1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1996 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 0-28494 Millennium Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 04-3177038 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 640 Memorial Drive, Cambridge, MA 02139 (Address of principal executive offices, including zip code) 617-679-7000 (Registrant's telephone number, including area code) Common Stock, $.001 par value (Title of Class) 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 --- --- Number of shares of Common Stock outstanding as of August 5, 1996 was 23,833,211. 2 MILLENNIUM PHARMACEUTICALS, INC. REPORT ON FORM 10-Q FOR THE QUARTERLY PERIOD ENDED JUNE 30, 1996 TABLE OF CONTENTS PAGE ---- PART I - FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS (unaudited) Condensed Balance Sheets June 30, 1996 and December 31, 1995 3 Condensed Statements of Operations for the six months ended June 30, 1996 and 1995 4 Condensed Statements of Cash Flows for the six months ended June 30, 1996 and 1995 5 Notes to Condensed Financial Statements 6 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 8 PART II - OTHER INFORMATION 12 ITEM 1. LEGAL PROCEEDINGS 12 ITEM 2. CHANGES IN SECURITIES 12 ITEM 3. DEFAULTS UPON SENIOR SECURITIES 12 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 12 ITEM 5. OTHER INFORMATION 12 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 12 SIGNATURES 13 EXHIBIT INDEX 14 2 3 Millennium Pharmaceuticals, Inc. Condensed Balance Sheets JUNE 30, DECEMBER 31, 1996 1995 ----------------------------- (Unaudited) (Note) ASSETS Current assets: Cash and cash equivalents $ 14,803,701 $ 10,586,260 Short-term investments 53,965,804 7,260,284 Prepaid expenses and other current assets 2,032,987 694,763 ----------------------------- Total current assets 70,802,492 18,541,307 Property and equipment, net 9,648,118 4,905,528 Due from strategic partner 1,603,337 1,463,333 Deposits and other assets 461,998 194,682 ----------------------------- $ 82,515,945 $ 25,104,850 ============================= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,583,021 $ 1,122,446 Accrued expenses 711,827 567,611 Deferred revenue 1,708,984 3,110,000 Current portion of long-term debt 1,600,000 1,600,000 Current portion of capital lease obligations 2,002,184 1,643,168 ----------------------------- Total current liabilities 8,606,016 8,043,225 Long-term debt, net 666,667 1,466,667 Capital lease obligations, net 2,749,960 2,499,088 Stockholders' equity: Series A,B,C and D Convertible Preferred Stock, $0.001 par value: 14,000,000 shares authorized and 11,783,333 shares issued and outstanding ($22,450,000 in aggregate liquidation preference) -- 11,783 Common Stock, $0.001 par value: 25,000,000 shares authorized; 23,851,320 shares in 1996 and 4,211,926 shares in 1995 issued and outstanding 23,851 4,212 Additional paid-in capital 87,504,175 22,722,267 Deferred compensation (2,900,241) -- Notes receivable from officers (320,522) (266,681) Unrealized loss on securities (166,597) -- Accumulated deficit (13,647,364) (9,375,711) ----------------------------- Total stockholders' equity 70,493,302 13,095,870 ----------------------------- Total liabilities and stockholders' equity $ 82,515,945 $ 25,104,850 ============================= Note: The balance sheet at December 31, 1995 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. See notes to condensed financial statements. 3 4 Millennium Pharmaceuticals, Inc. Condensed Statements of Operations (Unaudited) THREE MONTHS ENDED SIX MONTHS ENDED JUNE 30, JUNE 30, 1996 1995 1996 1995 ------------------------------------------------------------ Revenue under strategic alliances $ 5,100,533 $ 2,500,000 $ 12,658,849 $ 5,000,000 Costs and expenses: Research and development 8,080,200 4,209,979 14,713,849 8,077,325 General and administrative 1,785,827 944,182 3,051,223 1,716,595 ------------------------------------------------------------ 9,866,027 5,154,161 17,765,072 9,793,920 ------------------------------------------------------------ Loss from operations (4,765,494) (2,654,161) (5,106,223) (4,793,920) Interest income 829,977 57,947 1,249,896 147,139 Interest expense (193,997) (229,207) (415,326) (479,164) ------------------------------------------------------------ Net loss $ (4,129,514) $ (2,825,421) $ (4,271,653) $ (5,125,945) ============================================================ Net loss per share $ (0.19) $ (0.15) $ (0.21) $ (0.27) ============================================================ Shares used in computing net loss per share 22,268,382 19,150,695 20,717,782 19,150,695 ------------------------------------------------------------ See notes to condensed financial statements. 4 5 Millennium Pharmaceuticals, Inc. Condensed Statements of Cash Flows (Unaudited) SIX MONTHS ENDED JUNE 30, 1996 1995 ---------------------------- CASH USED IN OPERATIONS $ (4,630,518) $ (4,771,552) INVESTING ACTIVITIES Purchase of property and equipment (4,476,350) (856,715) Sale of short-term investments 20,211,766 -- Purchase of short-term investments (66,917,286) -- ---------------------------- Net cash used in investing activities (51,181,870) (856,715) FINANCING ACTIVITIES Proceeds from sale of Preferred Stock 3,499,992 2,250,000 Proceeds from sale of Common Stock 58,268,318 2,538 Repurchase of Common Stock (829) -- Payments of long-term debt (800,000) (133,333) Payments of capital lease obligations (937,652) (820,481) ---------------------------- Net cash provided by financing activities 60,029,829 1,298,724 ---------------------------- Increase (decrease) in cash and cash equivalents 4,217,441 (4,329,543) Cash and cash equivalents at beginning of year 10,586,260 6,105,468 ---------------------------- Cash and cash equivalents at end of period $ 14,803,701 $ 1,775,925 ============================ NON-CASH INVESTING AND FINANCING ACTIVITIES: Equipment acquired under capital leases $ 1,547,540 $ 352,245 ============================ Deferred compensation $ 3,187,283 -- ============================ See notes to condensed financial statements. 