UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2005
OR
| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____ to _____
Commission File Number: 0-21696
ARIAD Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
Delaware | 22-3106987 |
(State or other jurisdiction of | (I.R.S. Employer Identification No.) |
incorporation or organization) | |
26 Landsdowne Street, Cambridge, Massachusetts 02139
(Address of principal executive offices) (Zip Code)
Registrant’s Telephone Number, Including Area Code: (617) 494-0400
Former Name, Former Address and Former Fiscal Year,
If Changed Since Last Report: 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 by check mark whether the Registrant is a shell company (as defined in Rule 12b - 2 of the Exchange Act).
Yes | | No |X|
The number of shares of the Registrant’s common stock outstanding as of October 31, 2005 was 61,638,129.
ARIAD PHARMACEUTICALS, INC.
TABLE OF CONTENTS
PART I. | | |
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ITEM 1. | | |
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ITEM 2. | | |
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ITEM 3. | | 17 |
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ITEM 4. | | 18 |
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PART II. | | 19 |
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ITEM 1. | | 19 |
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ITEM 6. | | 20 |
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ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES | |
In thousands, except share and per share data | | September 30, 2005 | | December 31, 2004 | |
| | (Unaudited) | | | |
| | | | | |
ASSETS | | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 69,464 | | $ | 18,556 | |
Marketable securities | | | 26,362 | | | 56,950 | |
Inventory and other current assets | | | 1,439 | | | 1,965 | |
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Total current assets | | | 97,265 | | | 77,471 | |
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Property and equipment: | | | | | | | |
Leasehold improvements | | | 16,942 | | | 12,693 | |
Equipment and furniture | | | 9,394 | | | 6,525 | |
Construction in progress | | | — | | | 2,049 | |
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Total | | | 26,336 | | | 21,267 | |
Less accumulated depreciation and amortization | | | (19,306 | ) | | (18,031 | ) |
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Property and equipment, net | | | 7,030 | | | 3,236 | |
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Intangible and other assets, net | | | 5,921 | | | 6,482 | |
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Total assets | | $ | 110,216 | | $ | 87,189 | |
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LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | |
Current liabilities: | | | | | | | |
Current portion of long-term debt | | $ | 1,920 | | $ | 1,920 | |
Accounts payable | | | 2,177 | | | 2,129 | |
Accrued compensation and benefits | | | 662 | | | 310 | |
Accrued product development expenses | | | 8,163 | | | 2,934 | |
Other accrued expenses | | | 2,045 | | | 591 | |
Deferred revenue - current portion | | | 894 | | | 713 | |
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Total current liabilities | | | 15,861 | | | 8,597 | |
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Long-term debt | | | 6,215 | | | 7,655 | |
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Deferred revenue | | | 72 | | | 404 | |
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Deferred executive compensation | | | 2,522 | | | 3,093 | |
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Stockholders’ equity: | | | | | | | |
Common stock, $.001 par value; authorized, 145,000,000 shares; issued and outstanding, 61,625,870 shares in 2005 and 52,688,673 shares in 2004 | | | 62 | | | 53 | |
Additional paid-in capital | | | 318,339 | | | 259,122 | |
Deferred compensation | | | (166 | ) | | (58 | ) |
Accumulated other comprehensive loss | | | (50 | ) | | (61 | ) |
Accumulated deficit | | | (232,639 | ) | | (191,616 | ) |
| | | | | | | |
Total stockholders’ equity | | | 85,546 | | | 67,440 | |
| | | | | | | |
Total liabilities and stockholders’ equity | | $ | 110,216 | | $ | 87,189 | |
| | | | | | | |
See notes to unaudited condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
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License revenue | | $ | 321 | | $ | 185 | | $ | 975 | | $ | 563 | |
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Operating expenses: | | | | | | | | | | | | | |
Research and development | | | 12,381 | | | 7,401 | | | 35,128 | | | 18,836 | |
General and administrative | | | 2,892 | | | 2,386 | | | 7,808 | | | 7,169 | |
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Total operating expenses | | | 15,273 | | | 9,787 | | | 42,936 | | | 26,005 | |
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Loss from operations | | | (14,952 | ) | | (9,602 | ) | | (41,961 | ) | | (25,442 | ) |
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Other income (expense): | | | | | | | | | | | | | |
Interest income | | | 474 | | | 281 | | | 1,236 | | | 778 | |
Interest expense | | | (116 | ) | | (58 | ) | | (298 | ) | | (195 | ) |
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Total other income, net | | | 358 | | | 223 | | | 938 | | | 583 | |
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Net loss | | $ | (14,594 | ) | $ | (9,379 | ) | $ | (41,023 | ) | $ | (24,859 | ) |
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Net loss per share | | $ | (.25 | ) | $ | (.18 | ) | $ | (.75 | ) | $ | (.49 | ) |
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Weighted-average number of shares of common stock outstanding | | | 57,662,708 | | | 52,544,234 | | | 54,474,950 | | | 50,840,247 | |
See notes to unaudited condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) |
| | | | | |
| | Nine Months Ended September 30, | |
In thousands | | 2005 | | 2004 | |
Cash flows from operating activities: | | | | | | | |
Net loss | | $ | (41,023 | ) | $ | (24,859 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | |
Depreciation and amortization | | | 1,323 | | | 751 | |
Deferred executive compensation expense | | | 453 | | | 1,022 | |
Stock-based compensation | | | 408 | | | 517 | |
Increase (decrease) from: | | | | | | | |
Inventory and other current assets | | | 525 | | | (857 | ) |
Other assets | | | (8 | ) | | 25 | |
Accounts payable | | | 48 | | | 2,025 | |
Accrued compensation and benefits | | | 352 | | | (201 | ) |
Accrued product development expenses | | | 5,229 | | | 3,136 | |
Other accrued expenses | | | 1,454 | | | (184 | ) |
Deferred revenue | | | (151 | ) | | (188 | ) |
Deferred executive compensation paid | | | (445 | ) | | (137 | ) |
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Net cash used in operating activities | | | (31,835 | ) | | (18,950 | ) |
| | | | | | | |
Cash flows from investing activities: | | | | | | | |
Proceeds from sales and maturities of marketable securities | | | 47,812 | | | 16,590 | |
Purchases of marketable securities | | | (16,687 | ) | | (18,534 | ) |
Investment in property and equipment | | | (5,069 | ) | | (761 | ) |
Investment in intangible assets | | | (584 | ) | | (516 | ) |
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Net cash provided by (used in) investing activities | | | 25,472 | | | (3,221 | ) |
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Cash flows from financing activities: | | | | | | | |
Repayment of borrowings | | | (1,440 | ) | | (1,350 | ) |
Proceeds from issuance of common stock, net of issuance costs | | | 57,860 | | | 40,001 | |
Proceeds from issuance of stock pursuant to stock option and purchase plans | | | 850 | | | 2,169 | |
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Net cash provided by financing activities | | | 57,270 | | | 40,820 | |
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Net increase in cash and cash equivalents | | | 50,907 | | | 18,649 | |
Cash and cash equivalents, beginning of period | | | 18,556 | | | 51,674 | |
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Cash and cash equivalents, end of period | | $ | 69,464 | | $ | 70,323 | |
See notes to unaudited condensed consolidated financial statements.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
1. Management Statement
In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to present fairly the financial position as of September 30, 2005, the results of operations for the three-month and nine-month periods ended September 30, 2005 and 2004 and cash flows for the nine-month periods ended September 30, 2005 and 2004. The results of operations for the nine-month period ended September 30, 2005 are not necessarily indicative of the results to be expected for the full year. These financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K, as amended, for the year ended December 31, 2004, which includes consolidated financial statements and notes thereto for the years ended December 31, 2004, 2003 and 2002.
