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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
| (Mark One) | |
ý |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2003 |
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OR |
|
o |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO |
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COMMISSION FILE NUMBER 000-19319
VERTEX PHARMACEUTICALS INCORPORATED
(Exact name of registrant as specified in its charter)
| MASSACHUSETTS (State or other jurisdiction of incorporation or organization) |
04-3039129 (I.R.S. Employer Identification No.) |
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130 WAVERLY STREET, CAMBRIDGE, MASSACHUSETTS (Address of principal executive offices) |
02139-4242 (zip code) |
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(617) 444-6100 (Registrant's telephone number, including area code) |
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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 ý NO o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act).
YES ý NO o
Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.
Common Stock, par value $.01 per share Class |
76,707,207 Outstanding at May 9, 2003 |
Vertex Pharmaceuticals Incorporated
Part I. Financial Information |
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Item 1. |
Condensed Consolidated Financial Statements |
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Condensed Consolidated Balance Sheets March 31, 2003 and December 31, 2002 |
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Condensed Consolidated Statements of Operations Three Months Ended March 31, 2003 and 2002 |
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Condensed Consolidated Statements of Cash Flows Three Months Ended March 31, 2003 and 2002 |
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Notes to Condensed Consolidated Financial Statements |
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Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
Quantitative and Qualitative Disclosures about Market Risk |
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Item 4. |
Controls and Procedures |
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Part II. Other Information |
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Item 6. |
Exhibits and Reports on Form 8-K |
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Signature |
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Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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2
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Balance Sheets
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March 31, 2003 |
December 31, 2002 |
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|---|---|---|---|---|---|---|---|---|---|
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(Unaudited) |
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| |
(In thousands, except share and per share data) |
||||||||
| Assets: | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 180,773 | $ | 108,098 | |||||
| Marketable securities, available for sale | 499,316 | 526,886 | |||||||
| Accounts receivable | 11,925 | 13,200 | |||||||
| Prepaid expenses | 4,585 | 4,349 | |||||||
| Other current assets | 1,376 | 4,039 | |||||||
| Total current assets | 697,975 | 656,572 | |||||||
| Restricted cash | 26,092 | 26,091 | |||||||
| Property and equipment, net | 87,346 | 95,991 | |||||||
| Investments | 18,863 | 26,433 | |||||||
| Other assets | 10,030 | 10,633 | |||||||
| Total assets | $ | 840,306 | $ | 815,720 | |||||
Liabilities and Stockholders' Equity |
|||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 10,000 | $ | 16,745 | |||||
| Accrued expenses and other current liabilities | 25,897 | 29,306 | |||||||
| Accrued interest | 518 | 4,463 | |||||||
| Deferred revenue | 14,108 | 11,888 | |||||||
| Obligations under capital leases | 1,374 | 1,965 | |||||||
| Other obligations | 4,394 | 230 | |||||||
| Total current liabilities | 56,291 | 64,597 | |||||||
| Obligations under capital leases, excluding current portion | 23 | 99 | |||||||
| Collaborator development loan | 13,500 | 5,000 | |||||||
| Other obligations, excluding current portions | 8,787 | 5,845 | |||||||
| Deferred revenue, excluding current portion | 46,436 | 46,598 | |||||||
| Convertible subordinated notes (due September 2007) | 315,000 | 315,000 | |||||||
| Total liabilities | 440,037 | 437,139 | |||||||
| Commitments and contingencies | |||||||||
| Stockholders' equity: | |||||||||
| Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding | | | |||||||
| Common stock, $0.01 par value; 200,000,000 shares authorized; 76,685,706 and 76,357,412 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively | 767 | 764 | |||||||
| Additional paid-in capital | 797,609 | 794,206 | |||||||
| Accumulated other comprehensive income | 4,435 | 6,764 | |||||||
