnel will likely increase. In addition, the manufacture of blood contacting surfaces of the Company's products requires a high degree of precision. These surfaces are manufactured from polyurethane-based materials. The quality and composition of polyurethane-based products can vary significantly based on numerous factors including humidity, temperature, material content and air flow during the manufacturing process. The Company's products also incorporate plastic components for non-blood contacting surfaces. The Company relies on third- party vendors to provide these components to the Company's specifications. The Company is not able to fully inspect the quality of all vendor supplied components and, therefore, relies on its vendors with respect to the quality of these components. Once the plastic-based components of the Company's products have been assembled, accessibility for inspection is limited. If a defect is detected in as few as one of the Company's products, or in one component of a Company product, it can result in the recall or restriction on sale of products. Once assembled, in most cases, the Company's blood contacting components cannot be reworked for human use. The manufacturing lead times for parts and assemblies, particularly the polyurethane-based components, can take many weeks from the date that all materials and components are received by the Company. In addition, vendor lead times for materials and components of the Company's products vary significantly, with lead times for certain materials and components exceeding six months. The Company is planning to expand its manufacturing facility for the BVS during the next twelve months. There can be no assurance that the products manufactured in the expanded facility will be manufactured at the same cost and quality as the BVS is currently being manufactured. In addition, to the extent that the Company's products under development have been manufactured, they have been manufactured as prototypes with, at most, pilot-scale production. The Company's products under development are likely to involve additional manufacturing complexities and high quality requirements. There can be no assurance that the Company will be able to increase production of the BVS or manufacture future products, if developed and approved, in commercial quantities on a consistent and timely basis, with acceptable cost and quality. The inability to manufacture current and future products in sufficient quantities in a timely manner, and with acceptable cost and quality, would have a material adverse effect on the Company's business, financial condition and results of operations. The Company relies on outside vendors to supply certain components used in the BVS and in its products under development. Certain of the components of the BVS are supplied by sole source vendors or are custom made for the Company. From time to time, suppliers of certain components of the BVS have indicated that they intend to discontinue, or have discontinued, making such components. In addition, certain of these components are supplied from single sources due to quality considerations, costs or constraints imposed by regulatory authorities. There are relatively few additional sources of supply for such components and establishing additional or replacement suppliers for such components cannot be accomplished quickly and may require FDA approval. In the past, certain suppliers have announced that, due to government regulation or in an effort to reduce potential product liability exposure, they intend to limit or terminate sales of certain products to the medical industry. There can be no assurance that, if such an interruption were to occur, the Company would be able to find suitable alternative supplies at reasonable prices or would be able to obtain requisite regulatory approvals in a timely manner, if at all. Similarly, when and if the Company reaches the clinical testing stage of its products under development, it may find that certain components become more 32 difficult to source from outside vendors due to the product liability risk perceived by those vendors. The Company's inability to obtain acceptable components in a timely manner or to find suitable replacements at an acceptable cost would have a material adverse effect on the Company's business, financial condition and results of operations. RESEARCH AND PRODUCT DEVELOPMENT The Company has substantial expertise in electro-mechanical systems, cardiac physiology and experimental surgery, blood-material interactions, fluid mechanics and hemodynamics, internal and external electronic hardware, software, plastics processing, lasers and optical physics. The Company's research and development efforts are focused on the development of new products, primarily related to mechanical cardiac assist and heart replacement, and the continued enhancement of the BVS and related technologies. The Company's research and development personnel also are involved in establishing protocols, monitoring and submitting test data to the FDA and corresponding foreign regulatory agencies to obtain the necessary clearances and approvals for its products. Sophisticated tools, such as 3- dimensional CAD/CAM, and procedures are used in an effort to ensure smooth transition of new products from research to product development to manufacturing. Cardiac assist products currently under development by the Company include the TAH, the Heart Booster, and a variety of specialized pumps, such as a miniaturized rotary blood pump and a magnetically-suspended centrifugal pump. The Company is also developing devices in the area of minimally invasive surgery applications, such as tissue welding and vascular welding for the repair of small arteries. During the six months ended September 30, 1997 and the fiscal years ended March 31, 1997, 1996 and 1995, the Company expended $3.7 million, $3.8 million, $3.2 million and $2.5 million, respectively, on research and development. A substantial portion of these expenses were funded by government contracts and grants. See "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business--Strategic Relationships." STRATEGIC RELATIONSHIPS Genzyme In July 1997, the Company sold 1,153,846 shares of Common Stock to Genzyme Corporation ("Genzyme"). In connection with this sale, the Company and Genzyme agreed to discuss collaborative arrangements that would allow them to jointly develop and commercialize products which combine biotechnology and biomedical engineering, primarily for the surgical market. A potential target for collaboration is minimally invasive cardiac surgery, an emerging field in which surgeons use new products and techniques to reduce the trauma, recovery period, and expense of heart surgery. The Company and Genzyme are engaged in ongoing discussions regarding this potential collaboration. The Chief Executive Officer of Genzyme is a member of the Company's board of directors. There can be no assurance that the Company and Genzyme will agree to jointly collaborate on any project, that any such project would result in the development of any product, or that any such product, if developed, would be commercially successful. See "Certain Transactions." National Heart, Lung and Blood Institute Since the Company's inception, United States government agencies, particularly the NHLBI, have provided significant support to the Company's product development efforts. The most significant current funding from the NHLBI supports the Company's development of the TAH and Heart Booster. In September 1996, the Company received an $8.5 million extension to its TAH Contract from the NHLBI. In September 1995, the Company received a $4.3 million contract from the NHLBI to develop the Heart Booster. During the six months ended September 30, 1997 and the fiscal years ended March 31, 1997, 1996 and 1995, the 33 Company recognized revenues of $3.7 million, $4.2 million, $3.1 million and $2.3 million, respectively, under United States government contracts and grants. All of the Company's government contracts and grants contain provisions making them terminable at the convenience of the government and are subject to government appropriations. There can be no assurance that the government will not terminate, reduce or delay the funding for any of the Company's contracts. In addition, there can be no assurance that the Company will be successful in obtaining any new government contracts or further extensions to existing contracts. COMPETITION Competition in the cardiac assist market is intense and subject to rapid technological change and evolving industry requirements and standards. Many of the companies developing or marketing cardiac assist products have substantially greater financial, product development, sales and marketing resources and experience than the Company. These competitors may develop superior products or products of similar quality at the same or lower prices. Moreover, there can be no assurance that improvements in current or new technologies will not make them technically equivalent or superior to the Company's products in addition to providing cost or other advantages. Other advances in medical technology, biotechnology and pharmaceuticals may reduce the size of the potential markets for the Company's products or render those products obsolete. The BVS is the only device that can provide full circulatory assistance approved by the FDA as a bridge-to-recovery device for the treatment of patients with reversible heart failure. However, the Company is aware of at least one other company, Thoratec Laboratories Corporation, seeking approval of a temporary cardiac assist device to address this market. Approval by the FDA of products that compete directly with the BVS would increase competitive pricing and other pressures and could have a material adverse effect on the Company's business, financial condition and results of operations. The Company believes that it would compete with any such product on the basis of cost, clinical outcome and customer relations. There can be no assurance that the Company would be able to compete effectively with respect to these factors. The Company is aware of other artificial heart development efforts in the United States, Canada, Europe and Japan. A team comprised of Pennsylvania State University and 3M Corporation, Inc. has been developing a heart replacement device for many years with significant NHLBI support. There are a number of companies, including Thermo Cardiosystems, Inc. and Novacor, a division of Baxter International, Inc., which are developing permanent cardiac assist products, including implantable left ventricular assist devices and miniaturized rotary ventricular assist devices, that may address markets that overlap with certain segments of the markets targeted by the Company's TAH. The Company's TAH may compete with those VADs for some patient groups, notably patients with severe congestive heart failure due to predominant left ventricle dysfunction. An implantable VAD supplements the pumping ability of a failing ventricle. In contrast, the TAH is being designed to replace failing ventricles. The Company believes that Thermo Cardiosystems, Inc. has commenced clinical testing for PMA approval of LVADs for permanent cardiac assist. The Company believes that the TAH, LVADs and other VADs, if developed, will generally be used to address the needs of different patient populations, with an overlap for certain segments of the heart failure population. There can be no assurance that the Company will develop and receive FDA approval to market its TAH on a timely basis, if at all, or that once developed, the TAH will be commercially successful. The Company's customers frequently have limited budgets. As a result, the Company's products compete against the broad range of medical devices for these limited funds. The Company's success will depend in large part upon its ability to enhance its existing products and to develop new products to meet regulatory and customer requirements and to achieve market acceptance. The Company believes that important competitive factors with respect to the development and commercialization of its products include the relative speed with which it can develop products, establish clinical utility, complete clinical testing and regulatory approval processes, obtain reimbursement and supply commercial quantities of the product to the market. There can be no assurance that the Company will be able to compete successfully or that competition will not have a material adverse effect on the Company's business, financial condition and results of operations. 34 THIRD-PARTY REIMBURSEMENT The Company's BVS product is, and most of its products under development are intended to be, sold to medical institutions. Medical institutions and their physicians typically seek reimbursement for the use of these products from third-party payors, including Medicare, Medicaid, private health insurers and managed care organizations. As a result, market acceptance of the Company's current and proposed products may depend in large part on the extent to which reimbursement is available to medical institutions and their physicians for use of the Company's products. The level of reimbursement provided by United States and foreign third-party payors varies according to a number of factors, including the medical procedure category, payor, location, outcome and cost. In the United States, many private health care insurance carriers follow the recommendations of HCFA, which establishes guidelines for the reimbursement of health care providers treating Medicare and Medicaid patients. Internationally, healthcare reimbursement systems vary significantly. In certain countries, medical center budgets are fixed regardless of levels of patient treatment. In other countries, such as Japan, reimbursement from government or third party payors must be applied for and approved. As of the date of this Prospectus, under HCFA guidelines, Medicare reimburses medical institutions for Medicare patients based on the category of surgical procedures in which the BVS is used and incrementally reimburses physicians for the use of the BVS. Medicare does not, however, currently reimburse medical institutions for the incremental cost of using the BVS above the amount allowed for the reimbursement category of the surgical procedure. Certain private health insurers and managed care providers provide incremental reimbursement to both the medical institutions and their physicians. The Company is currently petitioning HCFA to assign a higher paying reimbursement category whenever the BVS is used. In October 1995, HCFA established a special "ICD-9" code for the BVS in an effort to more clearly track and evaluate hospital and physician costs associated specifically with the BVS compared to current reimbursement levels, so that HCFA can determine the appropriate category and level of reimbursement. There can be no assurance that HCFA will reassign the BVS to a higher paying category in a timely manner, if at all. No reimbursement levels have been established for the Company's products under development, including the TAH. Prior to approving coverage for new medical devices, most third-party payors require evidence that the product has received FDA approval or clearance for marketing, is safe and effective and not experimental or investigational, and is medically necessary and appropriate for the specific patient for whom the product is being used. Increasing numbers of third-party payors require evidence that the procedures in which the products are used, as well as the products themselves, are cost- effective. There can be no assurance that the Company's products under development will meet these criteria, that third-party payors will reimburse physicians and medical institutions for the use of the products or that the level of reimbursement will be sufficient to support the widespread use of the products. Furthermore, there can be no assurance that third-party payors will continue to provide reimbursement for the use of BVS or that such payors will not reduce the current level of reimbursement for the product. Failure to achieve adequate reimbursement for its current or proposed products would have a material adverse effect on the Company's business, financial condition and results of operations. ABIODENT SUBSIDIARY ABIODENT, Inc. ("ABIODENT"), a wholly owned subsidiary of the Company, manufactures and markets the PerioTemp periodontal screening system ("PerioTemp") and markets the Halimeter for early detection and assessment of risk of periodontal disease and other sources of halitosis. ABIODENT is operated independently from the Company's cardiac assist activities. As of September 30, 1997, ABIODENT employed eight full-time employees. The PerioTemp is a tool for use by dentists, periodontists and other dental specialists to instantly detect sites of gum inflammation. The PerioTemp patented technology, developed in part through funding from the National Institute of Dental Research, consists of a book-sized console, containing a microprocessor that is 35 connected to a probe, shaped much like a dentist's probe, with a heat-sensing tip. The device is used in a manner which is consistent with traditional probing but includes an instantaneous display and record of temperature deviations from normal inside the pockets between teeth and the surrounding gum. According to published sources, gum temperature has been shown to be a reliable indicator of the presence of inflammation, a precursor of periodontal disease. The PerioTemp also allows the clinician to record gum pocket depth and bleeding point information. ABIODENT markets the PerioTemp in conjunction with the Halimeter, to provide differential evaluation of the sources of halitosis. ABIODENT purchases the Halimeter from Interscan, Inc. under a distribution arrangement which is exclusive to ABIODENT if it meets certain defined sales volume levels. ABIODENT markets its dental products with complementary products of others used in preventive and cosmetic dental programs. Revenues from this subsidiary have represented less than ten percent of the Company's total revenues in all periods presented in this Prospectus. The Company believes that it cannot alone adequately support the investment that the continued growth of its dental business requires and is looking for alternative ways to support its dental business. PATENTS AND PROPRIETARY RIGHTS The Company's business depends significantly upon its proprietary technology. The Company relies on a combination of trade secret laws, patents, copyrights, trademarks and confidentiality agreements and other contractual provisions to establish, maintain and protect its proprietary rights, all of which afford only limited protection. There can be no assurance that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to the Company's trade secrets or disclose such technology or that the Company can meaningfully protect its trade secrets. The Company has been issued or allowed 22 patents and has pending three patent applications in the United States. The Company has obtained or applied for corresponding patents and patent applications for certain of these patents and patent applications in a limited number of foreign countries. These patents relate to the BVS and certain of its products under development including the TAH. The Company's United States patents expire at various times from 2003 to 2016. There can be no assurance that the Company's pending patent applications or any future applications will be approved, that any patents will provide the Company with competitive advantages or will not be challenged by third parties, or that the patents of others will not render the Company's patents obsolete or otherwise have an adverse effect on the Company's ability to conduct business. Because foreign patents may afford less protection under foreign law than is available under United States patent law, there can be no assurance that any such patents issued to the Company will adequately protect the Company's proprietary information. Others may have filed and may file patent applications in the future that are similar or identical to those of the Company. To determine the priority of inventions, the Company may have to participate in interference proceedings declared by the United States Patent and Trademark Office or opposition proceedings before a foreign patent office that could result in substantial cost to the Company. No assurance can be given that any such interfering patent or patent application will not have priority over patent applications filed on behalf of the Company or that the Company will prevail in any opposition proceeding. The medical device industry is characterized by a large number of patents and by frequent and substantial intellectual property litigation. There can be no assurance that the Company's products and technologies do not infringe any patents or proprietary rights of third parties. The Company has in the past and may in the future be notified that it may be infringing intellectual property rights possessed by others. Any intellectual property litigation would be costly and could divert the efforts and attention of the Company's management and technical personnel, which could have a material adverse effect on the Company's business, financial condition and results of operations. There can be no assurance that infringement claims will not be asserted in the future or such assertions, if proven to be true, will not prevent the Company from selling its products or materially and adversely affect the Company's business, financial condition and results of 36 operations. If any such claims are asserted against the Company's intellectual property rights, it may seek to enter into a royalty or licensing arrangement. There can be no assurance, however, that a license will be available on reasonable terms, or at all. The Company could decide, in the alternative, to resort to litigation to challenge such claims or to design around the patented technology. Such actions could be costly and would divert the efforts and attention of the Company's management and technical personnel, which would materially and adversely affect the Company's business, financial condition and results of operations. The Company has recently received a letter from a third party alleging that certain technology incorporated into the transcutaneous energy transmission system component of