5 6 MILLENNIUM PHARMACEUTCALS, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS JUNE 30, 1996 (unaudited) 1 - BASIS OF PRESENTATION The accompanying condensed financial statements have been prepared in accordance with generally accepted accounting principles 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 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. Interim results for the three- and six-month periods ended June 30, 1996 are not necessarily indicative of the results that may be expected for the year ended December 31, 1996. For further information, refer to the financial statements and footnotes thereto included in the Company's Form S-1 filed on May 6, 1996. Effective January 1, 1996, the Company adopted Statement of Financial Accounting Standard (SFAS) No. 121, "Accounting for the Impairment of Long-Lived Assets to be Disposed of." The adoption of the new standard had no effect on the financial statements. Effective January 1, 1996, the Company adopted SFAS No. 123 "Accounting and Disclosure of Stock-Based Compensation." As allowed under the SFAS, the Company has elected to continue to follow Accounting Principals Board Opinion No. 25, "Accounting for Stock Issued to Employees" (AFB 25) in accounting for its employee stock options. The adoption of the standard had no effect on the financial statements. 2 - NET LOSS PER SHARE Net loss per share is computed using the weighted-average number of outstanding shares of Common Stock and Common Stock Equivalents, assuming conversion of Series A, B, C and D Convertible Preferred Stock into Common Stock (as of their original date of issuance), which occurred upon completion of the Company's initial public offering on May 7, 1996 and the exercise of stock options and warrants (using the treasury stock method). Common Stock equivalents are excluded from the computation when their effect is anti-dilutive; however, pursuant to the requirements of the Securities and Exchange Commission, Common Stock equivalent shares relating to stock options and warrants (using the treasury stock method and an initial public offering price of $12.00 per share) and Convertible Preferred Stock issued during the twelve month period prior to the initial public offering are included for both periods presented whether or not anti-dilutive. 3 - SHAREHOLDERS' EQUITY In February, 1996, the Company issued 388,888 shares of Series D Convertible Preferred Stock to a private institutional investor at $9.00 per share and received net proceeds of approximately $3,500,000. The rights and privileges of the Series D stock are substantially consistent with previously issued convertible preferred stock series. 6 7 In May 1996, the Company completed an initial public offering of 4,500,000 shares of common stock at $12.00 per share. The underwriters exercised their over allotment option for 675,000 shares. The Company received proceeds, net of underwriting discounts, of approximately $57,753,000. The proceeds of the offering are being used for research and development, working capital and general corporate purposes. 4 - SUBSEQUENT EVENT In July 1996, the Company entered into a strategic alliance with American Home Products Corporation (AHP) to discover and develop targets and assays to identify and develop small molecule drugs and vaccines for treatment and prevention of disorders of the central nervous system. The alliance becomes effective on August 1, 1996. Payments by AHP to the Company for up-front fees and research funding could total up to approximately $90.0 million if the research program continues for its full seven year period and the Company achieves specified research objectives. In the event that specified research, product development and associated regulatory milestones are achieved, AHP will be obligated to make milestone payments to the Company. 7 8 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. This Report on Form 10-Q may contain forward-looking statements which involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that may cause such a difference include, but are not limited to, the progress of the Company's research and development programs, the Company's ability to compete successfully, the Company's ability to attract and retain qualified personnel, the Company's ability to enter into and maintain collaborations with third parties, the Company's ability to enter into and progress in clinical trials, the time and costs involved in obtaining regulatory approvals, the costs involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the ability of the Company to establish development and commercialization capacities or relationships, the costs of manufacturing and the Company's ability to obtain additional funds. Overview The Company was incorporated in January 1993 and has devoted substantially all of its resources to the development and application of genetics, genomics and bioinformatics technology used to identify the genes responsible for major diseases, as well as comprehensive technologies to elucidate the role of these genes in disease initiation and progression. To date, all of the Company's revenue has resulted from payments from strategic partners and the Company has not received any revenue from the