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TABLE OF CONTENTS QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 2009
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
ý | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended | ||
or | ||
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period fromto | ||
Commission File No. 0-16614
PONIARD PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
Washington (State or other jurisdiction of incorporation or organization) | 91-1261311 (IRS Employer Identification No.) |
7000 Shoreline Court, Suite 270, South San Francisco, CA 94080
(Address of principal executive offices)
Registrant's telephone number, including area code:(650) 583-3774
Indicate by check mark whether the Registrant:registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ý No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
Large accelerated filero | ||||||||
Non-accelerated filer | o | (Do not check if a smaller reporting company) | Smaller reporting company | 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 ý
As of OctoberJuly 31, 2008, 34,687,7242009, 34,742,847 shares of the Registrant'sregistrant's common stock, $.02$0.02 par value per share, were outstanding.
TABLE OF CONTENTS
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBERJUNE 30, 20082009
PAGE | ||||||||
---|---|---|---|---|---|---|---|---|
PART I | FINANCIAL INFORMATION | |||||||
Item 1. | Financial Statements: | |||||||
Condensed Consolidated Balance Sheets as of | 3 | |||||||
Condensed Consolidated Statements of Operations for the Three and | 4 | |||||||
Condensed Consolidated Statements of Cash Flows for the | 5 | |||||||
Notes to Condensed Consolidated Financial Statements (unaudited) | 6 | |||||||
Item 2. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 17 | ||||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 23 | ||||||
Item 4. | Controls and Procedures | 23 | ||||||
PART II | OTHER INFORMATION | |||||||
Item 1A. | Risk Factors | 25 | ||||||
Item 4. | Submission of Matters to a Vote of Security Holders | 25 | ||||||
Item 6. | Exhibits | 25 | ||||||
Signatures | 26 | |||||||
Exhibit Index | 27 |
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS(unaudited)
(inIn thousands, except share data)
| June 30, 2009 | December 31, 2008 | ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | September 30, 2008 | December 31, 2007 | | (Unaudited) | (Note 1) | ||||||||||||||||
ASSETS | ASSETS | ASSETS | ||||||||||||||||||||
Current assets: | Current assets: | Current assets: | ||||||||||||||||||||
Cash and cash equivalents | $ | 45,527 | $ | 29,335 | Cash and cash equivalents | $ | 18,603 | $ | 44,144 | |||||||||||||
Cash—restricted | 281 | 281 | Cash—restricted | 281 | 281 | |||||||||||||||||
Investment securities | 38,515 | 63,286 | Investment securities | 31,306 | 28,611 | |||||||||||||||||
Prepaid expenses and other current assets | 1,370 | 955 | Prepaid expenses and other current assets | 929 | 977 | |||||||||||||||||
Total current assets | 85,693 | 93,857 | Total current assets | 51,119 | 74,013 | |||||||||||||||||
Facilities and equipment, net of depreciation of $1,236 and $954 | 1,183 | 1,121 | Facilities and equipment, net of depreciation of $1,183 and $1,319 | 331 | 1,123 | |||||||||||||||||
Other assets | 309 | 141 | Other assets | 174 | 289 | |||||||||||||||||
Licensed products, net | 9,110 | 10,021 | Licensed products, net | 8,199 | 8,807 | |||||||||||||||||
Total assets | $ | 96,295 | $ | 105,140 | Total assets | $ | 59,823 | $ | 84,232 | |||||||||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | LIABILITIES AND SHAREHOLDERS' EQUITY | LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||||||||||
Current liabilities: | Current liabilities: | Current liabilities: | ||||||||||||||||||||
Accounts payable | $ | 892 | $ | 677 | Accounts payable | $ | 2,029 | $ | 604 | |||||||||||||
Accrued liabilities | 8,425 | 4,550 | Accrued liabilities | 7,866 | 10,688 | |||||||||||||||||
Current maturities of note payable and capital lease obligations | 7,917 | 4,247 | Current portion of note payable | 8,561 | 7,886 | |||||||||||||||||
Total current liabilities | 17,234 | 9,474 | Total current liabilities | 18,456 | 19,178 | |||||||||||||||||
Long-term liabilities: | Long-term liabilities: | Long-term liabilities: | ||||||||||||||||||||
Note payable and capital lease obligations, net of current portion and discount of $3,311 and $1,018 | 19,094 | 6,561 | Note payable obligation, noncurrent portion, net | 13,496 | 17,407 | |||||||||||||||||
Total long-term liabilities | 19,094 | 6,561 | ||||||||||||||||||||
Commitments and contingencies (Note 12) | Commitments and contingencies (Note 12) | |||||||||||||||||||||
Shareholders' equity: | Shareholders' equity: | Shareholders' equity: | ||||||||||||||||||||
Preferred stock, $.02 par value, 2,998,425 shares authorized: | Preferred stock, $0.02 par value, 2,998,425 shares authorized: | |||||||||||||||||||||
Convertible preferred stock, Series 1, 205,340 shares issued and outstanding (entitled in liquidation to $5,300 and $5,175, respectively) | 4 | 4 | Convertible preferred stock, Series 1, 205,340 shares issued and outstanding (entitled in liquidation to $5,175) | 4 | 4 | |||||||||||||||||
Common stock, $.02 par value, 200,000,000 shares authorized: | Common stock, $0.02 par value, 200,000,000 shares authorized: | |||||||||||||||||||||
34,687,724 and 34,662,689 shares issued and outstanding | 694 | 693 | 34,729,885 and 34,687,724 shares issued and outstanding | 695 | 694 | |||||||||||||||||
Additional paid-in capital | 407,735 | 401,225 | Additional paid-in capital | 412,052 | 409,244 | |||||||||||||||||
Accumulated deficit, including other comprehensive income (loss) of $(592) and $59 | (348,466 | ) | (312,817 | ) | Other comprehensive loss | (19 | ) | (354 | ) | |||||||||||||
Accumulated deficit | (384,861 | ) | (361,941 | ) | ||||||||||||||||||
Total shareholders' equity | 59,967 | 89,105 | ||||||||||||||||||||
Total shareholders' equity | 27,871 | 47,647 | ||||||||||||||||||||
Total liabilities and shareholders' equity | $ | 96,295 | $ | 105,140 | ||||||||||||||||||
Total liabilities and shareholders' equity | $ | 59,823 | $ | 84,232 | ||||||||||||||||||
See notes to the condensed consolidated financial statements.
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)
(inIn thousands, except per share amounts)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | ||||||||||
Revenues | $ | — | $ | — | $ | — | $ | — | ||||||
Operating expenses: | ||||||||||||||
Research and development | 9,024 | 5,050 | 24,511 | 16,362 | ||||||||||
General and administrative | 3,383 | 2,806 | 11,289 | 8,584 | ||||||||||
Total operating expenses | 12,407 | 7,856 | 35,800 | 24,946 | ||||||||||
Loss from operations | (12,407 | ) | (7,856 | ) | (35,800 | ) | (24,946 | ) | ||||||
Other income (expense): | ||||||||||||||
Interest income | 547 | 1,319 | 2,210 | 3,062 | ||||||||||
Interest expense | (329 | ) | (422 | ) | (1,021 | ) | (1,332 | ) | ||||||
Other, net | (48 | ) | — | (12 | ) | — | ||||||||
Other income, net | 170 | 897 | 1,177 | 1,730 | ||||||||||
Net loss | (12,237 | ) | (6,959 | ) | (34,623 | ) | (23,216 | ) | ||||||
Preferred stock dividends | (125 | ) | (125 | ) | (375 | ) | (375 | ) | ||||||
Net loss applicable to common shares | $ | (12,362 | ) | $ | (7,084 | ) | $ | (34,998 | ) | $ | (23,591 | ) | ||
Net loss per share applicable to common shares—basic and diluted | $ | (0.36 | ) | $ | (0.20 | ) | $ | (1.01 | ) | $ | (0.80 | ) | ||
Weighted average common shares outstanding—basic and diluted | 34,688 | 34,657 | 34,685 | 29,449 | ||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | 2009 | 2008 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 5,653 | $ | 9,151 | $ | 13,757 | $ | 15,487 | ||||||||
General and administrative | 3,435 | 3,723 | 6,519 | 7,906 | ||||||||||||
Restructuring | — | — | 468 | — | ||||||||||||
Asset impairment loss | — | — | 588 | — | ||||||||||||
Total operating expenses | 9,088 | 12,874 | 21,332 | 23,393 | ||||||||||||
Loss from operations | (9,088 | ) | (12,874 | ) | (21,332 | ) | (23,393 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest expense | (796 | ) | (331 | ) | (1,663 | ) | (692 | ) | ||||||||
Interest income and other, net | 164 | 674 | 325 | 1,699 | ||||||||||||
Total other income (expense) | (632 | ) | 343 | (1,338 | ) | 1,007 | ||||||||||
Net loss | (9,720 | ) | (12,531 | ) | (22,670 | ) | (22,386 | ) | ||||||||
Preferred stock dividends | (125 | ) | (125 | ) | (250 | ) | (250 | ) | ||||||||
Net loss applicable to common shares | $ | (9,845 | ) | $ | (12,656 | ) | $ | (22,920 | ) | $ | (22,636 | ) | ||||
Net loss per share applicable to common shares—basic and diluted | $ | (0.28 | ) | $ | (0.36 | ) | $ | (0.66 | ) | $ | (0.65 | ) | ||||
Weighted average common shares outstanding—basic and diluted | 34,712 | 34,688 | 34,700 | 34,684 | ||||||||||||
See notes to the condensed consolidated financial statements.