the Company's TAH may infringe the patent or other intellectual property rights of that party. The Company is in the preliminary stages of assessing the allegations, but does not believe that it is infringing any patent or other intellectual property rights of this third party. There can be no assurance that the Company would prevail in the defense of an infringement claim, if made. If infringement of the proprietary rights of the third party were determined to exist, the Company would either be required to use or develop alternative technology or to seek a license of the technology. There can be no assurance that the Company could obtain a license of this technology on a timely basis or on reasonable terms, if at all. In addition, there can be no assurance that the Company could develop or license alternative technology on a timely basis, if at all. As a result, a determination of infringement could have a material adverse affect on the Company's development of the TAH and on its business, financial condition and results of operations. Any patent or intellectual property dispute or litigation could result in product development delays, would be costly and could divert the efforts and attention of the Company's management and technical personnel, and could have a material adverse effect on the Company's business, financial condition and results of operations. Certain of the Company's products have been developed in part under government contracts pursuant to which the Company may be required to manufacture a substantial portion of the product in the United States and the government may obtain certain rights to use or disclose technical data developed under those contracts. The Company retains the right to obtain patents on any inventions developed under those contracts (subject to a non- exclusive, non-transferable, royalty-free license to the government), provided it follows certain prescribed procedures. The Company purchased certain of its technology, including technology incorporated in the BVS, from the Abiomed Limited Partnership (the "Partnership"), in which the Company has a 61.7% interest. As a result of this purchase, the Company is required to pay the Partnership a royalty through August 3, 2000. See Note 7 to the Consolidated Financial Statements. GOVERNMENT REGULATION Clinical testing,trials, manufacture and sale of the Company'sour products and products under development, including the BVS, TAHAbioCor, AbioBooster and Heart Booster and the Company's dental devices,AbioVest are, or will be, subject to regulation by the FDA and corresponding state and foreign regulatory agencies. Noncompliance with applicable regulatory requirements can result in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, failurerefusal of the government to grant pre-market clearance or pre- marketmarketing approval for devices, withdrawal of marketing approvals, and criminal prosecution. The FDA also has the authority to request repair, replacement or refund of the cost of any device manufactured or distributed by ABIOMED. U.S. CLINICAL USE REGULATIONS. The BVS is classified as a Class III medical device under FDA rules, as will be the Company.AbioCor, the AbioBooster and AbioVest. In the United States,U.S., medical devices are classified into one of three classes (i.e., Class I, II or III) based on the basis of the controls deemed necessary by the FDA to reasonably ensure their safety and effectiveness. Class IIII medical devices are subject to general controls, such as labeling, pre-market notification and adherence to the FDA's Current Good Manufacturing Practices requirements set forth in the Quality System Regulation ("QSR"), which include testing, control and documentation requirements. Class II devices are subject to general and special controls, such as performance standards, post-market surveillance, patient registries and QSR compliance.most rigorous regulation. Class III devices, which are typically life-sustaining, life-supporting andor implantable devices, or new devices that have been found not to be substantially equivalent to legally marketed devices, must generally receive pre-market approval, or PMA, by the FDA to ensure their safety and effectiveness. Class III devices are also subject to some of the requirements applicable to Class I and Class II devices, including general controls, such as labeling, pre-market notification, performance standards, post-market surveillance, patient registries and must generally also receive pre-market approval by the FDAadherence to ensure their safetyQSR/GMP requirements, which include testing, control and effectiveness. 37 Before introducing a new device into the market, the Company must generally obtain FDA clearance or approval through either clearance of a 510(k) notification or receipt of a Pre-Market Approval ("PMA"). A 510(k) clearance will be granted if the submitted information establishes that the proposed device is "substantially equivalent" to a legally marketed Class I or Class II medical device or a Class III medical device for which the FDA has not required PMAs. The Company has received FDA market clearance under Section 510(k) for the PerioTemp.documentation requirements. A PMA application must be filed if a proposed device is not substantially equivalent to a legally marketed Class I or Class II device, or if it is a Class III device for which the FDA has required PMAs. A PMA application must be supported by valid scientific evidence, which typically includes extensive information including relevant bench tests, laboratory and animal studies and clinical trial data to demonstrate the safety and effectiveness of the device. The PMA application also must contain a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and the proposed labeling, advertising literature and training materials. By regulation, the FDA has 180 days to review the PMA application, and during that time an advisory committee may evaluate the application and provide recommendations to the FDA. Advisory Committeecommittee reviews often occur over a significantly protracted period, and a number of devices for which FDA approval has been sought have never been cleared for marketing. In addition, 48 modifications to a device that is the subject of an approved PMA, or to its labeling or manufacturing process, may require approval by the FDA, including the submission of PMA supplements or new PMAs.PMAs and approval by the FDA. If clinical trials of a device are required in order to obtain FDA approval and the device presents a "significant risk," the sponsor of the trial will have to file an Investigational Device Exemption ("IDE")IDE application prior to commencing clinical trials. The IDE application must be supported by data, which typically includes the results of animal testing performed in conformance with Good Laboratory Practices and formal laboratory testing.testing and documentation in accordance with appropriate design controls and scientific justification. If the FDA approves the IDE application, is approved byand the FDAinstitutional review boards or IRBs at the institutions at which the clinical trials will be performed approve the clinical protocol and all of the appropriate Institutional Review Boards ("IRBs"),related materials, clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents a "nonsignificant risk" to the patient, a sponsor may begin the clinical trial after obtaining approval for the study by one or more appropriate IRBs without the need for FDA approval. Sponsors of clinical trials are permitted to charge for investigational devices distributed in the course of the study provided that compensation does not exceed recovery of the costs of manufacture, research, development and handling. An IDE supplement must be submitted to and approved by the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness or the rights, safety or welfare of human subjects. In November 1992, the Company receivedFDA approved our PMA approval from the FDA for the BVS. In 1996 and 1997, the FDA approved the use of the BVS for additional indications, expanding its use to the treatment of all patients with potentially reversible heart failure. In May 1998, we received notice from the FDA that the BVS had successfully concluded a required post-market surveillance study. The TAH andprimary purpose of this post-market surveillance study was to provide a warning system to alert the Heart Boosterhealth care community to any potential problems with a device within a reasonable time of the initial marketing of the device. Post-market surveillance provides clinical monitoring of the experiences with a device once it is distributed in the general population under actual conditions of use. The AbioCor will be classified as a Class III devicesdevice and therefore will beis subject to the IDE and PMA processes and QSR/GMP requirements. We have submitted information pertinent to the QSR.IDE for the AbioCor under the FDA's pre-IDE process. The pre-IDE process encourages discussion between ABIOMED and the FDA regarding the content of the regulatory submission throughout the process of developing and testing the device and provides ABIOMED early guidance on pre-clinical and clinical testing required for regulatory approvals. We anticipate seeking initial approval of the AbioCor for a limited category of indications and patients, and subsequent approval for additional indications and patient populations. After the initial PMA is approved, we will need to file supplemental PMAs for the additional indications. If we obtain approval of the AbioCor in this manner, the FDA may initially impose conditions on use of the AbioCor. Nevertheless, we believe that this phased approach will permit us to obtain initial marketing approval for the AbioCor more quickly than if we were to seek a single, broader approval. U.S. MANUFACTURING AND SALES REGULATION. Any devices, including the BVS, that are manufacturedwhich we manufacture or distributed by the Companydistribute pursuant to FDA clearances or approvals, are subject to pervasive and continuing regulation by the FDA and certain state agencies.other regulatory authorities. Manufacturers of medical devices for marketing in the United StatesU.S. are required to adhere to the QSRQSR/GMP requirements and must also comply with Medical Devices Reporting, ("MDR") requirementsor MDR, which requires that a firm report to the FDA any incident in which its product may have caused or contributed to a death or serious injury, or in which its product malfunctioned and, if the malfunction were to recur, it would be likely to cause or contribute to a death or serious injury. Labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission. Current FDA enforcement policy prohibits the marketing of approved medical devices for unapproved uses. The Company isWe are subject to routine inspection by the FDA and certain state agenciesother regulatory authorities for compliance with the QSRQSR/GMP and MDR requirements, as well as other applicable regulations. In addition, the FDA requires that manufacturers of certain devices, including the BVS, conduct postmarket surveillance studies after receiving approval of a PMA application. The primary purpose of required postmarket surveillance is to provide an early warning system to alert the health care community to 3849 any potential problems with a device within a reasonable time of the initial marketing of the device. Postmarket surveillance provides clinical monitoring of the early experiences with the device once it is distributed in the general population under actual conditions of use. The Company isINTERNATIONAL REGULATION. We are also subject to regulation in each of the foreign countries in which it sells itswe sell our products. Many of the regulations applicable to the Company'sour products in these counties are similar to those of the FDA. The Company hasWe have obtained the requisite foreign regulatory approvals for sale of the BVS in many foreign countries, including most of Western Europe, and has recently commenced the regulatory approval process in Japan. The Company believesEurope. We believe that foreign regulations relating to the manufacture and sale of medical devices are becoming more stringent. The European Union has adopted regulations requiring that medical devices such as the BVS comply with the Medical DeviceDevices Directive, by June 15, 1998, which includes ISO-9001 and CE certification. The Company's BVS currently has German MedGV approval but is not yet certified forIn 1998, we received ISO-9001 compliance. The Company is working to obtain ISO-9001 and independent CE certification for its BVS facility. There can be no assurance that the Company will obtain such certification in a timely manner, if at all. Unless ISO and CE certification are obtained, the Company's sale of the BVS into the European Union may be restricted.BVS. Many manufacturers of medical devices, including the Company,ABIOMED, have often relied on foreign markets for the initial commercial introduction of their products. The more stringentHowever, an evolving foreign regulatory environment could make it more difficult, costly and time consuming for the Companyus to pursue this strategy for new products. Implantable devices such as the AbioCor must comply with the Active Implantable Medical Devices Directive. We are working toward ISO-9001 and CE certification of the AbioCor. Any FDA, foreigndelay in obtaining these certifications for the AbioCor or state regulatory approvals or clearances, once obtained, can be withdrawn or modified. Delayother products under development on a timely basis could delay commercial sales of the products in the Company obtaining, or inability of the Company to obtain and maintain, any necessary United States or foreign clearances or approvals for new or existing products or product enhancements, or cost overruns resulting from these regulatory requirements, would have a material adverse effect on the Company's business, financial condition and results of operations.European Union. EMPLOYEES As of September 30, 1997, the CompanyDecember 1, 1999, we had 166209 full-time employees. The Company hasemployees, including - 103 in research and development, - 38 in sales, clinical support, marketing and field service, and - 44 in manufacturing and quality assurance. Our remaining employees work in a variety of areas, including information technology, human resources, accounting, facilities, corporate development and management. We have entered into contractual agreements with all of itsour employees, which include strict confidentiality and non-competenon-competition commitments by each employee. None of the Company'sour employees is represented by a union. The Company considers itsWe consider our employee relations to be good. PROPERTIES The Company leases itsWe lease our headquarters, and research and development and production facilities in threetwo separate buildings in an industrial office park covering approximately 55,000 square feet.park. The addresses of these leased spaces are 3322 Cherry Hill Drive and 2433 Cherry Hill Drive in Danvers, Massachusetts and 66 Cherry Hill Drive in Beverly, Massachusetts. AllThese facilities are located approximately 22 miles north of Boston. Our primary facility consists of approximately 80,000 square feet of space under an operating lease that expires in 2010. During 1999 we moved our research and development, sales and marketing and general and administrative departments into this facility, and it now serves as our headquarters. A significant portion of this leased space is under construction for an expanded manufacturing area for the AbioCor and BVS. The leaseslease contains provisions to allow termination by us, subject to a defined termination fee, in 2005 and contains options to extend beyond 2010 at the primarymarket rates. In addition, we lease facilities representingof 23,000 square feet, and 22,000 square feet, respectively, expireexpiring in April 2000, and 18,000 square feet, expiring in June 2001, respectively. All leasesin the same industrial park as our primary facility. We have optionsan option to extend the lease on the 18,000 square foot space at market rates. These facilities contain our AbioCor and BVS manufacturing areas. It is our intention to move these manufacturing areas to our new larger facilities that are currently under construction and consolidate all of our operations in one building. We could experience manufacturing interruptions or delays if our new facilities are not available and qualified before the leases on the current spaces expire and we are not able to reach acceptable terms for extension of the leases. 50 LEGAL PROCEEDINGS On January 20, 1998, World Heart Corporation and the Ottawa Heart Institute Research Corporation filed a complaint in the U.S. District Court for the District of Delaware. World Heart Corporation is currently developing an LVAD, using technology developed by the Ottawa Heart Institute Research Corporation. The Company's facilities include fabrication areascomplaint seeks damages and injunctive relief for medicalalleged breaches of contract, misappropriation of trade secrets, conversion of trade secrets and dentalpatent infringement by ABIOMED. The plaintiffs' claims and allegations relate to a transcutaneous energy transmission device manufacturing,being developed by the Ottawa Heart Institute Research Corporation in connection with its LVAD under development. Between 1992 and development facilities1995, we evaluated prototypes of the Ottawa Heart Institute Research Corporation's transcutaneous energy transmission device for laboratorypossible use in connection with the AbioCor and durability testingdetermined that it did not meet our needs. The plaintiffs allege that we subsequently utilized aspects of plasticstheir proprietary technology in developing our own transcutaneous energy transmission device. We do not believe that we are infringing any intellectual property rights of the plaintiffs, and electronics. The Company has begun improving approximately 18,000 square feet of this space to better accommodate its BVS growth and to allow for expanded engineering, production and testing relatinghave so stated in our response to the TAH.complaint. We are vigorously defending the case. On October 20, 1999, World Heart Corporation informed us that they have determined that our transcutaneous energy transmission device does not infringe the asserted patent. On November 22, 1999, the parties filed with the court to permanently dismiss the patent infringement claim, but the plaintiffs continue to press the remaining claims. Unless action is initiated by the plaintiffs or by the court to dismiss the remaining claims prior to trial, we intend to defend ourselves in court. A trial is scheduled to commence in early 2000. Although we believe all of the plaintiffs' claims and allegations are without merit, it is possible that our defense may not prevail. If we do not prevail, we might be required to use or develop alternative transcutaneous or non-transcutaneous technology, to seek a license to use certain technology, or to modify the design of our transcutaneous energy transmission device. Although alternative technologies may be used to provide energy to the AbioCor, such alternative technologies, though functional, may lack features of our current design. As a result, if we do not prevail, our development of the AbioCor may be adversely affected and our business may be harmed. On May 7, 1999, we filed a motion requesting leave of court to assert a counterclaim alleging that World Heart Corporation and Ottawa Heart Institute Research Institute misappropriated our trade secrets. The Company believescourt has deferred action on that these facilities are adequate for its current needs. LEGAL PROCEEDINGS The Company is not a party to any material pending legal proceedings. 39motion. 51 MANAGEMENT EXECUTIVE OFFICERS, KEY EMPLOYEES AND DIRECTORS The Company's executive officers, key employees and directors are as follows:EXECUTIVE OFFICERS AND KEY EMPLOYEES
NAME AGE TITLE ------------------------------------- --- ------------------------------------POSITION - ---- -------- ----------------------------------------------------- David M. Lederman, Ph.D*............. 53............... 55 Chairman of the Board of Directors, President, Chief Executive Officer and Assistant Treasurer Robert T.V. Kung, Ph.D*.............. 53................ 55 Senior Vice President--Research and Development,President--Chief Scientific Officer, and Assistant Secretary Anthony W. Bailey*..................... 44 Vice President--Engineering and Director AbioCor Program William J. Bolt........................ 47 Vice President--Cardiac Assist Products John E. Hart........................... 43 Vice President--Marketing Douglas McNair, MD, Ph.D............... 46 Vice President--Clinical Affairs David Nikka............................ 45 Vice President--Human Resources Janice T. Piasecki..................... 45 Vice President--Regulatory Affairs Eugene D. Rabe*...................... 41........................ 43 Senior Vice President--Global Sales Marketing and Clinical ProgramsServices John F. Thero*....................... 37......................... 39 Senior Vice President--Finance, Chief Financial Officer, Treasurer and Assistant Secretary Anthony W. Bailey.................... 41 Vice President--Engineering William J. Bolt...................... 45 Vice President (in charge of ABIODENT) David Nikka.......................... 42 Vice President--Resources and Administration Janice Piasecki...................... 43 Vice President--Regulatory Affairs Edward G. Taylor, Ph.D............... 46 Vice President--Program Director, Implantable Artificial HeartMichael Verga.......................... 37 Chief Intellectual Property Counsel
OUTSIDE DIRECTORS
NAME AGE - ---- -------- W. Gerald Austen, M.D................ 67 DirectorM.D.................. 69 Paul Fireman......................... 53 DirectorB. Fireman........................ 55 John F. O'Brien...................... 54 DirectorO'Brien........................ 56 Desmond H. O'Connell, Jr. ........... 61 DirectorJr............... 63 Henri A. Termeer..................... 51 DirectorTermeer....................... 53
