UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended January 31, 2005 or [ ] 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 0-944 POSSIS MEDICAL, INC. (exact name of registrant as specified in its charter) Minnesota 41-0783184 - --------------------------------------------- ---------------------------- (State or other jurisdiction of incorporation (I.R.S. Employer organization) Identification No.) 9055 Evergreen Blvd NW Minnesota MN 55433-8003 - ------------------------------------------------- ----------------------------- (Address of principal executive offices) (Zip Code) 783-780-4555 - -------------------------------------------------------------------------------- (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 short 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 _X_ No _ Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes _X_ No ___ The number of shares outstanding of the Registrant's Common Stock, $.40 par value, as of February 28, 2005 was 17,431,278. 1 POSSIS MEDICAL, INC. INDEX PAGE ---- PART I. FINANCIAL INFORMATION ITEM 1. Financial Statements Consolidated Balance Sheets, January 31, 2005 and July 31, 2004............................................. 3 Consolidated Statements of Income and Comprehensive Income for the three and six months ended January 31, 2005 and 2004...... 4 Consolidated Statements of Cash Flows for the six months ended January 31, 2005 and 2004 ................... 5 Notes to Consolidated Financial Statements.................... 6 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations...........................10 ITEM 3. Quantitative and Qualitative Disclosures about Market Risk ...18 ITEM 4. Controls and Procedures.......................................18 PART II. OTHER INFORMATION ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds...19 ITEM 4. Submission of Matters to a Vote of Security Holders...........20 ITEM 6. Exhibits......................................................20 SIGNATURES....................................................21 2 PART 1 FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS POSSIS MEDICAL, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (UNAUDITED) January 31, 2005 July 31, 2004 ---------------- ----------------- ASSETS CURRENT ASSETS: Cash and cash equivalents ............................. $ 4,794,650 $ 8,411,784 Marketable securities ................................. 36,819,665 39,759,403 Trade receivables (less allowance for doubtful accounts and returns of $516,000 and $536,000, respectively) .......................... 8,365,936 10,232,180 Inventories ........................................... 6,075,061 5,389,653 Prepaid expenses and other assets ..................... 495,158 958,616 Deferred tax asset .................................... 890,000 890,000 ------------ ------------ Total current assets ........................ 57,440,470 65,641,636 PROPERTY AND EQUIPMENT, net ................................ 4,907,753 5,073,775 DEFERRED TAX ASSET ......................................... 12,685,949 15,103,949 OTHER ASSET ............................................... 218,704 201,341 ------------ ------------ TOTAL ASSETS ............................................... $ 75,252,876 $ 86,020,701 ============ ============ LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Trade accounts payable ................................ $ 939,798 $ 1,791,694 Accrued salaries, wages, and commissions .............. 2,535,380 4,228,804 Other liabilities ..................................... 2,165,809 2,222,465 ------------ ------------ Total current liabilities .................... 5,640,987 8,242,963 OTHER LIABILITIES .......................................... 340,273 160,536 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY: Common stock-authorized, 100,000,000 shares of $0.40 par value each; issued and outstanding, 17,424,965 and 18,254,942 shares, respectively 6,969,986 7,301,977 Additional paid-in capital ............................ 76,581,908 88,434,540 Unearned compensation ................................. (33,000) (15,000) Accumulated other comprehensive loss .................. (141,000) (136,000) Retained deficit ...................................... (14,106,278) (17,968,315) ------------ ------------ Total shareholders' equity ....................... 69,271,616 77,617,202 ------------ ------------ TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY ................. $ 75,252,876 $ 86,020,701 ============ ============ See notes to consolidated financial statements. 3 POSSIS MEDICAL, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME FOR THE THREE AND SIX MONTHS ENDED JANUARY 31, 2005 AND 2004 (UNAUDITED) Three Months Ended Six Months Ended ---------------------------------- ---------------------------------- Jan. 31, 2005 Jan. 31, 2004 Jan. 31, 2005 Jan. 31, 2004 ------------- ------------- ------------- ------------- Product sales ................................... $ 16,168,884 $ 17,448,677 $ 33,670,872 $ 33,050,965 Cost of sales and other expenses: Cost of medical products ................... 4,283,418 3,967,145 8,587,757 7,786,376 Selling, general and administrative ........ 6,711,939 6,659,517 14,268,521 13,374,067 Research and development ................... 2,604,131 1,978,868 5,041,835 4,106,111 ------------ ------------ ------------ ------------ Total cost of sales and other expenses 13,599,488 12,605,530 27,898,113 25,266,554 ------------ ------------ ------------ ------------ Operating income ................................ 2,569,396 4,843,147 5,772,759 7,784,411 Gain (loss) on sale of securities .......... 1,950 (15,516) 20,031 (34,033) Interest income ............................ 306,701 160,570 593,133 320,922 ------------ ------------ ------------ ------------ Income before income taxes ...................... 2,878,047 4,988,201 6,385,923 8,071,300 Provision for income taxes ...................... 1,208,886 1,869,900 2,523,886 3,025,900 ------------ ------------ ------------ ------------ Net income ...................................... 1,669,161 3,118,301 3,862,037 5,045,400 Other comprehensive (loss) income, net of tax: Unrealized (loss) gain on securities ....... (130,000) 82,000 (5,000) 151,000 ------------ ------------ ------------ Comprehensive income ............................ $ 1,539,161 $ 3,200,301 $ 3,857,037 $ 5,196,400 ============ ============ ============ ============ Weighted average number of common shares outstanding: Basic .................................. 17,669,526 17,774,155 17,875,233 17,775,941 Diluted ................................ 18,294,815 19,163,894 18,740,501 19,109,416 Net income per common share: Basic .................................. $ 0.09 $ 0.18 $ 0.22 $ 0.28 ============ ============ ============ ============ Diluted ................................ $ 0.09 $ 0.16 $ 0.21 $ 0.26 ============ ============ ============ ============ See notes to consolidated financial statements. 