1

                                   FORM 10-Q

                       SECURITIES AND EXCHANGE COMMISSION
                              Washington, DC 20459

[x]      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the quarterly period ended JuneSeptember 30, 1997

[  ]     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d)  OF THE SECURITIES
EXCHANGE ACT OF 1934

For the transition period from             to              .
                               -----------    -------------

                         Commission file number 0-20713
                                                -------

                                 ENTREMED, INC.
                                 --------------
             (Exact name of registrant as specified in its charter)

           
               Delaware                                 58-1959440
               --------                               --------------Delaware                                      58-1959440
           --------                                      ----------
(State or other jurisdiction of             (I.R.S. Employer Identification No.)
incorporation or organization)
Suite 200 9610 Medical Center Drive Rockville, Maryland ------------------- (Address of principal executive offices) 20850 ----- (Zip code) (301) 217-9858 -------------- (Registrant's telephone number, including area code) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES NO X --- -------- ----- Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the most recent practicable date.
Class Outstanding at JulyOctober 31, 1997 --------------------------- ----------------------------- ---------------------------------- ------------------------------- Common Stock $.01 Par Value 12,229,768
2 ENTREMED, INC. Table of Contents
PART I. FINANCIAL INFORMATION PAGE ---- Item 1 -- Financial Statements Consolidated Balance Sheets as of JuneSeptember 30, 1997 and December 31, 1996 3 Consolidated Statements of Operations for the Three Months Ended JuneSeptember 30, 1997 and 1996, and the SixNine Months Ended JuneSeptember 30, 1997 and 1996 4 Consolidated Statements of Cash Flows for the SixNine Months Ended JuneSeptember 30, 1997 and 1996 5 Notes to Consolidated Financial Statements 6 Item 2 -- Management's Discussion and Analysis of Financial Condition and Results of Operations 8 Part II. OTHER INFORMATION Item 1 -- Legal Proceedings 1011 Item 2 -- Changes in Securities 1011 Item 3 -- Defaults upon Senior Securities 1011 Item 4 -- Submission of Matters to Vote of Security Holders 1011 Item 5 -- Other Information 11 Item 6 -- Exhibits and Reports on Form 8-K 11 SIGNATURES 12
2 3 ENTREMED, INC. CONSOLIDATED BALANCE SHEETS
September 30, December 31, 1997 1996 ----------------- ----------------- ASSETS (unaudited) Current assets: Cash and cash equivalents $ 29,385,42725,946,492 $ 33,051,206 Short term investments 19,924,50020,011,850 19,669,623 Interest receivable 466,039330,892 401,673 Grant and other receivable 28,586 - Prepaid expenses 185,855137,457 97,962 ------------- ----------------------------- ----------------- Total current assets 49,961,82146,455,277 53,220,464 ------------- ----------------------------- ----------------- Furniture and equipment, net 1,109,1991,442,682 824,559 ------------- ----------------------------- ----------------- Other assets 403,319402,819 101,316 ------------- ----------------------------- ----------------- Total assets $ 51,474,33948,300,778 $ 54,146,339 ============= ============================= ================= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 756,550496,360 $ 600,303 Accrued liabilities 520,461417,178 957,718 Capital lease obligations - 104,152 Deferred revenue 1,591,667 2,509,167 2,509,167 ------------- ----------------------------- ----------------- Total current liabilities 3,786,1782,505,205 4,171,340 ------------- ----------------------------- ----------------- Deferred revenue, less current portion 1,886,6671,711,666 2,236,666 ------------- ----------------------------- ----------------- Minority Interest 36,99755,048 44,142 ============= ============----------------- ----------------- Stockholders' equity: Preferred stock, $1.00 par value 5,000,000 shares authorized, no shares issued and outstanding as of JuneSeptember 30, 1997 (unaudited) and December 31, 1996 - - Common stock, $.01 par value: 20,000,000 shares authorized, 12,182,63212,229,768 (unaudited) and 12,009,598 shares issued and outstanding as of JuneSeptember 30, 1997 and December 31, 1996, respectively 121,826122,297 120,096 Additional paid-in capital 73,503,47473,588,328 72,830,898 Accumulated deficit (27,860,803)(29,681,766) (25,256,803) ------------- ----------------------------- ----------------- Total stockholders' equity 45,764,49744,028,859 47,694,191 ------------- ----------------------------- ----------------- Total liabilities and stockholders' equity $ 51,474,33948,300,778 $ 54,146,339 ============= ============================= =================