- -------- *Executive------------------------ * Executive Officer Dr. DavidDR. DAVID M. LedermanLEDERMAN founded the CompanyABIOMED in 1981, and has served as Chairman of the Board and Chief Executive Officer since that time, and astime. He is also President for the majority of that time.ABIOMED. Prior to founding ABIOMED, he was Chairman of the Medical Research Group at the Everett Subsidiary of Avco Corporation. HeCorporation which he joined in 1972. Dr. Lederman has made many important contributions in the field of cardiac assist and heart replacement technology, has authored over 40 medical publications, and originated the design and development of ABIOMED's artificial heart blood pumps and their valves, has authored over 40 medical publications,valves. Dr. Lederman is a member of numerous medical and scientific professional organizations and has been a frequent speaker in forums on cardiac support systems and on the financing and commercialization of advanced medical technology. Dr. Lederman received a Ph.D. degree in Aerospace Engineering from Cornell University. Dr. RobertDR. ROBERT T.V. KungKUNG has served asABIOMED since 1982 and has been Senior Vice President and Chief Scientific Officer since 1995. He was Vice President of Research and Development of the Company since 1987. Fromfrom 1987 to 1995 and Chief Scientist from 1982 to 1987, he served as Chief Scientist of the Company. Since 1995, Dr. Kung has served as the Senior Vice President of the Company.1987. Prior to joining ABIOMED, heDr. Kung was a Principal Research Scientist at Schafer Associates from 1978 to 1982 and at the Avco Everett Research Laboratory.Laboratory from 1972 to 1978. He developed non-linear optical techniques for laser applications and investigated physical and chemical phenomena in re-entry physics. Dr. Kung has been Principal Investigator for the Company's TAHABIOMED's National Institute of Health-funded AbioCor and Heart BoosterAbioBooster programs 52 and has conceived of and directed the development of the Company'sABIOMED's laser-based minimally invasive technologies, as well as the PerioTemp.technologies. Dr. Kung received a Ph.D. degree in Physical Chemistry from Cornell University. Mr. Eugene D. Rabe joined the Company in 1993, as its Vice-President for Sales. In 1996, he assumed responsibility for all domestic sales, clinical and field support. Recently he was promoted to Vice-President Global Sales, Marketing and Clinical Programs. Prior to joiningMR. ANTHONY W. BAILEY has served ABIOMED he was Vice- President, Sales and 40 Marketing for Endosonics Corporation before which he was a Sales Manager for St. Jude Medical, Inc. He has been involved in the sales and marketing of cardiovascular/cardiological devices for over ten years. Mr. Rabe received a Bachelor's degree from St. Cloud State University and his MBA from the University of California. Mr. John F. Thero joined the Company in 1994 as Vice President, Finance and Administration and Chief Financial Officer. Prior to joining ABIOMED, during the period 1992 to 1995, Mr. Thero was Chief Financial Officer and acting President for the restructuring of two venture-backed companies. From 1987 to 1992, Mr. Thero was employed, in various capacities including Chief Financial Officer, by Aries Technology, Inc. From 1983 to 1987, Mr. Thero was employed by the commercial audit division of Arthur Andersen & Co. during which time he became a Certified Public Accountant. Mr. Thero received a B.A. in Economics/Accounting from The College of the Holy Cross. Mr. Anthony W. Bailey joined the Company insince 1997, to lead the Electronics System Development of the Implantable Artificial Heart Program and is currently Vice President--Engineering. Prior to joining ABIOMED, duringPresident, Engineering and Director of the AbioCor Program. From 1987 to 1997, Mr. Bailey was Vice President and General Manager for Pace Medical, Inc., a manufacturer of external pacemakers, rhythm management analyzers and accessories. Fromfrom 1982 to 1987, he was Manager of Design and Development at Shiley Infusaid, Inc., a manufacturer of implantable drug pumps and infusion ports. Prior to that, Mr. Bailey served in various engineering functions with manufacturers of implantable pacemakers, data acquisition and control systems and medical monitoring equipment. Mr. Bailey received his Bachelor's degree from the University of Lowell. Mr. WilliamMR. WILLIAM J. Bolt joinedBOLT has served ABIOMED since 1982 and, has been Vice President, Cardiac Assist Products since 1998. He is currently responsible for BVS-product line operations including manufacturing, quality assurance, engineering support and new product development not related to the Company in 1982. Since that time,AbioCor. From 1994 to 1998 he haswas President of ABIOMED's dental subsidiary, ABIODENT. From 1982 to 1994, he served in various roles, from DirectorVice President of Operations to Vice President of Engineering, andwhere he was the engineer in-charge whenof the BVSdevelopment of the BVS-5000 and PerioTemp systems were developed. He is presently responsible for the business operations of ABIODENT, including dental product sales, marketing, manufacturing and engineering support.other systems. Mr. Bolt received ahis Bachelor's degree in Electrical Engineering and a Masters degree in Business Administrationan MBA from Northeastern University. MR. JOHN E. HART has served ABIOMED since 1999 as Vice President, Marketing. Prior to joining ABIOMED, he was Senior Director, Marketing for the Vascular Therapies Division of U.S. Surgical Corporation/Tyco Healthcare Group from 1997 to 1999, Senior Manager, Cardiology Marketing Programs for the Cordis division of Johnson & Johnson, from 1996 to 1997, and Marketing/New Business Development Director for the Professional Healthcare Sector of Kimberly-Clark from 1992 to 1996. Mr. David Nikka joinedHart has worked with C.R. Bard in various global marketing management positions and in sales and manufacturing with the CompanyEthicon division of Johnson & Johnson. Mr. Hart received a Bachelor's degree from Trenton State College and an MBA from New Hampshire College. DR. DOUGLAS MCNAIR has served ABIOMED since 1998 as Vice President of Clinical Affairs. Prior to joining ABIOMED, he was Group Vice President for Regulatory and Government Affairs at Cerner Corporation from 1986 to 1998. Previously, Dr. McNair was a faculty member of the Departments of Medicine and Pathology at Baylor College of Medicine and served under Drs. Michael DeBakey and Antonio Gotto as Co-Director of the Design and Analysis unit of the NIH National Research and Demonstration Center on Atherosclerosis at Baylor. He has been an IRB member, a Principal Investigator for various in-vitro testing and medical device products, and has directed clinical trials for Cerner and other medical device firms. Since 1992, he has served as a lecturer and member of the Board of Trustees for the Midwest Bioethics Center. Dr. McNair has an M.D. and a Ph.D. degree in Biomedical Engineering from the University of Minnesota. MR. DAVID NIKKA has served ABIOMED since 1997 as its Vice President--Resources and Administration.President of Human Resources. Prior to joining ABIOMED, he was Vice President, Human Resources from 1991 to 1997 for Genzyme Genetics, Director of Human Resources from 1989 to 1991 for Genzyme Corporation and Director of Human Resources for Integrated Genetics from 19861987 to 1989. Mr. Nikka received his Bachelor Degree from Boston University. Mr. NikkaHe is past Chairperson of both the BIOBiotechnology Industry Organization and the Massachusetts Biotechnology Council Human ResourceResources Committees. Ms. Janice Piasecki joined the Company inMr. Nikka received his Bachelor's degree from Boston University. MS. JANICE T. PIASECKI has served ABIOMED since 1991 and has been Vice-President, Regulatory Affairs since 1994. From 1991 to 1994, she served as Manager of Clinical Research and Regulatory Affairs. In thisher role, she has worked extensively on our domestic and international regulatory submissions, including the PMA submissionssubmission process for the BVS whichthat led to FDA approvals. She was promoted to Vice-President, Regulatory Affairs in 1994. Prior to joining ABIOMED, she held positionpositions of Investigator for the United States Food and Drug Administration, and Manager of Regulatory Affairs for C.R. Bard.Bard Ms. Piasecki received her B.S.Bachelor's degree in Biology and Chemistry from Boston College. Dr. Edward G. Taylor joined the Company at the end of 1996 as53 MR. EUGENE D. RABE has served ABIOMED since 1993 and has been Senior Vice President of Global Sales and DirectorServices since 1999. Mr. Rabe assumed responsibility for international sales in 1996, and was Vice President of the Artificial Heart Program.Sales from 1993 to 1999. Prior to joining ABIOMED, Dr. Taylor worked in the United States Air Force from 1972 to 1996 where he attained the rank of ColonelMr. Rabe was Vice President, Sales and Marketing for Endosonics Corporation. Mr. Rabe was most recently the Program Directoremployed as a Sales Manager for the Airborne Warning and Control System (AWACS) in the United States, Europe and Japan. Previously he had directed high technology research and development of nationally significant defense programs, including self-protection avionics for Air Force One.St. Jude Medical, Inc. He was alsohas been involved in the launchmanagement of sales and operationmarketing of reconnaissance and communication satellites. Dr. Taylor holdscardiovascular/cardiological devices for over twelve years. Mr. Rabe received a Bachelor's degree from St. Cloud State University and an MBA from the Illinois InstituteUniversity of California. MR. JOHN F. THERO has served ABIOMED since 1994 and has been Senior Vice President of Finance, Treasurer and Chief Financial Officer since 1991. From 1994 to 1999 he was Vice President of Finance, Treasurer and Chief Financial Officer. Prior to joining ABIOMED, Mr. Thero was Chief Financial Officer and acting President for the restructuring of two venture-backed companies from 1992 to 1995. From 1987 to 1992, he was employed in various capacities including Chief Financial Officer, by Aries Technology, Inc. From 1983 to 1987, he was employed by the commercial audit division of Arthur Andersen LLP during which time he became a Certified Public Accountant. Mr. Thero received a Bachelor's degree in Economics/Accounting from The College of the Holy Cross. MR. MICHAEL VERGA has served ABIOMED since August 1999 as Chief Intellectual Property Counsel. Prior to joining ABIOMED, he was a patent attorney for the law firm of Wolf, Greenfield & Sacks, P.C. Mr. Verga has eight years of experience in domestic and foreign patent prosecution with particular experience in the medical device, software, electronics, computer architecture, electromagnetics and semiconductor disciplines. Mr. Verga has also worked as a software and systems engineer, and engineering manager in the avionics and flight simulation industry. He is a member of the Massachusetts Bar and is registered to practice before the U.S. Patent and Trademark Office. Mr. Verga received his Bachelor's degree in Engineering from Hofstra University, a Master's degree in Electrical Engineering from the Air Force InstituteUniversity of TechnologyHouston and a Ph.D. degree in Estimation and ControlJuris Doctor from the Massachusetts Institute of Technology. 41 Dr.American University. DR. W. Gerald AustenGERALD AUSTEN, M.D. has served as a directorDirector of the CompanyABIOMED since 1985. From 19691974 to the present, Dr. Austen has been Chief of the Surgical Services at Massachusetts General Hospital, and from 1974 to the present, has been the Edward D. Churchill Professor of Surgery at Harvard Medical School. HeDr. Austen became President of the Massachusetts General Physicians Organization in 1994.1994 and since 1999 has served as Chairman of the Board. From 1969 to 1997 Dr. Austen was Chief of the Surgical Services at Massachusetts General Hospital. Dr. Austen is the former President of the American College of Surgeons, the American Association for Thoracic Surgery, the American Surgical Association and the Massachusetts and American Heart Associations. Dr. Austen is a member of the Institute of Medicine of the National Academy of Sciences, a Fellow of the American Academy of Arts and Sciences and a life member of the corporation of the Massachusetts Institute of Technology. Mr. Paul FiremanMR. PAUL B. FIREMAN has served as a directorDirector of the CompanyABIOMED since 1987. He is the founder of Reebok International Ltd., a leading worldwide designer, marketer and distributor of sports, fitness and casual footwear, apparel and equipment. Mr. Fireman has served as Chief Executive Officer and as a directorDirector of that company sinceReebok International Ltd., which he founded, from 1979 to the present. He has served as Reebok's Chairman of the Board of Directors sincefrom 1985 andto the present. He has also served as Reebok's President from 1989 to the present, after initially serving as President from 1979 to 1987 and since 1989.1987. Mr. Fireman has also served as the chairmanChairman of the Entrepreneurial Advisory Board of Babson College since 1995. Mr. JohnMR. JOHN F. O'BrienO'BRIEN has served as a directorDirector of ABIOMED since 1989. Since August 1989 he has been the President and Chief Executive Officer and a directorDirector of First Allmerica Financial Life Insurance Company (formerly State Mutual Life Assurance Company of America). Since January 1995 he has been President, Chief Executive Officer and a Director of Allmerica Financial Corporation, a financial services holding company.Corporation. Mr. O'Brien is also President, Chief Executive Officer and a directorDirector of Allmerica Property & Casualty Companies, Inc.; Chairman of the Board, President and Chief Executive Officer of Citizens Corporation; and a trusteeTrustee and Chairman of the Board of Allmerica Securities Trust, Allmerica Investment Trust and Allmerica Funds. From 1972 until 1989, Mr. O'Brien was employed by Fidelity Investments in various capacities, including as Group Managing Director of FMR Corp. Mr. O'Brien is 54 also a directorDirector of Cabot Corporation and TJX Companies, Inc. and a Trustee of the Worcester Art Museum. Mr. DesmondMR. DESMOND H. O'Connell, Jr.O'CONNELL, JR. has served as a directorDirector of the CompanyABIOMED since 1995. He has beenis currently the President, Chief Executive Officer and a Director of Serologicals Corporation. He is currently an independent management consultant since September 1990 and has served as a director of Chryslais International Corporation, an international contract research organization, since 1991.consultant. From December 1992 until December 1993, he served as the Chairman, Management Committee of Pharmakon Research International, Inc., a provider of pre-clinical testing services to pharmaceutical biotechnology companies. During 1991, he briefly served as Chairman of the Board and Chief Executive Officer of Osteotech, Inc., a medical products company. Mr. O'Connell was with the BOC Group, PLC an industrial gas and health care company, in senior management positions from 1980 to 1990, and was a member of the Board of Directors of BOC Group, PLC from 1983 to 1990. From April 1990 until September 1990, Mr. O'Connell was President and Chief Executive Officer of BOC Health Care. From 1986 to April 1990, he was Group Managing Director of BOC Group, PLC. Prior to joining BOC, Mr. O'Connell held various positions at Baxter Laboratories, Inc. including chief executiveChief Executive of the Therapeutic and Diagnostic Division and Vice President, Corporate Development. Mr. HenriO'Connell had been a Director of Chryslais International Corporation from 1991 through May, 1999. MR. HENRI A. TermeerTERMEER has served as a directorDirector of the CompanyABIOMED since 1987. Mr. Termeer has served as President and a directorDirector of Genzyme a biotechnology company engaged in the production and marketing of human health care products,Corporation, since 1983, as its Chief Executive Officer since 1985, and as its Chairman of the Board since 1988. Mr. Termeer is also Chairman of the Board of Genzyme Transgenics Corporation. He is also a directorDirector of AutoImmune, Inc., GelTex Pharmaceuticals, Inc. and Diacrin, Inc. andIn addition, Mr. Termeer serves as a trusteeTrustee of Hambrecht & Quist Healthcare Investors and Hambrecht & Quist Life Sciences Investors. 4255 CERTAIN TRANSACTIONS In July 1997, the Company sold a total of 1,242,710 shares of Common Stock to Genzyme and certain of the Company's directors for a purchase price of $13.00 per share, for a total purchase price of $16.2 million. The Chief Executive Officer of Genzyme, Henri A. Termeer, is a director of the Company. Of the shares sold, 1,153,846 shares were sold to Genzyme, 23,480 shares were sold to Paul Fireman, 7,692 shares were sold to Desmond H. O'Connell, Jr. and 57,692 shares were sold to John F. O'Brien. In addition, simultaneously with this transaction, David M. Lederman, the President and Chief Executive Officer of the Company sold 153,846 shares of Common Stock to Paul Fireman, a director of the Company. In connection with these transactions, the Company granted Genzyme certain registration rights with respect to the shares of Common Stock purchased by Genzyme. Commencing in July 1998, Genzyme may on up to three occasions require the Company to register not less than 25% of Genzyme's shares of Common Stock. Genzyme has also been granted certain piggyback registration rights to participate in underwritten public offerings by the Company, subject to certain limitations, commencing in July 1998. In addition, the other purchasers received similar piggyback registration rights commencing in July 1998, with respect to the 242,710 shares of Common Stock purchased by them. In connection with its purchase of the Common Stock, Genzyme agreed, subject to certain limited exceptions, not to acquire additional voting securities of the Company for a period of five years following the consummation of the transaction without the consent of the Company, and, during that five year period, to vote its shares in the same proportion as votes cast by other stockholders of the Company or, in Genzyme's discretion, in accordance with the recommendations of the Company's Board of Directors. 43 PRINCIPAL AND SELLING STOCKHOLDERS The following table sets forth certain information regardingas of December 1, 1999 with respect to the beneficial ownership of the Company's Common Stock as of September 30, 1997, and as adjusted to reflect the sale of the Common Stock offered hereby, (i)our common stock by each person who is known by the Company to own beneficially more than 5% of the outstanding sharesour directors, each of Common Stock, (ii) by each executive officer and director of the Company, (iii) by allour executive officers, all of our directors and directors of the Companyexecutive officers as a group, and (iv) by each person we know to be the beneficial owner of the Selling Stockholders.five percent or more of our common stock. This information is based upon information received from or on behalf of the individuals named individuals. All Selling Stockholders are executive officers of the Company.
BENEFICIAL OWNERSHIP NUMBER BENEFICIAL OWNERSHIP PRIOR TO OFFERING(1) OF AFTER OFFERING(1) ----------------------- SHARES ----------------------- NUMBER OF PERCENTAGE OF BEING NUMBER OF PERCENTAGE OF SHARES OWNERSHIP OFFERED SHARES OWNERSHIP --------- ------------- ------- --------- ------------- David M. Lederman, Ph.D(2)................ 1,322,554 16.0% 115,000 1,207,554 11.5% Genzyme Corporation..... 1,153,846 14.0% -- 1,153,846 11.0% Robert T.V. Kung, Ph.D(3)(4)............. 173,188 2.1% 35,000 138,188 1.3% Eugene D. Rabe(4)....... 18,750 * -- 18,750 * John F. Thero(4)........ 7,764 * -- 7,764 * W. Gerald Austen, M.D.(4)................ 25,400 * -- 25,400 * Paul Fireman(4)......... 225,226 2.7% -- 225,226 2.1% John F. O'Brien(4)...... 85,092 1.0% -- 85,092 * Desmond H. O'Connell, Jr.(4)................. 18,092 * -- 18,092 * Henri A. Termeer(4)(5).. 1,179,246 14.2% -- 1,179,246 11.2% All executive officers and directors as a group(2)(3)(4)(5) (9 persons)............... 3,055,312 36.2% 150,000 2,905,312 27.2%
- -------- *Represents beneficialtherein. We determined ownership of less than 1% of the outstanding shares of Common Stock. (1) Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generallyCommission. Beneficial ownership includes voting power and/or investment power with respect to securities. Beneficial ownership also includes sharesthe securities held by the named individuals. Shares of common stock subject to options currently exercisable or exercisable within 60 days of September 30, 1997. PercentageDecember 1, 1999, are deemed outstanding for purposes of beneficial ownership is based on 8,264,556 sharescomputing the percentage beneficially owned by the person holding the options but are not deemed outstanding for purposes of Common Stock outstanding on September 30, 1997 and 10,514,556 shares of Common Stock outstanding upon completion of this offering. Unlesscomputing the percentage beneficially owned by any other person. Except as otherwise noted, each person identified possessesthe persons or entities named have sole voting and investment power with respect to theall shares listed. (2) Includes 725,923shown as beneficially owned by them.
NUMBER OF SHARES PERCENT PERCENT BENEFICIALLY BEFORE AFTER NAME OWNED OFFERING OFFERING - ---- ------------ -------- -------- David M. Lederman........................................... 1,271,200 14.7% 12.5% c/o ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923 Genzyme Corporation......................................... 1,153,846 13.3% 11.3% One Kendall Square Cambridge, MA 02139 W. Gerald Austen............................................ 31,200 * * Paul B. Fireman............................................. 231,026 2.7% 2.3% John F. O'Brien............................................. 83,392 1.0% * Desmond H. O'Connell, Jr.................................... 28,892 * * Henri A. Termeer............................................ 1,185,046 13.7% 11.7% Anthony W. Bailey........................................... 5,132 * * Robert T.V. Kung............................................ 232,625 2.6% 2.3% Eugene D. Rabe.............................................. 51,625 * * John F. Thero............................................... 47,250 * * All Current Executive Officers and Directors as a group (10 3,167,388 35.3% 31.1% persons)..................................................