4 POSSIS MEDICAL, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED JANUARY 31, 2005 AND 2004 (UNAUDITED) 2005 2004 ------------ ------------ OPERATING ACTIVITIES: Net income ................................................ $ 3,862,037 $ 5,045,400 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation .............................................. 1,142,743 844,159 Gain on asset disposal .................................... (11,569) (12,525) Stock compensation expense ................................ 141,000 123,646 (Gain) loss on sale of marketable securities .............. (2,668) 34,033 Deferred taxes ............................................ 2,421,864 2,924,030 Decrease (increase) in trade receivables .................. 1,866,244 (1,262,758) Increase in inventories ................................... (998,768) (953,798) Decrease in prepaid expenses and other assets ............. 446,095 31,775 Decrease in trade accounts payable ........................ (851,896) (35,470) Decrease in accrued and other liabilities ................. (1,570,343) (82,756) ------------ ------------ Net cash provided by operating activities ............. 6,444,739 6,655,736 INVESTING ACTIVITIES: Additions to property and equipment ....................... (660,652) (1,336,087) Proceeds from sale of fixed assets ........................ 8,860 14,370 Proceeds from sale of marketable securities ............... 26,149,824 11,914,534 Purchase of marketable securities ......................... (23,216,282) (14,222,867) ------------ ------------ Net cash provided by (used in) investing activities .. 2,281,750 (3,630,050) FINANCING ACTIVITIES: Proceeds from issuance and exercise of options and warrants 777,745 2,060,994 Repurchase of common stock ................................ (13,121,368) (2,794,306) ------------ ------------ Net cash used in financing activities ................ (12,343,623) (733,312) ------------ ------------ (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS .......... (3,617,134) 2,292,374 CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD .......... 8,411,784 4,782,942 ------------ ------------ CASH AND CASH EQUIVALENTS AT END OF PERIOD ................ $ 4,794,650 $ 7,075,316 ============ ============ SUPPLEMENTAL CASH FLOW DISCLOSURE: Cash paid for income taxes ................................ $ 217,150 $ 101,870 Issuance of restricted stock .............................. 36,000 36,000 Inventory transferred to property and equipment ........... 39,360 -- See notes to consolidated financial statements. 5 POSSIS MEDICAL, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America 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. The accompanying consolidated financial statements and notes should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company's 2004 Annual Report. 2. STOCK OPTIONS Pursuant to Statement of Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation, we apply the recognition and measurement principles of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, to our stock options and other stock-based compensation plans. In accordance with APB Opinion No. 25, compensation cost for stock options is recognized in income based on the excess, if any, of the quoted market price of the stock at the grant date of the award or other measurement date over the amount an employee must pay to acquire the stock. The exercise price for stock options granted to employees equals the fair market value of our common stock at the date of grant, thereby resulting in no recognition of compensation expense. The following table illustrates the effect on net income and earnings per share if we had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation. Three Months Ended Six Months Ended January 31, January 31, 2005 2004 2005 2004 -------------- -------------- -------------- -------------- Net income: Net income - as reported .................... $ 1,669,161 $ 3,118,301 $ 3,862,037 $ 5,045,400 Less estimated stock-based employee compensation determined under fair value based method, net of tax ........... (704,000) (738,000) (1,288,000) (1,301,000) -------------- -------------- -------------- -------------- Net income - pro forma ...................... $ 965,161 $ 2,380,301 $ 2,574,037 $ 3,744,400 ============== ============== ============== ============== Earnings per common share: Basic - as reported ......................... $ 0.09 $ 0.18 $ 0.22 $ 0.28 Less estimated stock-based employee compensation determined under fair value based method, net of tax ...... (0.04) (0.05) (0.08) (0.07) -------------- -------------- -------------- -------------- Basic - pro forma ........................... $ 0.05 $ 0.13 $ 0.14 $ 0.21 ============== ============== ============== ============== Diluted - as reported ....................... $ 0.09 $ 0.16 $ 0.21 $ 0.26 Less estimated stock-based employee compensation determined under fair value based method, net of tax ........... (0.04) (0.04) (0.07) (0.06) -------------- -------------- -------------- -------------- Diluted - pro forma ......................... $ 0.05 $ 0.12 $ 0.14 $ 0.20 ============== ============== ============== ============== Weighted average common shares outstanding Basic ....................................... 17,669,526 17,774,155 17,875,233 17,775,941 Diluted ..................................... 18,294,815 19,163,894 18,740,501 19,109,416 6 We estimated the fair values using the Black-Scholes option-pricing model, modified for dividends and using the following assumptions: 2005 2004 ---------------- ----------------- Risk-free rate...................................... 4.1-4.5% 4.0-4.6% Expected dividend yield............................. 0% 0% Expected stock price volatility..................... 54-68% 59-64% Expected option term................................ 10 years 10 years Fair value per option............................... $8.72-19.88 $11.85-14.02 For purposes of determining the pro forma amounts, the fair value of options is amortized to expense over the option-vesting period in determining the pro forma impact. The option-vesting period is six months to four years. Beginning with our fiscal year 2006, an in accordance with SFAS 123(R), the Company will be required to recognize the compensation costs relating to share-based transactions in the consolidated statement of operations. See note 4. 3. INTERIM FINANCIAL STATEMENTS Operating results for the three and six month periods ended January 31, 2005 are not necessarily indicative of the results that may be expected for the year ending July 31, 2005. 