2. Marketable Securities
The Company has classified its marketable securities as available-for-sale and, accordingly, carries such securities at aggregate fair value. At September 30, 2005, all of the Company’s marketable securities consisted of United States government or agency securities.
At September 30, 2005, the aggregate fair value and amortized cost of the Company’s marketable securities were $26,362,000 and $26,412,000, respectively. Gross unrealized gains and losses were $1,000 and $51,000, respectively, at September 30, 2005.
At December 31, 2004, the aggregate fair value and amortized cost of the Company’s marketable securities were $56,950,000 and $57,011,000, respectively. Gross unrealized gains and losses were $0 and $61,000 respectively, at December 31, 2004.
Realized gains and losses on investment security transactions are reported on the specific-identification method. Realized gains and losses on sales of marketable securities were not material during the nine months ended September 30, 2005. Changes in market values resulted in a decrease in net unrealized loss of $11,000 for the nine-month period ended September 30, 2005.
3. Intangible and Other Assets
Intangible and other assets, net, was comprised of the following at September 30, 2005 and December 31, 2004:
| | | | | |
In thousands | | 2005 | | 2004 | |
| | | | | |
Capitalized patent and license costs | | $ | 9,342 | | $ | 8,796 | |
Less accumulated amortization | | | (4,604 | ) | | (4,067 | ) |
| | | 4,738 | | | 4,729 | |
Unvested deferred executive compensation (Note 5) | | | 1,111 | | | 1,690 | |
Other | | | 72 | | | 63 | |
| | $ | 5,921 | | $ | 6,482 | |
The cost of purchased patents, costs incurred in filing patent applications and certain license fees are capitalized. Capitalized costs related to issued patents are amortized over a period not to exceed seventeen years or the remaining life of the patent, whichever is shorter, using the straight-line method. Capitalized license fees are amortized over the period to which they relate. Amortization expense for intangible assets amounted to $537,000 and $522,000 for the nine months ended September 30, 2005 and 2004, respectively. In addition, capitalized patent and license costs are expensed when it is determined that such technology will not be pursued. The Company expensed $38,000 and $25,000 for the three months ended September 30, 2005 and 2004, respectively, and $38,000 and $57,000 for the nine months ended September 30, 2005 and 2004, respectively, in accordance with this policy.
4. Long-Term Debt
Long-term debt was comprised of the following at September 30, 2005 and December 31, 2004:
In thousands | | 2005 | | 2004 | |
| | | | | |
Bank term note at prime rate or LIBOR +2% (average of 5.6% at September 30, 2005) | | $ | 8,135 | | $ | 9,575 | |
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Less current portion | | | (1,920 | ) | | (1,920 | ) |
Long-term debt | | $ | 6,215 | | $ | 7,655 | |
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The loan is secured by a lien on all assets of the Company excluding intellectual property, which the Company has agreed not to pledge to any other party. This loan is payable in monthly installments of $160,000, plus interest, with a balloon payment of $3.3 million in March 2008. The loan requires the Company to maintain a minimum of $13.0 million in unrestricted cash, cash equivalents and investments. The agreement also contains certain covenants that restrict additional indebtedness, additional liens, sales of assets and dividends, distributions or repurchases of common stock.
The aggregate future principal payments of the above debt agreement are $480,000 for the remainder of 2005, $1.9 million in each of 2006 and 2007, and $3.9 million in 2008.
5. Executive Compensation Plan
Under the Company’s deferred executive compensation plan (the “1997 Plan”), participants may be granted options to purchase shares of certain designated mutual funds at a discount equal to the amount of the award. The options vest equally over four years. Total expense related to this plan amounted to $453,000 and $516,000 for the nine months ended September 30, 2005 and 2004, respectively.
Effective in October 2005, the Company established a new deferred executive compensation plan (the “2005 Plan”) and amended the 1997 Plan to meet the new requirements of Section 409A of the Internal Revenue Code. Under the 2005 Plan, the Company may grant deferred performance-based or ad hoc bonuses to its executive officers, key employees and key advisors. Such awards will include vesting and payment provisions, as provided under the terms of the 2005 Plan. The value of amounts deferred under the 2005 Plan will be based on the actual performance of investments designated by the Company from time to time. In October 2005, the Company made awards under the 2005 Plan in the aggregate amount of $962,000, which will vest over 4 years. The Company will recognize expense related to these awards over the vesting period.
6. Net Loss Per Share
Net loss per share amounts have been computed based on the weighted-average number of common shares outstanding during each period. Because of the net loss reported in each period, diluted and basic per share amounts are the same. For the nine months ended September 30, 2005 and 2004, options to purchase 5,992,644 and 6,095,508 shares of common stock, respectively, were not included in the computation of net loss per share, because the effect would have been anti-dilutive.
7. Common Stock - Sale of Shares and Shelf Registration
On December 19, 2003, the Company filed a shelf registration statement with the United States Securities and Exchange Commission (“SEC”) registering 7,000,000 shares of its common stock. The filing was declared effective on January 9, 2004. On March 29, 2004, the Company sold 5,060,000 of these registered shares in an underwritten public offering at a price of $8.50 per share for net proceeds of approximately $40.0 million. At September 30, 2005, the Company had 1,940,000 shares that remain available for issuance under this shelf registration.