- ------------------------ * Less than 1%. The shares listed above as being beneficially owned by Dr. Lederman include 675,923 shares held by Dr. Lederman's wife, as to which Dr. Lederman disclaims beneficial ownership. (3) Includes 60,000Dr. Lederman has granted the underwriters an option to purchase 100,000 shares heldof common stock as part of the underwriters' over-allotment option. If the option is exercised in full, after this offering, Dr. Lederman will beneficially own 1,171,200 shares of common stock, or 11.5% of the shares outstanding. The shares listed above as being beneficially owned by Dr. Kung's wife and 12,000 shares held in trust for the benefit of certain relatives of Dr. Kung, as to which Dr. Kung disclaims beneficial ownership. (4) Includes the following shares subject to options which are exercisable within 60 days after September 30, 1997: Dr. Kung--51,188; Mr. Rabe-- 18,750; Mr. Thero--7,500; Dr. Austen--25,000; Mr. Fireman--25,000; Mr. O'Brien--25,000; Mr. O"Connell--5,000; Mr. Termeer--25,000. (5) IncludesTermeer include 1,153,846 shares held by Genzyme Corporation as to which Mr. Termeer disclaims beneficial ownership. Mr. Termeer is the Chief Executive Officer of Genzyme. 44Genzyme Corporation. The shares listed above as being beneficially owned by Dr. Kung include 55,400 shares held by Dr. Kung's wife and 16,600 shares held in trust for the benefit of certain relatives of Dr. Kung, as to which Dr. Kung disclaims beneficial ownership. The preceding table also includes the following shares subject to options exercisable within 60 days of December 1, 1999: Dr. Austen--22,500; Mr. Fireman--22,500; Mr. O'Brien--22,500; Mr. O'Connell--10,000; Mr. Termeer--22,500; Mr. Bailey--5,000; Dr. Kung--110,625; Mr. Rabe--51,625; and Mr. Thero--47,250. 56 DESCRIPTION OF CAPITAL STOCK As of September 30, 1997, the Company's1999, ABIOMED's authorized capital stock consisted of 25,000,000 shares of Common Stock, $.01 par value,common stock and 1,000,000 shares of Class B Preferred Stock,preferred stock, $.01 par value ("Preferred Stock").value. COMMON STOCK As of September 30, 1997,1999, there were 8,264,5568,657,742 shares of Common Stockcommon stock outstanding. TheseApproximately 404 stockholders held these shares were held of record, by approximately 340 stockholders, including multiple beneficial holders at depositories, banks, and brokers listed as a single holder in the street name of each respective depository, bank, or broker. There will be 10,514,55610,169,867 shares of Common Stockcommon stock outstanding after giving effect to the sale of the shares of Common Stockcommon stock offered herebyunder this prospectus by the Company.ABIOMED. The holders of Common Stock are entitled tocommon stock have one vote per share on all matters to be voted on bywhich stockholders andmay vote. They are entitled to receive any dividends if any, as may belegally declared from time to time by the Board of Directors from funds legally available therefore. Upon liquidationDirectors. If ABIOMED is liquidated or dissolution of the Company,dissolved, the holders of Common Stockthe common stock are entitled to receive all assets available for distribution to the stockholders, subject to any preferential or other rights of the holders of Preferred Stock.preferred stock. The Common Stockcommon stock has no preemptive or other subscription rights, and there are no conversion rights or redemption or sinking fund provisions with respect to such shares. The holders of Common Stockcommon stock do not have cumulative voting rights in the election of directors. All of the shares of Common Stockcommon stock are, and the shares to be sold in the offering will be, fully paid and nonassessable. PREFERRED STOCK The CompanyABIOMED has no Preferred Stockpreferred stock outstanding. The Board of Directors has the authority tomay, without stockholder approval, issue the Preferred Stockpreferred stock in one or more series and to fix the dividend rights dividendand rate, conversion rights, voting rights, rights and terms of redemption, liquidation preferences, sinking fund terms, and other rights preferences, privileges and restrictions of any series of Preferred Stock,preferred stock, the number of shares constituting any such series and its designation. If the designation thereof, without further vote or action by the stockholders. The Board of Directors issues preferred stock, the issuance may without stockholder approval, issue Preferred Stock with rights and privileges which could, among other things, have the effect of delaying deferring or preventing a change in control of ABIOMED. If the Company. The issuanceBoard of Preferred StockDirectors issues preferred stock with voting and conversion rights, may adversely affect the voting power and other rights of the holders of Common Stock, including the loss of voting control to others. The Companycommon stock could be adversely affected. We currently hashave no plans to issue any of the Preferred Stock.preferred stock. The Board of Directors has designated 25,000 shares of the Preferred Stockpreferred stock as the "Series A Junior Participating Preferred Stock" in connection with the Rightsrights described below. ANTI-TAKEOVER EFFECT OF PROVISIONS OF THE CERTIFICATE OF INCORPORATION AND BY- LAWS,BY-LAWS, RIGHTS DISTRIBUTION AND DELAWARE LAW Certificate of Incorporation and By-lawsCERTIFICATE OF INCORPORATION AND BY-LAWS The Certificate of Incorporation includes several provisions, in addition to the Preferred Stock, whichpreferred stock, that may render more difficultdiscourage an unfriendly tender offer, proxy contest, merger, or other change in control of the Company.control. These provisions are intended to enhance the likelihood of continuity and stability in the composition of the Board of Directors and in the policies formulated by the Board of Directors andDirectors. These provisions are also intended to discourage certain types of transactions that may involve an actual or threatened change of control of the Company.ABIOMED. These provisions are also designed to reduce theour vulnerability of the Company to unsolicited acquisition proposals and to discourage certain tactics that may be used in proxy fights. However, suchthese provisions could have the effect of discouraging others from making tender offers for the shares of Common Stock and, as a consequence,offers. Consequently, they also may inhibit fluctuations in the market price fluctuations of the shares of Common Stockcommon stock which could result from actual or rumored takeover attempts. Such factors also may have the effect of preventing changes in the management of the Company. 45 The CertificateABIOMED. Our certificate of Incorporation (i) provides for the classification of the Company'sincorporation contains provisions that: - classify our Board of Directors into three classes, (ii) eliminatesclasses; 57 - eliminate the ability of stockholders to enlarge the Board of Directors, (iii) providesDirectors; - provide that Board vacancies in the office of a director shall be in the first instancebe filled by the remaining directors, exceptand in the caseabsence of theany directors, elected by the Common Stock voting as a separate class, in which case it shall be filled by the holders of that class voting as a separate class, (iv) providesstockholders; - provide that directors may only be removed "for cause" and only by the class or classes of stock which elected them,them; and (v) requires- require an 80% affirmative vote of all votes entitled to be cast to amend the preceding provisions. The existence of a classified board is designed to provide continuity and stability to our management and to render certain hostile takeovers more difficult. The classification of directors has the effect of making it more difficult to change the composition of the Board of Directors. It may therefore make it more difficult for a third party to acquire control of ABIOMED by delaying, deferring or preventing a change of control that a stockholder might consider would result in a premium for its stock. At least two stockholder meetings, instead of one, are required to effect a change in the control of the Board. The By-lawsOur by-laws provide that advance written notice of any stockholder nomination for director must be provided not less than 45 nor more than 60 days prior to the anticipated date of the annual meeting for election of directors. The CertificateOur certificate of Incorporationincorporation explicitly directs the Board of Directors to take into account all relevant factors in exercising its business judgment in determining what is in the best interests of the CompanyABIOMED and its stockholders in evaluating certain tender offers and business combination proposals. Relevant factors include, without limitation,include: - the Board's estimate of the future value of the Company,ABIOMED; - the resources and future prospects of the other party,party; and - the possible social, legal, environmental and economic effects on the Company and on theABIOMED, our employees, customers, suppliers and creditors of the Company and on the communities in which the Company'sour facilities are located. The CertificateOur certificate of Incorporationincorporation and the By-lawsby-laws also provide that all stockholder action must be effected at a duly called meeting and not by written consent. The authority of the Board of Directors to issue authorized but unissued shares of Common Stockcommon stock might be considered as having the effect of discouraging an attempt by another person or entity to effect a takeover or otherwise gain control of the CompanyABIOMED, since the issuance of additional shares of Common Stockcommon stock would dilute the voting power of the Common Stockcommon stock then outstanding. Rights DistributionRIGHTS DISTRIBUTION On August 13, 1997, the Board of Directors declared a dividend of one preferred share purchase right (a "Right") for each outstanding share of Common Stockcommon stock on August 28, 1997 (the "Record Date") to the stockholders of record on that date. Each Rightright entitles the registered holder to purchase from the Companyus one one-thousandth of a share of Series A Junior Participating Preferred Stock, par value $0.01 per share, (the "Preferred Shares"), of the Company,ABIOMED, at a price of $90.00 per one one-thousandth of a Preferred Share,share, subject to adjustment. Subject to certain limited exceptions until the earlier to occur of (i) ten days following a public announcement that a person or group of affiliated or associated persons (an "Acquiring Person") has acquired beneficial ownership of 15% or more of the outstanding shares of Common Stock, or (ii) ten business days (or such later date as may be determined by action of the Board of Directors prior to such time as any person becomes an Acquiring Person) following the commencement of, or announcement of an intention to make, a tender offer or exchange offer the consummation of which would result in the beneficial ownership by a person or group of 15% or more of the outstanding shares of Common Stock (the earlier of such dates being called the "Distribution Date"), the Rights will beThe rights are evidenced by the Common Stockcommon stock certificates with a copy of the Summary of Rights attached thereto.to them until the earlier of the tenth day following a public announcement that a person or group has acquired 15% or more of the outstanding common stock and the tenth business day following the commencement or announcement of a tender offer or exchange offer which would result in a person or group owning 15% or more of the common stock. As soon as practicable followingpossible after the Distribution Date,earlier of either of the above occurrences, the rights will become exercisable, separate certificates evidencing the Rights ("Right Certificates")rights will be mailed to stockholders of record on the Distribution Datedate of such occurrence and the separate Right Certificates58 rights certificates alone will evidence the Rights.rights. The Rightsrights will expire on the earlier of (i) August 13, 2007, or (ii) the date on which the Rights are redeemed. 46 In the event thatif not redeemed earlier. If any person becomes an Acquiring Person, proper provision will be made so thatacquires more than 15% of the outstanding common stock, each holder of a Right,right, other than Rights beneficiallyrights owned by the Acquiring Person and its affiliates and associates (whichsuch person which will thereafter be void),voided, will thereafter have the right to receive upon exercise, that number of shares of Common Stockcommon stock having a twice the market value of two times the exercise price of the Right. In the event that, at any timeright. If, after a person becomes an Acquiring Person,acquires 15% or more of the Company isoutstanding common stock, we are acquired in a merger or other business combination transaction or 50% or more of itsour consolidated assets or earning power are sold, proper provision will be made so that each holder of a Rightright will thereafter have the right to receive upon the exercise thereof at the then current exercise price of the Right, that number of shares of common stock of the acquiring company which at the time of such transaction will have atwice the market value of two times the exercise price of the Right. At anyright. Any time after anya person becomes an Acquiring Personacquires more than 15% of the outstanding common stock and prior tobefore the acquisition by any person or group of a majority of the outstanding shares of Common Stock,common stock, the Board of Directors may exchange the Rightsrights (other than Rightsrights owned by such person or group which have become void), in whole or in part, at an exchange ratio of one share of Common Stockcommon stock per Right,right, subject to adjustment. At any time prior to the time any Person becomes an Acquiring Person, theThe Board of Directors of the Company may redeem the Rightsrights, in whole, but not in part, at any time before a person acquires 15% or more of the outstanding common stock. The redemption price ofshall be $0.001 per Right (the "Redemption Price").right. The redemption of the Rights may be made effective at such time, on such basis and with such conditions as the Board of Directors, in its soleown discretion, may establish. Immediately upon any redemptiondetermine the time of effectiveness and the terms of the Rights, theredemption. The right to exercise the Rightsany rights will terminate and thewhen they are redeemed. The only right of the holders of Rightsthe rights after redemption will be to receive the Redemption Price.redemption price. The Board of Directors may amend the terms of the Rights may be amended by the Board of Directorsrights without the consentapproval of the holders of the Rights, except that from andrights. However, after such time as anya person becomes an Acquiring Person no such amendmentacquires 15% or more of the outstanding common stock, the Board of Directors may not adversely affect the interests of the holders of the Rights (other thanrights. DELAWARE TAKEOVER STATUTE As a Delaware corporation, we are subject to the Acquiring Person and its affiliates and associates).General Corporation Law of the State of Delaware, Takeover Statute Pursuant toincluding Section 203, an anti-takeover law enacted in 1988. In general, Section 203 restricts the ability of a public Delaware law, Delaware corporations are prohibitedcorporation from engaging in a wide range"business combination" with an "interested stockholder" for a period of specified transactions with any "interestedthree years after the date of the transaction in which the person became an interested stockholder. An interested stockholder" defined to include, among others, includes any person or entity who in the last three years obtained 15% or more of any class or series of stock entitled to vote generally in the election of directors, unless, among other exceptions, the transaction is approved by (i)directors. However, if the Board of Directors prior to the date the interested stockholder obtained such status or (ii) the holders of two-thirds of the outstanding shares of each class or series of stock entitledapproved the transaction, the person is not deemed to vote generally in the election of directors, not including those shares owned by thebe an interested stockholder. By virtue of the Company's decisionBecause we have not to optopted out of the provisions of this law, it applies to us. As a result, potential acquirors may be discouraged from attempting to acquire us. This may have the Company.effect of depriving our stockholders of acquisition opportunities to sell or otherwise dispose our stock at above-market prices typical of such acquisitions. TRANSFER AGENT AND REGISTRAR The Transfer Agent and Registrar for the Common Stockcommon stock is Boston EquiServe LP. 4759 UNDERWRITING The Underwriters named below, actingWe are offering the shares of common stock described in this prospectus through their representatives BancAmerica Robertson Stephens and UBSa number of underwriters. Banc of America Securities LLC (the "Representatives"),and Salomon Smith Barney Inc. are the representatives of the underwriters. We have severally agreed, subjectentered into a firm commitment underwriting agreement with the representatives. Subject to the terms and conditions of the Underwriting Agreement,underwriting agreement, we have agreed to purchase fromsell to each of the Companyunderwriters, and the Selling Stockholdersunderwriters have each agreed to purchase, the number of shares of Common Stock set forth opposite their names below. The Underwriters are committedcommon stock listed next to purchase and pay for all such shares, if any are purchased.its name in the following table.
NUMBER UNDERWRITER OF UNDERWRITER SHARES - ----------- --------- BancAmerica Robertson Stephens..................................... UBSBanc of America Securities LLC.................................................LLC.............................. Salomon Smith Barney Inc.................................... --------- Total.......................................................... 2,400,000Total..................................................... 1,500,000 =========
The Representatives have advised the Company and the Selling Stockholders that the Underwriters propose tounderwriters initially will offer the shares of Common Stock to the public at the price to the public set forthspecified on the cover page of this Prospectusprospectus. The underwriters may allow to some dealers a concession of not more than $ per share. The underwriters also may allow, and to certainany dealers at such price lessmay reallow, a concession of not more than $ per share of which $ may be reallowed to some other dealers. AfterIf all the public offering,shares are not sold at the public offering price, concessionthe underwriters may change the offering price and reallowancethe other selling terms. The common stock is offered subject to dealers may be reduceda number of conditions, including: - receipt and acceptance of our common stock by the Representatives. No such reduction shall changeunderwriters; and - the amountright to reject orders in whole or in part. The underwriters have an option to buy up to 125,000 additional shares of proceedscommon stock from ABIOMED and an option to buy up to 100,000 additional shares of common stock from Dr. David M. Lederman. These additional shares would cover sales of shares by the underwriters which exceed the number of shares specified in the table above, and will be sold first by Dr. Lederman and then by ABIOMED in the event that the option is not exercised in full. The underwriters have 30 days to exercise this option. If the underwriters exercise this option, they will each purchase additional shares approximately in proportion to the amounts specified in the table above. ABIOMED will pay the expenses, other than the underwriting discounts and commissions paid by Dr. Lederman, associated with the exercise of the over-allotment option. The following table shows the per share and total underwriting discounts and commissions to be received by the Company and Selling Stockholders as set forth on the cover page of this Prospectus. The Company has grantedpaid to the Underwriters anunderwriters and the estimated offering expenses to be paid by ABIOMED and 60 Dr. Lederman. These amounts are shown assuming no exercise and full exercise of the underwriters' option exercisable duringto purchase additional shares.
PAID BY ABIOMED --------------------------- NO EXERCISE FULL EXERCISE ----------- ------------- Per share............................................ $ $ Total................................................ $ $
PAID BY DR. LEDERMAN --------------------------- NO EXERCISE FULL EXERCISE ----------- ------------- Per share............................................ -- $ Total................................................ -- $
ABIOMED, each of its executive officers and directors, and certain of their family members and trusts who own securities of ABIOMED, and Genzyme Corporation, which holds 1,153,846 shares of common stock, have entered into lock-up agreements with the 30-dayunderwriters. Under those agreements, ABIOMED and those holders of stock and options may not dispose of or hedge any ABIOMED common stock or securities convertible into or exchangeable for shares of ABIOMED common stock. These restrictions will be in effect for a period of 90 days after the date of this Prospectus, to purchase up to 360,000 additional sharesprospectus. At any time and without notice, Banc of Common Stock at the same price per share as the Company and Selling Stockholders will receive for the 2,400,000 shares that the Underwriters have agreed to purchase. To the extent that the Underwriters exercise such option, eachAmerica Securities LLC may, in its sole discretion, release all or some of the Underwriterssecurities from these lock-up agreements. ABIOMED and Dr. Lederman will have a firm commitment to purchase approximatelyindemnify the same percentage of such additional shares that the number of shares of Common Stock to be purchased by it shown in the above table represents as a percentage of the 2,400,000 shares offered hereby. If purchased, such additional shares will be sold by the Underwriters on the same terms as those on which the 2,400,000 shares are being sold. The Company will be obligated, pursuant to the option, to sell shares to the Underwriters to the extent the option is exercised. The Underwriters may exercise such option only to cover over-allotments made in connection with the sale of shares of Common Stock offered hereby. 