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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2007
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-15281
REPROS THERAPEUTICS INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware (State or other jurisdiction of incorporation or organization) | 2408 Timberloch Place, Suite B-7 The Woodlands, Texas 77380 (Address of principal executive offices and zip code) | 76-0233274 (IRS Employer Identification No.) |
(281) 719-3400
(Registrant’s telephone number,
including area code)
including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yesþ Noo
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filero Accelerated filerþ Non-accelerated filero
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yeso Noþ
As of August 6, 2007, there were outstanding 12,774,904 shares of Common Stock, par value $.001 per share, of the Registrant.
REPROS THERAPEUTICS INC.
(A development stage company)
(A development stage company)
For the Quarter Ended June 30, 2007
INDEX
Page | ||||||||
FACTORS AFFECTING FORWARD-LOOKING STATEMENTS | 3 | |||||||
PART I. | 4 | |||||||
Item 1. | ||||||||
5 | ||||||||
6 | ||||||||
For the three-months and six-months ended June 30, 2007 and 2006 and from Inception (August 20, 1987) through June 30, 2007 | ||||||||
7 | ||||||||
For the six-months ended June 30, 2007 and 2006 and from Inception (August 20, 1987) through June 30, 2007 | ||||||||
8 | ||||||||
Item 2. | 12 | |||||||
Item 3. | 20 | |||||||
Item 4. | 20 | |||||||
PART II. | ||||||||
Item 1. | 22 | |||||||
Item 1A. | 22 | |||||||
Item 4. | 22 | |||||||
Item 5. | 22 | |||||||
Item 6. | 23 | |||||||
SIGNATURES | 24 | |||||||
Certification of CEO Pursuant to Section 302 | ||||||||
Certification of CFO Pursuant to Section 302 | ||||||||
Certification of CEO Pursuant to Section 906 | ||||||||
Certification of CFO Pursuant to Section 906 |
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FACTORS AFFECTING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “may,” “anticipate,” “believe,” “expect,” “estimate,” “project,” “suggest,” “intend” and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks, uncertainties and assumptions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, expected, estimated, projected, suggested or intended. These risks and uncertainties include risks associated with the early stage of development of Proellex™ and Androxal™ and uncertainty related to the Company’s ability to obtain approval of the Company’s products by the Food and Drug Administration (“FDA”) and regulatory bodies in other jurisdictions, the Company’s ability to raise additional capital on acceptable terms or at all, uncertainty relating to the Company’s patent portfolio, and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission. For additional discussion of such risks, uncertainties and assumptions, see “Item 1. Business” and “Item 1A. Risk Factors” included in the Company’s annual report on Form 10-K for the year-ended December 31, 2006 and “Part I. Financial Information — Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” included elsewhere in this quarterly report on Form 10-Q.
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
The following unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Rule 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all necessary adjustments (which include only normal recurring adjustments) considered necessary for a fair statement of the interim periods presented have been included. The year-end balance sheet data was derived from audited financial statements, but does not include all the disclosures required by accounting principles generally accepted in the United States of America. Operating results for the six-month period ended June 30, 2007 are not necessarily indicative of the results that may be expected for the year ended December 31, 2007. 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, 2006.
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REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited and in thousands except per share amounts)
(unaudited and in thousands except per share amounts)
June 30, | December 31, | |||||||
2007 | 2006 | |||||||
ASSETS | ||||||||
Current Assets | ||||||||
Cash and cash equivalents | $ | 7,872 | $ | 1,136 | ||||
Marketable securities | 23,945 | 5,600 | ||||||
Prepaid expenses and other current assets | 555 | 225 | ||||||
Total current assets | 32,372 | 6,961 | ||||||
Fixed Assets,net | 56 | 65 | ||||||
Other assets,net | 938 | 823 | ||||||
Total assets | $ | 33,366 | $ | 7,849 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current Liabilities | ||||||||
Accounts payable | $ | 1,927 | $ | 1,973 | ||||
Accrued expenses | 1,097 | 2,086 | ||||||
Total current liabilities | 3,024 | 4,059 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ Equity | ||||||||
Undesignated Preferred Stock, $.001 par value, 5,000,000 shares authorized, none issued and outstanding | — | — | ||||||
Common Stock, $.001 par value, 20,000,000 shares authorized, 14,711,939 and 12,087,997 shares issued, respectively; 12,774,904 and 10,150,962 shares outstanding, respectively | 15 | 12 | ||||||
Additional paid-in capital | 151,640 | 118,066 | ||||||
Cost of treasury stock, 1,937,035 and 1,937,035 shares, respectively | (5,948 | ) | (5,948 | ) | ||||
Deficit accumulated during the development stage | (115,365 | ) | (108,340 | ) | ||||
Total stockholders’ equity | 30,342 | 3,790 | ||||||