On February 18, 2005, the Company filed a shelf registration statement with the SEC, which was amended on March 11, 2005, registering 9,500,000 shares of common stock. The filing was declared effective on March 14, 2005. On August 10, 2005 and August 18, 2005, the Company sold an aggregate of 8,625,000 of these registered shares in an underwritten public offering at a price of $7.20 per share for net proceeds of approximately $57.9 million. At September 30, 2005, the Company had 875,000 shares that remain available for issuance under this shelf registration.
Lehman Brothers served as the sole-book running manager for both our March 2004 and August 2005 public offerings, for which it received underwriting discounts and commissions of $1,399,090 and $2,018,250, respectively. The spouse of a member of our Board of Directors is a vice chairman of Lehman Brothers. We believe the transactions with Lehman Brothers were entered into on terms no less favorable to us than we could have obtained from unaffiliated third parties.
8. Stock-Based Compensation
The Company uses the intrinsic value method to measure compensation expense associated with grants of stock options to employees. On a pro forma basis, had the Company used the fair value method to measure compensation for all stock options, the net loss and net loss per share would have been reported as follows:
| | Three Months Ended September 30, | | Nine Months Ended September 30, | |
| | | | | | | | | |
In thousands (except per share data) | | 2005 | | 2004 | | 2005 | | 2004 | |
| | | | | | | | | |
Net loss, as reported | | $ | (14,594 | ) | $ | (9,379 | ) | $ | (41,023 | ) | $ | (24,859 | ) |
Effect of stock options if valued at fair value | | | (2,006 | ) | | (994 | ) | | (2,978 | ) | | (3,096 | ) |
| | | | | | | | | | | | | |
Pro forma net loss | | $ | (16,600 | ) | $ | (10,373 | ) | $ | (44,001 | ) | $ | (27,955 | ) |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
Net loss per share, as reported | | $ | (.25 | ) | $ | (.18 | ) | $ | (.75 | ) | $ | (.49 | ) |
Effect of stock options if valued at fair value | | | (.03 | ) | | (.02 | ) | | (.05 | ) | | (.06 | ) |
| | | | | | | | | | | | | |
Pro forma net loss per share | | $ | (.28 | ) | $ | (.20 | ) | $ | (.80 | ) | $ | (.55 | ) |
| | | | | | | | | | | | | |
For purposes of calculating the above disclosure, the fair value of options on their grant date was measured using the Black-Scholes option pricing model. Key assumptions used to apply this pricing model included risk-free interest rates of 4.05% for 2005, and 3.7% for 2004, expected lives of the option grants ranging from one to six years and expected rates of volatility for the underlying stock of 109% for 2005, and 115% for 2004. Using this model, the weighted average fair value per option for all options granted in 2005 and 2004 was $6.15 and $6.00, respectively.
In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123(R), Share-Based Payment, which revised SFAS No. 123 and superseded APB Opinion No.25, Accounting for Stock Issued to Employees. SFAS No. 123(R) requires that companies recognize compensation expense associated with grants of stock options and other equity instruments to employees in the financial statements. On April 21, 2005, the SEC amended Regulation S-X to modify the effective date of SFAS No. 123(R) and, as a result, the Company will be required to adopt SFAS No. 123(R) as of January 1, 2006. The Company has not yet determined the impact of adoption of SFAS No. 123(R) on its consolidated financial statements.
9. Litigation
NF-κB Patent Infringement Litigation and Reexamination
In 2002, the Company, together with Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research and Harvard University (collectively, the “Plaintiffs”) filed a lawsuit in the United States District Court for the District of Massachusetts (the “U.S. District Court”) against Eli Lilly and Company (“Lilly”) alleging infringement upon issuance of certain claims (“the NF-kB ‘516 Claims”) of the Plaintiffs’ U.S. Patent No. 6,410,516 (the “‘516 Patent”) covering methods of treating human disease by regulating NF-kB cell-signaling activity through sales of Lilly’s osteoporosis drug, Evista®, and Lilly’s septic shock drug, Xigris®, and seeking monetary damages from Lilly.
On April 4, 2005, Lilly filed an ex parte request in the United States Patent and Trademark Office (“PTO”) to reexamine the patentability of certain claims of the ‘516 Patent. On June 8, 2005, the PTO mailed to counsel for the patentees of the ‘516 Patent its Order granting a reexamination of all of the claims of the ‘516 Patent. On August 4, 2005, counsel for the patentees of the ‘516 Patent filed a Petition requesting the PTO to vacate its Order granting reexamination of the ‘516 Patent and a Petition requesting the PTO to stay its reexamination (“Patentee’s Petitions”). On October 6, 2005, the PTO mailed to counsel for patentees of the ‘516 Patent its Decision denying Patentee’s Petitions.
In connection with its request for reexamination of the ‘516 patent, Lilly filed a motion in the U.S. District Court on April 4, 2005 requesting a stay of the NF-κB patent infringement litigation by the Court pending reexamination of the ‘516 Patent by the PTO. On June 6, 2005, the U.S. District Court denied Lilly’s motion. On August 8, 2005, the U.S. District Court entered an order setting a pretrial conference in this case for February 21, 2006 and setting trial to commence on April 10, 2006.
The ultimate outcome of the request for reexamination and litigation cannot be determined at this time, and, as a result, no determination can be made with respect to the PTO’s allowance of the claims of the ‘516 patent in the reexamination, nor can any determination be made with respect to the validity or infringement of the claims of the ‘516 patent in the Lilly litigation, nor can an estimate of a damage award or range of awards in the Lilly litigation, if any, be made.
We are engaged in the discovery and development of breakthrough medicines to treat disease by regulating cell signaling with small molecules. Breakthrough medicines are products, created de novo, that may be used to treat diseases in innovative ways. Our initial disease focus is cancer, and we are developing a comprehensive approach that addresses the greatest medical need - novel therapies for aggressive and advanced-stage disease for which current treatments are inadequate. In oncology, our goal is to create a series of novel small-molecule product candidates that provide targeted and highly potent anti-cancer activity to treat both solid tumors and hematologic cancers, as well as the spread of primary tumors to distant sites. Medinol Ltd. (“Medinol”) is also developing stents to deliver our lead cancer product candidate to prevent reblockage at sites of vascular injury following stent-assisted angioplasty. We also have an exclusive license to pioneering technology and patents related to certain NF-κB treatment methods and the discovery and development of drugs to regulate NF-κB cell-signaling activity, which may be useful in treating certain diseases. Additionally, we have developed a proprietary portfolio of cell-signaling regulation technologies, our ARGENT technology, to control intracellular processes with small molecules, providing versatile tools for use in cell biology, functional genomics, proteomics and drug discovery research.