The accompanying notes are an integral part of the financial statements. 3 4 ENTREMED, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
Three Months Ended SixNine months ended JuneSeptember 30, JuneSeptember 30, 1997 1996 1997 1996 ------------------------ ------------------------------------------------------- ----------------------------- Revenues: Collaborative research and development $ 1,042,500 $ 1,042,500 $ 2,085,0003,127,500 $ 2,085,0003,127,500 Licensing 50,000 50,000 100,000 100,000 ----------- ----------- -----------150,000 150,000 Grant revenues 148,540 - 148,540 - ------------- ------------- ------------- ------------ Total revenues 1,241,040 1,092,500 1,092,500 2,185,000 2,185,000 ----------- ----------- -----------3,426,040 3,277,500 ------------- ------------- ------------- ------------ Expenses: Research & development 1,743,560 1,246,045 4,162,395 3,309,3152,825,840 2,429,696 6,988,235 5,739,011 General & administrative 1,219,501 472,224 1,969,161 1,243,635 ----------- ----------- -----------882,078 721,022 2,851,239 1,964,657 ------------- ------------- ------------- ------------ 2,963,061 1,718,269 6,131,556 4,552,9503,707,918 3,150,718 9,839,474 7,703,668 Interest expense - (8,643)(5,565) (1,418) (18,190)(23,755) Interest income 685,877 169,474 1,336,829 245,795 ----------- ---------- -----------663,966 704,247 2,000,795 950,042 ------------- ------------- ------------- ------------ Net loss before minority interest (1,184,684) (464,938) (2,611,145) (2,140,345)(1,802,912) (1,359,536) (4,414,057) (3,499,881) Minority interest 4,191 - 7,145 - ----------- ---------- -----------(18,051) (19,551) (10,906) (19,551) ------------- ------------- ------------- ------------ Net loss $ (1,180,493)(1,820,963) $ (464,938) $(2,604,000) $(2,140,345) ------------ ---------- ----------- -----------(1,379,087) $ (4,424,963) $ (3,519,432) ============= ============= ============= ============ Net loss per share $ (0.10)(0.15) $ (0.06)(0.11) $ (0.22)(0.36) $ (0.29)(0.39) ============= ============= ============= ============ ========== =========== =========== Weighted average number of shares outstanding 12,134,490 7,676,696 12,089,347 7,494,366 ---------- --------- ---------- ---------12,219,288 11,993,912 12,132,660 8,994,214 ============= ============= ============= ============ Pro forma net loss per share $ (0.05) $ (0.23) ========== ==========(0.35) ============ Pro forma weighted average number of shares outstanding 9,237,136 9,274,585 ========= =========10,181,028 ============
The accompanying notes are an integral part of the financial statements. 4 5 ENTREMED, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
SixNine Months Ended JuneSeptember 30, 1997 1996 ---------------------------------------------------------------- CASH FLOWS FROM OPERATING ACTIVITIES Net loss $ (2,604,000) $(2,140,345)(4,424,963) $ (3,519,432) Adjustments to reconcile net loss to net cash used by operating activities: Depreciation and amortization 129,101 98,136227,624 151,207 Warrants issued for consulting services 291,000 - Minority interest (7,145) -10,906 19,551 Changes in assets and liabilities: Accounts receivable - 2,500,000(28,586) 2,399,711 Prepaid Expenses (87,893) (212,438)(39,495) (156,800) Accounts payable 156,247 440,016(103,943) 1,043,878 Accrued liabilities (437,257) 144,500(540,540) 500 Deferred revenue (349,999) (350,000)(1,442,500) (1,442,499) Deposits (2,003)(1,503) (422) Interest receivable (64,366) (26,709) ------------ -----------70,781 (43,748) ---------------- ---------------- Net cash provided (used)used by operating activities (2,976,315) 452,738 ------------ -----------(5,981,219) (1,548,054) ---------------- ---------------- CASH FLOWS FROM INVESTING ACTIVITIES Maturities of short-term investments 9,874,72314,874,723 - Purchases