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(unaudited)(In thousands)(in thousands)(Unaudited)
| Nine Months Ended September 30, | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
| 2008 | 2007 | ||||||||
Cash flows from operating activities: | ||||||||||
Net loss | $ | (34,623 | ) | $ | (23,216 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
Depreciation and amortization | 1,193 | 1,130 | ||||||||
Amortization of discount on notes payable | 440 | 593 | ||||||||
Amortization of discount on investment securities | (392 | ) | (716 | ) | ||||||
Stock options and warrants issued for services | 95 | 56 | ||||||||
Stock-based employee compensation | 5,519 | 3,480 | ||||||||
Change in operating assets and liabilities: | ||||||||||
Prepaid expenses and other assets | (415 | ) | (662 | ) | ||||||
Accounts payable | 215 | (206 | ) | |||||||
Accrued liabilities | 3,750 | 1,271 | ||||||||
Net cash used in operating activities | (24,218 | ) | (18,270 | ) | ||||||
Cash flows from investing activities: | ||||||||||
Proceeds from sales and maturities of investment securities | 65,800 | 37,860 | ||||||||
Purchases of investment securities | (41,288 | ) | (87,032 | ) | ||||||
Facilities and equipment purchases | (344 | ) | (735 | ) | ||||||
Net cash provided by (used in) investing activities | 24,168 | (49,907 | ) | |||||||
Cash flows from financing activities: | ||||||||||
Net proceeds from bank note payable | 19,997 | — | ||||||||
Repayment of principal on notes payable | (3,375 | ) | (2,900 | ) | ||||||
Payment of debt issuance costs | (200 | ) | — | |||||||
Proceeds from stock options and warrants exercised | 91 | — | ||||||||
Repayment of capital lease obligation | (21 | ) | (28 | ) | ||||||
Net proceeds from issuance of common stock and warrants | — | 69,946 | ||||||||
Increase in restricted cash | — | (145 | ) | |||||||
Payment of licensed product payable | — | (5,000 | ) | |||||||
Payment of preferred dividends | (250 | ) | (250 | ) | ||||||
Net cash provided by financing activities | 16,242 | 61,623 | ||||||||
Net increase (decrease) in cash and cash equivalents | 16,192 | (6,554 | ) | |||||||
Cash and cash equivalents: | ||||||||||
Beginning of period | 29,335 | 44,148 | ||||||||
End of period | $ | 45,527 | $ | 37,594 | ||||||
Supplemental disclosure of non-cash financing activity: | ||||||||||
Accrual of preferred dividend | $ | 125 | $ | 125 | ||||||
Capital lease | $ | — | $ | 133 | ||||||
Supplemental disclosure of cash paid during the period for: | ||||||||||
Interest | $ | 529 | $ | 759 | ||||||
| Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | |||||||
Cash flows from operating activities: | |||||||||
Net loss | $ | (22,670 | ) | $ | (22,386 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
Depreciation and amortization | 773 | 790 | |||||||
Amortization of discount on notes payable | 745 | 332 | |||||||
(Amortization) accretion of (discount) premium on investment securities | 220 | (238 | ) | ||||||
Gain on disposal of facilities and equipment | (18 | ) | — | ||||||
Asset impairment loss | 588 | — | |||||||
Restructuring | 31 | — | |||||||
Stock-based compensation issued for services | 65 | 12 | |||||||
Stock-based employee compensation | 2,719 | 3,992 | |||||||
Change in operating assets and liabilities: | |||||||||
Prepaid expenses and other assets | 164 | (453 | ) | ||||||
Accounts payable | 1,425 | 127 | |||||||
Accrued liabilities | (2,835 | ) | 2,644 | ||||||
Net cash used in operating activities | (18,793 | ) | (15,180 | ) | |||||
Cash flows from investing activities: | |||||||||
Proceeds from maturities of investment securities | 24,650 | 50,900 | |||||||
Purchases of investment securities | (27,230 | ) | (29,901 | ) | |||||
Facilities and equipment purchases | (18 | ) | (212 | ) | |||||
Proceeds from disposals of equipment and facilities | 24 | — | |||||||
Net cash provided by (used in) investing activities | (2,574 | ) | 20,787 | ||||||
Cash flows from financing activities: | |||||||||
Repayment of principal on notes payable | (3,943 | ) | (2,082 | ) | |||||
Proceeds from stock options and warrants exercised | 19 | 91 | |||||||
Payment of preferred dividends | (250 | ) | (250 | ) | |||||
Net cash used in financing activities | (4,174 | ) | (2,241 | ) | |||||
Net increase (decrease) in cash and cash equivalents | (25,541 | ) | 3,366 | ||||||
Cash and cash equivalents at beginning of period | 44,144 | 29,335 | |||||||
Cash and cash equivalents at end of period | $ | 18,603 | $ | 32,701 | |||||
Supplemental disclosure of non-cash financing activities: | |||||||||
Accrual of preferred dividend | $ | 250 | $ | 250 | |||||
Supplemental disclosure of cash paid during the period for: | |||||||||
Interest | $ | 946 | $ | 371 |
See notes to the condensed consolidated financial statements.
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Basis of presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of Poniard Pharmaceuticals, Inc. and its subsidiary (the Company). All intercompany balances and transactions have been eliminated in consolidation. The Company has historically experienced recurring operating losses and negative cash flows from operations. As of September 30, 2008, the Company had net working capital of $68,459,000 and had an accumulated deficit of $348,466,000 with total shareholders' equity of $59,967,000.
The accompanying condensed consolidated financial statements contained herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). CertainAs permitted under those rules, certain footnotes or other financial information and note disclosuresthat are normally included in annual financial statements prepared in accordance with accounting principlesrequired by U.S. generally accepted in the United States of Americaaccounting principles have been condensed or omitted pursuant to thosesuch rules and regulations, although the Company believes that the disclosures made are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the Company's Annual Report on Form 10-K for the year ended December 31, 2007 filed with the SEC on March 13, 2008, and available on the SEC's website, www.sec.gov.
The accompanying condensed consolidated financial statements are unaudited.regulations. In the opinion of the Company's management, the accompanying interim unaudited condensed consolidated financial statements reflectinclude all adjustments consisting(consisting only of normal recurring accrualsadjustments) necessary to present fairlyfor a fair presentation of the Company's financial position and cash flows as of SeptemberJune 30, 2008 and2009, the results of operations for the three and ninesix months ended SeptemberJune 30, 2009 and 2008 and 2007.cash flows for the six months ended June 30, 2009 and 2008.
The results of operations for the periods ended SeptemberJune 30, 20082009 and 20072008 are not necessarily indicative of the expected operating results for the full year.
The balance sheet as of December 31, 2008 has been derived from the audited financial statements at that date. The balance sheet does not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. For further information, refer to the financial statements and footnotes thereto included in the Company's annual report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 16, 2009, and available on the SEC's website,www.sec.gov.
EstimatesReclassifications: Certain balances and Uncertainties:results from prior years have been reclassified to conform to the Company's current year presentation. The Company's reclassifications had no effect on net earnings or shareholders' equity.
Use of Estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Subsequent Events Evaluation: Management has reviewed and evaluated material subsequent events, if any, occurring after the balance sheet date of June 30, 2009 through the financial statements issuance date of August 7, 2009. All appropriate subsequent event disclosures, if any, have been made in the notes to our unaudited condensed consolidated financial statements.
Going concern: The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for a reasonable period of time. The Company has historically experienced recurring operating losses and negative cash flows from operations. As of June 30, 2009, the Company had working capital of $32,663,000, an accumulated deficit of $384,861,000, and total shareholders' equity of $27,871,000.
The Company's current loan facility contains covenants that restrict certain financing activities by the Company and require the Company to maintain a minimum amount of unrestricted cash (see
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 1. Basis of presentation (Continued)
Note 5 for further details). Taking into account the minimum unrestricted cash requirement and the Company's projected operating results, the Company believes that its current cash, cash equivalents and investment securities balances will provide adequate resources to fund operations at least into the first quarter of 2010. However, given the uncertainties of outcomes of the Company's ongoing clinical trials, there is no assurance that the Company can achieve its projected operating results. The Company has no assurance that, especially in light of the current distressed economic environment, the lenders will be willing to waive or renegotiate the terms of the loan agreement to address or avoid financial or other defaults. These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. Management is developing plans to address the Company's liquidity needs, including raising additional capital through the public or private sale of equity or debt securities or through the establishment of credit or other funding facilities and entering into strategic collaborations, which may include joint ventures or partnerships for product development and commercialization, merger, sale of assets or other similar transactions and taking other actions to limit the Company's expenditures. There can be no assurance that the Company can obtain financing or otherwise raise additional funds, if at all, on terms acceptable to the Company or to its lenders.
Note 2. Fair value measurements
TheEffective January 1, 2008, the Company holds available-for-sale securities that are measured at fair value which is determined on a recurring basis. These securities are classified within Level 2 of the fair value hierarchy prescribed by Statement of Financial Accounting Standard (SFAS)adopted SFAS No. 157, "Fair Value Measurements," because the value of the securities is based on quoted market prices or broker/dealer quotations.