sale of products or services. The Company has entered into several strategic alliances: in March 1994 with Hoffmann La-Roche, Inc. ("Roche") in obesity and type II diabetes; in October 1995 and March 1996 with Eli Lilly and Company ("Lilly") in atherosclerosis and select areas of oncology, respectively; in December 1995 with Astra AB ("Astra") in inflammatory respiratory diseases; and in July 1996 with American Home Products in certain disorders of the central nervous system. These agreements have provided the Company with various combinations of equity investments, up-front and follow-on fees and research funding and may provide certain additional payments upon the attainment of research and regulatory milestones and royalty and/or profit sharing payments based on sales of any products resulting from the collaborations. Revenue recognized under these collaborations through June 30, 1996 has aggregated approximately $43,502,000. Although the Company intends to enter into additional strategic alliances, it also expects to incur increasing expenses and additional losses for at least the next several years, primarily due to expansion of its research and development programs. Payments under strategic alliance and licensing arrangements will be subject to significant fluctuation in both timing and amounts resulting in periods of profitability and periods of losses; therefore, the Company's results of operations for any period may not be comparable to the results of operations for any other period. 8 9 Results of Operations Quarters Ended June 30, 1996 and June 30, 1995 Revenue under strategic alliances increased to $5,100,533 for the three months ended June 30, 1996 (the "1996 Period") from $2,500,000 for the three months ended June 30, 1995 (the "1995 Period"). The increase for the 1996 Period was due to strategic alliance revenue from three partners - Roche, Lilly, and Astra - compared with revenue in the 1995 Period from only Roche. Research and Development expenses increased to $8,080,200 for the three months ended June 30, 1996 from $4,209,979 for the three months ended June 30, 1995. The increase was primarily attributable to increased payroll and personnel expenses as the Company hired additional research and development personnel, increased purchase of laboratory supplies, increased equipment depreciation and facilities expenses in connection with the expansion of the Company's research efforts and increased costs associated with the collection of patient information and DNA samples. The Company expects research and development expenses to continue to increase as personnel and research and development facilities are expanded to accommodate the Company's existing strategic alliances. Such expenses will also increase to the extent that the Company enters into additional strategic alliances with third parties. General and administrative expenses increased to $1,785,827 for the three months ended June 30, 1996 from $944,182 for the three months ended June 30, 1995. The increase was primarily attributable to increased payroll and personnel expenses as the Company hired additional management and administrative personnel, and professional fees in connection with the overall scale-up of the Company's operations and business development efforts. It is anticipated that general and administrative expenses will continue to increase as the Company continues to expand its operations. The Company had net interest income of $635,980 for the three months ended June 30, 1996 and net interest expense of $171,260 for the three months ended June 30, 1995. The transition to net interest income was due to increased interest income earned on higher balances of cash and investment securities. The Company has recorded a non-cash charge of approximately $3,200,000 relating to compensation expense associated with the grant of options between January 1, 1996 and May 2, 1996 to purchase 1,174,447 shares of Common Stock. For the three month period ended June 30, 1996 the Company recognized approximately $195,000 of such compensation expense. The remaining deferred compensation will be recognized ratably over the vesting period of the options, which is generally four years. Six Months Ended June 30, 1996 and June 30, 1995 Revenue under strategic alliances increased to $12,658,849 for the six months ended June 30, 1996 (the "1996 Period") from $5,000,000 for the six months ended June 30, 1995 (the "1995 Period"). The increase for the 1996 Period was due to strategic alliance revenue from three partners - Roche, Lilly and Astra compared with revenue in the 1995 Period from only Roche. Effective March 1996, Lilly exercised its option to enter into a strategic alliance in select areas of 9 10 oncology. In connection with the execution of this agreement, the Company recognized $2,750,000 of revenue that had been previously deferred. Research and Development expenses increased to $14,713,849 for the 1996 Period from $8,077,325 for the 1995 Period. The increase was primarily attributable to increased payroll and personnel expenses as the Company hired additional research and development personnel, increased purchase of laboratory supplies, increased equipment depreciation and facilities expenses in connection with the expansion of the Company's research efforts and increased costs associated with the collection of patient information and DNA samples. The Company expects research and development expenses to continue to increase as personnel and research and development facilities are expanded to accommodate the Company's existing strategic alliances. Such expenses will also increase to the extent that the Company enters