4. RECENT ACCOUNTING PRONOUNCEMENTS In November 2003 and March 2004, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue No. 03-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments." The consensus reached requires companies to apply new guidance for evaluating whether an investment is other-than-temporarily impaired and also requires quantitative and qualitative disclosure of debt and equity securities, classified as available-for-sale or held-to-maturity, that are determined to be only temporarily impaired at the balance sheet date. The Company incorporated the required disclosures for investments accounted for under SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities," as required in the fourth quarter of fiscal year 2004. In September 2004, the consensus was indefinitely delayed as it relates to the measurement and recognition of impairment losses for all securities in the scope of paragraphs 10-20 of EITF 03-1. The disclosures prescribed by EITF No. 03-1 and guidance related to impairment measurement prior to the issuance of this consensus continue to remain in effect. Adoption is not expected to have a material impact on the Company's consolidated earnings, financial position or cash flows. In December 2004, the Financial Accounting Standards Board published SFAS No. 123 (revised 2004), Share-Based Payment. SFAS No. 123(R) revises SFAS No. 123, Accounting for Stock-Based Compensation, and supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees. The revised statement addresses the accounting for share-based payment transactions with employees and other third parties, eliminates the ability to account for share-based payment transactions using APB Opinion No. 25 and requires that the compensation costs relating to such transactions be recognized in the consolidated statement of operations based on the grant-date fair value of those instruments. The revised statement is effective as of the first interim period beginning after June 15, 2005 and will be applicable for all of the Company's fiscal year ending July 31, 2006. The Company is currently determining what impact the newly issued statement will have on its results of operations and financial position. See the "Stock-Based Compensation" discussion in Note 2, which includes the pro forma impact of recognizing stock-based compensation under SFAS No. 123, on the Company's net income and income per common share for the three months and six months ended January 31, 2005 and 2004. 7 5. MARKETABLESECURITIES During the quarter ended January 31, 2005, the Company invested its excess cash and cash equivalents in a professionally managed portfolio of marketable securities. All securities in this portfolio as of January 31, 2005 were classified as available-for-sale and consisted primarily of U.S. government securities and corporate bonds. These investments are reported at fair value. The unrealized loss, net of taxes, on these investments of approximately $130,000 and $5,000, respectively, for the three and six months ended January 31, 2005 is included within other comprehensive loss. The unrealized gain, net of taxes, on these investments, of approximately $82,000 and $151,000, respectively, for the three and six months ended January 31, 2004 is included within other comprehensive gain. The net unrealized loss included in shareholders' equity as of January 31, 2005 was $141,000, net of tax and the net unrealized gain included in shareholders' equity as of January 31, 2004 was $51,000, net of tax. 6. INVENTORIES Inventories are stated at the lower of cost (on the first-in, first-out basis) or market. Inventory balances were as follows: January 31, July 31, 2005 2004 -------------- --------------- Finished goods................................. $ 2,493,846 $ 2,018,152 Work-in-process................................ 1,198,054 1,260,449 Raw materials.................................. 2,383,161 2,111,052 -------------- --------------- $ 6,075,061 $ 5,389,653 ============== =============== 8 7. PROPERTY AND EQUIPMENT Property is carried at cost and depreciated using the straight-line method over the estimated useful lives of the various assets. Property and equipment balances and corresponding lives were as follows: January 31, July 31, 2005 2004 Life ----------- ----------- ------------- Leasehold improvements ...... $ 2,223,769 $ 2,189,955 10 years Equipment ................... 10,159,556 9,525,117 3 to 10 years Assets in construction ...... 279,297 526,793 N/A ----------- ----------- 12,662,622 12,241,865 Less accumulated depreciation 7,754,869 7,168,090 ----------- ----------- Property and equipment - net $ 4,907,753 $ 5,073,775 =========== =========== 8. SEGMENT AND GEOGRAPHIC INFORMATION AND CONCENTRATION OF CREDIT RISK The Company's operations are in one business segment: the design, manufacture and distribution of cardiovascular medical devices. The Company evaluates revenue performance based on the worldwide revenues of each major product line and profitability based on an enterprise-wide basis due to shared infrastructures to make operating and strategic decisions. Total revenues from sales in the United States and outside the United States are as follows: Three Months Ended Six Months Ended ------------------------- ------------------------ Jan. 31 Jan. 31 Jan. 31 Jan. 31 2005 2004 2005 2004 ------------ ----------- ----------- ----------- United States..................... $15,617,004 $17,008,188 $32,815,862 $32,318,259 Non-United States................. 551,880 440,489 855,010 732,706 ------------ ----------- ----------- ----------- Total revenues.................... $16,168,884 $17,448,677 $33,670,872 $33,050,965 ============ =========== =========== =========== 9. NET INCOME PER COMMON SHARE Basic income per common share is computed by dividing net income for the period by the weighted average number of common shares outstanding during the period. Diluted income per share is computed using the treasury stock method by dividing net income by the weighted average number of common shares plus the dilutive effect of outstanding stock options, stock warrants and shares issuable under the employee stock purchase plan. 10. COMMON STOCK During the six months ended January 31, 2005, stock options for the purchase of 70,089 shares of the Company's common stock were exercised at prices between $3.88 and $16.66 per share resulting in proceeds of $347,000. During the six months ended January 31, 2004, stock options and warrants for the purchase of 202,921 shares of the Company's common stock were exercised at prices between $2.22 and $17.50 per share resulting in proceeds of $1,689,000. 9 During the six months ended January 31, 2005 and 2004, the Company issued 37,580 and 24,445 shares in connection with its employee stock purchase plan. During the six months ended January 31, 2005 and 2004, the Company issued 2,754 and 1,884 shares of restricted stock to the outside members of the Board of Directors. During the six months ended January 31, 2005, the Company repurchased 940,400 shares in the public market at stock prices between $10.66 and $18.34 per share for $13,121,000. During the six months ended January 31, 2004, the Company repurchased 161,600 shares in the public market at stock prices between $15.65 and $19.29 per share for $2,794,000. 