Measurements" (SFAS No. 157) as it applies to its financial assets and liabilities. The SFAS No. 157 framework requires fair value to be determined based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. SFAS No. 157 establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Unaudited)
Note 2. Fair value measurements (Continued)
fair value. The standard describes the following three levels of inputs that may be used to measure fair value:
The determination of a financial instrument's level within the fair value hierarchy is based on an assessment of the lowest level of any input that is significant to the fair value measurement. The Company utilizes the market approach to measure fair value for its financial assets and liabilities. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. The Company's investment securities, consisting
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 2. Fair value judged to be other-than-temporary (of which there have been none to date) on available-for-sale securities are included in interest income.measurements (Continued)
The following table presents a summary of the Company's assets and liabilitiesthat are measured at fair value on a recurring basis:basis (in thousands):
| Fair Value Measurements as of September 30, 2008 | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Level 1 | Level 2 | Level 3 | Fair Value Measurements as of June 30, 2009 | |||||||||||||||||||||
| (in thousands) | Total | Level 1 | Level 2 | Level 3 | |||||||||||||||||||||
Cash equivalents | $ | 44,679 | $ | 44,679 | $ | — | $ | — | $ | 17,134 | $ | 17,134 | $ | — | $ | — | ||||||||||
Investment securities | 38,515 | — | 38,515 | — | 31,306 | — | 31,306 | — | ||||||||||||||||||
Total | $ | 83,194 | $ | 44,679 | $ | 38,515 | $ | — | ||||||||||||||||||
$ | 48,440 | $ | 17,134 | $ | 31,306 | $ | — | |||||||||||||||||||
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY At June 30, 2009 the cash equivalents balance consists of money market funds and investment securities are comprised of corporate debt securities and federal government and agency securities.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Unaudited)
Note 3. Investment securities
The Company's investment securities, consisting of debt securities, are classified as available-for-sale. Unrealized holding gains or losses on these securities are included in other comprehensive income. Realized gains and losses and declines in value judged to be other-than-temporary (of which there have been none to date) on available-for-sale securities are included in interest income.
Investment securities consisted of the following at June 30, 2009 (in thousands):
| | Gross Unrealized | | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amortized Cost | Estimated Fair Value | |||||||||||||
| Gains | (Losses) | |||||||||||||
Type of security: | |||||||||||||||
Corporate debt securities, with unrealized gains | $ | 13,599 | $ | 27 | $ | — | $ | 13,626 | |||||||
Corporate debt securities, with unrealized losses | 7,234 | — | (59 | ) | 7,175 | ||||||||||
Federal government and agency securities | 10,492 | 13 | — | 10,505 | |||||||||||
$ | 31,325 | $ | 40 | $ | (59 | ) | $ | 31,306 | |||||||
Net unrealized loss | $ | (19 | ) | ||||||||||||
Maturity: | |||||||||||||||
Less than one year | $ | 31,325 | $ | 31,306 | |||||||||||
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 3. Investment securities (Continued)
Investment securities consisted of the following at September 30,December 31, 2008 (in thousands):
| | | Gross Unrealized | | | | Gross Unrealized | | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | Amortized Cost | Estimated Fair Value | | Amortized Cost | Estimated Fair Value | ||||||||||||||||||||||||
| | Gains | (Losses) | | Gains | (Losses) | ||||||||||||||||||||||||
Type of security: | Type of security: | Type of security: | ||||||||||||||||||||||||||||
Corporate debt securities, with unrealized gains | $ | 10,706 | $ | 26 | $ | — | $ | 10,732 | ||||||||||||||||||||||
Corporate debt securities, with unrealized losses | 13,261 | — | (382 | ) | 12,879 | |||||||||||||||||||||||||
Federal government and agency securities | 4,998 | 2 | — | 5,000 | ||||||||||||||||||||||||||
Corporate debt securities | $ | 39,107 | $ | 11 | $ | (603 | ) | $ | 38,515 | $ | 28,965 | $ | 28 | $ | (382 | ) | $ | 28,611 | ||||||||||||
Net unrealized loss | $ | (592 | ) | Net unrealized loss | $ | (354 | ) | |||||||||||||||||||||||
Maturity: | Maturity: | Maturity: | ||||||||||||||||||||||||||||
Less than one year | $ | 36,858 | $ | 36,694 | Less than one year | $ | 27,912 | $ | 27,561 | |||||||||||||||||||||
Due in 1–2 years | 2,249 | 1,821 | Due in 1-2 years | 1,053 | 1,050 | |||||||||||||||||||||||||
$ | 39,107 | $ | 38,515 | $ | 28,965 | $ | 28,611 | |||||||||||||||||||||||
As of SeptemberJune 30, 2008,2009, the Company held a debt security issued by American General Finance Corporation (AGFC), a wholly-owned subsidiary of American International Group, Inc. (AIG), with a par value of $1,200,000, coupon rate of 3.875%, amortized cost of approximately $1,194,000$1,198,000 and maturity date of October 1, 2009. The market value for this security as of SeptemberJune 30, 2008,2009, based on Level 2 inputs as described in SFAS No. 157, was approximately $788,000,$1,146,000, resulting in an unrealized loss of approximately $406,000.$52,000. This unrealized loss was the result of a downgrade by S&P inhas resulted from downgrades from various rating agencies since September 2008, reducing the credit rating of AGFC, from A+ to BBB, in connection with the downgrade in its rating on AIG. On October 3, 2008, Moody's followed with a downgrade of AGFC's credit rating, from A3 to Baa1.2008. The Company's management has concluded that the unrealized loss on the AGFC debt security, and the other debt securities that it holds, is temporary due to a)(a) the relatively short duration of the decline in value of the investments; b)(b) the assessment of the Company's management that it is probable that all contractual amounts under the debt securities will be received and c)(c) the Company's intent and ability to hold the securities until at least substantially all of the cost is recovered.
Note 4. Bank loanAccrued liabilities
Accrued liabilities consist of the following (in thousands):
| June 30, 2009 | December 31, 2008 | |||||
---|---|---|---|---|---|---|---|
Clinical trials | $ | 5,939 | $ | 8,266 | |||
Accrued expenses | 868 | 689 | |||||
Compensation | 820 | 1,164 | |||||
Severance | 2 | 285 | |||||
Other | 237 | 284 | |||||
$ | 7,866 | $ | 10,688 | ||||
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 5. Note payable
On September 2, 2008, the Company entered into an Amended and Restated Loan and Security Agreement (loan agreement), with GE Business Financial Services Inc. (formerly known as Merrill Lynch Capital) and Silicon Valley Bank. The loan agreement amends and restates in its entirety the earlier Loan and Security Agreement dated as of October 25, 2006 (original loan), with Merrill Lynch Capital and Silicon Valley Bank, pursuant to which the Company obtained a $15,000,000 capital loan that was to mature on April 1, 2010.
The loan agreement provides for a $27,600,000 senior secured term loan facility (loan facility) to be made available as follows: (i) an initial term loan advance in the amount of $17,600,000, which is comprised of (a) the outstanding principal balance of $7,600,000 remaining on the original loan and (b) an additional cash advance in the amount of $10,000,000 (cash portion), which was fully funded on September 2, 2008; and (ii) a second term loan advance in the amount of $10,000,000, which was fully funded on September 30, 2008. The cash portion of the initial term loan advance and the proceeds of the second term loan advance will be used to fund the Company's clinical trials and for general
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Unaudited)
Note 4. Bank loan (Continued)
corporate purposes. The advances under the loan facility are repayable over 42 months, commencing on October 1, 2008. Interest on the advances is fixed at 7.80% per annum. Final loan payments in the amounts of $1,070,000 and $900,000 are due upon maturity or earlier repayment of the initial term loan advance and the second term loan advance, respectively. Additionally, as a condition to the amendment and restatement of the original loan, the Company agreed to modification of the final payment obligations under the original loan, pursuant to which the Company paid $600,000 to Silicon Valley Bank on September 2, 2008, the effective date of the loan facility, and will pay $675,000 to GE Business Financial Services on the earlier of March 31, 2010 or the date of repayment of the loan facility. All final payment amounts will beare being accreted to the note payable balance over the term of the loan facility using the effective interest rate method and reflected as additional interest expense. All interest payable under the loan agreement and the full amount of the final payments must be paid upon any prepayment of a term loan advance. The loan facility is secured by a first lien on all of the non-intellectual property assets of the Company.
In connection with the loan agreement, the Company issued to the lenders ten-year warrants to purchase an aggregate of 219,920 shares of the Company's common stock at an exercise price of $4.297 per share. The fair value of the warrants using the Black-Scholes option-pricing model was approximately $928,000 based upon assumptions of expected volatility of 90%, a contractual term of ten years, an expected dividend rate of zero and a risk-free interest rate of 3.74%. The portion of the loan proceeds allocable to the warrants is approximately $806,000 based on the relative fair value of the warrants, which the Company recorded as additional discount to notes payable. The total of the final loan payments and the proceeds allocated to the warrants of approximately $4,051,000 will beare being amortized to interest expense using an effective interest rate of 13.8%. At June 30, 2009, the outstanding principal balance under the loan facility was $22,057,000, net of discount of $2,274,000.
The loan agreement contains restrictions on the Company's ability to, among other things, dispose of certain assets, engage in certain mergers and acquisition transactions, incur indebtedness, create liens on assets, make investments, pay dividends and repurchase stock. The loan agreement also contains covenants requiring the Company to maintain unrestricted cash in an amount equal to the lesser of (i) $17,940,000 or (ii) the outstanding aggregate principal balance of the term loans plus $4,000,000. The loan agreement contains events of default that include nonpayment of principal, interest or fees, breaches of covenants, material adverse changes, bankruptcy and insolvency events, cross defaults to any other indebtedness, material judgments, inaccuracy of representations and warranties, and events
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 5. Note payable (Continued)
constituting a change of control. The occurrence of an event of default would increase the applicable rate of interest by 5% and could result in the acceleration of the Company's payment obligations under the loan agreement.