Since our inception in 1991, we have devoted substantially all of our resources to our research and development programs. We receive no revenue from the sale of pharmaceutical products, and most of our revenue to date was received in connection with a joint venture we had with a large pharmaceutical company from 1997 to 1999. Except for the gain on the sale of our fifty percent interest in that joint venture in December 1999, which resulted in net income for fiscal 1999, we have not been profitable since inception. We expect to incur substantial operating losses for the foreseeable future, primarily due to costs associated with our pharmaceutical product development programs, including costs for clinical trials and product manufacturing, personnel and our intellectual property. We expect that losses will fluctuate from quarter to quarter and that these fluctuations may be substantial. As of September 30, 2005, we had an accumulated deficit of $232.6 million and cash, cash equivalents and marketable securities of $95.8 million and working capital of $81.4 million.
General
Our operating losses are primarily due to the costs associated with our pharmaceutical product development programs, personnel and intellectual property protection and enforcement. As our product development programs progress, we incur significant costs for toxicology and pharmacology studies, product development, manufacturing, clinical trials and regulatory support. These costs can vary significantly from quarter to quarter depending on the number of product candidates in development, the stage of development of each product candidate, the number of patients enrolled in and complexity of clinical trials and other factors. Costs associated with our intellectual property include legal fees and other costs to prosecute, maintain, protect and enforce our intellectual property, which can fluctuate from quarter to quarter depending on the status of patent issues being pursued.
Because we currently receive no revenue from the sale of pharmaceutical products and receive only limited license revenue, we have, most recently, relied primarily on the capital markets as our source of funding. In March 2004, we raised approximately $40.0 million, and in August 2005, we raised approximately $57.9 million, through underwritten public offerings of our common stock. We also utilize long-term debt to supplement our funding, particularly as a means to fund investment in property and equipment and infrastructure needs. In addition, we may seek funding from collaborations with pharmaceutical, biotechnology and/or medical device companies for development and commercialization of our product candidates. These collaborations may take the form of licensing arrangements, co-development or joint venture arrangements or other structures. If funding from these various sources is unavailable on reasonable terms, we may be required to reduce our operating expenses in order to conserve cash and capital by delaying, scaling back or eliminating one or more of our product development programs.
Critical Accounting Policies and Estimates
Our financial position and results of operations are affected by subjective and complex judgments, particularly in the areas of deferred compensation benefits for executives and key employees, stock-based compensation to consultants, and the carrying value of intangible assets.
In determining expense related to our deferred executive compensation plan and stock-based compensation to consultants, recorded balances are adjusted at each reporting period to reflect fair value utilizing the Black-Scholes option pricing model that takes into account, among other things, the price and volatility of our common stock or other underlying securities, a risk-free discount rate, and an estimate of the life of the option contract. Fluctuations in those factors can result in uneven expense charges or credits to our statements of operations. If, for example, the market prices of the underlying securities in our executive deferred compensation plan were 10% higher at September 30, 2005, we would have recognized an additional $283,000 in compensation expense in the nine month period ended September 30, 2005. Similarly, if the price and volatility of our common stock were 10% greater as of September 30, 2005, we would have recognized an increase of $9,000 in stock-based compensation to consultants in the nine month period ended September 30, 2005.
At September 30, 2005, we reported $4.7 million of intangible assets, consisting of capitalized costs related primarily to purchased and issued patents, patent applications and licenses, net of accumulated amortization. These costs are being amortized over the estimated useful lives of the underlying patents or licenses. Changes in these lives or a decision to discontinue using the technologies could result in material changes to our balance sheet and statements of operations. For example, during 2005, 2004 and 2003, we expensed $38,000, $87,000 and $520,000, respectively, of unamortized costs related to certain intangible assets which we are not actively pursuing any longer. We have concluded that the carrying value of our remaining intangible assets is not currently impaired because such assets are utilized in our product development programs and/or continue to be viable technologies for collaborations or licensing efforts which we continue to pursue. If we were to abandon the underlying technologies or terminate our efforts to pursue collaborations or license agreements, we may be required to write off a portion of the carrying value of our intangible assets.
Results of Operations
For the three months ended September 30, 2005 and 2004
Revenue
We recognized license revenue of $321,000 in the three month period ended September 30, 2005, compared to $185,000 in the corresponding period in 2004. The increase in license revenue was due primarily to a license agreement into which we entered in January 2005 with Medinol to develop and commercialize stents and other medical devices to deliver our lead product candidate, AP23573, to prevent reblockage of injured vessels following stent-assisted angioplasty.
Operating Expenses
Research and Development Expenses
Research and development expenses increased by $5.0 million, or 67%, to $12.4 million in the three month period ended September 30, 2005, compared to $7.4 million in the corresponding period in 2004. The research and development process necessary to develop a pharmaceutical product for commercialization is subject to extensive regulation by numerous governmental authorities in the United States and other countries. This process typically takes years to complete and requires the expenditure of substantial resources. Current requirements include:
· | preclinical toxicology, pharmacology and metabolism studies, as well as in vivo efficacy studies in relevant animal models of disease; |
· | manufacturing of drug product for preclinical studies and clinical trials and ultimately for commercial supply; |
· | submission of the results of preclinical studies and information regarding manufacturing and control and proposed clinical protocol to the United States Food and Drug Administration (“FDA”) in an Investigational New Drug application (“IND”) (or similar filings with regulatory agencies outside the United States); |
· | conduct of clinical trials designed to provide data and information regarding the safety and efficacy of the product candidate in humans; and |
· | submission of all the results of testing to the FDA in a New Drug Application (“NDA”) (or similar filings with regulatory agencies outside the United States). |
Upon approval by the appropriate regulatory authorities, including in some countries approval of product pricing, we may commence commercial marketing and distribution of the product.
We group our research and development (“R&D”) expenses into two major categories: direct external expenses and all other R&D expenses. Direct external expenses consist of costs of outside parties to conduct laboratory studies, to develop manufacturing processes and manufacture the product candidate, to conduct and manage clinical trials and similar costs related to our clinical and preclinical studies. These costs are accumulated and tracked by product candidate. All other R&D expenses consist of costs to compensate personnel, to purchase lab supplies and services, to maintain our facility, equipment and overhead and similar costs of our research and development efforts. These costs apply to work on our clinical and preclinical candidates as well as our discovery research efforts. These costs are not tracked by product candidate because the number of product candidates and projects in R&D may vary from time to time and because we utilize internal resources across multiple projects at the same time.
