UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One) |
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x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2006 |
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OR |
o |
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 000-19319
VERTEX PHARMACEUTICALS INCORPORATED
(Exact name of registrant as specified in its charter)
MASSACHUSETTS |
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04-3039129 |
(State or other jurisdiction of |
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(I.R.S. Employer |
incorporation or organization) |
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Identification No.) |
130 WAVERLY STREET |
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CAMBRIDGE, |
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MASSACHUSETTS |
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02139-4242 |
(Address of principal executive offices) |
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(zip code) |
(617) 444-6100
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES x NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer x |
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Accelerated Filer o |
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Non-Accelerated Filer o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO x
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
Common Stock, par value $0.01 per share |
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111,801,481 |
Class |
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Outstanding at August 7, 2006 |
Vertex Pharmaceuticals Incorporated
Form 10-Q
For the Quarter Ended June 30, 2006
Table of Contents
Item 1. Condensed Consolidated Financial Statements
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share data)
|
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June 30, |
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December 31, |
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||||
Assets |
|
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
41,430 |
|
|
$ |
78,045 |
|
|
Marketable securities, available for sale |
|
220,911 |
|
|
283,112 |
|
|
||
Accounts receivable |
|
183,668 |
|
|
20,595 |
|
|
||
Prepaid expenses |
|
6,580 |
|
|
3,303 |
|
|
||
Total current assets |
|
452,589 |
|
|
385,055 |
|
|
||
Marketable securities, available for sale |
|
53,523 |
|
|
46,353 |
|
|
||
Restricted cash |
|
41,482 |
|
|
41,482 |
|
|
||
Property and equipment, net |
|
59,971 |
|
|
54,533 |
|
|
||
Investments |
|
14,849 |
|
|
18,863 |
|
|
||
Other assets |
|
3,064 |
|
|
2,712 |
|
|
||
Total assets |
|
$ |
625,478 |
|
|
$ |
548,998 |
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
|
||
Accounts payable |
|
$ |
8,277 |
|
|
$ |
6,210 |
|
|
Accrued expenses and other current liabilities |
|
46,480 |
|
|
42,061 |
|
|
||
Accrued interest |
|
3,185 |
|
|
3,184 |
|
|
||
Deferred revenue |
|
42,931 |
|
|
31,449 |
|
|
||
Accrued restructuring expense |
|
7,862 |
|
|
14,351 |
|
|
||
Other obligations |
|
|
|
|
2,988 |
|
|
||
Total current liabilities |
|
108,735 |
|
|
100,243 |
|
|
||
Accrued restructuring expense, excluding current portion |
|
28,416 |
|
|
28,631 |
|
|
||
Collaborator development loan |
|
19,997 |
|
|
19,997 |
|
|
||
Deferred revenue, excluding current portion |
|
133,239 |
|
|
851 |
|
|
||
Convertible subordinated notes (due September 2007) |
|
42,102 |
|
|
42,102 |
|
|
||
Convertible senior subordinated notes (due February 2011) |
|
117,993 |
|
|
117,998 |
|
|
||
Total liabilities |
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450,482 |
|
|
309,822 |
|
|
||
Commitments and contingencies: |
|
|
|
|
|
|
|
||
Stockholders equity: |
|
|
|
|
|
|
|
||
Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding at June 30, 2006 and December 31, 2005, respectively |
|
|
|
|
|
|
|
||
Common stock, $0.01 par value; 200,000,000 shares authorized; 110,600,314 and 108,153,149 shares issued and outstanding at June 30, 2006 and December 31, 2005, respectively |
|
1,089 |
|
|
1,081 |
|
|
||
Additional paid-in capital |
|
1,282,984 |
|
|
1,243,960 |
|
|
||
Deferred compensation, net |
|
|
|
|
(13,408 |
) |
|
||
Accumulated other comprehensive income (loss) |
|
8,252 |
|
|
(2,873 |
) |
|
||
Accumulated deficit |
|
(1,117,329 |
) |
|
(989,584 |
) |
|
||
Total stockholders equity |
|
174,996 |
|
|
239,176 |
|
|
||
Total liabilities and stockholders equity |
|
$ |
625,478 |
|
|
$ |
548,998 |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
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2006 |
|
2005 |
|
2006 |
|
2005 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
||||
Royalties |
|
$ |
9,005 |
|
$ |
7,467 |
|
$ |
18,184 |
|
$ |
13,620 |
|
Collaborative and other research and development revenues |
|
20,721 |
|
24,854 |
|
50,629 |
|
47,307 |
|
||||
Total revenues |
|
29,726 |
|
32,321 |
|
68,813 |
|
60,927 |
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
||||
Royalty payments |
|
2,885 |
|
2,489 |
|
5,880 |
|
4,519 |
|
||||
Research and development(1) |
|
91,250 |
|
59,357 |
|
166,452 |
|
116,792 |
|
||||
Sales, general and administrative(1) |
|
14,370 |
|
10,814 |
|
27,249 |
|
20,441 |
|
||||
Restructuring expense/(credit) |
|
443 |
|
(1,743 |
) |
1,210 |
|
171 |
|
||||
Total costs and expenses |
|
108,948 |
|
70,917 |
|
200,791 |
|
141,923 |
|
||||
Loss from operations |
|
(79,222 |
) |
(38,596 |
) |
(131,978 |
) |
(80,996 |
) |
||||
Interest income |
|
3,921 |
|
2,247 |
|
7,901 |
|
4,566 |
|
||||
Interest expense |
|
(2,357 |
) |
(4,639 |
) |
(4,714 |
) |
(9,278 |
) |
||||
Loss from continuing operations before cumulative effect of a change in accounting principle |
|
(77,658 |
) |
(40,988 |
) |
(128,791 |
) |
(85,708 |
) |
||||
Cumulative effect of a change in accounting principleFAS 123(R)* |
|
|
|
|
|
1,046 |
|
|
|
||||
Net loss |
|
(77,658 |
) |
$ |
(40,988 |
) |
(127,745 |
) |
$ |
(85,708 |
) |
||
Basic and diluted net loss from continuing operations per common share |
|
$ |
(0.72 |
) |
$ |
(0.50 |
) |
$ |
(1.19 |
) |
$ |
(1.06 |
) |
Basic and diluted cumulative effect of a change in accounting principle per common share |
|
|
|
|
|
0.01 |
|
|
|
||||
Basic and diluted net loss per common share |
|
$ |
(0.72 |
) |
$ |
(0.50 |
) |
$ |
(1.18 |
) |
$ |
(1.06 |
) |
Basic and diluted weighted average number of common shares outstanding |
|
108,523 |
|
82,274 |
|
107,985 |
|
80,859 |
|
(1) Includes the following stock-based compensation expense:
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
||||
Research and development |
|
$ |
9,755 |
|
$ |
927 |
|
$ |
16,161 |
|
$ |
1,764 |
|
Sales, general and administrative |
|
1,892 |
|
202 |
|
3,611 |
|
396 |
|
||||
Total |
|
$ |
11,647 |
|
$ |
1,129 |
|
$ |
19,772 |
|
$ |
2,160 |
|
* The Company adopted Financial Accounting Standards Board Statement No. 123 (R), Share-Based Payments, using a modified prospective method. See Note 3 to the Condensed Consolidated Financial Statements, Stock-based Compensation, for further detail.
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Vertex Pharmaceuticals Incorporated
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
|
|
Six Months Ended |
|
||||
|
|
2006 |
|
2005 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
||
Net loss |
|
$ |
(127,745 |
) |
$ |
(85,708 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
||
Depreciation and amortization |
|
13,059 |
|
13,371 |
|
||
Non-cash stock-based compensation expense under FAS 123(R) |
|
19,772 |
|
|
|
||
Other non-cash based compensation expense |
|
1,793 |
|
3,651 |
|
||
Cumulative effect of a change in accounting principle |
|
(1,046 |
) |
|
|
||
Realized loss on marketable securities |
|
|
|
53 |
|
||
Loss on disposal of property and equipment |
|
2 |
|
272 |
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
||
Accounts receivable |
|
1,927 |
|
(2,050 |
) |
||
Prepaid expenses |
|
(3,277 |
) |
(2,262 |
) |
||
Accounts payable |
|
2,067 |
|
2,769 |
|
||
Accrued expenses and other liabilities |
|
1,591 |
|
(6,571 |
) |
||
Accrued restructuring expense |
|
(6,704 |
) |
(12,030 |
) |
||
Accrued interest |
|
1 |
|
406 |
|
||
Deferred revenue |
|
(21,130 |
) |
(20,641 |
) |
||
Net cash used in operating activities |
|
(119,690 |
) |
(108,740 |
) |
||
Cash flows from investing activities: |
|
|
|
|
|
||
Purchase of marketable securities |
|
(93,370 |
) |
(48,685 |
) |
||
Sales and maturities of marketable securities |
|
163,292 |
|
133,897 |
|
||
Expenditures for property and equipment |
|
(18,232 |
) |
(7,383 |
) |
||
Restricted cash |
|
|
|
840 |
|
||
Investments and other assets |
|
(572 |
) |
48 |
|
||
Net cash provided by investing activities |
|
51,118 |
|
78,717 |
|
||
Cash flows from financing activities: |
|
|
|
|
|
||
Issuances of common stock from employee benefit plans, net |
|
31,927 |
|
4,715 |
|
||
Issuances of common stock from stock offering, net |
|
|
|
165,331 |
|
||
Debt exchange costs |
|
(218 |
) |
|
|
||
Net cash provided by financing activities |
|
31,709 |
|
170,046 |
|
||
Effect of changes in exchange rates on cash |
|
248 |
|
(334 |
) |
||
Net increase (decrease) in cash and cash equivalents |
|
(36,615 |
) |
139,689 |
|
||
Cash and cash equivalentsbeginning of period |
|
78,045 |
|
55,006 |
|
||
Cash and cash equivalentsend of period |
|
41,430 |
|
$ |
194,695 |
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
||
Cash paid for interest |
|
$ |
4,445 |
|
$ |
8,341 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Vertex Pharmaceuticals Incorporated
Notes to Condensed Consolidated Financial Statements
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 Companys annual financial statements have been condensed or omitted. The interim financial statements, in the opinion of management, reflect all normal recurring adjustments (including accruals) necessary for a fair presentation of the financial position and results of operations for the interim periods ended June 30, 2006 and 2005.
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 ending December 31, 2006. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2005, which are contained in the Companys 2005 Annual Report on Form 10-K that was filed with the Securities and Exchange Commission on March 16, 2006.
Basic and Diluted Net Loss per Common Share
Basic net loss per share is based upon the weighted average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net 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 of adding such shares is 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), the assumed conversion of convertible notes and the vesting of unvested restricted shares of common stock. Common equivalent shares have not been included in the net loss per share calculations because the effect of including them would have been anti-dilutive. Total potential gross common equivalent shares consisted of the following (in thousands, except per share amounts):
|
|
At June 30, |
|
||||
|
|
2006 |
|
2005 |
|
||
Stock options |
|
14,617 |
|
16,133 |
|
||
Weighted-average exercise price, per share |
|
$ |
25.30 |
|
$ |
22.02 |
|
Convertible notes |
|
8,354 |
|
16,454 |
|
||
Weighted-average conversion price, per share |
|
$ |
19.16 |
|
$ |
19.15 |
|
Unvested restricted shares |
|
1,739 |
|
1,598 |
|
Stock-based Compensation Expense
The Company adopted Financial Accounting Standards Board Statement No. 123(R), Share-Based Payments (FAS 123(R)), as of January 1, 2006. FAS 123(R) revises FAS Statement No. 123, Accounting for Stock-Based Compensation (FAS 123), supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and amends FAS Statement No. 95, Statement of Cash Flows. FAS 123(R) requires companies to expense the fair value of employee stock options and other
5
forms of stock-based employee compensation over the employees service periods. Compensation cost is measured at the fair value of the award at the grant date and is adjusted to reflect actual forfeitures and the outcomes of certain conditions. See Note 3, below, for additional information regarding the Companys stock-based compensation.
Research and Development
All research and development costs, including amounts funded by research collaborators, are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits; laboratory supplies; contract services, including clinical trial costs; and infrastructure costs, including facilities costs and depreciation. The Companys collaborators have funded portions of the Companys research and development programs related to specific drug candidates and research targets, including, in 2006, VX-950 (telaprevir), VX-702, VX-770, kinases, and certain cystic fibrosis research targets, and, in 2005, VX-950 (telaprevir), VX-702, kinases, and certain cystic fibrosis research targets.
The following table details the research and development expenses for collaborator-sponsored and Company-sponsored programs for the three months ended June 30, 2006 and 2005 (in thousands):
|
|
For the Three Months Ended |
|
For the Three Months Ended |
|
||||||||||||||||||
|
|
Research |
|
Development |
|
Total |
|
Research |
|
Development |
|
Total |
|
||||||||||
Collaborator-sponsored Programs |
|
$ |
9,612 |
|
|
$ |
41,652 |
|
|
$ |
51,264 |
|
$ |
16,976 |
|
|
$ |
14,814 |
|
|
$ |
31,790 |
|
Company-sponsored Programs |
|
26,809 |
|
|
13,177 |
|
|
39,986 |
|
12,836 |
|
|
14,731 |
|
|
27,567 |
|
||||||
Total |
|
$ |
36,421 |
|
|
$ |
54,829 |
|
|
$ |
91,250 |
|
$ |
29,812 |
|
|
$ |
29,545 |
|
|
$ |
59,357 |
|
The total research and development expense for the three months ended June 30, 2006 and 2005 includes $9.8 million and $0.9 million, respectively, of stock-based compensation expense. The following table details the research and development expenses for collaborator-sponsored and Company-sponsored programs for the six months ended June 30, 2006 and 2005 (in thousands):
|
|
For the Six Months Ended |
|
For the Six Months Ended |
|
||||||||||||||||||
|
|
Research |
|
Development |
|
Total |
|
Research |
|
Development |
|
Total |
|
||||||||||
Collaborator-sponsored Programs |
|
$ |
29,153 |
|
|
$ |
70,830 |
|
|
$ |
99,983 |
|
$ |
33,428 |
|
|
$ |
26,431 |
|
|
$ |
59,859 |
|
Company-sponsored Programs |
|
43,540 |
|
|
22,929 |
|
|
66,469 |
|
26,386 |
|
|
30,547 |
|
|
56,933 |
|
||||||
Total |
|
$ |
72,693 |
|
|
$ |
93,759 |
|
|
$ |
166,452 |
|
$ |
59,814 |
|
|
$ |
56,978 |
|
|
$ |
116,792 |
|
The total research and development expense for the six months ended June 30, 2006 and 2005 includes $16.2 million and $1.8 million, respectively, of stock-based compensation expense.
Restructuring Expense
The Company records costs and liabilities associated with exit and disposal activities, as defined in Statement of Financial Accounting Standards No. 146, Accounting for Costs Associated with Exit or Disposal Activities (FAS 146), at fair value in the period the liability is incurred. In periods subsequent to initial measurement, changes to the liability are measured using the credit-adjusted risk-free discount rate applied in the initial period.
6
The Company recognizes revenue in accordance with the Securities and Exchange Commissions (SEC) Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements (SAB 101), as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition (SAB 104), and for revenue arrangements entered into after June 30, 2003, Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with Multiple Deliverables (EITF 00-21).
The Companys revenues are generated primarily through collaborative research, development and commercialization agreements. The terms of the agreements typically include payment to Vertex of non-refundable up-front license fees, funding of research and development efforts, milestone payments and/or royalties on product sales.
Agreements containing multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the collaborator and whether there is objective and reliable evidence of fair value of the undelivered obligation(s). The consideration received is allocated among the separate units based on each units fair value or using the residual method, and the applicable revenue recognition criteria are applied to each of the separate units.
The Company recognizes revenues from non-refundable, up-front license fees on a straight-line basis over the contracted or estimated period of performance, which is typically the research or development term. Research and development funding is recognized as earned, ratably over the period of effort.
Substantive milestones realized in collaboration arrangements are recognized as earned when the corresponding payment is reasonably assured, subject to the following policies in those circumstances where the Company has obligations remaining after achievement of the milestone:
· In those circumstances where collection of a substantive milestone is reasonably assured, the Company has remaining obligations to perform under the collaboration arrangement and the Company has evidence of fair value for its remaining obligations, management considers the milestone payment and the remaining obligations to be separate units of accounting. In these circumstances, the Company uses the residual method under EITF 00-21 to allocate revenue among the milestones and the remaining obligations.
· In those circumstances where collection of a substantive milestone is reasonably assured, the Company has remaining obligations to perform under the collaboration arrangement and the Company does not have sufficient evidence of fair value for its remaining obligations, management considers the milestone payment and the remaining obligations on the contract as a single unit of accounting. In those circumstances where the collaboration does not require specific deliverables at specific times or at the end of the contract term, but rather the Companys obligations are satisfied over a period of time, substantive milestones are recognized over the period of performance. This typically results in a portion of the milestone payment being recognized as revenue on the date the milestone is achieved equal to the applicable percentage of the performance period that has elapsed as of the date the milestone is achieved, with the balance being deferred and recognized over the remaining period of performance.
The Company evaluates whether milestones are substantive at the inception of the agreement based on the contingent nature of the milestone, specifically reviewing factors such as the technological risk that must be overcome as well as the level of effort and investment required to achieve the milestone. Milestones that are not considered substantive and do not meet the separation criteria are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance.
Payments received after performance obligations are met completely are recognized when earned.
7
Royalty revenue is recognized based upon actual and estimated net sales of licensed products in licensed territories as provided by the licensee, and is recognized in the period the sales occur. Differences between actual royalty revenues and estimated royalty revenues, which have not historically been significant, are reconciled and adjusted for in the quarter they become known.
At June 30, 2006, the Company had four stock-based employee compensation plans: the 1991 Stock Option Plan (the 1991 Plan), the 1994 Stock and Option Plan (the 1994 Plan), the 1996 Stock and Option Plan (the 1996 Plan) and the 2006 Stock and Option Plan (the 2006 Plan, and together with the 1991 Plan, the 1994 Plan, and the 1996 Plan, collectively, the Stock and Option Plans), and one Employee Stock Purchase Plan (the ESPP). Pursuant to the Stock and Option Plans, the Company may issue restricted stock and options to its directors, employees and consultants for services. Each option granted under the Stock and Option Plans has an exercise price equal to the market value of the underlying common stock on the date of grant. The price per share of restricted stock granted to employees is equal to $0.01, the par value of the Companys common stock. Vesting of options and restricted stock is ratable over specified periods, generally four or five years, and is determined by the Management Development and Compensation Committee of the Companys Board of Directors. All options awarded under the Stock and Option Plans expire not more than ten years from the grant date. Pursuant to the ESPP, participating employees may periodically purchase shares of the Companys common stock at a discount to the fair value of the stock on specified measurement dates, using funds withheld from their compensation over specified offering terms.
The Company reserved an aggregate of 8,000,000 shares under the 1991 Plan and 1994 Plan. The Company reserved 22,000,000 shares under the 1996 Plan and 7,302,380 shares under the 2006 Plan. At June 30, 2006, the Company had approximately 7,105,000 shares of common stock available for grants under the 2006 Plan, and no shares were available for grants under the 1991 Plan, the 1994 Plan or the 1996 Plan. As of June 30, 2006, approximately 621,000 shares remained available for future purchases under the ESPP.