Note 6. Restructuring and asset impairment
Effective March 31, 2009, the Company implemented a strategic restructuring plan to refocus its cash resources on clinical and commercial development of picoplatin, resulting in the discontinuation of the Company's preclinical research operations and reducing its workforce by approximately 12%, or eight employees. The Company incurred severance charges totaling $296,000 related to the reduction in staff. All severance charges related to the restructuring have been paid as of June 30, 2009. The Company incurred additional charges totaling approximately $172,000 related to the closure of its lab facilities in South San Francisco, California. Of this amount, $6,000 was incurred as share-based compensation expense, $12,000 was a write-off of prepaid expenses, and $154,000 was incurred for contract and other termination costs. As of June 30, 2009, $13,000 remained unpaid and is payable within one year.
The following table summarizes the impact of the restructuring charges through June 30, 2009 (in thousands):
Description | Initial Restructuring Charge | Payment of Restructuring Obligations | Accrued Restructuring Charge as of March 31, 2009 | Payment of Restructuring Obligations | Accrued Restructuring Charge as of June 30, 2009 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Employee termination benefits | $ | 296 | $ | (111 | ) | $ | 185 | $ | (185 | ) | $ | — | |||||
Contract termination costs | 125 | — | 125 | (125 | ) | — | |||||||||||
Other termination costs | 47 | (18 | ) | 29 | (16 | ) | 13 | ||||||||||
Subtotal | 172 | (18 | ) | 154 | (141 | ) | 13 | ||||||||||
Total | $ | 468 | $ | (129 | ) | $ | 339 | $ | (326 | ) | $ | 13 | |||||
In conjunction with the decision to discontinue the Company's preclinical research operations, the Company recognized an asset impairment loss of $588,000 on certain facilities and equipment related to the lab in South San Francisco, California. The loss on the assets was determined based on estimates of potential sales values of used equipment. These impairment charges established new cost bases for the impaired assets, which are included in assets held for sale and reported in the prepaid expenses and other current assets line on the accompanying Condensed Consolidated Balance Sheets.
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 6. Restructuring and asset impairment (Continued)
The following table summarizes information related to the impairment charges (in thousands):
| So. San Francisco Lab Equipment & Leasehold Improvements | |||
---|---|---|---|---|
Impairment Loss | $ | 588 | ||
Impaired Carrying Value as of March 31, 2009 | $ | 57 | ||
Disposals of Assets | — | |||
Post Impairment Carrying Value as of March 31, 2009 | $ | 57 | ||
Disposals of Assets | (6 | ) | ||
Post Impairment Carrying Value as of June 30, 2009 | $ | 51 | ||
Note 5.7. Picoplatin license and amendment
The Company has entered into an exclusive worldwide license, as amended, with Genzyme Corporation (successor to AnorMED, Inc.) for the development and commercial sale of picoplatin. Under that license, the Company is solely responsible for the development and commercialization of picoplatin. Genzyme retains the right, at the Company's cost, to prosecute its patent applications and maintain all licensed patents. The parties executed the license agreement in April 2004, at which time the Company paid a one-time up-front payment of $1,000,000 in common stock and $1,000,000 in cash. The original agreement excluded Japan from the licensed territory and provided for $13,000,000 in
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Unaudited)
Note 5. Picoplatin license and amendment (Continued)
development and commercialization milestones, payable in cash or a combination of cash and common stock, and a royalty rate of up to 15% on product net sales after regulatory approval. The parties amended the license agreement on September 18, 2006, modifying several key financial terms and expanding the licensed territory to include Japan, thereby providing the Company worldwide rights. In consideration of the amendment, the Company paid Genzyme $5,000,000 in cash on October 12, 2006 and an additional $5,000,000 in cash on March 30, 2007. The amendment eliminated all development milestone payments to Genzyme. Genzyme remains entitled to receive up to $5,000,000 in commercialization milestones upon the attainment of certain levels of annual net sales of picoplatin after regulatory approval. The amendment also reduced the royalty payable to Genzyme to a maximum of 9% of annual net product sales. In addition, the amendment reducedsales and eliminated the sharing of sublicense revenues with Genzyme on and after September 18, 2007.Genzyme.
The Company accounted for all payments made in consideration of the picoplatin license, as amended, by capitalizing them as an intangible asset. The Company's capitalization of the total $12,000,000 of picoplatin license payments is based on the Company's reasonable expectation at the time of acquisition and through the date of the amendment that the intravenous formulation of picoplatin, as it existed at the time of the acquisition of the picoplatin license and the license amendment, would be used in research and development (R&D) projects and therefore had alternative future uses in the treatment of different cancer indications. At the time of acquisition, the Company planned to use intravenous picoplatin in a Phase II clinical trial in patients with small cell lung cancer and reasonably expected that the intravenous formulation could be used in additional, currently identifiable R&D projects in the form of clinical trials for other solid tumor cancer indications, such as prostate and colorectal cancers.
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 7. Picoplatin license and amendment (Continued)
The Company determined the original useful life of the picoplatin intangible asset in accordance with the requirements of FASBthe Financial Accounting Standards Board's (FASB) SFAS No. 142, "Goodwill and Other Intangible Assets." The Company, at the time of acquisition of the picoplatin license, reasonably anticipated using intravenous picoplatin in clinical trials that could be conducted during the remaining term of the primary patent, which is active through 2016. The Company concluded that the twelve years remaining for the primary patent term was the appropriate useful life for the picoplatin intangible asset, in satisfaction of the expected use and legal life provisions of SFAS No. 142, and is amortizing the initial $2,000,000 license payment over this twelve year useful life beginning in April 2004. The Company concluded that no change in the twelve-year useful life of the picoplatin intangible asset occurred as a result of the 2006 license amendment and is, therefore, continuing to amortize the initial $2,000,000 license payment over the twelve year useful life and is amortizing the license amendment payment of $10,000,000 over the remainder of the twelve year useful life of the picoplatin intangible asset.
Licensed Products consistsproducts consist of the picoplatin amortizable intangible asset with a gross amount of $12,000,000, and net of accumulated amortization of $2,890,000$3,801,000 and $1,979,000$3,193,000 at SeptemberJune 30, 20082009 and December 31, 2007,2008, respectively.
Note 6.8. Net loss per common share
Basic and diluted loss per share are based on net loss applicable to common shares, which is comprised of net loss and preferred stock dividends in all periods presented. Shares used to calculate basic loss per share are based on the weighted average number of common shares outstanding during
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Unaudited)
Note 6. Net loss per common share (Continued)
the period. Shares used to calculate diluted loss per share are based on the potential dilution that would occur upon the exercise or conversion of securities into common stock using the treasury stock method. The calculation of diluted loss per share excludes the effect of the following stock options and warrants to purchase additional shares of common stock because the share increments would not be dilutive.
| Three and Nine Months Ended September 30, | Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 | 2007 | 2009 | 2008 | 2009 | 2008 | ||||||||||||||
Common stock options | 5,397,071 | 4,434,039 | 5,782,192 | 5,337,944 | 5,782,192 | 5,337,944 | ||||||||||||||
Performance-based restricted stock units | 56,901 | — | 56,901 | — | ||||||||||||||||
Common stock warrants | 6,165,129 | 5,946,876 | 5,496,651 | 5,946,876 | 5,496,651 | 5,946,876 |
In addition, 39,015 shares of common stock that would be issuable upon conversion of the Company's Series 1 preferred stock are not included in the calculation of diluted loss per share for the periods ended SeptemberJune 30, 20082009 and 2007,2008, respectively, because the effect of including such shares would not be dilutive.
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 7.9. Stock-based compensation
A summary of the fully vested stock options is presented below (shares and aggregate intrinsic value in thousands):
| Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Exercisable at September 30, 2008 | 2,247 | $ | 7.97 | 7.4 | $ | 351 |
| Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term in Years | Aggregate Intrinsic Value | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Options exercisable at June 30, 2009 | 3,068 | $ | 7.18 | 6.7 | $ | 2,310 |
The Company recorded the following amounts of stock-based compensation expense, not including expense for options granted to non-employee consultants, for the periods presented (in thousands):
| | Three Months Ended September 30, | Nine Months Ended September 30, | | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | 2008 | 2007 | 2008 | 2007 | | 2009 | 2008 | 2009 | 2008 | ||||||||||||||||||
Research and development expense | Research and development expense | $ | 387 | $ | 223 | $ | 1,192 | $ | 857 | Research and development expense | $ | 284 | $ | 372 | $ | 604 | $ | 805 | ||||||||||
General and administrative expense | General and administrative expense | 1,140 | 929 | 4,327 | 2,623 | General and administrative expense | 1,142 | 1,262 | 2,115 | 3,187 | ||||||||||||||||||
Total | $ | 1,527 | $ | 1,152 | $ | 5,519 | $ | 3,480 | Total | $ | 1,426 | $ | 1,634 | $ | 2,719 | $ | 3,992 | |||||||||||
The amountscompensation expense for the three and ninesix months ended SeptemberJune 30, 2008 includeincludes the grant of stock options duringin the first quarter of 2008 to Company officers to purchase an aggregate of 460,000 shares of common stock. Certain options that were granted to officers of the Company during 2006 and 2007 vest 50% in equal monthly installments over four years from the date of grant and vest 50% on the seven-year anniversary of the date of grant, subject to accelerated vesting of up to 25% of such portion of the option, to the extent ofoptions, based on the Company's achievement of annual performance goals established under its annualmanagement incentive plan, at the discretion of the equity awards subcommittee of the Company's
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(Unaudited)
Note 7. Stock-based compensation (Continued)
committee of the Company's board of directors. Based on the overall achievement of corporate goals in 2006 and 2007 the equity awards subcommittee accelerated vesting with respect to 20% of the shares subject to the seven-year vesting schedule in both the second quarter of 2007 and the first quarter of 2008, resulting in2008. As of June 30, 2009, the cumulative accelerated vesting of 40%equals 60% of the shares subject to the seven-year vesting as of September 30, 2008.schedule.
