SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
| [X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For The Quarterly Period Ended March 31, 2003
OR
| [ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 0-19171
ICOS CORPORATION
| Delaware (State or other jurisdiction of incorporation or organization) |
91-1463450 (I.R.S. Employer Identification No.) |
| 22021 - 20th Avenue S.E., Bothell, WA | 98021 |
|
|
|
| (Address of principal executive offices) | (Zip code) |
(425) 485-1900
Not Applicable
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 [ ]
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act).
Yes [X] No [ ]
Indicate the number of shares outstanding of each of the issuers classes of Common Stock, as of the latest practicable date.
| Class | Outstanding at March 31, 2003 | |||
Common Stock, $0.01 par value |
62,278,333 | |||
ICOS CORPORATION
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2003
TABLE OF CONTENTS
| PAGE NO. | ||||||
PART I. Financial Information |
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ITEM
1. Financial Statements |
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Condensed Consolidated Statements of Operations for the three months ended
March 31, 2003 and 2002 |
1 | |||||
Condensed Consolidated Balance Sheets as of March 31, 2003 and
December 31, 2002 |
2 | |||||
Condensed Consolidated Statements of Cash Flows for the three months ended
March 31, 2003 and 2002 |
3 | |||||
Notes to Condensed Consolidated Financial Statements |
4 | |||||
ITEM 2. |
||||||
Managements Discussion and Analysis of Results of Operations and
Financial Condition |
8 | |||||
ITEM 3. |
||||||
Quantitative and Qualitative Disclosure about Market Risk |
15 | |||||
ITEM 4. |
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Controls and Procedures |
15 | |||||
PART II. Other Information |
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ITEM 6. |
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Exhibits and Reports on Form 8-K |
15 | |||||
SIGNATURE |
16 | |||||
CERTIFICATIONS |
17 | |||||
PART 1. Financial Information
ITEM 1. Financial Statements
ICOS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
| (in thousands, except per share data) | ||||||||||
| Three Months Ended March 31, | ||||||||||
| 2003 | 2002 | |||||||||
Revenue: |
||||||||||
Collaboration revenue from related parties |
$ | 5,348 | $ | 19,356 | ||||||
Licenses of technology |
633 | 1,380 | ||||||||
Contract manufacturing |
1,100 | 1,800 | ||||||||
Total revenue |
7,081 | 22,536 | ||||||||
Operating expenses: |
||||||||||
Research and development |
27,288 | 35,398 | ||||||||
Marketing and selling |
921 | 3,158 | ||||||||
General and administrative |
2,141 | 1,809 | ||||||||
Total operating expenses |
30,350 | 40,365 | ||||||||
Operating loss |
(23,269 | ) | (17,829 | ) | ||||||
Other income (expense): |
||||||||||
Equity in losses of affiliates |
(21,547 | ) | (24,724 | ) | ||||||
Interest and other income |
3,712 | 3,333 | ||||||||
Loss before income taxes |
(41,104 | ) | (39,220 | ) | ||||||
Income tax recovery |
612 | | ||||||||
Net loss |
$ | (40,492 | ) | $ | (39,220 | ) | ||||
Net loss per common share basic and diluted |
$ | (0.65 | ) | $ | (0.65 | ) | ||||
Weighted-average common shares outstanding basic and diluted |
62,174 | 60,017 | ||||||||
See accompanying notes to condensed consolidated financial statements.
1
ICOS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
| (in thousands) | |||||||||||
| March 31, | December 31, | ||||||||||
| 2003 | 2002 | ||||||||||
| ASSETS | |||||||||||
Current assets: |
|||||||||||
Cash and cash equivalents |
$ | 92,967 | $ | 40,450 | |||||||
Investment securities, at market value |
62,681 | 159,680 | |||||||||
Interest receivable |
3,520 | 5,099 | |||||||||
Receivables from affiliates |
7,400 | 7,959 | |||||||||
Other |
6,170 | 2,652 | |||||||||
Total current assets |
172,738 | 215,840 | |||||||||
Investment securities, at market value |
148,436 | 148,796 | |||||||||
Property and equipment, net |
19,455 | 20,209 | |||||||||
Other |
632 | 815 | |||||||||
| $ | 341,261 | $ | 385,660 | ||||||||
| LIABILITIES AND STOCKHOLDERS EQUITY | |||||||||||
Current liabilities: |
|||||||||||
Payables and accruals |
$ | 19,828 | $ | 25,985 | |||||||
Due to affiliates |
24,424 | 25,012 | |||||||||
Deferred revenue |
2,104 | 2,305 | |||||||||
Total current liabilities |
46,356 | 53,302 | |||||||||
Deferred revenue |
17,101 | 14,726 | |||||||||
Stockholders equity: |
|||||||||||
Common stock |
623 | 621 | |||||||||
Additional paid-in capital |
779,177 | 777,697 | |||||||||
Accumulated other comprehensive income |
2,462 | 3,280 | |||||||||
Accumulated deficit |
(504,458 | ) | (463,966 | ) | |||||||
Total stockholders equity |
277,804 | 317,632 | |||||||||
| $ | 341,261 | $ | 385,660 | ||||||||
See accompanying notes to condensed consolidated financial statements.