On January 1, 2006, Vertex adopted Statement of Financial Accounting Standards No. 123(R), Share-Based Payments (FAS 123(R)), using the modified prospective method, pursuant to which the Company applies the provisions of FAS 123(R) to its consolidated financial statements on a going-forward basis. The modified prospective transition method requires the application of the accounting standard as of January 1, 2006, the first day of Vertexs fiscal year 2006. Prior periods have not been restated. FAS 123(R) requires companies to recognize share-based payments to employees as compensation expense using the fair value method. Under the fair value recognition provisions of FAS 123(R), stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the service period, which generally is the vesting period of the award. The fair value of stock options and shares purchased pursuant to the ESPP is calculated using the Black-Scholes valuation model. The fair value of restricted stock is based on intrinsic value. The expense recognized over the service period includes an estimate of awards that will be forfeited. Prior to adoption of FAS 123(R), Vertex recorded the impact of forfeitures as they occurred. In connection with the adoption of FAS 123(R) during the first half of fiscal year 2006, Vertex recorded a $1.0 million benefit from the cumulative effect of changing from recording forfeitures related to restricted stock awards as they occurred to estimating forfeitures during the service period.
Stock-based compensation expense recognized during the first half of 2006 includes: (a) ESPP awards with offering periods commencing May 15, 2005 and November 15, 2005, based on the grant-date fair value estimated in accordance with the provisions of FAS 123, (b) stock options and restricted awards granted prior to, but not yet vested as of December 31, 2005, based on the grant-date fair value estimated in accordance with the provisions of FAS 123, and (c) stock options and restricted stock awards granted after
8
December 31, 2005, based on the grant-date fair value and ESPP awards with the offering period commencing May 15, 2006, in accordance with the provisions of FAS 123(R). These amounts reflect estimated forfeitures of those awards.
The estimated fair value of Vertexs stock-based awards, less estimated forfeitures, is amortized over the awards service periods on a ratable basis. No equity compensation cost was capitalized during the first half of 2006.
The effect of recording stock-based compensation for the three and six months ended June 30, 2006 was as follows (in thousands):
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||
Stock-based compensation expense by type of award: |
|
|
|
|
|
|
|
|
|
||
Stock options |
|
|
$ |
9,804 |
|
|
|
$ |
15,402 |
|
|
Restricted shares |
|
|
1,412 |
|
|
|
3,139 |
|
|
||
ESPP |
|
|
431 |
|
|
|
1,231 |
|
|
||
Total stock-based compensation |
|
|
$ |
11,647 |
|
|
|
$ |
19,772 |
|
|
Effect of stock-based compensation on income by line item: |
|
|
|
|
|
|
|
|
|
||
Research and development |
|
|
$ |
9,755 |
|
|
|
$ |
16,161 |
|
|
Sales, general and administrative |
|
|
1,892 |
|
|
|
3,611 |
|
|
||
Total stock-based compensation |
|
|
$ |
11,647 |
|
|
|
$ |
19,772 |
|
|
Cumulative effect of a change in accounting principleFAS 123(R) |
|
|
|
|
|
|
$ |
(1,046 |
) |
|
|
Net stock-based compensation expense included in net loss |
|
|
$ |
11,647 |
|
|
|
$ |
18,726 |
|
|
As a result of the adoption of FAS 123(R):
· the Companys net loss from continuing operations for the three and six months ended June 30, 2006 is greater by $10.3 million and $16.1 million, respectively;
· the Companys net loss for the three and six months ended June 30, 2006 is greater by $10.3 million and $15.1 million, respectively; and
· basic and diluted loss per share for the three and six months ended June 30, 2006 is greater by $0.10 and $0.14, respectively.
The Company uses the Black-Scholes valuation model to estimate the fair value of stock options at the grant date. The Black-Scholes valuation model requires the Company to make certain estimates and assumptions, including assumptions related to the expected price volatility of the Companys stock, the period during which the options are outstanding, the rate of return of risk free investments, and the expected dividend yield for the Companys stock. The Company validates its estimates and assumptions through consultations with independent third parties having relevant expertise.
9
The fair values of options granted during the three and six months ended June 30, 2006 were calculated using the following weighted-average assumptions:
|
|
For the |
|
For the |
|
||||
Expected stock price volatility |
|
|
57.92 |
% |
|
|
57.26 |
% |
|
Expected term of options |
|
|
5.64 |
years |
|
|
5.64 |
years |
|
Risk free interest rate |
|
|
5.04 |
% |
|
|
4.61 |
% |
|
Expected annual dividends |
|
|
|
|
|
|
|
|
|
The weighted-average valuation assumptions were determined as follows:
· Expected stock price volatility: In 2006, the Company changed its method of estimating expected volatility from relying exclusively on historical volatility to relying exclusively on implied volatility. Options to purchase the Companys stock with remaining terms of greater than a year are regularly traded in the market. Expected stock price volatility is calculated using the trailing one month average of daily implied volatilities prior to grant date.
· Expected term of options: The expected term of options represents the period of time options are expected to be outstanding. The Company used historical data to estimate employee exercise and post-vest termination behavior. The Company believes that all groups of employees exhibit similar exercise and post-vest termination behavior and therefore does not stratify employees into multiple groups.
· Risk-free interest rate: The Company bases the risk-free interest rate on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term assumption.
· Expected annual dividends: The estimate for annual dividends is $0.00, because the Company has not historically and does not intend for the foreseeable future to pay a dividend.
The following table summarizes information related to the outstanding and vested options during the six months ended June 30, 2006:
|
|
Stock |
|
Weighted-average |
|
Weighted-average |
|
Aggregate |
|
||||||||||
Outstanding at December 31, 2005 |
|
|
14,669 |
|
|
|
$ |
22.84 |
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,060 |
|
|
|
$ |
35.36 |
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,801 |
) |
|
|
$ |
16.11 |
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(221 |
) |
|
|
$ |
16.64 |
|
|
|
|
|
|
|
|
|
|
|
Expired |
|
|
(90 |
) |
|
|
$ |
61.19 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
14,617 |
|
|
|
$ |
25.30 |
|
|
|
6.09 |
|
|
|
$ |
210,492 |
|
|
Exercisable at June 30, 2006 |
|
|
9,669 |
|
|
|
$ |
27.08 |
|
|
|
4.92 |
|
|
|
$ |
142,620 |
|
|
Exercisable and expected to vest |
|
|
13,972 |
|
|
|
$ |
25.36 |
|
|
|
5.97 |
|
|
|
$ |
203,022 |
|
|
The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value, based on the average of the high and low price of the Companys common stock of $35.44 on June 30, 2006, which would have been received by option holders if all option holders had exercised their options on that date.
All options granted during the three and six months ended June 30, 2006 and 2005 were granted with exercise prices equal to the fair market value of the Companys common stock on the date of grant and had weighted-average grant date fair values of $19.83 and $6.35 for the three months, respectively and $20.01 and $5.38 for the six months, respectively.
10
The total intrinsic value of options exercised during the three months ended June 30, 2006 and 2005 was $9.8 million and $0.9 million, respectively. The total cash received from employees as a result of employee stock option exercises during the three months ended June 30, 2006 and 2005 was approximately $6.7 million and $2.2 million, respectively. The total intrinsic value of options exercised during the six months ended June 30, 2006 and 2005 was $36.3 million and $1.0 million, respectively. The total cash received from employees as a result of employee stock option exercises during the six months ended June 30, 2006 and 2005 was approximately $29.0 million and $2.8 million, respectively.
The Company settles employee stock option exercises with newly issued common shares.
As of June 30, 2006, there was $47.1 million of total unrecognized compensation cost, net of estimated forfeitures, related to unvested options granted under the Stock and Option Plans. That cost is expected to be recognized over a weighted-average period of 2.64 years.
The following table summarizes the restricted stock activity of the Company during the six months ended June 30, 2006:
|
|
Restricted |
|
Weighted Average |
|
|||||
|
|
(Shares in thousands) |
|
(per Share) |
|
|||||
Outstanding at December 31, 2005 |
|
|
1,521 |
|
|
|
$ |
11.02 |
|
|
Granted |
|
|
414 |
|
|
|
$ |
35.38 |
|
|
Vested |
|
|
(155 |
) |
|
|
$ |
10.09 |
|
|
Cancelled |
|
|
(41 |
) |
|
|
$ |
17.68 |
|
|
Outstanding at June 30, 2006 |
|
|
1,739 |
|
|
|
$ |
16.75 |
|
|
The total fair value of the shares vesting during the three months ended June 30, 2006 and 2005 (measured on the date of vesting) was $0.5 million and $0.9 million, respectively. The total fair value of the shares vesting during the six months ended June 30, 2006 and 2005 (measured on the date of vesting) was $5.8 million and $1.3 million, respectively.
As of June 30, 2006, there was $17.2 million of total unrecognized compensation expense, net of estimated forfeitures, related to unvested restricted stock granted under the Stock and Option Plans. That cost is expected to be recognized over a weighted-average period of 2.94 years.
ESPP
Vertex adopted the ESPP on July 1, 1992. The ESPP permits eligible employees to enroll in a twelve-month offering period comprising two six-month purchase periods. Participants may purchase shares of the Companys common stock, through payroll deductions, at a price equal to 85% of the fair market value of the common stock on the first day of the applicable twelve-month offering period, or the last day of the applicable six-month purchase period, whichever is lower. Purchase dates under the ESPP occur on May 14 and November 14 of each year.
During the first half of 2006, the following shares were issued to employees under ESPP (shares in thousands):
|
|
Six months ended |
|
|||
Number of shares |
|
|
221 |
|
|
|
Average price paid |
|
|
$ |
13.20 |
|
|
11
The total stock-based compensation expense related to the ESPP for the three and six months ended June 30, 2006 is $0.4 million and $1.2 million, respectively. The following table reflects the weighted average assumptions used in the Black-Scholes valuation model for the ESPP at June 30, 2006:
Expected stock price volatility |
|
57.99% |
|
Expected term |
|
0.87 years |
|
Risk-free interest rate |
|
4.07% |
|
Expected annual dividends |
|
|
|
The weighted-average fair value of each purchase right granted during the first half of 2006 and 2005 was $11.85 and $4.60, respectively.
The expected stock price volatility for ESPP offerings beginning before the fourth quarter of 2005 is based on historical volatility, while the volatility for offerings beginning in the fourth quarter of 2005 and the second quarter of 2006 is based on implied volatility. The expected term represents purchases and purchase periods that take place within the offering period. The Company bases the risk free interest rate on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term assumption. The Company has not historically and does not intend for the foreseeable future to pay a dividend and therefore the estimate is zero.
Prior to the adoption of FAS 123(R)
In accordance with Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation, Transition and Disclosure, for periods prior to January 1, 2006, the Company adopted the disclosure-only provisions of FAS 123 and also applied APB 25 and related interpretations in accounting for all stock awards granted to employees. Under APB 25, provided that other criteria were met, when the exercise price of stock options granted to employees equaled the market price of the common stock on the date of the grant, no compensation expense was recognized. Additionally, under APB 25, the Company was not required to record compensation expense for the cost of options or shares issued under the ESPP. Accordingly, no expense related to options or ESPP shares was recorded prior to January 1, 2006.
Prior to January 1, 2006, the Company recorded stock-based compensation expense related to restricted stock awards over the related vesting period for an amount equal to the difference between the price per share of restricted stock issued and the fair value of the Companys common stock at the date of grant or issuance. Prior to January 1, 2006, the Company recorded forfeitures as they occurred.
The following table illustrates the effect on net loss and net loss per share for the three and six months ended June 30, 2005 if the fair value recognition provisions of FAS 123 had been applied to the Companys stock-based employee compensation. Employee stock-based compensation expense was amortized on a straight-line basis, because the Companys valuation of options subject to FAS 123 assumed a single weighted-average expected life for each award. Included in employee stock-based compensation expense for the three and six months ended June 30, 2005 is expense related to the modification of certain stock awards in accordance with an officers severance agreement.
12
|
|
For the |
|
For the |
|
||||||
|
|
(in thousands, except per share data) |
|
||||||||
Net loss attributable to common stockholders, as reported |
|
|
$ |
(40,988 |
) |
|
|
$ |
(85,708 |
) |
|
Add: Employee stock-based compensation expense included in net loss, net of tax |
|
|
1,129 |
|
|
|
2,160 |
|
|
||
Deduct: Total stock-based employee compensation expense determined under the fair value based method for all awards, net of tax |
|
|
(10,554 |
) |
|
|
(21,284 |
) |
|
||
Pro forma net loss |
|
|
$ |
(50,413 |
) |
|
|
$ |
(104,832 |
) |
|
Basic and diluted net loss per common share, as reported |
|
|
$ |
(0.50 |
) |
|
|
$ |
(1.06 |
) |
|
Basic and diluted net loss per common share, pro forma |
|
|
$ |
(0.61 |
) |
|
|
$ |
(1.30 |
) |
|
The fair value of each option granted during the three and six months ended June 30, 2005 was estimated on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions:
|
|
For the |
|
For the |
|
||||
Expected stock price volatility |
|
|
60.00 |
% |
|
|
60.00 |
% |
|
Risk free interest rate |
|
|
3.77 |
% |
|
|
3.60 |
% |
|
Expected term of options |
|
|
4.00 |
years |
|
|
4.13 |
years |
|
Expected annual dividends |
|
|
|
|
|
|
|
|
|
The fair value of each ESPP purchase right outstanding during the three and six months ended June 30, 2005 was estimated on the date of subscription using the Black-Scholes option pricing model with the following weighted-average assumptions:
Expected stock price volatility |
|
60.00 |
% |
|
|
Risk free interest rate |
|
2.63 |
% |
|
|
Expected term of options |
|
0.82 |
years |
|
|
Expected annual dividends |
|
|
|
|
|
13
For the three and six months ended June 30, 2006 and 2005, comprehensive loss was as follows (in thousands):
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
||||
Net loss |
|
$ |
(77,658 |
) |
$ |
(40,988 |
) |
$ |
(127,745 |
) |
$ |
(85,708 |
) |
Changes in other comprehensive loss: |
|
|
|
|
|
|
|
|
|
||||
Unrealized holding gains (losses) on marketable securities |
|
(2,849 |
) |
999 |
|
10,877 |
|
(138 |
) |
||||
Foreign currency translation adjustment |
|
206 |
|
(252 |
) |
248 |
|
(334 |
) |
||||
Total change in other comprehensive loss |
|
(2,643 |
) |
747 |
|
11,125 |
|
(472 |
) |
||||
Total comprehensive loss |
|
$ |
(80,301 |
) |
$ |
(40,241 |
) |
$ |
(116,620 |
) |
$ |
(86,180 |
) |
On June 10, 2003, Vertex adopted a plan to restructure its operations to coincide with its increasing internal emphasis on advancing drug candidates through clinical development to commercialization. The restructuring was designed to re-balance the Companys relative investments in research and development. The restructuring plan included a workforce reduction, write-offs of certain assets and a decision not to occupy approximately 290,000 square feet of specialized laboratory and office space in Cambridge, Massachusetts under lease to Vertex (the Kendall Square lease). The Kendall Square lease commenced in January 2003 and has a 15-year term. In the second quarter of 2005, the Company revised its assessment of its real estate requirements. The Company now plans to occupy approximately 120,000 square feet of the facility subject to the Kendall Square lease (the Kendall Square Facility) beginning in 2006. As of June 30, 2006, the Company had begun occupying a portion of the building. The remaining rentable square footage of the Kendall Square Facility currently is subleased to third parties.
For the three months ended June 30, 2006, the Company recorded approximately $0.4 million of restructuring expense, which was attributable to the imputed interest cost relating to the restructuring accrual. The activity related to the restructuring accrual and related expense for the three months ended June 30, 2006 is as follows (in thousands):
|
|
|
|
Cash |
|
|
|
|
|
|
|
|||||||||||||||
|
|
|
|
payments, |
|
Cash received |
|
Charge, |
|
|
|
|||||||||||||||
|
|
Accrual as of |
|
second |
|
from subleases, |
|
second |
|
Accrual as of |
|
|||||||||||||||
|
|
March 31, |
|
quarter |
|
second quarter |
|
quarter |
|
June 30, |
|
|||||||||||||||
|
|
2006 |
|
2006 |
|
2006 |
|
2006 |
|
2006 |
|
|||||||||||||||
Lease restructuring expense |
|
|
$ |
41,719 |
|
|
|
$ |
(7,904 |
) |
|
|
$ |
2,020 |
|
|
|
$ |
443 |
|
|
|
$ |
36,278 |
|
|
For the six months ended June 30, 2006, the Company recorded approximately $1.2 million of restructuring expense, which was primarily attributable to the imputed interest cost relating to the restructuring accrual. The activity related to the restructuring accrual and related expense for the six months ended June 30, 2006 is as follows (in thousands):
|
|
|
|
Cash |
|
Cash received |
|
Charge, |
|
|
|
||||||||||||||
|
|
|
|
payments, |
|
from subleases, |
|
six months |
|
Accrual as |
|
||||||||||||||
|
|
Accrual as of |
|
six months |
|
six months |
|
ended |
|
of |
|
||||||||||||||
|
|
December 31, |
|
ended June 30, |
|
ended June 30, |
|
June 30, |
|
June 30, |
|
||||||||||||||
|
|
2005 |
|
2006 |
|
2006 |
|
2006 |
|
2006 |
|
||||||||||||||
Lease restructuring expense |
|
|
$ |
42,982 |
|
|
|
$ |
(11,884 |
) |
|
|
$ |
3,970 |
|
|
|
1,210 |
|
|
|
$ |
36,278 |
|
|
14
During the three months ended June 30, 2005, the Company recorded a restructuring net credit of approximately $1.7 million. This net credit resulted from adjusting the portion of the restructuring accrual for the portion of the Kendall Square Facility that Vertex expects to occupy, which is partially offset by (i) a charge in the amount of the estimated incremental ongoing lease obligations associated with the portion of the Kendall Square Facility that the Company does not intend to occupy and (ii) imputed interest costs relating to the restructuring liability. The activity related to the restructuring accrual for the three months ended June 30, 2005 is as follows (in thousands):
|
|
|
|
|
|
|
|
Portion of |
|
|
|
|
|
||||||||||||||||||
|
|
|
|
Cash |
|
|
|
facility |
|
|
|
|
|
||||||||||||||||||
|
|
|
|
Payments, |
|
Cash received |
|
Vertex expects |
|
Charge, |
|
|
|
||||||||||||||||||
|
|
Accrual as of |
|
second |
|
from sublease, |
|
to occupy, |
|
second |
|
|
|
||||||||||||||||||
|
|
March 31, |
|
quarter |
|
second quarter |
|
second |
|
quarter |
|
Accrual as of |
|
||||||||||||||||||
|
|
2005 |
|
2005 |
|
2005 |
|
quarter 2005 |
|
2005 |
|
June 30, 2005 |
|
||||||||||||||||||
Lease restructuring expense |
|
|
$ |
52,305 |
|
|
|
$ |
(7,242 |
) |
|
|
$ |
493 |
|
|
|
$ |
(10,018 |
) |
|
|
$ |
8,275 |
|
|
|
$ |
43,813 |
|
|
The activity related to the restructuring accrual for the six months ended June 30, 2005 is as follows (in thousands):
|
|
|
|
Cash |
|
|
|
Portion of |
|
|
|
|
|
||||||||||||||||||
|
|
|
|
Payments, |
|
Cash received |
|
facility |
|
Charge, |
|
|
|
||||||||||||||||||
|
|
|
|
six months |
|
from sublease, |
|
Vertex expects |
|
Six months |
|
|
|
||||||||||||||||||
|
|
Accrual as of |
|
ended |
|
six months ended |
|
to occupy, |
|
ended |
|
|
|
||||||||||||||||||
|
|
December 31, |
|
June 30, |
|
June 30, |
|
six months ended |
|
June 30, |
|
Accrual as of |
|
||||||||||||||||||
|
|
2004 |
|
2005 |
|
2005 |
|
June 30, 2005 |
|
2005 |
|
June 30, 2005 |
|
||||||||||||||||||
Lease restructuring expense |
|
|
$ |
55,843 |
|
|
|
$ |
(13,017 |
) |
|
|
$ |
816 |
|
|
|
$ |
(10,018 |
) |
|
|
$ |
10,189 |
|
|
|
$ |
43,813 |
|
|
In accordance with FAS 146, the Companys initial estimate of its liability for its net ongoing costs associated with the Kendall Square lease obligation was recorded in the second quarter of 2003 at fair value. The restructuring expense incurred from the second quarter of 2003 through the end of the first quarter of 2005 (i.e., immediately prior to the Companys decision to utilize a portion of the Kendall Square Facility for its operations) relates to the estimated incremental net ongoing lease obligations associated with the entire Kendall Square Facility, together with imputed interest costs relating to the restructuring liability. The restructuring expense incurred in the period beginning in the second quarter of 2005 continues to be estimated in accordance with FAS 146, but relates only to the portion of the building that the Company does not intend to occupy for its operations. The remaining lease obligations, which are associated with the portion of the Kendall Square Facility that the Company expects to occupy and use for its operations, are recorded as rental expense in the period incurred. The Company reviews its assumptions and estimates quarterly and updates its estimates of this liability as changes in circumstances require. As required by FAS 146, the expense and liability recorded is calculated using probability-weighted discounted cash-flows of the Companys estimated ongoing lease obligations, including contractual rental and build-out commitments, net of estimated sublease rentals, offset by related sublease costs.