Direct external expenses are further categorized as costs for clinical programs and costs for preclinical programs. Preclinical programs include product candidates undergoing toxicology, pharmacology, metabolism and efficacy studies and manufacturing process development required before testing in humans can begin. Product candidates are designated as clinical programs once we have filed an IND with the FDA, or a similar filing with regulatory agencies outside the United States, for the purpose of commencing clinical trials in humans.
Our research and development expenses for the three month period ended September 30, 2005, as compared to the corresponding period in 2004, were as follows:
| | | | | |
| | Three months ended September 30, | | Increase/ | |
In thousands | | | 2005 | | | 2004 | | (decrease) | |
Direct external expenses: | | | | | | | | | | |
Clinical programs | | $ | 7,173 | | $ | 4,063 | | $ | 3,110 | |
Preclinical programs | | | 219 | | | 69 | | | 150 | |
All other R&D expenses | | | 4,989 | | | 3,269 | | | 1,720 | |
| | $ | 12,381 | | $ | 7,401 | | $ | 4,980 | |
AP23573, our lead product candidate which is in Phase 2 clinical trials, was our only clinical program in 2005 and 2004. Direct external expenses for AP23573 increased by $3.1 million in the three-month period ended September 30, 2005, as compared to the corresponding period in 2004, due primarily to increases in clinical trial costs of $3.0 million. In the third quarter of 2005, we continued to enroll patients in our existing clinical trials of AP23573. The increase in clinical trial costs is directly related to the increased enrollment, the costs of evaluating enrolled patients, the costs of managing the trials, laboratory costs and the costs of compiling and analyzing results obtained in the trials.
Through September 30, 2005, we have incurred a total of approximately $34.7 million in direct external expenses for AP23573 from the date it became a clinical program. We expect that our direct external costs for AP23573 will increase in the fourth quarter of 2005 and during 2006 as we continue to expand our clinical trials for this product candidate.
Preclinical programs consist primarily of our oncogenic kinase inhibitor program and our bone-targeted mTOR inhibitor program. Direct external expenses on preclinical programs will increase or decrease from period to period depending on the status and number of programs in this stage of development and the mix between external and internal efforts applied to such programs. Direct external expenses for preclinical programs increased by $150,000 in the three month period ended September 30, 2005 as compared to the corresponding period in 2004 due primarily to the conduct in 2005 of additional studies related to these programs. We expect that our direct external expenses for preclinical programs will increase in the remainder of 2005 and during 2006 as we continue to move these programs forward in development.
All other R&D expenses increased by $1.7 million in the three month period ended September 30, 2005 as compared to the corresponding period in 2004 due to higher personnel and related costs as a result of an increase in the number of personnel and salary adjustments, increases in laboratory supplies and services, depreciation and amortization costs due to investments in property and equipment, and maintenance and utility costs related to our facility. We expect that all other R&D expenses will continue to increase in the remainder of 2005 and during 2006 in support of our clinical and preclinical development programs.
The successful development of our products is uncertain and subject to a number of risks. We cannot be certain that any of our product candidates will prove to be safe and effective or will meet all of the applicable regulatory requirements needed to receive and maintain marketing approval. Data from preclinical studies and clinical trials are susceptible to varying interpretations that could delay, limit or prevent regulatory clearance. We, the FDA or other regulatory authorities may suspend clinical trials at any time if we or they believe that the subjects participating in such trials are being exposed to unacceptable risks or if such regulatory agencies find deficiencies in the conduct of the trials or other problems with our products under development. Delays or rejections may be encountered based on additional governmental regulation, legislation, administrative action or changes in FDA or other regulatory policy during development or the review process. Other risks associated with our product development programs are described in Risk Factors in our Form 10-K, as amended, for the fiscal year ended December 31, 2004, which has been filed with the SEC. Due to these uncertainties, accurate and meaningful estimates of the ultimate cost to bring a product to market, the timing of completion of any of our drug development programs and the period in which material net cash inflows from any of our drug development programs will commence are unavailable.
General and Administrative Expenses
General and administrative expenses were $2.9 million in the three month period ended September 30, 2005, as compared to $2.4 million in the corresponding period in 2004. Professional fees increased by $535,000 to $1.5 million in the three month period ended September 30, 2005 as compared to $997,000 in the corresponding period in 2004, due primarily to costs related to business and commercial development initiatives. This increase was offset in part by a decrease in expenses related to a restricted stock grant to our Chief Executive Officer in January 2004 which was fully amortized by December 31, 2004. We expect that our general and administrative expenses will continue to increase in the remainder of 2005 and during 2006 as necessary to support our research and development programs.
We expect that our operating expenses in total will increase in the remainder of 2005 and during 2006 for the reasons described above, and such increases could be substantial given the anticipated expansion of our clinical trials for AP23573. Operating expenses may fluctuate from quarter to quarter. The actual amount of any increase in operating expenses will depend on the progress of our product development programs, including preclinical and clinical studies and product manufacturing, the status of our patent infringement litigation with Lilly and our ability to raise funding through equity offerings, collaborations, licensing, joint ventures or other sources.
Interest Income/Expense
Interest income increased to $474,000 in the three month period ended September 30, 2005 from $281,000 in the corresponding period in 2004, as a result of a higher interest yields from our securities, offset in part by a lower average balance of funds invested in 2005.
Interest expense increased to $116,000 in the three month period ended September 30, 2005 from $58,000 in the corresponding period in 2004, as a result of higher interest rates in 2005 and higher average loan balances.
Operating Results
We reported a loss from operations of $15.0 million in the three month period ended September 30, 2005 compared to a loss from operations of $9.6 million in the corresponding period in 2004, an increase in loss of $5.4 million, or 56%. Such increase was due primarily to the increase in operating expenses noted above. We expect that our loss from operations will continue to increase in the remainder of 2005 and during 2006 due to the expected increases in research and development expenses and general and administrative expenses described above. Such increases could be substantial. Losses may fluctuate depending on the extent to which, if at all, we enter into collaborations for one or more of our product candidates or licenses for our technologies. The extent of operating losses will also depend on our ability to raise funds from other sources, such as the capital markets, which will influence the amount we will spend on research and development and the development timelines for our product candidates.
We reported a net loss of $14.6 million in the three month period ended September 30, 2005, compared to a net loss of $9.4 million in the corresponding period in 2004, an increase in net loss of $5.2 million or 56%, and a net loss per share of $0.25 and $0.18, respectively.