No income tax benefit has been recorded for stock option exercisesexpense as the Company has a full valuation allowance and management has concluded it is more likely than not that the Company's net deferred tax assetassets will not be realized. As of SeptemberJune 30, 2008,2009, total unrecognized compensation costs related to employee stock optionscompensation was $14,361,000,$9,744,000, which is expected to be recognized over a weighted average period of approximately three2.5 years.
Estimated fair values of stock options granted have been determined using the Black-Scholes option pricing model with the following assumptions for the periods presented:
| Three Months Ended September 30, | Nine Months Ended September 30, | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2009 | 2008 | 2009 | 2008 | ||||||||||||||||||
Expected term (in years) | 3.99 | 6.08 | 4.87 | 6.42 | 8.5 | 7.8 | 6.2 | 5.0 | ||||||||||||||||||
Risk-free interest rate | 2.95 | % | 4.62 | % | 3.05 | % | 5.15 | % | 3.41 | % | 3.67 | % | 2.42 | % | 3.06 | % | ||||||||||
Expected stock price volatility | 90 | % | 93 | % | 90 | % | 102 | % | 95 | % | 90 | % | 95 | % | 90 | % | ||||||||||
Expected dividend rate | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % | 0 | % |
PONIARD PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
Note 9. Stock-based compensation (Continued)
During 2008 the Company awarded 92,000 restricted stock units (RSUs) under the 2004 Incentive Compensation Plan, as amended and restated, to non-officer employees as an incentive for future performance. An additional 4,000 RSUs were awarded in 2009. Upon vesting, each RSU is payable with one share of the Company's common stock. The average fair value of the RSUs was $3.13 per unit, or approximately $299,000 in total, based upon the closing market price of the Company's common stock on the award dates. The RSUs vest based on the achievement of certain performance milestones during 2009 and 2010. As of June 30, 2009, the first two performance milestones were achieved and 40% of the shares vested and have been released. The third performance milestone, if achieved no later than June 30, 2010, would result in the vesting of the remaining 60% upon date of achievement. As of June 30, 2009, the Company determined that the third milestone is probable of being achieved and is therefore recognizing the related stock-based compensation expense on a pro-rata basis through the estimated date of achievement.
Note 8.10. Comprehensive loss
The Company's comprehensive loss for the three and ninesix months ended SeptemberJune 30, 2009 and 2008 is summarized as follows (dollars in(in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | 2009 | 2008 | 2009 | 2008 | ||||||||||||||||||
Net loss | $ | 12,237 | $ | 6,959 | $ | 34,623 | $ | 23,216 | $ | 9,720 | $ | 12,531 | $ | 22,670 | $ | 22,386 | ||||||||||
Net unrealized (gain) loss on investment securities | 531 | (60 | ) | 651 | (52 | ) | ||||||||||||||||||||
Net unrealized loss (gain) on investment securities | (337 | ) | 107 | (335 | ) | 120 | ||||||||||||||||||||
Comprehensive loss | $ | 12,768 | $ | 6,899 | $ | 35,274 | $ | 23,164 | $ | 9,383 | $ | 12,638 | $ | 22,335 | $ | 22,506 | ||||||||||
Note 9.11. Recent accounting pronouncements
In September 2006,June 2009, the Financial Accounting Standards Board (FASB)FASB issued SFAS No. 157, "Fair Value Measurements,168, "TheFASB Accounting Standards Codification™ and the Hierarchy of Generally Accepted Accounting Principles." for all financial instruments and non-financial instruments accounted for at fair value on a recurring basis.This standard replaces SFAS No. 157 introduces a framework162, "The Hierarchy of Generally Accepted Accounting Principles," and establishes only two levels of U.S. generally accepted accounting principles ("GAAP"), authoritative and nonauthoritative. The FASB Accounting Standards Codification (the "Codification") will become the source of authoritative, nongovernmental GAAP, except for measuring fair valuerules and expands disclosure requirements about fair value measurements. SFAS No. 157 applies tointerpretive releases of the SEC, which are sources of authoritative GAAP for SEC registrants. All other non-grandfathered, non-SEC accounting pronouncements that require or permit fair value measurements, but doesliterature not included in itself require any new fair value measurements. SFAS No. 157 for financial assets and liabilitiesthe Codification will become nonauthoritative. This standard is effective for fiscal yearsfinancial statements for interim or annual reporting periods ending after September 15, 2009. The Company will begin to use the new guidelines and numbering system prescribed by the Codification when referring to GAAP for the quarter ended September 30, 2009. As the Codification was not intended to change or alter existing GAAP, it will not have any other impact on the Company's consolidated financial statements.
In June 2008, the FASB ratified the consensus opinion in EITF Issue No. 07-5, "Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock" (EITF 07-5). EITF 07-5 provides guidance for determining whether an equity-linked financial instrument or embedded feature is considered indexed to an entity's own stock. The consensus establishes a two-step
PONIARD PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (Continued)
(Unaudited)
Note 9.11. Recent accounting pronouncements (Continued)
beginning after November 15, 2007.approach as a framework for determining whether an instrument or embedded feature is indexed to an entity's own stock. The Company adoptedapproach includes evaluating (1) the standard for those assetsinstrument's contingent exercise provisions, if any, and liabilities(2) the instrument's settlement provisions. If a financial instrument is shown not to be indexed solely to its issuing company's stock, it is required to be classified as of January 1, 2008a liability and re-measured at fair value at each reporting period, with no material impact on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments and Hedging Activities." SFAS No. 161 requires companies with derivative instruments to disclose information that should enable financial statement users to understand how and why a company uses derivative instruments, how derivative instruments and related hedged items are accounted for under SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities," and how derivative instruments and related hedged items affect a company's financial position, financial performance and cash flows. SFAS No. 161changes in fair value recognized in operating results. EITF 07-5 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years.2008. The Company is currently evaluating this statementadopted EITF 07-5 on January 1, 2009 and, its impact, if any, onfor the Company's consolidated financial statements.
In April 2008,three months ended March 31, 2009, applied the FASB issued FASB Staff Position (FSP) FAS 142-3, "Determinationrequirements of the Useful Lifeconsensus to warrants issued by the Company in connection with a financing in 2005 (the 2005 financing warrants), which contain provisions requiring the adjustment of Intangible Assets." This FSP amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, "Goodwill and Other Intangible Assets." The intent of this FSP is to improve the consistency between the useful life of a recognized intangible asset under SFAS No. 142exercise price and the periodnumber of expected cash flows usedshares issuable if the Company sells shares of common stock at a price lower than the then-current exercise price of the warrants. The Company recorded the cumulative effect of adopting EITF 07-5 with respect to measure the 2005 financing warrants as of January 1, 2009 (reductions in both additional paid-in capital and accumulated deficit of approximately $1,255,000). The fair value of the asset under SFAS No. 141R,liability recorded with respect to the 2005 financing warrants was estimated to be $57,000 and $54,000 as of January 1, 2009 and March 31, 2009, respectively, resulting in a credit of $3,000 to other GAAP. FSP FAS 142-3 is effectiveincome for the three months ended March 31, 2009. Subsequent to March 31, 2009 and upon further review of the adjustment terms of the warrants, the Company determined that the warrants' exercise provisions became fixed when an adjustment floor was reached in connection with a financing in 2006, and, therefore, the Company's application of EITF 07-5 to the 2005 financing warrants in the first quarter of 2009 was not appropriate. Accordingly, (i) the liability associated with the 2005 financing warrants was derecognized as of June 30, 2009, (ii) the $3,000 credit to other income recognized for the three months ended March 31, 2009 was reversed for the three months ended June 30, 2009, and (iii) the $1,255,000 reduction in additional paid in capital and accumulated deficit that was recognized as the cumulative effect of adopting EITF 07-5 as of January 1, 2009 were reversed as of June 30, 2009. Management believes that the effect was not material to either the March 31, 2009 or the June 30, 2009 financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Early adoption is prohibited.accordingly, has reflected the correction in the June 30, 2009 financial statements.
Note 12. Commitments and contingencies
The Company is currently evaluatingentered into a picoplatin active pharmaceutical ingredient (API) commercial supply agreement with W.C. Heraeus (Heraeus) in March 2008. Under this statementagreement Heraeus will produce picoplatin API to be used for preparing picoplatin finished drug product for commercial use. Manufacturing services are provided on a purchase order, fixed-fee basis, subject to certain purchase price adjustments and its impact, if any, on the Company's consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141R (revised 2007), "Business Combinations," which replaces SFAS No. 141.minimum quantity requirements. The statement retainscosts to Heraeus for the purchase methodand set-up of accounting for acquisitions, but requires a numberdedicated equipment as required under the commercial supply agreement, estimated to be approximately $1,727,000 (including interest charges of changes, including changesapproximately $322,000) will be repaid by the Company in the way assetsform of a surcharge on an agreed upon amount of the picoplatin API ordered and liabilities are recognized indelivered on or before December 31, 2013. If the accounting forCompany orders and takes delivery of less than the agreed upon amount of picoplatin API through December 31, 2013, it will be obligated to pay the balance of the dedicated equipment cost as of that date. As of June 30, 2009, Heraeus had completed partial construction of the dedicated equipment at a purchase. It also changes the recognitioncost of assets acquired and liabilities assumed arising from contingencies, requires the capitalization of in-process research and development at fair value, and requires the expensing of acquisition-related costs as incurred. SFAS No. 141R is effective for acquisitions occurring in fiscal years beginning after December 15, 2008. Whileapproximately $1,421,000 (including interest). Because the Company is currently evaluatingnot under a present obligation to pay this statementamount and its impact, ifthe agreement is not under any potential circumstance of default or termination, it is not probable that a financial liability exists for this amount as of June 30, 2009 and therefore no such liability was recorded on the Company'scondensed consolidated financial statements, it believesbalance sheet as of that the adoption of SFAS No. 141R would have an impact on the accounting for any future acquisition, if one were to occur.