In estimating the expense and liability under its Kendall Square lease obligation, the Company estimated (i) the costs to be incurred to satisfy its rental and build-out commitments under the lease (including operating costs), (ii) the time necessary to sublease the space, (iii) the projected sublease rental rates, and (iv) the anticipated durations of subleases. The Company validates its estimates and assumptions through consultations with independent third parties having relevant expertise. The Company used a credit-adjusted risk-free rate of approximately 10% to discount the estimated cash flows. The Company will review its estimates and assumptions on at least a quarterly basis, until the termination of the Kendall Square lease, and will make whatever modifications management believes necessary, based on the Companys best judgment, to reflect any changed circumstances. The Companys estimates have changed in the past, and may change in the future, resulting in additional adjustments to the estimate of liability,
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and the effect of any such adjustments could be material. Because the Companys estimate of the liability includes the application of a discount rate to reflect the time-value of money, the estimate of the liability will increase each quarter simply as a result of the passage of time. Changes to the Companys estimate of the liability are recorded as additional restructuring expense/(credit).
Altus Pharmaceuticals, Inc. completed the initial public offering of its common stock in January 2006. At June 30, 2006 the Company owned 817,749 shares of Altus common stock and warrants to purchase 1,962,494 shares of Altus common stock. In addition, Vertex holds 450,000 shares of Altus redeemable preferred stock, which are not convertible into common stock and which are redeemable at the Companys option on or after December 31, 2010, or by Altus at any time. The Company was restricted from trading Altus securities for a period of six months following the initial public offering.
As a result of the public offering, at June 30, 2006, Altus common stock was classified as an available-for-sale investment and recorded at fair value, based on quoted market prices. Unrealized gains and losses on the Altus common stock are included as a component of accumulated other comprehensive income, which is a separate component of stockholders equity, until such gains and losses are realized. At June 30, 2006, the fair market value of the Altus common stock investment was $15.1 million, with a cost basis of $4.0 million. In July 2006, the Company sold the 817,749 shares of Altus common stock for approximately $11.7 million, resulting in a realized gain of approximately $7.7 million to be recognized in the third quarter of 2006.
The Company will continue to account for the Altus warrants under the cost method of accounting until the end of the lock-up period, at which time the warrants will be classified as derivatives. Gains or losses on the fair market value of the warrants, as derivatives, will be included in the consolidated statements of operations. Vertex will continue to account for the redeemable preferred stock under the cost method of accounting.
The Company continues to assess the Altus warrants and redeemable preferred stock on a quarterly basis to determine if there has been any estimated decrease in the fair value of that investment below the carrying value that might require Vertex to write down its cost basis of the investment. If any adjustment to the fair value of an investment reflects a decline in the value of that investment below its cost, the Company will consider the available evidence, including the duration and extent to which the decline is other-than-temporary. If the decline is considered other-than-temporary, the cost basis of the investment will be written down to fair value as a new cost basis, and the amount of the write-down will be included in the consolidated statements of operations. Vertex has not identified facts or circumstances which would cause the Company to determine that the investment basis of its interest in Altus should be changed.
7. Convertible Subordinated Notes
At June 30, 2006, the Company had approximately $42.1 million in aggregate principal amount of 5% Convertible Subordinated Notes due in September 2007 (2007 Notes) and approximately $118.0 million in aggregate principal amount of 5.75% Convertible Senior Subordinated Notes due in February 2011 (the 2011 Notes) outstanding. The 2007 Notes are convertible, at the option of the holder, into common stock at a price equal to $92.26 per share, subject to adjustment under certain circumstances. The 2007 Notes bear interest at the rate of 5% per annum, and the Company is required to make semi-annual interest payments on the outstanding principal balance of the 2007 Notes on March 19 and September 19 of each year. The 2007 Notes are redeemable by the Company at any time at specific redemption prices if the closing price of the Companys common stock exceeds 120% of the conversion price for at least 20 trading days within a period of 30 consecutive trading days. The 2011 Notes are convertible, at the option of the holder, into common stock at a price equal to $14.94 per share, subject to adjustment under certain
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circumstances. The 2011 Notes bear interest at the rate of 5.75% per annum, and the Company is required to make semi-annual interest payments on the outstanding principal balance of the 2011 Notes on February 15 and August 15 of each year. On or after February 15, 2007, the Company may redeem the 2011 Notes at a redemption price equal to the principal amount plus accrued and unpaid interest, if any.
In August 2006, the Company agreed to exchange approximately 4.1 million shares of newly issued common stock for $58.3 million in aggregate principal amount of outstanding 2011 Notes plus all accrued and unpaid interest thereon. As a result of these exchanges, the Company expects to incur a non-cash charge of approximately $5.0 million in the third quarter of 2006. This charge is related to the incremental shares issued in the transaction over the number that would have been issued upon the conversion of the notes under the original conversion terms.
8. Significant Revenue Arrangements
Janssen Pharmaceutica, N.V.
In June 2006, the Company entered into a collaboration agreement with Janssen Pharmaceutica, N.V. for the development, manufacture and commercialization of VX-950 (telaprevir), the Companys HCV protease inhibitor currently in Phase IIb clinical trials. Under the agreement, Janssen will fund 50% of the costs incurred in developing VX-950 (telaprevir) in the parties territories (North America for the Company, and the rest of the world, other than the Far East, for Janssen) and has exclusive rights to commercialize VX-950 (telaprevir) in Europe, South America, the Middle East, Africa and Australia. The agreement provides for Janssen to make a $165 million up-front license payment to the Company, which was included in accounts receivable and deferred revenue at June 30, 2006 and subsequently paid to the Company in July 2006. Janssen has further agreed to make additional contingent milestone payments totaling up to $380 million based on the successful development, approval and launch of VX-950 (telaprevir). The agreement also provides the Company with royalties on any sales of VX-950 (telaprevir) in the Janssen territory, with a tiered royalty structure having a royalty rate averaging in the mid-20% range and provides that Janssen will contribute to the manufacture of VX-950 (telaprevir). Janssen may terminate the agreement without cause at any time upon six months notice to the Company. There has been no revenue recognized related to the agreement in the first half of 2006.
Merck & Co.
On June 26, 2006, the Company agreed with Merck & Co., Inc. to extend the research program term and corresponding research funding for the parties ongoing research collaboration for three months beyond the original termination date of June 21, 2006. The research program term will now extend until September 21, 2006. For the three and six months ended June 30, 2006, the Company recognized $9.1 million and $28.2 million, respectively, in revenue related to its agreement with Merck, which amounts include both research funding and upfront and product candidate development milestone payments.
Cystic Fibrosis Foundation
In January 2006, Vertex amended its research collaboration agreement with Cystic Fibrosis Foundation Therapeutics Incorporated (CFFT) to extend the term during which CFFT is providing funding for research of cystic fibrosis transmembrane regulator (CFTR) protein corrector compounds through the first quarter of 2008. In March 2006, Vertex and CFFT further amended the agreement to include development stage funding from CFFT for the purpose of accelerating the clinical development of VX-770, a CFTR potentiator compound. The agreement, as amended, provides that CFFT will pay up to $13.3 million to Vertex for specified VX-770 development activities through the end of 2007. Under the amended agreements, Vertex retains the right to develop and commercialize VX-770 and any other compounds discovered in the research collaboration, and will pay royalties to CFFT upon the approval and
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commercialization of any compounds discovered under the collaboration. For the three and six months ended June 30, 2006, Vertex recognized $2.8 million and $5.2 million, respectively, in revenue related to its agreement with CFFT.
As permitted under Massachusetts law, Vertexs 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 certain 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 and sites 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 and/or commercialization collaboration agreements. With respect to the Companys clinical trials and sponsored research agreements, these indemnification provisions typically apply to any claim asserted against the investigator or the investigators institution relating to personal injury or property damage, violations of law or certain breaches of the Companys contractual obligations arising out of the research or clinical testing of the Companys 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 Companys contractual obligations. The indemnification provisions appearing in the Companys collaboration agreements are similar, but in addition provide some limited indemnification for its collaborator in the event of third party claims alleging infringement of intellectual property rights. In each of the cases above, the indemnification obligation generally survives the termination of the agreement for some extended period, although the obligation typically 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. The Company has purchased insurance policies covering personal injury, property damage and general liability that reduce its exposure for indemnification and would enable it 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. Accordingly, the Company believes the estimated fair value of these indemnification arrangements is minimal.
Effective on March 28, 2003, the Company sold certain assets of PanVera LLC to Invitrogen Corporation for approximately $97 million. The agreement with Invitrogen requires the Company to indemnify Invitrogen against any loss it may suffer by reason of Vertexs breach of certain representations and warranties, or 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 Companys aggregate obligations under the indemnity are, with a few exceptions that 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 (which period has ended), although there is no corresponding time limit for claims made based on breaches of covenants. Invitrogen has made no claims to date under this indemnity, and the Company believes that the estimated fair value of the remaining indemnification obligation is minimal.
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Effective on December 3, 2003, the Company sold certain instrumentation assets to Aurora Discovery, Inc. for approximately $4.3 million. The agreement with Aurora requires the Company to indemnify Aurora against any loss it may suffer by reason of the Companys breach of certain representations and warranties, or 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 Companys aggregate obligations under the indemnity are capped at one-half of the purchase price, and apply to claims under representations and warranties made within fifteen months after closing (which period has ended), although there is no corresponding time limit for claims made based on breaches of covenants. Aurora has made no claims to date under this indemnity, and the Company believes that the estimated fair value of the remaining indemnification obligation is minimal.
On February 10, 2004, Vertex entered into a Dealer Manager Agreement with UBS Securities LLC in connection with the exchange of approximately $153.1 million of 2011 Notes for approximately $153.1 million of 2007 Notes. On September 13, 2004, the Company entered into a second Dealer Manager Agreement with UBS Securities in connection with the exchange of approximately $79.3 million of 2011 Notes for approximately $79.3 million of 2007 Notes. Each of the Dealer Manager Agreements requires the Company to indemnify UBS Securities against any loss UBS Securities may suffer by reason of the Companys breach of representations and warranties relating to the exchanges of the convertible notes, the Companys failure to perform certain covenants in those agreements, the inclusion of any untrue statement of material fact in the materials provided to potential investors in the 2011 Notes, the omission of any material fact needed to make those materials not misleading, and any actions taken by the Company or its representatives in connection with the exchanges. The representations, warranties and covenants in the Dealer Manager Agreements are of a type customary in agreements of this sort. The Company believes the estimated fair value of these indemnification obligations is minimal.
On June 7, 2005, the Company entered into a Purchase Agreement with Merrill Lynch, Pierce, Fenner & Smith Incorporated, as the representative of the several underwriters named therein, relating to the Companys 2005 public offering of common stock. The Purchase Agreement requires the Company to indemnify the underwriters against any loss they may suffer by reason of the Companys breach of representations and warranties relating to that public offering, the Companys failure to perform certain covenants in those agreements, the inclusion of any untrue statement of material fact in the prospectus used in connection with that offering, the omission of any material fact needed to make those materials not misleading, and any actions taken by the Company or its representatives in connection with the offering. The representations, warranties and covenants in the Purchase Agreement are of a type customary in agreements of this sort. The Company believes the estimated fair value of these indemnification obligations is minimal.
The Company has certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
On December 17, 2003, a purported class action, Marguerite Sacchetti v. James C. Blair et al., was filed in the Superior Court of the State of California, County of San Diego, naming as defendants all of the directors of Aurora who approved the merger of Aurora and Vertex, which closed in July 2001. The plaintiffs claim that Auroras directors breached their fiduciary duty to Aurora by, among other things, negligently conducting a due diligence examination of Vertex by failing to discover alleged problems with VX-745, a Vertex drug candidate that was the subject of a development program which was terminated by Vertex in September 2001. Vertex has certain indemnity obligations to Auroras directors under the terms of the merger agreement between Vertex and Aurora. This case was dismissed with prejudice in the first
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quarter of 2006 in connection with a settlement that resulted in payment to the plaintiff by the defendants directors and officers liability insurer of under $200,000.
11. New Accounting Pronouncements
In May 2005, the FASB issued FAS No. 154, Accounting Changes and Error Corrections (FAS 154). FAS No. 154 replaced APB Opinion No. 20, Accounting Changes, and FAS No. 3, Reporting Accounting Changes in Interim Financial Statements. FAS No. 154 requires retrospective application to prior periods financial statements of changes in accounting principle, unless it is impractible to determine either the period-specific effects or the cumulative effect of the change. The Company adopted FAS 154 beginning on January 1, 2006; its adoption did not have a material impact on the Companys consolidated financial statements.
In November 2005, FASB issued FSP FAS 115-1 and FAS 124-1, The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments (FSP FAS 115-1), which provides guidance for determining when investments in certain debt and equity securities are considered impaired, whether an impairment is other-than-temporary, and on measuring such impairment loss. FSP FAS 115-1 also includes accounting considerations subsequent to the recognition of an other-than-temporary impairment and requires certain disclosures about unrealized losses that have not been recognized as other-than-temporary impairments. FSP FAS 115-1 is required to be applied to reporting periods beginning after December 15, 2005. The Company adopted FSP FAS 115-1 in the first quarter of 2006. Adoption of FSP FAS 115-1 did not have a material impact on the Companys consolidated results of operations or financial condition.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
We are a biotechnology company in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. We have built a drug discovery capability that integrates biology, chemistry, biophysics, automation and information technologies, with a goal of making the drug discovery process more efficient and productive. Currently, a Vertex-discovered compound for the treatment of HIV infection, fosamprenavir calcium (marketed as Lexiva in the United States and Telzir in Europe), is being marketed by our collaborator GlaxoSmithKline. We have a number of drug candidates in development and a broad-based discovery effort.
We are concentrating most of our drug development resources at the present time on three compounds in specific markets: VX-950 (telaprevir) for the treatment of hepatitis C virus (HCV) infection in North America, VX-702 for the treatment of rheumatoid arthritis (RA) in North America and Europe and VX-770 for the treatment of cystic fibrosis (CF) worldwide. We rely on collaborators for (i) financial support for certain drug development programs and (ii) to conduct all or a portion of the development, manufacturing and commercialization activities for certain of our other drug candidates, either worldwide or in the markets upon which we are not currently focused.
Drug Discovery and Development
Discovery and development of a new pharmaceutical product is a lengthy and resource-intensive process, which may take 10 to 15 years or more. Throughout this entire process, potential drug candidates are subjected to rigorous evaluation, driven in part by stringent regulatory considerations, designed to generate information concerning efficacy, proper dosage levels and a variety of other physical and chemical characteristics that are important in determining whether a proposed drug candidate should be approved for marketing. The toxicity characteristics and profile of drug candidates at varying dose levels administered for varying periods of time also are monitored continually and evaluated during the nonclinical and clinical development process. Most chemical compounds that are investigated as potential drug candidates never progress into formal development, and most drug candidates that do advance into formal development never become commercial products. A drug candidates failure to progress or advance may be the result of any one or more of a wide range of adverse experimental outcomes including, for example, the lack of acceptable absorption characteristics or other physical properties, the lack of sufficient efficacy against the disease target, difficulties in developing a cost-effective manufacturing or formulation method or the discovery of toxicities or side effects that are unacceptable for the disease indication being treated.
Given the uncertainties of the research and development process, it is not possible to predict with confidence which, if any, of our current research and development efforts will result in a marketable pharmaceutical product. We monitor the results of our discovery research and our nonclinical and clinical trials and frequently evaluate our portfolio investments with the objective of balancing risk and potential return in light of new data and scientific, business and commercial insights. This process can result in relatively abrupt changes in focus and priority as new information becomes available and we gain additional insights into ongoing programs and potential new programs.
Business Strategy
We have elected to diversify our research and development activities across a relatively broad array of investment opportunities, due in part to the high risks associated with the biotechnology and pharmaceutical business. We plan to expend significant resources on development and commercialization of some of our drug product candidates in certain markets, and rely on collaborators to develop and commercialize certain of our other drug candidates either worldwide or in markets upon which we are not
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currently focused. This diversification strategy requires more significant financial resources than would be required if we pursued a more limited approach.
Because we have incurred losses from our inception and expect to incur losses for the foreseeable future, we are dependent in large part on our continued ability to raise significant funding to finance our discovery and development operations and our overhead and to meet our long-term contractual commitments and obligations. In the past, we have secured funds principally through capital market transactions, strategic collaborative agreements, proceeds from the disposition of assets, investment income and the issuance of stock under our employee benefit programs. At June 30, 2006, we had $315.9 million of cash, cash equivalents and available-for-sale securities, $42.1 million in principal amount of 5% Convertible Subordinated Notes due 2007 (the 2007 Notes) and $118.0 million in principal amount of 5.75% Convertible Senior Subordinated Notes due 2011 (the 2011 Notes). In early July 2006, we received $165.0 million as an upfront payment under our June 30, 2006 VX-950 (telaprevir) collaboration agreement with Janssen. In early August 2006, we agreed to exchange approximately 4.1 million newly issued shares of our common stock for approximately $58.3 million in aggregate principal amount of outstanding 2011 Notes, including accrued and unpaid interest, reducing our outstanding aggregate principal amount of outstanding 2011 Notes to approximately $59.6 million. In order to fund our research, development and manufacturing activities, particularly for later stage compounds including VX-950 (telaprevir), we expect to continue to pursue a general financing strategy that may lead us to undertake one or more additional capital transactions, which may or may not be similar to transactions in which we have engaged in the past. We cannot be sure that any such financing opportunities will be available on acceptable terms.
