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, 2006
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
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2408 Timberloch Place, Suite B-7
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76-0233274 |
(State or other jurisdiction of
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The Woodlands, Texas 77380
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(IRS Employer |
incorporation or
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(Address of principal executive
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Identification No.) |
organization)
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offices and zip code) |
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(281) 719-3400
(Registrants telephone number,
including area code)
Zonagen, Inc.
(Former name, former address and former fiscal year, if changed since report)
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 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 filer o Accelerated filer o Non-accelerated filer þ
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 3, 2006, there were outstanding 10,150,962 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, 2006
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 early stage of 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 (FDA) and regulatory bodies in other jurisdictions, the Companys ability to raise
additional capital on acceptable terms or at all, 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, 2005 and Part II. Other Information Item 1A. Risk Factors
included in the Companys quarterly report on Form 10-Q for the quarter ended June 30, 2006 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 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 nine-month period ended September 30, 2006 are not
necessarily indicative of the results that may be expected for the year ended December 31, 2006.
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, 2005.
4
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except per share amounts)
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September 30, |
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December 31, |
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2006 |
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2005 |
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(unaudited) |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
|
$ |
2,117 |
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$ |
2,165 |
|
Marketable securities |
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7,750 |
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|
14,667 |
|
Prepaid expenses and other current assets |
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256 |
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231 |
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Total current assets |
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10,123 |
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17,063 |
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Fixed Assets, net |
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69 |
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19 |
|
Other assets, net |
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737 |
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|
600 |
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|
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|
|
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Total assets |
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$ |
10,929 |
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$ |
17,682 |
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|
|
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|
|
|
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
905 |
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$ |
338 |
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Accrued expenses |
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1,006 |
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|
389 |
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|
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Total current liabilities |
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1,911 |
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|
727 |
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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, $.001 par value, 20,000,000 shares
authorized, 12,087,997 and 12,016,636 shares issued,
respectively; 10,150,962 and 10,079,601 shares
outstanding, respectively |
|
|
12 |
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|
12 |
|
Additional paid-in capital |
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|
117,847 |
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|
117,166 |
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Deferred compensation |
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|
|
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|
(130 |
) |
Cost of treasury stock, 1,937,035 and 1,937,035 shares, respectively |
|
|
(5,948 |
) |
|
|
(5,948 |
) |
Deficit accumulated during the development stage |
|
|
(102,893 |
) |
|
|
(94,145 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
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|
9,018 |
|
|
|
16,955 |
|
|
|
|
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Total liabilities and stockholders equity |
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$ |
10,929 |
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$ |
17,682 |
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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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2006 |
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2005 |
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2006 |
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2005 |
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2006 |
|
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 |
|
Product royalties |
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|
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|
|
|
|
|
|
|
|
627 |
|
Research and development grants |
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4 |
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1,219 |
|
Interest income |
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146 |
|
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|
175 |
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|
486 |
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|
456 |
|
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|
14,242 |
|
Gain on disposal of fixed assets |
|
|
|
|
|
|
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|
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|
102 |
|
Other Income |
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35 |
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Total revenues and other income |