11. ACCRUED WARRANTY COSTS The Company estimates the amount of warranty claims on sold product that may be incurred based on current and historical data. The actual warranty expense could differ from the estimates made by the Company based on product performance. The following table presents the changes in the Company's product warranty liability: Accrued warranty costs at July 31, 2004........................................ $293,500 Payments made for warranty costs............................................... (208,000) Accrual for product costs...................................................... 89,000 ---------- Accrued warranty costs at January 31, 2005..................................... $171,500 ========== ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OUR BUSINESS Possis Medical Inc. develops, manufactures and markets pioneering medical devices for the large and growing cardiovascular and vascular treatment markets. The AngioJet(R) Rheolytic(TM) Thrombectomy System (AngioJet System) is marketed worldwide for blood clot removal from native coronary arteries, leg arteries, coronary bypass grafts and AV dialysis access grafts. The AngioJet System consists of a drive unit (capital equipment), which powers a disposable pump, and a family of disposable catheters, each aimed at a specific indication. The Company expanded its product line with the introduction of the XMI(R) Rapid Exchange catheter (XMI RX) in December 2003 for the removal of blood clots in peripheral arteries, the introduction of the AVX(TM)(R) catheter in July 2003 for the removal of blood clots in AV-access grafts and the introduction of the Xpeedior(R) Plus 120 catheter in August 2002 to remove blood clots in peripheral arteries greater than or equal to 3mm in diameter. In February 2004, the Company released its XMI RX in a full market release for peripheral arterial use in the U.S. In May 2004, the Company received approval from the U.S. Food & Drug Administration (FDA) to market the XMI RX for coronary indications. The Company also received Community Europe (CE) mark approval in May 2004, allowing coronary marketing of the XMI RX in the European Community. This new product will put our proven XMI technology into a configuration preferred by many physicians, increasing our utility and acceptance in the interventional lab. 10 The AVX catheter is an improved version of our Xpeedior 60 catheter and designed specifically for the av-access market. The new AVX catheter is a slightly shorter length catheter with a new hub design and hemostasis valve that is easier to use. In addition, it is 25% more powerful than the Xpeedior 60, putting more thrombectomy action in the hands of the physician. The Company's Xpeedior Plus 120 catheter is an improved version of our Xpeedior 100. Compared to the Xpeedior 100 catheter, the new Xpeedior Plus 120 catheter's increased length will allow the physician to treat more distal vessels. The Xpeedior Plus 120 catheter also has the added features of dual marker bands, a braided shaft and a sleek tapered tip for greater ease of use. In addition to the Company's XMI RX and Xpeedior catheters, the XMI catheter and XVG(R) (XVG) catheter continue to be utilized by physicians. The XVG, XMI, XMI RX and Xpeedior catheters feature the Company's patented Cross-Stream(R) Technology. This exclusive technology platform intensifies the action at the tip of the catheter, which doubles the clot removal rate and triples the treatable vessel size compared to other available mechanical thrombectomy devices on the market today. In addition, Cross-Stream Technology has been able to deal more effectively than previous catheters with "mural thrombus," the older, more organized material that adheres to vessel walls and can complicate patient results. The Company employs a variety of flexible drive unit acquisition programs including outright purchase and various evaluation programs. The Company has no leasing programs for its capital equipment. The purchasing cycle for the AngioJet System drive unit varies depending on the customer's budget cycle. The Company has signed contracts with eight purchasing groups in order to accelerate orders and increase market penetration. These purchasing groups evaluate and screen new medical technologies on behalf of their members, and once they recommend a technology, such as the AngioJet System, they negotiate pre-determined discounts on behalf of their members. The benefit for the Company is access to the recommended vendor list, along with marketing support provided by the purchasing group. The purchasing groups receive a marketing fee on their member purchases from the Company. These discounts and marketing fees have been offset by the increase in sales to the member hospitals of the purchasing group. There has been no material negative effect on the Company's margins due to these discounts and marketing fees. The discounts reduce gross revenue on the income statement, while marketing fees are included in selling, general and administrative expense on the income statement. 11 In April 2004, the Company announced that it had signed a three year agreement to be the exclusive distributor of the Angiometrx Metricath(TM) products in the United States. The Metricath System is an innovative, catheter-based technology that allows cardiologists to quickly and easily measure arterial size during procedures for treatment of coronary artery disease. Such measurements are helpful to select appropriately sized stents to achieve optimum patient outcomes from coronary angioplasty and related stent implantation procedures. The Metricath System was developed in response to the limitations of existing measurement technologies, which require large capital investment and which do not offer the ease of use of the Metricath System. The Metricath(TM) System received FDA 510(k) clearance for sale in the United States in July 2003. During a limited market release it was discovered that the Metricath System had several product design issues that need to be addressed prior to full market release. Angiometrx is currently addressing these product design issues. Future market release for the Metricath System will be dependent upon the resolution of these issues. The Company's AngioJet Rheolytic Thrombectomy System was approved by the U.S. FDA in 1999 for removing thrombus in coronary vessels and saphenous vein bypass grafts during percutaneous coronary intervention (balloon angioplasty and stenting). This approval includes use in heart attack victims, who are assumed to have thrombus whether or not it is angiographically visible. However, in the years following approval, AngioJet was mostly used in patients with large visible thrombus. Some physician customers proposed a study of AngioJet use specifically in heart attack patients. Therefore, in order to further support and expand AngioJet use in such patients, the Company agreed to