of short-term investments (10,129,600)(15,216,950) - Investments (300,000) (200,000)(55,883) Purchases of furniture & equipment (413,741) (113,104) ------------ -----------(845,747) (207,985) ---------------- ---------------- Net cash used by investing activities (968,618) (313,104) ------------ -----------(1,487,974) (263,868) ---------------- ---------------- CASH FLOWS FROM FINANCING ACTIVITIES Payment of capital lease obligations (104,152) (194,033)(294,048) Proceeds from salesissuance of common stock 383,306 48,666,755 ------------ -----------468,631 48,666,765 --------------- --------------- Net cash provided by financing activities 279,154 48,472,722 ------------ -----------364,479 48,372,717 --------------- --------------- Net increase in cash and cash equivalents (3,665,779) 48,612,356(7,104,714) 46,560,795 Cash and cash equivalents at beginning of period 33,051,206 6,885,099 ------------ -------------------------- --------------- Cash and cash equivalents at end of period $ 29,385,427 $55,497,455 ============ ===========25,946,492 $ 53,445,894 =============== =============== SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION AND NONCASH INVESTMENT AND FINANCING ACTIVITIES Interest paid $ 1,418 $ 18,190 ============ ===========23,755 =============== ===============
The accompanying notes are an integral part of the financial statements. 5 6 ENTREMED, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS JUNESEPTEMBER 30, 1997 (UNAUDITED) 1. BASIS OF PRESENTATION The accompanying unaudited consolidated financial information of EntreMed, Inc. (the "Company") includes the accounts of its 85% owned subsidiary, Cytokine Sciences, Inc. Cytokine Sciences was formed in June 1996 and was capitalized with $250,000 by EntreMed for the purpose of acquiring the assets of Innovative Therapeutics, Inc., which acquisition was completed in July 1996 in exchange for 15% of the common stock of Cytokine Sciences, Inc. The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such consolidated financial statements do not include all of the information and disclosures required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the sixnine month period ended JuneSeptember 30, 1997 are not necessarily indicative of the results that may be expected for the year ending December 31, 1997. For further information, refer to the Company's audited financial statements and footnotes thereto included in the Company's Form 10-K for the year ended December 31, 1996. 2. NET LOSS PER SHARE Net loss per share is based on the weighted average number of common shares outstanding. Pursuant to Securities and Exchange Commission Staff Accounting Bulletin No. 83, common and convertible preferred stock issued for consideration below the initial public offering (the "IPO") price of $15.00 and stock options and warrants issued with exercise prices below the IPO price during the twelve-month period preceding the initial filing of the registration statement (commonly referred to as "Cheap Stock"), have been included in the calculation of common shares using the treasury stock method through April 12, 1996 in the sixnine month period ended JuneSeptember 30, 1996, as if they were outstanding prior to the effective date of the IPO. The net loss per share amounts for the three and sixnine months ended JuneSeptember 30, 1996 as required by generally accepted accounting principles, which dodoes not give effect to the pro forma conversion of preferred stock and Cheap Stock described above, or any stock option or warrant common share equivalents considered antidilutive, is as follows:
ThreeNine months ended Six months ended JuneSeptember 30, 1996 June 30, 1996 Net loss per share $(0.10) $(0.30)$ (0.40) Weighted average common shares outstanding 12,134,490 7,068,7038,710,439