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146 |
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|
175 |
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|
486 |
|
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|
460 |
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|
44,980 |
|
Expenses |
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Research and development |
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3,073 |
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|
1,641 |
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|
7,245 |
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4,231 |
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107,606 |
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General and administrative |
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713 |
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|
461 |
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1,989 |
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|
1,357 |
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|
30,536 |
|
Interest expense and amortization
of intangibles |
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|
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|
|
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|
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|
|
|
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|
388 |
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|
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Total expenses |
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3,786 |
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|
2,102 |
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|
9,234 |
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|
5,588 |
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|
138,530 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Loss from continuing operations |
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|
(3,640 |
) |
|
|
(1,927 |
) |
|
|
(8,748 |
) |
|
|
(5,128 |
) |
|
|
(93,550 |
) |
Loss from discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,828 |
) |
Gain on disposal |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before cumulative effect of
change in accounting principle |
|
|
(3,640 |
) |
|
|
(1,927 |
) |
|
|
(8,748 |
) |
|
|
(5,128 |
) |
|
|
(94,439 |
) |
Cumulative effect of change in accounting
principle |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,454 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,640 |
) |
|
$ |
(1,927 |
) |
|
$ |
(8,748 |
) |
|
$ |
(5,128 |
) |
|
$ |
(102,893 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
Loss per share basic and diluted: |
|
$ |
(0.36 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.54 |
) |
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
|
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Shares used in loss per share calculation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
10,150 |
|
|
|
10,080 |
|
|
|
10,145 |
|
|
|
9,501 |
|
|
|
|
|
Diluted |
|
|
10,150 |
|
|
|
10,080 |
|
|
|
10,145 |
|
|
|
9,501 |
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
6
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited and in thousands)
|
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|
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
From Inception |
|
|
|
|
|
|
|
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|
(August 20, 1987) |
|
|
|
Nine Months Ended |
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|
through |
|
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|
September 30, |
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|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
Cash Flows from Operating Activities |
|
|
|
|
|
|
|
|
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|
|
|
Net loss |
|
$ |
(8,748 |
) |
|
$ |
(5,128 |
) |
|
|
(102,893 |
) |
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 |
|
|
12 |
|
|
|
5 |
|
|
|
3,792 |
|
Noncash expenses related to stock-based transactions |
|
|
570 |
|
|
|
64 |
|
|
|
3,387 |
|
Common stock issued for agreement not to compete |
|
|
|
|
|
|
|
|
|
|
200 |
|
Series B Preferred Stock issued for consulting services |
|
|
|
|
|
|
|
|
|
|
18 |
|
Maturities of marketable securities |
|
|
29,957 |
|
|
|
17,925 |
|
|
|
54,782 |
|
Purchases of marketable securities |
|
|
(23,040 |
) |
|
|
(29,178 |
) |
|
|
(33,997 |
) |
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 |
|
|
(26 |
) |
|
|
(170 |
) |
|
|
42 |
|
(Decrease) increase in accounts payable and
accrued expenses |
|
|
1,184 |
|
|
|
36 |
|
|
|
3,107 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
(91 |
) |
|
|
(16,446 |
) |
|
|
(72,485 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Maturities (purchases) of marketable securities |
|
|
|
|
|
|
|
|
|
|
(28,723 |
) |
Capital expenditures |
|
|
(62 |
) |
|
|
(8 |
) |
|
|
(2,359 |
) |
Purchase of technology rights and other assets |
|
|
(136 |
) |
|
|
(147 |
) |
|
|
(2,757 |
) |
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 |
|
|
(198 |
) |
|
|
(155 |
) |
|
|
(31,436 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of |
|
|
|
|
|
|
18,180 |
|
|
|
102,404 |
|
offering costs
(Increase) decrease in prepaid offering costs |
|
|
|
|
|
|
600 |
|
|
|
|
|
Exercise of stock options |
|
|
241 |
|
|
|
85 |
|
|
|
326 |
|
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 |
|
|
241 |
|
|
|
18,865 |
|
|
|
106,038 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(48 |
) |
|
|
2,264 |
|
|
|
2,117 |
|
Cash and cash equivalents at beginning of period |
|
|
2,165 |
|
|
|
736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
2,117 |
|
|
$ |
3,000 |
|
|
$ |
2,117 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
7
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A development stage company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2006
(Unaudited)
NOTE 1 Organization, Operations and Liquidity
Repros Therapeutics Inc., formerly known as Zonagen, 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.
Our second product candidate is Androxal, an orally available small molecule compound being
developed for the treatment of testosterone deficiency in men with secondary hypogonadism.
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 that became effective on September
15, 2006.
Due to our public float exceeding $75 million at the end of our second fiscal quarter ended
June 30, 2006, we will become an accelerated filer at the end of the current year and be subject to
additional regulatory requirements, including Section 404 of Sarbanes-Oxley which will require us
to include in our annual report for the period ending December 31, 2006 a report by management on
our internal control over financial reporting and an accompanying auditors report. These
additional activities will result in increased costs to us as we evaluate the implications of any
new rules and respond to their requirements.