48 The Underwriting Agreement contains covenants of indemnity among the Underwriters, the Company and the Selling Stockholdersunderwriters against certain civil liabilities, including liabilities under the Securities ActAct. If ABIOMED and liabilities arising from breaches of representations and warranties contained inDr. Lederman are unable to provide this indemnification, it will contribute to payments the Underwriting Agreement. The Company's executive officers, directors, Genzyme and each of the Selling Stockholders who, in the aggregate hold approximately 2,872,874 shares of Common Stock (2,722,874 shares of Common Stock after the sale of shares of Common Stock by the Selling Stockholders in the offering) have agreed in writing with the Representatives that, for a period of 90 days from the date of this Prospectus ("Lock-up Period"), subject to certain limited exceptions, each will not, directly or indirectly, without the prior written consent of BancAmerica Robertson Stephens, sell, offer, contract to sell, pledge, grant any option to purchase or otherwise dispose of any shares of Common Stock or any securities convertible into or exchangeable for, or any rights to purchase or acquire, Common Stock held by them, thereafter acquired by them or whichunderwriters may be deemedrequired to be beneficially owned by them. However, BancAmerica Robertson Stephens may,make in its sole discretion at any time or from time to time, without notice, release all or any portionrespect of the securities subject to the lock-up agreements.those liabilities. In addition, the Company has agreed that during the Lock-up Period, it will not, without the prior written consent of BancAmerica Robertson Stephens, issue, sell, contract to sell or otherwise dispose of any shares of Common Stock, any options or warrants to purchase any shares of Common Stock or any securities convertible into, exercisable for or exchangeable for shares of Common Stock other than the Company's sale of shares inconnection with this offering, the issuanceunderwriters may purchase and sell shares of Common Stock uponcommon stock in the exerciseopen market. These transactions may include: - short sales; - stabilizing transactions; and - purchases to cover positions created by short sales. Short sales involve the sale by the underwriters of outstanding options and under the Company's existing employee stock purchase plan, the Company's issuance of options under existing employee and director stock options plans and under certain other conditions. See "Risk Factors-- Shares Eligible For Future Sale." The offering price for the Common Stock has been determined by negotiations among the Company, the Selling Stockholders and the Representatives of the Underwriters, based largely upon the market price for the Common Stock as reported on the Nasdaq National Market. The Underwriters do not intend to confirm sales to any accounts over which they exercise discretionary authority in excess of 5% of thea greater number of shares than they are required to purchase in this offering. Stabilizing transactions consist of Common Stock offered hereby. The Representatives have advisedbids or purchases made for the Company that, pursuant to Regulation M under the Securities Act, certain persons participatingpurpose of preventing or retarding a decline in the offering may engage in transactions, including stabilizing bids, syndicate covering transactions or the imposition of penalty bids, which may have the effect of stabilizing or maintaining the market price of the Common Stock atcommon stock while this offering is in progress. The underwriters may also impose a level abovepenalty bid. This means that whichif the representatives purchase shares in the open market in stabilizing transactions or to cover short sales, the representatives can require the underwriters that sold those shares as part of this offering to repay the underwriting discount received by them. The underwriters may engage in activities that stabilize, maintain or otherwise affect the price of the common stock, including: - over-allotment; - stabilization; - syndicate covering transactions; and - imposition of penalty bids. 61 As a result of these activities, the price of the common stock may be higher than the price that otherwise might otherwise prevailexist in the open market. A "stabilizing bid" is a bid for orIf the purchase of the Common Stock on behalf of the Underwriters for the purpose of fixing or maintaining the price of the Common Stock. A "syndicate covering transaction" is the bid for or the purchase of the Common Stock on behalf of the Underwriters to reduce a short position incurred by the Underwriters in connection with the offering. A "penalty bid" is an arrangement permitting the Representatives to reclaim the selling concession otherwise accruing to an Underwriter or syndicate member in connection with the offering if the Common Stock originally sold by such Underwriter or syndicate member is purchased by the Representatives in a syndicate covering transaction and has therefore not been effectively placed by such Underwriter or syndicate member.underwriters commence these activities, they may discontinue them at any time. The Representatives have advised the Company that suchunderwriters may carry out these transactions may be effected on the Nasdaq National Market, in the over-the-counter-market or otherwise and, if commenced, may be discontinued at any time.otherwise. In connection with this offering, certain Underwriterssome underwriters and any selling group members who are qualified market makers on the Nasdaq National Market may engage in passive market making transactions in the Common Stockcommon stock on the Nasdaq StockNational Market in accordance with Rule 103 of Regulation M, underduring the Securities Exchange Actbusiness day before the pricing of 1934 ("Exchange Act").the offering, before the commencement of offers or sales of the common stock. Passive market making consists of displaying bids on the Nasdaq National Market limited by the bid prices of independentmakers must comply with applicable volume and price limitations and must be identified as a passive market makers and making purchases limited by such prices and effected in response to order flow. Net purchases bymaker. In general, a passive market maker on each daymust display its bid at a price not in excess of the highest independent bid for the security; if all independent bids are limited to a specific percentage oflowered below the passive market maker's average daily trading volume inbid, however, the Common Stock during a specific period andbid must then be discontinuedlowered when such limit is reached. Passive market making may stabilize the market price of the Common Stock at a level above that which might otherwise prevail and, if commenced, may be discontinued at any time. 49 Since September 1996, an entity affiliated with UBS Securities LLC has managed certain assets of the Company, primarily in the form of marketable securities, held by ABD Holding, Inc., a wholly owned subsidiary of the Company. The Company pays quarterly fees for such services based on a percentage of the assets managed. UBS Securities LLC also received fees in connection with its role as the Company's financial advisor in connection with the implementation of a stockholder rights plan for the holders of the Company's Common Stock in August 1997 and its opinion as to the fairness from a financial point of view of the consideration received by the Company pursuant to a private placement of the Company's Common Stock in July 1997. See "Certain Transactions."purchase limits are exceeded. LEGAL MATTERS TheFoley, Hoag & Eliot LLP, Boston, Massachusetts, will pass on the validity of the securitiescommon stock offered hereby has been passedby this prospectus for us. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston, Massachusetts, will pass upon for the Company and the Selling Stockholders by Brown, Rudnick, Freed & Gesmer, Boston, Massachusetts. Certaincertain legal matters in connection with this offering will be passed upon for the Underwriters by Testa, Hurwitz & Thibeault, LLP, Boston, Massachusetts. A member of Brown, Rudnick, Freed & Gesmer, counsel to the Company, is the Secretary of the Company.underwriters. EXPERTS The audited financial statements included orand incorporated by reference in this Prospectus orprospectus and elsewhere in this Registration Statementthe registration statement have been audited by Arthur Andersen LLP, independent public accountants, as indicated in their reportreports with respect thereto, and are included or incorporated by reference herein in reliance upon the authority of said firm as experts in giving said report. AVAILABLEaccounting and auditing. WHERE YOU CAN FIND MORE INFORMATION The Company is subject to the informational requirements of the Exchange Act,We file annual, quarterly and in accordance therewith filescurrent reports, proxy statements and other information with the Commission. Such reports, proxy statementsSEC. You may read and other information filed by the Company can be inspected and copiedcopy any document we file at the SEC's public reference facilities maintained by the Commissionroom at 450 Fifth Street, NW, Room 1024, Judiciary Plaza, Washington, D.C., 20549, and at the Commission's Regional Offices at Citicorp Center, 500 West Madison Street, Suite 1400,SEC's public reference rooms in Chicago, Illinois 60661 and 7 World Trade Center, Suite 1300, New York, New York 10048,York. Please call the SEC at prescribed rates. In addition, such reports, proxy statements and information are available through the Commission's Electronic Data Gathering and Retrieval System at http://www.sec.gov. The Company's Common Stock is listed on the Nasdaq National Market, and reports, proxy statements and certain other1-800-SEC-0330 for further information concerning the Company canpublic reference rooms. Our SEC filings are also be inspectedavailable to the public on the SEC's Website at the offices of the Nasdaq National Market, 1735 K Street NW, Washington, D.C. 20006. The Company hasHTTP://WWW.SEC.GOV. We have filed with the CommissionSEC a Registration Statementregistration statement on Form S-3 under the Securities Act of 1933 as amended, with respect to the Common Stock beingcommon stock offered hereby.in connection with this prospectus. This Prospectus, which constitutes a part of the Registration Statement,prospectus does not contain all of the information set forth in such Registration Statementthe registration statement. We have omitted certain parts of the registration statement in accordance with the rules and regulations of the SEC. For further information with respect to us and the exhibits and schedules theretocommon stock, you should refer to which reference is hereby made. The statementsthe registration statement. Statements contained in this Prospectusprospectus as to the contents of any contract or other document are not necessarily complete and, in each instance, you should refer to the copy of such contract or document filed as an exhibit to or incorporated by reference in the registration statement. Each statement as to the contents of such Registration Statement arecontract or document is qualified in their entiretyall respects by such reference. The Registration Statement, together with its exhibits and schedules,You may be inspectedobtain copies of the registration statement from the SEC's principal office in Washington, D.C. upon payment of the fees prescribed by the SEC, or you may examine the registration statement without charge at the Public Reference Sectionoffices of the Commission in Washington, D.C. atSEC described above. The SEC allows us to "incorporate by reference" the address noted above,information we file with them, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus, and copies of allinformation that we file later with the SEC will automatically update and supersede this information. We incorporate by 62 reference the documents listed below and any future filings we will make with the SEC under Sections 13(a), 13(c), 14 or any part thereof may be obtained from the Commission upon payment15(d) of the prescribed fees. 50 INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE The following documents filed by the Company with the Commission pursuant to theSecurities Exchange Act are incorporated herein by reference:of 1934. (1) the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 1997;1999; (2) the Company's Quarterly ReportsReport on Form 10-Q for the fiscal quartersquarter ended June 30, and September 30, 1997;1999; (3) the Company's CurrentQuarterly Report on Form 8-K filed with10-Q for the Commissionfiscal quarter ended September 30, 1999; (4) Proxy Statement used for our annual meeting of stockholders held on August 25, 1997;11, 1999; and (4)(5) the description of the Company's Common Stockour common stock and the Rightsrights we distributed to stockholders in 1997 contained in the Company's Registration Statementsour registration statements on Form 8-A filed with the CommissionSEC on June 11, 1987 and August 25, 1997. All reports and other documents subsequently filed by the Company pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this Prospectus and prior to the termination of the offering shall be deemed to be incorporated by reference in this Prospectus and shall be part hereof from the date of the filing of such document. Any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this Prospectus to the extent that a statement contained herein, or in any other subsequently filed document that also is (or is deemed to be) incorporated by reference herein, modifies or supersedes such statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of the Registration Statement or this Prospectus. The Company will provide without charge to each person, including any beneficial owner, to whom this Prospectus is delivered, upon written or oralYou may request of such person, a copy of any ofthese filings at no cost, by writing or telephoning at the documents referred to above (other than exhibits). Requests for such documents should be submitted in writing to:following address: ABIOMED, Inc. Investor Relations ABIOMED, Inc.,22 Cherry Hill Drive Danvers, Massachusetts 01923 (978) 777-5410 You should rely only on the information or by telephone at (978) 777-5410. 51representations provided in this prospectus. We have authorized no one to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted. You should not assume that the information in this prospectus is accurate as of any date other than the date on the front of the document. 63 ABIOMED, INC. AND SUBSIDIARIES INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
PAGE ------------ Report of Independent Public Accountants..................................Accountants.................... F-2 Consolidated Balance Sheets as of March 31, 19961998 and 19971999 and September 30, 19971999 (unaudited)............................................................................. F-3 Consolidated Statements of Operations for the Fiscal Years Ended March 31, 1995, 19961997, 1998 and 19971999 and for the Six Months Ended September 30, 19961998 and 19971999 (unaudited)...................................................................... F-4 Consolidated Statements of Stockholders' InvestmentEquity for the Fiscal Years Ended March 31, 1995, 19961997, 1998 and 19971999 and for the Six Months Ended September 30, 19971999 (unaudited).................................................. F-5 Consolidated Statements of Cash Flows for the Fiscal Years Ended March 31, 1995, 19961997, 1998 and 19971999 and for the Six Months Ended September 30, 19961998 and 19971999 (unaudited)...................................................................... F-6 Notes to Consolidated Financial Statements................................Statements.................. F-7
F-1 ABIOMED, INC. AND SUBSIDIARIES REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS To ABIOMED, Inc.: We have audited the accompanying consolidated balance sheets of ABIOMED, Inc. (a Delaware corporation) and subsidiaries as of March 31, 19961998 and 1997,1999, and the related consolidated statements of operations, stockholders' investmentequity and cash flows for each of the three years in the period ended March 31, 1997.1999. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of ABIOMED, Inc. and subsidiaries as of March 31, 19961998 and 1997,1999, and the results of their operations and their cash flows for each of the three years in the period ended March 31, 1997,1999, in conformity with generally accepted accounting principles. Arthur AndersenARTHUR ANDERSEN LLP Boston, Massachusetts May 8, 1997April 30, 1999 F-2 ABIOMED, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS
MARCH 31, --------------------------- SEPTEMBER 30, -------------------------- ------------- 1996 1997 19971998 1999 1999 ------------ ------------ ------------- (unaudited)(UNAUDITED) ASSETS Current Assets: Cash and cash equivalents (Note 1).................................................... $ 2,938,3322,683,151 $ 1,616,6969,279,210 $ 711,4255,117,314 Short-term marketable securities (Note 1).......................... 7,709,110 7,744,664 23,600,089............. 23,714,641 8,902,031 8,543,274 Accounts receivable, net of allowance for doubtful accounts of $111,000, $229,000 and $231,000approximately $204,000 at March 31, 1996, 19971998 and 1999 and $210,000 at September 30, 1997, respectively............ 2,606,289 4,816,500 6,257,7971999......... 5,356,348 6,437,225 6,916,380 Inventories (Note 1)............... 1,653,512 1,820,783 1,847,624.................................. 2,327,442 2,895,857 3,559,112 Prepaid expenses and other current assets............................ 92,280 173,172 391,383assets............. 208,387 335,403 578,774 ------------ ------------ ------------------------- Total current assets............. 14,999,523 16,171,815 32,808,318assets.............................. 34,289,969 27,849,726 24,714,854 ------------ ------------ ------------------------- Property and Equipment, at cost (Note 1): Machinery and equipment............ 2,378,851 3,147,837 3,981,322equipment............................... 4,100,905 5,443,930 5,854,020 Furniture and fixtures ............ 156,048 241,867 380,242fixtures................................ 533,460 575,166 1,036,796 Leasehold improvements............. 378,998 1,118,677 1,262,937improvements................................ 1,561,189 1,728,351 2,026,496 ------------ ------------ ------------- 2,913,897 4,508,381 5,624,501 Less -- Accumulated------------ 6,195,554 7,747,447 8,917,312 Less--Accumulated depreciation and amortization.................. 2,331,145 2,618,603 2,988,902amortization....... 2,674,238 3,884,088 5,109,700 ------------ ------------ ------------- 582,752 1,889,778 2,635,599------------ 3,521,316 3,863,359 3,807,612 ------------ ------------ ------------ Other Assets, net (Notes 1 and 7): 627,154 485,000 904,286(Note 8).............................. 943,839 1,268,536 1,136,334 ------------ ------------ ------------------------- $ 16,209,42938,755,124 $ 18,546,59332,981,621 $ 36,348,20329,658,800 ============ ============ ========================= LIABILITIES AND STOCKHOLDERS' INVESTMENTEQUITY Current Liabilities: Accounts Payable...................payable...................................... $ 777,9432,057,473 $ 1,289,024874,648 $ 1,132,7301,728,964 Accrued expenses (Notes 8 and 9)... 1,486,981 2,032,506 2,567,027(Note 10)............................ 2,948,604 4,830,620 4,438,945 ------------ ------------ ------------------------- Total current liabilities........ 2,264,924 3,321,530 3,699,757liabilities......................... 5,006,077 5,705,268 6,167,909 ------------ ------------ ------------------------- Long-term Liabilities................................... 63,604 204,816 158,775 ------------ ------------ ------------ Liabilities of Discontinued Operations, net (Note 2).... 667,466 -- -- ------------ ------------ ------------ Commitments and Contingencies (Notes 56 and 8) Stockholders' Equity (Notes 3 and 7) Stockholders' Investment (Notes 2 and 6): Class B Preferred Stock, $.01 par value -- Authorized --value--Authorized-- 1,000,000 sharesshares; issued and outstanding-- none.....outstanding--none...... -- -- -- Common Stock, $.01 par value -- Authorized --25,000,000 sharesvalue--Authorized--25,000,000 shares; issued and outstanding -- 5,518,054, 7,008,282outstanding--8,567,015, 8,650,802 and 8,264,5568,657,742 shares at March 31, 1996,1998, March 31, 19971999 and September 30, 1997, respectively...................... 55,180 70,082 82,646 Class A Common Stock, $.01 par value -- Authorized -- 2,346,000 shares issued and outstanding-- 1,428,000 shares at March 31, 1996 and none at March 31, 1997 and September 30, 1997, respectively............ 14,280 --1999, respectively........... 85,670 86,508 86,577 Additional paid-in capital........... 36,625,221 37,169,893 53,221,747capital............................ 57,454,983 58,219,906 58,287,537 Accumulated deficit.................. (22,750,176) (22,014,912) (20,655,947)deficit................................... (24,522,676) (31,234,877) (35,041,998) ------------ ------------ ------------------------- Total stockholders' investment....... 13,944,505 15,225,063 32,648,446equity........................ 33,017,977 27,071,537 23,332,116 ------------ ------------ ------------------------- $ 16,209,42938,755,124 $ 18,546,59332,981,621 $ 36,348,20329,658,800 ============ ============ =========================
The accompanying notes are an integral part of these consolidated financial statements.THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL STATEMENTS. F-3 ABIOMED, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS
SIX MONTHS ENDED YEARS ENDED MARCH 31, SEPTEMBER 30, ------------------------------------- ----------------------- 1995 1996--------------------------------------- ------------------------- 1997 1996 19971998 1999 1998 1999 ----------- ----------- ----------- ----------- ----------- (unaudited) (unaudited)(UNAUDITED) Revenues (Note 1): Products..............Products................................. $10,872,203 $17,260,577 $18,078,957 $ 6,892,9317,877,493 $ 9,725,332 $12,311,178 $5,759,555 $9,324,205 Contracts............. 2,337,505 3,118,2787,615,342 Contracts................................ 4,150,752 1,753,849 3,680,2525,184,859 4,010,647 2,893,176 2,904,648 ----------- ----------- ----------- ---------- ---------- 9,230,436 12,843,610 16,461,930 7,513,404 13,004,457----------- ----------- 15,022,955 22,445,436 22,089,604 10,770,669 10,519,990 ----------- ----------- ----------- ---------- --------------------- ----------- Costs and expenses:Expenses: Cost of products...... 3,288,833 3,921,319 5,360,449 2,122,853 3,437,803product revenues................. 4,427,189 6,502,256 6,772,132 3,000,211 2,472,455 Research and development (Note 1)............. 2,464,519 3,218,211 3,832,918 1,780,737 3,654,181........ 3,772,609 9,090,517 13,449,545 6,984,224 6,842,159 Selling, general and administrative....... 4,278,392 5,740,830 7,068,403 3,229,235 4,970,150administrative...... 6,081,884 9,054,095 9,772,292 4,538,306 5,410,000 ----------- ----------- ----------- ---------- ---------- 10,031,744 12,880,360 16,261,770 7,132,825 12,062,134----------- ----------- 14,281,682 24,646,868 29,993,969 14,522,741 14,724,614 ----------- ----------- ----------- ---------- --------------------- ----------- Income (Loss) From Operations.............. 741,273 (2,201,432) (7,904,365) (3,752,072) (4,204,624) Interest and other income, net........... 535,104 1,206,317 1,192,164 727,003 397,503 ----------- ----------- ----------- ----------- ----------- Income (Loss) From Continuing Operations... 1,276,377 (995,115) (6,712,201) (3,025,069) (3,807,121) Loss From Discontinued Operations (Note 2)....................................... (541,113) (1,512,649) -- -- -- ----------- ----------- ----------- ----------- ----------- Net Income (Loss).......................... $ 735,264 $(2,507,764) $(6,712,201) $(3,025,069) $(3,807,121) =========== =========== =========== =========== =========== Income (loss) from operations............. (801,308) (36,750) 200,160 380,579 942,323 InterestContinuing Operations per Share (Note 1): Basic.................................... $ 0.18 $ (0.12) $ (0.78) $ (0.35) $ (0.44) Diluted.................................. 0.18 (0.12) (0.78) (0.35) (0.44) Loss from Discontinued Operations per Share (Notes 1 and other income............... 449,124 527,874 535,104 256,537 416,6422): Basic.................................... (0.07) (0.19) -- -- -- Diluted.................................. (0.08) (0.19) -- -- -- ----------- ----------- ----------- ---------- --------------------- ----------- Net income (loss).......Income (Loss) per Share (Note 1): Basic.................................... $ (352,184)0.11 $ 491,124(0.31) $ 735,264(0.78) $ 637,116 $1,358,965(0.35) $ (0.44) Diluted.................................. 0.10 (0.31) (0.78) (0.35) (0.44) =========== =========== =========== ========== ========== Net income (loss) per common and common equivalent share=========== =========== Weighted Average Shares Outstanding (Note 1)..................... $ (0.05) $ 0.07 $ 0.10 $ 0.09 $ 0.17 =========== =========== =========== ========== ========== Weighted average number of common and common equivalent shares outstanding (Note 1)... 6,511,777 6,995,664: Basic.................................... 6,978,569 8,074,150 8,619,100 8,598,869 8,653,108 Diluted.................................. 7,162,347 7,196,343 7,868,675 =========== =========== =========== ========== ==========8,074,150 8,619,100 8,598,869 8,653,108
The accompanying notes are an integral part of these consolidated financial statements.THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL STATEMENTS. F-4 ABIOMED, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF STOCKHOLDERS' INVESTMENTEQUITY
CLASS A COMMON STOCK COMMON STOCK ------------------- --------------------- ---------------------- ADDITIONAL TOTAL NUMBER $0.01$.01 NUMBER $0.01$.01 PAID-IN ACCUMULATED STOCKHOLDERS' OF SHARES PAR VALUE OF SHARES PAR VALUE CAPITAL DEFICIT INVESTMENTEQUITY --------- --------- ---------- --------- ----------- ------------ ------------- Balance, March 31, 1994................... 4,432,686 $44,327 2,040,000 $20,400 $33,413,242 $(22,889,116) $10,588,853 Stock options exercised............. 1,100 11 -- -- 6,314 -- 6,325 Stock issued under employee stock purchase plan......... 639 7 -- -- 3,873 -- 3,880 Stock issued in exchange for amount due to Abiomed Limited Partnership........... 451,427 4,514 -- -- 3,053,341 -- 3,057,855 Net loss............... -- -- -- -- -- (352,184) (352,184) --------- ------- ---------- ------- ----------- ------------ ----------- Balance, March 31, 1995................... 4,885,852 48,859 2,040,000 20,400 36,476,770 (23,241,300) 13,304,729 Conversion of Class A Common Stock to Common Stock................. 612,000 6,120 (612,000) (6,120) -- -- -- Stock options exercised............. 19,425 194 -- -- 143,018 -- 143,212 Stock issued under employee stock purchase plan......... 777 7 -- -- 5,433 -- 5,440 Net income............. -- -- -- -- -- 491,124 491,124 --------- ------- ---------- ------- ----------- ------------ ----------- Balance, March 31, 1996...................1996............. 5,518,054 55,180$55,180 1,428,000 14,280 36,625,221 (22,750,176) 13,944,505$14,280 $36,625,221 $(22,750,176) $13,944,505 Conversion of Class A Common Stock to Common Stock................. 1,428,000 14,280 (1,428,000) (14,280) -- -- -- Stock options exercised.............exercised........... 59,112 611 -- -- 533,142 -- 533,753 Stock issued to directors and under employee stock purchase plan.........plan............................ 3,116 11 -- -- 11,530 -- 11,541 Net income.............income........................ -- -- -- -- -- 735,264 735,264 --------- ------- ---------- ------- ----------- ------------ ----------- Balance, March 31, 1997...................1997............. 7,008,282 70,082 -- -- 37,169,893 (22,014,912) 15,225,063 Sales of Common Stock, net........ 1,532,710 15,327 -- -- 20,054,077 -- 20,069,404 Stock options exercised............. 12,015 120exercised........... 20,015 200 -- -- 83,448151,180 -- 83,568151,380 Stock issued to directors and under employee stock purchase plan......... 1,549 17plan............................ 6,008 61 -- -- 15,76479,833 -- 15,781 Private placement of Common Stock ......... 1,242,710 12,427 -- -- 15,952,642 -- 15,965,06979,894 Net income.............loss.......................... -- -- -- -- -- 1,358,965 1,358,965(2,507,764) (2,507,764) --------- ------- ---------- ------- ----------- ------------ ----------- Balance, March 31, 1998............. 8,567,015 85,670 -- -- 57,454,983 (24,522,676) 33,017,977 Stock options exercised........... 69,400 694 -- -- 635,447 -- 636,141 Stock issued to directors and under employee stock purchase plan............................ 14,387 144 -- -- 129,476 -- 129,620 Net loss.......................... -- -- -- -- -- (6,712,201) (6,712,201) --------- ------- ---------- ------- ----------- ------------ ----------- Balance, March 31, 1999............. 8,650,802 86,508 -- -- 58,219,906 (31,234,877) 27,071,537 Stock options exercised (unaudited)..................... 2,300 23 -- -- 18,377 -- 18,400 Stock issued to directors and under employee stock purchase plan (unaudited)................ 4,640 46 -- -- 49,254 -- 49,300 Net loss (unaudited).............. -- -- -- -- -- (3,807,121) (3,807,121) --------- ------- ---------- ------- ----------- ------------ ----------- Balance, September 30, 19971999 (unaudited)....... 8,264,556 82,646....................... 8,657,742 $86,577 -- -- 53,221,747 (20,655,947) 32,648,446$58,287,537 $(35,041,998) $23,332,116 ========= ======= ========== ======= =========== ============ ===========