6 7 2. NET LOSS PER SHARE (cont.) Pro forma net loss per common share for the sixnine month period ended JuneSeptember 30, 19971996 is calculated using the weighted average number of common shares outstanding, Cheap Stock as described above and assumes the conversion of the convertible preferred stock at the beginning of the period. In February 1997, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 128, "Earnings per Share" ("SFAS 128"), effective December 1997. SFAS 128 will require the Company to present both "basic" and "diluted" loss per share amounts on the face of the statement of operations, replacing the existing net loss per share. Under SFAS 128, basic loss per share would not have changed from the reported loss per share of $(0.10)$(0.15) and $(0.06)$(0.11) for the three month periods ended JuneSeptember 30, 1997 and 1996, respectively, and $(0.22)$(0.36) for the sixnine month period ended JuneSeptember 30, 1996.1997. Basic loss per share for the sixnine month period ended JuneSeptember 30, 19971996 would have been $(0.30)$(0.40). Diluted loss per share would not have differed from basic loss per share as stock option or warrant common share equivalents are antidilutive. 3. INITIAL PUBLIC OFFERING On June 17, 1996, the Company completed an initial public offering of 3,200,000 shares of the Company's common stock at a price of $15.00 per share. Bristol-Myers Squibb Company, a party to a collaboration with the Company, also purchased from the Company in a private placement on the closing of the offering 333,333 shares of the Company's common stock at $15.00 per share. The initial public offering resulted in net proceeds to the Company of approximately $43,500,000 and the private placement with Bristol-Myers Squibb Company ("BMS") resulted in net proceeds to the Company of an additional $5,000,000. 4. CONTINGENCIES The Company is a party to certain litigation filed in August 1995 in the United States District Court for the Eastern District of Tennessee by Bolling McCool & Twist, a consulting firm. The suit relates to a claim for services rendered in the approximate amount of $50,000 and seeks a finder's fee in an unspecified amount in connection with the Bristol-Myers collaboration. The Company is unable to predict with certainty the eventual outcome of the lawsuit. The Company is contesting the action vigorously and believes that this proceeding will not have a material adverse effect on the Company or its financial statements, although there can no assurance that this will be the case. 7 8 ITEM 2. MANAGEMENT'S DISCUSSIONS AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. GENERAL Since its inception in September 1991, the Company has devoted substantially all of its efforts and resources to sponsoring and conducting research and development on its own behalf and through collaborations with corporate partners and academic research and clinical institutions, and establishing its facilities and hiring personnel. In December 1995, the Company entered into a collaboration agreement with Bristol-Myers Squibb Company ("BMS") in which BMS made an equity investment in the Company and agreed to pay certain research and development fees and expenses, license fees, milestone payments, and royalties on net sales, if any. Through JuneSeptember 30, 1997, with the exception of license fees and research and development funding from BMS andas well as certain research grants, the Company had not generated any revenue from operations. The Company anticipates its revenue sources for the next several years will be limited to research grants and future collaboration payments from BMS and from other collaborators under arrangements that may be entered into in the future. The timing and amounts of such revenues, if any, will likely fluctuate and depend upon the achievement of specified milestones. RESULTS OF OPERATIONS Three and SixNine Months Ended JuneSeptember 30, 1997 and JuneSeptember 30, 1996 Revenues wereincreased approximately 14% from $1,092,500 for the three month periodsmonths ended JuneSeptember 30, 1996 ("1996 Three Months") to $1,241,000 for the three months ended September 30, 1997 ("1997 Three Months") and Juneapproximately 5% from $3,277,500 for the nine months ended September 30, 1996 ("1996 ThreeNine Months") and $2,185,000to $3,426,000 for the six month periodsnine months ended JuneSeptember 30, 1997 ("1997 Six Months") and June 30, 1996 ("1996 SixNine Months"). This reflectsincrease is due to grant revenue receivedearned under a Small Business Innovative Research program from the BMS collaboration agreementNational Institutes of Health which was executedawarded to the Company in December 1995.May 1997. There were no grant revenues during the 1996 Three Months and 1996 Nine Months. The BMS collaborative research and development fees relate to the amortization over five years of a one-time payment of $2,500,000 received in December 1995 and the amortization of semi-annual payments of $1,835,000 under the