Due to the fact that our public float exceeded $75 million, we applied for and were accepted
on the NASDAQ Global Market listing on August 21, 2006.
On May 2, 2006, at the Companys Annual Shareholders Meeting, the Companys shareholders
approved a corporate name change from Zonagen, Inc. to Repros Therapeutics Inc. This name change
was made to better reflect the Companys focus on the reproductive and hormonal health market.
On February 1, 2005 the Company completed its follow-on public offering of 5,060,000 shares of
its common stock at $4.00 per share (which included the underwriters exercise of its over
allotment option for 660,000 shares). The shares offered by the Company were issued out of its
existing treasury stock, and the offering resulted in net proceeds to the Company of approximately
$18.2 million.
The Company has experienced negative cash flows from operations since inception and has funded
its activities to date primarily from equity financings and corporate collaborations. The Company
will continue to require substantial funds for research and development, including
8
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.
Depending
upon the timing of certain clinical activities, we believe our cash
resources will be sufficient until March 31, 2007. We will need to raise additional capital through the sale of equity
securities and/or through collaborative arrangements with potential corporate partners 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 our capital expenditures, which will delay the development and approval process of our
product candidates.
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 and conduct clinical trials for additional indications, seek to obtain regulatory
approvals and conduct long-term animal safety studies.
RPRXs 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 manufacturing, sales and marketing 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 September 30, 2006, the Company had an accumulated deficit of $102.9 million. Losses
have resulted principally from costs incurred in conducting clinical trials for the Companys
product candidates, 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 this
tax asset to the Company could be substantially diminished.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the condensed consolidated financial statements and the reported amounts
of revenues and expenses during the reporting period. Actual results could differ from those
estimates.
9
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. 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 result of operations or financial
position.
In September 2006, the SEC released Staff Accounting Bulletin No. 108 Considering the Effects
of Prior Year Misstatements When Quantifying Misstatements in Current Year Financial Statements
(SAB 108). SAB 108 provides interpretative guidance on how public companies quantify financial
statement misstatements. There have been two common approaches used to quantify such errors. Under
an income statement approach, the roll-over method, the error is quantified as the amount by
which the current year income statement is misstated. Alternatively, under a balance sheet
approach, the iron curtain method, the error is quantified as the cumulative amount by which the
current year balance sheet is misstated. In SAB 108, the SEC established an approach that requires
quantification of financial statement misstatements based on the effects of the misstatements on
each of the companys financial statements and the related financial statement disclosures. This
model is commonly referred to as a dual approach because it requires quantification of errors
under both the roll-over and iron curtain methods. SAB 108 is effective for the Company as of
January 1, 2007. The adoption of SAB 108 will not have a material impact on the Companys
consolidated financial statements.
NOTE 2 Stock-based Compensation
The Company has two stock option plans available: the 2000 Non-Employee Directors Stock
Option Plan (2000 Plan) and the 2004 Stock Option Plan (2004 Plan). As of September 30, 2006,
there were 252,935 shares available for grant under the 2004 Plan and 500,000 shares available for
grant under the 2000 Plan. The 2000 Plan has an evergreen provision pursuant to which the number
of shares available under such plan are automatically increased each year on the day after the
Companys Annual Shareholders Meeting by the number of shares granted during the prior year under
such plan (or by one-half percent of the Companys then outstanding common stock, if greater).
There are no significant differences between the other provisions of the two plans, other than the
length of time the directors have to exercise their options under the 2000 Plan, which is two years
from the cessation of service to the Company compared to ninety (90) days for employees. Options
are granted with an exercise price per share which is equal to the fair market value per share of
common stock on the date of grant. Vesting provisions for each grant are determined by the board
of directors and typically vest quarterly over a three year period. All options expire no later
than the tenth anniversary of the grant date.