Collaborations have been and will continue to be an important component of our business strategy.
On June 30, 2006, we entered into a License, Development, Manufacturing and Commercialization Agreement with Janssen Pharmaceutica, N.V., an affiliate of the Johnson & Johnson Company, for the development, manufacture and commercialization of VX-950 (telaprevir), which is currently being investigated in Phase II clinical trials for the treatment of HCV infection. Under our agreement with Janssen, we will collaborate with Janssen to develop VX-950 (telaprevir) worldwide except for the Far East, and Janssen will be responsible for commercializing the compound worldwide except for North America and the Far East. We have retained exclusive commercial rights to VX-950 (telaprevir) in North America and will lead the global development program. Under the agreement, we received an upfront payment of $165 million in July 2006. In addition, the agreement provides for up to $380 million in milestone payments, contingent upon the successful development and commercialization of VX-950 (telaprevir). Janssen will fund 50% of costs for the VX-950 (telaprevir) development program for North America and the Janssen territories beginning on the date of the agreement. Janssen is responsible for commercialization of VX-950 (telaprevir) in Janssens territory and will pay us tiered royalties on any product sales, averaging in the mid -20% range, and will be responsible for paying certain third party royalties. In connection with the development and commercialization of VX-950 (telaprevir), we will work with Tibotec Pharmaceuticals, also a Johnson & Johnson company, to establish a global health initiative to increase the prevention, diagnosis, treatment and cure of HCV infection, to be principally directed toward developing countries.
Also in June 2006, we extended the two-year research program term under our Exclusive Research Collaboration, License and Commercialization Agreement with Merck & Co, Inc. by an additional three months, until September 2006. Our research collaboration with Novartis Pharma AG, together with the corresponding research funding, expired during the second quarter of 2006. We expect that the revenue and funding from collaborations that support our development stage compounds, such as the Janssen agreement, will in the future provide a proportionately higher level of financial support for the Companys R&D activities than revenue from research collaboration agreements.
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Our pipeline also includes other potential drug candidates that we may choose to develop with or through a collaborator, as we maintain focus on our core product candidates. We may also seek collaborators for our research programs.
Clinical Development Programs
We are focusing our 2006 preclinical and clinical development investment on VX-950 (telaprevir), VX-702 and VX-770. As a result of our progress in the first half of 2006 in the VX-950 (telaprevir) development program, we currently plan to further increase our investment in that compound to support the global Phase IIb clinical development program. We also currently are incurring and expect to continue to incur significant costs to manufacture VX-950 (telaprevir) drug product, in advance of obtaining regulatory marketing approval, in sufficient quantities to support a timely commercial product launch if we are successful in obtaining such approval. Investment in these activities at the current stage of clinical development is subject to considerable risk that VX-950 (telaprevir) will not advance to product registration, placing our full investment in the compound at risk.
We currently are conducting two major Phase II clinical trials of VX-950 (telaprevir)PROVE I in the United States and PROVE 2 in Europe, as part of a global Phase II development program for VX-950 (telaprevir). We expect that together, the two clinical trials will evaluate sustained viral response (SVR) rates in 580 treatment-naïve patients infected with genotype 1 HCV. Our global Phase II development program in treatment-naïve patients has three objectives: (i) to evaluate the optimal SVR rate that can be achieved with VX-950 (telaprevir) therapy in combination with the current standard of care; (ii) to evaluate the optimal treatment duration for VX-950 (telaprevir) combination therapy; and (iii) to evaluate the role of ribavirin in VX-950 (telaprevir)-based therapy. We have enrolled over 100 patients in PROVE 1 to date. In addition to these two clinical trials, we expect to begin additional clinical trials of VX-950 (telaprevir) in the second half of the year, including a Phase II clinical trial in patients who have failed prior standard of care treatment. We anticipate those additional clinical trials to enroll approximately 400 patients. By the end of the first quarter of 2007, we expect to have enrolled approximately 1,000 patients in clinical trials of VX-950 (telaprevir). We collaborate in the Far East clinical development of VX-950 (telaprevir) with Mitsubishi Pharma Corporation, which began the first Phase I clinical trial of VX-950 (telaprevir) in the Far East.
We recently revised our clinical development plans for VX-702, and now expect to initiate a Phase II clinical trial of VX-702 on a background of methotrexate in patients with RA in 2007.
We have completed dosing in the first two cohorts of healthy volunteers in the single dose Phase I clinical trial of VX-770, which targets a key mechanism underlying the progression of cystic fibrosis. In the second half of 2006, we plan to evaluate multiple doses of VX-770 in healthy volunteers and assess single doses of VX-770 in patients with CF.
We believe that each of these programs requires that we make a comprehensive investment to realize its full clinical and commercial value. We also recognize that development investment at this stage is subject to the considerable risk that any one or more of these compounds will not advance to product registration. Each compound could fail to progress or advance due to a wide range of adverse experimental outcomes, placing our full investment in the compound at risk. While we attempt to stage our investments to mitigate these financial risks, drug discovery and development by its nature is a very risky undertaking. We expect to continue to evaluate and prioritize investment in our clinical development programs based on the emergence of new clinical and nonclinical data in each program throughout 2006 and in subsequent years.
In the clinical development program being conducted by our collaborator Merck for VX-680, an investigational drug candidate targeting Aurora kinase, Merck began patient enrollment in a Phase II clinical trial of VX-680 in patients with advanced lung cancer. A Phase II clinical trial of VX-680 in
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patients with advanced colorectal cancer and an extended Phase I clinical trial of patients with hematologic cancers are ongoing. We now expect that our collaborator GSK will initiate Phase III development of brecanavir, a novel HIV protease inhibitor currently being evaluated in a Phase II clinical trial, in 2007.
Financial Guidance
The key financial measures for which we have provided guidance are as follows:
Net Loss: In July 2006, we revised our expected net loss on a GAAP basis upward from our previous guidance of a range of $205 to $225 million, including an estimated $34 million in stock-based compensation expense and an estimated $6 million of restructuring expense, to incorporate additional research and development investment related to our expanded global Phase IIb program for VX-950 (telaprevir). We now expect that the net loss on a GAAP basis for 2006 will be in the range of $222 million to $237 million. This net loss estimate includes an estimated $38 million in stock-based compensation expense and an estimated $4 million of restructuring expense as a result of imputed interest charges relating to the restructuring accrual.
Revenues: We expect that the Companys revenue will be in the range of $210 to $235 million in 2006.
Research and Development (R&D) Expense: We expect that R&D expense will be in the range of $375 to $395 million for 2006, including approximately $31 million of stock-based compensation expense. In July 2006, we increased our estimate for R&D expense by $25 million from a range of $350 to $370 million, including $28 million of stock-based compensation expense. The increase is a result of the anticipated increased investment in our global Phase IIb program for VX-950 (telaprevir).
Sales, General and Administrative (SG&A) Expense: We expect our SG&A expense will be in the range of $55 to $60 million for 2006, including approximately $6 million of stock-based compensation expense.
Cash, Cash Equivalents and Available-for-Sale Securities: As a result of the $165 million upfront payment that we received in early July 2006 as part of the VX-950 (telaprevir) collaboration with Janssen, we expect cash, cash equivalents and available-for-sale securities at the end of 2006 to be in excess of $400 million.
The financial measures set forth above are forward-looking and are subject to risks and uncertainties that could cause our actual results to vary materially, including the risks and uncertainties that we describe in Risk Factors in Item 1A of our 2005 Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 16, 2006, and in the section below entitled Forward-Looking Statements.
Liquidity and Capital Resources
We have incurred operating losses since our inception and historically have financed our operations principally through public and private offerings of our equity and debt securities, strategic collaborative agreements that include research and development funding, development milestones and royalties on the sales of products, proceeds from the disposition of assets, investment income and proceeds from the issuance of stock under our employee benefit programs.
At June 30, 2006, we had cash, cash equivalents and available-for-sale securities of $315.9 million, a decrease of $91.6 million from $407.5 million at December 31, 2005. This decrease is primarily the result of investment in our clinical development activities, offset by approximately $31.9 million received from the issuance of common stock under our employee benefit plans. Expenditures for property and equipment during the six months ended June 30, 2006 were $18.2 million.
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In July 2006, we received a $165.0 million upfront payment under our collaboration with Janssen for the development, manufacture and commercialization of VX-950 (telaprevir). Under the terms of the Agreement, Janssen will fund 50% of drug development costs incurred on or after June 30, 2006 in the global development program for VX-950 (telaprevir).
At June 30, 2006, we had approximately $42.1 million in aggregate principal amount of 2007 Notes and approximately $118.0 million in aggregate principal amount of 2011 Notes outstanding. The 2011 Notes are convertible into common stock at the option of the holder at a price equal to $14.94 per share, subject to adjustment under certain circumstances. The 2007 Notes are convertible into common stock at the option of the holder at a price equal to $92.26 per share, subject to adjustment under certain circumstances. In August 2006, we exchanged approximately 4.1 million shares of newly issued common stock for approximately $58.3 million in aggregate principal amount of outstanding 2011 Notes, plus accrued interest. As a result of these exchanges we expect to incur a non-cash charge of approximately $5.0 million in the third quarter of 2006. This charge is related to the incremental shares issued in the transaction over the number that would have been issued upon the conversion of the notes under the original conversion terms.
In July 2006, we sold 817,749 shares of Altus Pharmaceuticals common stock for approximately $11.7 million, resulting in a realized gain of approximately $7.7 million, to be recognized in the third quarter of 2006.
We expect to continue to make significant investments in our pipeline, particularly in clinical trials for certain of our product candidates, in our ion channel and kinase discovery efforts and in our effort to prepare for potential registration, regulatory approval and commercial launch of our existing and future product candidates. We also expect to continue incurring significant costs to manufacture VX-950 (telaprevir) drug products in advance of obtaining regulatory marketing approval, in sufficient quantities to support a timely commercial product launch if we are successful in obtaining such approval. Consequently, we expect to incur losses on a quarterly and annual basis for the foreseeable future.
As part of our strategy for managing our capital structure, we have from time to time adjusted the amount and maturity of our debt obligations through new issues, privately negotiated transactions and market purchases, depending on market conditions and our perceived needs at the time. During the remainder of 2006, we expect to continue pursuing a general financial strategy that may lead us to undertake one or more additional capital transactions. Any such capital transactions may or may not be similar to transactions in which we have engaged in the past.
To the extent that our current cash and marketable securities, in addition to the above-mentioned sources, are not sufficient to fund our activities, it will be necessary to raise additional funds through public offerings or private placements of our securities or other methods of financing. We also will continue to manage our capital structure and consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.
There have been no significant changes to our commitments and obligations as reported in our 2005 Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 16, 2006.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements prepared in accordance with GAAP. 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 consolidated
25
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 circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.
We believe that the application of the accounting policies for restructuring and other expense, revenue recognition, research and development expenses, investments and stock-based compensation, all of which are important to our financial condition and results of operations, require significant judgments and estimates on the part of management. Our accounting polices, including the ones discussed below, are more fully described in Note B, Accounting Policies, to our consolidated financial statements included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 16, 2006.
Restructuring Expense
We record liabilities associated with restructuring activities based on estimates of fair value in the period the liabilities are incurred, in accordance with FAS 146. As prescribed by FAS 146, we use a probability-weighted discounted cash-flow analysis to calculate the amount of the liability. The probability-weighted discounted cash-flow analysis is based on managements assumptions and estimates of our ongoing lease obligations, including contractual rental commitments, build-out commitments and building operating costs, and estimates of income from subleases, based on the term and timing of such subleases. We discount the estimated cash flows using a discount rate of approximately 10%. These cash flow estimates are reviewed and may be adjusted in subsequent periods. Adjustments are based, among other things, on managements assessment of changes in factors underlying the estimates. Because our estimate of the liability includes the application of a discount rate to reflect the time-value of money, the estimate will increase simply as a result of the passage of time, even if all other factors remain unchanged.
Our estimates of our restructuring liability have changed in the past, and it is possible that our assumptions and estimates will change in the future, resulting in additional adjustments to the amount of the estimated liability. The effect of any such adjustments could be material. For example, we currently have two subleases for portions of the Kendall Square Facility with terms of six and seven years, respectively, and we have made certain estimates and assumptions relating to future sublease terms following the expiration of the current subleases. Market variability may require adjustments to those assumptions in the future. We will review our assumptions and judgments related to the lease restructuring on at least a quarterly basis until the Kendall Square lease is terminated or expires, and make whatever modifications we believe are necessary, based on our best judgment, to reflect any changed circumstances.
The accrual for restructuring expense of $36.3 million at June 30, 2006 is related to the portion of the Kendall Square Facility that we do not intend to occupy. This estimate represents our best judgment of the assumptions and estimates most appropriate in measuring the ongoing obligation.
Revenue Recognition
We recognize revenue in accordance with the Securities and Exchange Commissions (SEC) Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements (SAB 101), as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition, (SAB 104) and for revenue arrangements entered into after June 30, 2003, Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with Multiple Deliverables (EITF 00-21).
Our revenues are generated primarily through collaborative research, development and commercialization agreements. The terms of the agreements typically include payment to us of non-
26
refundable up-front license fees, funding of research and development efforts, milestone payments and/or royalties on product sales.
Agreements containing multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the collaborator and whether there is objective and reliable evidence of fair value of the undelivered obligation(s). The consideration received is allocated among the separate units based on each units fair value or the residual method, and the applicable revenue recognition criteria are applied to each of the separate units.
We recognize revenues from non-refundable, up-front license fees on a straight-line basis over the contracted or estimated period of performance, which is typically the research or development term. Research and development funding is recognized as earned, ratably over the period of effort.
Substantive milestones realized in collaboration arrangements are recognized as earned when the corresponding payment is reasonably assured, subject to the following policies in those circumstances where we have obligations remaining after achievement of the milestone:
· In those circumstances where collection of a substantive milestone is reasonably assured, we have remaining obligations to perform under the collaboration arrangements and we have evidence of fair value for our remaining obligations, we consider the milestone payment and the remaining obligations to be separate units of accounting. In these circumstances, we use the residual method under EITF 00-21, Revenue Arrangements with Multiple Deliverables to allocate revenue among the milestones and the remaining obligations.
· In those circumstances where collection of a substantive milestone is reasonably assured, we have remaining obligations to perform under the collaboration arrangement, and we do not have sufficient evidence of fair value for our remaining obligations, we consider the milestone payment and the remaining obligations on the contract as a single unit of accounting. In those circumstances where the collaboration does not require specific deliverables at specific times or at the end of the contract term, but rather our obligations are satisfied over a period of time, substantive milestones are recognized over the period of performance. This typically results in a portion of the milestone payment being recognized as revenue at the date the milestone is achieved equal to the applicable percentage of the performance period that has elapsed as of the date the milestone is achieved, with the balance being deferred and recognized over the remaining period of performance.
We evaluate whether milestones are substantive at the inception of the agreement based on the contingent nature of the milestone, specifically reviewing factors such as the technological risk that must be overcome as well as the level of effort and investment required to achieve the milestone. Milestones that are not considered substantive and do not meet the separation criteria are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance.
Payments received after performance obligations are met completely are recognized when earned.
Royalty revenue is recognized based upon actual and estimated net sales of licensed products in licensed territories as provided by the licensee and is recognized in the period the sales occur. Differences between actual royalty revenues and estimated royalty revenues, which have not historically been significant, are reconciled and adjusted for in the quarter they become known.
Research and Development Costs
All research and development costs, including amounts funded by research and development collaborations, are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities including salaries and benefits; laboratory supplies; contract services, including clinical trial costs; and infrastructure costs, including facilities costs
27
and depreciation. To record clinical trial, contract services and other outside costs, we are required to make estimates of the costs incurred in a given accounting period and record accruals at period-end, because the third party service periods and billing terms do not always coincide with our period-end. We base our estimates on our knowledge of the research and development programs, services performed for the period, past history for related activities and the expected duration of the third party service contract, where applicable.
Altus Investment
Altus Pharmaceuticals, Inc. completed an initial public offering in January 2006. At June 30, 2006, we owned 817,749 shares of Altus common stock and warrants to purchase 1,962,494 shares of Altus common stock. In addition, we hold 450,000 shares of Altus redeemable preferred stock, which are not convertible into common stock and which are redeemable at our option on or after December 31, 2010, or by Altus at any time. We were restricted from trading Altus securities for a period of six months following the initial public offering. The period ended in July 2006.
As a result of the public offering, the common stock is classified as an available-for-sale investment and is recorded at fair value, based on quoted market prices, with unrealized gains and losses included as a component of accumulated other comprehensive income, which is a separate component of stockholders equity, until such gains and losses are realized. At June 30, 2006, the fair market value of the Altus common stock investment was $15.1 million, with a cost value of $4.0 million. In July 2006, we sold the 817,749 shares of common stock for approximately $11.7 million. We expect to record a gain of approximately $7.7 million on this sale in the third quarter of 2006.
We continued to account for the warrants under the cost method of accounting until the end of the restricted trading period in July 2006, after which time the warrants have been classified as derivatives. Gains or losses on the fair market value of the warrants, as derivatives, will be included in the consolidated statements of operations beginning in the third quarter of 2006. We continue to account for the redeemable preferred stock under the cost method of accounting.
We continue to assess the Altus warrants and redeemable preferred stock on a quarterly basis to determine if there has been any estimated decrease in the fair value of that investment below the carrying value that might require us to write down the cost basis of the investment. If any adjustment to the fair value of an investment reflects a decline in the value of that investment below its cost, we consider the evidence available to us, including the duration and extent to which the decline is other-than-temporary. If the decline is considered other-than-temporary, the cost basis of the investment is written down to fair value as a new cost basis and the amount of the write-down is included in the consolidated statements of operations. We have not identified facts or circumstances which would cause us to determine that the investment basis of our interest in Altus should be changed.
Stock-based compensation
We adopted the provisions of Statement of Financial Accounting Standards Board No. 123(R), Share-Based Payments (FAS 123(R)), on January 1, 2006. FAS 123(R) requires us to measure compensation cost of stock-based compensation at the grant date, based on the fair value of the award, and to recognize that cost as an expense over the employees requisite service period (generally the vesting period of the equity award). Prior to January 1, 2006, we accounted for stock-based compensation to employees in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and related interpretations. We also followed the disclosure requirements of Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (FAS 123). We elected to adopt the modified prospective transition method as provided by FAS 123(R) and accordingly, financial statement amounts for the periods prior to January 1, 2006 that are presented in this Form 10-Q have not been restated to reflect the fair value method.