Results of Operations
For the nine months ended September 30, 2005 and 2004
Revenue
We recognized license revenue of $975,000 in the nine month period ended September 30, 2005, compared to $563,000 in the corresponding period of 2004. The increase in license revenue was due primarily to a license agreement into which we entered in January 2005 with Medinol to develop and commercialize stents and other medical devices to deliver our AP23573 to prevent reblockage of injured vessels following stent-assisted angioplasty.
Operating Expenses
Research and Development Expenses
Research and development expenses increased by $16.3 million, or 86%, to 35.1 million in the nine month period ended September 30, 2005, compared to $18.8 million in the corresponding period in 2004.
Our research and development expenses for the nine month period ended September 30, 2005, as compared to the corresponding period in 2004, were as follows:
| | | | | |
| | Nine months ended September 30, | | Increase/ | |
In thousands | | 2005 | | 2004 | | (decrease) | |
Direct external expenses: | | | | | | | | | | |
Clinical programs | | $ | 20,580 | | $ | 6,700 | | $ | 13,880 | |
Preclinical programs | | | 1,023 | | | 3,225 | | | (2,202 | ) |
All other R&D expenses | | | 13,525 | | | 8,911 | | | 4,614 | |
| | $ | 35,128 | | $ | 18,836 | | $ | 16,292 | |
Direct external expenses for AP23573, our sole clinical program in 2005 and 2004, increased by $13.9 million in the nine month period ended September 30, 2005 as compared to the corresponding period in 2004 due primarily to increases in clinical trial costs of $9.5 million and manufacturing-related costs of $4.0 million. In 2005, we continued to enroll patients in our existing clinical trials of AP23573 and initiated new clinical trials in additional disease indications, including prostate and endometrial cancer. The increase in clinical trial costs is directly related to the increased enrollment, the costs of evaluating enrolled patients, the costs of managing the trials, laboratory costs and the costs of compiling and analyzing results obtained in the trials. Manufacturing costs for AP23573 increased in the nine month period ended September 30, 2005, as compared to the corresponding period in 2004, due to an increase in the quantities of drug product manufactured for the clinical trials and investments in manufacturing process development.
Direct external expenses for preclinical programs decreased by $2.2 million in the nine month period ended September 30, 2005, as compared to the corresponding period in 2004, due primarily to the completion of certain pharmacology and toxicology studies conducted by outside contract laboratories in 2004.
All other R&D expenses increased by $4.6 million in the nine month period ended September 30, 2005, as compared to the corresponding period in 2004, due to higher personnel and related costs as a result of an increase in the number of personnel and salary adjustments, increases in laboratory supplies and services, depreciation and amortization costs due to investments in property and equipment, and maintenance and utility costs related to our facility.
General and Administrative Expenses
General and administrative expenses increased to $7.8 million in the nine month period ended September 30, 2005 from $7.2 million in the corresponding period in 2004. Professional fees increased by $988,000 to $4.2 million in the nine month period ended September 30, 2005 as compared to $3.2 million in the corresponding period in 2004, due primarily to costs related to business and commercial development initiatives. This increase was offset in part by a decrease in expenses related to a restricted stock grant to our Chief Executive Officer in January 2004 which was fully amortized by December 31, 2004.
Interest Income/Expense
Interest income increased to $1.2 million in the nine month period ended September 30, 2005 from $778,000 in the corresponding period in 2004, as a result of a higher level of funds invested and higher interest yields from our securities in 2005, offset in part by lower average balances of funds invested.
Interest expense increased to $298,000 in the nine month period ended September 30, 2005 from $195,000 in the corresponding period in 2004, as a result of higher average loan balances and higher interest rates in 2005.
Operating Results
We reported a loss from operations of $42.0 million in the nine month period ended September 30, 2005, compared to a loss from operations of $25.4 million in the corresponding period in 2004, an increase in loss of $16.6 million, or 65%. Such increase was due primarily to the increases in operating expenses noted above.
We reported a net loss of $41.0 million in the nine month period ended September 30, 2005, compared to a net loss of $24.9 million in the corresponding period in 2004, an increase in net loss of $16.1 million or 65%, and a net loss per share of $0.75 and $0.49, respectively.
Liquidity and Capital Resources
We have financed our operations and investments primarily through sales of our common stock to institutional investors and, to a lesser extent, through issuances of our common stock pursuant to our stock option and employee stock purchase plans, supplemented by the issuance of long-term debt. We sell securities and incur debt when the terms of such transactions are deemed favorable to us and as necessary to fund our current and projected cash needs. We seek to balance the level of cash, cash equivalents and marketable securities on hand with our projected needs and to allow us to withstand periods of uncertainty relative to the availability of funding on favorable terms.
Sources of Funds
For the nine months ended September 30, 2005 and 2004, our sources of funds were as follows:
| | Nine Months Ended September 30, | |
In thousands | | 2005 | | 2004 | |
| | | | | |
Sales of common stock pursuant to underwritten public offerings | | $ | 57,860 | | $ | 40,001 | |
Issuances of common stock pursuant to stock option and purchase plans | | | 850 | | | 2,169 | |
| | $ | 58,710 | | $ | 42,170 | |
In August 2005 and March 2004, we completed underwritten public offerings of our common stock from which we realized net proceeds of approximately $57.9 million and $40.0 million, respectively. In addition, we issued shares of our common stock upon exercise of outstanding stock options under our stock option plans and pursuant to our employee stock purchase plan.
Uses of Funds
The primary uses of our cash are to fund our operations and working capital requirements and, to a lesser degree, to repay our long-term debt, to invest in intellectual property and to invest in our property and equipment as needed for our business. For the nine months ended September 30, 2005 and 2004, our uses of funds were as follows:
| | Nine Months Ended September 30, | |
In thousands | | 2005 | | 2004 | |
| | | | | |
Net cash used in operating activities | | $ | 31,835 | | $ | 18,950 | |
Repayment of borrowings | | | 1,440 | | | 1,350 | |
Investment in intangible assets | | | 584 | | | 516 | |
Investment in property and equipment | | | 5,069 | | | 761 | |
| | $ | 38,928 | | $ | 21,577 | |
The net cash used in operating activities is comprised of our net losses, adjusted for non-cash expenses and working capital requirements. As noted above, our net loss for the nine months ended September 30, 2005 increased by $16.1 million, as compared to the corresponding period in 2004, due primarily to the costs of advancing our product candidates through preclinical and clinical phases of development. However, as a result of increases in our accounts payable and accrued expenses from December 31, 2004 to September 30, 2005, our net cash used in operating activities increased by only $12.9 million for the nine months ended September 30, 2005, compared with the corresponding period in 2004. Also, as noted above, we expect that our loss from operations will increase in the remainder of 2005 and during 2006 due to continued progress in development of our product candidates, and we expect that our net cash used in operations will increase accordingly. We also expect that our investment in intangible assets, consisting of our intellectual property, will increase in support of our product development activities. We expect that our capital expenditures will increase over the remainder of 2005 as we complete additional building improvements in our laboratory and office facility.