On January 1, 2006, we adopted SFAS No. 123 (revised 2004), Share-Based Payments (SFAS
123(R)) and are using the modified prospective method of adoption, which does not require
restatement of prior periods. The revised standard eliminated the intrinsic value method of
accounting for share-based employee compensation under APB Opinion No. 25, Accounting
10
for Stock-Based Compensation, which we previously used (see pro-forma disclosure of prior
period included herein). The revised standard generally requires the recognition of the cost of
employee services for share-based compensation based on the grant date fair value of the equity or
liability instruments issued. The effect of adoption of the new standard related to stock option
plans was an additional expense of $219,000 ($0.02 per share, basic and diluted) for the
three-months ended September 30, 2006, of which $37,000 was recorded to Research and Development
expense and $182,000 was recorded to General and Administrative expense and $570,000 ($0.06 per
share, basic and diluted) for the nine-months ended September 30, 2006, of which $90,000 was
recorded to Research and Development expense and $480,000 was recorded to General and
Administrative expense. At September 30, 2006, there was $749,000 of total unrecognized
compensation cost related to non-vested stock options. This compensation is expected to be
recognized over a weighted-average period of approximately 1 year.
Under SFAS 123(R), we continue to use the Black-Scholes option pricing model to estimate the
fair value of our stock options. However, we will apply the expanded guidance under SFAS 123R for
the development of our assumptions used as inputs for the Black-Scholes option pricing model for
grants issued after January 1, 2006. Expected volatility is determined using historical
volatilities based on historical stock prices for a period equal to the expected term. The
expected volatility assumption is adjusted if future volatility is expected to vary from historical
experience. The expected term of options represents the period of time that options granted are
expected to be outstanding and falls between the options vesting and contractual expiration dates.
The risk-free interest rate is based on the yield at the date of grant of a zero-coupon U.S.
Treasury bond whose maturity period equals the options expected term. Options to purchase an
aggregate of 25,000 shares of common stock options at an exercise price of $12.70 per share were
granted to non-employee members of the Companys Board of Directors for their re-election to the
Board at the Companys Annual Meeting held on May 2, 2006. An option to purchase 20,000 shares of
common stock was granted to an employee on June 14, 2006 at an exercise price of $8.41 per share
and an option to purchase 20,000 shares of common stock was granted to an employee on August 16,
2006 at an exercise price of $8.00. All stock options were granted at the closing price of the
Companys common stock on the date of grant. The following assumptions were used for stock option
grants: risk-free interest rate of 3.5% to 5.0%; no expected dividends; expected lives of 4.2 to 7
years; and expected volatility of 84% to 90%.
Due to our net operating loss position there are no anticipated windfall tax benefits upon
exercise of options.
Prior to the adoption of SFAS 123(R) we recorded deferred compensation in equity for options
issued in the money under APB Opinion No. 25. Due to the adoption of SFAS 123(R) on January 1,
2006, we eliminated $130,000 from deferred compensation to additional paid in capital.
The following table presents the pro-forma effect on net income and earnings per share as if
we had applied the fair value recognition of SFAS 123 to stock-based compensation prior to the
adoption of SFAS 123(R) during the three-month and nine-month periods ended September 30, 2005 (in
thousands except per share amounts):
11
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2005 |
|
|
September 30, 2005 |
|
Net loss, as reported |
|
$ |
(1,927 |
) |
|
$ |
(5,128 |
) |
Add: Stock-based
employee compensation
expense included in
reported net income,
net of related tax
effects |
|
|
26 |
|
|
|
64 |
|
Deduct: Total
stock-based employee
compensation expense
determined under fair
value based method for
all awards, net of
related tax effects |
|
|
(181 |
) |
|
|
(591 |
) |
|
|
|
|
|
|
|
Pro-forma net loss |
|
$ |
(2,082 |
) |
|
$ |
(5,655 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share- |
|
|
|
|
|
|
|
|
Basic as reported |
|
$ |
(0.19 |
) |
|
$ |
(0.54 |
) |
Basic pro-forma |
|
|
(0.21 |
) |
|
|
(0.60 |
) |
Diluted as reported |
|
|
(0.19 |
) |
|
|
(0.54 |
) |
Diluted pro-forma |
|
|
(0.21 |
) |
|
|
(0.60 |
) |
The following table summarizes the Companys stock option activity for the nine-months
ended September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate |
|
|
|
|
|
|
Weighted Average |
|
Intrinsic Value |
|
|
Stock Options |
|
Exercise Price |
|
(in thousands) |
Outstanding at December 31, 2005 |
|
|
1,715,363 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
65,000 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(71,361 |
) |
|
|
|
|
|
$ |
308 |
|
Forfeited |
|
|
(176,854 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
1,532,148 |
|
|
$ |
4.51 |
|
|
$ |
4,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2006 |
|
|
1,077,172 |
|
|
$ |
4.58 |
|
|
$ |
3,358 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average remaining contractual term of shares exercisable at September 30,
2006 is 6.0 years.