In June 2007, the FASB ratified the EITF consensus on EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities." EITF Issue No. 07-3 requires that nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. Such amounts should be recognized as an expense as the related goods are delivered or the related services are performed. Entities should continue to evaluate whether they expect the goods to be delivered or services to be rendered. If an entity does not expect the goods to be delivered or services to be rendered, the capitalized advance payment should be charged to expense. The Company adopted EITF Issue No. 07-3 on January 1, 2008, resulting in the temporary deferral of costs incurred for research and development activities from the time payouts are made until the time goods or services are provided.date.
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Important Information Regarding Forward-Looking Statements
This Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and are subject to change based on various important factors, many of which are beyond our control. In some cases, you can identify forward-looking statements by terminology such as "currently," "may," "will," "should," "expect," "plan," "intend," "anticipate," "believe," "target," "estimate," "predict," "potential," "propose" or "continue," the negative of these terms or other terminology. These statements reflect our current views with respect to future events and are only predictions. Actual events or results may differ materially.based on assumptions and are subject to risks and uncertainties that are difficult to predict. In evaluating these statements, you should specifically consider various factors described below in the section entitled "Risk Factors." These and other factors may cause our actual results to differ materially from any forward-looking statements contained in this report or otherwise made by us.
Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. You should not place undue reliance on our forward-looking statements, which speak only as of the date of this report. We undertake no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this report, or to reflect the occurrence of unanticipated events.
Critical Accounting Policies and Estimates
Our critical accounting policies and estimates have not materially changed except for our accounting for the fair value measurements of financial assets and liabilities, from those reported in our Annual Report on Form 10-K for the year ended December 31, 20072008 filed with the SEC on March 13, 2008.16, 2009. For a more complete description, please refer to our Annual Report on Form 10-K. Refer to Note 9, Fair Value Measurements, included in this Form 10-Q for the three and nine months ended September 30, 2008, for a more complete discussion of our accounting for the fair value measurements of our financial assets and liabilities and the related disclosures.
Results of Operations
Three and NineSix Months Ended SeptemberJune 30, 20082009 Compared to the Three and NineSix Months Ended SeptemberJune 30, 20072008
We had no revenue for the three and nine months ended September 30, 2008 and 2007, respectively.
Total operating expenses for the third quarter of 2008 increased 58% to $12.4 million, from $7.9 million for the third quarter of 2007, and increased 44% to $35.8 million for the nine months ended September 30, 2008, from $24.9 million for the same period in 2007.
Research and development (R&D) expenses increased 79% to $9.0 million for the third quarter of 2008, from $5.1 million for the third quarter of 2007. R&D expenses increased 50% to $24.5 million for the nine months ended September 30, 2008, from $16.4 million for the same period in 2007. The increase in R&D expenses for the three and nine months ended September 30, 2008 resulted primarily from increased costs associated with our picoplatin clinical trials and pre-clinical programs.
General and administrative (G&A) expenses increased 21% to $3.4 million for the third quarter of 2008, from $2.8 million for the third quarter of 2007. G&A expenses increased 32% to $11.3 million for the nine months ended September 30, 2008, from $8.6 million for the same period in 2007. The increases in G&A expenses for the three months ended September 30, 2008 are due primarily to higher stock-based compensation expense, higher costs for consultants and increased legal costs. The increases
in G&A expenses for the nine months ended September 30, 2008 are due primarily to higher stock-based compensation expense and increased personnel costs.
Cash, cash equivalents and investment securities as of September 30, 2008 were $84.0 million, compared with $92.6 million at December 31, 2007. During September 2008, we received approximately $20.0 million in net proceeds from our amended and restated bank term loan facility. On April 30, 2007, we received approximately $70.0 million in net proceeds from a public offering of 11.8 million shares of our common stock. We are using these proceeds for the continued clinical development of picoplatin, including funding our ongoing clinical trials in small cell lung cancer, advanced colorectal cancer and hormone-refractory prostate cancer, for discovery and research for new product candidates, and for general corporate purposes, including working capital. We believe that our current cash and cash equivalent balances will provide adequate resources to fund operations at least through the first quarter of 2010.
As discussed below, we currently are conducting multiple ongoing clinical studies of picoplatin and, in April 2007, treated our first patient in our Phase III pivotal clinical study in small cell lung cancer. These clinical studies, as well as increases in personnel, initiation of internal research programs and plans for continued future growth, are expected to result in significant increases in our operating costs, including research and development and administrative expenses. We will require substantial additional funding to support our picoplatin and other proposed clinical development programs and to fund our operations. In the event that we do not obtain sufficient additional funds, we may be required to delay, reduce or curtail the scope of our picoplatin and other product development activities.
Major Research and Development Programs
Our major research and development program is picoplatin, a new generation platinum-based chemotherapeutic designed to overcome platinum resistance in the treatment of solid tumors. We completed patient enrollment in our Phase II clinical study of picoplatin in small cell lung cancer in August 2006 and, based on positive interim median overall survival data from that ongoing study, we initiated a Phase III pivotal clinical trial of picoplatin in small cell lung cancer in April 2007. We completed enrollment in our Phase III trial in March 2009. In May 2006, we treated our first patients in separatetwo Phase I/II clinical studies evaluating picoplatin as a first-line treatment ofof: (1) advanced colorectal cancer and hormone-refractory(2) castration-resistant (or hormone-refractory) prostate cancer. We initiated the Phase II component of our prostate cancer study in July 2007 and completed enrollment in December 2007. We initiated enrollment in the Phase II component of our colorectal cancer study in November 2007 and completed enrollment in May 2008. In AprilWe initiated the Phase II component of our prostate cancer study in July 2007 we initiatedand completed enrollment in December 2007. We also have completed a Phase I study of an oral formulation of picoplatin in advanced solid tumors.
Research and development expenses decreased 38% to $5.7 million, from $9.2 million during the second quarter of 2009, and decreased 11% to $13.8 million, from $15.5 million in the six months
ended June 30, 2009 compared to the comparable periods in 2008. Our research and development expenses are summarized as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | % Change | 2009 | 2008 | % Change | ||||||||||||||
| ($ in thousands) | | ($ in thousands) | | ||||||||||||||||
Research | $ | 15 | $ | 894 | (98 | )% | $ | 764 | $ | 1,571 | (51 | )% | ||||||||
Contract manufacturing | 845 | 1,489 | (43 | )% | 1,807 | 2,121 | (15 | )% | ||||||||||||
Clinical | 4,452 | 6,380 | (30 | )% | 10,517 | 10,978 | (4 | )% | ||||||||||||
Share-based compensation | 341 | 388 | (12 | )% | 669 | 817 | (18 | )% | ||||||||||||
Total | $ | 5,653 | $ | 9,151 | (38 | )% | $ | 13,757 | $ | 15,487 | (11 | )% | ||||||||
Research expenses decreased significantly during the second quarter of 2009 from the comparable period in 2008 as a result of the discontinuation of our in-house preclinical research operations in connection with our strategic restructuring implemented effective March 31, 2009. Contract manufacturing costs decreased 43% to $0.8 million in the second quarter of 2009 and decreased 15% to $1.8 million in the first six months of 2009 from the comparable periods in 2008. These decreases reflect reduced drug production activity due to the Company's trials nearing completion. Clinical costs decreased 30% to $4.5 million in the second quarter of 2009 and decreased 4% to $10.5 million in the first six months of 2009 from the comparable periods in 2008. These decreases reflect reduced clinical activity in connection with our current picoplatin studies, all of which are fully enrolled and two of which are in a follow-up or extended follow-up stage. Share-based compensation expense decreased 12% and 18% to $0.3 million and $0.7 million, respectively, for the three and six month periods ended June 30, 2009 from the comparable periods in 2008, due primarily to lower per share fair values of options granted in the first half of 2009, which reflect lower price levels in our common stock during the first half of 2009, and, for the six months ended June 30, 2009, to the acceleration of vesting of certain stock options in the first quarter of 2008.
The following table shows expenses incurred for preclinical study support, contract manufacturing for clinical supplies and clinical trial services provided by third parties, as well as other associated costs for our picoplatin product candidate. The table also presents unallocated costs which consist of facilities, consulting fees, patent costs and other costs not directly allocable to development programs:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | % Change | 2009 | 2008 | % Change | ||||||||||||||
| ($ in thousands) | | ($ in thousands) | | ||||||||||||||||
Picoplatin | $ | 4,072 | $ | 6,789 | (40 | )% | $ | 10,446 | $ | 10,839 | (4 | )% | ||||||||
Other unallocated costs and overhead | 1,240 | 1,974 | (37 | )% | 2,642 | 3,831 | (31 | )% | ||||||||||||
Share-based compensation | 341 | 388 | (12 | )% | 669 | 817 | (18 | )% | ||||||||||||
Total research and development costs | $ | 5,653 | $ | 9,151 | (38 | )% | $ | 13,757 | $ | 15,487 | (11 | )% | ||||||||
Our external costs for picoplatin for the three and six month periods ended June 30, 2009 and for the comparable periods in 2008, reflect costs associated with our various picoplatin clinical studies and the manufacture of drug product to support our clinical trials. We expect our external costs for picoplatin to increase slightly during the balance of 2009 as we prepare for submission of our rolling New Drug Application, offset by lower costs for clinical trials upon completion.