Contractual Obligations
We have substantial fixed contractual obligations under various research and licensing agreements, consulting and employment agreements, lease agreements and long-term debt instruments. These contractual obligations were comprised of the following as of September 30, 2005:
In thousands | | | | Payments Due By Period | |
| | Total | | In 2005 | | 2006 through 2008 | | 2009 through 2010 | | After 2010 | |
| | | | | | | | | | | |
Long-term debt* | | $ | 8,135 | | $ | 480 | | $ | 7,655 | | $ | — | | $ | — | |
| | | | | | | | | | | | | | | | |
Operating leases, net of sub-leases | | | 1,008 | | | 137 | | | 871 | | | — | | | — | |
| | | | | | | | | | | | | | | | |
Other long-term obligations ** | | | 9,661 | | | 812 | | | 8,254 | | | 230 | | | 365 | |
| | | | | | | | | | | | | | | | |
Total fixed contractual obligations | | $ | 18,804 | | $ | 1,429 | | $ | 16,780 | | $ | 230 | | $ | 365 | |
| | | | | | | | | | | | | | | | |
* Long-term debt consists of scheduled principal payments on such debt. Interest on our long-term debt is based on variable interest rates. Assuming a constant interest rate of 5.6%, our average interest rate on our debt at September 30, 2005, over the remaining term of the debt, our interest expense would total approximately $147,000 for the remainder of 2005 and $682,000 in the period 2006 through 2008.
** Other long-term obligations are comprised primarily of employment agreements and license agreements. The license agreements generally provide for payment by us of annual license fees, milestone payments and royalties upon successful commercialization of products. All license agreements are cancelable by us. The above table reflects remaining license fees for the lives of the agreements but excludes milestone and royalty payments, as such amounts are not probable or estimable at this time.
Liquidity
At September 30, 2005, we had cash, cash equivalents and marketable securities totaling $95.8 million and working capital of $81.4 million, compared to cash, cash equivalents and marketable securities totaling $75.5 million and working capital of $68.9 million at December 31, 2004.
We will require substantial additional funding for our research and development programs, including pre-clinical development and clinical trials, for operating expenses including intellectual property protection and enforcement, for the pursuit of regulatory approvals, and for establishing manufacturing, marketing and sales capabilities. In order to fund our needs, we may (1) sell common stock through public or private offerings as market conditions permit, (2) enter into partnerships for our product candidates, and/or (3) license our cell-signaling technologies, including our ARGENT and NF-kB intellectual property portfolios. We have available 2,815,000 shares of our common stock under currently effective shelf registration statements, which may be sold to raise capital.
We believe that our cash, cash equivalents and marketable securities should be sufficient to satisfy our capital and operating requirements into 2007. However, there are numerous factors that are likely to affect our spending levels, including the timing of the start of the initial registration trial for AP23573, the timing of product and process development work for AP23573, the manufacture of drug product for clinical trials and potential product launch, if approved, developments in our ongoing clinical trials, the timing and terms of a partnership, if any, to commercialize AP23573 outside of the U.S., the status of our in-house efforts to prepare for the potential launch of AP23573 in the U.S., the progress of our preclinical programs, and developments in our NF-kB litigation, among other factors. These variables could result in earlier depletion of our current funds if we are to achieve our intended timelines for development. In any event, we expect to need additional capital in order to pursue our business plan, which we will seek to raise through the sale of additional securities, collaborative partnerships, and possible additional credit arrangements. There can be no assurance, however, that adequate resources will be available when needed or on terms acceptable to us.
Securities Litigation Reform Act
Safe harbor statement under the Private Securities Litigation Reform Act of 1995: Except for the historical information contained in this Quarterly Report on Form 10-Q, the matters discussed herein are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are identified by the use of words such as “anticipate,”“estimate,”“expect,”“project,”“intend,”“plan,”“believe,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such statements are based on management’s current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding our ability to accurately estimate the timing and actual research and development expenses and other costs associated with the preclinical and clinical development and manufacture of our product candidates, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding our ability to successfully enroll and conduct preclinical and clinical studies of product candidates, risks and uncertainties regarding our ability to manufacture our product candidates on a commercial scale or to supply our product candidates to collaborators, risks and uncertainties regarding our and our collaborator’s ability to successfully enroll and conduct preclinical and clinical studies of product candidates, risks and uncertainties that clinical trial results at any phase of development may be adverse or may not be predictive of future result or lead to regulatory approval of any of our or any collaborator’s product candidates, risks and uncertainties of third-party intellectual property claims relating to our and any collaborator’s product candidates, and risks and uncertainties relating to regulatory oversight, the timing, scope, cost and outcome of legal proceedings, future capital needs, key employees, dependence on collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement rates, competition and other risks detailed under the heading “Risk Factors” in our Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2004, which has been filed with the SEC. As a result of these and other factors, actual events or results could differ materially from those described herein. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
We invest our available funds in accordance with our investment policy to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment.
We invest cash balances in excess of operating requirements first in short-term, highly liquid securities, with maturities of 90 days or less, and money market accounts. Depending on our level of available funds and our expected cash requirements, we may invest a portion of our funds in marketable securities, consisting generally of corporate debt and U.S. government and agency securities. Maturities of our marketable securities are generally limited to periods necessary to fund our liquidity needs and may not in any case exceed three years. These securities are classified as available-for-sale. Available-for-sale securities are recorded on the balance sheet at fair market value with unrealized gains or losses reported as a separate component of stockholders’ equity (accumulated other comprehensive income or loss). Realized gains and losses on marketable security transactions are reported on the specific-identification method. Interest income is recognized when earned. A decline in the market value of any available-for-sale security below cost that is deemed other than temporary results in a charge to earnings and establishes a new cost basis for the security.
Our investments are sensitive to interest rate risk. We believe, however, that the effect, if any, of reasonable possible near-term changes in interest rates on our financial position, results of operations and cash flows generally would not be material due to the current short-term nature of these investments. In particular, at September 30, 2005, because our available funds are invested solely in short-term securities with remaining maturities of twelve months or less, our risk of loss due to changes in interest rates is not material.