NOTE 3 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 September 30, 2006, all securities were classified as
trading securities. The cost basis including purchased premium for these securities was $7.8
million and $14.7 million at September 30, 2006 and December 31, 2005, respectively.
Marketable securities as of September 30, 2006 consist of only short term investments. The
Companys investments typically include corporate bonds and notes, Euro-dollar bonds, taxable
auction securities and asset-backed securities. The Companys 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.
12
NOTE 4 Patents
As of September 30, 2006, the Company had approximately $737,000 in internal capitalized
patent costs reflected on its balance sheet. Of this amount, $368,000 relates to patents for
Proellex, which is being developed as an oral treatment for uterine fibroids and endometriosis, and
$369,000 relates to patents for Androxal, which is being developed as an oral treatment for
testosterone deficiency.
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 in the same manner
as basic loss per share, except that, among other changes, the average share price for the period
is used in all cases when applying the treasury stock method of potentially dilutive outstanding
options.
The following table presents information necessary to calculate earnings per share for the
three-month and nine-month periods ended September 30, 2006 and 2005 (in thousands, except per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net Loss |
|
$ |
(3,640 |
) |
|
$ |
(1,927 |
) |
|
$ |
(8,748 |
) |
|
$ |
(5,128 |
) |
Average common shares
outstanding |
|
|
10,150 |
|
|
|
10,080 |
|
|
|
10,145 |
|
|
|
9,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share |
|
$ |
(0.36 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per share |
|
$ |
(0.36 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other potential common stock of 1,532,148 and 1,710,363 for the periods ended September
30, 2006 and 2005, respectively, were excluded from the above calculation of diluted loss per share
since they were antidilutive.
NOTE 6 Stockholders Equity
As of September 30, 2006, the Company had 1,532,148 options outstanding, of which 1,077,172
were vested. All outstanding options have exercise prices ranging from $2.40 to $33.25 with a
weighted average exercise price of $4.51. In January 2006, we received $203,600 from the exercise
of 66,361 stock options that were exercised by former directors. These options expired on January
14, 2006. An additional 176,854 stock options expired unexercised in the first quarter of 2006.
As of September 30, 2006, management held 113,000 stock options which are scheduled to expire
during 2006 and have an exercise price of $8.38. On July 18, 2006 stock options for 5,000 shares,
that were scheduled to expire, were exercised by a consultant at $7.50 per share.
NOTE 7 Commitments and Contingencies
We are not currently a party to any material legal proceedings.
13
In addition to general operating obligations, as of September 30, 2006 the Company had open
purchase order commitments and potential future contractual obligations, which both span into and
through the year 2008, for the clinical development of both Proellex and Androxal in the amounts of
$5.7 million and $3.9 million, respectively. The management services agreements for clinical
trials are generally cancelable on 30 days notice, although the Company would be responsible for
expenses incurred to the point of termination and close out. Included in purchase order
commitments is the remaining $1.1 million of an initial five year, $1.6 million requirements
agreement for the commercial supply of the active pharmaceutical ingredient for our drug Proellex
which was entered into on April 26, 2006. The Company paid an up-front and non-refundable $500,000
payment of that commitment at the time of signing. The Company may incur an additional $500,000
milestone payment relating to this contract before year-end 2006 depending upon the contractors
ability to reach such milestone specified in the commercial supply agreement. In addition, not
included in open purchase orders, the Company also has an obligation to purchase a specified amount
of bulk Proellex drug if the contractor is successful in supplying that bulk drug by year-end 2006.