The accompanying notes are an integral part of these consolidated financial statements.THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL STATEMENTS. F-5 ABIOMED, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED YEARS ENDED MARCH 31, SEPTEMBER 30, ---------------------------------- ------------------------ 1995 1996------------------------------------------ -------------------------- 1997 1996 1997 --------- ----------1998 1999 1998 1999 ------------ ------------ ------------ ------------ ----------- ----------- ----------- (unaudited) (unaudited)(UNAUDITED) Cash flowsFlows from operating activities:Operating Activities: Net income (loss)....... $(352,184) $ 491,124.............. $ 735,264 $ 637,116(2,507,764) $ 1,358,965(6,712,201) $ (3,025,069) $(3,807,121) Adjustments to reconcile net income (loss) to net cash provided by (used in)used in operating activities --activities: Depreciation and amortization.......... 353,293 349,756 429,612 192,168 441,376 Noncash transactions related to Abiomed Limited Partnership... (251,883) -- -- -- --amortization............... 424,225 876,939 1,385,988 763,872 1,330,504 Changes in current assets and liabilities --liabilities: Accounts receivable... (73,518) (830,555) (2,210,211) (337,286) (1,441,297) Inventories........... 815,518 (244,232) (167,271) (164,591) (26,841)receivable, net... (2,217,017) (805,313) (1,080,877) 194,661 (479,155) Inventories................ (39,362) (858,704) (568,415) (882,131) (663,255) Prepaid expenses and other current assets............... 58,530 (38,450)assets................... (80,892) (112,073) (708,574)(266,941) (627,851) (212,506) (216,061) Assets and liabilities of discontinued operations, net...................... (56,591) 1,155,934 (667,466) (56,778) -- Accounts payable...... (65,894) 579,663payable........... 511,081 148,932 (156,294)768,449 (1,182,825) (813,063) 854,316 Accrued expenses...... 428,244 259,602 545,525 (252,435) 534,521 --------- ---------- ----------- ----------expenses........... 514,611 1,013,650 1,882,016 287,609 (391,675) Long-term liabilities...... -- (63,604) 141,212 23,865 (46,041) ------------ ------------ ------------ ------------ ----------- Net cash provided by (used in)used in operating activities......... 912,106 566,908 (236,892) 111,831 1,856 --------- ---------- ----------- ----------activities... (208,681) (687,354) (7,430,419) (3,719,540) (3,418,488) ------------ ------------ ------------ ------------ ----------- Cash flowsFlows from investing activities: (Purchases) maturitiesInvesting Activities: Proceeds from the sale of short termshort-term marketable security investments, net....... (604,618) 2,701,323 (35,554) 4,519,658 (15,855,425)securities................... 43,654,918 50,501,474 40,360,661 18,772,594 7,440,457 Purchases of short-term marketable securities........ (43,690,472) (66,471,451) (25,548,051) (15,496,494) (7,081,700) Purchases of property and equipment.......... (132,087) (322,642) (1,594,484) (531,873) (1,116,120) Purchasesequipment.................... (1,591,846) (2,540,168) (1,551,893) (1,174,378) (1,169,865) ------------ ------------ ------------ ------------ ----------- Net cash (used in) provided by investing activities.... (1,627,400) (18,510,145) 13,260,717 2,101,722 (811,108) ------------ ------------ ------------ ------------ ----------- Cash Flows from Financing Activities: Proceeds from sales of Abiomed Limited Partnership units from limited partners (Note 7)......Common Stock, net................... -- (770,000)20,069,404 -- -- -- --------- ---------- ----------- ---------- ----------- Net cash provided by (used in) investing activities......... (736,705) 1,608,681 (1,630,038) 3,987,785 (16,971,545) --------- ---------- ----------- ---------- ----------- Cash flows from financing activities: Registration fees and costs in connection with exchange of common stock for amounts due to Abiomed Limited Partnership............ (51,573) -- -- -- -- Proceeds from private placement of Common Stock, net............. -- -- -- -- 15,965,069 Proceeds from exercise of stock options and stock issued under employee purchase plan.... 10,205 148,652plan......................... 545,294 266,401 99,349 --------- ---------- ----------- ----------231,274 765,761 651,506 67,700 ------------ ------------ ------------ ------------ ----------- Net cash (used in) provided by financing activities......... (41,368) 148,652activities....... 545,294 266,401 16,064,418 --------- ---------- ----------- ----------20,300,678 765,761 651,506 67,700 ------------ ------------ ------------ ------------ ----------- Net increase (decrease)(Decrease) Increase in cash and cash equivalents, excluding investments............. 134,033 2,324,241 (1,321,636) 4,366,017 (905,271) Cash and cash equivalents,Cash Equivalents........... (1,290,787) 1,103,179 6,596,059 (966,312) (4,161,896) Cash and Cash Equivalents, excluding investments,marketable securities, at beginning of period..... 480,058 614,091 2,938,332 2,938,332 1,616,696 --------- ---------- ----------- ----------period......................... 2,870,759 1,579,972 2,683,151 2,683,151 9,279,210 ------------ ------------ ------------ ------------ ----------- Cash and cash equivalents,Cash Equivalents, excluding investments,marketable securities, at end of period..................period... $ 614,091 $2,938,3321,579,972 $ 1,616,696 $7,304,3492,683,151 $ 711,425 ========= ========== =========== ==========9,279,210 $ 1,716,839 $ 5,117,314 ============ ============ ============ ============ ===========
The accompanying notes are an integral part of these consolidated financial statements.THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL STATEMENTS. F-6 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 1997 AND SEPTEMBER 30, 1997 (UNAUDITED)(INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (1) SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES ABIOMED, Inc. and subsidiaries (the Company)"Company") is engaged primarily in the research, development, manufacture and commercializationmarketing of medical devices, with a primary focus onproducts designed to safely and effectively assist or replace the developmentpumping function of cardiac assist and heart replacement technology. In particular, the failing heart. The Company markets and sells the BVS-5000 system, a bi-ventricular temporary cardiac assist device, from whichartificial heart and is developing the majority of the Company's product revenues have been derived.AbioCor-TM- Implantable Replacement Heart. The accompanying consolidated financial statements reflect the application of certain significant accounting policies described below. (a) Principles of Consolidation(A) PRINCIPLES OF CONSOLIDATION The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, and beginning in fiscal 1996, the accounts of its majority-owned subsidiary Abiomed Limited Partnership. All significant intercompany accounts and transactions have been eliminated in consolidation. (b) Uses of Estimates in the Preparation of Financial Statements(B) USES OF ESTIMATES IN THE PREPARATION OF FINANCIAL STATEMENTS The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. (c) Interim Financial Statementsestimated or assumed. (C) INTERIM FINANCIAL STATEMENTS The accompanying consolidated financial statements include amounts from interim periods ended September 30, 1998 and 1999 that are unaudited but, in the opinion of management, include all adjustments (consisting only of normal, recurring adjustments) necessary for a fair presentation of results for these interim periods. The results of operations for the six months ended September 30, 19971999 are not necessarily indicative of results to be expected for the fiscal year ending March 31, 1998. (d) Product Revenues2000. (D) PRODUCT REVENUES The Company recognizes product revenues at the time products are shipped to the customers. Service revenues, which are not material, are recognized ratably over the periods of the service contracts. In fiscal 1995, 19961997, 1998, 1999 and 1997, 13%, 9%the six months ended September 30, 1998 and 1999, all product revenues were derived from sales of the BVS 5000 and 7%, 6%, 3%, 4% and 3%, respectively, of product revenues were from customers located outside of the United States. No customer accounted for greater than 10% of product revenues during fiscal 1995, 19961997, 1998, 1999 or 1997. During the year ended March 31, 1997 and the six months ended September 30, 1997,1998 and 1999. (E) CONTRACT REVENUES Research and development is a significant portion of the Company recognized $580,000Company's operations. The Company's research and $870,000, respectively,development efforts are focused on the development of product revenuesnew products, primarily related to sales-type lease transactions. The termscardiac assist and heart replacement, including the continued enhancement of these noncancellable leases are for one to three years. As of September 30, 1997, the long-termBVS and related technologies. A portion of these lease payments, approximately $490,000, is included in other assets and the current portion, approximately $350,000, is included in accounts receivable. (e) Contract Revenues In fiscal 1995, 1996 and 1997, the majority of the Company's research and development contract revenues were generated fromexpenses have been supported by F-7 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (1) SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) contracts and grants with various government agencies. Each of theseThe Company's government-sponsored research and development contracts and grants generally provide for revenuespayment on a cost-plus-fixed-fee basis. The Company recognizes revenuerevenues under its government contracts and grants as work is performed, provided that the government has appropriated sufficient funds for the work. The Company retains rights to all technological discoveries and products resulting from these efforts. Costs associated with these contracts and grants are recorded in the accompanying consolidated financial statements of operations as part of research and development expenses and totaled approximately $1,718,000, $2,457,000, $3,232,000, $1,396,000$4,110,000, $2,957,000, $1,591,000 and $3,410,000$1,185,000 for fiscal 1995, 19961997, 1998, 1999 and 1997, and for the six months ended September 30, 19961998 and 1997,1999, respectively. F-7 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(CONTINUED) MARCH 31, 1997 AND SEPTEMBERThe Company, at its sole discretion, may elect to further develop government-funded technologies or products by spending resources outside or above the contract limits. In fiscal 1999 and during the six months ended September 30, 1997 (UNAUDITED) (f)1999, the majority of the Company's research and development expenditures were directed to development of the AbioCor Implantable Replacement Heart. These expenditures included amounts funded under the Company's government contract and amounts funded from the Company's own resources. Company funding of such expenses is discretionary and not included in the contracts and grants costs per above. (F) INVENTORIES Inventories Inventories include raw materials, work-in-process and finished goods, are pricedstated at the lower of cost (first-in, first-out) or market and consist of the following:
MARCH 31, -------------------------------------------- SEPTEMBER 30, 1996 1997 19971998 1999 1999 ---------- ---------- ------------- (unaudited) Raw materials............................ $ 799,548 $ 896,433 $ 919,677$1,320,600 $1,403,253 $1,494,188 Work-in-process.......................... 428,287 373,383 360,025483,723 636,125 1,121,670 Finished goods........................... 425,677 550,967 567,922523,119 856,479 943,254 ---------- ---------- ---------- $1,653,512 $1,820,783 $1,847,624$2,327,442 $2,895,857 $3,559,112 ========== ========== ==========
Finished goods and work-in-process inventories consist of direct material, labor and overhead. (g) Depreciation and Amortization(G) DEPRECIATION AND AMORTIZATION The Company provides for depreciation and amortization by charges to operations in amounts that allocate the cost of depreciable assets over their estimated useful lives as follows:
ESTIMATED CLASSIFICATION METHOD USEFUL LIFE - -------------- ------------------- ------------- Machinery and equip- ment................... Sum-of-the-year's digits/equipment.......................... Straight-line 3- 5 Years Furniture and fixtures.. Sum-of-the-year's digits/fixtures........................... Straight-line 5-10 Years Leasehold improvements..improvements........................... Straight-line Life of lease
(h) Net Income (Loss)F-8 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (1) SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) (H) NET INCOME (LOSS) PER SHARE Basic net income (loss) per Common and Common Equivalent Share Net income per common and common equivalent share is computed by dividing net income by the weighted average number of common and common equivalent shares outstanding during the period using the treasury stock method. Net loss per share is computed by dividing the net loss(loss) by the weighted average number of common shares outstanding during the period excludingperiod. Diluted net income (loss) per share is computed by dividing net income (loss) by the weighted average number of dilutive common shares outstanding during the period. Diluted weighted average shares reflect the dilutive effect, if any, of common stock options outstanding. (i) Cashbased on the treasury stock method. No common stock options are considered dilutive in periods, such as the fiscal years ended March 31, 1998, 1999 and Cash Equivalentsthe six months ended September 30, 1998 and 1999, in which a loss is reported because all such common equivalent shares are antidilutive. The number of shares that otherwise would have been dilutive for the fiscal years ended March 31, 1998, 1999 and the six months ended September 30, 1998 and 1999 were 287,709, 95,426, 214,195 and 283,768, respectively. (I) CASH AND CASH EQUIVALENTS The Company classifies any marketable security with an originala maturity date of 90 days or less at the time of purchase as a cash equivalent. (j) Investments(J) MARKETABLE SECURITIES The Company classifies any security including marketable securities, with an originala maturity of greater than 90 days at the time of purchase as investmentsmarketable securities and classifies investmentsmarketable securities with a maturity of greater than one year from the balance sheet date as long-term investments. Under Statement of Financial Accounting Standards (SFAS)SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities, investmentsACCOUNTING FOR CERTAIN INVESTMENTS IN DEBT AND EQUITY SECURITIES, securities that the Company has the positive intent and ability to hold to maturity are reported at amortized cost and classified as held-to-maturity.held-to-maturity securities. The Company has classified all investmentsmarketable securities at March 31, 19961998 and 19971999 and September 30, 1999 as held-to-maturity.held-to-maturity securities. The amortized cost and market value of short-term investmentsmarketable securities were approximately $7,709,000$23,715,000 and $7,545,000$23,886,000 at March 31, 19961998, $14,102,000 and $7,745,000 and $7,689,000$14,188,000 at March 31, 1997,1999, and $11,552,000 and $11,550,000 at September 30, 1999, respectively. At March 31, 1997,1999 and September 30, 1999 these short-term investments consisted primarily of government grade securities. F-8 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED(K) DISCLOSURES ABOUT FAIR VALUE OF FINANCIAL STATEMENTS--(CONTINUED) MARCH 31, 1997 AND SEPTEMBER 30, 1997 (UNAUDITED) (k) Disclosures about Fair Value of Financial InstrumentsINSTRUMENTS As of March 31, 19961998 and 19971999 and September 30, 1999, the Company's financial instruments were comprised of cash and cash equivalents, marketable securities, accounts receivable and accounts payable, and short term investments, the carrying amounts of which approximated fair market value. (l) Recent Accounting Pronouncements For fiscal 1997, under(L) COMPREHENSIVE INCOME SFAS No. 121 Accounting130, REPORTING COMPREHENSIVE INCOME, requires disclosure of all components of comprehensive income and loss on an annual and interim basis. Comprehensive income and loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. There were no components of comprehensive F-9 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (1) SUMMARY OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) income or loss that require disclosure for the Impairment of Long- lived Assetsyears ending March 31, 1997, 1998, and 1999 or for Long-lived Assetsthe six months ended September 30, 1998 and 1999. (M) SEGMENT AND ENTERPRISE WIDE DISCLOSURES SFAS No. 131, DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION, requires certain financial and supplementary information to be Disposeddisclosed on an annual and interim basis for each reportable segment of an enterprise. The Company believes that it operates in one business segment: the research, development, and sale of medical devices. (N) RECLASSIFICATION OF PRIOR YEAR AMOUNTS Certain prior year financial statement information has been reclassified to be consistent with the current year presentation. (O) RECENT ACCOUNTING PRONOUNCEMENTS In June 1998, the FASB issued SFAS No. 133, ACCOUNTING FOR DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES, as amended by SFAS No. 137, effective for years beginning after June 15, 2000 but permitting early adoption as of the beginning of any fiscal quarter after its issuance. The Company is required to review impairmentadopted the new statement effective January 1, 1999. The new standard requires that all companies record derivatives on the balance sheet as assets or liabilities, measured at fair value. Gains or losses resulting from changes in the values of long-lived assets and certain intangibles whenever events indicate thatthose derivatives would be accounted for depending on the carrying amountuse of the assets may not be recoverable.derivative and whether it qualifies for hedge accounting. The adoption of this statement diddoes not have a material impactan effect on the Company's results of operations. On March 3, 1997,operations or financial position. (2) DISCONTINUED OPERATIONS In fiscal 1998, the Financial Accounting Standards Board (FASB) issued SFAS No. 128, Earnings Per Share, superseding Accounting Principles Board (APB) Opinion No. 15. SFAS No. 128 establishes standardsCompany made the decision to shift all of its focus to the Company's core cardiovascular business and to sell, license or otherwise dispose of its dental business. The Company reported a $1,513,000 loss, $0.19 per share, from discontinued operations for the computationyear ended March 31, 1998. This loss included a $967,000 provision for estimated losses to be incurred through the date of final disposition, including the disposal of assets and presentationextinguishment of earnings per share (EPS)the liabilities of the business. In fiscal 1999, the Company incurred costs associated with the discontinuance of operations of $402,000, and applies to entitieswrote off all remaining assets totaling $335,000. As of March 31, 1999 and September 30, 1999, reserves of $230,000 and $205,000, respectively, remain as a contingency against additional costs associated with publicly held common stock or potential common stock. This statement is effective for fiscal years ending after December 15, 1997 and requires restatementthe discontinuation of all prior-period EPS data presented. The statement is not expected to have a material impact on the Company's EPS presentation. (2)dental business. (3) CAPITAL STOCK Each share of Common Stock has a voting right of one vote per share.share and generally has the right to elect, as a class, at least 25% of the Company's directors. During fiscal 1996 and 1997, respectively, 612,000 and 1,428,000 shares of Class A Common Stock, representing all of the remaining shares of Class A Common Stock, were converted to Common Stock. As of August 1997, Class A Common Stock is no longer authorized. OnIn July 15, 1997, the Company completed a private placement of 1,242,710 shares of its Common Stock to Genzyme Corporation and certain of the Company's directors. Proceeds to the Company from F-10 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (3) CAPITAL STOCK (CONTINUED) the private placement, net of direct expenses of approximately $145,000, totaled approximately $16,010,000. In November 1997, the Company completed an offering of 290,000 shares of its Common Stock. Proceeds to the Company from the private placement,stock offering, net of direct expenses of approximately $145,000 in direct transaction related expenses,$725,000, totaled approximately $15,965,000.$4,060,000. The Company has authorized 1,000,000 shares of Class B Preferred Stock, $.01 par value, of which the designation, rights and privileges can be set by the Board of Directors. No shareshares of Class B Preferred Stock hashave been issued or isare outstanding. OnIn August 13, 1997, the Company declared a dividend of one Preferred Share Purchase Right (the "Right") for each outstanding share of Common Stock to its stockholders of record at August 28, 1997. Each right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series A Junior Participating Preferred Stock with a par value of $0.01 per share, at a price of $90.00 per one one-thousandth of a share, subject to adjustment.amendment. In accordance with the terms set forth in the Rights Agreement, the Rights are not exercisable until the occurrence of certain events, as defined. In addition, the registered holders of the Rights will have no rights as a Common stockholder of the Company until the Rights are exercised. The terms of the Rights may be amended by the Board of Directors. The Rights will expire on August 13, 2007. F-9 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(CONTINUED) MARCH 31, 1997 AND SEPTEMBER 30, 1997 (UNAUDITED) (3) LINE(4) LINES OF CREDIT WITH A BANK The Company has an unsecured demand line of credit agreement with a bank under which it can borrow up to $3,000,000 from a bank at the bank's prime rate.rate (8.25% at September 30, 1999). The Company is required to maintain a compensating balance of $100,000 plus 5% of any amounts outstanding under the arrangement. The line of credit expires in October 2000. There were no borrowings under the company'sCompany's line of credit at March 31, 19961998 and 19971999 and September 30, 1997. The1999. On October 14, 1999, the Company entered into an agreement with the bank whereby it will be able to draw up to $1.2 million in term loans through March 31, 2000 for the acquisition of manufacturing equipment and leasehold improvements. These promissory notes are subject to various financing covenants, secured by the acquired equipment and leasehold improvements and are to be repaid in equal monthly installments through September 1, 2003. These notes will bear interest at either the bank's prime rate or LIBOR rate, at the Company's election. Subsequent to September 30, 1999, the Company has renewedborrowed a total of $250,000 under this line of credit in each ofloan facility at the past three years. The current line of credit expires in September 1998. (4)bank's prime rate. (5) INCOME TAXES The Company accounts for income taxes in accordance with the provisions of SFAS No. 109, Accounting for Income Taxes.ACCOUNTING FOR INCOME TAXES. The asset and liability approach used under SFAS No. 109 requires a recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax basesbasis of other assets and liabilities. At March 31, 19971999, the Company had available net operating loss carryforwards of approximately $21,241,000.$28,908,000. The Company also had available, at March 31, 1997,1999, approximately $766,000$1,171,000 of tax creditscredit carryforwards to reduce future federal income taxes, if any. The net operating loss and tax credit F-11 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (5) INCOME TAXES (CONTINUED) carryforwards expire through 2010.2019. These carryforwards are subject to review by the Internal Revenue Service and may be subject to limitation in any given year under certain conditions. During 1997,The following table summarizes the Company utilized a portion of itsCompany's approximate net operating loss carryforward to reduce its current year taxable income. The Company has placed a valuation allowance of approximately $11,330,000(NOL) and credit carryforwards that are available as of March 31, 1997 against its otherwise recognizable net deferred1999 to offset future taxable income and income tax, assetrespectively. The NOLs and carryforwards are organized by the fiscal year in which they were generated.