As of SeptemberJune 30, 2008,2009, we have incurred external costs of approximately $47.0$64.8 million in connection with our entire picoplatin clinical program. Total estimated future costs of our picoplatin Phase II and Phase III clinical trials in small cell lung cancer are in the ranges of $0.1 million to $0.3$0.2 million and $33.0$20.0 million to $39.0$25.0 million, respectively, through 2009,2010, including the cost of drug supply. Total estimated future costs of our picoplatin Phase II clinical trial in colorectal cancer and our Phase II clinical trial in hormone-refractory
castration-resistant prostate cancer are in the ranges of $4.0 million to $6.0 million and $1.8$1.5 million to $2.5$3.0 million, respectively, through 2009,2010, including the cost of drug supply. Total estimated future costs of our Phase I clinical trial inof an oral formulation of picoplatin are in the range of $0.2$0.1 million to $0.5$0.3 million through 2009, including the cost of drug supply.2010. These costs could be substantially higher if we have to repeat, revise or expand the scope of any of our clinical trials. Material cash inflows relating to our picoplatin development will not commence unless and until we complete required clinical trials and obtain U.S. Food and Drug Administration, or FDA and foreign regulatory agency marketing approvals, and then only if picoplatin finds acceptance in the marketplace. To date, we have not received any revenues from product sales of picoplatin.
The risks and uncertainties associated with completing the development of picoplatin on schedule, or at all, include the following, as well as the other risks and uncertainties described in this report and in our Annual Report on Form 10-K for the year ended December 31, 2007:2008:
If we fail to obtain marketing approvals for picoplatin, are unable to secure adequate clinical and commercial supplies of picoplatin APIactive pharmaceutical ingredient and finished drug product, or do not complete development and obtain United States and foreign regulatory agency approvals on a timely basis, our operations, financial position and liquidity could be severely impaired, including as follows:
Because of the many risks and uncertainties relating to completion of clinical trials, receipt of marketing approvals and acceptance in the marketplace, we cannot predict the period in which material cash inflows from our picoplatin program will commence, if ever.
SummaryGeneral and Administrative
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | % Change | 2009 | 2008 | % Change | ||||||||||||||
| ($ in thousands) | | ($ in thousands) | | ||||||||||||||||
General and administrative | $ | 2,293 | $ | 2,461 | (7 | )% | $ | 4,404 | $ | 4,719 | (7 | )% | ||||||||
Share-based compensation | 1,142 | 1,262 | (10 | )% | 2,115 | 3,187 | (34 | )% | ||||||||||||
Total | $ | 3,435 | $ | 3,723 | (8 | )% | $ | 6,519 | $ | 7,906 | (18 | )% | ||||||||
The decrease in general and administrative expense for the three months ended June 30, 2009 is due primarily to lower consulting costs and, for the six months ended June 30, 2009, the decrease is due primarily to lower travel costs and lower consulting costs. Share-based compensation expense included in general and administrative expenses decreased 10% and 34% to $1.1 million and $2.1 million, respectively, for the three and six month periods ended June 30, 2009 from the comparable periods in 2008, due primarily to lower per share fair values of Researchoptions granted during the first half of 2009, which reflect lower price levels in our common stock during the first half of 2009, and, Development Costs.for the six months ended June 30, 2009, to the acceleration of vesting of certain stock options in the first quarter of 2008.
Restructuring and Asset Impairment Loss Our
Effective March 31, 2009, we implemented a strategic restructuring plan to refocus our cash resources on clinical and commercial development administration overhead costs,of picoplatin, resulting in the discontinuation of our preclinical research operations and reducing our workforce by approximately 12%, or eight employees. This restructuring resulted in charges of $0.5 million in the first quarter of 2009 consisting of rent, utilities, consulting fees, patent costs$0.3 million in severance charges and $0.2 million in other various overhead costs,expenses related to the closure of our lab facilities in South San Francisco, California.
In conjunction with the decision to discontinue our preclinical research operations, we also recognized an asset impairment loss of $0.6 million on certain facilities and equipment related to the lab in South San Francisco, California. The loss on the assets was determined based on estimates of potential sales values of used equipment. These impairment charges established new cost bases for the impaired assets, which are included in total researchassets held for sale and development expense for each period, but are not allocated among our various projects. Our total researchreported in the prepaid expenses and development costs includeother assets line on the costs of various research efforts directed toward the identificationaccompanying Condensed Consolidated Balance Sheets.
Other Income and evaluation of future product candidates. These other research projects are preclinical and not considered major projects. Our total research and development costs are summarized below:
Summary of Research and Development Costs
Expense
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 | 2007 | 2008 | 2007 | |||||||||
| (in thousands) | (in thousands) | |||||||||||
Picoplatin | $ | 6,773 | $ | 2,972 | $ | 17,860 | $ | 10,602 | |||||
Discontinued programs | — | 12 | — | 123 | |||||||||
Other overhead and research costs | 2,251 | 2,066 | 6,651 | 5,637 | |||||||||
Total research and development costs | $ | 9,024 | $ | 5,050 | $ | 24,511 | $ | 16,362 | |||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | % Change | 2009 | 2008 | % Change | ||||||||||||||
| ($ in thousands) | | ($ in thousands) | | ||||||||||||||||
Interest expense | $ | (796 | ) | $ | (331 | ) | 140 | % | $ | (1,663 | ) | $ | (692 | ) | 140 | % | ||||
Interest income and other, net | 164 | 674 | (76 | )% | 325 | 1,699 | (81 | )% | ||||||||||||
Total | $ | (632 | ) | $ | 343 | (284 | )% | $ | (1,338 | ) | $ | 1,007 | (233 | )% | ||||||
Interest expense increased 140% for the three and six months ended June 30, 2009 to $0.8 million and $1.7 million, respectively, from the comparable periods in 2008. The increase was primarily due to increased interest costs resulting from additional borrowings in September 2008 under our loan facility. Interest income and other, net decreased 76% to $0.2 million during the second quarter of 2009 and 81% to $0.3 million for the first six months of 2009 from the comparable periods in 2008. The decrease was primarily due to decreased average yields from our investment securities portfolio.
Liquidity and Capital Resources
| June 30, 2009 | December 31, 2008 | |||||
---|---|---|---|---|---|---|---|
| ($ in thousands) | ||||||
Cash, cash equivalents and investment securities | $ | 49,909 | $ | 72,755 | |||
Working capital | 32,663 | 54,835 | |||||
Shareholders' equity | 27,871 | 47,647 |
| Six Months Ended June 30, | |||||||
---|---|---|---|---|---|---|---|---|
| 2009 | 2008 | ||||||
| ($ in thousands) | |||||||
Cash provided by (used in): | ||||||||
Operating activities | $ | (18,793 | ) | $ | (15,180 | ) | ||
Investing activities | (2,574 | ) | 20,787 | |||||
Financing activities | (4,174 | ) | (2,241 | ) |
We have historically experienced recurring operating losses and negative cash flows from operations. Cash, cash equivalents and investment securities, net of restricted cash of $0.3 million, totaled $49.9 million at June 30, 2009 compared to $72.8 million at December 31, 2008. As of SeptemberJune 30, 2008,
2009, we had net working capital of $68.5$32.7 million, an accumulated deficit total of $348.5$384.9 million, and total shareholders' equity of $60.0$27.9 million.
We have financed our operations to date primarily through the sale of equity securities, debt instruments, technology licensing and collaborative agreements and debt instruments.agreements. We invest excess cash in investment securities
that will be used to fund future operating costs. Cash used for operating activities for the ninesix months ended SeptemberJune 30, 20082009 totaled $24.4$18.8 million. There were no revenues or other income sources for the quarter ended September 30, 2008. Cash, cash equivalents and investment securities, net of restricted cash of $0.3 million, totaled $84.0 million at September 30, 2008 compared to $92.6 million at December 31, 2007. We believe that our current cash, cash equivalents and investment securities will provide adequate resources to fund operations at least through the first quarter of 2010.
On September 2, 2008, we entered into an amended and restated loan and security agreement (loan agreement) with GE BusinessHealthcare Financial Services Inc. (formerly known as Merrill Lynch Capital) and Silicon Valley Bank, establishing a $27.6 million senior secured loan facility. The loan agreement amends and restates our earlier loan and security agreement with Silicon Valley Bank and Merrill Lynch Capital dated as of October 25, 2006, pursuant to which we obtained a $15.0 million capital loan that was to mature on April 1, 2010 (original loan). Funds under the loan facility were made available as follows: (i) an initial term loan advance in the amount of $17.6 million, which was comprised of (a) the outstanding principal balance of $7.6 million remaining on the original loan and (b) an additional cash advance in the amount of approximately $10.0 million, which was fully funded on September 2, 2008; and (ii) a second term loan advance in the amount of $10.0 million, which was fully funded on September 30, 2008. The advances under the loan facility are repayable over 42 months, commencing on October 1, 2008. Interest on the advances is fixed at 7.80% per annum. Final payments in the amounts of $1.1 million and $0.9 million are due upon maturity or earlier repayment of the initial term loan advance and the second term loan advance, respectively. Additionally, as a condition to the amendment and restatement of the original loan, we agreed to modification of the final payment obligations under the original loan pursuant to which we paid $0.6 million to Silicon Valley Bank on September 2, 2008, the effective date of the loan facility, and will pay $0.7 million to GE BusinessHealthcare Financial Services on the earlier of March 31, 2010 or the date of repayment of the loan facility. The loan facility is secured by a first lien on all of our non-intellectual property assets.