On October 18, 2006, the Company contracted Pharm-Olam International Ltd. to conduct a 12
month open label extension safety study related to its current European Phase 2 endometriosis
clinical study.
The Company amended its current facility lease effective April 1, 2006 for its
office/laboratory space in The Woodlands, Texas. The amendment increased the leased space to
approximately 7,100 square feet from 4,800 square feet to provide additional space needed for the
Companys planned increase in headcount. This lease amendment increased the Companys obligations
under its lease by approximately $20,000 per year, for a total of $59,600 per year, for the
remainder of the lease term which expires on June 30, 2010. The lease term was not affected as a
result of the amendment.
14
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, 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.
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 that became effective on September
15, 2006.
Due to our public float exceeding $75 million at the end of our second fiscal quarter ended
June 30, 2006, we will become an accelerated filer at the end of the current fiscal year and be
subject to additional regulatory requirements, including Section 404 of Sarbanes-Oxley which will
require us to include in our annual report for the period ending December 31, 2006 a report by
management on our internal control over financial reporting and an accompanying auditors report.
These additional activities will result in increased costs to us as we evaluate the implications of
any new rules and respond to their requirements.
Due to the fact that our public float exceeded $75 million, we applied for and were accepted
for listing on the NASDAQ Global Market listing on August 21, 2006.
On May 2, 2006, at the Companys Annual Shareholders Meeting, the Companys shareholders
approved a corporate name change from Zonagen, Inc. to Repros Therapeutics Inc. This name change
was made to better reflect the Companys focus on the reproductive and hormonal health market.
We currently have three ongoing clinical studies, a Proellex 150 patient U.S. Phase 2
clinical study for the treatment of uterine fibroids, a Proellex 40 patient European Phase 2
clinical study for the treatment of endometriosis and an Androxal U.S. Phase 3 clinical study for
the treatment of testosterone deficiency in men resulting from secondary hypogonadism. We intend
to enroll all completed patients from each of our studies into a 12-month open label extension
study.
We also continue to maintain our patent portfolio on our phentolamine-based products for the
treatment of sexual dysfunction and continue to explore opportunities
to create value from these assets through product out-licensing or partnering.
15
Proellex
Our lead product candidate, Proellex, is an orally active small molecule compound which is
being developed to alleviate symptoms associated with both uterine fibroids and endometriosis by
selectively blocking the progesterone receptor in women. The National Uterine Fibroid Foundation
estimates that possibly 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. We are developing Proellex under an exclusive worldwide license from
the National Institutes of Health (NIH).
The current standards of care for uterine fibroids and endometriosis include surgery and
treatment with drugs. The most effective drugs on the market are gonadotropin releasing hormone
(GnRH) agonists, such as Lupron® (leuprolide acetate). GnRH is a peptide hormone that plays an
important role in the regulation of the human reproductive system. Chronic administration of GnRH
agonists down regulate the GnRH receptors and block the action of GnRH and its activity in
stimulating the pituitary follicle stimulating hormone and leuteinizing hormone steroid hormone
secretions. Lupron is marketed by TAP Pharmaceuticals, a joint venture between Abbott Laboratories
and Takeda Chemical Industries, Ltd. Tap Pharmaceuticals reported total Lupron sales of $698.8
million in 2005 in the United States and Canada for all indications.
We believe Proellex may have advantages in treating uterine fibroids and endometriosis as
compared to treatment with GnRH agonists. Unlike Proellex, GnRH agonists induce a low estrogen,
menopausal-like state in women. Because estrogen is necessary for the maintenance of bone mineral
density, GnRH agonists tend to promote bone loss and are not recommended to be used for more than
six months at a time. When women cease treatment with GnRH agonists, fibroids rapidly regenerate
and symptoms associated with endometriosis quickly reappear. We believe Proellex may have
advantages over treatment with GnRH agonists because, in our Phase 1b human clinical study and our
animal research to date, Proellex maintained a tonic estrogen state and therefore should maintain
mineral bone density. We believe Proellex may provide an attractive alternative to surgery because
of its potential to treat these conditions in a long-term or chronic fashion, resolving the
symptoms that most commonly lead to surgical treatment.