2
ICOS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| (in thousands) | ||||||||||||
| Three Months Ended March 31, | ||||||||||||
| 2003 | 2002 | |||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (40,492 | ) | $ | (39,220 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
1,478 | 1,303 | ||||||||||
Gain on sale of investment securities, net |
(1,290 | ) | (117 | ) | ||||||||
Amortization of investment premiums (discounts), net |
1,826 | 1,259 | ||||||||||
Equity in losses of affiliates |
21,547 | 24,724 | ||||||||||
Revenue from licenses of technology in excess of cash received |
(633 | ) | (1,380 | ) | ||||||||
Stock compensation expense |
199 | 105 | ||||||||||
Change in operating assets and liabilities: |
||||||||||||
Receivables |
227 | (9,558 | ) | |||||||||
Other assets |
(1,385 | ) | (882 | ) | ||||||||
Payables and accruals |
(5,419 | ) | 436 | |||||||||
Net cash used in operating activities |
(23,942 | ) | (23,330 | ) | ||||||||
Cash flows from investing activities: |
||||||||||||
Purchases of investment securities |
(19,167 | ) | (83,577 | ) | ||||||||
Maturities of investment securities |
26,365 | 43,695 | ||||||||||
Sales of investment securities |
88,991 | 22,381 | ||||||||||
Acquisitions of property and equipment |
(725 | ) | (1,906 | ) | ||||||||
Investments in affiliates |
(22,135 | ) | (15,642 | ) | ||||||||
Net cash provided by (used in) investing activities |
73,329 | (35,049 | ) | |||||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from stock options and warrants |
1,061 | 4,517 | ||||||||||
Borrowings under line of credit |
2,069 | 2,353 | ||||||||||
Net cash provided by financing activities |
3,130 | 6,870 | ||||||||||
Net increase (decrease) in cash and cash equivalents |
52,517 | (51,509 | ) | |||||||||
Cash and cash equivalents, beginning of period |
40,450 | 260,905 | ||||||||||
Cash and cash equivalents, end of period |
$ | 92,967 | $ | 209,396 | ||||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Debt forgiveness upon achievement of clinical milestone |
$ | 3,055 | $ | 674 | ||||||||
Income tax benefit receivable |
$ | 612 | $ | | ||||||||
See accompanying notes to condensed consolidated financial statements.
3
ICOS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in thousands unless otherwise noted)
(unaudited)
1. Summary of Significant Accounting Policies
The accompanying condensed consolidated financial statements present the results of operations, financial position and cash flows of ICOS Corporation and its wholly-owned subsidiaries, herein collectively referred to as ICOS. All material intercompany transactions and balances between entities consolidated in these financial statements have been eliminated.
The accompanying condensed consolidated financial statements have not been audited. We have condensed or omitted certain information and footnote disclosures normally included in financial statements presented in accordance with accounting principles generally accepted in the United States. We believe the disclosures made are adequate to make the information presented not misleading. However, you should read these condensed consolidated financial statements in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2002.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Ultimate results could differ from those estimates.
In our opinion, the accompanying condensed consolidated financial statements include all adjustments, consisting only of normal recurring items, necessary to present fairly our financial position as of March 31, 2003 and December 31, 2002, and our results of operations and cash flows for the three months ended March 31, 2003 and 2002. Interim results are not necessarily indicative of results for a full year.
Stock Based Compensation
We apply the provisions of Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations in accounting for our employee stock option grants. Accordingly, we do not recognize compensation expense for options granted to employees with an exercise price equal to or in excess of the fair value of the underlying common shares at the date of grant. We recognize compensation expense for restricted stock grants over the vesting period.
Had we determined compensation cost based on the fair value of our stock options on the grant date under Statement of Financial Accounting Standards No. 123, Accounting for Stock Based Compensation, our net loss and net loss per share would have been the pro forma amounts indicated as follows:
4
| Three Months Ended | |||||||||
| March 31, | |||||||||
| 2003 | 2002 | ||||||||
Net loss: |
|||||||||
As reported |
$ | (40,492 | ) | $ | (39,220 | ) | |||
Add: Stock based employee
compensation expense included in
reported net loss |
69 | | |||||||
Deduct: Stock based employee
compensation expense determined
under fair value based method for
all awards |
(11,564 | ) | (8,611 | ) | |||||
Pro forma |
$ | (51,987 | ) | $ | (47,831 | ) | |||
Net loss per sharebasic and diluted: |
|||||||||
As reported |
$ | (0.65 | ) | $ | (0.65 | ) | |||
Pro forma |
$ | (0.84 | ) | $ | (0.80 | ) | |||
The per share weighted-average grant date fair value of stock options awarded during the three months ended March 31, 2003 and 2002, was $13.79 and $31.60, respectively, using the Black-Scholes option pricing model with the following assumptions:
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2003 | 2002 | |||||||
Expected dividend yield |
0.0 | % | 0.0 | % | ||||
Risk-free interest rate |
3.3 | % | 4.8 | % | ||||
Expected volatility |
67.9 | % | 68.8 | % | ||||
Expected life in years |
6.4 | 6.3 | ||||||
2. Revenue from Collaborations and Licenses of Technology, and Equity in Losses of Affiliates
The following tables summarize our revenue from collaborations with related parties and licenses of technology, and equity in losses of affiliates for the three months ended March 31, 2003 and 2002.