sponsor a post-marketing study to test the ability of AngioJet treatment to reduce the final infarction size in patients with acute myocardial infarct (heart attack). The AiMI study (AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction) was a prospective randomized trial that between 2001 and 2004 enrolled 480 patients with anterior or predicted large inferior infarcts at 32 sites in the U.S. and Canada. Visible thrombus at presentation was not a consideration for enrollment. AiMI patients were randomized to receive either AngioJet treatment followed immediately by conventional balloon angioplasty and stenting, or ballooning and stenting alone. The study's primary endpoint was final infarct size assessed by nuclear imaging. Clinical investigators and the Company were blinded to study outcomes until its completion. The AiMI study results were first released in August 2004, and first presented to the cardiology community at the Transcatheter Cardiovascular Therapeutics (TCT) conference in September 2004. The study showed no benefit for infarct size reduction using AngioJet, with larger infarct sizes occurring in the AngioJet treatment group in patients with inferior myocardial infarcts. However, other secondary endpoints were neutral. The AiMI investigators concluded that routine use of AngioJet in all acute heart attack patients to reduce final infarct size cannot be recommended. The results also suggested that there may be a higher mortality risk when using the AngioJet in acute MI, but this is less conclusive because of possibly important clinical differences between the two treatment groups at baseline that favored the control group and the unusually low death rate noted in the control group, compared to other large, recent AMI studies. The investigators also noted that AngioJet has a longstanding history of safe use in elective removal of large and potentially dangerous thrombus, and the selective use of the AngioJet for acute myocardial infarction in cases of such thrombus was not specifically studied in AIMI. Still, these study results have negatively impacted AngioJet catheter sales for coronary applications. The Company expects U.S. AngioJet System sales to grow primarily through obtaining additional FDA approved product uses, introduction of new catheter models for existing indications, introduction of AngioJet System-related products, more face-time selling to existing accounts, peer-to-peer selling, and the publication of clinical performance and cost-effectiveness data. CRITICAL ACCOUNTING POLICIES The consolidated financial statements include accounts of the Company and all wholly-owned subsidiaries. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions in certain circumstances that affect amounts reported in the accompanying consolidated financial statements and related footnotes. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. The Company's most critical accounting policies are those described below. Application of these accounting policies involves the exercise of judgment and use of assumptions as to future uncertainties and, as a result, actual results could differ from these estimates. 12 Revenue Recognition Revenues associated with products that are already maintained at customer locations are recognized and ownership and risk of loss are transferred to the customer when the Company receives a valid purchase order from the customer. Revenues associated with products that are not maintained at the customer locations are recognized and title and risk of loss are transferred to the customer when a valid purchase order is received and the products are received at the customer's location. Provisions for returns are recorded in the same period the related revenues are recognized. Revenue recognition for drive unit extended warranties is amortized on a straight-line basis over the life of the warranty period. Allowance for Returns Accounts receivable are reduced by an allowance for items that may be returned in the future. The allowance requires us to make estimates at the time the account receivable is recorded concerning the likelihood for returns in the future. The estimate is based upon historical product return experience, customer complaint rates, information received from our customers and assumptions that are believed to be reasonable under the circumstances. Management, on a quarterly basis, evaluates the adequacy of the allowance for returns. Management believes the amount of the allowance for returns is appropriate; however, actual returns incurred could differ from the original estimate, requiring adjustments to the allowance. Allowance for Doubtful Accounts Substantially all of the Company's receivables are due from health care facilities located in the United States. The estimated allowance for doubtful accounts is based upon the age of the outstanding receivables and the payment history and creditworthiness of each customer. Management, on a quarterly basis, evaluates the adequacy of the allowance for doubtful accounts. Management believes the amount of the allowance for doubtful accounts is appropriate; however, nonpayment of accounts could differ from the original estimate, requiring adjustments to the allowance. Inventories Inventories are valued at the lower of cost or market. In order to determine the market value of inventory on a quarterly basis, management assesses the inventory quantities on hand to estimated future usage and sales and, if necessary, sets up a obsolescence reserve for inventory deemed excess or obsolete to estimated market value. Management believes the amount of the reserve for inventory obsolescence is appropriate; however, actual obsolete inventory could differ from the original estimate, requiring adjustments to the reserve. Warranty Reserve The Company provides a one-year limited warranty on its AngioJet System drive unit and a limited warranty on AngioJet System disposable products. The Company establishes a warranty reserve at the time products are sold, which is based upon historical frequency of claims relating to the Company's products and the cost to replace disposable products and to repair drive units under warranty. Management, on a quarterly basis, evaluates the adequacy of the warranty reserve. Management believes the amount of the warranty reserve is appropriate, given our historical experience; however, actual claims incurred could differ from the original estimate, requiring adjustments to the reserve. 13 RESULTS OF OPERATIONS Three and Six Month Periods Ended January 31, 2005 and 2004 Total product sales for the three months ended January 31, 2005 decreased $1,280,000 or 7%, to $16,169,000 compared to $17,449,000 for the comparable period in fiscal 2004. Total product sales for the six months ended January 31, 2005 increased $620,000, or 2%, to $33,671,000 compared to $33,051,000 for the comparable period in fiscal 2004. The Company recorded net income for the quarter ended January 31, 2005 of $1,669,000, or $0.09 per diluted share, compared to net income of $3,118,000, or $0.16 per diluted share, in the comparable quarter in 2004. For the six months ended January 31, 2005, the Company recorded net income of $3,862,000 or $0.21 per diluted share, compared to net income of $5,045,000, or $0.26 per diluted share, in the same period in 2004. Revenue - AngioJet System U.S. AngioJet System revenue for the three months ended January 31, 2005 decreased 8% to $15,585,000 from $17,001,000 for the same period in 2004. U.S. AngioJet System revenue for the six months ended January 31, 2005 increased 1% to $32,783,000 from $32,311,000 for the same period in 2004. The main factor in the revenue decrease during the second quarter is due to the negative impact from the results of the AiMI post-marketing study. The nominal increase in revenue during the six months ended January 31, 2005 as compared to 2004 is also due to this same impact from the results of the AiMI post-marketing study. As of January 31, 2005, the Company had a total of 1,422 domestic drive units in the field, compared to 1,168 drive units at January 31, 2004, and 1,371 units as of October 31, 2004. During the three month period ended January 31, 2005, the Company's catheter sales decreased approximately 6% to approximately 12,000 catheters versus approximately 12,800 catheters in the same prior year period. During the six month period ended January 31, 2005, the Company's catheter sales increased approximately 2% to approximately 24,900 catheters versus approximately 24,200 catheters in the same prior year period. The average catheter utilization rate per installed domestic drive unit was 8.3 in the second quarter of fiscal 2004, compared to a rate of 10.8 in the same prior year period, and compared to a rate of 9.3 in the first quarter of fiscal 2005. The Company sold 58 and 115 drive units during the three and six months ended January 31, 2005, respectively, compared to 51 and 106 drive units in the same periods in the prior year, respectively. Foreign sales of the AngioJet System for the three and six month periods ended January 31, 2005 were $552,000 and $855,000, respectively. This compared to foreign sales of the AngioJet System of $440,000 and $733,000, respectively, for the same periods the previous year. The Company has recently hired an outside consultant to expand product penetration in Germany. Limited foreign sales are primarily due to cost constraints in overseas markets. In European markets, where public sector funds are more crucial for hospital operation, Euro devaluations generated higher public sector deficits, which, in turn, forced reductions in hospital procedure and equipment budgets. Cost of Medical Products 14 Cost of medical products increased $316,000 to $4,283,000 in the three month period ended January 31, 2005 over the same period in the previous year, and increased $801,000 to $8,588,000 for the six month period ended January 31, 2005 over the same period in the previous year. These increases are primarily due to the unallocated production overhead and the increase in overhead. For the three months ended January 31, 2005, gross profit decreased by $1,596,000 to $11,885,000 over the same period in the previous year. This resulted in a gross profit margin of 74% as a percentage of product sales. Gross profit decreased $181,000 to $25,083,000, or 74% as a percentage of product sales, for the six month period ended January 31, 2005 over the same period in the previous year. This compares to gross margins as a percentage of product sales of 77% and 76% for the three and six month periods ended January 31, 2004. The decrease in the gross margin rate for the three and six months ending January 31, 2005 was primarily due to lower revenue and to lower mix of XMI RX and XMI catheters compared to the same periods in the previous year. This was offset by the impact of higher international sales versus the prior year period. The Company believes that gross margins as a percent of sales will be in the lower to mid seventies for the remainder of fiscal 2005. Selling, General and Administrative Expense Selling, general and administrative expense increased $52,000 to $6,712,000 for the three months ended January 31, 2005 and increased $894,000 to $14,269,000 for the six months ended January 31, 2005, compared to the same periods in the previous year. The primary factors in the changes in the expense for the three months ended January 31, 2005 were $283,000 of additional expenses associated with the growth in the sales force, increased medical insurance expense of $204,000 and increased depreciation of $112,000. These increases were offset by a reduction in marketing clinical trial expense of $394,000 and reduction in incentives of $141,000. The primary factors for the expense increase for the six months ended January 31, 2005 were the $623,000 additional expenses associated with the growth in the sales force, increased medical insurance expense of $424,000, increase in executive benefit plan expense of $162,000, increase in depreciation of $220,000, an increase in sales conventions and sales meetings of $136,000, and increase in building rent and operating costs of $108,000 and an increase in patent expense of $113,000. This increase was partially offset by a reduction in expenses associated with marketing clinical trials of $572,000 and a reduction of incentives of $215,000. Research and Development Expense Research and development expense increased $625,000 to $2,604,000, in the three months ended January 31, 2005, when compared to the same period in the prior year. Research and development expense increased $936,000 to $5,042,000 in the six months ended January 31, 2005. The increase was largely due to the timing of expenses incurred for various research and development projects including the new drive unit, an associated project to combine the pump and catheter, 6 French peripheral catheter and projects relating to the improvement of the rapid exchange catheter and the distal occlusion guidewires. We expect research and development expense to remain relatively stable for the balance of the fiscal year. 15 Interest Income Interest income increased $146,000 in the three months ended January 31, 2005 to $307,000, when compared to the same period in the prior year. Interest income increased $272,000 in the six months ended January 31, 2005, when compared to the same period in the prior year. The increase was due to the recent interest rate increases and the increase in the amount of cash available for investments. Excess cash is invested in an enhanced cash management portfolio of marketable securities. The Company expects interest income to increase in fiscal 2005 as compared to fiscal 2004 as cash is generated from operations. Provision For Income Taxes The Company recorded a provision for income taxes of $1,209,000 and $1,870,000 for