Proellex is a new chemical entity which means that the compound will be required to go through
the full clinical approval process, including amongst other requirements a two-year carcinogenicity
study which began in July 2006. The Company previously completed a nine-month dog and a six-month
rat study testing the safety of Proellex. In addition, we completed a nine-month primate
feasibility study looking at the effects of Proellex on the endometrium.
We are currently conducting a 12-week 150 patient U.S. Phase 2 clinical study of Proellex for
the treatment of uterine fibroids. We intend to enroll patients that have completed this study
into a 12-month open label extension safety study.
16
As
of September 1, 2006, 253 patients were screened at 17 active clinical sites for enrollment into the Phase 2 study and 88 patients had been randomized to drug and 87 patients
were awaiting randomization. The Company believes it will be able to report top-line, 12-week
initial interim data from the randomized 88 patients before year-end 2006. As of November 1, 2006
a total of 121 patients were accepted into the study. Patient screening for this study is
scheduled to conclude on November 17, 2006. Patients that have already completed this 12-week U.S.
Phase 2 study began to roll into the one-year open-label extension safety study in September
2006. We believe the earliest we can submit a New Drug Application (NDA) is in Q4, 2008.
The 150 patient U.S. Phase 2 clinical study is designed to assess both improvement of symptoms
associated with uterine fibroids as well as effects on the fibroid itself. The study is testing
two doses of Proellex versus placebo in a double-blind design. Doses being used in this trial were
previously tested in our European Phase 1b, 12-week clinical study of Proellex, in women with
uterine fibroids which was completed in late 2004. Results from the Phase 1b study showed
significant reduction in uterine fibroid size, pain and bleeding. We hope this U.S. Phase 2 study
will serve as the first of two required pivotal trials of efficacy.
We are also currently conducting a six-month Proellex European Phase 2, 40 patient clinical
study, for the treatment of endometriosis at three active clinical sites. Study screening was
completed in October 2006 with a total of 39 patients. This European Phase 2 study is comparing
three doses of double blinded Proellex against open label Lucrin®, also know as Lupron®, which is
the current pharmaceutical standard of care. As of September 1, 2006, 37 patients had been
randomized to drug. The Company believes it will be able to report top-line three-month initial
interim data from 36 patients before year-end 2006.
On October 24, 2006, we reported initial partial clinical data relating to 16 patients
enrolled in our Proellex European Phase 2 study that had completed three-months of the study
six-month dosing regimen. We reported study results based on an endometriosis symptom survey which
demonstrated a reduction of distress related to pain in all doses of Proellex or Lucrin over the
course of three-month exposure to the drugs. Daily pain diaries indicated that women on Lucrin on
average experienced 19.4 days of pain over the three-month period whereas women on 50 mg Proellex
exhibited less than 1 day of pain over the same period. Women on 25mg and 12.5mg of Proellex
exhibited more days of pain than that recorded by women receiving the highest dose of Proellex or
Lucrin. There appeared to be a dose dependent effect on pain reduction. Because the effects of
GnRH agonists are best evaluated after at least three months of dosing, these preliminary results
may be reversed by the final results of this clinical trial. On average, Lucrin reduced estrogen
levels to post-menopausal levels (<20 pg/ml) whereas all doses of Proellex maintained estrogen
concentrations in the low normal range. Women with post-menopausal levels of estrogen have been
shown to be at greater risk for bone loss and other medical conditions. Lucrin, therefore, is not
indicated for treatment lasting longer than six months.
Women in the study were closely monitored for changes in the structure of the endometrium.
Results in these 16 women suggest that there is a dose dependent effect of Proellex on the
endometrium. Compared to baseline measurements, after three months on treatment, zero of the three
women receiving 50mg, one of the four women receiving 25mg, and two of the four women receiving
12.5mg Proellex exhibited thickening of the endometrium. Five of the 16 women received Lucrin, and
as expected, did not have a thickening of the endometrium due to a low estrogenic state. We intend
to enroll patients that have completed this study into a 12-month open label extension safety study. Patients are anticipated to begin enrollment into the
12-month open label safety study in December 2006.