| Three Months Ended March 31, | ||||||||||
| 2003 | 2002 | |||||||||
Collaboration revenue from related parties: |
||||||||||
Lilly ICOS LLC (Lilly ICOS) |
$ | 2,053 | $ | 1,361 | ||||||
Suncos Corporation (Suncos) |
2,058 | 13,889 | ||||||||
ICOS-Texas Biotechnology L.P. (ICOS-TBC) |
1,237 | 4,106 | ||||||||
| $ | 5,348 | $ | 19,356 | |||||||
Licenses of technology: |
||||||||||
Lilly ICOS |
$ | 31 | $ | 623 | ||||||
ICOS Clinical Partners, L.P. |
| 427 | ||||||||
Biogen, Inc. (Biogen) |
602 | 330 | ||||||||
| $ | 633 | $ | 1,380 | |||||||
Equity in losses of affiliates: |
||||||||||
Lilly ICOS |
$ | (21,547 | ) | $ | (14,230 | ) | ||||
Suncos |
| (7,984 | ) | |||||||
ICOS-TBC |
| (2,510 | ) | |||||||
| $ | (21,547 | ) | $ | (24,724 | ) | |||||
5
3. Affiliate Operating Results
Lilly ICOS
Lilly ICOS, our 50/50 owned joint venture with Eli Lilly and Company (Lilly), began selling its first commercial product, Cialis (tadalafil), for the treatment of erectile dysfunction, in the European Union in January 2003. Cialis is currently available, by prescription, in pharmacies across Europe. Cialis is also available outside of North America and the European Union, in which markets Lilly has exclusive rights and pays royalties to Lilly ICOS equal to 20% of net sales.
The following table summarizes the operating results of Lilly ICOS for the three months ended March 31, 2003 and 2002.
| Three Months Ended March 31, | ||||||||||
| 2003 | 2002 | |||||||||
Revenue: |
||||||||||
Product sales, net |
$ | 16,615 | $ | | ||||||
Royalties |
975 | | ||||||||
Total revenue |
17,590 | | ||||||||
Cost of sales |
1,604 | | ||||||||
Research and development: |
||||||||||
Lilly and other |
16,446 | 10,839 | ||||||||
ICOS |
1,773 | 1,184 | ||||||||
Selling, general and administrative: |
||||||||||
Lilly and other |
40,582 | 16,222 | ||||||||
ICOS |
280 | 215 | ||||||||
Total expenses |
60,685 | 28,460 | ||||||||
Net loss |
$ | (43,095 | ) | $ | (28,460 | ) | ||||
Suncos
For the first quarter of 2002, Suncos incurred $16.0 million of operating losses related to the development of Pafase®. In December 2002, the Pafase development program was discontinued after an interim analysis did not demonstrate clinical benefit in a Phase 3 study for severe sepsis. Upon discontinuation of the Pafase program, Suncos accrued estimated close-out costs, primarily associated with the programs clinical and manufacturing activities. In the first quarter of 2003, no adjustments to those estimated costs were necessary.
ICOS-TBC
For the first quarter of 2002, ICOS-TBC incurred $5.0 million of operating
losses related to its endothelin receptor antagonist program. All research and
development costs of ICOS-TBC were charged to expense as incurred. In January
2003, we announced that joint development of the endothelin receptor antagonist
program, through ICOS-TBC, would not continue. Texas Biotechnology Corporation (Texas
Biotechnology) agreed to be responsible for all costs and expenses of ICOS-TBC
incurred subsequent to December 31, 2002. On April 22, 2003, ICOS entered into
an agreement whereby Texas Biotechnology acquired all of our interests in
ICOS-TBC for $10.0
6
Table of Contents
million, with $4.0 million paid on that date and the balance payable, with interest, in two installments over an 18-month period. The installment payments and interest are secured by an irrevocable standby letter of credit from a major U.S. bank. In the second quarter of 2003, our results of operations will include a gain of $10.0 million from this transaction.
4. Income Tax Recovery
In the first quarter of 2003, we recognized a federal alternative minimum income tax benefit of $0.6 million as a result of filing a refund claim for such taxes paid for the year ended December 31, 1998.
5. Comprehensive Loss