into additional strategic alliances with third parties. General and administrative expenses increased to $3,051,223 for the 1996 Period from $1,716,595 for the 1995 Period. The increase was primarily attributable to increased payroll and personnel expenses as the Company hired additional management and administrative personnel, and professional fees in connection with the overall scale-up of the Company's operations and business development efforts. It is anticipated that general and administrative expenses will continue to increase as the Company continues to expand its operations. The Company had net interest income of $834,570 for the 1996 Period and net interest expense of $332,025 for the 1995 Period. The transition to net interest income was due to increased interest income earned on higher balances of cash and investment securities. The Company has recorded a non-cash charge of approximately $3,200,000 relating to compensation expense associated with the grant of options between January 1, 1996 and May 2, 1996 to purchase 1,174,447 shares of Common Stock. For the six month period ended June 30, 1996 the Company recognized approximately $286,000 of such compensation expense. The remaining deferred compensation will be recognized ratably over the vesting period of the options, which is generally four years. Liquidity and Capital Resources The Company has financed its operations since inception primarily through strategic alliances, private placement of equity securities, issuance of debt and capital leases. In May 1996, the Company completed an initial public offering of common stock resulting in proceeds, net of underwriting discounts, of $57,753,000. Through June 30, 1996, the Company recognized approximately $43,502,000 of revenue under strategic alliances. The private placement of equity securities has provided the Company with aggregate gross proceeds of approximately $25,590,000. The Company has obtained $4,000,000 in long-term debt, $6,888,000 in capital lease financings, and $1,100,000 to finance the build-out of an 8,000 square foot in-house animal facility. As of June 30, 1996, the Company had approximately $68,770,000 in cash, cash equivalents and short-term investments. The Company believes that existing cash and investment securities, anticipated cash flow from its current strategic alliances, and net proceeds from the initial public offering in May 1996 will be sufficient to support the Company's 10 11 operations for at least the next 24 months. The Company's actual future cash requirements, however, will depend on many factors, including progress of its disease research programs, the number and breadth of these programs, achievement of milestones under strategic alliance arrangements, the ability of the Company to establish and maintain additional strategic alliance and licensing arrangements, and the progress of the development efforts of the Company's strategic partners. These factors also include the level of the Company's activities relating to commercialization rights it has retained in its strategic alliance arrangements, competing technological and market developments, the costs associated with the collection of patient information and DNA samples, the costs involved in obtaining and enforcing patent claims and other intellectual property rights, and the costs and timing of regulatory approvals. The Company expects that it will require significant additional financing in the future, which it may seek to raise through public or private equity offerings, debt financings, or additional strategic alliance and licensing arrangements. No assurance can be given that additional financing or strategic alliance and licensing arrangements will be available when needed or that, if available, such financing will be obtained on terms favorable to the Company or its stockholders. The Company's forecast of the period of time through which its financial resources will be adequate to support its operations is forward-looking information, and, as such, actual results may vary. 11 12 PART II - OTHER INFORMATION Item 1. Legal Proceedings. None Item 2. Changes in Securities. None Item 3. Defaults Upon Senior Securities. None Item 4. Submission of Matters to a Vote of Security Holders. None Item 5. Other Information. None Item 6. Exhibits and Reports on Form 8-K. (a) Exhibits The exhibits listed in the Exhibit Index are included in this report. (b) Reports on form 8-K None 12 13 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. MILLENNIUM PHARMACEUTICALS, INC. (Registrant) Date: August 12, 1996 By: /s/ Mark J. Levin ----------------------------- Mark J. Levin Chief Executive Officer (Principal Executive Officer) Date: August 12, 1996 By: /s/ Harry F. Arader, Jr. ----------------------------- Harry F. Arader, Jr. Chief Financial Officer (Principal Financial and Accounting Officer) 13 14 EXHIBIT INDEX The following exhibits are filed as part of this Quarterly Report on Form 10-Q: Exhibit No. Description - ------- ----------- 10.1+ CNS Research, Collaboration and License Agreement effective as of August 1, 1996 by and between American Home Products Corporation and the Company. 10.2+ Bioinformatics Access and License Agreement effective as of August 1, 1996 by and between American Home Products Corporation and the Company. 10.3+ Transcription Profiling Technology Access and License Agreement effective as of August 1, 1996 by and between American Home Products Corporation and the Company. 11 Statement regarding Computation of Pro Forma Net Loss Per Common Share. 27 Financial Data Schedule. - -------------------- + Confidential treatment requested as to certain portions. 14