the three months ended January 31, 2005 and 2004, respectively. The Company recorded a provision for income taxes of $2,524,000 and $3,026,000 for the six months ended January 31, 2005 and 2004, respectively. During the second quarter of fiscal 2005 the Company determined it had nexus in states in which it had not previously filed corporate state income tax returns. The Company will file the appropriate corporate state income tax returns in these states including prior years to obtain the appropriate net operating loss carry-forwards. The Company expensed an additional $100,000 of corporate state income tax expense relating to the filing of these state corporate income tax returns during the three months ended January 31, 2005. Going forward the corporate income tax rate is expected to be approximately 38%. The Company became profitable in the third quarter of fiscal 2001 and has maintained profitability since. In fiscal 2004 and 2003, the Company increased its deferred tax asset by an additional $2,578,000 and $2,777,000, respectively. These increases were related to tax benefits from disqualified stock options that are recorded directly in the Consolidated Statement of Changes in Shareholders' Equity. Management believes the remaining valuation allowance is necessary as it is more likely than not that $690,000 of the deferred tax asset will not be realizable due to the expiration of research and development tax credits. LIQUIDITY AND CAPITAL RESOURCES The Company's cash, cash equivalents and marketable securities totaled approximately $41,614,000 at January 31, 2005 versus $48,171,000 at July 31, 2004. The $6,557,000 net decrease in cash, cash equivalents and marketable securities in the most recent six-month period was primarily due to the use of $13,121,000of cash to repurchase common stock offset by net cash provided by operating activities of $6,445,000. Net cash provided by operating activities was primarily due to the net income of $3,862,000, depreciation of $1,143,000, non-cash stock compensation expense of $141,000 and a decrease in the deferred tax asset of $2,422,000, a decrease in accounts receivable of $1,866,000 and a decrease in prepaid expenses of $446,000. This net cash provided by operating activities was partially offset by an increase in inventory of $999,000, a decrease in accounts payable of $852,000 and a decrease in accrued and other liabilities of $1,570,000. Depreciation includes company-owned drive units at customer locations, as well as property and equipment. The decrease in the deferred tax asset was due to the utilization of the net operating loss carryovers to offset current taxes payable. The decrease in accounts receivable was due to the reduced revenue in the second quarter of fiscal 2005 compared to the first quarter of fiscal 2005. The decrease to prepaid expenses was due to the expensing of prepaid insurance. Inventory increased to meet the expected increase in demand of the AngioJet System. This demand was less than expected due to the AiMI post-marketing study results. The decrease in accounts payable and accrued liabilities were due to the timing of payments. This decrease included the payment of fiscal 2004 corporate incentives in September 2004. Cash provided in investing activities was $2,282,000 including the net proceeds of marketable securities of $2,934,000 and the purchase of $661,000 of property and equipment. Net cash used in financing activities was $12,344,000, which resulted from the repurchase of 940,400 shares of the Company's stock in open market transactions for $13,121,000, offset by the cash received in connection with the exercise of stock options of $778,000. 16 The Company expects its cash on hand and funds from operations to be sufficient to cover both short-term and long-term operating requirements of its current AngioJet business and the repurchase of its common stock as authorized by the Board of Directors. OFF-BALANCE SHEET OBLIGATIONS The Company does not have any material off-balance-sheet arrangements. OUTLOOK The Company expects overall revenue from the AngioJet System, primarily in the United States, will be in the range of $64 million to $66 million in fiscal 2005. Gross margin as a percent of sales for fiscal 2005 is expected to be in the low to mid seventies. The Company expects selling, general and administrative expenses to be relatively flat throughout the remainder of fiscal 2005 as a result of the Company's recent expansion of its sales force to enhance market penetration and to address customer concerns about the recent AiMI post-marketing study results. Research and development expenditures are expected to be consistent with the levels during the first two quarters of fiscal 2005. This level may change if the Company initiates a clinical trial relating to deep vein thrombosis and or pulmonary embolism. The Company expects net income per diluted share for the full year in the range of $0.30 to $0.36. The Company anticipates third quarter revenue to be approximately $15 million and net income in the range of $0.04 to $0.07 per diluted share. FORWARD-LOOKING STATEMENTS Certain statements made in Management's Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Form 10-Q, and particularly the statements made in the section captioned "Outlook," are "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to among other things, financial projections such as anticipated gross margins, overall revenue, expected expense levels, anticipated revenue increases and investment levels. Forward-looking statements in this 10-Q are based on the Company's current expectations and assumptions and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Factors that could affect the realization of forward looking statements include: 17 o changes in clinical and market acceptance of our products; o changes in the health care industry generally, such as restrictions imposed on sales time at interventional labs; consolidation of industry participants, cost containment and trends toward managed care; o changes in supplier requirements by group purchasing organizations; unanticipated costs or other difficulties and uncertainties associated with lengthy and costly new product development and regulatory clearance processes; o changes in governmental laws and regulations; o changes in reimbursement; o the development of new competitive products such as inexpensive aspiration devices, combined aspiration/occlusion products and compounds that may make our products obsolete; o sudden restrictions in supply of key materials; o the effectiveness of our sales and marketing efforts in re-establishing coronary product usage, o our ability to effectively manage new product development timelines, o our ability to generate suitable clinical registry data to support growing use of the AngioJet in coronary applications, o our the ability to obtain additional regulatory approvals on a timely basis; o our ability to obtain regulatory clearance in new foreign markets and o our ability to retain and motivate skilled employees, especially for sales positions. We also caution you not to place undue reliance on forward-looking statements, which speak only as of the date made. Any or all forward-looking statements in this report and in any other public statements we make may turn out to be inaccurate or false. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Except as required by federal securities laws, we undertake no obligation to update any forward-looking statement. A discussion of these and other factors that could impact our future results are set forth in the risk factors included in Exhibit 99.1 to the Company's Form 10-K for the year ended July 31, 2004 as filed with the Securities and Exchange Commission. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The Company invests its excess cash in a professionally managed, institutional fixed income portfolio of short duration. The market risk on a diversified portfolio of relatively short duration is minimal, while enhancing returns above money market levels. The product sales for the Company's foreign subsidiary are in U.S. Dollars ("USD") except for product sales in Germany, which are in Euro's. The German product sales were minimal during the second quarter. As of January 31, 2005, the Company opened a foreign bank account in which the German product sales receipts are deposited and immediately transferred to the operating bank account in the United States. The balance in the German bank account was zero as of January 31, 2005. ITEM 4. CONTROLS AND PROCEDURES Evaluation of disclosure controls and procedures - ------------------------------------------------ Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the "Exchange Act")). Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were adequately designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in applicable rules and forms. 18 Changes in internal control over financial reporting - ---------------------------------------------------- During the fiscal quarter ended January 31, 2005, there has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) or 15d-15(f) under the Exchange Act) that has materially affected, or are is likely to materially affect, our internal control over financial reporting. PART II. OTHER INFORMATION ITEM. 2 UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS (C) COMPANY REPURCHASES OF EQUITY SECURITIES - ---------------------------------------------------------------------------------------------------------------------------------- (d) Maximum Number (or Approximate Dollar (c) Total Number of Value) of Shares that Shares Purchased as Part May Yet Be Purchased (a) Total Number of (b) Average Price of Publicly Announced Under the Plans or Period Shares Purchased (1) Paid per Share Plans or Programs Programs (1) - ---------------------------------------------------------------------------------------------------------------------------------- November 1, 2004 to November 30, 2004 - - - - - ---------------------------------------------------------------------------------------------------------------------------------- December 1, 2004 to December 31, 2004 182,400 $12.21 182,400 - - ---------------------------------------------------------------------------------------------------------------------------------- January 1, 2005 to January 31, 2005 255,000 $13.01 255,000 - - ---------------------------------------------------------------------------------------------------------------------------------- Total 437,400 $12.56 437,400 - - ---------------------------------------------------------------------------------------------------------------------------------- (1) The Company repurchased an aggregate of 437,400 shares of its common stock pursuant to the repurchase program that it publicly announced on August 23, 2004 providing for the repurchase of shares having a value of up to $10,000,000. The shares were purchased in open market transactions. The Company purchased all of the remaining shares under the August 2004 authorization during the second quarter of fiscal 2005. On February 23, 2005, the Company announced authorization to use up to an additional $15 million to effect stock repurchases through December 2006. 19 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS a. The 2004 annual meeting of shareholders of Possis Medical, Inc. was held on December 8, 2004. b. By the following vote, management's nominees were elected as directors of the Corporation for one year or until their successors are elected and qualified: FOR WITHHELD ----------- --------- Robert G. Dutcher ..................... 15,778,711 359,638 Mary K. Brainerd....................... 15,200,974 937,375 Seymour J. Mansfield................... 15,734,549 403,800 William C. Mattison, Jr................ 15,115,191 1,023,158 Whitney A. McFarlin.................... 14,461,731 1,676,618 Donald C. Wegmiller.................... 15,290,765 847,584 Rodney A. Young........................ 14,464,612 1,673,737 The names of each Director whose term of office as a Director continued after the meeting are as follows: Robert G. Dutcher, Mary K, Brainerd, Seymour J. Mansfield, William C. Mattison, Jr., Whitney A. McFarlin, Donald C. Wegmiller, and Rodney A. Young. c. By a vote of 15,088,597 in the affirmative, 1,002,529 in the negative and 47,223 abstaining, the appointment of Deloitte & Touche LLP as the Corporation's certified public accountants was ratified. ITEM 6. EXHIBITS Exhibits Certain of the following exhibits are incorporated by reference from prior filings. The form with which each exhibit was filed and the date of filing are indicated below. Exhibit Description - -------------------------------------------------------------------------------- 31.1 Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2 Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1 Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2 Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 20 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. POSSIS MEDICAL, INC. DATE: March 4, 2005 BY: /s/ ROBERT G. DUTCHER ---------------------------------------- ROBERT G. DUTCHER Chairman, President and Chief Executive Officer DATE: March 4, 2005 BY: /s/ EAPEN CHACKO ----------------------------------------- EAPEN CHACKO Vice President of Finance and Chief Financial Officer 21 EXHIBIT INDEX Certain of the following exhibits are incorporated by reference from prior filings. The form with which each exhibit was filed and the date of filing are indicated below. Exhibit Description - -------------------------------------------------------------------------------- 31.1 Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2 Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1 Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2 Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 22