Total liabilities and stockholders’ equity | $ | 33,366 | $ | 7,849 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
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REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited and in thousands except per share amounts)
(unaudited and in thousands except per share amounts)
From Inception | ||||||||||||||||||||
(August 20, 1987) | ||||||||||||||||||||
through | ||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | June 30, | ||||||||||||||||||
2007 | 2006 | 2007 | 2006 | 2007 | ||||||||||||||||
Revenues | ||||||||||||||||||||
Licensing fees | $ | — | $ | — | $ | — | $ | — | $ | 28,755 | ||||||||||
Product royalties | — | — | — | — | 627 | |||||||||||||||
Research and development grants | — | — | — | — | 1,219 | |||||||||||||||
Interest income | 442 | 166 | 759 | 340 | 15,111 | |||||||||||||||
Gain on disposal of fixed assets | — | — | — | — | 102 | |||||||||||||||
Other Income | — | — | — | — | 35 | |||||||||||||||
Total revenues and other income | 442 | 166 | 759 | 340 | 45,849 | |||||||||||||||
Expenses | ||||||||||||||||||||
Research and development | 3,207 | 2,363 | 6,235 | 4,171 | 118,508 | |||||||||||||||
General and administrative | 609 | 666 | 1,549 | 1,276 | 32,975 | |||||||||||||||
Interest expense and amortization of intangibles | — | — | — | — | 388 | |||||||||||||||
Total expenses | 3,816 | 3,029 | 7,784 | 5,447 | 151,871 | |||||||||||||||
Loss from continuing operations | (3,374 | ) | (2,863 | ) | (7,025 | ) | (5,107 | ) | (106,022 | ) | ||||||||||
Loss from discontinued operations | — | — | — | — | (1,828 | ) | ||||||||||||||
Gain on disposal of discontinued operation | — | — | — | — | 939 | |||||||||||||||
Net loss before cumulative effect of change in accounting principle | (3,374 | ) | (2,863 | ) | (7,025 | ) | (5,107 | ) | (106,911 | ) | ||||||||||
Cumulative effect of change in accounting principle | — | — | — | — | (8,454 | ) | ||||||||||||||
Net loss | $ | (3,374 | ) | $ | (2,863 | ) | $ | (7,025 | ) | $ | (5,107 | ) | $ | (115,365 | ) | |||||
Loss per share — basic and diluted: | $ | (0.26 | ) | $ | (0.28 | ) | $ | (0.57 | ) | $ | (0.50 | ) | ||||||||
Weighted average shares used in loss per share calculation: | ||||||||||||||||||||
Basic | 12,775 | 10,146 | 12,268 | 10,143 | ||||||||||||||||
Diluted | 12,775 | 10,146 | 12,268 | 10,143 |
The accompanying notes are an integral part of these consolidated financial statements.
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REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited and in thousands)
(unaudited and in thousands)
From Inception | ||||||||||||
(August 20, 1987) | ||||||||||||
through | ||||||||||||
Six Months Ended June 30, | June 30, | |||||||||||
2007 | 2006 | 2007 | ||||||||||
Cash Flows from Operating Activities | ||||||||||||
Net loss | $ | (7,025 | ) | $ | (5,107 | ) | (115,365 | ) | ||||
Gain on disposal of discontinued operations | — | — | (939 | ) | ||||||||
Gain on disposal of assets | — | — | (102 | ) | ||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
Noncash financing costs | — | — | 316 | |||||||||
Noncash inventory impairment | — | — | 4,417 | |||||||||
Noncash patent impairment | — | — | 1,339 | |||||||||
Noncash decrease in accounts payable | — | — | (1,308 | ) | ||||||||
Depreciation and amortization | 16 | 6 | 3,814 | |||||||||
Noncash expenses related to stock-based transactions | 487 | 351 | 4,093 | |||||||||
Common stock issued for agreement not to compete | — | — | 200 | |||||||||
Series B Preferred Stock issued for consulting services | — | — | 18 | |||||||||
Sales and maturities of marketable securities | 18,060 | 22,107 | 76,042 | |||||||||
Purchases of marketable securities | (36,405 | ) | (18,475 | ) | (71,452 | ) | ||||||
Changes in operating assets and liabilities (net effects of purchase of businesses in 1988 and 1994): | ||||||||||||
Decrease (increase) in receivables | — | — | (199 | ) | ||||||||
Decrease (increase) in inventory | — | — | (4,447 | ) | ||||||||
Decrease (increase) in prepaid expenses and other current assets | (330 | ) | (106 | ) | (256 | ) | ||||||
(Decrease) increase in accounts payable and accrued expenses | (1,036 | ) | 477 | 4,219 | ||||||||
Net cash provided by (used in) operating activities | (26,233 | ) | (747 | ) | (99,610 | ) | ||||||
Cash Flows from Investing Activities | ||||||||||||
Maturities (purchases) of marketable securities | — | — | (28,723 | ) | ||||||||
Capital expenditures | (3 | ) | (60 | ) | (2,364 | ) | ||||||
Purchase of technology rights and other assets | (118 | ) | (87 | ) | (2,962 | ) | ||||||
Proceeds from sale of PP&E | — | — | 225 | |||||||||
Cash acquired in purchase of FTI | — | — | 3 | |||||||||
Proceeds from sale of subsidiary, less $12,345 for operating losses during 1990 phase-out period | — | — | 138 | |||||||||
Proceeds from sale of the assets of FTI | — | — | 2,250 | |||||||||
Increase in net assets held for disposal | — | — | (213 | ) | ||||||||
Net cash used in investing activities | (121 | ) | (147 | ) | (31,646 | ) | ||||||
Cash Flows from Financing Activities | ||||||||||||
Proceeds from issuance of common stock, net of offering costs | 33,053 | — | 135,457 | |||||||||
(Increase) decrease in prepaid offering costs | — | — | — | |||||||||
Exercise of stock options | 37 | 203 | 363 | |||||||||
Proceeds from issuance of preferred stock | — | — | 23,688 | |||||||||
Purchase of treasury stock | — | — | (21,487 | ) | ||||||||
Proceeds from issuance of notes payable | — | — | 2,839 | |||||||||
Principal payments on notes payable | — | — | (1,732 | ) | ||||||||
Net cash provided by (used by) financing activities | 33,090 | 203 | 139,128 | |||||||||
Net increase (decrease) in cash and cash equivalents | 6,736 | (691 | ) | 7,872 | ||||||||
Cash and cash equivalents at beginning of period | 1,136 | 2,165 | — | |||||||||
Cash and cash equivalents at end of period | $ | 7,872 | $ | 1,474 | $ | 7,872 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
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REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
(A development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2007
(Unaudited)
June 30, 2007
(Unaudited)
NOTE 1 — Organization, Operations and Liquidity
Repros Therapeutics Inc. (“the Company”, “RPRX”, or “we, “us” or “our”) was organized on August 28, 1987 and is a development stage company. We are a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. Our lead product candidate, Proellex, is an orally available small molecule compound that we are developing for the treatment of uterine fibroids and endometriosis. We are also developing Androxal, which causes increased testosterone secretion from the testes, for the treatment of testosterone deficiency in men resulting from secondary hypogonadism.
On February 5, 2007 the Company completed a follow-on public offering of 2,610,000 shares of common stock at $13.75 per share. The net proceeds from the sale of shares of common stock in this offering were approximately $33.1 million.
We have experienced negative cash flows from operations since inception and have funded our activities to date primarily from equity financings and corporate collaborations. We will continue to require substantial funds for research and development, including preclinical studies and clinical trials of our product candidates, and to commence sales and marketing efforts if appropriate, if the FDA or other regulatory approvals are obtained. We believe that our existing capital resources under our current operating plan will be sufficient to fund our operations through at least June 30, 2008. There can be no assurance that changes in our current strategic plans or other events will not result in accelerated or unexpected expenditures.
Our results of operations may vary significantly from year to year and quarter to quarter, and depend, among other factors, on our ability to be successful in our clinical trials, the regulatory approval process in the United States and other foreign jurisdictions and the ability to complete new licenses and product development agreements. The timing of our revenues may not match the timing of our associated product development expenses. To date, research and development expenses have generally exceeded revenue in any particular period and/or fiscal year.
As of June 30, 2007, we had an accumulated deficit of $115.4 million. Losses have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop our products and from the associated administrative costs required to support those efforts. Due to various tax regulations, including change in control provisions in the tax code, the value of the tax asset created by these accumulated losses can be substantially diminished. We have recorded a full valuation allowance for all deferred tax assets.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and
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assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Recent Accounting Pronouncements
In June 2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (FIN 48), which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS No. 109, “Accounting for Income Taxes.” FIN 48 establishes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. This interpretation also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. FIN 48 is effective for the Company as of January 1, 2007. The adoption of FIN 48 did not have an impact on the Company’s consolidated financial statements.
In September 2006, FASB issued SFAS No. 157, “Fair Value Measurements’” which defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair value measurements. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years. Earlier application is encouraged provided that the reporting entity has not yet issued financial statements for that fiscal year including financial statements for an interim period within that fiscal year. The Company is assessing SFAS No. 157 and has not determined yet the impact that the adoption of SFAS No. 157 will have on the financial statements.
In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities — Including an Amendment of FASB Statement No. 115.” This pronouncement permits entities to use the fair value method to measure certain financial assets and liabilities by electing an irrevocable option to use the fair value method at specified election dates. After election of the option, subsequent changes in fair value would result in the recognition of unrealized gains or losses as period costs during the period the change occurred.
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SFAS No. 159 becomes effective as of the beginning of the first fiscal year that begins after November 15, 2007, with early adoption permitted. However, entities may not retroactively apply the provisions of SFAS No. 159 to fiscal years preceding the date of adoption. We are currently evaluating the impact that SFAS No. 159 may have on our financial statements.
NOTE 2 — Marketable Securities
Management determines the appropriate classification of investments in debt and equity securities at the time of purchase and re-evaluates such designation as of each subsequent balance sheet date. Securities for which the Company has the ability and intent to hold to maturity are classified as “held to maturity”. Securities classified as “trading securities” are recorded at fair value. Gains and losses on trading securities, realized and unrealized, are included in earnings and are calculated using the specific identification method. Any other securities are classified as “available for sale.” At June 30, 2007, all securities were classified as trading securities. The fair value and cost basis including purchased premium for these securities was $23.9 million and $5.6 million at June 30, 2007 and December 31, 2006, respectively.
Marketable securities as of June 30, 2007 consist of only short term investments. The Company’s investments typically include corporate bonds and notes, Euro-dollar bonds, taxable auction securities and asset-backed securities. The Company’s policy is to require minimum credit ratings of A2/A and A1/P1 with maturities of up to three years. The average life of the investment portfolio may not exceed 24 months.
NOTE 3 — Patents
As of June 30, 2007, the Company had approximately $938,000 in internal capitalized patent costs reflected on its balance sheet. Of this amount, $411,000 relates to patents for Proellex, which is being developed as an oral treatment for uterine fibroids and endometriosis, and $527,000 relates to patents for Androxal, which is being developed as an oral treatment for testosterone deficiency.
NOTE 4 — Accrued Expenses
Accrued expenses consist of the following (in thousands):
June 30, 2007 | December 31, 2006 | |||||||
Research and development costs | $ | 821 | $ | 1,686 | ||||
Payroll | — | 123 | ||||||
Patent Costs | 40 | 127 | ||||||
Other | 236 | 150 | ||||||
Total | $ | 1,097 | $ | 2,086 | ||||
NOTE 5 — Loss Per Share
Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year. Diluted loss per share is computed using the average share price for the period and applying the treasury stock method to potentially dilutive outstanding options. In all applicable periods all potential common stock equivalents were antidilutive and accordingly were not included in the computation of diluted loss per share.
The following table presents information necessary to calculate loss per share for the three-
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month and six-month periods ended June 30, 2007 and 2006 (in thousands, except per share amounts):
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Net Loss | $ | (3,374 | ) | $ | (2,863 | ) | $ | (7,025 | ) | $ | (5,107 | ) | ||||
Average common shares outstanding | 12,775 | 10,146 | 12,268 | 10,143 | ||||||||||||
Basic loss per share | $ | (0.26 | ) | $ | (0.28 | ) | $ | (0.57 | ) | $ | (0.50 | ) | ||||
Diluted loss per share | $ | (0.26 | ) | $ | (0.28 | ) | $ | (0.57 | ) | $ | (0.50 | ) | ||||
Other potential common stock of 1,556,815 and 1,517,148 for the periods ended June 30, 2007 and 2006, respectively, were excluded from the above calculation of diluted loss per share since they were antidilutive.
NOTE 6 — Stockholders’ Equity
On February 5, 2007 the Company completed a follow-on public offering of 2,610,000 shares of common stock at $13.75 per share. The net proceeds from the sale of shares of common stock in this offering were approximately $33.1 million.
On March 9, 2007 the Company’s Board of Directors voted to terminate its current 2000 Employee Stock Purchase Plan.
NOTE 7 — Commitments and Contingencies
We are not currently a party to any material legal proceedings or other contingent liabilities.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements reflect the Company’s current views with respect to future events and financial performance and are subject to certain risks, uncertainties and assumptions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated in such forward-looking statements. The following discussion of financial condition should be read in conjunction with the accompanying consolidated financial statements and related notes.
Overview
Repros Therapeutics Inc., (“the Company”, “RPRX,” or “we,” “us” or “our”), was organized on August 28, 1987. We are a development stage biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. We are developing Proellex, a selective blocker of the progesterone receptor in women, for the treatment of uterine fibroids and endometriosis. We are also developing Androxal, for the treatment of testosterone deficiency in men resulting from secondary hypogonadism.
Our lead product candidate, Proellex, is an orally active small molecule which we are developing for two indications: the oral treatment of uterine fibroids and the oral treatment of endometriosis. The National Uterine Fibroid Foundation estimates that as many as 80% of all women in the United States have uterine fibroids, and one in four of these women have symptoms severe enough to require treatment. According to The Endometriosis Association, endometriosis affects 5.5 million women in the United States and Canada and millions more worldwide.
In July 2007 we provided endometrial biopsy findings from our U.S. three-month and European six-month studies of Proellex™ in the treatment of uterine fibroids and endometriosis, respectively. In June 2007, we provided top-line data from our six-month European Phase 1/2 study which indicated that Proellex demonstrated superior efficacy and safety when compared to the pharmaceutical standard of care in the treatment of endometriosis. In April 2007, we provided top-line data from our three-month U.S. Phase 2 clinical trial of Proellex in uterine fibroid patients which showed a statistically significant improvement in our primary endpoint. Unequivocal efficacy was demonstrated in the treatment of both conditions along with a reduction of pain associated with endometriosis and a reduction of bleeding in uterine fibroids patients.
We are conducting a U.S. one-year open label safety trial for patients that have completed the Proellex U.S. Phase 2 uterine fibroids clinical trial. Currently there are 41 patients enrolled in this clinical trial.
We intend to begin a U.S. Phase 2 clinical trial with Proellex for the treatment of endometriosis in the third quarter of 2007 and a U.S. Phase 3 clinical trial with Proellex for the treatment of uterine fibroids by year-end 2007.
Our second product candidate, Androxal, is an orally active proprietary small molecule compound designed to treat testosterone deficiency due to secondary hypogonadism by restoring
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normal testosterone production in males with functional testes and diminished pituitary function, a common condition in the aging male. According to the Urology Channel, recent estimates show that approximately 13 million men in the United States experience testosterone deficiency. The current gold standard in the industry is Androgel®, with reported sales in North America of approximately $282 million in 2005. Estimated sales of all androgens in North America in 2006 is approximately $570 million.
In June 2007 we provided top-line results from our six-month U.S. non-pivotal Phase 3 study of Androxal™. This trial demonstrated statistically significant increases in testosterone levels versus placebo, without suppression of luteinizing hormone (“LH”) and non-inferiority on all measured outcomes to Androgel.
We are conducting a U.S. one-year open label safety trial for patients that have completed the Androxal U.S. Phase 3 clinical trial. Currently, there are 90 patients enrolled in this clinical trial. We also intend to initiate our first pivotal U.S. Phase 3 clinical trial with Androxal in the fourth quarter of 2007.
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Our current product pipeline is summarized below:
Estimate of Completion of | ||||||
Product | Current Phase of | Current Phase and Future | ||||
Candidate | Indication | Development | Clinical Development(1) | |||
Proellex | -Uterine fibroids | -U.S. Phase 2 clinical trial (3-month) | -Reported U.S. Phase 2 data (2Q2007) | |||
-U.S. Open Label Safety Study (12-month) | -Currently 41 patients enrolled (July 2007), One year interim extension data anticipated (4Q2007) | |||||
-Initiate proposed U.S. Phase 3 pivotal trial (YE2007) | ||||||
-Submit Proellex NDA for uterine fibroids end of 2008 | ||||||
-Endometriosis | -European Phase 1/2 clinical trial (6-month) | -Reported top-line Phase 1/2 data (2Q2007), | ||||
-Initiate proposed U.S. Phase 2 clinical trial (3Q2007) | ||||||
Androxal | -Male Secondary Hypogonadism | Non-pivotal U.S. Phase 3 (6-month) | -Reported top-line Phase 3 data (2Q2007) | |||
-U.S. Open Label Safety Study (12-month) | -Currently 90 patients enrolled (July 2007) | |||||
-Initiate proposed U.S. Phase 3 pivotal trial (4Q2007) | ||||||
-Submit Androxal NDA end of 2008 |
(1) | The information in the column labeled “Estimate of Completion of Current Phase and Future Clinical Development” contains forward-looking statements regarding timing of completion of product development phases. The successful development of our product candidates is highly uncertain. Estimated completion dates and R&D expenses can vary significantly for each product candidate and are difficult to predict. The actual timing of completion of those phases could differ materially from the estimates provided in the table. We currently have no collaborators on the development of any of our product candidates. |
All clinical trial results, including those related to Proellex and Androxal, are subject to review by the FDA, and the FDA may disagree with our conclusions about safety and efficacy.
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We caution that results obtained in early stage clinical trials may be reversed by the results of later stage clinical trials with significantly larger and more diverse patient populations treated for longer periods of time.
We intend to seek strategic out-licensing or other corporate partnering opportunities with respect to Androxal to permit us to continue to fund our clinical trial programs. In addition, we also are continuing to seek strategic out-licensing opportunities with respect to our phentolamine-based products for the treatment of sexual dysfunction and for our preclinical breast cancer indication of Proellex.
Our Androxal product candidate and its uses are covered in the United States by six pending patent applications and one issued U.S. patent. Foreign coverage of our Androxal product candidate includes five issued foreign patents and 57 foreign pending patent applications and one PCT application. The issued patents and pending applications relate to methods and compositions for treating certain conditions including the treatment of testosterone deficiency in men. Androxal (the trans isomer of clomiphene) is purified from clomiphene citrate. A third party individual holds two issued patents related to the use of an anti-estrogen such as clomiphene citrate and others for use in the treatment of androgen deficiency and disorders related thereto. In our prior filings with the SEC, we have described our request to the U.S. Patent and Trademark Office, or PTO, for re-examination of one of these patents based on prior art. The third party amended the claims in the re-examination proceedings, which led the PTO to determine that the amended claims are patentable in view of those publications under consideration and a re-examination certificate was issued. However, we believe that the amended claims are invalid based on additional prior art publications, and our request for re-examination by the PTO in light of a number of these additional publications and other publications cited by the PTO, has been granted. In June, 2007, the PTO issued a final Office action in the re-examination, rejecting all of the claims. The patent holder will have an opportunity to respond to the final rejections. We also believe that the second of these two patents is invalid in view of published prior art not considered by the PTO. Nevertheless, there is no assurance that either patent will ultimately be found invalid over the prior art. If such patents are not invalidated by the PTO we may be required to obtain a license from the holder of such patents in order to develop Androxal further or attempts may be made to undertake further legal action to invalidate such patents. If such licenses were not available on acceptable terms or at all, we may not be able to successfully commercialize Androxal.
We have not generated any substantial revenue from the commercial sale of any of our current product candidates. We will not receive any revenue from commercial sales unless we complete the clinical trial process, obtain regulatory approval, and successfully commercialize one or more of our product candidates. We cannot be certain when or if any net cash inflow from any of our current product candidates will commence.
We have experienced negative cash flows from operations since inception and have funded our activities to date primarily from equity financings and corporate collaborations. We believe that our existing capital resources under our current operating plan will be sufficient to fund our operations through at least June 30, 2008. There can be no assurance that changes in our current strategic plans or other events will not result in accelerated or unexpected expenditures.
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We will need to raise additional capital through the sale of equity securities and/or through partnerships to continue the clinical development of our products. If we are not able to raise capital through the sale of equity securities, or cannot locate an alternative source of financing, the outcome would have a material adverse effect on us and the clinical development timeline of our product candidates. If we are not able to raise adequate capital for our clinical development plans, then we will have to adjust our plans, which will delay the approval process of our product candidates.
Our results of operations may vary significantly from year to year and quarter to quarter, and depend, among other factors, on our ability to be successful in our clinical trials, the regulatory approval process in the United States and other foreign jurisdictions and the ability to complete new licenses and product development agreements. The timing of our revenues may not match the timing of our associated product development expenses. To date, research and development expenses have generally exceeded revenue in any particular period and/or fiscal year.
On February 5, 2007, we completed a follow-on public offering of 2,610,000 shares of our common stock at a purchase price of $13.75 per share. As a result of the offering, we received approximately $33.1 million in net proceeds which we intend to use to continue our clinical development of Proellex and Androxal.
Effective January 8, 2007, we voluntarily withdrew the listing of our common stock from NYSE Arca, Inc., formerly the Pacific Exchange, in order to streamline administrative requirements and reduce expenses.
Employees and Consultants
We currently have seven full-time employees and utilize the services of contract research organizations, contract manufacturers and various consultants to assist us in performing regulatory, clinical development and manufacturing activities related to the clinical development of our products. We are highly dependent on our various contract organizations to adequately perform the activities required to obtain regulatory approval of our products and to complete development and manufacturing thereof.
Research and Development
The clinical development of pharmaceutical products is a complex undertaking, and many products that begin the clinical development process do not obtain regulatory approval. The costs associated with our clinical trials may be impacted by a number of internal and external factors, including the number and complexity of clinical trials necessary to obtain regulatory approval, the number of eligible patients necessary to complete our clinical trials and any difficulty in enrolling these patients, and the length of time to complete our clinical trials. Given the uncertainty of these potential costs, we are unable to estimate the total costs we will incur for the clinical development of our product candidates over those costs currently projected. We do, however, expect these costs to increase substantially in future periods as we continue later-stage clinical trials, initiate new clinical trials for additional indications and seek to obtain regulatory approvals. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could cause our research and
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development expenditures to increase and, in turn, have a material adverse effect on our results of operations.
We have limited financial resources and personnel and anticipate that we will need to raise additional capital and hire additional key employees in order to be able to successfully develop each of our current product candidates through clinical trials and to be able to market them, should regulatory approval be obtained, on a worldwide basis. Alternatively, we may elect to partner with a larger and more experienced pharmaceutical company with better resources for one or more of our product candidates and/or target indications. As a result, we believe that an out-license of one or more of our product candidates could occur at some point in the future, and discussions are held from time to time with potential partners to explore possible arrangements; however, there can be no assurance that such an agreement will be entered into by us.
Recent Accounting Pronouncements
In June 2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (FIN 48), which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS No. 109, “Accounting for Income Taxes.” FIN 48 establishes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. This interpretation also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. FIN 48 is effective for the Company as of January 1, 2007. The adoption of FIN 48 did not have an impact on the Company’s consolidated financial statements.
In September 2006, FASB issued SFAS No. 157, “Fair Value Measurements’” which defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair value measurements. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years. Earlier application is encouraged provided that the reporting entity has not yet issued financial statements for that fiscal year including financial statements for an interim period within that fiscal year. The company is assessing SFAS No. 157 and has not determined yet the impact that the adoption of SFAS No. 157 will have on its financial statements.
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In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities — Including an Amendment of FASB Statement No. 115.” This pronouncement permits entities to use the fair value method to measure certain financial assets and liabilities by electing an irrevocable option to use the fair value method at specified election dates. After election of the option, subsequent changes in fair value would result in the recognition of unrealized gains or losses as period costs during the period the change occurred. SFAS No. 159 becomes effective as of the beginning of the first fiscal year that begins after November 15, 2007, with early adoption permitted. However, entities may not retroactively apply the provisions of SFAS No. 159 to fiscal years preceding the date of adoption. We are currently evaluating the impact that SFAS No. 159 may have on our financial statements.
Results of Operations
Three-Month and Six-Month Periods Ended June 30, 2007 and 2006
Our results of operations may vary significantly from quarter to quarter and year to year, and depend on, among other factors, our ability to be successful in our clinical trials, the regulatory approval process in the United States and other foreign jurisdictions and the ability to complete new licenses and product development agreements. The timing of our revenues may not match the timing of our associated product development expenses. To date, research and development expenses have generally exceeded revenue in each particular period and/or fiscal year.
Revenues and other income. Total revenues and other income for the three-month period ended June 30, 2007 increased to $442,000 as compared to $166,000 for the same period in the prior year and increased to $759,000 for the six-month period ended June 30, 2007 as compared to $340,000 for the same period in the prior year.
Interest income increased 166% to $442,000 for the three-month period ended June 30, 2007, as compared to $166,000 for the same period in the prior year and increased 123% to $759,000 for the six-month period ended June 30, 2007 as compared to $340,000 for the same period in the prior year. The increase in interest income for the three-month and six-month periods ended June 30, 2007 as compared to the same periods in the prior year is primarily due to an increase in marketable securities as a result of the completion of the Company’s follow-on public offering on February 5, 2007 in which we received approximately $33.1 million in net proceeds.
Research and Development Expenses. Research and development (“R&D”) expenses primarily include clinical regulatory affairs activities and preclinical and clinical study development expenses. R&D expenses increased 36% to approximately $3.2 million for the three-month period ended June 30, 2007 as compared to approximately $2.4 million for the same period in the prior year and increased 49% to approximately $6.2 million for the six-month period ended June 30, 2007 as compared to $4.2 million for the same period in the prior year. The increase in R&D expenses for the three-month period ended June 30, 2007 as compared to the same period in the prior year is primarily due to an increase of $756,000 in our current clinical activities, an
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increase in preclinical activities of $246,000 and an increase in personnel costs of $79,000, partially offset by a decrease in manufacturing activities of $316,000. The increase in R&D expenses for the six-month period ended June 30, 2007 as compared to the same period in the prior year is primarily due to an increase of $1.3 million in our current clinical activities, an increase in preclinical activities of $375,000, an increase in personnel costs of $160,000, an increase in non-cash stock compensation expense of $75,000 and an increase in legal expenses of $70,000 related to our patent portfolio.
General and Administrative Expenses. General and administrative expenses decreased 9% to $609,000 for the three-month period ended June 30, 2007 as compared to $666,000 for the same period in the prior year and increased 21% to approximately $1.5 million for the six-month period ended June 30, 2007 as compared to $1.3 million for the same period in the prior year. The decrease in expenses for the three-month period ended June 30, 2007 as compared to the same period in the prior year is primarily due to a decrease in investor relations costs of $71,000 and a decrease in non-cash stock compensation expense of $31,000, partially offset by an increase in personnel costs of $23,000. The increase in expenses for the six-month period ended June 30, 2007 as compared to the same period in the prior year is primarily due to an increase in personnel costs of $89,000, an increase in non-cash stock compensation expense of $60,000, an increase in strategic administrative fees of $50,000, an increase in professional services of $33,000 and an increase of $19,000 in costs associated with meeting the requirements of Section 404 of the Sarbanes-Oxley Act.
Liquidity and Capital Resources
We had cash, cash equivalents and marketable securities of approximately $31.8 million at June 30, 2007 as compared to $6.7 million at December 31, 2006. This increase in cash is primarily due to the completion of our follow-on public offering of 2,610,000 shares on February 5, 2007 in which we received approximately $33.1 million in net proceeds. On September 5, 2006 we filed a Form S-3 shelf registration statement with the Securities and Exchange Commission for up to 5,000,000 shares of common stock of which we have utilized 2,610,000 leaving us with 2,390,000 available shares.
Depending upon the timing of certain clinical activities, we believe our cash resources will be sufficient to fund operations through at least June 30, 2008. We will need to raise additional capital through the sale of equity securities and/or through partnerships to continue the clinical development of our products. If we are not able to raise capital through the sale of equity securities, or cannot locate an alternative source of financing, the outcome would have a material adverse effect on us and the clinical development timelines of our product candidates. If we are not able to raise adequate capital for our clinical development plans, then we will have to reduce capital expenditures, which will delay the development and approval process of our product candidates. We cannot assure that additional funding will be available on acceptable terms, or at all.
There can be no assurance that changes in our current strategic plans or other events will not result in accelerated or unexpected expenditures. We expect clinical and preclinical development expenses to increase substantially in future periods as we continue later-stage clinical trials, initiate new clinical trials for additional indications, seek to obtain regulatory
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approvals and conduct long-term animal safety studies.
As of June 30, 2007, we had an accumulated deficit of $115.4 million. We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. Inception to date losses have resulted principally from costs incurred in conducting clinical trials and for research and development activities related to efforts to develop our products and from the associated administrative costs required to support those efforts. We have financed our operations primarily with proceeds from public offerings and private placements of equity securities, funds received under collaborative agreements and Small Business Innovative Research (“SBIR”) grants. We are actively developing Proellex for the treatment of uterine fibroids and endometriosis and Androxal for the treatment of testosterone deficiency in men with secondary hypogonadism and believe we have enough funds to continue such development through at least June 30, 2008. We will need substantial additional capital in order to continue such development beyond such date.
Our capital requirements will depend on many factors, including the costs and timing of seeking regulatory approvals of our products; the problems, delays, expenses and complications frequently encountered by development stage companies; the progress of our preclinical and clinical activities; the costs associated with any future collaborative research, manufacturing, marketing or funding arrangements; our ability to obtain regulatory approvals; the success of our potential future sales and marketing programs; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; changes in economic, regulatory or competitive conditions of our planned business; and additional costs associated with being a publicly-traded company. Estimates about the adequacy of funding for our activities are based on certain assumptions, including the assumption that the development and regulatory approval of our products can be completed at projected costs and that product approvals and introductions will be timely and successful. There can be no assurance that changes in our research and development plans, acquisitions or other events will not result in accelerated or unexpected expenditures. To satisfy our capital requirements, we may seek to raise additional funds in the public or private capital markets. We also may seek additional funding through corporate collaborations and other financing vehicles. There can be no assurance that any such funding will be available to us on favorable terms or at all. If we are successful in obtaining additional financing, the terms of such financing may have the effect of diluting or adversely affecting the holdings or the rights of the holders of our common stock.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk. Cash, cash equivalents and investments were approximately $31.8 million at June 30, 2007. These assets were primarily invested in investment grade corporate bonds and commercial paper with maturities of less than 6 months, which are classified as Trading Securities. We do not invest in derivative securities. Although our portfolio is subject to fluctuations in interest rates and market conditions, no significant gain or loss on any security is expected to be recognized in earnings due to the expected short holding period.
Item 4. Controls and Procedures
Based on their evaluation as of the end of the period covered by this Quarterly Report on
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Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), are effective.
In connection with the evaluation described above, we identified no change in internal control over financial reporting that occurred during the fiscal quarter ended June 30, 2007 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II — OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any material legal proceedings.
Item 1A. Risk Factors
There were no material changes from risk factors as previously disclosed in the registrant’s Form 10-K for the fiscal year ended December 31, 2006 in response to Item 1A. to Part I of Form 10-K.
Item 4. Submission of Matters to a Vote of Security Holders
The 2007 Annual Meeting of the Company’s Stockholders was held on May 15, 2007 to consider and vote upon the following proposals:
(1) Election of Directors. The following individuals were nominated and elected as directors, with the following number of shares voted for and withheld with respect to each director.
For | Withheld | |||||||
Joseph S. Podolski | 10,134,999 | 49,752 | ||||||
Louis Ploth, Jr. | 9,263,493 | 921,258 | ||||||
Daniel F. Cain | 10,152,391 | 32,360 | ||||||
Jean Fourcroy, M.D., Ph.D., M.P.H. | 10,150,683 | 34,068 | ||||||
Jeffrey R. Harder, J.D. | 9,128,325 | 1,056,426 | ||||||
Nola Masterson . | 10,133,476 | 51,275 | ||||||
David Poorvin, Ph.D. | 10,151,533 | 33,218 |
(2) To approve an amendment to the Company’s 2004 Stock Option Plan to increase the number of shares available from 750,000 to 1,000,000.
For 8,630,084 Against 156,916 Abstain 25,959 Not Voted 3,953,042
(3) To ratify the election of PricewaterhouseCoopers LLP as the Company’s registered independent public accounting firm for the fiscal year-ended December 31, 2007.
For 10,162,159 Against 17,959 Abstain 4,633 Not Voted 0
Item 5. Other Information
None
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Item 6. Exhibits
31.1* | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). | |
31.2* | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). | |
32.1* | Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). | |
32.2* | Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). |
* | Filed herewith. | |
** | Portions of this exhibit have been omitted based on a request for confidential treatment pursuant to Rule 24b-2 of the Exchange Act. Such omitted portions have been filed separately with the Commission. |
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
REPROS THERAPEUTICS INC.
Date: August 8, 2007
By: | /s/ Joseph S. Podolski | |||
Joseph S. Podolski | ||||
President, Chief Executive Officer and Director (Principal Executive Officer) | ||||
Date: August 8, 2007
By: | /s/ Louis Ploth, Jr. | |||
Louis Ploth, Jr. | ||||
Vice President Business Development, Chief Financial Officer, Director and Secretary (Principal Financial and Accounting Officer) | ||||
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Exhibit Index
Item 6. Exhibits
31.1* | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). | |
31.2* | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). | |
32.1* | Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). | |
32.2* | Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). |
* | Filed herewith. | |
** | Portions of this exhibit have been omitted based on a request for confidential treatment pursuant to Rule 24b-2 of the Exchange Act. Such omitted portions have been filed separately with the Commission. |
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