28
Under FAS 123(R), we determine the fair value of awarded stock options and ESPP shares using the Black-Scholes valuation model. The Black-Scholes valuation model requires us to make certain assumptions and estimates concerning our stock price volatility, the rate of return of risk-free investments, the anticipated term of the awards, and our anticipated dividends. In determining the amount of expense to be recorded, judgment is also required to estimate forfeiture rates for awards based on the probability that employees will complete the required service period. If actual forfeitures differ significantly from our estimates, our results could be materially impacted.
Three Months Ended June 30, 2006 Compared with Three Months Ended June 30, 2005
Our net loss for the three months ended June 30, 2006 was $77,658,000, or $0.72 per basic and diluted common share, compared to net loss of $40,988,000, or $0.50 per basic and diluted common share for the three months ended June 30, 2005. Included in the net loss for the quarter ended June 30, 2006 is stock-based compensation expense of $11,647,000 and restructuring expense of $443,000. Included in the net loss for the quarter ended June 30, 2005 is stock-based compensation expense of $1,129,000 and a credit to restructuring expense of $1,743,000. The increase in the net loss is primarily the result of increased development investment related to VX-950 (telaprevir) as well as increased charges for stock-based compensation due to the adoption of FAS 123(R) on January 1, 2006.
Revenues
Total revenues decreased $2,595,000 to $29,726,000 for the three months ended June 30, 2006, compared to $32,321,000 for the three months ended June 30, 2005. In the second quarter of 2006, revenue was comprised of $9,005,000 in royalties and $20,721,000 in collaborative research and development revenue. In the second quarter of 2005, revenue was comprised of $7,467,000 in royalties and $24,854,000 in collaborative research and development revenue.
Royalties consist principally of Lexiva/Telzir royalty revenue, based on actual and estimated worldwide net sales. We began earning royalties on sales of Lexiva in the United States in the fourth quarter of 2003 and on Telzir in the European Union in third quarter of 2004. The increase in royalty revenue is due to an increase in Lexiva/Telzir sales. We pay a royalty to a third party on sales of Lexiva/Telzir.
Collaborative research and development revenue decreased $4,133,000, or 17%, for the three months ended June 30, 2006, as compared with the same period in 2005. This decrease is primarily related to the expiration of our research collaboration with Novartis in April 2006.
With the signing of the VX-950 (telaprevir) collaboration with Janssen, we expect that for the foreseeable future the revenue and funding from collaborations that support our development-stage compounds, including development cost reimbursements and milestones, will provide a proportionately higher level of financial support for the Companys research and development activities than revenue from research collaboration agreements.
Costs and Expenses
Research and development expenses increased $31,893,000, or 54%, to $91,250,000, including $9.8 million of stock-based compensation, for the three months ended June 30, 2006, from $59,357,000, including $0.9 million of stock-based compensation, for the same period in 2005. The increase in research and development expenses was driven primarily by investment in our clinical development programs for VX-950 (telaprevir) and VX-702 as well as an increase in stock-based compensation expense of $8,828,000
29
due to the adoption of FAS 123(R). Development expenses accounted for 79%, or $25,284,000, of the aggregate increase in research and development expenses.
Research and development expenses consist primarily of salary and benefits, laboratory supplies, contractual services and infrastructure costs, including facilities costs and depreciation. Set forth below is a summary that reconciles our total research and development expenses for the three months ended June 30, 2006 and 2005 (in thousands):
|
|
Three Months Ended |
|
|
|
|
|
|||||||
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
|
|||||
Research Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Salary and benefits |
|
$ |
16,136 |
|
$ |
10,066 |
|
$ |
6,070 |
|
|
60 |
% |
|
Laboratory supplies and other direct expenses |
|
5,965 |
|
5,419 |
|
546 |
|
|
10 |
% |
|
|||
Contractual services |
|
1,772 |
|
1,750 |
|
22 |
|
|
1 |
% |
|
|||
Infrastructure costs |
|
12,548 |
|
12,577 |
|
(29 |
) |
|
|
% |
|
|||
Total research expenses |
|
$ |
36,421 |
|
$ |
29,812 |
|
$ |
6,609 |
|
|
|
|
|
Development Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Salary and benefits |
|
$ |
14,292 |
|
$ |
6,330 |
|
$ |
7,962 |
|
|
126 |
% |
|
Laboratory supplies and other direct expenses |
|
4,610 |
|
2,763 |
|
1,847 |
|
|
67 |
% |
|
|||
Contractual services |
|
25,376 |
|
13,844 |
|
11,532 |
|
|
83 |
% |
|
|||
Infrastructure costs |
|
10,551 |
|
6,608 |
|
3,943 |
|
|
60 |
% |
|
|||
Total development expenses |
|
$ |
54,829 |
|
$ |
29,545 |
|
$ |
25,284 |
|
|
|
|
|
Total Research and Development Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Salary and benefits |
|
$ |
30,428 |
|
$ |
16,396 |
|
$ |
14,032 |
|
|
86 |
% |
|
Laboratory supplies and other direct expenses |
|
10,575 |
|
8,182 |
|
2,393 |
|
|
29 |
% |
|
|||
Contractual services |
|
27,148 |
|
15,594 |
|
11,554 |
|
|
74 |
% |
|
|||
Infrastructure costs |
|
23,099 |
|
19,185 |
|
3,914 |
|
|
20 |
% |
|
|||
Total research and development expenses |
|
$ |
91,250 |
|
$ |
59,357 |
|
$ |
31,893 |
|
|
|
|
|
Sales, general and administrative expenses increased to $14,370,000, including $1,892,000 of stock-based compensation, for the three months ended June 30, 2006, compared to $10,814,000, including $202,000 of stock-based compensation, for the same period in 2005. The change is due to an increase in infrastructure costs to support increases in research and development.
Restructuring expense for the three months ended June 30, 2006 was $443,000, compared to a restructuring credit for the three months ended June 30, 2005 of $1,743,000. The charge in the three months ended June 30, 2006 resulted primarily from an imputed interest cost related to the restructuring accrual. The restructuring credit for the three months ended June 30, 2005 resulted from an adjustment of the portion of restructuring accrual relating to the portion of the Kendall Square Facility that we are occupying, offset by (i) a charge in the amount of the estimated incremental net ongoing lease obligation associated with the portion of the Kendall Square Facility that we still do not intend to occupy and (ii) imputed interest costs relating to the restructuring liability.
30
The activity related to the restructuring accrual and related expense for the three months ended June 30, 2006 is as follows (in thousands):
|
|
|
|
Cash |
|
|
|
|
|
|
|
|||||||||||||||
|
|
|
|
payments, |
|
Cash received |
|
Charge, |
|
|
|
|||||||||||||||
|
|
Accrual as of |
|
second |
|
from subleases, |
|
second |
|
Accrual as of |
|
|||||||||||||||
|
|
March 31, |
|
quarter |
|
second quarter |
|
quarter |
|
June 30, |
|
|||||||||||||||
|
|
2006 |
|
2006 |
|
2006 |
|
2006 |
|
2006 |
|
|||||||||||||||
Lease restructuring expense |
|
|
$ |
41,719 |
|
|
|
$ |
(7,904 |
) |
|
|
$ |
2,020 |
|
|
|
$ |
443 |
|
|
|
$ |
36,278 |
|
|
The activity related to the restructuring accrual and related expense for the three months ended June 30, 2005 is as follows (in thousands):
|
|
|
|
|
|
|
|
Portion of |
|
|
|
|
|
||||||||||||||||
|
|
|
|
Cash |
|
|
|
facility |
|
|
|
|
|
||||||||||||||||
|
|
|
|
payments, |
|
Cash received |
|
Vertex expects |
|
Charge, |
|
|
|
||||||||||||||||
|
|
Accrual as of |
|
second |
|
from sublease, |
|
to occupy, |
|
second |
|
|
|
||||||||||||||||
|
|
March 31, |
|
quarter |
|
second quarter |
|
second |
|
quarter |
|
Accrual as of |
|
||||||||||||||||
|
|
2005 |
|
2005 |
|
2005 |
|
quarter 2005 |
|
2005 |
|
June 30, 2005 |
|
||||||||||||||||
Lease restructuring expense |
|
|
$ |
52,305 |
|
|
|
$ |
(7,242 |
) |
|
|
$ |
493 |
|
|
|
$ |
(10,018 |
) |
|
$ |
8,275 |
|
|
$ |
43,813 |
|
|
Interest income increased $1,674,000, or 74%, to $3,921,000 for the three months ended June 30, 2006 from $2,247,000 for the three months ended June 30, 2005. The increase is a result of higher portfolio yields.
Interest expense decreased $2,282,000, or 49%, to $2,357,000 for the three months ended June 30, 2006 from $4,639,000 for the three months ended June 30, 2005. The decrease resulted from reduction of outstanding debt in 2005.
As of June 30, 2006, there was approximately $64,353,000 of unrecognized compensation cost, net of forfeitures, related to stock-based awards granted under the Stock and Option Plans. We expect to recognize that cost over a weighted-average period of 2.72 years.
Six Months Ended June 30, 2006 Compared with Six Months Ended June 30, 2005
Our net loss for the six months ended June 30, 2006 was $127,745,000, or $1.18 per basic and diluted common share, compared to net loss of $85,708,000, or $1.06 per basic and diluted common share for the six months ended June 30, 2005. Included in the net loss for the six months ended June 30, 2006 is stock-based compensation expense of $19,772,000, restructuring expense of $1,210,000 and the effect of a cumulative benefit of accounting change of $1,046,000, related to the adoption of FAS 123(R). Included in the net loss for the six months ended June 30, 2005 is stock-based compensation expense of $2,160,000 and restructuring expense of $171,000.
Revenues
Total revenues increased $7,886,000 to $68,813,000 for the six months ended June 30, 2006, compared to $60,927,000 for the six months ended June 30, 2005. In the first half of 2006, revenue was comprised of $18,184,000 in royalties and $50,629,000 in collaborative research and development revenue. In the first half of 2005, revenue was comprised of $13,620,000 in royalties and $47,307,000 in collaborative research and development revenue.
Collaborative research and development revenue increased $3,322,000, or 7%, in the first half of 2006, as compared with the same period in 2005. This increase primarily relates to milestone payments from Merck upon the initiation of Phase II clinical trials of VX-680, partially offset by reduced research funding under our Novartis collaboration, which expired in April 2006.
31
Costs and Expenses
Research and development expenses increased $49,660,000, or 43%, to $166,452,000, including $16.2 million of stock-based compensation, for the six months ended June 30, 2006 from $116,792,000, including $1.8 million of stock-based compensation, for the same period in 2005. The increase in research and development expenses was driven primarily by investment in our clinical development programs for VX-950 (telaprevir) and VX-702 as well as an increase in stock-based compensation expense of $14,397,000 due to the adoption of FAS 123(R). Development expenses accounted for 74%, or $36,781,000, of the aggregate increase in research and development expenses.
Research and development expenses consist primarily of salary and benefits, laboratory supplies, contractual services and infrastructure costs, including facilities costs and depreciation. Set forth below is a summary that reconciles our total research and development expenses for the six months ended June 30, 2006 and 2005 (in thousands):
|
|
Six Months Ended |
|
|
|
|
|
|||||||
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
|
|||||
Research Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Salary and benefits |
|
$ |
30,843 |
|
$ |
20,143 |
|
$ |
10,700 |
|
|
53 |
% |
|
Laboratory supplies and other direct expenses |
|
11,866 |
|
11,012 |
|
854 |
|
|
8 |
% |
|
|||
Contractual services |
|
3,581 |
|
3,511 |
|
70 |
|
|
2 |
% |
|
|||
Infrastructure costs |
|
26,403 |
|
25,148 |
|
1,255 |
|
|
5 |
% |
|
|||
Total research expenses |
|
$ |
72,693 |
|
$ |
59,814 |
|
$ |
12,879 |
|
|
|
|
|
Development Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Salary and benefits |
|
$ |
26,080 |
|
$ |
12,589 |
|
$ |
13,491 |
|
|
107 |
% |
|
Laboratory supplies and other direct expenses |
|
8,445 |
|
4,829 |
|
3,616 |
|
|
75 |
% |
|
|||
Contractual services |
|
41,035 |
|
26,743 |
|
14,292 |
|
|
53 |
% |
|
|||
Infrastructure costs |
|
18,199 |
|
12,817 |
|
5,382 |
|
|
42 |
% |
|
|||
Total development expenses |
|
$ |
93,759 |
|
$ |
56,978 |
|
$ |
36,781 |
|
|
|
|
|
Total Research and Development Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Salary and benefits |
|
$ |
56,923 |
|
$ |
32,732 |
|
$ |
24,191 |
|
|
74 |
% |
|
Laboratory supplies and other direct expenses |
|
20,311 |
|
15,841 |
|
4,470 |
|
|
28 |
% |
|
|||
Contractual services |
|
44,616 |
|
30,254 |
|
14,362 |
|
|
47 |
% |
|
|||
Infrastructure costs |
|
44,602 |
|
37,965 |
|
6,637 |
|
|
17 |
% |
|
|||
Total research and development expenses |
|
$ |
166,452 |
|
$ |
116,792 |
|
$ |
49,660 |
|
|
|
|
|
Sales, general and administrative expenses increased to $27,249,000, including $3,611,000 of stock-based compensation, for the six months ended June 30, 2006, compared to $20,441,000, including $396,000 of stock-based compensation, for the same period in 2005. The change is due to an increase in infrastructure costs to support the growing research and development effort.
Restructuring expense for the six months ended June 30, 2006 was $1,210,000, compared to a restructuring expense for the six months ended June 30, 2005 of $171,000. The charge in the six months ended June 30, 2006 resulted primarily from an imputed interest cost related to the restructuring accrual. The expense for the six months ended June 30, 2005 includes an adjustment of the portion of restructuring relating to the portion of the Kendall Square Facility that we expect to occupy, offset by (i) a charge in the amount of the estimated incremental net ongoing lease obligation associated with the portion of the Kendall Square Facility that we still do not intend to occupy and (ii) imputed interest costs relating to the restructuring liability.
32
The activity related to the restructuring accrual and related expense for the six months ended June 30, 2006 is as follows (in thousands):
|
|
|
|
Cash, |
|
Cash received |
|
Charge |
|
|
|
||||||||||||||
|
|
|
|
payments |
|
from subleases, |
|
six months |
|
|
|
||||||||||||||
|
|
Accrual as of |
|
six months |
|
six months |
|
ended |
|
Accrual as of |
|
||||||||||||||
|
|
Dec. 31, |
|
ended June 30, |
|
ended June 30, |
|
June 30, |
|
June 30, |
|
||||||||||||||
|
|
2005 |
|
2006 |
|
2006 |
|
2006 |
|
2006 |
|
||||||||||||||
Lease restructuring expense |
|
|
$ |
42,982 |
|
|
|
$ |
(11,884 |
) |
|
|
$ |
3,970 |
|
|
|
1,210 |
|
|
|
$ |
36,278 |
|
|
The activity related to the restructuring accrual and related expense for the six months ended June 30, 2005 is as follows (in thousands):
|
|
|
|
Cash |
|
Cash received |
|
Portion of |
|
|
|
|
|
||||||||||||||||||
|
|
|
|
payments, |
|
from sublease, |
|
Vertex |
|
Charge, |
|
|
|
||||||||||||||||||
|
|
|
|
six months |
|
six months |
|
expects |
|
Six months |
|
|
|
||||||||||||||||||
|
|
Accrual as of |
|
ended |
|
ended |
|
to occupy, |
|
ended |
|
Accrual as of |
|
||||||||||||||||||
|
|
December 31, |
|
June 30, |
|
June 30, |
|
six months ended |
|
June 30, |
|
June 30, |
|
||||||||||||||||||
|
|
2004 |
|
2005 |
|
2005 |
|
June 30, 2005 |
|
2005 |
|
2005 |
|
||||||||||||||||||
Lease
restructuring |
|
|
$ |
55,843 |
|
|
|
$ |
(13,017 |
) |
|
|
$ |
816 |
|
|
|
$ |
(10,018 |
) |
|
|
$ |
10,189 |
|
|
|
$ |
43,813 |
|
|
Interest income increased $3,335,000, or 73%, to $7,901,000 for the six months ended June 30, 2006 from $4,566,000 for the six months ended June 30, 2005. The increase is a result of higher portfolio yields.
Interest expense decreased $4,564,000, or 49%, to $4,714,000 for the six months ended June 30, 2006 from $9,278,000 for the six months ended June 30, 2005. The decrease resulted from our reduction of outstanding debt in 2005.
Pursuant to the adoption of FAS 123(R), stock-based compensation expense is recognized over the service period, including an estimate of awards that will be forfeited. Previously, we recorded the impact of forfeitures as they occurred. In connection with the adoption of FAS 123(R) during the first half of fiscal year 2006, we recorded a $1,046,000 benefit from the cumulative effect of changing from recording forfeitures related to restricted stock awards as they occurred to estimating forfeitures during the service period.
In May 2005, the FASB issued FAS No. 154, Accounting Changes and Error Corrections (FAS 154). FAS No. 154 replaces APB Opinion No. 20, Accounting Changes and FAS No. 3, Reporting Accounting Changes in Interim Financial Statements. FAS No. 154 requires retrospective application to prior periods financial statements of changes in accounting principle, unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change. We adopted FAS 154 beginning on January 1, 2006; its adoption did not have a material impact on our consolidated financial statements.
In November 2005, FASB issued FSP FAS 115-1 and FAS 124-1, The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments (FSP FAS 115-1), which provides guidance on determining when investments in certain debt and equity securities are considered impaired, whether an impairment is other-than-temporary, and on measuring such impairment loss. FSP FAS 115-1 also includes accounting considerations subsequent to the recognition of an other-than-temporary impairment and requires certain disclosures about unrealized losses that have not been recognized as other-than-temporary impairments. FSP FAS 115-1 is required to be applied to reporting periods beginning after December 15, 2005. We adopted FSP FAS 115-1 in the first quarter of 2006. Adoption of
33
FSP FAS 115-1 did not have a material impact on our consolidated results of operations or financial condition.
Our disclosure in this Quarterly Report on Form 10-Q contains forward-looking statements. Forward-looking statements give our current expectations or present forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as anticipate, estimate, expect, project, intend, plan, believe and other words and phrases of similar meaning in connection with any discussion of future operating or financial performance. In particular, these statements include forward-looking statements about our business, including our expectations that:
· we will incur a substantial loss for the year ending December 31, 2006;
· the estimates and assumptions used in determining the value of stock-based compensation under FAS 123(R), including assumptions relating to future stock volatility, award forfeiture rates and employee behavior, will prove accurate;
· the estimates and assumptions used in evaluating the future obligations arising from the Kendall Square lease, including assumptions relating the costs to be incurred to satisfy our buildout requirements under the lease, the time necessary to sublease the space, projected sublease rental rates and the duration of future subleases, will prove accurate;
· we will rely on collaborators to develop and commercialize certain of our drug candidates either worldwide or in markets upon which we are not currently focused;
· the timing of our drug development activities will be as set forth in this Quarterly Report;
· we may choose to develop some of our drug candidates with or through a collaborator, as we maintain focus on our core product candidates;
· we may seek collaborators for our research programs;
· our increased clinical investment will be as a result of our investment in our core programs;
· we will continue to evaluate and prioritize investment in our clinical development programs based on the emergence of new clinical and nonclinical data in each program in 2006 and in subsequent years;
· we will further increase our investment in VX-950 (telaprevir) to support the global Phase IIb development program;
· we will continue to incur significant manufacturing costs for VX-950 (telaprevir) drug product in quantities to support a timely commercial launch;
· our timelines for development and commercialization of VX-950 (telaprevir) will be as we have projected;
· PROVE 1 and PROVE 2 together will evaluate sustained viral response (SVR) rates in 580 treatment naïve patients infected with genotype 1 HCV;
· we will begin additional clinical trials of VX-950 (telaprevir) in approximately 400 patients in the second half of the year, including a Phase IIb study in patients who failed prior standard of care treatment;
· by the end of the first quarter of 2007, we will have enrolled approximately 1,000 patients in clinical trials of VX-950 (telaprevir);
· we will initiate a Phase II clinical trial of VX-702 on a background of methotrexate in patients with RA in 2007;
34
· we will evaluate multiple doses of VX-770 in healthy volunteers and assess single doses of VX-770 in patients with CF;
· GSK will initiate a Phase III clinical trial of brecanavir in 2007;
· our net loss on a GAAP basis for 2006 will be in the range of $222 million to $237 million, including an estimated $38 million in stock-based compensation expense and an estimated $4 million of restructuring expense;
· our 2006 revenue will be in the range of $210 to $235 million;
· our SG&A expense will be in the range of $55 to $60 million for 2006, including approximately $6 million of stock-based compensation expense;
· our R&D expense in 2006 will be in the range of $375 million to $395 million, including approximately $31 million of stock-based compensation expense;
· our cash, cash equivalents and available-for-sale securities at the end of 2006 will be in excess of $400 million;
· we will incur a non-cash charge of approximately $5.0 million related to the August 2006 debt exchange in the third quarter of 2006;
· we will record a gain of approximately $7.7 million on the sale of Altus common stock in the third quarter of 2006;
· we will continue to make significant investments in our pipeline, particularly in clinical trials for certain of our product candidates, in our ion channel and kinase discovery efforts and in our effort to prepare for potential registration, regulatory approval and commercial launch of our existing and future product candidates;
· we will incur losses on a quarterly and annual basis for the foreseeable future;
· for the foreseeable future, revenue and funding from collaborations that support our development-stage compounds will provide a proportionately higher level of financial support for the Companys research and development activities than revenue and funding from research collaborations;
· we will continue pursuing a general financial strategy that may lead us to undertake one or more additional capital transactions, which may or may not be similar to transactions in which we have engaged in the past; and
· we will continue to manage our capital structure and consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile.
Any or all of our forward-looking statements in this Quarterly Report may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Many factors mentioned in our discussion in this Quarterly Report will be important in determining future results. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause our actual results to vary materially. These risks and uncertainties include, among other things, the risk that (1) any one or more of our internal drug development programs or our development programs with collaborators will not proceed as planned for technical, scientific or commercial reasons, due to U.S. Food and Drug Administration disagreement on trial designs, due to patient enrollment issues, due to manufacturing delay or due to judgments based on new information from non-clinical studies or clinical trials or from other sources, (2) one or more of our assumptions underlying our revenue expectations or our expense expectations will not be realized, (3) we will be unable to realize one or more of our financial objectives for 2006 due to unexpected and costly program delays (including delays due to regulatory action or lack of action) or any number of other financial, technical or collaboration considerations, (4) unexpected costs associated with one or more of
35
our programs will necessitate a reduction in our investment in other programs or a change in our financial projections, (5) future competitive or other market factors may adversely impact the commercial potential for our product candidates in HCV and inflammation and other areas, (6) due to scientific, medical or technical developments, our drug discovery efforts will not ultimately result in commercial products or assets that can generate revenue, (7) we will be unable to enter into new collaborative relationships to support our research and development programs on acceptable terms, or at all, (8) the key estimates and assumptions underlying our forward-looking statements will turn out to be incorrect or not reflective of changing scientific knowledge or business conditions in the future, as well as other risks set forth under the heading Risk Factors appearing in Item 1A of our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 16, 2006 and updated on this Quarterly Report on Form 10-Q, which are factors that we think could cause our actual results to differ materially from expected results. Other factors besides those listed there could also adversely affect us. Consequently, no forward-looking statement can be guaranteed. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As part of our investment portfolio, we own financial instruments that are sensitive to market risks. The investment portfolio is used to preserve our capital until it is required to fund operations, including our research and development activities. None of these market risk sensitive instruments are held for trading purposes. As of June 30, 2006, there were no derivative financial instruments in our investment portfolio.
Interest Rate Risk
We invest our cash in a variety of financial instruments, principally securities issued by the U.S. government and its agencies, investment grade corporate bonds and notes and money market instruments. These investments are denominated in U.S. dollars. All of our interest-bearing securities are subject to interest rate risk, and could decline in value if interest rates fluctuate. Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help ensure portfolio liquidity, and we have implemented guidelines limiting the term to maturity of our investment instruments. Due to the conservative nature of these instruments, we do not believe that we have a material exposure to interest rate risk.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Companys chief executive officer and chief financial officer, after evaluating the effectiveness of the Companys disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, at the end of the period covered by this report, our disclosure controls and procedures were effective and designed to provide reasonable assurance that the information required to be disclosed is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms. These procedures and controls include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Companys management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our Companys management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
36
Changes in Internal Controls Over Financial Reporting
No change in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) occurred during the second fiscal quarter, ended June 30, 2006, that has affected, or is reasonably likely to affect, our internal control over financial reporting.
37
We depend on our collaborators to work with us to develop, manufacture and commercialize many of our drug candidates.
We are currently focusing our development activities on three drug candidates, VX-950 (telaprevir), VX-702, and VX-770. We have granted development and commercialization rights to VX-950 (telaprevir) to Mitsubishi Pharma Corp. (Far East) and to Janssen Pharmaceutica, N.V. (rest of world other than North America and Far East). The success of our collaborations depends on the efforts and activities of our collaborators. We also have granted Far East rights to VX-702 to our collaborator Kissei Pharmaceuticals. For some compounds on which we are not currently focusing our development efforts, we have granted worldwide rights to a collaborator, such as our VX-680 collaboration with Merck and Co., Inc., our Lexiva/Telzir, brecanavir and VX-409 collaborations with GlaxoSmithKline and our VX-944 collaboration with Avalon Pharmaceuticals.
We expect to receive significant financial support under our Janssen collaboration agreement, as well as meaningful technical and manufacturing contributions to the VX-950 (telaprevir) program. The success of our global collaborations depends on the efforts and activities of our collaborators. Similarly, the success of our key in-house programs, such as for VX-950 (telaprevir) and VX-702, is dependent upon the continued financial and other support that our collaborators have agreed to provide. Each of our collaborators has significant discretion in determining the efforts and resources that it will apply to the collaboration. Our existing and any future collaborations may not be scientifically or commercially successful.
The risks that we face in connection with these existing and any future collaborations include the following:
· Our collaboration agreements are subject to termination under various circumstances, including, as in the case of our agreement with Janssen, termination without cause. Any such termination could delay the development and commercial sale of our drug candidates, including VX-950 (telaprevir).
· Our collaborators may change the focus of their development and commercialization efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their development and commercialization priorities following mergers and consolidations, which have been common in recent years in these industries. The ability of some of our product candidates to reach their potential could be limited if our collaborators decrease or fail to increase development or commercialization efforts related to those products.
· Our collaboration agreements may have the effect of limiting the areas of research and development that we may pursue, either alone or in collaboration with third parties.
· Our collaborators may develop and commercialize, either alone or with others, products that are similar to or competitive with the products that are the subject of the collaboration with us.
For additional risk factors relating to the Company and its business, see Item 1A of our 2005 Annual Report on Form 10-K, which was filed with the Commission on March 16, 2006.
38
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
(c) The table set forth below shows all repurchases of securities by the Company during the three months ended June 30, 2006:
Period |
|
|
|
Total Number |
|
Average Price |
|
Total Number of Shares |
|
Maximum Number of |
|
|||||||||
April 1, 2006 to April 30, 2006 |
|
|
3,070 |
|
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
||
May 1, 2006 to May 31, 2006 |
|
|
9,863 |
|
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
||
June 1, 2006 to June 30, 2006 |
|
|
10,497 |
|
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
(1) Under the terms of the Companys 1996 Stock and Option Plan and 2006 Stock and Option Plan, the Company may award shares of restricted stock to its employees and consultants. These shares of restricted stock typically are subject to a lapsing right of repurchase on the part of the Company. The Company may exercise this right of repurchase in the event that a restricted stock recipients service to the Company is terminated. If the Company exercises this right, it is required to repay the purchase price paid by or on behalf of the recipient for the repurchased restricted shares, which typically is the par value per share of $0.01. Repurchased shares are returned to the applicable Stock and Option Plan under which they were issued. Shares returned to the 2006 Stock and Option Plan are available for future awards under the terms of that plan.
Item 4. Submission of Matters to a Vote of Security Holders
The Companys annual meeting of stockholders was held on May 11, 2006.
The stockholders elected Mr. Eric K. Brandt, Mr. Bruce I. Sachs and Dr. Eve E. Slater to serve on the Board of Directors until the annual meeting of stockholders to be held in 2009. The tabulation of votes with respect to the election of such directors is as follows:
|
|
For |
|
Withheld |
|
Eric K. Brandt |
|
88,536,811 |
|
1,731,254 |
|
Bruce I. Sachs |
|
82,425,075 |
|
7,842,991 |
|
Eve E. Slater |
|
89,937,730 |
|
330,336 |
|
Following the meeting, the Companys Board of Directors consists of Charles A. Sanders (Chairman), Joshua S. Boger, Eric K. Brandt, Roger W. Brimblecombe, Stuart J.M. Collinson, Eugene Cordes, Matthew W. Emmens, Bruce I. Sachs, Eve E. Slater and Elaine S. Ullian.
In addition, the stockholders approved the adoption of the Companys 2006 Stock and Option Plan at the annual meeting. The tabulation of votes with respect to the adoption of the 2006 Stock and Option Plan is as follows:
For |
|
Against |
|
Abstain |
|
47,050,901 |
|
25,806,926 |
|
62,757 |
|
39
Exhibit No. |
|
Description |
10.1 |
|
License, Development, Manufacturing and Commercialization Agreement, dated June 30, 2006, by and between Vertex Pharmaceuticals Incorporated and Janssen Pharmaceutica, N.V. |
10.2 |
|
Letter Agreement, dated June 26, 2006, by and between Merck & Co., Inc. and Vertex Pharmaceuticals Incorporated. |
31.1 |
|
Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 |
|
Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 |
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
Confidential portions of this document have been filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.
40
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.
August 9, 2006 |
VERTEX PHARMACEUTICALS INCORPORATED |
|
|
By: |
/s/ IAN F. SMITH |
|
|
Ian F. Smith |
|
|
Executive Vice President and Chief Financial Officer |
|
|
(principal financial officer and duly authorized officer) |
41
Exhibit Index
Exhibit No. |
|
Description |
10.1 |
|
License, Development, Manufacturing and Commercialization Agreement, dated June 30, 2006, by and between Vertex Pharmaceuticals Incorporated and Janssen Pharmaceutica, N.V. |
10.2 |
|
Letter Agreement, dated June 26, 2006, by and between Merck & Co., Inc. and Vertex Pharmaceuticals Incorporated. |
31.1 |
|
Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 |
|
Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 |
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
Confidential portions of this document have been filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.
42
Exhibit 10.1
Execution Copy
Confidential Treatment Requested. Confidential portions of this document have been redacted
and have been separately filed with the Commission.
LICENSE, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION AGREEMENT
by and between
Vertex Pharmaceuticals Incorporated
and
Janssen Pharmaceutica, N.V.
CONFIDENTIAL TREATMENT REQUESTED
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
TABLE OF CONTENTS
|
|
|
Article 1 |
Definitions |
|
1.1 |
Intentionally Left Blank |
1 |
1.2 |
Additional Development Activities |
1 |
1.3 |
Affiliate |
1 |
1.4 |
API |
1 |
1.5 |
[***] |
1 |
1.6 |
Business Day |
1 |
1.7 |
Calendar Quarter |
2 |
1.8 |
Calendar Year |
2 |
1.9 |
Change of Control |
2 |
1.10 |
Clinical Trial |
2 |
1.11 |
Code |
2 |
1.12 |
Combination Product |
2 |
1.13 |
Commercialization or Commercialize |
2 |
1.14 |
Committees |
3 |
1.15 |
(Intentionally left blank) |
3 |
1.16 |
Compound |
3 |
1.17 |
Control or Controlled by |
3 |
1.18 |
Desired Label |
3 |
1.19 |
Development or Develop |
3 |
1.20 |
Development Program |
3 |
1.21 |
[***] |
3 |
1.22 |
[***] |
3 |
1.23 |
Diligent Efforts |
3 |
1.24 |
Effective Date |
3 |
1.25 |
EMEA |
4 |
1.26 |
European Union or EU |
4 |
1.27 |
Excluded Claim |
4 |
1.28 |
Excluded Territory |
4 |
1.29 |
Exclusivity Period |
4 |
1.30 |
Executive Officers |
4 |
1.31 |
Existing Third Party Agreements |
4 |
1.32 |
Far East |
4 |
1.33 |
FDA |
4 |
1.34 |
Field |
4 |
1.35 |
First Commercial Sale |
4 |
1.36 |
FTE |
4 |
1.37 |
FTE Rate |
4 |
1.38 |
GAAP |
5 |
1.39 |
Generic Version |
5 |
1.40 |
Global Development Costs |
5 |
1.41 |
Global Development Plan or GDP |
5 |
1.42 |
Good Clinical Practice or GCP |
6 |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
i
1.43 |
Good Laboratory Practice or GLP |
6 |
1.44 |
Good Manufacturing Practice or GMP |
6 |
1.45 |
HCV Infection |
6 |
1.46 |
Improvement |
6 |
1.47 |
IND |
6 |
1.48 |
Indemnitee |
6 |
1.49 |
Indemnitor |
6 |
1.50 |
Information |
6 |
1.51 |
Initiation |
7 |
1.52 |
Invention |
7 |
1.53 |
Investigator-Initiated Clinical Study |
7 |
1.54 |
Janssen Know-How |
7 |
1.55 |
Janssen Patent Rights |
7 |
1.56 |
Joint Commercialization Committee and JCC |
7 |
1.57 |
Joint Development Committee and JDC |
8 |
1.58 |
Joint Information and Inventions |
8 |
1.59 |
Joint Manufacturing Committee and JMC |
8 |
1.60 |
Joint Patent Rights |
8 |
1.61 |
Joint Philanthropic Committee and JPC |
8 |
1.62 |
Joint Steering Committee and JSC |
8 |
1.63 |
Key Country |
8 |
1.64 |
Key Opinion Leaders or KOLs |
8 |
1.65 |
MAA |
8 |
1.66 |
Major Market Countries |
8 |
1.67 |
Manufacturing or Manufacture |
8 |
1.68 |
Manufacturing Cost |
9 |
1.69 |
(Intentionally left blank) |
9 |
1.70 |
Marketing Authorization |
9 |
1.71 |
Material Adverse Effect |
9 |
1.72 |
Medical Science Liaisons or MSL |
9 |
1.73 |
Milestone Event |
9 |
1.74 |
Milestone Payment |
9 |
1.75 |
NDA |
9 |
1.76 |
[***] |
9 |
1.77 |
Net Sales |
9 |
1.78 |
Non-Incurred Amount |
11 |
1.79 |
Non-Publishing Party |
11 |
1.80 |
[***] |
11 |
1.81 |
North America |
11 |
1.82 |
[***] |
11 |
1.83 |
Packaging |
11 |
1.84 |
Packaging Regulatory Approval |
11 |
1.85 |
Party |
11 |
1.86 |
Patent Costs |
11 |
1.87 |
Permitted Sublicensee |
12 |
1.88 |
Person |
12 |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
ii
1.89 |
Phase I Clinical Trial |
12 |
1.90 |
Phase II Clinical Trial |
12 |
1.91 |
Phase III Clinical Trial |
12 |
1.92 |
Phase IV Clinical Trial |
12 |
1.93 |
Philanthropic Funds |
12 |
1.94 |
Pivotal Clinical Trial |
12 |
1.95 |
Primary Detail |
13 |
1.96 |
Product |
13 |
1.97 |
Product Candidate |
13 |
1.98 |
Publishing Party |
13 |
1.99 |
Regulatory Approval |
13 |
1.100 |
Regulatory Authority |
13 |
1.101 |
Related Party |
13 |
1.102 |
Results |
13 |
1.103 |
Sales Call |
13 |
1.104 |
Sales Representative |
13 |
1.105 |
Specifications |
14 |
1.106 |
Supply Agreement |
14 |
1.107 |
Tablet |
14 |
1.108 |
Territory |
14 |
1.109 |
Territory Product Materials |
14 |
1.110 |
Third Party |
14 |
1.111 |
Third Party Product |
14 |
1.112 |
Trademark |
14 |
1.113 |
U.S. and United States and United States of America |
14 |
1.114 |
Valid Patent Claim |
14 |
1.115 |
Vertex Know-How |
14 |
1.116 |
Vertex Patent Rights |
14 |
1.117 |
VX-950 |
15 |
|
|
|
Article 2 |
Collaboration Scope and Governance |
15 |
2.1 |
Purposes of the Collaboration |
15 |
2.2 |
Joint Steering Committee |
15 |
2.3 |
Committee Governance |
16 |
2.4 |
Alliance Managers |
17 |
|
|
|
Article 3 |
Global Development of Product Candidate |
17 |
3.1 |
Current Status |
17 |
3.2 |
Development Program |
17 |
3.3 |
Joint Development Committee |
18 |
3.4 |
Global Development Plan |
18 |
3.5 |
Additional Development Activities |
19 |
3.6 |
Development Efforts; Manner of Performance; Reports |
20 |
3.7 |
Regulatory Submissions and Regulatory Approvals |
21 |
|
|
|
Article 4 |
Manufacture and Supply |
23 |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
iii
4.1. |
General Background |
23 |
4.2 |
Joint Manufacturing Committee |
24 |
4.3 |
Manufacturing Director |
24 |
4.4 |
Initial Forecast |
24 |
4.5 |
Supply of Product |
24 |
4.6 |
Packaging |
26 |
4.7 |
Support for Establishment of Supply Capabilities |
26 |
|
|
|
Article 5 |
Commercialization in the Territory |
27 |
5.1 |
Janssen Commercialization Efforts. |
27 |
5.2 |
Joint Commercialization Committee |
27 |
5.3 |
Commercialization Plans |
28 |
5.4 |
Scientific Meetings; [***] |
29 |
5.5 |
Advertising and Promotional Materials |
29 |
5.6 |
Referral of Orders; Returns |
30 |
5.7 |
Adverse Event and Product Complaint Reporting Procedures |
30 |
5.8 |
Commercial Information |
31 |
5.9 |
[***] |
31 |
5.10 |
Recalls, Market Withdrawals or Corrective Actions |
31 |
5.11 |
Medical Inquiries |
32 |
|
|
|
Article 6 |
Philanthropic Program |
32 |
|
|
|
Article 7 |
License Grants |
33 |
7.1 |
Development License |
33 |
7.2 |
Commercialization License |
33 |
7.3 |
Know-How License |
33 |
7.4 |
Licenses from Janssen |
34 |
7.5 |
Manufacturing License |
34 |
7.6 |
License of Trademarks |
34 |
7.7 |
Right to Sublicense |
34 |
7.8 |
Vertex Retained Rights |
35 |
7.9 |
No Implied Licenses |
35 |
7.10 |
[***] |
35 |
7.11 |
[***] |
35 |
|
|
|
Article 8 |
(Intentionally left blank) |
36 |
|
|
|
Article 9 |
Financial Provisions |
36 |
9.1 |
Upfront License Fee |
36 |
9.2 |
Milestones |
36 |
9.3 |
Development Cost Reimbursement |
37 |
9.4 |
Royalties |
38 |
9.5 |
Third Party Licenses |
40 |
9.6 |
Reports; Payment of Royalty |
40 |
9.7 |
Audits |
41 |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
iv
9.8 |
Payments |
41 |
9.9 |
Income Tax Withholding |
42 |
9.10 |
Interest Penalty |
42 |
9.11 |
[***] |
42 |
|
|
|
Article 10 |
Intellectual Property Ownership, Protection and Related Matters |
42 |
10.1 |
Filing, Prosecution and Maintenance of Vertex Patent Rights |
42 |
10.2 |
Filing, Prosecution and Maintenance of Joint Patent Rights |
43 |
10.3 |
Option to Prosecute and Maintain Patents |
43 |
10.4 |
Interference, Opposition, Re-examination and Re-issue |
44 |
10.5 |
Enforcement and Defense |
44 |
10.6 |
Patent Term Restoration |
46 |
10.7 |
Third Party Claims |
46 |
10.8 |
Trademarks |
47 |
|
|
|
Article 11 |
Confidentiality, Publication and Publicity |
47 |
11.1 |
Nondisclosure Obligation |
47 |
11.2 |
Employee, Consultant and Advisor Obligations |
48 |
11.3 |
Publication |
49 |
11.4 |
Publicity/Use of Names |
50 |
|
|
|
Article 12 |
Representations and Warranties: Indemnification |
50 |
12.1 |
Representations and Warranties of Vertex |
50 |
12.2 |
Representations and Warranties of Janssen |
52 |
12.3 |
Indemnification |
53 |
|
|
|
Article 13 |
Term and Termination |
54 |
13.1 |
Term and Expiration |
54 |
13.2 |
Termination by Janssen Without Cause |
54 |
13.3 |
Termination for Cause |
55 |
13.4 |
Effect on License of Termination by Janssen for Cause |
55 |
13.5 |
Effect of Termination by Vertex for Cause or by Janssen Without Cause |
56 |
13.6 |
[***] |
58 |
13.7 |
Survival |
58 |
13.8 |
Non-exclusive Remedies |
59 |
|
|
|
Article 14 |
Governing Law and Dispute Resolution |
59 |
14.1 |
Governing Law |
59 |
14.2 |
Referral to Executive Officers |
59 |
14.3 |
Final Decision-Making Authority |
59 |
14.4 |
Decision to Terminate or Suspend a Study Based on Safety Concerns |
60 |
14.5 |
Dispute Resolution |
60 |
|
|
|
Article 15 |
Miscellaneous |
63 |
15.1 |
Force Majeure |
63 |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
v
15.2 |
Assignment |
63 |
15.3 |
Severability |
64 |
15.4 |
Notices |
64 |
15.5 |
Entire Agreement; Amendments |
65 |
15.6 |
Headings |
65 |
15.7 |
Independent Contractors |
65 |
15.8 |
Waiver |
65 |
15.9 |
Cumulative Remedies |
65 |
15.10 |
Waiver of Rule of Construction |
65 |
15.11 |
Certain Conventions |
66 |
15.12 |
Counterparts |
66 |
15.13 |
Performance by Affiliates |
66 |
15.14 |
Standstill |
66 |
15.15 |
Export Controls |
67 |
Schedules |
|
Schedule 1.7 |
Janssen Universal Calendar |
Schedule 1.19 |
[***] |
Schedule 1.31 |
Existing Third Party Agreements |
Schedule 1.32 |
Far East |
Schedule 1.55 |
Janssen Patent Rights |
Schedule 1.116 |
Vertex Patent Rights |
Schedule 1.117 |
VX-950 |
[***] |
|
Exhibits |
|
|
|
Exhibit 4.5(a) |
Supply Agreement Key Elements |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
vi
License, Development, Manufacturing and Commercialization Agreement
This License, Development, Manufacturing and Commercialization Agreement (this Agreement) is effective as of June 30, 2006 (the Effective Date) and is entered into by and between Vertex Pharmaceuticals Incorporated, a Massachusetts corporation with corporate offices at 130 Waverly Street, Cambridge, MA 02139-4242, United States of America (Vertex) and Janssen Pharmaceutica, N.V., a Belgium corporation with corporate offices at 30, Turnhoutsesteenweg, B-2340 Beerse, Belgium (Janssen).
Background
WHEREAS, Vertex is developing VX-950, a novel inhibitor of the NS3/4A hepatitis C viral protease, under a global development plan; and
WHEREAS, Vertex and Janssen would like Janssen to assist in the development of, and to commercialize, VX-950 in the Territory (as defined below).
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
2
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
3
[***]
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
4
[***]
[***]
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
5
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
6
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
7
(i) customary transportation charges relating to the Product, including handling charges and insurance premiums relating thereto;
(ii) sales taxes, excise taxes and duties paid by and not refunded to the selling party and directly related to sale of the Product, and any other equivalent governmental charges imposed upon the importation, use or sale of the Product, but excluding income and similar taxes;
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
8
(iii) government-mandated rebates;
(iv) customary trade, quantity and prompt payment discounts allowed on the Product;
(v) allowances or credits to customers on account of retrospective price reductions affecting the Product; and
(vi) customary Product rebates and Product wholesaler charge-backs including those customarily granted to managed care entities
(vii) [***]
[***]
For the purposes of determining royalty rates and the royalties payable on Combination Products, Net Sales of a Product shall be calculated as follows: [***]
For purposes of clarity, no permitted deduction to Net Sales will be counted more than once or, with the exception of [***], adjusted more than [***] following the calculation of Net Sales for a given month.
Solely for the purposes of this Section 1.77, a Related Party of Janssen or of any of its Affiliates shall include a distributor acting as an actual or constructive sublicensee of rights granted hereunder with respect to sales of a Product in a particular country in the Territory, as evidenced by the fact that the distributor holds (A) sales and distribution rights for the Product in that country, coupled with (B) pricing authority or government pricing negotiation authority with respect to wholesalers or sub-distributors in that country.
If Janssen or any of its Related Parties makes any transfer of a Product to a Third Party as part of a multiproduct transaction, Net Sales of each unit of the Product transferred will be determined on a country-by-country basis, and will be equal to [***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
9
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
10
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
11
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
12
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
13
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
14
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
15
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
16
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
17
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
18
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
19
(a) Clinical. Vertex will be responsible for providing Product Candidate supply under the Global Development Plan and, subject to availability, for Additional Development Activities pursuant to the provisions of Section 3.6.4.
(b) Commercial. The Parties intend that (i) Janssen will be responsible for the Manufacture of Product for Commercialization in the Territory including but not limited to Intermediates, API, and Product, and (ii) Vertex will be responsible for the Manufacture of Product for Commercialization outside the Territory, provided that Janssen will, as a secondary source for Vertex, also be responsible for the Manufacture of Product for Commercialization by Vertex outside the Territory as described in Section 4.5(d).
(c) Technical Transfer. Accordingly, the Parties will commence technical transfer activities [***] with the goal of enabling Janssen to supply Product for Commercialization in the Territory at Product launch and, as soon as practicable, to serve as a secondary source for Product for Commercialization outside the Territory as described in Section 4.5(d). In the event the Joint Manufacturing Committee determines that Janssens progress under the Technical Transfer Plan (as defined in Section 4.5(b)) [***] Vertex shall [***] to supply Product to Janssen in accordance with the terms of the Supply Agreement (as defined in Section 4.5(a)).
(d) [***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
20
(a) Supply Agreement. Within [***] of the Effective Date, Janssen and Vertex will negotiate [***], and separately enter into a supply agreement for the supply by Vertex, [***], of Janssens requirements of Product for distribution and sale in the Territory (the Supply Agreement). The Supply Agreement shall include the Supply Agreement Key Elements attached hereto as Exhibit 4.5(a) and such customary representations, warranties, covenants and conditions as are necessary or appropriate for transactions of this type, not inconsistent with the terms and conditions hereof; [***] Vertex will supply Product to Janssen [***] In the event Regulatory Authorities in the Territory require different specifications, [***]
(b) Technical Transfer to Janssen. Within [***] Janssen will propose to the JMC a plan for establishing manufacturing capabilities necessary for Janssen to manufacture the Product for the Territory and for use outside the Territory as a secondary source for Vertex (the Technical Transfer Plan). Following approval of the Technical Transfer Plan by the JMC, Janssen will commence and use Diligent Efforts to perform technical transfer activities and achieve its supply and secondary source obligations in accordance with such plan, the capacity expectations described in section 4.5(d) below and any applicable supply agreement. Janssen will provide Vertex with all documentation that is required and useful to effect regulatory filings necessary for regulatory approval of secondary source manufacturing facilities. Vertex will assist with such technical transfer by providing both technical documentation and FTE resources as may be reasonably requested to inform Janssen about the manufacturing process, subject to the understanding that Vertex will provide [***] at the initiation of the
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
21
technical transfer for each discrete aspect of the manufacturing process: [***] Following the initiation of the technical transfer, individuals having the expertise shared with Janssen at the initiation of the technical transfer (as provided above) will be available to participate in [***] project teleconferences with Janssen during the execution of the Technical Transfer Plan. If requested by Janssen and agreed by Vertexs Third Party suppliers, Vertex will use reasonable efforts [***] Notwithstanding the foregoing, Janssen will retain sole responsibility for the implementation and progress of the Technical Transfer Plan and for meeting its needs for Product Supply (either through its own Manufacturing activities or through the supply agreement) at launch and thereafter.
(c) Sale of Intermediates. [***], and subject to the terms of the Supply Agreement, Vertex will use Diligent Efforts to supply Janssen with the raw materials, Intermediates required for its manufacture of the API to be converted into Product for Commercialization in the Territory and, as a secondary source to Vertex, for Product to be sold outside the Territory. [***]
(d) Notice of Establishment of Supply Capability; Secondary Source Capacity. Janssen shall notify Vertex promptly following its establishment of supply capability for Manufacture of Product for Commercialization in the Territory. [***] following delivery of such notice, the Parties will enter into a supply agreement for Janssen to be a secondary supplier, which supply agreement shall include usual and customary terms including, but not limited to, provisions for good faith forecasts, binding purchase orders for periodic orders by Vertex from Janssen, purchase price, and term, for supply of [***] provided the purchase price shall be [***]
In addition, Janssen agrees to use [***] to supply additional quantities of [***] if requested by Vertex, provided, however, [***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
22
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
23
(a) Janssen shall develop relevant educational, sales, promotion and advertising materials relating to the Product (Territory Product Materials), for use in the Territory, that shall be consistent with the Territory Commercialization Plan and compliant with applicable law and the provisions of applicable Regulatory Approvals. Copies of all Territory Product Materials used in the Territory will be archived by Janssen in accordance with applicable law. Upon Vertexs request, Janssen shall provide copies of the material core Territory Product Materials for the Key Countries to Vertex for its review and comment prior to their first use. Moreover, upon request, Janssen shall provide copies of any other Territory Product Materials for other countries in the Territory to Vertex for its review and comment. Janssen will provide Vertex with any English translations, if available, of such Territory Product Materials that are produced for its own use. Janssen will consider in good faith any comments Vertex may have with respect to such Territory Product Materials. Upon Janssens request, Vertex shall provide Janssen with copies of the material core educational, sales, promotion and advertising materials relating to the Product in North America (North American Product Material), for review and comment prior to their use. Vertex will consider in good faith any comments Janssen may have with respect to such North American Product Material. Requests for North American Product Material and Territory Product Materials shall be made through a member of the JCC or his or her designee.
(b) Subject to any limitations imposed by applicable law, all Territory Product Materials and all documentary information and oral presentations, whether in hard-copy written, electronic or other media form regarding the education, marketing and promotion for the Product in countries of the Territory shall acknowledge the Parties license arrangement and shall display the Janssen or Janssen Affiliate and Vertex names and logos with equal prominence.
(c) In the event that Janssen uses, in a majority of the Major Market Countries in the Territory, the same Trademark for the Product used by Vertex in the United States, at Vertexs option the Parties will coordinate the establishment, content, operation, and maintenance of any site or domain on the internet which incorporates the Trademark, and the related annual cost [***] The costs incurred by Vertex in the search for and selection of the Trademark will be shared in the same proportion.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
24
(d) Where not prohibited by law or regulation, and subject to any required Regulatory Approval, which Janssen shall use diligent efforts to obtain, Vertexs name and logo will be carried on all Product packaging, package inserts, labels and containers, and on all printed, electronic and digital material related thereto (including educational materials and advertisements), with a prominence substantially equivalent to that of Janssen, or the Janssen Affiliate that is the most prominent name listed on any such material.
[***] of this Agreement, the Parties shall meet to establish a safety oversight working group (the Safety Oversight Working Group) composed of members of both Parties, which during the [***] and as otherwise provided in the Pharmacovigilance Agreement, shall discuss processes and procedures for sharing information needed to support each Partys respective regulatory responsibilities and to comply with applicable regulatory pharmacovigilance requirements. Any such procedures shall not be construed to restrict either Partys ability to take action that it deems to be appropriate or required of it under
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
25
the applicable regulatory requirements, but when permitted by applicable laws and regulations, the Parties shall consult with each other before taking such action.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
26
Vertex and Janssen along with their respective Affiliates share the goal of promoting the diagnosis, prevention, treatment and cure of HCV Infection worldwide. In addition to Developing and Commercializing the Product in their respective territories, the Parties intend to engage in worldwide philanthropic activities directed toward this goal. Accordingly, the Parties agree that, [***], each Party will set aside an amount [***] to apply in furtherance of such philanthropic objectives (the Philanthropic Funds). Each Party shall make its contribution no later than [***]. The Philanthropic Funds will be provided by each Party in any one of a variety of approved forms at such Partys election, such as [***] Also as part of this philanthropic program, the Parties shall consider in good faith activities and programs to increase the access to the Product, especially in countries identified by the World Health Organization as developing countries. In addition, as part of the Philanthropic program, Janssen may [***] The disposition of the Philanthropic Funds shall be determined by consensus of the members of a Joint Philanthropic Committee (JPC), with equal representation from each Party; provided, however, that the Philanthropic Funds shall be allocated in such a way as to maximally benefit the causes of the diagnosis, prevention, treatment and cure of HCV Infection. If the JPC is unable to reach consensus, either Party may refer the matter to the Executive Officers in accordance with Section 14.2. Each Party will afford equal recognition to the other Party in any public description by that Party of activities under this Article 6.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
27
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
28
Notwithstanding the foregoing, if Janssen wishes to grant a sublicense to a Third Party of its Development or Commercialization rights in [***] For the avoidance of doubt, Janssen shall not be required to seek the consent of Vertex in respect of sublicenses granted to its Affiliates.
(This Article is intentionally left blank).
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
29
Milestone Event |
|
Milestone |
||
|
|
(USD) |
||
|
|
|
|
|
[***] |
|
[***] |
|
[***] |
[***]
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
30
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
Royalties on sales of Products, at the royalty rates determined as set forth above with reference to annual aggregate Net Sales in the Territory, shall be payable on a country-by-country basis until, [***] For purposes of determining aggregate Calendar Year Net Sales under this Section 9.4.1 for any Calendar Year, [***].
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
31
If such independent accountants review of Janssens royalty reports shows an underpayment, Janssen shall remit or cause its Related Parties to remit to Vertex within [***] after Janssens receipt of such report: (i) the amount of such underpayment plus interest as determined under Section 9.10 below, and (ii) if such underpayment exceeds [***] of the total amount owed for the period being audited, the reasonable and necessary fees and expenses of the independent accountant performing the audit. If such underpayment does not exceed [***], the fees and expenses of the independent accountant
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
32
performing any such audit shall be paid by Vertex. [***] Upon prior written notice to Janssen as provided above, Vertex shall have a further right, exercisable not more frequently than once [***], to audit Net Sales, deductions taken from gross sales, and royalties earned by Vertex in any country in which a prior audit has shown an understatement of royalties due of at least [***].
Janssen shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the sublicensee to make reports to Janssen, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by Vertexs independent accountant to the same extent required of Janssen under this Agreement.
Upon the expiration of [***] the calculation of royalties payable with respect to such year shall be binding and conclusive upon the Parties, and Janssen and its Related Parties shall be released from any liability or accountability with respect to royalties for such Calendar Year.
Vertex shall treat all financial Information subject to review under this Section 9.7 or under any sublicense agreement in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with Janssen and/or its Related Parties obligating it to retain all such Information in confidence pursuant to such confidentiality agreement.
(a) Janssen will make all payments to Vertex under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by law in effect at the time of payment, and Janssen has notified Vertex of any such deduction or withholding in the royalty report.
(b) Any tax required to be withheld on amounts payable under this Agreement will promptly be paid by Janssen on behalf of Vertex to the appropriate governmental authority, and Janssen will furnish Vertex with proof of payment of such tax. Any such tax required to be withheld will be an expense of and borne by Vertex.
(c) Janssen and Vertex will cooperate with respect to all documentation required by any taxing authority or reasonably requested by Janssen or Vertex to secure a reduction in the rate of applicable withholding taxes.
(d) If Janssen had a duty to withhold taxes in connection with any payment it made to Vertex under this Agreement but Janssen failed to withhold, and such taxes were assessed against and paid by Janssen, then Vertex will indemnify and hold harmless Janssen from and against such taxes (including interest but excluding penalties). If Janssen makes a
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
33
claim under this Section 9.9(d), it will comply with the obligations imposed by Section 9.9(b) as if Janssen had withheld taxes from a payment to Vertex.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
34
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
35
[***]
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
36
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
37
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
38
A combination consisting of multiple components shall not be deemed to fall within the foregoing exclusions merely because one or more individual components of that disclosure are published or available to the general public or in the rightful possession of the receiving Party, unless the combination itself is published or available to the general public or otherwise falls within one of the foregoing exclusions.
If a Party is required by judicial or administrative process to disclose Information that is subject to the non-disclosure provisions of this Section 11.1, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Section 11.1, and the receiving Party shall cooperate with any reasonable attempts of the disclosing Party to limit any such disclosure required by law, including without limitation by way of obtaining an order of confidentiality, to ensure the continued confidential treatment of such Information.
The confidential and non-use obligations of this Section 11.1 shall survive the termination or expiration of this Agreement.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
39
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
40
This Section 11.3 shall terminate with the termination of this Agreement, but the provisions of Section 11.1 hereof shall continue to govern the disclosure by one Party, whether by publication or otherwise, of Information of the other.
In addition to the foregoing restrictions on public disclosure, if either Party concludes that a copy of this Agreement must be filed with a securities exchange or regulatory or governmental body to which that Party is subject, wherever situated, such Party shall provide the other Party with a copy of this Agreement showing any sections as to which the filing Party proposes to request confidential treatment, will provide the other Party with an opportunity and a reasonable time period to comment on any such proposal and to suggest additional portions of the Agreement for confidential treatment and will take such Partys comments into consideration before filing the Agreement. If the filing Party disagrees with the other Partys additional confidential treatment request, the Parties shall attempt in good faith to discuss the matter before the Agreement is filed.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
41
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
42
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
43
(b) Janssen will indemnify Vertex from and against any Third Party Claims arising out of any Additional Development Activities conducted by or at the direction of Janssen or its Affiliates, and
(c) Vertex will indemnify Janssen from and against any Third Party Claims arising out of any Additional Development Activities conducted by or at the direction of Vertex.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
44
Following any delivery by Janssen of notice of termination pursuant to this Section 13.2, Janssen and Vertex will cooperate in good faith to agree and implement a transition plan, in order to give effect to Section 13.5. Until the earlier of (i) transfer of any central marketing authorization from Janssen to Vertex or its designee or the effective date of any such termination, Janssen will use all reasonable efforts to agree and implement a transition plan and will continue to use Diligent Efforts to Develop, Manufacture and Commercialize Product Candidates and Products in the Territory in accordance with the plans then in effect and approved by the JDC and/or JCC, and will otherwise conduct itself with the objective of avoiding a negative impact, either by its actions or inaction, on the value of a Product Candidate or Product.
(i) the written notice of breach referenced above shall detail the specific obligation under this Agreement which is alleged to have been breached; the manner of such alleged breach; and the steps which must be taken in order to remedy such breach; and
(ii) the terminating Party has provided the defaulting Party with a reasonable amount of time (but no more than [***]) in which to complete any steps which might be taken to remedy the breach, as stated in the notification of breach;
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
45
If Vertex terminates this Agreement under Section 13.3 or Janssen terminates this Agreement under Section 13.2:
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
46
(b) Janssen will appoint Vertex as Janssens and/or its Affiliates agent for all Product-related matters involving Regulatory Authorities in the Territory.
(c) if Vertex so requests, Janssen and its Affiliates will assign to Vertex any agreements with Third Parties relating solely to the Development, Manufacture or Commercialization of the Product to which Janssen is a party to the extent permitted by the applicable law and the terms of such agreements, and Janssen will use best efforts not to enter into any agreement that restricts its ability to comply with this provision.
(d) Janssen will, upon request by Vertex, appoint Vertex or its designee as its exclusive distributor of the Product in the Territory, and grant Vertex or its designee the right to appoint sub-distributors.
(e) Janssen will, at its cost, return to Vertex or its designee all inventory of Intermediates and Product in its possession as of the date of termination and, at Vertexs election, make payment to Vertex for any Intermediates and Product ordered by Janssen pursuant to the Supply Agreement but not yet paid for.
(f) Notwithstanding the provisions of Section 11.1, Vertex shall be able to disclose any such data and information as is necessary to exercise its rights with respect to a Compound, Product Candidate or Product.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
47
(g) Notwithstanding termination of this Agreement, this Section 13.5.4 shall remain in effect until the completion by Janssen of all actions which are required by it to enable a full transfer to Vertex of all filings for Regulatory Approvals and all Marketing Authorizations relating to any Product.
This section 13.6 is not a termination provision under section 13.7 of this Agreement.
Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including without limitation the obligation to pay royalties for Product(s) sold prior to such expiration or termination or make other payments under this Agreement. In addition to any other provisions which by their terms specifically survive expiration or termination of this Agreement, the following provisions shall indefinitely survive any expiration or termination of this Agreement: Section 7.4, provided that any and all licenses granted under Section 7.4 shall be non-exclusive, Sections 9.6, 9.7, 9.9, and 9.11, Article 11, Section 12.3, Article 13, sections 14.1, 14.2, 14.3, and 14.5, sections 15.1, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 15.10, 15.11, 15.12, 15.13, 15.14, and 15.15, and the definitions of terms from Article 1 that are part of the recitation of any of the sections listed in this section 13.7.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
48
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
49
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
50
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
51
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
52
if to Vertex, to: |
|
Vertex Pharmaceuticals Incorporated |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
53
and: |
|
Attn: General
Counsel |
|
|
|
if to Janssen, to: |
|
Janssen Pharmaceutica, N.V. |
and: |
|
Office of the General Counsel |
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a business day; (b) on the next business day after dispatch if sent by internationally-recognized overnight courier; and/or (c) on the fifth (5th) business day following the date of mailing if sent by other internationally-recognized courier or by mail. Notices hereunder will not be deemed sufficient if provided only between or among each Partys representatives on any committee established in accordance with this Agreement.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
54
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
55
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.
JANSSEN PHARMACEUTICA, N.V. |
VERTEX PHARMACEUTICALS |
|||||||
|
|
|||||||
By: |
/s/Dirk Collier |
|
By: |
/s/Kenneth S. Boger |
|
|||
Name: Dirk Collier |
Name: Kenneth S. Boger |
|||||||
Title: Board Member |
Title: Senior Vice President and General Counsel |
|||||||
|
|
|||||||
|
|
|||||||
Date: 30/6/06 |
Date: June 30, 2006 |
|||||||
|
|
|||||||
By: |
/s/Didier de Chaffoy de Courcelles |
|
|
|||||
Name: Didier de Chaffoy de Courcelles |
|
|||||||
Title: Senior Vice President, Research and |
|
|||||||
|
Early Development Europe |
|
||||||
|
|
|
||||||
Date: 30/6/06 |
|
|||||||
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
56
Schedule 1.7
Janssen 2006 Universal Calendar
|
|
M |
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T |
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W |
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T |
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F |
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S |
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S |
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JAN |
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2 |
|
3 |
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4 |
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5 |
|
6 |
|
7 |
|
8 |
|
(4 Weeks) |
|
9 |
|
10 |
|
11 |
|
12 |
|
13 |
|
14 |
|
15 |
|
|
|
16 |
|
17 |
|
18 |
|
19 |
|
20 |
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21 |
|
22 |
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|
23 |
|
24 |
|
25 |
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26 |
|
27 |
|
28 |
|
29 |
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30 |
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31 |
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|
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FEB |
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|
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1 |
|
2 |
|
3 |
|
4 |
|
5 |
|
(4 Weeks) |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
|
11 |
|
12 |
|
|
|
13 |
|
14 |
|
15 |
|
16 |
|
17 |
|
18 |
|
19 |
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|
|
20 |
|
21 |
|
22 |
|
23 |
|
24 |
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25 |
|
26 |
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27 |
|
28 |
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|
|
MAR |
|
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1 |
|
2 |
|
3 |
|
4 |
|
5 |
|
(5 Weeks) |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
|
11 |
|
12 |
|
|
|
13 |
|
14 |
|
15 |
|
16 |
|
17 |
|
18 |
|
19 |
|
|
|
20 |
|
21 |
|
22 |
|
23 |
|
24 |
|
25 |
|
26 |
|
|
|
27 |
|
28 |
|
29 |
|
30 |
|
31 |
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|
|
APR |
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|
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|
|
|
|
|
1 |
|
2 |
|
(4 Weeks) |
|
3 |
|
4 |
|
5 |
|
6 |
|
7 |
|
8 |
|
9 |
|
|
|
10 |
|
11 |
|
12 |
|
13 |
|
14 |
|
15 |
|
16 |
|
|
|
17 |
|
18 |
|
19 |
|
20 |
|
21 |
|
22 |
|
23 |
|
|
|
24 |
|
25 |
|
26 |
|
27 |
|
28 |
|
29 |
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MAY |
|
1 |
|
2 |
|
3 |
|
4 |
|
5 |
|
6 |
|
7 |
|
(4 Weeks) |
|
8 |
|
9 |
|
10 |
|
11 |
|
12 |
|
13 |
|
14 |
|
|
|
15 |
|
16 |
|
17 |
|
18 |
|
19 |
|
20 |
|
21 |
|
|
|
22 |
|
23 |
|
24 |
|
25 |
|
26 |
|
27 |
|
28 |
|
|
|
29 |
|
30 |
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
JUN |
|
|
|
|
|
|
|
1 |
|
2 |
|
3 |
|
4 |
|
(5 Weeks) |
|
5 |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
|
11 |
|
|
|
12 |
|
13 |
|
14 |
|
15 |
|
16 |
|
17 |
|
18 |
|
|
|
19 |
|
20 |
|
21 |
|
22 |
|
23 |
|
24 |
|
25 |
|
|
|
26 |
|
27 |
|
28 |
|
29 |
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
JUL |
|
|
|
|
|
|
|
|
|
|
|
1 |
|
2 |
|
(4 Weeks) |
|
3 |
|
4 |
|
5 |
|
6 |
|
7 |
|
8 |
|
9 |
|
|
|
10 |
|
11 |
|
12 |
|
13 |
|
14 |
|
15 |
|
16 |
|
|
|
17 |
|
18 |
|
19 |
|
20 |
|
21 |
|
22 |
|
23 |
|
|
|
24 |
|
25 |
|
26 |
|
27 |
|
28 |
|
29 |
|
30 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUG |
|
|
|
1 |
|
2 |
|
3 |
|
4 |
|
5 |
|
6 |
|
(4 Weeks) |
|
7 |
|
8 |
|
9 |
|
10 |
|
11 |
|
12 |
|
13 |
|
|
|
14 |
|
15 |
|
16 |
|
17 |
|
18 |
|
19 |
|
20 |
|
|
|
21 |
|
22 |
|
23 |
|
24 |
|
25 |
|
26 |
|
27 |
|
|
|
28 |
|
29 |
|
30 |
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEP |
|
|
|
|
|
|
|
|
|
1 |
|
2 |
|
3 |
|
(5 Weeks) |
|
4 |
|
5 |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
|
|
|
11 |
|
12 |
|
13 |
|
14 |
|
15 |
|
16 |
|
17 |
|
|
|
18 |
|
19 |
|
20 |
|
21 |
|
22 |
|
23 |
|
24 |
|
|
|
25 |
|
26 |
|
27 |
|
28 |
|
29 |
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OCT |
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
(4 Weeks) |
|
2 |
|
3 |
|
4 |
|
5 |
|
6 |
|
7 |
|
8 |
|
|
|
9 |
|
10 |
|
11 |
|
12 |
|
13 |
|
14 |
|
15 |
|
|
|
16 |
|
17 |
|
18 |
|
19 |
|
20 |
|
21 |
|
22 |
|
|
|
23 |
|
24 |
|
25 |
|
26 |
|
27 |
|
28 |
|
29 |
|
|
|
30 |
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOV |
|
|
|
|
|
1 |
|
2 |
|
3 |
|
4 |
|
5 |
|
(4 Weeks) |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
|
11 |
|
12 |
|
|
|
13 |
|
14 |
|
15 |
|
16 |
|
17 |
|
18 |
|
19 |
|
|
|
20 |
|
21 |
|
22 |
|
23 |
|
24 |
|
25 |
|
26 |
|
|
|
27 |
|
28 |
|
29 |
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DEC |
|
|
|
|
|
|
|
|
|
1 |
|
2 |
|
3 |
|
(5 Weeks) |
|
4 |
|
5 |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
|
|
|
11 |
|
12 |
|
13 |
|
14 |
|
15 |
|
16 |
|
17 |
|
|
|
18 |
|
19 |
|
20 |
|
21 |
|
22 |
|
23 |
|
24 |
|
|
|
25 |
|
26 |
|
27 |
|
28 |
|
29 |
|
30 |
|
31 |
|
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Schedule 1.19
[***]
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Schedule 1.31
Existing Third Party Agreements
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Schedule 1.32
Far East
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Schedule 1.55
Janssen Patent Rights
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Schedule 1.116
Vertex Patent Rights
[***]
Docket No. |
|
Serial No. |
|
Patent No. |
|
Publication No. |
|
Status |
|
Filed |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
VPI/00-131 BR |
|
0113666-6 |
|
|
|
|
|
PUBLISHED |
|
08/31/2001 |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
VPI/00-131 CN |
|
01815055 |
|
|
|
|
|
PUBLISHED |
|
08/31/2001 |
VPI/00-131 CO |
|
03016961 |
|
|
|
|
|
PUBLISHED |
|
08/31/2001 |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
VPI/00-131 EA |
|
200300318 |
|
|
|
|
|
PUBLISHED |
|
08/31/2001 |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
VPI/00-131 EP |
|
01968040.4 |
|
|
|
1320540 |
|
PUBLISHED |
|
08/31/2001 |
VPI/00-131 HK |
|
03108422.8 |
|
|
|
|
|
PUBLISHED |
|
01/20/2003 |
VPI/00-131 HR |
|
20030139 |
|
|
|
02/2005 |
|
PUBLISHED |
|
08/31/2001 |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
|
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|
[***] |
|
[***] |
[***] |
|
[***] |
|
|
|
|
|
[***] |
|
[***] |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Docket No. |
|
Serial No. |
|
Patent No. |
|
Publication No. |
|
Status |
|
Filed |
[***] |
|
[***] |
|
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|
|
[***] |
|
[***] |
[***] |
|
[***] |
|
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[***] |
|
[***] |
[***] |
|
[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
|
[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
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[***] |
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[***] |
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[***] |
[***] |
|
[***] |
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[***] |
|
[***] |
[***] |
|
[***] |
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[***] |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
2
Docket No. |
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Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
3
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VPI/04-139 US |
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11/264,746 |
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US 2006/0105978 |
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PUBLISHED |
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10/31/2005 |
VPI/04-139 WO |
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PCT/US2005/039240 |
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WO 2006/050250 |
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PUBLISHED |
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10/31/2005 |
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
4
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VPI/04-136 WO |
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WO 2006/039488 |
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09/30/2005 |
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VPI/04-114 US |
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11/147,524 |
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5
VPI/03-172 US |
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10/974,558 |
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Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
6
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VPI/03-149 TW |
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093127683 |
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200518669 |
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Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
7
Schedule 1.117
VX-950
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[***]
[***]
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Exhibit 4.5(a)
Supply Agreement Key Elements
The Parties agree to negotiate the terms of a supply agreement in good faith, subject to the terms of this Agreement, which will include the following:
1. Vertex will supply Product that meets the Specifications (unless otherwise agreed by Vertex) to Janssen [***] the Effective Date of the Agreement.
2. Janssen will forecast and place orders with Vertex for its Product requirements and its requirement of Intermediates for Commercialization in the Territory, commencing [***] of the first requested delivery of Tablets. Based on the current Development Program, the first forecast to be provided under the Supply Agreement will be due [***] Based on the forecast, Vertex will make commitments to Third Party Manufacturers for Territory supplies, in accordance with lead-time or contractual obligations with Third Party Manufacturers, that will be binding on Janssen.
3. Vertex will supply Janssen through its Third Party Manufacturers in accordance with the terms of the Third Party Manufacturer agreements.
4. Vertex will supply the Product to Janssen at [***]. All [***] directly related to supply of Product to the Territory will be borne by Janssen. Vertex will provide financial transparency for all [***] associated with supply of Product for the Territory.
5. Delivery will be FCA facility (see INCOTERMS 2000).
6. Janssen will be responsible for shipping and handling charges arising in connection with Product delivered to Janssen, and for defining the method of shipment and for undertaking, at its expense, any validation that may be required.
7 Rights with respect to non-conforming product, shortage of supply and late delivery will be consistent with comparable rights that Vertex has with the relevant Third Party Manufacturers. [***]
8. [***]
9. Representations, warranties, insurance and indemnification will be no more extensive than those which Vertex has in the relevant Third Party Agreements.
10. Vertexs liability will be limited to its own negligence. [***] In the event product delivered to Janssen is non-conforming, Janssens remedy will be that Vertex will [***] to seek remedies available pursuant to the relevant Third Party Manufacturing Agreements and pass those remedies on to Janssen.
11. The agreement will include provisions that address continuity of supply concerns for Janssen.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
12. The Parties will execute a Quality Agreement.
Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Exhibit 10.2
June 26, 2006
Vertex Pharmaceuticals Incorporated
130 Waverly Street
Cambridge, MA 02139
Attn: Office of Business Development
Re: Exclusive Research Collaboration, License and Commercialization Agreement (as amended by that certain letter agreement, dated February 4, 2005, and as may be subsequently amended, the Agreement), effective as of June 21, 2004, by and between Merck & Co., Inc. (Merck), and Vertex Pharmaceuticals Incorporated (Vertex).
Ladies and Gentlemen:
This Letter (this Letter) will confirm the understanding of Merck and Vertex regarding the extension of the Agreements Research Program Term and is intended to be legally binding on both Parties. Capitalized terms used but not otherwise defined in this Letter shall have the meanings provided in the Agreement.
Vertex and Merck agree as follows:
1. Extension of Research Program Term. In accordance with Section 1.55 of the Agreement, Vertex and Merck agree to a three-month extension of the Research Program Term. As a result, the Research Program Term will end on September 21, 2006.
2. This Letter shall be deemed effective as of June 26, 2006. Except as amended by this Letter, the terms of the Agreement remain in full force and effect in all other respects, unless further amended by written agreement in accordance with Section 9.9 of the Agreement. On and after the effectiveness of this Letter, each reference in the Agreement to this Agreement, hereinafter or words of like import referring to the Agreement shall mean and be a reference to the Agreement as amended by this Letter.
3. This Letter may be executed (including, without limitation, by facsimile signature) in two counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument.
If the foregoing is acceptable to you, please sign this Letter in the space provided below and return it to me.
Sincerely,
Merck & Co., Inc.
By: |
/s/Stephen H. Friend |
|
||
|
Name: |
Stephen H. Friend, MD, Ph.D. |
||
|
Title: |
Executive Vice President |
||
|
|
Advanced Technologies & Oncology |
||
Acknowledged and Agreed to
As of the effective date specified in Section 2 above:
Vertex Pharmaceuticals Incorporated
By: |
/s/Kenneth S. Boger |
|
|
|
Name: |
Kenneth S. Boger |
|
|
Title: |
Senior VP & General Counsel |
|
CERTIFICATION
I, Joshua S. Boger, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Vertex Pharmaceuticals Incorporated;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: August 9, 2006 |
/s/ JOSHUA S. BOGER |
|
Joshua S. Boger |
|
President and Chief Executive Officer |
CERTIFICATION
I, Ian F. Smith, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Vertex Pharmaceuticals Incorporated;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: August 9, 2006 |
/s/ IAN F. SMITH |
|
Ian F. Smith |
|
Executive Vice President and Chief Financial Officer |
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350,
Chapter 63 of Title 18, United States Code)
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of Vertex Pharmaceuticals Incorporated, a Massachusetts corporation (the Company), does hereby certify, to such officers knowledge, that the Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 (the Form 10-Q) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: August 9, 2006 |
|
/s/ JOSHUA S. BOGER |
|
|
Joshua S. Boger |
|
|
President and Chief Executive Officer |
|
|
(principal executive officer) |
|
|
|
Dated: August 9, 2006 |
|
/s/ IAN F. SMITH |
|
|
Ian F. Smith |
|
|
Executive Vice President and Chief Financial Officer |
|
|
(principal financial officer) |