We have an executive compensation plan which provides participants, in lieu of a cash bonus, an option to purchase certain designated mutual funds at a discount equal to the amount of the bonus. These deferred compensation arrangements are accounted for as derivatives under SFAS No. 133. The fair value of the derivatives is reflected as a liability on our balance sheet. As of September 30, 2005, in the event of a hypothetical 10% increase in the fair market value of the underlying mutual funds and after giving effect to the related volatility change, we would incur approximately $283,000 of additional compensation expense.
At September 30, 2005, we had $8.1 million outstanding under a bank term note which bears interest at prime or, alternatively, LIBOR + 2%. This note is sensitive to interest rate risk. In the event of a hypothetical 10% increase in the interest rate on which the loan is based (67.5 basis points), we would incur approximately $48,000 of additional interest expense per year based on expected balances over the next twelve months.
(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our 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, our disclosure controls and procedures were adequate and effective to ensure that material information relating to us, including our consolidated subsidiaries, was made known to them by others within those entities, particularly during the period in which this Quarterly Report on Form 10-Q was being prepared.
In designing and evaluating our disclosure controls and procedures, our management recognizes 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 is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the last fiscal quarter, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
NF-κB Patent Infringement Litigation and Reexamination
The information contained in Part II, Item 1 of our Annual Report on Form 10-K, as amended, for the year ended December 31, 2004 (File No. 0-21826) is incorporated by reference.
In 2002, the Company, together with Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research and Harvard University (collectively, the “Plaintiffs”) filed a lawsuit in the United States District Court for the District of Massachusetts (the “U.S. District Court”) against Eli Lilly and Company (“Lilly”) alleging infringement upon issuance of certain claims (“the NF-kB ‘516 Claims”) of the Plaintiffs’ U.S. Patent No. 6,410,516 (the “’516 Patent”) covering methods of treating human disease by regulating NF-kB cell-signaling activity through sales of Lilly’s osteoporosis drug, Evista®, and Lilly’s septic shock drug, Xigris®, and seeking monetary damages from Lilly.
On April 4, 2005, Lilly filed an ex parte request in the United States Patent and Trademark Office (“PTO”) to reexamine the patentability of certain claims of the ’516 Patent. On June 8, 2005, the PTO mailed to counsel for the patentees of the ‘516 Patent its Order granting a reexamination of all of the claims of the ‘516 Patent. On August 4, 2005, counsel for the patentees of the ‘516 Patent filed a Petition requesting the PTO to vacate its Order granting reexamination of the ‘516 Patent and a Petition requesting the PTO to stay its reexamination (“Patentee’s Petitions”). On October 6, 2005, the PTO mailed to counsel for patentees of the ‘516 Patent its Decision denying Patentee’s Petitions.
In connection with its request for reexamination of the ‘516 patent, Lilly filed a motion in the U.S. District Court on April 4, 2005 requesting a stay of the NF-κB patent infringement litigation by the Court pending reexamination of the ‘516 Patent by the PTO. On June 6, 2005, the U.S. District Court denied Lilly’s motion. On August 8, 2005, the U.S. District Court entered an order setting a pretrial conference in this case for February 21, 2006 and setting trial to commence on April 10, 2006.
The ultimate outcome of the request for reexamination and litigation cannot be determined at this time, and, as a result, no determination can be made with respect to the PTO’s allowance of the claims of the ‘516 patent in the reexamination, nor can any determination be made with respect to the validity or infringement of the claims of the ‘516 patent in the Lilly litigation, nor can an estimate of a damage award or range of awards in the Lilly litigation, if any, be made.
10.1 | ARIAD Pharmaceuticals, Inc. 2005 Executive Compensation Plan. |
10.2 | Amendment to ARIAD Pharmaceuticals, Inc. 1997 Executive Compensation Plan. |
10.3 | ARIAD Pharmaceuticals, Inc. Amended and Restated 2001 Stock Plan. |
10.4 | Executive Bonus and Stock Option Arrangements. |
10.5 | Director Compensation Arrangements. |
10.6 | Amendment to Employment Agreements, as of October 4, 2005, between ARIAD Pharmaceuticals, Inc. and each of Laurie A. Allen, Esq., Camille L. Bedrosian, M.D., David L. Berstein, Esq., Timothy P. Clackson, Ph.D., Edward M. Fitzgerald and John D. Iuliucci, Ph.D. |
31.1 | Certification of the Chief Executive Officer. |
| |
31.2 | Certification of the Chief Financial Officer. |
| |
32.1 | Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
ARIAD and the ARIAD logo are our registered trademarks and ARGENT is our trademark. The domain name and website address www.ariad.com, and all rights thereto, are registered in the name of, and owned by, ARIAD. The information in our website is not intended to be part of this Quarterly Report on Form 10-Q. We include our website address herein only as an inactive textual reference and do not intend it to be an active link to our website.
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.
| | ARIAD Pharmaceuticals, Inc. |
| | (Registrant) |
| | |
| By: | /s/ Harvey J. Berger, M.D. |
| | Harvey J. Berger, M.D. |
| | Chairman and Chief Executive Officer |
| | |
| | |
| By: | /s/ Edward M. Fitzgerald |
| | Edward M. Fitzgerald |
| | Senior Vice President, Finance and Corporate Operations |
| | and Chief Financial Officer |
| | (Duly authorized officer, principal financial officer |
Date: November 8, 2005 | | and chief accounting officer) |
Exhibit No. | Title |
| |
10.1 | ARIAD Pharmaceuticals, Inc. 2005 Executive Compensation Plan. |
10.2 | Amendment to ARIAD Pharmaceuticals, Inc. 1997 Executive Compensation Plan. |
10.3 | ARIAD Pharmaceuticals, Inc. Amended and Restated 2001 Stock Plan. |
10.4 | Executive Bonus and Stock Option Arrangements. |
10.5 | Director Compensation Arrangements. |
10.6 | Amendment to Employment Agreements, as of October 4, 2005, between ARIAD Pharmaceuticals, Inc. and each of Laurie A. Allen, Esq., Camille L. Bedrosian, M.D., David L. Berstein, Esq., Timothy P. Clackson, Ph.D., Edward M. Fitzgerald and John D. Iuliucci, Ph.D. |
31.1 | Certification of the Chief Executive Officer. |
| |
31.2 | Certification of the Chief Financial Officer. |
| |
32.1 | Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |