e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2008
or
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o |
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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)
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Delaware
(State or other jurisdiction of
incorporation or
organization)
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2408 Timberloch Place, Suite B-7
The Woodlands, Texas 77380
(Address of principal executive
offices and zip code)
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76-0233274
(IRS Employer
Identification No.) |
(281) 719-3400
(Registrants telephone number,
including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes þ 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 the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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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 þ
As of November 5, 2008, there were outstanding 15,174,904 shares of Common Stock, par value
$.001 per share, of the Registrant.
REPROS THERAPEUTICS INC.
(A development stage company)
For the Quarter Ended September 30, 2008
INDEX
2
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 Companys ability to raise additional capital on acceptable terms or at all,
the continued development of Proellex® and Androxal® and uncertainty related to the Companys
ability to obtain approval of the Companys products by the Food and Drug Administration, or FDA,
and regulatory bodies in other jurisdictions, uncertainty relating to the Companys patent
portfolio, and other risks and uncertainties described in the Companys 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 Companys annual report on Form
10-K for the year-ended December 31, 2007 and Part I. Financial Information Item 2. Managements
Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital
Resources included elsewhere in this quarterly report on Form 10-Q.
3
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 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 nine-month period ended September 30, 2008 are not necessarily
indicative of the results that may be expected for the year ended December 31, 2008. For further
information, refer to the financial statements and footnotes thereto included in the Companys
annual report on Form 10-K for the year-ended December 31, 2007.
4
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share amounts)
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September 30, |
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December 31, |
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2008 |
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2007 |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
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$ |
9,360 |
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$ |
1,779 |
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Marketable securities |
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24,124 |
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Prepaid expenses and other current assets |
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897 |
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479 |
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Total current assets |
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10,257 |
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26,382 |
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Fixed Assets, net |
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34 |
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47 |
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Other Assets, net |
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1,579 |
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1,170 |
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Total assets |
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$ |
11,870 |
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$ |
27,599 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
2,720 |
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$ |
2,281 |
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Accrued expenses |
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3,495 |
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1,258 |
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Total current liabilities |
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6,215 |
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3,539 |
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Commitments and Contingencies |
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Stockholders Equity |
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Undesignated Preferred Stock, $.001 par value, 5,000,000
shares authorized, none issued and outstanding |
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Common Stock, $.001 par value, 20,000,000 shares
authorized, 14,711,939 shares issued
and 12,774,904 shares outstanding |
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15 |
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15 |
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Additional paid-in capital |
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152,973 |
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152,033 |
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Cost of treasury stock, 1,937,035 shares |
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(5,948 |
) |
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(5,948 |
) |
Deficit accumulated during the development stage |
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(141,385 |
) |
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(122,040 |
) |
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Total stockholders equity |
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5,655 |
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24,060 |
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Total liabilities and stockholders equity |
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$ |
11,870 |
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$ |
27,599 |
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The accompanying notes are an integral part of these consolidated financial statements.
5
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited and in thousands except per share amounts)
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From Inception |
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(August 20, 1987) |
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Three Months Ended |
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Nine Months Ended |
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through |
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September 30, |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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2008 |
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Revenues |
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Licensing fees |
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$ |
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$ |
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$ |
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$ |
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$ |
28,755 |
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Product royalties |
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627 |
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Research and development grants |
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1,219 |
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Interest income |
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45 |
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396 |
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405 |
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1,155 |
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16,265 |
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Gain on disposal of fixed assets |
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102 |
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Other income |
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35 |
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Total revenues and
other income |
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45 |
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396 |
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405 |
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1,155 |
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47,003 |
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Expenses |
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Research and development |
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5,874 |
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3,196 |
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17,514 |
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9,430 |
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142,207 |
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General and administrative |
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750 |
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568 |
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2,236 |
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2,117 |
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36,450 |
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Interest expense and amortization
of intangibles |
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388 |
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Total expenses |
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6,624 |
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3,764 |
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19,750 |
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11,547 |
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179,045 |
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Loss from continuing operations |
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(6,579 |
) |
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|
(3,368 |
) |
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|
(19,345 |
) |
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(10,392 |
) |
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(132,042 |
) |
Loss from discontinued operations |
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|
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|
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(1,828 |
) |
Gain on disposal of discontinued operation |
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|
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|
|
|
|
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|
939 |
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|
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|
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|
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|
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Net loss before cumulative effect of
change in accounting principle |
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(6,579 |
) |
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|
(3,368 |
) |
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(19,345 |
) |
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|
(10,392 |
) |
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(132,931 |
) |
Cumulative effect of change in accounting
principle |
|
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|
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|
|
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|
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(8,454 |
) |
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|
|
|
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|
|
|
|
|
|
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|
Net loss |
|
$ |
(6,579 |
) |
|
$ |
(3,368 |
) |
|
$ |
(19,345 |
) |
|
$ |
(10,392 |
) |
|
$ |
(141,385 |
) |
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|
Loss per share basic and diluted: |
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$ |
(0.51 |
) |
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$ |
(0.26 |
) |
|
$ |
(1.51 |
) |
|
$ |
(0.84 |
) |
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Weighted average shares used in loss per share calculation: |
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|
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Basic |
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|
12,775 |
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|
|
12,775 |
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|
12,775 |
|
|
|
12,439 |
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|
|
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|
Diluted |
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|
12,775 |
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|
12,775 |
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|
|
12,775 |
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|
|
12,439 |
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|
The accompanying notes are an integral part of these consolidated financial statements.
6
Repros Therapeutics, Inc. and Subsidiary
(A development stage company)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands except share amounts)
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Deficit |
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Accumulated |
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Additional |
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During the |
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Total |
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Common Stock |
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Paid-in |
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|
Treasury Stock |
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|
Development |
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Stockholders |
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Shares |
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Amount |
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Capital |
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|
Shares |
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Amount |
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Stage |
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Equity |
|
Balance at December 31, 2007 |
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|
14,711,939 |
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|
$ |
15 |
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|
$ |
152,033 |
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|
|
1,937,035 |
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|
$ |
(5,948 |
) |
|
$ |
(122,040 |
) |
|
$ |
24,060 |
|
Stock based option compensation |
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|
|
|
|
|
|
|
|
|
613 |
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|
|
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|
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|
613 |
|
Proceeds from a shareholder transaction |
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|
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|
|
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|
327 |
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|
|
|
|
|
|
|
|
|
|
|
|
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|
327 |
|
Net loss |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
(19,345 |
) |
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|
(19,345 |
) |
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Balance at September 30, 2008 |
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|
14,711,939 |
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|
$ |
15 |
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|
$ |
152,973 |
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|
|
1,937,035 |
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|
$ |
(5,948 |
) |
|
$ |
(141,385 |
) |
|
$ |
5,655 |
|
|
|
|
|
|
|
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|
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The accompanying notes are an integral part of these consolidated financial statements.
7
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited and in thousands)
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From Inception |
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|
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|
(August 20, 1987) |
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|
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|
through |
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|
Nine Months Ended September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
Cash Flows from Operating Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(19,345 |
) |
|
$ |
(10,392 |
) |
|
|
(141,385 |
) |
Gain on disposal of discontinued operations |
|
|
|
|
|
|
|
|
|
|
(939 |
) |
Gain on disposal of fixed 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 |
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|
|
|
|
|
|
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|
|
1,339 |
|
Noncash decrease in accounts payable |
|
|
|
|
|
|
|
|
|
|
(1,308 |
) |
Depreciation and amortization |
|
|
32 |
|
|
|
25 |
|
|
|
3,864 |
|
Noncash stock-based compensation |
|
|
613 |
|
|
|
686 |
|
|
|
5,099 |
|
Common stock issued for agreement not to
compete |
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|
|
|
|
|
|
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|
200 |
|
Series B Preferred Stock issued for consulting
services |
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|
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|
|
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|
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|
18 |
|
Changes in operating assets and liabilities
(net effects of purchase of businesses in 1988 and 1994): |
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|
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|
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Increase in receivables |
|
|
|
|
|
|
|
|
|
|
(199 |
) |
Increase in inventory |
|
|
|
|
|
|
|
|
|
|
(4,447 |
) |
Increase in prepaid expenses and other
current assets |
|
|
(418 |
) |
|
|
(284 |
) |
|
|
(595 |
) |
(Decrease) increase in accounts payable and
accrued expenses |
|
|
2,675 |
|
|
|
(912 |
) |
|
|
7,410 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(16,443 |
) |
|
|
(10,877 |
) |
|
|
(126,312 |
) |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Change in trading marketable securities |
|
|
24,124 |
|
|
|
(20,335 |
) |
|
|
(191 |
) |
Capital expenditures |
|
|
(4 |
) |
|
|
(3 |
) |
|
|
(2,371 |
) |
Purchase of technology rights and other assets |
|
|
(423 |
) |
|
|
(196 |
) |
|
|
(3,624 |
) |
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 provided by (used in) investing activities |
|
|
23,697 |
|
|
|
(20,534 |
) |
|
|
(3,783 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of offering costs |
|
|
|
|
|
|
33,053 |
|
|
|
135,457 |
|
Exercise of stock options |
|
|
|
|
|
|
37 |
|
|
|
363 |
|
Proceeds from a shareholder transaction |
|
|
327 |
|
|
|
|
|
|
|
327 |
|
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 financing activities |
|
|
327 |
|
|
|
33,090 |
|
|
|
139,455 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
7,581 |
|
|
|
1,679 |
|
|
|
9,360 |
|
Cash and cash equivalents at beginning of period |
|
|
1,779 |
|
|
|
1,136 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
9,360 |
|
|
$ |
2,815 |
|
|
$ |
9,360 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
8
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2008
(Unaudited)
NOTE 1 Organization, Operations and Liquidity
Repros Therapeutics Inc. (the Company, or we, us or our), was organized on August 28,
1987. We are a development stage biopharmaceutical company focused on the development of oral
small molecule drugs to treat male and female reproductive disorders.
Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being
developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are
also developing Proellex as a short course pre-surgical treatment for anemia associated with
excessive menstrual bleeding related to uterine fibroids.
Our second product candidate, Androxal®, is a single isomer of clomiphene citrate and is an
orally active proprietary small molecule compound. We are developing Androxal for men of
reproductive age with low testosterone levels who want to improve or maintain their fertility
and/or sperm function while being treated for low testosterone. In November 2008, we received
guidance from the FDA suggesting submission of a new IND to the Division of Metabolic and Endocrine
Products, or DMEP, for the investigation of Androxal for an additional potential indication as a
treatment for type 2 diabetes. We plan to submit a new IND for this indication to the DMEP as soon
as practicable.
We were previously developing Androxal in the United States to treat testosterone deficiency
due to secondary hypogonadism by restoring normal testosterone production in males with functional
testes and diminished pituitary function, a common condition in the aging male. At this time, we
do not believe we have a clear clinical path to develop Androxal for this indication in the United
States and although we believe Androxal could be developed outside of the U.S., due to the limited
European market for this indication and our limited internal resources, we do not intend to pursue
approval outside of the U.S. at this time.
We also continue to maintain our patent portfolio of our phentolamine-based products for the
treatment of sexual dysfunction. We continue to try to create value from these assets in various
ways which includes the potential for future product out-licensing. However, no R&D investments
are being made in these programs at this time.
On October 2, 2008, we completed a direct registered offering of 2.4 million shares of our
common stock at a purchase price of $6.50 per share for aggregate proceeds after expenses of
approximately $15.5 million pursuant to an effective shelf registration statement. Certain of the
purchasers under this offering were granted in their purchase agreements an option to purchase an
aggregate of up to $10 million of additional shares of our common stock at the greater of the fair
market value, defined as the average of the closing prices for the 30 trading days immediately
prior to the date of exercise, or $7.80 per share. Such option becomes exercisable at such time as
9
we have less than $10 million in cash and cash equivalents and expires on September 29, 2009.
In addition, the purchasers who received such option also received a right of first offer to
purchase their respective pro-rata portion of any future financings, excluding certain corporate
activities, that expires on September 29, 2010.
As part of the terms of the October 2, 2008 financing, we amended our Standstill Agreement
with Efficacy Capital Ltd. to permit Efficacy Capital to own up to 40% of our outstanding shares of
stock and to permit Efficacy Capital to designate two directors to serve on our Board of Directors.
Pursuant to that amendment, the Board increased its number to nine and appointed Mark Lappe, a
Managing Partner of Efficacy Capital, and John C. Reed, M.D., Ph.D., President and CEO of Burnham
Institute for Medical Research, to the vacancies on the Board created by such increase. The
Company amended its Rights Agreement to reflect the increase to 40% described above.
As of September 30, 2008, we had accumulated losses of $141.4 million and had cash and cash
equivalents of $9.4 million which is exclusive of $15.5 million in net proceeds received from our
October 2, 2008 common stock sale. We have experienced negative cash flows from operations since
inception and have funded our activities to date primarily from equity financings and corporate
collaborations. Based on our current planned clinical programs, we will need to raise additional
capital in the third quarter of 2009 in order to continue our development efforts. It is also
possible that our current clinical trial activities will be more costly and take longer than we
anticipate; accordingly, there can be no assurance that additional capital will not be necessary
prior to the time anticipated. There can be no assurance that we will be successful in obtaining
additional capital on acceptable terms, or at all, in amounts sufficient to continue to fund our
operations and clinical product development. Therefore, there is substantial doubt about our
ability to continue as a going concern over the next twelve months.
Our results of operations may vary significantly from quarter to quarter and year to year, 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 do 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.
Our losses from inception to date 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. Under
SFAS No. 109, Accounting for Income Taxes, a net operating loss (NOL), requires the recognition
of deferred tax assets. As the Company has incurred losses since inception, and since there is no
certainty of future profits, a valuation allowance has been provided in full on our deferred tax
assets in the accompanying consolidated financial statements. If the Company has an opportunity to
use this NOL to off-set tax liabilities in the future, the use of this asset would be restricted
based on Internal Revenue Service, state and local NOL use guidelines.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and
10
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 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. SFAS No. 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007 and interim periods within
those fiscal years. Issued in February 2008, FSP 157-1 Application of FASB Statement No. 157 to
FASB Statement No. 13 and Other Accounting Pronouncements That Address Fair Value Measurements for
Purposes of Lease Classification or Measurement under Statement 13 removed leasing transactions
accounted for under Statement 13 and related guidance from the scope of SFAS No. 157. FSP 157-2
Partial Deferral of the Effective Date of Statement 157 (FSP 157-2), deferred the effective date
of SFAS No. 157 for all nonfinancial assets and nonfinancial liabilities to fiscal years beginning
after November 15, 2008. The implementation of SFAS No. 157 for financial assets and financial
liabilities, effective January 1, 2008, did not have a material impact on our consolidated
financial position and results of operations. The implementation of SFAS No. 157 for nonfinancial
assets and nonfinancial liabilities will not have a material impact on our consolidated financial
position and results of operations.
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 did not apply the fair value
option under SFAS 159, which is elective. We have reclassified all cash flows, related to our
trading securities, from operating to investing activities in the accompanying statement of cash
flows to reflect the nature of the investments in accordance with paragraph 16 of SFAS 159.
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS
141R), which replaces SFAS 141, Business Combinations. SFAS 141R retains the fundamental
requirements in Statement 141 that the purchase method of accounting be used for all business
combinations. This statement further establishes principles and requirements for how the acquiring
entity recognizes and measures in its financial statements the identifiable assets acquired,
including goodwill, the liabilities assumed, and any noncontrolling interest in the acquiree. SFAS
141R also determines what information to disclose to enable users of the financial statements to
evaluate the nature and financial effects of the business combination. SFAS 141R applies
prospectively to business combinations for which the acquisition date is on or after the beginning
of the first annual reporting period beginning on or after December 15, 2008, and the
11
Company cannot estimate any impact this statement may have on the Companys results of
operations or financial position as any potential business combinations after the implementation
date are unknown.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statementsan amendment of ARB No. 51 (SFAS 160). SFAS 160 addresses the accounting
and reporting for entities that consolidate a noncontrolling interest, sometimes called a minority
interest. SFAS 160 is effective for fiscal years beginning after December 15, 2008, but is not
expected to have any impact on the Companys consolidated financial statements as the Company does
not currently consolidate any noncontrolling interest entities.
In March 2008, the FASB issued SFAS No. 161 Disclosures About Derivative Instruments and
Hedging Activities an amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 amends SFAS 133
by requiring expanded disclosures about an entitys derivative instruments and hedging activities.
SFAS 161 requires qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of and gains and losses on derivative
instruments, and disclosures about credit-risk-related contingent features in derivative
instruments. SFAS 161 is effective for the Company as of January 1, 2009. The Company does not
expect any impact of adopting SFAS 161 on its consolidated financial statements.
In April 2008, the FASB issued FSP 142-3, Determination of the Useful Life of Intangible
Assets, (FSP 142-3). FSP 142-3 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. FSP 142-3 is effective for fiscal years
beginning after December 15, 2008. The implementation of this standard will not have a material
impact on our consolidated financial position and results of operations.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS No. 162). SFAS No. 162 identifies the sources of accounting principles and the
framework for selecting the principles used in the preparation of financial statements. SFAS No.
162 is effective 60 days following the SECs approval of the Public Company Accounting Oversight
Board amendments to AU Section 411, The Meaning of Present Fairly in Conformity with Generally
Accepted Accounting Principles. The implementation of this standard will not have a material
impact on our consolidated financial position and results of operations.
NOTE 2 Marketable Securities
In the past the Companys investments typically included corporate bonds and notes,
Euro-dollar bonds and asset-backed securities. The Companys policy is to require minimum credit
ratings of A2/A and A1/P1. Due to the current financial markets, as of September 30, 2008, as a
means of protecting our cash resources, we invested all of our cash resources in a money market
fund that is backed by U.S. government securities.
12
Marketable securities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basis of Fair Value |
|
|
September 30, |
|
|
|
|
|
|
Measurement |
|
|
2008 |
|
|
December 31, 2007 |
|
|
|
|
|
|
|
|
Money Market Securities |
|
Level 1 |
|
$ |
9,332 |
|
|
$ |
1,696 |
|
Corporate Bonds |
|
Level 2 |
|
|
|
|
|
|
9,632 |
|
Taxable Auction Securities |
|
Level 3 |
|
|
|
|
|
|
6,400 |
|
Certificates of Deposit |
|
Level 2 |
|
|
|
|
|
|
4,503 |
|
Medium and Short Term
Notes |
|
Level 2 |
|
|
|
|
|
|
2,594 |
|
Municipal Bonds |
|
Level 2 |
|
|
|
|
|
|
995 |
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
9,332 |
|
|
$ |
25,820 |
|
|
|
|
|
|
|
SFAS No. 157, Fair Value Measurements, establishes a fair value hierarchy that prioritizes
the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest
priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1
measurements) and the lowest priority to unobservable inputs (level 3 measurements). The three
levels of the fair value hierarchy under SFAS No. 157 are described below:
Basis of Fair Value Measurement
|
Level 1 |
|
Unadjusted quoted prices in active markets that are accessible
at the measurement date for identical, unrestricted assets or
liabilities; |
|
|
Level 2 |
|
Quoted prices in markets that are not considered to be active or
financial instruments for which all significant inputs are
observable, either directly or indirectly; |
|
|
Level 3 |
|
Prices or valuations that require inputs that are both
significant to the fair value measurement and unobservable. |
A financial instruments level within the fair value hierarchy is based on the lowest level of
any input that is significant to the fair value measurement. In determining fair value, the
Company first determines what level of measurements are applicable in the fair value hierarchy.
The Companys marketable securities are generally classified within level 1 or level 2 of the
fair value hierarchy because they were valued using quoted market prices or broker or dealer
quotations with reasonable levels of price transparency. The Companys money market securities,
totaling $9.3 million (included in cash equivalents) at September 30, 2008, are classified within
level 1 of the fair value hierarchy. The Company does not adjust the quoted price for such
instruments.
At December 31, 2007 the Company held $6.4 million in taxable auction rate securities (ARS).
These securities were sold or redeemed at par value from January 1, 2008 through June 18, 2008. As
of September 30, 2008 the Company did not hold any ARS.
13
Valuations are adjusted if necessary to reflect illiquidity and/or non-transferability, and
such adjustments are generally based on available market evidence. In the absence of such
evidence, managements best estimate is used.
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 September 30, 2008, we held no securities which would have
been classified as trading securities and would have been classified as current assets.
NOTE 3 Patents
As of September 30, 2008, the Company had approximately $1,579,000 in internal capitalized
patent costs reflected on its balance sheet. Of this amount, $717,000 relates to patent costs for
Proellex and $862,000 relates to patent costs for Androxal.
NOTE 4 Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
December 31, 2007 |
|
Research and development costs |
|
$ |
3,152 |
|
|
$ |
955 |
|
Payroll |
|
|
|
|
|
|
63 |
|
Patent costs |
|
|
139 |
|
|
|
51 |
|
Other |
|
|
204 |
|
|
|
189 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,495 |
|
|
$ |
1,258 |
|
|
|
|
|
|
|
|
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 period. 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.
14
The following table presents information necessary to calculate loss per share for the three
and nine-month periods ended September 30, 2008 and 2007 (in thousands, except per share
amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Net loss |
|
$ |
(6,579 |
) |
|
$ |
(3,368 |
) |
|
$ |
(19,345 |
) |
|
$ |
(10,392 |
) |
Average common
shares outstanding |
|
|
12,775 |
|
|
|
12,775 |
|
|
|
12,775 |
|
|
|
12,439 |
|
Basic and diluted
loss per share |
|
$ |
(0.51 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.51 |
) |
|
$ |
(0.84 |
) |
Other potential common stock of 1,743,565 and 1,576,815 common shares underlying stock options
for the periods ended September 30, 2008 and 2007, respectively, were excluded from the above
calculation of diluted loss per share since they were antidilutive.
NOTE 6 Contingencies
Our Androxal product candidate and its uses are covered in the United States by two issued
U.S. patents and seven pending patent applications. Foreign coverage of our Androxal product
candidate includes ten issued foreign patents and 65 foreign pending patent applications. The
issued patents and pending applications relate to methods and compositions for treating certain
conditions including the treatment of testosterone deficiency in men, the treatment of metabolic
syndrome and conditions associated therewith, and the treatment of infertility in hypogonadal 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 reexamination proceedings, which led the PTO to determine that the
amended claims are patentable in view of those publications under consideration and a reexamination
certificate was issued. However, we believe that the amended claims are invalid based on
additional prior art publications, and our request for reexamination by the PTO in light of a
number of these additional publications and other publications cited by the PTO, has been granted.
All of the claims have been finally rejected in the reexamination. The patent holder has appealed
the rejections and has recently filed a Request for Oral Hearing. 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.
15
Item 2. Managements 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 Companys 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, or we, us or our), was organized on August 28,
1987. We are a development stage biopharmaceutical company focused on the development of oral
small molecule drugs to treat male and female reproductive disorders.
Our current product pipeline consists of the following (with the respective status of
development):
Proellex® (female reproductive health)
|
|
|
Phase 3 three-month short course treatment of symptomatic uterine fibroids
associated with anemia in women who may consider having a subsequent hysterectomy |
|
|
|
|
Phase 3 for the chronic treatment of symptomatic uterine fibroids |
|
|
|
|
Phase 2 for the treatment of symptomatic endometriosis |
Androxal® (male reproductive health)
|
|
|
Phase 2b proof-of-concept trial in men with low testosterone levels wanting to
improve or maintain their fertility and/or sperm number and function |
|
|
|
|
Request pre-IND meeting with the FDAs Division of Metabolic and Endocrine
Products to investigate Androxal as a treatment for type 2 diabetes |
Proellex
Our lead drug, Proellex, is a selective progesterone receptor modulator (PRM) and is being
developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are
also developing Proellex as a short course pre-surgical treatment for anemia associated with
excessive menstrual bleeding related to uterine fibroids. During the first quarter of 2008, we
filed an Investigational New Drug Application, or IND, for Proellex for the treatment of anemia
associated with uterine fibroids and also initiated two 65-patient Phase 3 pivotal clinical trials
with Proellex for this indication. Our goal is to file a New Drug Application, or NDA, for this
16
indication
in late 2009.
During the first quarter of 2008, we initiated two 75-patient Phase 3 pivotal clinical trials
with Proellex for the chronic treatment of uterine fibroids and anticipate filing a NDA for this
indication in late 2010. In addition, during the first quarter of 2008, we also initiated two 400
patient Proellex Open Label Safety Studies. We intend to complete patient enrollment for one 400
patient Open Label Safety Study then start enrollment in the second Open Label Safety study.
The initiation of these Phase 3 clinical trials and Open Label Studies included awarding the
trials to three clinical research organizations, the process of identifying and contracting the
clinical sites to be used as well as other various activities required to complete these clinical
trials. During the second quarter of 2008, we implemented a centralized patient recruitment
advertising campaign for our Phase 3 Proellex clinical trials and in July 2008 we took the
necessary steps to begin additional patient recruitment advertising for one of our 400 patient
Proellex Open Label Safety Studies.
During 2008 we disclosed the following clinical trial and animal safety data relating to
Proellex:
|
|
|
initial results from 13 women who had endometrial biopsies post menses following
last dose of drug in a two drug cycle extension study showed that results of
assessments of the post menses tissues are that of a benign endometrium. While
previous end of drug cycle biopsies from these subjects all had histological
changes consistent with those induced by progesterone receptor modulators (Proellex
class of drugs), none of these post drug cessation biopsies reflected any of those
histological changes. These key findings indicate that the effects of Proellex on
the endometrium are present during drug exposure and are reversible upon cessation
of drug treatment; |
|
|
|
|
results from a pilot study of the potential for adverse cardiac events
associated with administration of doses of Proellex up to four times higher than
the intended marketed dose showed that despite up to a four fold increase in
Proellex plasma concentrations over seven days the QTc did not change; and |
|
|
|
|
initial macroscopic findings from a two-year rat carcinogenicity study and a
six-month mouse carcinogenicity study showed no potential for tumor induction as
compared to placebo. |
To review all of the clinical development information that has been disclosed regarding our
products please go to www.reprosrx.com and also see our filings at www.sec.gov.
We are also currently conducting a Phase 2 clinical trial with Proellex for the treatment of
endometriosis. We provided initial interim data from this trial in July 2008 which showed that
severe pain, the most troublesome symptom associated with endometriosis, was significantly reduced
in one to two months of treatment. We intend to file a NDA for this indication in late 2010.
Uterine fibroids, anemia associated with uterine fibroids and endometriosis affect a
17
significant number of women of childbearing age in the developed world. There is no
currently-approved effective long-term drug treatment for uterine fibroids or endometriosis. In
the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe
uterine fibroids.
In addition to the clinical trials discussed above we are also conducting additional human
clinical trials and animal safety studies with Proellex to support our future NDA submissions.
Androxal
Our second product candidate, Androxal, is a single isomer of clomiphene citrate and is an
orally active proprietary small molecule compound.
During the second quarter of 2008, we initiated a Phase 2b proof-of-concept Androxal clinical
trial in men of reproductive age with low testosterone levels who want to improve or maintain their
fertility and/or sperm function while being treated for low testosterone. This trial includes a
control group that will be given Testim®, a popular testosterone replacement therapy. We believe
Androxal will be superior to the existing drugs used to normalize testosterone as, to our
knowledge, only Androxal has the property of restoring both luteinizing hormone, or LH, and
follicle stimulating hormone, or FSH, levels. LH and FSH are the pituitary hormones that stimulate
testicular testosterone and sperm production, respectively. We intend to have an End of Phase 2
Meeting with the Food and Drug Administration, or FDA, in the second half of 2009. According to the
Urology Channel, recent estimates show that approximately 13 million men in the United States
experience testosterone deficiency.
In November 2008, we received guidance from the FDA suggesting submission of a new IND to the
Division of Metabolic and Endocrine Products, or DMEP, for the investigation of Androxal as a
potential treatment for type 2 diabetes. We plan to submit a new IND for this indication to the
DMEP as soon as practicable.
In addition to the clinical trials discussed above, we are also conducting a long-term Open
Label Safety Study and animal safety study with Androxal to support our future NDA submissions.
We were previously developing Androxal in the United States to treat testosterone deficiency
due to secondary hypogonadism by restoring normal testosterone production in males with functional
testes and diminished pituitary function, a common condition in the aging male. Based on a Type
C meeting held with the FDA on October 15, 2007 we do not believe we have a clear clinical path
to develop Androxal for this indication in the United States at this time. Although we believe
Androxal could be developed outside of the United States, due to the limited European market for
this indication and our limited internal resources we do not intend to pursue approval outside of
the United States at this time.
Our Androxal product candidate and its uses are covered in the United States by two issued
U.S. patents and seven pending patent applications. Foreign coverage of our Androxal product
candidate includes ten issued foreign patents and 65 foreign pending patent applications. The
issued patents and pending applications relate to methods and compositions for treating
18
certain conditions including the treatment of testosterone deficiency in men, the treatment of
metabolic syndrome and conditions associated therewith, and the treatment of infertility in
hypogonadal 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 reexamination proceedings, which led the PTO to determine that the
amended claims are patentable in view of those publications under consideration and a reexamination
certificate was issued. However, we believe that the amended claims are invalid based on
additional prior art publications, and our request for reexamination by the PTO in light of a
number of these additional publications and other publications cited by the PTO, has been granted.
All of the claims have been finally rejected in the reexamination. The patent holder has appealed
the rejections and has recently filed a Request for Oral Hearing. 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.
Other Programs
We continue to maintain our patent portfolio of our phentolamine-based products for the
treatment of sexual dysfunction. We continue to try to create value from these assets in various
ways which includes the potential for future product out-licensing. However, no R&D investments
are being made in these programs at this time.
General
On October 2, 2008, we completed a direct registered offering of 2.4 million shares of our
common stock at a purchase price of $6.50 per share for aggregate proceeds after expenses of
approximately $15.5 million pursuant to an effective shelf registration statement. Certain of the
purchasers under this offering were granted in their purchase agreements an option to purchase an
aggregate of up to $10 million of additional shares of our common stock at the greater of the fair
market value, defined as the average of the closing prices for the 30 trading days immediately
prior to the date of exercise, or $7.80 per share. Such option becomes exercisable at such time as
we have less than $10 million in cash and cash equivalents and expires on September 29, 2009. In
addition, the purchasers who received such option also received a right of first offer to purchase
their respective pro-rata portion of any future financings, excluding certain corporate activities,
that expires on September 29, 2010.
As part of the terms of the October 2, 2008 financing, we amended our Standstill Agreement
with Efficacy Capital Ltd. to permit Efficacy Capital to own up to 40% of our outstanding shares of
stock and to permit Efficacy Capital to designate two directors to serve on our Board of Directors.
Pursuant to that amendment, the Board increased its number to nine and
19
appointed Mark Lappe, a Managing Partner of Efficacy Capital, and John C. Reed, M.D., Ph.D.,
President and CEO of Burnham Institute for Medical Research, to the vacancies on the Board created
by such increase. The Company amended its Rights Agreement to reflect the increase to 40%
described above.
The Company plans to use the proceeds from the financing to fund its research and development
activities, including the ongoing pivotal Phase 3 trials of its lead product candidate, Proellex®,
as a pre-surgical short course treatment of anemia associated with uterine fibroids and as a
chronic treatment of uterine fibroids and its Phase 2 clinical trial for the treatment of
endometriosis as well as for working capital and general corporate purposes.
On July 3, 2008, Efficacy Capital paid $327,320 to the Company as disgorgement of short swing
profits under Section 16(b) of the Exchange Act as a result of certain inadvertent sales by
Efficacy that occurred in March 2008 and that were within six months of certain purchases by
Efficacy. The amount received from Efficacy has been reported as additional paid in capital for
the quarter ended September 30, 2008. Efficacy is an affiliate of the Company as a result of its
beneficial ownership of more than 10% of the Companys common stock.
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 recognize that the total costs we will incur for the
clinical development of our product candidates may exceed our current estimates. We do, however,
expect these costs to increase substantially in future periods as we continue later-stage clinical
development trials. Any failure by us to obtain, or any delay in obtaining, regulatory approvals
could cause our research and development expenditures to increase and, in turn, have a material
adverse effect on our results of operations.
We have not generated any substantial revenue from commercial sale of our current product
candidates. We will not receive any revenue from commercial sales unless we, or a potential
partner, complete the clinical trial development process, obtain regulatory approval, and
successfully commercialize one or more of our product candidates. We cannot be certain when or if
any of our current product candidates will ever generate cash flow.
As of September 30, 2008, we had an accumulated deficit of $141.4 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. Under SFAS No. 109, Accounting for Income
Taxes, a net operating loss (NOL) requires the recognition of deferred tax assets. As we have
incurred losses since inception, and since there is no certainty of future profits, a valuation
allowance has been provided in full on our deferred tax assets in the accompanying consolidated
financial statements. If we have an opportunity to use this NOL to off-set tax liabilities in the
future, the use of this asset would be restricted based on Internal Revenue Service, state and
local NOL use guidelines.
20
We have 7 permanent full-time employees who utilize the services of contract research
organizations, contract manufacturers and various consultants to assist us in performing clinical
and regulatory services for the clinical development of our products as well as administrative
services. We are substantially dependent on our various contract groups to adequately perform the
activities required to obtain regulatory approval of our products as well as other consultants that
perform various administrative services.
Our results of operations may vary significantly from year to year and quarter to quarter, and
depend, among other factors, on our ability to raise additional capital on acceptable terms or at
all, 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.
Recent Accounting Pronouncements
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. SFAS No. 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007 and interim periods within
those fiscal years. Issued in February 2008, FSP 157-1 Application of FASB Statement No. 157 to
FASB Statement No. 13 and Other Accounting Pronouncements That Address Fair Value Measurements for
Purposes of Lease Classification or Measurement under Statement 13 removed leasing transactions
accounted for under Statement 13 and related guidance from the scope of SFAS No. 157. FSP 157-2
Partial Deferral of the Effective Date of Statement 157 (FSP 157-2), deferred the effective date
of SFAS No. 157 for all nonfinancial assets and nonfinancial liabilities to fiscal years beginning
after November 15, 2008. The implementation of SFAS No. 157 for financial assets and financial
liabilities, effective January 1, 2008, did not have a material impact on our consolidated
financial position and results of operations. The implementation of SFAS No. 157 for nonfinancial
assets and nonfinancial liabilities will not have a material impact on our consolidated financial
position and results of operations.
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 did not apply the fair value
option under SFAS 159, which is elective. We have reclassified all cash flows, related to our
trading securities, from operating to investing activities in the accompanying statement of cash
flows to reflect the nature of the investments in accordance with paragraph 16 of SFAS 159.
21
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS
141R), which replaces SFAS 141, Business Combinations. SFAS 141R retains the fundamental
requirements in Statement 141 that the purchase method of accounting be used for all business
combinations. This statement further establishes principles and requirements for how the acquiring
entity recognizes and measures in its financial statements the identifiable assets acquired,
including goodwill, the liabilities assumed, and any noncontrolling interest in the acquiree. SFAS
141R also determines what information to disclose to enable users of the financial statements to
evaluate the nature and financial effects of the business combination. SFAS 141R applies
prospectively to business combinations for which the acquisition date is on or after the beginning
of the first annual reporting period beginning on or after December 15, 2008, and we cannot
estimate any impact this statement may have on our results of operations or financial position as
any potential business combinations after the implementation date are unknown.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statementsan amendment of ARB No. 51 (SFAS 160). SFAS 160 addresses the accounting
and reporting for entities that consolidate a noncontrolling interest, sometimes called a minority
interest. SFAS 160 is effective for fiscal years beginning after December 15, 2008, but is not
expected to have any impact on our consolidated financial statements as we do not currently
consolidate any noncontrolling interest entities.
In March 2008, the FASB issued SFAS No. 161 Disclosures About Derivative Instruments and
Hedging Activities an amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 amends SFAS 133
by requiring expanded disclosures about an entitys derivative instruments and hedging activities.
SFAS 161 requires qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of and gains and losses on derivative
instruments, and disclosures about credit-risk-related contingent features in derivative
instruments. SFAS 161 is effective for the Company as of January 1, 2009. The Company does not
expect any impact of adopting SFAS 161 on its consolidated financial statements.
In April 2008, the FASB issued FSP 142-3, Determination of the Useful Life of Intangible
Assets, (FSP 142-3). FSP 142-3 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. FSP 142-3 is effective for fiscal years
beginning after December 15, 2008. The implementation of this standard will not have a material
impact on our consolidated financial position and results of operations.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS No. 162). SFAS No. 162 identifies the sources of accounting principles and the
framework for selecting the principles used in the preparation of financial statements. SFAS No.
162 is effective 60 days following the SECs approval of the Public Company Accounting Oversight
Board amendments to AU Section 411, The Meaning of Present Fairly in Conformity with Generally
Accepted Accounting Principles. The implementation of this standard will not have a material
impact on our consolidated financial position and results of operations.
22
Results of Operations
Three-Month and Nine-Month Periods Ended September 30, 2008 and 2007
Revenues and Other Income. Total revenues and other income for the three-month period ended
September 30, 2008 decreased to $45,000 as compared to $396,000 for the same period in the prior
year and decreased to $405,000 for the nine-month period ended September 30, 2008 as compared to
$1.2 million for the same period in the prior year.
Interest income decreased 89% to $45,000 for the three-month period ended September 30, 2008,
as compared to $396,000 for the same period in the prior year and decreased 65% to $405,000 for the
nine-month period ended September 30, 2008 as compared to $1.2 million for the same period in the
prior year. The decrease in interest income for the three-month and nine-month periods ended
September 30, 2008 as compared to the same periods in the prior year is primarily due to lower
combined cash, cash equivalents and marketable securities balances and reduced interest rate yields
that have occurred as we moved our cash investments solely into money market accounts.
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 84% to approximately $5.9 million for the three-month period
ended September 30, 2008 as compared to approximately $3.2 million for the same period in the prior
year and increased 86% to approximately $17.5 million for the nine-month period ended September 30,
2008 as compared to $9.4 million for the same period in the prior year. The increase in R&D
expenses for the three-month period ended September 30, 2008 as compared to the same period in the
prior year is primarily due to an increase of $2.5 million in our current clinical and preclinical
activities. The increase in R&D expenses for the nine-month period ended September 30, 2008 as
compared to the same period in the prior year is primarily due to an increase of $8.3 million in
our current clinical and preclinical activities and an increase in consulting expenses of $291,000,
partially offset by a decrease in manufacturing activities of $738,000. Included in the nine-month
period ended September 30, 2008 is a $100,000 milestone payment to the National Institutes of
Health, under our license agreement, relating to the initiation of a Phase 3 clinical trial with
Proellex.
General and Administrative Expenses. General and administrative expenses increased 32% to
approximately $750,000 for the three-month period ended September 30, 2008 as compared to
approximately $568,000 for the same period in the prior year and increased 6% to approximately $2.2
million for the nine-month periods ended September 30, 2008 as compared to approximately $2.1
million for the same period in the prior year. The increase in expenses for the three-month period
ended September 30, 2008 as compared to the same period in the prior year is primarily due to an
increase in professional services of $176,000, partially offset by a decrease in non-cash stock
compensation expense of $38,000. The increase in expenses for the nine-month period ended
September 30, 2008 as compared to the same period in the prior year is primarily due to an increase
in professional services of $272,000, partially offset by a decrease in non-cash stock compensation
expense of $155,000.
23
Liquidity and Capital Resources
On October 2, 2008, we completed a direct registered offering of 2.4 million shares of our
common stock at a purchase price of $6.50 per share for aggregate proceeds after expenses of
approximately $15.5 million pursuant to an effective shelf registration statement. Certain of the
purchasers under this offering were granted in their purchase agreements an option to purchase an
aggregate of up to $10 million of additional shares of our common stock at the greater of the fair
market value, defined as the average of the closing prices for the 30 trading days immediately
prior to the date of exercise, or $7.80 per share. Such option becomes exercisable at such time as
we have less than $10 million in cash and cash equivalents and expires on September 29, 2009. In
addition, the purchasers who received such option also received a right of first offer to purchase
their respective pro-rata portion of any future financings, excluding certain corporate activities,
that expires on September 29, 2010.
Net cash of approximately $16.4 million was used in operating activities during the nine-month
period ended September 30, 2008 as compared to $10.9 million for the same period in the prior year.
The major uses of cash for operating activities during the nine-month period ended September 30,
2008 was to fund our clinical development programs and associated administrative costs of $19.3
million, net of interest income, partially offset by an increase in our accrued liabilities.
We had cash and cash equivalents of approximately $9.4 million as of September 30, 2008 as
compared to cash, cash equivalents and marketable securities of $25.9 million as of December 31,
2007. As of September 30, 2008, we had accumulated losses of $141.4 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 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. Therefore, there is substantial doubt about our ability to
continue as a going concern over the next twelve months.
Based on our current planned clinical programs, we will need to raise additional capital in
the third quarter of 2009 in order to continue our development efforts. It is also possible that
our current clinical trial activities will be more costly and take longer than we anticipate;
accordingly, there can be no assurance that additional capital will not be necessary prior to the
time anticipated. There can be no assurance that we will be successful in obtaining additional
capital on acceptable terms, or at all, in amounts sufficient to continue to fund our operations
and clinical product development.
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 other funding arrangements; our ability to obtain regulatory approvals; the success of our
potential future sales and marketing programs; the cost of filing, prosecuting and 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
24
based on certain assumptions that the development and regulatory approval of our products can
be completed at projected costs and 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 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
holders of our common stock. See Item 1A. Risk Factors in our Form 10-K for the year ended
December 31, 2007 and Note 1. Organization and Operations of Notes to Consolidated Financial
Statements for additional disclosure about our need for additional capital.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk. We had cash and cash equivalents of approximately $9.4 million at
September 30, 2008 which is held in an account backed by U.S. government securities. Although this
cash account is subject to fluctuations in interest rates and market conditions, no significant
gain or loss on this account is expected to be recognized in earnings. We do not invest in
derivative securities.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Based on their evaluation as of the end of the period covered by this Quarterly Report on 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.
Changes in Internal Control over Financial Reporting
In connection with the evaluation described above, we identified no change in internal control
over financial reporting that occurred during the fiscal quarter ended September 30, 2008 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
25
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our Androxal product candidate and its uses are covered in the United States by two issued
U.S. patents and seven pending patent applications. Foreign coverage of our Androxal product
candidate includes ten issued foreign patents and 65 foreign pending patent applications. The
issued patents and pending applications relate to methods and compositions for treating certain
conditions including the treatment of testosterone deficiency in men, the treatment of metabolic
syndrome and conditions associated therewith, and the treatment of infertility in hypogonadal 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 reexamination proceedings, which led the PTO to determine that the
amended claims are patentable in view of those publications under consideration and a reexamination
certificate was issued. However, we believe that the amended claims are invalid based on
additional prior art publications, and our request for reexamination by the PTO in light of a
number of these additional publications and other publications cited by the PTO, has been granted.
All of the claims have been finally rejected in the reexamination. The patent holder has appealed
the rejections and has recently filed a Request for Oral Hearing. 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.
Item 1A. Risk Factors
Other than the additional risk factor included below relating to financial markets, there were
no material changes from the risk factors previously disclosed in the registrants Form 10-K for
the fiscal year ended December 31, 2007 in response to Item 1A. Risk Factors to Part I of Form
10-K.
Financial Markets. The financial markets have been experiencing extreme volatility and
disruption. Even though we completed an offering of 2.4 million shares of our common stock for
aggregate net proceeds of $15.5 million, we will require additional capital in the third quarter of
2009 to continue our development efforts. However, due to the uncertainty in the financial
markets, access to capital may be limited on terms acceptable to us or may not be available at all.
Item 5. Other Information
None
26
Item 6. Exhibits
|
10.1 |
|
First Amendment to Standstill Agreement, dated as of July 28, 2008, between the
Company and Efficacy Capital, Ltd. (incorporated by reference to Exhibit 10.1 to the Companys Form
8-K as filed with the Commission on July 28, 2008). |
|
|
10.2 |
|
Common Stock Purchase Agreement between Repros Therapeutics Inc. and Efficacy
Capital, Ltd. dated September 29, 2008 (incorporated by reference to Exhibit 10.1 to the
Companys Form 8-K as filed with the Commission on September 29, 2008 (the Form
8-K)). |
|
|
10.3 |
|
Amended and Restated Common Stock Purchase Agreement, dated as of September 29,
2008, between the Company and the affiliate of Vermillion Asset Management LLC named
therein (incorporated by reference to Exhibit 10.4 to the Companys Form 8-K as filed
with the Commission on October 3, 2008). |
|
|
10.4 |
|
Common Stock Purchase Agreement between Repros Therapeutics Inc. and the
affiliate of Vermillion Asset Management LLC named therein dated September 29, 2008
(incorporated by reference to Exhibit 10.3 to the Form 8-K). |
|
|
10.5 |
|
Common Stock Purchase Agreement between Repros Therapeutics Inc. and John C.
Reed dated September 29, 2008 (incorporated by reference to Exhibit 10.4 to the Form
8-K). |
|
|
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). |
27
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.
|
|
|
|
|
Date: November 10, 2008 |
REPROS THERAPEUTICS INC.
|
|
|
By: |
/s/ Joseph S. Podolski
|
|
|
|
Joseph S. Podolski |
|
|
|
President, Chief Executive
Officer and Director
(Principal Executive Officer) |
|
|
Date: November 10, 2008 |
|
|
|
By: |
/s/ Louis Ploth, Jr.
|
|
|
|
Louis Ploth, Jr. |
|
|
|
Vice President Business Development, Chief Financial Officer, Director and Secretary
(Principal Financial and Accounting Officer) |
|
28