The loan agreement contains restrictions on our ability to, among other things, dispose of certain assets, engage in certain mergers and acquisition transactions, incur indebtedness, create liens on assets, make investments, pay dividends and repurchase stock. The loan agreement also contains covenants requiring us to maintain a minimum amount of unrestricted cash in an amountduring the term of the loan equal to the lesser of (i) $17.94$17.9 million or (ii) the outstanding aggregate principal balance of the term loans plus $4.0 million. The loan agreement contains events of default that include nonpayment of principal, interest or fees, breaches of covenants, material adverse changes, bankruptcy and insolvency events, cross defaults to any other indebtedness, material judgments, inaccuracy of representations and warranties and events constituting a change of control. The occurrence of an event of default would increase the applicable rate of interest by 5% and could result in the acceleration of our payment obligations under the loan agreement. In connection with the loan agreement, we issued to the lenders ten-year warrants to purchase an aggregate of 219,920 shares of common stock at an exercise price of $4.297 per share. At SeptemberJune 30, 2008,2009, the outstanding principal amountnet loan balance under the loan facility was $26.9$22.1 million. We intend to use
Taking into account the termminimum unrestricted cash requirement under the loan advancesagreement and our projected operating results, we believe that our current cash, cash equivalent and investment securities balances will provide adequate resources to fund our clinical trials and for general corporate purposes.
On April 30, 2007, we completed a public offeringoperations at least into the first quarter of 11.8 million shares2010. However, given the uncertainties of our common stock at a priceoutcomes of $6.33 per share. Net proceeds of the public offering were $70.0 million. On April 26, 2006, we completed an equity financing, pursuant to which we issued to a group of institutional and other accredited investors an aggregate of 15.5 million shares of common stock at a cash purchase price of $4.20 per share. Investors in the 2006 equity financing also received five-year warrants to purchase an aggregate of 4.6 million shares of common stock at an exercise price of $4.62 per share. We received $62.0 million in net proceeds from the 2006 equity financing, which, along with the net proceeds received from our April 2007 public offering, we intend to use to fund the continued clinical and preclinical development of picoplatin, including funding our ongoing clinical trials, there is no assurance that we can achieve our projected operating results. Thereafter, unless we raise additional funds, we will be in default of the minimum unrestricted cash requirement and for general corporate purposes, including working capital.potentially other provisions of the loan agreement. The occurrence of an event of default would increase the applicable rate of interest by 5% and could result in the acceleration of our payment obligations under the loan agreement. We have no assurance that, especially in light of the current distressed economic environment, the lenders will be willing to waive or renegotiate the terms of the loan agreement to address or avoid financial or other defaults.
During the first ninesix months of 2008,ended June 30, 2009, we paid total rent (base rent and additional rent based on our share of facility common operating expenses) of $1.1$0.7 million under the operating leases for our South San Francisco headquarters facility and our Seattle facility. Of this amount, $0.9$0.6 million represents total aggregate minimum lease payments under these leases.
On March 28, 2008,We have entered into clinical supply agreements with Heraeus and Baxter, pursuant to which they produce picoplatin API and finished drug product, respectively, for our clinical trials. Manufacturing services under these clinical supply agreements are provided on a purchase order, fixed-fee basis. Our API clinical supply agreement continues in effect until it is terminated by mutual agreement of the parties or by either party in accordance with its terms. Our finished drug product clinical supply agreement runs for an initial term ending December 31, 2009, and is subject to renewal for two additional one-year terms, at our option. The total aggregate cost of clinical supplies of picoplatin API and finished drug product for the three and six months ended June 30, 2009 was $0.4 million and $1.0 million, respectively. We believe that we presently have adequate supplies of picoplatin API and finished drug product to complete our current clinical trials.
We also have entered into a commercial picoplatin API manufacturingcommercial supply agreement with W.C. Heraeus GmbH, which is also the manufacturer ofin March 2008 and a finished drug product commercial supply agreement with Baxter in November 2008. Under these agreements, Heraeus and Baxter will produce picoplatin API and finished drug product, respectively, for our clinical trials.commercial use. Manufacturing services are provided on a purchase order, fixed-fee basis, subject to certain purchase price adjustments and minimum quantity requirements. The costs to Heraeus for the purchase and set-up of dedicated equipment, estimated to be approximately $1.5$1.7 million (including interest charges of approximately $0.3 million), will be repaid by us in the form of a surcharge on an agreed upon amount of the picoplatin API ordered and delivered on or before December 31, 2013. If we order and take delivery of less than the agreed upon amount of picoplatin API through December 31, 2013, we will be obligated to pay the balance of the dedicated equipment cost as of that date. As of June 30, 2009, Heraeus had completed partial construction of the dedicated equipment at a cost of approximately $1.4 million (including interest). Because we are not under a present obligation to pay this amount and the agreement is not under any potential circumstance of default or termination, it is not probable that a financial liability exists for this amount as of June 30, 2009 and therefore no such liability was recorded on the condensed consolidated balance sheet as of that date.
If we are successful in our efforts to commercialize picoplatin, we would, under our amended license agreement with Genzyme, Corporation, be required to pay Genzyme up to $5.0 million in commercialization milestones upon the attainment of certain levels of annual net sales of picoplatin. Genzyme also would be entitled to royalty payments of up to 9% of annual net product sales.sales of product.
We will require substantial additional funding to develop and commercialize picoplatin and any other proposed products and to fund our operations. Management is continuously exploring financing alternatives, including:
If we are unable to obtain sufficient additional cash when needed, we may be forced to delay, scale back or eliminate some or all of our picoplatin trials and commercialization efforts, reduce our workforce, license our picoplatin product candidates for development and commercialization by third parties, attempt to sell the company or, if these efforts fail, cease operations or declare bankruptcy. Provisions of the loan agreement would limit our ability to dispose of certain assets, engage in certain mergers, incur certain indebtedness, make certain distributions and engage in certain investment activities.
Our actual capital requirements will depend upon numerous factors, including:
and potential penalties and the cost of complying with unrestricted cash requirements and other covenants under the loan agreement.
There can be no assurance that we willWe may not be able to raise additionalobtain capital or enter into relationships with corporate partners on a timely basis, on favorable terms, or at all. Conditions in the capital markets in general, and in the life science capital market specifically, may affect our potential financing sources and opportunities for strategic partnering. Our consolidated financial statements arehave been prepared onin accordance with accounting principles generally accepted in the United States, assuming that we will continue as a going concern basis; however, our inability to obtain additional cash as needed could have a material adverse effect on our financial position, results of operations and our ability to continue in existence. Our consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The report of independent registered public accountants issued in connection with our annual report on Form 10-K for the year ended December 31, 2008 contains a statement expressing substantial doubt regarding our ability to continue as a going concern.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our market rate risks at SeptemberJune 30, 20082009 have not changed materially from those discussed in Item 7A of our Form 10-K for the year ended December 31, 2007.2008.
Item 4. Controls and Procedures
Under the supervision and with the participation of the Company's management, including the Company's Chief Executive Officer and Chief Financial Officer, the Company has evaluated the effectiveness and design of its disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e)) as of SeptemberJune 30, 2008,2009, to ensure that the information disclosed by the Company in the reports that the Company files or submits under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the rules and forms. Based on this evaluation, the Chief Executive Officer and the Chief Financial Officer have concluded that, as of SeptemberJune 30, 2008,2009, these disclosure controls and procedures were effective.
There were no changes in the Company's internal control over financial reporting that occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the Company's control over financial reporting.
Limitations on the Effectiveness of Controls
The Company's management, including its Chief Executive Officer and its Chief Financial Officer, does not expect that the Company's disclosure controls or internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of that control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of control must be considered relative to their costs. Because of the inherent limitation in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the reality that judgments in decision-making can be faulty, and breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more persons, or by management override of the control. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with the policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Our Annual Report on Form 10-K for the year ended December 31, 20072008 filed with the SEC on March 13, 2008,16, 2009, contains a detailed discussion of certain risk factors that could materially adversely affect our business, operating results and/or financial condition. In addition to other information contained in this report, you should carefully consider the potential risks or uncertainties that we have identified in Part I, "Item 1A, Risk Factors," in our Form 10-K. Other than the updated risk factor set forth in our Form 10-Q for the period ended June 30, 2008, which was filed with the SEC on August 7, 2008, there have not been any material changes in the risk factors disclosed in our Form 10-K. These risk factors are not the only ones affecting our company. Additional risks and uncertainties not currently deemed to be material also may materially or adversely affect our business, financial condition or results of operations.
Item 4. Submission of Matters to a Vote of Security Holders
The Company's annual meeting of shareholders was held on June 24, 2009. The following nine nominees were reelected as directors, each to hold office until his successor is elected and qualified, by the vote set forth below:
Nominee | For | Abstain | |||||
---|---|---|---|---|---|---|---|
Gerald Mc Mahon | 29,793,694 | 260,649 | |||||
Robert S. Basso | 28,942,295 | 1,112,048 | |||||
Frederick B. Craves | 29,809,691 | 244,652 | |||||
E. Rolland Dickson | 28,940,610 | 1,113,733 | |||||
Carl S. Goldfischer | 29,806,213 | 248,130 | |||||
Robert M. Littauer | 28,884,803 | 1,169,540 | |||||
Ronald A. Martell | 29,809,396 | 244,947 | |||||
Nicholas J. Simon III | 28,602,180 | 1,452,163 | |||||
David R. Stevens | 29,811,948 | 242,395 |
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.
PONIARD PHARMACEUTICALS, INC. (Registrant) | ||||
Date: | By: | /s/ | ||
Chief Financial Officer |
Exhibit | Description | | |||
---|---|---|---|---|---|
10.1 | (A) | ||||
31.1 | Rule 13a-14(a)/15d-14(a) Certification of Chairman and Chief Executive Officer | ||||
31.2 | Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer | ||||
32.1 | Section 1350 Certification of Chairman and Chief Executive Officer | ||||
32.2 | Section 1350 Certification of Chief Financial Officer |