| Accumulated deficit | (402,542 | ) | (423,153 | ) | |||||
| Total stockholders' equity | 400,269 | 378,581 | |||||||
| Total liabilities and stockholders' equity | $ | 840,306 | $ | 815,720 | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Statements of Operations
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Three Months Ended March 31, |
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|---|---|---|---|---|---|---|---|---|
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2003 |
2002 |
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(Unaudited) |
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(In thousands, except per share data) |
|||||||
| Pharmaceutical revenues: | ||||||||
| Royalties | $ | 1,921 | $ | 2,474 | ||||
| Collaborative research and development revenues | 14,068 | 18,077 | ||||||
| Discovery tools and service revenues: | ||||||||
| Product sales and royalties | 5,862 | 15,210 | ||||||
| Service revenues | 758 | 4,934 | ||||||
| Total revenues | 22,609 | 40,695 | ||||||
| Costs and expenses: | ||||||||
| Royalty payments | 652 | 817 | ||||||
| Cost of product sales and royalties | 2,719 | 4,590 | ||||||
| Cost of service revenues | 796 | 3,234 | ||||||
| Research and development | 53,117 | 47,022 | ||||||
| Sales, general and administrative | 11,452 | 11,095 | ||||||
| Other expense | 3,899 | | ||||||
| Total costs and expenses | 72,635 | 66,758 | ||||||
| Gain on sale of assets | 69,232 | | ||||||
Income (loss) from operations |
19,206 |
(26,063 |
) |
|||||
| Interest income | 5,768 | 8,458 | ||||||
| Interest expense | (4,363 | ) | (4,462 | ) | ||||
| Net income (loss) | $ | 20,611 | $ | (22,067 | ) | |||
| Basic and diluted net income (loss) per common share | $ | 0.27 | $ | (0.29 | ) | |||
| Basic weighted average number of common shares outstanding | 76,411 | 75,161 | ||||||
| Diluted weighted average number of common shares outstanding | 77,362 | 75,161 | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Statements of Cash Flows
| |
Three Months Ended March 31, |
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|---|---|---|---|---|---|---|---|---|---|---|
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2003 |
2002 |
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(Unaudited) |
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(In thousands) |
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| Cash flows from operating activities: | ||||||||||
| Net income (loss) | $ | 20,611 | $ | (22,067 | ) | |||||
| Adjustments to reconcile net income (loss)to net cash used in operating activities: | ||||||||||
| Depreciation and amortization | 7,249 | 5,282 | ||||||||
| Non-cash based compensation expense | 799 | 841 | ||||||||
| Other non-cash items, net | | 320 | ||||||||
| Realized gains on marketable securities | (913 | ) | (835 | ) | ||||||
| Loss on disposal of property, plant and equipment | | | ||||||||
| Gain on the sale of assets | (69,232 | ) | | |||||||
| Changes in operating assets and liabilities: | ||||||||||
| Accounts receivable | 2,792 | 5,923 | ||||||||
| Prepaid expenses | (500 | ) | 1,458 | |||||||
| Other current assets | 344 | 1,081 | ||||||||
| Accounts payable | (5,997 | ) | (715 | ) | ||||||
| Accrued expenses and other current liabilities | (5,106 | ) | (7,583 | ) | ||||||
| Accrued interest | (3,940 | ) | (3,938 | ) | ||||||
| Deferred revenue | 3,821 | (9,297 | ) | |||||||
| Net cash used in operating activities | (50,072 | ) | (29,530 | ) | ||||||
| Cash flows from investing activities: | ||||||||||
| Purchase of marketable securities | (165,176 | ) | (244,679 | ) | ||||||
| Sales and maturities of marketable securities | 191,163 | 270,669 | ||||||||
| Proceeds from the sale of assets, net | 92,824 | | ||||||||
| Expenditures for property and equipment | (6,939 | ) | (9,812 | ) | ||||||
| Restricted cash and other assets | (36 | ) | (305 | ) | ||||||
| Net cash provided by investing activities | 111,836 | 15,873 | ||||||||
| Cash flows from financing activities: | ||||||||||
| Issuances of common stock | 3,177 | 2,178 | ||||||||
| Proceeds from collaborator development loan | 8,500 | | ||||||||
| Principal payments on notes payable, capital leases and other obligations | (667 | ) | (1,346 | ) | ||||||
| Net cash provided by financing activities | 11,010 | 832 | ||||||||
| Effect of changes in exchange rates on cash | (99 | ) | (151 | ) | ||||||
| Net increase (decrease) in cash and cash equivalents | 72,675 | (12,976 | ) | |||||||
| Cash and cash equivalentsbeginning of period | 108,098 | 189,205 | ||||||||
| Cash and cash equivalentsend of period | 180,773 | $ | 176,229 | |||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements
1. Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited and have been prepared by Vertex Pharmaceuticals Incorporated ("Vertex" or the "Company") in accordance with accounting principles generally accepted in the United States of America.