BMS collaboration agreement. The license fee represents the amortization over five years of a one-time $1,000,000 license fee received in December 1995 under the BMS collaboration agreement. Research and development expenses increased by 40%approximately 16% from approximately $1,246,000$2,430,000 in the 1996 Three Months to approximately $1,744,000$2,826,000 in the 1997 Three Months and by approximately 26%22% from approximately $3,309,000$5,739,000 in the 1996 SixNine Months to approximately $4,162,000$6,988,000 in the 1997 SixNine Months. Research and Developmentdevelopment expenditures include sponsored research payments to academic collaborators and expenses related to the Company's internal research programs. The increase in research and development costs reflects increased efforts in the Company's sponsored research and product development programs related to its angiogenesis and cell permeation technologies. Overall, research personnel increased from 18 as of January 1, 1996 to 3234 as of JuneSeptember 30, 1997. Research and development expenses are expected to continue to increase as the Company continues to expand its research and development efforts. General and administrative expenses increased from approximately $472,000$721,000 in the 1996 Three Months to approximately $1,220,000$882,000 in the 1997 Three Months, a 158%22% increase. For the 1997 SixNine Months general and administrative expenses were approximately $1,969,000$2,851,000 as compared to $1,244,000$1,965,000 for the 1996 SixNine Months, a 58%45% increase. The overall increase in general and administrative expenses during the 1997 period compared to the comparable periods of 1996 is a result of the Company incurring additional 8 9 expenses associated with being a public company, investigating potential strategic relationships, and increasing the administrative staff to support the research scientists and collaborative efforts the 8 9 Company is conducting. The 1997 Three Months and 1997 SixNine Months includeincludes a one time expense charge of approximately $400,000 related to certain consulting work.consultants to the Company, which includes a non-cash portion related to warrants issued as part of the services rendered of $291,000. The total number of administrative personnel the Company hadhas increased from 8 as of January 1, 1996 to 12 as of JuneSeptember 30, 1997. Interest income increased to approximately $686,000$2,001,000 in the 1997 ThreeNine Months as compared to $169,000from $950,000 in the 1996 Three Months and to $1,337,000 in the 1997 Six Months from $246,000 in the 1996 SixNine Months. This increase is a result of the investment of the proceeds received from the BMS collaboration agreement and the Company's initial public offering.offering in June 1996. During the Three Month periods, interest income decreased approximately 5% from approximately $704,000 in 1996 to approximately $664,000 in 1997. This decrease in interest income is due to the reduction of the Company's cash and short term investments as such working capital components are used to fund the Company's operations. The minority interest relates to the portion of the lossincome recognized by Cytokine Sciences that is attributable to the minority shareholders of Cytokine Sciences. Liquidity and Capital Resources At JuneSeptember 30, 1997, the Company had cash and cash equivalents of approximately $29,385,000$25,947,000 and short-term investments of $19,925,000approximately $20,012,000 with working capital of approximately $46,176,000,$43,950,000, primarily representing the net proceeds of the Company's initial public offering and concurrent private placement with BMS in June 1996 together with funds received under the BMS agreement entered into in December 1995. The Company's cash resources have been used to finance research and development, including sponsored research, capital expenditures, including leasehold improvements to the Company's laboratory facility, and general and administrative expenses. Over the next several years, the Company expects to incur substantial additional research and development costs, including preclinical and clinical trials, increased administrative expenses to support its research and development operations and increased capital expenditures for pilot manufacturing capacity, various equipment needs and facility improvements. As of JulyOctober 31, 1997, the Company was a party to sponsored research agreements and clinical trials requiring the Company to fund an aggregate of approximately $5,084,000$4,286,000 through 1999 (including $4,000,000$3,000,000 to Children's Hospital) and license agreements requiring milestone payments of up to $4,360,000 and additional payments upon attainment of regulatory milestones. 9 10 BMS is obligated to make additional semi-annual payments to the Company of $1,835,000 in each of June and December through June 2000 as well as additional payments in the event certain mostly late-stage regulatory milestones are achieved. BMS may terminate the collaboration agreement and return the licensed technology to the Company at any time upon six months notice, in which event it would have no further funding obligation to the Company. - ------------------------------------------------------------- Statements herein that are not descriptions of historical facts are forward-looking and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in the Company's Securities and Exchange Commission filings under "Risk Factors", including risks relating to the early stage of products under development; uncertainties relating to clinical trials' dependence on third parties' future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). 910 1011 PART II. OTHER INFORMATION Item 1. LEGAL PROCEEDINGS This information as set forth in Note 4 of "Notes to Condensed Consolidated Financial Statements" appearing in Item 1 of Part I of this report is incorporated herein by reference. Item 2. CHANGES IN SECURITIES Not applicable. Item 3. DEFAULT UPON SENIOR SECURITIES Not applicable. Item 4. SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS (a) The Company's annual meeting of stockholders was held on June 30, 1997 ("Annual Meeting"). (b) Not applicable. (c) At the Annual Meeting, the stockholders considered and approved the following proposals: (i) Election of Directors. The following sets forth the nominees who were elected directors of the Company for the term expiring in the year indicated as well as the number of votes cast for, against or withheld:
Term (Year Votes Expires) Name For Against Withheld -------- ----------------------- ---------- ------- -------- 2000 John W. Holaday, Ph. D. 10,645,392 23,223 - 2000 Wendell M. Starke 10,659,390 9,225 - 1999 Bart Chernow, M.D. 10,659,390 9,225 - 1999 Samuel R. Dunlap, Jr. 10,584,974 83,641 - 1999 Mark C. M. Randall 10,659,390 9,225 - 1998 Donald S. Brooks 10,659,390 9,225 - 1998 Leon E. Rosenberg, M.D. 10,659,278 9,337 - 1998 Lee F. Meier 10,659,390 9,225 -
(ii) Amendments to Stock Option Plan. At the Annual Meeting the stockholders approved and ratified an amendment to the 1996 Stock Option Plan ("Plan") to increase the number of shares of Common Stock available for option grants from 516,667 to 1,266,667. This proposal received 7,319,526 votes in favor, 505,414 votes against and 419,896 abstentions. In addition, 2,423,779 shares were not voted. 10 11 (iii) Amendment to Certificate of Incorporation. At the Annual Meeting, the stockholders approved a proposal to amend the Company's Certificate of Incorporation to provide for a classified board. This proposal received 7,566,539 votes in favor, 685,508 votes against and 27,889 abstentions. In addition, 2,388,680 shares were not voted. (iv) Ratification of Appointment of Ernst & Young LLP. At the Annual Meeting, stockholders ratified the selection of Ernst & Young LLP as the independent auditors. The proposal received 10,574,620 votes in favor, 78,334 votes against, and 15,662 abstentions.applicable Item 5. OTHER INFORMATION Not applicable. Item 6. EXHIBIT AND REPORTS ON FORM 8-K (a) The following exhibits are filed with this report: 11 Computation of Earnings Per Share 21 Subsidiaries of the Registrant 27.1 Financial Data Schedule (b) No reports on Form 8-K were filed by Registrant during the quarter ended JuneSeptember 30, 1997. 11 12 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. ENTREMED, INC. (Registrant) Date: AugustNovember 12, 1997 /s/ John W. Holaday --------------------------------------------------------------------------- John W. Holaday, Ph.D. President and Chief Executive Officer Date: AugustNovember 12, 1997 /s/ R. Nelson Campbell --------------------------------------------------------------------------- R. Nelson Campbell Chief Financial Officer 12