TAX DATES OF NOL CREDITS EXPIRATION ----------- ---------- ---------------------- Year Ended March 31, 1987............................... $ -- $ 52,000 3/31/02 1989............................... -- 144,000 3/31/04 1990............................... 532,000 -- 3/31/05 1991............................... 3,116,000 50,000 3/31/06 1992............................... 6,973,000 61,000 3/31/07 1993............................... 5,081,000 75,000 3/31/08 1994............................... 3,334,000 73,000 3/31/09 1995............................... 1,254,000 64,000 3/31/10 1996............................... -- 28,000 3/31/11 1997............................... -- 104,000 3/31/12 1998............................... 1,405,000 270,000 3/31/13 1999............................... 7,213,000 250,000 3/31/14--3/31/19 ----------- ---------- $28,908,000 $1,171,000 =========== ==========
Given the Company's history of operating losses, the Company has not given recognition to any of these future tax benefits in the accompanying consolidated financial statements due to the uncertainty surrounding the timing of the realization of the tax benefits. The deferred tax assetCompany has placed a valuation allowance of approximately $15,515,000 as of March 31, 1996 and 19971999 against its otherwise recognizable net deferred tax asset. The deferred tax asset consisted of the following:
MARCH 31, -------------------------- 1996 1997--------------------------- 1998 1999 ------------ ------------ Purchase of technology (Note 7)................. $ 1,573,000 $ 1,353,000 Net operating loss and tax credit carryforwards.................................. 9,082,000 9,262,000carryforwards............. $ 9,374,000 $ 12,734,000 Purchase of technology (Note 8)............................. 1,068,000 815,000 Nondeductible reserves...................................... 241,000 366,000 Nondeductible accruals...................................... 879,000 1,192,000 Depreciation................................................ 169,000 169,000 Other, net...................................... 549,000 715,000net.................................................. 533,000 239,000 ------------ ------------ 11,204,000 11,330,00012,264,000 15,515,000 Less--Valuation allowance....................... (11,204,000) (11,330,000)allowance................................... (12,264,000) (15,515,000) ------------ ------------ $ -- $ -- ============ ============
(5)F-12 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (6) COMMITMENTS (a) The Company leases its facilities and certain equipment under various operating lease agreements with terms through fiscal 2001.2010. Total rent expense under these leases, included in the accompanying consolidated statements of operations, was approximately $262,000, $233,000$324,000, $360,000, $350,000, $181,000 and $324,000$226,000 for fiscal 1995, 19961997, 1998 and 1997,1999 and the six months ended September 30, 1998 and 1999, respectively. F-10 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(CONTINUED) MARCH 31, 1997 AND SEPTEMBER 30, 1997 (UNAUDITED) Future minimum lease payments under these agreements are as follows:
YEARS ENDED MARCH 31, AMOUNT - --------------------- ------------------ 1998............................................................ $307,000 1999............................................................ 247,000 2000............................................................ 120,000 2001............................................................ 31,000 -------- $705,000 ========2000........................................................ $ 690,000 2001........................................................ 999,000 2002........................................................ 872,000 2003........................................................ 775,000 2004........................................................ 733,000 Thereafter.................................................. 2,250,000 ---------- $6,319,000 ==========
(b) The Company maintains various insurance coverages.coverage. Most policies renew on a fiscal year basis while severalcertain policies have been secured for a three- year period.three-year periods. Future insurance obligations under these insurance policies over a three-year period,the remaining policy terms are approximately $540,000. (6)$303,000 and $225,000 as of March 31, 1999 and September 30, 1999, respectively. (c) On July 30, 1999, the Company entered into an equipment lease line agreement with a leasing company that provides for up to $2,200,000 in leases for furniture and equipment. In connection with this lease line, on October 25, 1999, the Company entered into a 36-month operating lease for approximately $605,000 for office furniture to be used at its new facility leased at 22 Cherry Hill Drive, Danvers, Massachusetts. This lease provides for an additional 12-month option period at the then current fair market value rental rate. Future minimum lease payments under this noncancellable lease are approximately as follows:
YEARS ENDED MARCH 31, AMOUNT - --------------------- -------- 2000........................................................ $ 83,000 2001........................................................ 199,000 2002........................................................ 199,000 2003........................................................ 116,000 -------- $597,000 ========
(7) STOCK OPTIONSOPTION AND PURCHASE PLANS All stock options granted by the Company under the below-described plans described below were granted at the fair value of the stock at the date of grant. Outstanding stock options, if not exercised, expire 10 years from the date of grant. F-13 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (7) STOCK OPTION AND PURCHASE PLANS (CONTINUED) The 1992 Combination Stock Option Plan (the Combination Plan), as amended, approved by the Company's stockholders, combinedwas adopted in September 1992 as a combination and restatedrestatement of the Company's then outstanding Incentive Stock Optionincentive stock option plan and nonqualified plan. Options granted and outstanding under the Combination Plan are primarily held by Company employees and Nonqualified Plan. The options generally become exercisable ratably over five years. All of the options granted under the Combination Plan during the three years ended March 31, 1997 were to employees. In addition, the Company has a nonqualified stock option plan for nonemployeenon-employee directors (the Directors' Plan). The Directors' Plan, as amended, was adopted in July 1989 and amended, with shareholder approval, granted options to purchase 12,500 shares of the Company's Common Stock to each of the Company's then elected outside directors and provides for grants of options to purchase 12,500 shares of the Company's Common Stock to any newly elected eligible director. Thereafter, each eligible director will be granted a new optionand grants of additional options to purchase 12,500 shares of Common Stock to existing directors on July 1 of each successive fifth year. These options vest over a five-year period at the rate of 2,500 shares per year, commencing on June 30 of the year following the date of grant. F-11Separate from the Directors' Plan, non-employee directors of the Company receive as compensation an annual retainer of 400 shares of Common Stock. The Company issued 2,000 shares of its Common Stock for this purpose in the years ending March 31, 1998 and 1999, the fair value of which has been recorded as an expense in the accompanying consolidated statements of operations. No shares were granted to non-employee directors as compensation during the six months ended September 30, 1999. The Company adopted the 1998 Equity Incentive Plan (the Equity Incentive Plan) in August 1998. The Equity Incentive Plan provides for grants of options to key employees, directors, advisors and consultants as either incentive stock options or nonqualified stock options as determined by the Company's Board of Directors. A maximum of 500,000 shares of common stock may be awarded under this plan. Options granted under the Equity Incentive Plan are exercisable at such times and subject to such terms as the Board of Directors may specify at the time of each stock option grant. As of March 31, 1999, no stock options had been granted under the Equity Incentive Plan. In the six months ended September 30, 1999, the Company granted options to purchase 165,700 shares under this plan at an average exercise price of $13.51. All of these options were outstanding as of September 30, 1999 and none were exercisable under this plan as of that date. F-14 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--STATEMENTS (CONTINUED) MARCH 31, 1997(INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (7) STOCK OPTION AND SEPTEMBER 30, 1997 (UNAUDITED)PURCHASE PLANS (CONTINUED) The following table summarizes stock option activity under these plans:
COMBINATION PLAN DIRECTORS' PLAN ---------------------------------- --------------------------------------------------------------------- ----------------------------------- WEIGHTED WEIGHTED NUMBER AVERAGE NUMBER AVERAGE OF EXERCISE PRICE OF EXERCISE PRICE OPTIONS EXERCISE PRICE PER SHARE OPTIONS EXERCISE PRICE PER SHARE --------- ------------ --------- -------- -------------- --------- ------- -------------------------- --------- Options outstanding,Outstanding, March 31, 1994......... 410,830 $ 0.55-1996.......... 578,165 $0.55-$13.50 $ 8.47 95,000 $ 7.00-$13.88 $10.72 Options granted........ 17,000 5.63- 6.50 6.19 -- -- -- Options exercised...... (1,100) 5.75 5.75 -- -- -- Options canceled....... (31,500) 5.75- 13.50 8.48 -- -- -- -------- ------------- ------ ------- ------------- ------ Options outstanding, March 31, 1995......... 395,230 0.55-13.50 8.38 95,000 7.00-13.88 $10.72 Options granted........ 219,000 6.25-11.00 10.23 12,500 11.00 11.00 Options exercised...... (16,925) 5.75- 8.50 7.34 (2,500) 7.00 7.00 Options canceled....... (19,140) 5.75-13.50 9.90 (15,000) 11.00-11.13 11.02 -------- ------------- ------ ------- ------------- ------ Options outstanding, March 31, 1996......... 578,165 0.55-13.50 $ 9.09 90,000 7.00-13.88 10.81 Option granted.........$7.00-$13.88 $10.81 Granted............... 234,235 11.00-13.50 12.53 -- -- -- Options exercised...... (59,112)Exercised............. (58,912) 0.55-13.50 8.65 -- -- -- Options canceled....... (55,413)Canceled.............. (55,613) 5.75-13.50 11.45 -- -- -- -------- ------------- --------------- ------- ------------- ------ Options outstanding,Outstanding, March 31, 1997.........1997.......... 697,875 $ 5.63-$13.50 $10.295.63-13.50 10.29 90,000 $ 7.00-$13.88 $10.81 Option granted......... 159,750 10.00-12.15 11.527.00-13.88 10.81 Granted............... 178,850 10.00-18.00 11.91 50,000 14.00 14.00 Options exercised...... (12,015) 5.63-8.00 6.96Exercised............. (20,015) 5.63-10.63 7.56 -- -- -- Options canceled....... (21,200) 5.63-10.63 9.11Canceled.............. (37,325) 5.63-13.25 10.69 -- -- -- -------- ------------- --------------- ------- ------------- ------ Options outstanding,Outstanding, March 31, 1998.......... 819,385 5.63-18.00 10.71 140,000 7.00-14.00 11.95 Granted............... 337,250 9.25-14.50 11.87 -- -- -- Exercised............. (69,400) 5.63-13.50 9.17 -- -- -- Canceled.............. (129,850) 5.63-14.94 11.77 -- -- -- --------- ------- Outstanding, March 31, 1999.......... 957,385 5.63-18.00 11.08 140,000 7.00-14.00 11.95 Granted............... 129,850 8.88-14.88 12.96 -- Exercised............. (2,300) 8.00 8.00 -- Canceled.............. (21,750) 8.00-17.00 11.82 (7,500) 13.88 13.88 --------- ------- Outstanding, September 30, 1997..... 824,410 1999...... 1,063,185 $5.63-$ 5.63-$13.50 $10.53 140,000 $ 7.00-18.00 $11.30 132,500 $7.00-$14.00 $10.81 ========$11.84 ========= ======= Options exercisable:Exercisable: March 31, 1997......... 179,4151999........ 288,037 $5.63-$13.50 $ 5.63-$13.50 $8.96 70,000 $ 7.00-9.62 95,000 $7.00-$13.88 $10.76 ========$11.14 ========= ======= September 30, 1997..... 182,500 $ 5.63-1999.... 354,258 $5.63-$13.50 $9.02 82,500 $ 7.00-$10.07 100,000 $7.00-$14.00 $10.76 ========$11.21 ========= ======= Shares available for Future issuance,future issuance: March 31, 1997......... 459,032 107,500 ========1999........ 110,107 57,500 ========= ======= September 30, 1997..... 320,482 57,500 ========1999.... 2,007 65,000 ========= ======= EQUITY INCENTIVE PLAN ------------------------------------ WEIGHTED NUMBER AVERAGE OF EXERCISE PRICE OPTIONS PRICE PER SHARE -------- ------------- --------- Outstanding, March 31, 1996.......... -- -- -- Granted............... -- -- -- Exercised............. -- -- -- Canceled.............. -- -- -- ------- Outstanding, March 31, 1997.......... -- -- -- Granted............... -- -- -- Exercised............. -- -- -- Canceled.............. -- -- -- ------- Outstanding, March 31, 1998.......... -- -- -- Granted............... -- -- -- Exercised............. -- -- -- Canceled.............. -- -- -- ------- Outstanding, March 31, 1999.......... -- -- -- Granted............... 165,700 $13.38-$14.25 $13.51 Exercised............. -- -- -- Canceled.............. -- -- -- ------- Outstanding, September 30, 1999...... 165,700 $13.38-$14.25 $13.51 ======= Exercisable: March 31, 1999........ -- $ -- $ -- ======= September 30, 1999.... -- $ -- $ -- ======= Shares available for future issuance: March 31, 1999........ -- ======= September 30, 1999.... 334,300 =======
F-15 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (7) STOCK OPTION AND PURCHASE PLANS (CONTINUED) The following table summarizes certain data for options outstanding under the Combination, Directors' and Equity Incentive Plans at September 30, 1999.