The condensed consolidated financial statements reflect the operations of the Company and its wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated.
Certain information and footnote disclosures normally included in the Company's annual financial statements have been condensed or omitted. Certain prior year amounts have been reclassified to conform with current year presentation. The interim financial statements, in the opinion of management, reflect all adjustments (including normal recurring accruals) necessary for a fair statement of the financial position and results of operations for the interim periods ended March 31, 2003 and 2002.
The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the fiscal year, although the Company expects to incur a substantial loss for the year ended December 31, 2003. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2002, which are contained in the Company's 2002 Annual Report to its stockholders and in its Form 10-K filed with the Securities and Exchange Commission.
2. Accounting Policies
Basic and Diluted Net Income (Loss) per Common Share
Basic net income (loss) per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is based upon the weighted average number of common shares outstanding during the period plus additional weighted average common equivalent shares outstanding during the period when the effect is not anti-dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options, the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method, and the assumed conversion of convertible notes.
6
The following table sets forth a reconciliation of shares outstanding for basic and diluted net income (loss) per share, (shares in thousands):
| |
For the three months ended March 31, |
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|---|---|---|---|---|---|---|---|
| |
2003 |
2002 |
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| Basic net income (loss) per share: | |||||||
| Net income (loss) | $ | 20,611 | $ | (22,067 | ) | ||
| Weighted-average number of shares outstanding | 76,411 | 75,161 | |||||
| Basic net income (loss) per share | $ | 0.27 | $ | (0.29 | ) | ||
| Diluted net income (loss) per share: | |||||||
| Net income (loss) | $ | 20,611 | $ | (22,067 | ) | ||
| Weighted-average number of common shares outstanding | 76,411 | 75,161 | |||||
| Net effect of dilutive stock options at average market value | 951 | | |||||
| Weighted-average number of shares assuming dilution | 77,362 | 75,161 | |||||
| Diluted net income (loss) per share | $ | 0.27 | $ | (0.29 | ) | ||
| Weighted-average anti-dilutive stock options and convertible notes, excluded from the calculation of diluted net income (loss) per share | 19,061 | 19,843 | |||||
Segment information
The Company has two operating segments: (i) Pharmaceuticals and (ii) Discovery Tools and Services. The Company's Pharmaceuticals business seeks to discover, develop and commercialize major pharmaceutical products independently and with partners. The Company's Discovery Tools and Services business specializes in assay development, screening services, instrumentation and the manufacture and sale of proteins and reagents.
On March 28, 2003, the Company completed the sale of certain of PanVera LLC's assets, including certain biochemical and cellular assay capabilities and its commercial portfolio of proprietary reagents, probes and proteins, to Invitrogen Corporation. PanVera LLC is included in the Company's Discovery Tools and Services business segment and provides services and products that accelerate the discovery of new medicines by the pharmaceutical and biopharmaceutical industries. The sale did not include the instrumentation assets of the Discovery Tools and Services business segment.
Stock-Based Compensation
In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based Compensation, Transition and Disclosure" ("SFAS 148"). SFAS 148 amends SFAS No. 123 "Accounting for Stock-Based Compensation" ("SFAS 123"), to provide alternative methods of transition for a voluntary change to the fair-value based method of accounting for stock-based employee compensation. In addition, SFAS 148 amends the disclosure requirements of SFAS 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based compensation and the effect of the method used on reported results. The Company adopted the transition and annual disclosure requirements of SFAS 148 as required for its fiscal year ended December 31, 2002.
In accordance with SFAS 148, the Company has adopted the disclosure-only provisions of SFAS 123 and applies Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to
7
Employees" ("APB 25") and related interpretations in accounting for all awards granted to employees. Under APB 25, provided other criteria are met, when the exercise price of options granted to employees under these plans equals the market price of the common stock on the date of the grant, no compensation cost is required. When the exercise price of options granted to employees under these plans is less than the market price of the common stock on the date of grant, compensation costs are expensed over the vesting period. Subsequent changes to option terms can also give rise to compensation.
At March 31, 2003, the Company had one Employee Stock Purchase Plan ("ESPP") and three stock-based employee compensation plans, the 1991 Stock Option Plan, the 1994 Stock and Option Plan and the 1996 Stock and Option Plan (the "Plans"). No stock-based employee compensation costs are reflected in net income (loss), as all options granted under the Plans had an exercise price equal to the market value of the underlying common stock on the date of grant.
For stock options granted to non-employees, the Company recognizes compensation costs in accordance with the requirements of SFAS 123, which requires that companies recognize compensation expense for grants of stock, stock options and other equity instruments based on fair value.
The following table illustrates the effect on net income (loss) per share if the Company had applied the fair value recognition of SFAS 123 to the Company's stock-based employee compensation.
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Three Months Ended March 31, |
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|---|---|---|---|---|---|---|---|
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2003 |
2002 |
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(In thousands, except per share data) |
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| Net income (loss) attributable to common shareholders, as reported | $ | 20,611 | $ | (22,067 | ) | ||
| Deduct: Total additional stock-based employee compensation expense determined under the fair value based method for all awards | (14,768 | ) | (13,825 | ) | |||
| Pro forma net income (loss) | $ | 5,843 | $ | (35,892 | ) | ||
| Basic and diluted net income (loss) per common share, as reported | $ | 0.27 | $ | (0.29 | ) | ||
| Basic and diluted net income (loss) per common share, pro forma | $ | 0.08 | $ | (0.48 | ) | ||
3. Sale of Assets
On March 28, 2003, Vertex completed the sale of certain assets of the Discovery Tools and Services business including certain proprietary reagents, probes and proteins and certain biochemical and cellular assay capabilities to Invitrogen Corporation. In connection with the sale, Mirus Corporation ("Mirus") exercised a right of first refusal with respect to shares of Mirus owned by Vertex's wholly-owned subsidiary PanVera LLC. Additionally, on the same date, Mirus acquired certain of PanVera's assets. The aggregate gross consideration received by PanVera for the assets conveyed was approximately $95 million in cash (of which $93.2 million was received as of March 31, 2003), subject to certain adjustments including a closing balance sheet calculation of net assets sold, and assumption of certain liabilities. PanVera is included in the Company's Discovery Tools and Services business segment and, prior to the asset sale, provided services and products that accelerate the discovery of new medicines by the pharmaceutical and biopharmaceutical industries. The sale did not include the instrumentation assets of the Discovery Tools and Services business segment. In connection with the sale Vertex obtained a license from Invitrogen to make and use the reagents and probes sold to
8
Invitrogen solely for our drug discovery activities, independently and with partners, but has agreed that Vertex will not engage for a term of five years in the business of providing reagents, probes or assay development services to third parties. Vertex also agreed to purchase a minimum of $3 million of certain specified products annually from Invitrogen for three years after the completion of the sale. The prices of the products within the purchase commitment approximate fair value.
The Company recorded a gain on the PanVera asset sale of approximately $69 million in the first quarter of 2003. The gain was recorded net of transaction costs and certain accruals and receivables established for transaction bonuses payable by Vertex to former employees meeting certain employment requirements, an obligation in connection with certain annual contractual license fees under a customer agreement, estimated losses on the three year purchase commitment for anticipated payments in excess of the fair value of products to be purchased and an adjustment based upon the net book value of the assets sold on the closing date. Vertex has not recorded any income tax liability associated with the gain on the sale. It is anticipated that operating losses will be used to offset the taxable income generated from the sale. Accruals recorded in connection with the sale are included in other obligations, current and non-current, on the condensed consolidated balance sheets.
The financial statements for the three months ended March 31, 2003 reflect the operating results through March 28, 2003 of the assets and liabilities sold.
The agreement with Invitrogen requires the Company to indemnify Invitrogen against any loss which it may suffer by reason of our breach of certain representations and warranties, or our failure to perform certain covenants, contained in the agreement. The representations, warranties and covenants are of a type customary in agreements of this sort. The Company's aggregate obligations under the indemnity are, with a few exceptions which the Company believes are not material, capped at one-half of the purchase price, and apply to claims under representations and warranties made within fifteen months after closing, although there is no corresponding cap or time limit for claims made based on breaches of covenants. The Company believes the estimated fair value of these indemnification arrangements is minimal.
4. Lease Commitments
In January 2001 the Company entered into an agreement to lease approximately 290,000 square feet of laboratory and office space presently under construction in Kendall Square in Cambridge, Massachusetts (the "Kendall Square lease"). The term of this lease began January 1, 2003 and lease payments commence in May 2003. The Company has an obligation, staged over a number of years, to build out the leased premises into finished laboratory and office space. The lease will expire in 2017 with options to extend for two consecutive terms of ten years each, ultimately expiring in 2037. The Company is actively exploring alternatives to minimize its financial obligation under this lease. These alternatives include sharing, subleasing or exiting the lease space. The Company expects to finalize plans for this lease in the second quarter of 2003. Actions taken to minimize our financial obligation under the lease may result in a charge to our statement of operations which is not determinable at this time. For the three months ended March 31, 2003 the Company recorded $3,899,000 of expense related to this lease, which is included in the Condensed Consolidated Statement of Operations as other expense.
9
5. Segment Information
The Company has two operating segments: (i) Pharmaceuticals and (ii) Discovery Tools and Services. The Company's Pharmaceuticals business seeks to discover, develop and commercialize major pharmaceutical products independently and with partners. The Company's Discovery Tools and Services business specializes in assay development, screening services, instrumentation and the manufacture and sale of proteins and reagents. The Company evaluates segment performance based on loss before gains on sales of assets. The Company does not evaluate segment performance based on the segment's total assets and therefore the Company's assets are not reported by segment. The following table presents, by segment, the results of operations for the three months ended March 31, 2003 and 2002.
On March 28, 2003, the Company completed the sale of certain of PanVera LLC's assets, including certain biochemical and cellular assay capabilities and its commercial portfolio of proprietary reagents, probes and proteins, to Invitrogen Corporation. PanVera LLC is included in the Company's Discovery Tools and Services business segment and prior to the sale, provided services and products that accelerate the discovery of new medicines by the pharmaceutical and biopharmaceutical industries. The sale did not include the instrumentation assets of the Discovery Tools and Services business segment.
| (In thousands) |
Pharmaceuticals |
Discovery Tools and Services |
Total |
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|---|---|---|---|---|---|---|---|---|---|---|
| Three Months Ended March 31, 2003: | ||||||||||
| Revenues | $ | 15,989 | $ | 6,620 | $ | 22,609 | ||||
| Reportable segment income (loss) | $ | (48,264 | ) | $ | (357 | ) | $ | (48,621 | ) | |
| Three Months Ended March 31, 2002: | ||||||||||
| Revenues | $ | 20,551 | $ | 20,144 | $ | 40,695 | ||||
| Reportable segment income (loss) | $ | (31,030 | ) | $ | 8,963 | $ | (22,067 | ) | ||
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March 31, |
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|---|---|---|---|---|---|---|---|
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2003 |
2002 |
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| Total loss for reportable segments | $ | (48,621 | ) | $ | (22,067 | ) | |
| Gain on sale of assets | 69,232 | | |||||
| Total net income (loss) | $ | 20,611 | $ | (22,067 | ) | ||
6. Comprehensive Loss
For the three months ended March 31, 2003 and 2002, respectively, comprehensive income (loss) was as follows (in thousands):
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Three Months Ended March 31, |
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|---|---|---|---|---|---|---|---|---|
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2003 |
2002 |
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| Net income (loss) | $ | 20,611 | $ | (22,067 | ) | |||
| Changes in other comprehensive income (loss): | ||||||||
| Unrealized holding gains (losses) on marketable securities | (2,230 | ) | (6,041 | ) | ||||
| Foreign currency translation adjustment | (99 | ) | (151 | ) | ||||
| Total change in other comprehensive income (loss) | (2,329 | ) | (6,192 | ) | ||||
| Total comprehensive income (loss) | $ | 18,282 | $ | (28,259 | ) | |||
10
7. Guarantees
In November 2002, the FASB issued FASB Interpretation No. 45 ("FIN 45"), "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, an interpretation of FASB Statements No 5, 57 and 107 and Rescission of FASB Interpretation No. 34." FIN 45 elaborates on the disclosures to be made by a guarantor in its interim and annual financial statements about its obligations under certain guarantees that it has issued. It also requires that a guarantor recognize, at the inception of a guarantee, a liability for the fair value of certain guarantees. The initial recognition and measurement provisions of FIN 45 are applicable on a prospective basis to guarantees issued or modified after December 31, 2002.
As permitted under Massachusetts law, Vertex's Articles of Organization and Bylaws provide that the Company will indemnify certain of its officers and directors for certain claims asserted against them in connection with their service as an officer or director. The maximum potential amount of future payments that the Company could be required to make under these indemnification provisions is unlimited. However, the Company has purchased directors' and officers' liability insurance policies that reduce its monetary exposure and enable it to recover a portion of any future amounts paid. The Company believes the estimated fair value of these indemnification arrangements is minimal.
Vertex customarily agrees in the ordinary course of its business to indemnification provisions in agreements with clinical trials investigators in its drug development programs, in sponsored research agreements with academic and not-for-profit institutions, in various comparable agreements involving parties performing services for the Company in the ordinary course of business, and in its real estate leases. The Company also customarily agrees to certain indemnification provisions in its drug discovery and development collaboration agreements. With respect to the Company's clinical trials and sponsored research agreements, these indemnification provisions typically apply to any claim asserted against the investigator or the investigator's institution relating to personal injury or property damage, violations of law or certain breaches of the Company's contractual obligations arising out of the research or clinical testing of the Company's compounds or drug candidates. With respect to lease agreements, the indemnification provisions typically apply to claims asserted against the landlord relating to personal injury or property damage caused by the Company, to violations of law by the Company or to certain breaches of the Company's contractual obligations. The indemnification provisions appearing in the Company's collaboration agreements are similar, but in addition provide some limited indemnification for the collaborator in the event of third party claims alleging infringement of intellectual property rights. In each of the cases above, the term of these indemnification provisions generally survives the termination of the agreement, although the provision has the most relevance during the contract term and for a short period of time thereafter. The maximum potential amount of future payments that the Company could be required to make under these provisions is generally unlimited. Vertex has purchased insurance policies covering personal injury, property damage and general liability that reduce our exposure for indemnification and would enable us in many cases to recover a portion of any future amounts paid. The Company has never paid any material amounts to defend lawsuits or settle claims related to these indemnification provisions. As a result, the Company believes the estimated fair value of these indemnification arrangements is minimal.
8. Legal Proceedings
Chiron Corporation ("Chiron") filed suit on July 30, 1998 against Vertex and Eli Lilly and Company in the United States District Court for the Northern District of California, alleging infringement by the defendants of three U.S. patents issued to Chiron. The infringement action relates
11
to research activities by the defendants in the hepatitis C viral protease field and the alleged use of inventions claimed by Chiron in connection with that research. Chiron has requested damages in an unspecified amount, as well as an order permanently enjoining the defendants from unlicensed use of the claimed Chiron inventions. During 1999, Chiron requested and was granted a reexamination by the U.S. Patent and Trademark Office of all three of the patents involved in the suit. Chiron also requested and, over the opposition of Vertex and Eli Lilly, was granted a stay in the infringement lawsuit, pending the outcome of the patent reexamination. A Reexamination Certificate has been issued for each of the three Chiron patents-in-suit. Chiron has filed for reissue of two of the three patents-in-suit and has told the Company it intends to file for reissue of the third patent-in-suit. Chiron has also told the Company that it believes the stay should remain in effect while the reissue proceedings are pending. The Company has told Chiron that we will oppose continuation of the stay. While the length of the stay and the final outcome of the lawsuit cannot be determined, Vertex maintains that Chiron's claims are without merit and intends to defend the lawsuit, if and when it resumes, vigorously. We believe, based on information currently available, that the ultimate outcome of the action will not have a material impact on the Company's consolidated financial position.
On December 7, 2001 Oregon Health Sciences University filed suit against Vertex in the District Court of Oregon. The complaint in the suit seeks to name Dr. Bruce Gold, an employee of Oregon Health Sciences University, as an inventor and Oregon Health Sciences University as part owner of five of Vertex's neurophilin patents and associated damages. The suit stems from assays run on Vertex compounds by Dr. Gold under a sponsored research agreement in 1996. Vertex has investigated the inventorship on these patents and believes that Dr. Gold is not an inventor, Oregon Health Sciences has no ownership interest in any of these patents, and that the claims made in the complaint are without merit. Vertex intends to contest this claim vigorously. We believe, based on information currently available, that the ultimate outcome of the action will not have a material impact on the Company's consolidated financial position.
9. Recent Accounting Pronouncements
In September 2002, the FASB issued SFAS No. 146, "Accounting for Costs Associated with Exit or Disposal Activities," which supersedes EITF 94-3, "Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring)." The standard affects the accounting for restructuring charges and related activities. The provisions of this statement are required to be adopted for exit or disposal activities that are initiated after December 31, 2002. The adoption of SFAS No. 146 did not have a material impact on the Company's financial position and results of operations.
In November 2002, the FASB issued FASB Interpretation No. 45 ("FIN 45"), "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, an interpretation of FASB Statements No 5, 57 and 107 and Rescission of FASB Interpretation No. 34." FIN 45 elaborates on the disclosures to be made by a guarantor in its interim and annual financial statements about its obligations under certain guarantees that it has issued. It also requires that a guarantor recognize, at the inception of a guarantee, a liability for the fair value of certain guarantees. The initial recognition and measurement provisions of FIN 45 are applicable on a prospective basis guarantees issued or modified after December 31, 2002. The Company has adopted FIN No. 45 and has included the new disclosure requirements in the Notes to the Condensed Consolidated Financial Statements (see Note 7. Guarantees).
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In November 2002, the Emerging Issues Task Force reached a consensus on Issue No. 00-21 ("EITF 00-21"), "Revenue Arrangements with Multiple Deliverables." EITF 00-21 provides guidance on how to account for arrangements that involve the delivery or performance of multiple products, services and/or rights to use assets. The provisions of EITF 00-21 will apply to revenue arrangements entered into in fiscal periods beginning after June 15, 2003. Although the Company does not expect EITF 00-21 to have a material impact, the Company is still evaluating the potential impact of EITF 00-21 on its financial position and results of operations.
In January 2003, the FASB issued FASB Interpretation No. 46 ("FIN 46"), "Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51." FIN 46 requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46 must be applied for the first interim or annual period beginning after June 15, 2003. The adoption of FIN 46 did not have a material effect on the Company's consolidated financial statements.
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
We are a global biotechnology company with employees located in Cambridge, MA, San Diego, CA and Abingdon, UK. We had two operating segments: Pharmaceuticals and Discovery Tools and Services.
Our Pharmaceuticals business seeks to discover, develop, and commercialize major pharmaceutical products independently and with collaborators. Our proprietary, systematic, genomics-based discovery platform is designed to accelerate the discovery of new drugs and to expand intellectual property coverage of drug candidate compounds and classes of related compounds. We believe this approach, which targets gene families, has formed the basis for successful drug discovery and for the advancement of drug candidates by Vertex and its collaborators.
Our first approved product is Agenerase® (amprenavir), an HIV protease inhibitor, which we co-promote with GlaxoSmithKline. We earn a royalty from GlaxoSmithKline on sales of Agenerase. Agenerase is marketed worldwide. In Japan the drug is sold under the trade name Prozei. We have one drug candidate, 908 (GW 433908 or VX-175), for which a New Drug Application (NDA) is pending with the U.S. FDA. We have a total of 15 drug candidates in clinical or pre-clinical development including drug candidates focused on infectious diseases, autoimmune and inflammatory diseases and cancer, as well as other drug candidates targeting neurological disorders and genetic disorders. We intend to independently develop and commercialize certain of our own products for high-value markets where we can effectively reach large patient populations with a sales force focused on specialists. At the same time, we are collaborating with partners to develop and market other Vertex-discovered products for selected major therapeutic areas. We have significant collaborations with major pharmaceutical companies including Novartis, Aventis, GlaxoSmithKline and Serono, to develop and commercialize drug candidates serving markets where we believe our partner can more effectively compete. In these collaborations, we have retained rights to downstream milestone payments, license fees, product revenues, and royalty payments.
Our collaborations and contracts in the Pharmaceuticals business provide us with financial support and other valuable resources for our research programs, development of our clinical drug candidates, and marketing and sales of our products. We believe that we are positioned to commercialize multiple products, both independently and with our partners, in the coming years, which we expect will generate increased milestone payments, license fees, product revenues and royalty payments.
Our Discovery Tools and Services business, which we operated through our subsidiary PanVera LLC, specialized in assay development, screening services, the development, manufacture and sale of instruments, and the manufacture and sale of proteins and reagents. This business had contracts in place that required the delivery of products, licenses and services throughout 2002 and early 2003.
On March 28, 2003, Vertex completed the sale of certain assets of the Discovery Tools and Services business including certain proprietary reagents, probes and proteins and certain biochemical and cellular assay capabilities to Invitrogen Corporation. In connection with the sale, Mirus Corporation ("Mirus") exercised a right of first refusal with respect to shares of Mirus owned by PanVera LLC, Vertex's wholly-owned subsidiary. Additionally, on the same date, Mirus acquired certain of PanVera's assets. The aggregate gross consideration received by PanVera for the assets conveyed was approximately $95 million in cash (of which $93.2 million was received as of March 31, 2003) and assumption of certain liabilities. In connection with the PanVera LLC asset sale, we obtained a license from Invitrogen to make and use the reagents and probes sold to Invitrogen solely for our drug discovery activities, independently and with partners, but have agreed that we will not engage for a term of five years in the business of providing reagents, probes, or assay development services to third parties. We also agreed to a minimum purchase commitment of $3 million of products annually from Invitrogen for three years after the completion of the asset sale. We recorded a gain of $69 million on the sale in the first quarter of 2003.
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We have incurred annual operating losses since our inception and expect to incur losses for the foreseeable future. We plan to make significant investments in research and development for our potential pharmaceutical products. We expect that losses will fluctuate from year to year and that these fluctuations may be substantial.
Critical Accounting Policies
This discussion and analysis of our financial condition and results of operations is based upon our condensed consolidated financial statements that are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expense during the reported periods. These items are constantly monitored and analyzed by management for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are recorded in the period in which they become known. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circ