WEIGHTED WEIGHTED AVERAGE AVERAGE REMAINING NUMBER RANGE OF EXERCISE CONTRACTUAL OF SHARES EXERCISE PRICES PRICE LIFE (YEARS) --------- --------------- -------- ------------ Options outstanding, end of year:............... 159,425 $5.63-$8.00 $ 7.38 9.12 560,500 $8.88-$11.75 $10.90 8.25 239,210 $12.13-$13.25 $12.62 7.88 290,250 $13.38-$13.63 $13.46 7.38 112,000 $14.00-$18.00 $14.44 6.93 --------- 1,361,385 $11.63 7.99 ========= Options exercisable, end of year:............... 147,350 $5.63-$8.00 $ 7.45 9.16 182,440 $8.88-$11.75 $10.89 8.22 76,218 $12.13-$13.25 $12.59 6.76 25,325 $13.38-$13.63 $13.50 8.73 22,925 $14.00-$18.00 $14.00 5.67 --------- 454,258 $10.34 8.19 =========
The Company has an Employee Stock Purchase Plan (the Purchase Plan), as amended. Under the Purchase Plan, all employees (including officers and directors) of the Company who have completed six months of employment are eligible to purchase the Company's Common Stock at an exercise price equal to 85% of the fair market value of the Common Stock. The Company has reserved 100,000 shares of Common Stock for issuance under the Purchase Plan, of which 89,13874,292 shares are available for future issuance as of March 31, 1997.1999. During the fiscal years ended March 31, 19961998 and 1997,1999 and the six months ended September 30, 1997, 7771999, 4,039 shares, 1,11612,387 shares and 1,5494,640 shares, respectively, of Common Stock were sold pursuant to the Purchase Plan. F-12 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(CONTINUED) MARCH 31, 1997 AND SEPTEMBER 30, 1997 (UNAUDITED) In October 1995, FASB issued SFAS No. 123, Accounting for Stock-Based Compensation. SFAS No. 123ACCOUNTING FOR STOCK-BASED COMPENSATION, requires the measurement of the fair value of stock options, including stock purchase plans, or warrants granted to employees to be included in the statement of operations or disclosed in the notes to financial statements. The Company has determined that it will continue to account for stock-based compensation for employees under APB Opinion No. 25 and elect the disclosure-only alternative under SFAS No 123. The Company has computed the pro forma disclosures required under SFAS No. 123 for options granted in fiscal 19961997, 1998 and 19971999 F-16 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (7) STOCK OPTION AND PURCHASE PLANS (CONTINUED) using the Black-Scholes option pricing model prescribed by SFAS No. 123. The weighted average information and assumptions used for 1996 and 1997 are as follows:
1996SIX MONTHS ENDED YEAR ENDED MARCH 31, SEPTEMBER 30, ------------------------- ---------------- 1997 1998 1999 1998 1999 ------- ------- ------- ------- ------- Risk-free interest rate..................................rate.......................... 6.75% 6.75%5.50% 5.68% 5.50% 5.80% Expected dividend yield..................................yield.......................... -- -- Expected life............................................-- -- -- Assumed life..................................... 5 years 5 years Expected volatility...................................... 30%5 years 5 years 5 years Assumed volatility............................... 33% 33% 35% 33% 38%
The Black-Scholes option-pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option-pricing models require the input of highly subjective assumptions including expected stock price volatility. Because the Company's employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options. The total fair value of the options granted during fiscal 19961997, 1998 and 19971999 and during the six months ended September 30, 1998 and 1999 was computed as approximately $431,000$598,000, $501,000, $483,000, $251,000 and $598,000,$1,680,000, respectively. Of these amounts approximately $108,000$257,000, $383,000, $504,000, $267,000 and $257,000$408,000 would be charged to operations for the years ended March 31, 19961997, 1998 and 19971999 and during the six months ended September 30, 1998 and 1999, respectively. The remaining amount, approximately $664,000,amounts would be amortized over the remaining vesting periods.periods of the underlying options. Similarly, the total fair value of stock sold under thisthe Purchase Plan was computed as approximately $4,000$3,000, $17,000, $31,000, $9,000 and $3,000 during$11,000 for fiscal 19961997, 1998 and 1997.1999 and for the six months ended September 30, 1998 and 1999, respectively. The resulting pro forma compensation expense may not be representative of the amount to be expected in future years as pro forma compensation expense may vary based upon the number of options granted and shares purchased. The pro forma net income (loss) and pro forma net income (loss) per common share presented below have been computed assuming no tax benefit. The effect of a tax benefit has not been considered since a substantial portion of the stock options granted are incentive stock options and the Company does not anticipate a future deduction associated with the exercise of these stock options. F-17 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (7) STOCK OPTION AND PURCHASE PLANS (CONTINUED) The pro forma effect of SFAS No. 123 for the years ended March 31, 19961997, 1998 and 19971999 is as follows:
1996 1997 --------------------- ---------------------BASIC NET INCOME DILUTED NET INCOME NET INCOME (LOSS) (LOSS) PER SHARE (LOSS) PER SHARE ------------------------- ------------------- ------------------- AS PRO AS PRO AS REPORTED PRO FORMA AS REPORTED PROFORMA REPORTED FORMA ----------- --------- ----------- ----------------- -------- -------- -------- Net income..................... $491,124 $379,124 $735,264 $475,264 Pro forma net income per common and common equivalent share... Years Ended March 31, 1997............................. $ 0 .07735,264 $ 0 .05475,264 $ 0 .100.11 $ 0 .070.07 $ 0.10 $ 0.07 1998............................. $(2,507,764) $(2,907,764) $(0.31) $(0.36) $(0.31) $(0.36) 1999............................. $(6,712,201) $(7,247,201) $(0.78) $(0.84) $(0.78) $(0.84) Six Months Ended September 30, 1998............................. $(3,025,069) $(3,292,194) $(0.35) $(0.38) $(0.35) $(0.38) 1999............................. $(3,807,121) $(4,220,856) $(0.44) $(0.49) $(0.44) $(0.49)
(7)(8) ROYALTY OBLIGATION Commencing April 1, 1995 and endingUntil August 3, 2000, the Company owes a royalty to certain third parties equal in aggregate to approximately 2.1% of certain revenues derived from the BVS 5000BVS-5000 and certain F-13 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(CONTINUED) MARCH 31, 1997 AND SEPTEMBER 30, 1997 (UNAUDITED) other technology. This royalty is subject to certain maximum revenue amounts and to certain adjustments, as defined, in the event that the Company sells the underlying technology. For the years ended March 31, 19961997, 1998 and 1997,1999 and the six months ended September 30, 19971998 and 1999, the amount of this royalty, net of certain reimbursed expenses, was approximately $160,000, $216,000, $338,000, $341,000, $147,000 and $174,000$146,000, respectively. These amounts are reflected as part of the cost of product salesproducts in the accompanying consolidated financial statements.statements of operations. This royalty is paid to the third parties through Abiomed Limited Partnership which, at present, is inactive except with respect to the distribution of such royalties. During fiscal 1996,In 1995, the Company paid $770,000 to reduce its royalty obligation to 2.1%, as described above. This one-time payment capitalized by the Company is being amortized on a straight-line basis over the estimated useful life of the asset (5 years) and, net of accumulated amortization, is classified as a long-term other asset in the accompanying consolidated financial statements. (8)balance sheets. (9) EMPLOYEE DEFERRED COMPENSATION PROFIT-SHARING PLAN AND TRUST The Company has an Employee Deferred Compensation Profit-sharing Plan and Trustemployee deferred compensation profit-sharing plan (the 401(k) Plan) that covers all employees over 20 years of age who have completed at least six months of service with the Company.age. Contributions by the Company, arewhich consist of amounts paid by the Company to match a portion of employees' contributions and discretionary amounts determined by the Company's Board of Directors, and totaled approximately $36,000, $80,000$72,000, $144,000, $237,000, $0 and $59,000$150,000 for the fiscal years ended March 31, 1995, 19961997, 1998 and 1997,1999 and for the six months ended September 30, 1998 and 1999, respectively. (9)F-18 ABIOMED, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (INCLUDING DATA APPLICABLE TO UNAUDITED PERIODS) (10) ACCRUED EXPENSES Accrued expenses consist of the following:
MARCH 31, -------------------------------------------- SEPTEMBER 30, 1996 1997 19971998 1999 1999 ---------- ---------- ------------- (unaudited)(UNAUDITED) Salaries and benefits................... $ 703,478 $ 700,570 $1,227,718 Legal and audit......................... 72,436 76,914 103,106benefits.................................... $1,460,222 $2,606,089 $1,936,067 Contract services........................................ 321,512 336,960 547,215 Warranty................................................. 173,362 181,145 273,248 Sales taxes.............................................. 157,277 55,903 168,769 Professional fees........................................ 126,377 137,212 565,356 Deferred revenue......................................... 245,924 434,660 162,423 Customer advances....................... 56,067 287,882 67,340 Sales taxes............................. 214,521 172,836 221,023 Warranty................................ 72,662 227,093 187,472 Other................................... 367,817 567,211 760,368advances........................................ 85,284 65,095 84,314 Other.................................................... 378,646 1,013,556 701,553 ---------- ---------- ---------- $1,486,981 $2,032,506 $2,567,027$2,948,604 $4,830,620 $4,438,945 ========== ========== ==========
F-14F-19 [DRAWINGBVS-5000-REGISTERED TRADEMARK- BI-VENTRICULAR ASSIST SYSTEM [Photograph of BVS console and two blood pumps appear here.] BVS-5000 pneumatic console with two single-use BVS blood pumps mounted on bedside stand. The BVS provides a patient's failing heart with full circulatory assistance, while allowing the heart to rest, heal and recover its function. ABIOMED, the ABIOMED logo and BVS are our registered trademarks. Angioflex, AbioBooster, AbioCor and AbioVest are our trademarks. This prospectus also includes trademarks of companies other than ABIOMED. - ------------------------------------------------------------ - ------------------------------------------------------------ 1,500,000 Shares [ABIOMED LOGO] ------------------- Prospectus , 2000 ------------------- BANC OF A TAH IMPLANTED THE COMPANY'S TOTAL ARTIFICIAL HEART IS IN A WOMAN] A CLASS III DEVICE UNDER DEVELOPMENT AND HAS NOT BEEN APPROVED FOR SALE IN ANY COUNTRY. THE COMPANY DOES NOT INTEND TO APPLY FOR REGULATORY APPROVAL TO MARKET THIS DEVICE FOR SEVERAL YEARS, IF EVER, AND WILL BE REQUIRED TO SUCCESSFULLY COMPLETE CLINICAL TRIALS TO DEMONSTRATE ITS SAFETY AND EFFICACY PRIOR TO FILING FOR REGULATORY APPROVAL. SEE "RISK FACTORS." [ILLUSTRATION OF THE IMPLANTABLE ILLUSTRATION OF THE IMPLANTABLE COMPONENTS] COMPONENTS OF THE ABIOMED TAH, A BATTERY-POWERED TOTALLY IMPLANTABLE ARTIFICIAL HEART BEING DEVELOPED AS A PERMANENT REPLACEMENT DEVICE TO ASSUME THE FULL PUMPING FUNCTION OF BOTH THE LEFT AND RIGHT VENTRICLES OF THE HEART. DEVELOPMENTAL MODEL TAH WITH THE [PHOTOGRAPH OF TAH SYSTEM. IMPLANTABLE COMPONENTS: THE THORACIC COMPONENTS OF TAH SYSTEM ARE UNIT, THE INTERNAL RECHARGEABLE IDENTIFIED WITH CAPTIONS] BATTERY, THE INTERNAL ELECTRONICS PACKAGE AND THE INTERNAL COMPONENT OF THE ENERGY TRANSMISSION SYSTEM. [ABIOMED LOGO APPEARS HERE]AMERICA SECURITIES LLC SALOMON SMITH BARNEY - ------------------------------------------------------------ - ------------------------------------------------------------ PART II INFORMATION NOT REQUIRED IN PROSPECTUS ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION SEC Registration Fee................................................... $14,323Fee........................................ $ 20,294 NASD Filing Fee........................................................ 30,500Fee............................................. 8,187 Nasdaq National Market Listing Fee.....................................Fee.......................... 17,500 Transfer Agent and Registrant Fees.....................................Fees.......................... 2,500* Accounting Fees and Expenses...........................................Expenses................................ 50,000* Legal Fees and Expenses................................................ 175,000*Expenses..................................... 225,000* Printing and Engraving ................................................Engraving...................................... 60,000* Miscellaneous.......................................................... 50,177* ------- TOTAL................................................................ 400,000* =======Miscellaneous............................................... 116,519* -------- TOTAL................................................... $500,000* ========
- -------------------------------- * Estimated ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS The Company's CertificateABIOMED's certificate of Incorporationincorporation provides that, to the fullest extent permitted by Delaware law, no director of the CompanyABIOMED shall be personally liable to the CompanyABIOMED or its stockholders for monetary damages for breach of fiduciary duty as a director, notwithstanding any other provision of law. However, a director shall be liable to the extent required by law (i) for any breach of the director's duty of loyalty to the CompanyABIOMED or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) in respect of certain unlawful dividend payments or stock redemptions or repurchases, or (iv) for any transaction from which the director derived an improper personal benefit. The CompanyABIOMED entered into indemnification agreements with each of its directors and anticipates that it will enter into similar agreements with any future director. Generally, these agreements attempt to provide the maximum protection permitted by Delaware law with respect to indemnification. The indemnification agreements provide that the CompanyABIOMED will pay certain amounts incurred by a director in connection with any civil or criminal action or proceeding, specifically including actions by or in the name of the CompanyABIOMED (derivative suits) where the individual's involvement is by reason of the fact that he is or was a director or officer. For directors, such amounts include, to the maximum extent permitted by law, attorney's fees, judgments, civil or criminal fines, settlement amounts and other expenses customarily incurred in connection with legal proceedings. Under the indemnification agreements, a director will not receive indemnification if the director is found not to have acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company. The CompanyABIOMED. ABIOMED has also entered into similar agreements with certain of the Company'sits officers and top management personnel who are not also directors. The indemnification agreements with officers are slightly more restrictive. Generally, the indemnification agreements attempt to provide the maximum protection permitted by Delaware law with respect to indemnification of directors and officers. The effect of these provisions would be to permit such indemnification by the CompanyABIOMED for liabilities arising under the Securities Act of 1933, as amended. Reference is hereby made to Section 8 of the Underwriting Agreement amongbetween ABIOMED, the Company, the Selling Stockholdersunderwriters and the Underwriters,Dr. David M. Lederman, filed as Exhibit 1.1 to this Registration Statement,registration statement, for a description of indemnification arrangements among the Company, the Selling Stockholdersbetween ABIOMED and the Underwriters. Reference is hereby made to Section 2 of the Selling Stockholder Agreement among the Company and the Selling Stockholders, filed as Exhibit 99.1 to this Registration Statement, for a description of indemnification arrangements among the Company and the Selling Stockholders.underwriters. II-1 ITEM 16. EXHIBITS
EXHIBIT NUMBER -------- --------------------- 1.1 Form of Underwriting Agreement*** 3.1 Restated Certificate of Incorporation of the Company**ABIOMED, Inc.--Filed as Exhibit 3.1 to Registration Statement No. 333-36657* 3.2 Amended and Restated Bylaws of the Company--FiledABIOMED, Inc.--Filed as Exhibit 3(b)3.02 to the Company's AnnualQuarterly Report on Form 10-K10-Q for the fiscal yearperiod ended March 31, 1991*September 30, 1996* 3.3 Certificate of Designations of Series A Junior Participating Preferred Stock--Filed as Exhibit 3.3 Preferred Stock**to Registration Statement No. 333-36657* 4.1 Specimen Certificate of Common Stock--Filed as Exhibit 4.1 to Registration Statement No. 33-14861 on Form S-1* 4.2 Description of Capital Stock (contained in the Restated Certificate of Incorporation of the CompanyABIOMED, Inc. filed as Exhibit 3.1 and in the Certificate of Designations of Series A Junior Participating Preferred Stock filed as Exhibit 3.3)** 4.3 Rights Agreement between the RegistrantABIOMED, Inc. and BankBoston, N.A., as Rights Agent dated as of August 13, 1997 (including Form of Right Certificate attached thereto as Exhibit A)--Filed as Exhibit 4 to the Registrant'sABIOMED, Inc.'s Current Report on Form 8-K, dated August 13, 1997* 5.1 Legal Opinion of Brown, Rudnick, FreedFoley, Hoag & Gesmer*Eliot LLP*** 23.1 Consent of Arthur Andersen LLP*** 23.2 Consent of Brown, Rudnick, FreedFoley, Hoag & GesmerEliot LLP (included in Exhibit 23.2 5.1)*** 24.1 Power of Attorney (previously filed, except for Power(contained on the signature page of Attorney of one director which is filed herewith)this registration statement)** *** 99.1 Form of Selling Stockholder Agreement*** 99.2 Common Stock Purchase Agreement between the Company and Genzyme Corporation** 99.3 Common Stock Purchase Agreements between the Company and certain directors**
- -------------------------------- * Not filed herewith. In accordance with Rule 411 promulgated pursuant to the Securities Act of 1933, as amended, reference is made to the documents previously filed with the Commission, which are incorporated by reference herein. ** Previously filed.Filed herewith. *** Filed herewith.To be filed by amendment. ITEM 17. UNDERTAKINGS (a)The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial BONA FIDE offering thereof. Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the Registrantregistrant pursuant to the Registrants By-Laws,foregoing provisions, or otherwise, the Registrantregistrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event II-2 that a claim for indemnification against such liabilities (other than the payment by the Registrantregistrant of expenses incurred or paid by a director, officer or controlling II-2 person of the Registrantregistrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrantregistrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. (b) The undersigned Registrantregistrant hereby further undertakes that: (1) For purposes of determining any liability under the Securities Act, of 1933, each filing of the Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be initial bona fide offering thereof. (2) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrantregistrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. (3)(2) For the purpose of determining any liability under the Securities Act, of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. II-3 SIGNATURES PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OFPursuant to the requirements of the Securities Act of 1933, THE REGISTRANT CERTIFIES THAT IT HAS DULY CAUSED THIS AMENDMENT NO. 1 TO THE REGISTRATION STATEMENT TO BE SIGNED ON ITS BEHALFthe registrant certifies that it has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Boston, Commonwealth of Massachusetts, on December 17, 1999. ABIOMED, INC. By: /s/ DAVID M. LEDERMAN ----------------------------------------- Dr. David M. Lederman President and Chief Executive Officer
KNOW ALL BY THE UNDERSIGNED, THEREUNTO DULY AUTHORIZED, IN THE CITY OF BOSTON, COMMONWEALTH OF MASSACHUSETTS, ON OCTOBER 10, 1997. ABIOMED, Inc. /s/ Dr.THESE PRESENTS that each individual whose signature appears below hereby constitutes and appoints David M. Lederman By: _________________________________ DR. DAVID M. LEDERMANPRESIDENT AND CHIEF EXECUTIVE OFFICER PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS AMENDMENT NO. 1 TO THIS REGISTRATION STATEMENT HAS BEEN SIGNED BY THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED. SIGNATURE TITLE DATE Chief Executive /s/ David M. Lederman Officer, President October 10, 1997 - ------------------------------------- and Director DAVID M. LEDERMAN (Principal Executive Officer) Chief Financial /s/ John F. Thero, Officer, Vice October 10, 1997 - ------------------------------------- President--Finance JOHN F. THERO and Treasurer (Principal Financialeach of them, his true and Accounting Officer) Director * October 10, 1997 - ------------------------------------- DESMOND H. O'CONNELL, JR. Director * October 10, 1997 - ------------------------------------- JOHN F. O'BRIEN Director * October 10, 1997 - ------------------------------------- HENRI A. TERMEER Director * October 10, 1997 - ------------------------------------- W. GERALD AUSTEN Director * October 10, 1997 - ------------------------------------- PAUL FIREMAN /s/ David M. Lederman *By: ___________________________ DAVID M. LEDERMANATTORNEY-IN-FACTlawful attorneys-in-fact and agents with full power of substitution, for him and in his name, place and stead, in any and all capacities, to sign any and all pre- or post-effective amendments to this registration statement, any subsequent registration statement for the same offering which may be filed under Rule 462(b) under the Securities Act (a "Rule 462(b) registration statement") and any and all pre- or post- effective amendments thereto, and to file the same, with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing which they, or any of them, may deem necessary or advisable to be done in connection with this registration statement or any Rule 462(b) registration statement, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or any substitute or substitutes for any or all of them, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
SIGNATURE TITLE DATE --------- ----- ---- Chief Executive Officer, /s/ DAVID M. LEDERMAN President and Director ------------------------------------------- (Principal Executive December 17, 1999 David M. Lederman Officer) Chief Financial Officer, /s/ JOHN F. THERO Vice President--Finance ------------------------------------------- and Treasurer (Principal December 17, 1999 John F. Thero Financial and Accounting Officer) /s/ W. GERALD AUSTEN ------------------------------------------- Director December 17, 1999 W. Gerald Austen /s/ PAUL FIREMAN ------------------------------------------- Director December 17, 1999 Paul Fireman
II-4
SIGNATURE TITLE DATE --------- ----- ---- /s/ JOHN F. O'BRIEN ------------------------------------------- Director December 17, 1999 John F. O'Brien /s/ DESMOND H. O'CONNELL, JR. ------------------------------------------- Director December 17, 1999 Desmond H. O'Connell, Jr. /s/ HENRI A. TERMEER ------------------------------------------- Director December 17, 1999 Henri A. Termeer
II-5 EXHIBIT INDEX
EXHIBIT NUMBER DESCRIPTION ------- ------------ --------------------- 1.1 Form of Underwriting Agreement*** 3.1 Restated Certificate of Incorporation of the Company**ABIOMED, Inc.--Filed as Exhibit 3.1 to Registration Statement No. 333-36657* 3.2 Amended and Restated Bylaws of the Company--FiledABIOMED, Inc.--Filed as Exhibit 3(b)3.02 to the Company's AnnualQuarterly Report on Form 10-K10-Q for the fiscal yearperiod ended March 31, 1991*September 30, 1996* 3.3 Certificate of Designations of Series A Junior Participating Preferred Stock--Filed as Exhibit 3.3 Stock**to Registration Statement No. 333-36657* 4.1 Specimen Certificate of Common Stock--Filed as Exhibit 4.1 to Registration Statement No. 33-14861 on Form S-1* 4.2 Description of Capital Stock (contained in the Restated Certificate of Incorporation of the CompanyABIOMED, Inc. filed as Exhibit 3.1 and in the Certificate of Designations of Series A Junior Participating Preferred Stock filed as Exhibit 3.3)** 4.3 Rights Agreement between the RegistrantABIOMED, Inc. and BankBoston, N.A., as Rights Agent dated as of August 13, 1997 (including Form of Right Certificate attached thereto as Exhibit A)--Filed as Exhibit 4 to the Registrant'sABIOMED, Inc.'s Current Report on Form 8-K, dated August 13, 1997* 5.1 Legal Opinion of Brown, Rudnick, FreedFoley, Hoag & Gesmer*Eliot LLP*** 23.1 Consent of Arthur Andersen LLP*** 23.2 Consent of Brown, Rudnick, FreedFoley, Hoag & GesmerEliot LLP (included in Exhibit 5.1)*** 24.1 Power of Attorney (previously filed, except for Power(contained on the signature page of Attorney of one director of which is filed herewith)this registration statement)** *** 99.1 Form of Selling Stockholder Agreement*** 99.2 Common Stock Purchase Agreement between the Company and Genzyme Corporation** 99.3 Common Stock Purchase Agreements between the Company and certain directors**
- -------------------------------- * Not filed herewith. In accordance with Rule 411 promulgated pursuant to the Securities Act of 1933, as amended, reference is made to the documents previously filed with the Commission, which are incorporated by reference herein. ** Previously filed.Filed herewith. *** Filed herewith. To be filed by amendment.