17
Androxal
Our second product candidate Androxal, is a proprietary small molecule compound, and is
designed to restore normal testosterone production in males with functional testes and diminished
pituitary function, a common condition in the aging male. We believe Androxal may have advantages
over current therapies because it is being designed as an oral therapy that acts centrally to
restore normal testosterone function in the body, as compared to competitive products that simply
replace diminished testosterone. The administration of replacement testosterone has been linked to
numerous potential adverse effects, including shrinkage of the testes. We believe that Androxal
will not cause these adverse effects to the extent that such other replacement therapies do.
Testosterone is an important male hormone. Testosterone deficiency in men is linked to
several negative physical and mental conditions, including loss of muscle tone, reduced sexual
desire, and deterioration of memory and certain other cognitive functions. Testosterone production
normally decreases as men age, sometimes leading to testosterone deficiency. According to the
Urology Channel, recent estimates show that approximately 13 million men in the U.S. experience
testosterone deficiency. Current therapies focus on testosterone replacement by delivering
testosterone either through the skin, nasal spray or via injection. The current gold standard in
the industry is Androgel®, with reported sales of approximately $308 million in 2004 in North
America.
We estimate over 70% of men that have low testosterone suffer from secondary hypogonadism.
Secondary hypogonadism is caused by failure of the pituitary to provide appropriate hormone
signaling to the testis, thereby causing testosterone levels to drop to the point where pituitary
secretions fall under the influence of estrogen. In this state, estrogen further suppresses the
testicular stimulation from the pituitary. These men are readily distinguished from those that
have primary testicular failure via assessment of the levels of secretions of pituitary hormones
(i.e., men with primary testicular failure experience elevated secretions of pituitary hormones).
Secondary hypogonadism is not relegated only to older men although the condition becomes more
prevalent as men age.
Androxal is considered a new chemical entity by the FDA which means that the compound will be
required to go through the full clinical approval process, which will include amongst other
requirements a two-year carcinogenicity study. A revised two-year carcinogenicity study began in
September 2006. The Company previously completed a nine-month dog study and a six-month rat study
testing the safety of Androxal.
We are currently conducting a 24-week duration 200 patient U.S. Phase 3 clinical study of
Androxal in men with testosterone deficiency resulting from secondary hypogonadism. Originally
this study was intended to be 12-weeks in duration but was extended to 24 weeks in duration to
satisfy the U.S. FDAs request regarding the safety of restoring normal testicular function as
compared to placebo or the currently approved testosterone replacement therapies. We intend to
enroll patients that have completed the 24-week study into a 12-month open label
18
extension safety study. As of September 1, 2006, 494 patients had been screened at 19 active
clinical sites for enrollment into the U.S. Phase 3 Androxal study. Of those 494 patients, 297
were screening failures and 133 patients had been randomized to active drug. The Company believes
it will be able to report top-line, 12-week initial interim data from these 133 patients before
year-end 2006. Patient screening for this study was concluded on November 3, 2006 with a total of
191 patients accepted into the study. Based on our communications with the FDA, we believe that at
least two additional Phase 3 pivotal studies beyond this current study will be required before an
NDA can be submitted. We believe the earliest we can submit a NDA is in Q4, 2008.
Our U.S. Phase 3, 24-week 200 patient study is designed to assess both the safety of Androxal
and its efficacy in restoring normal pituitary and testicular function in men that are hypogonadal
due to secondary hypogonadism. This double-blind study will test two doses of Androxal versus
placebo and will include an open-label arm of the commercially available drug Androgel®. Doses to
be used in this U.S. Phase 3 trial were previously tested in a U.S. Phase 2 clinical study of 52
patients which was conducted over a 14-day duration.
Consistent with earlier reports, a majority of patients were deemed screening failures because
they did not meet the criteria of testosterone deficient as defined in the study. Interestingly,
only three patients failed screening due to diagnosis of hypogonadism due to testicular
dysfunction, a condition termed primary hypogonadism. This observation supports Repros belief
that the majority of men with low testosterone have secondary hypogonadism caused by a pituitary
deficiency.
Initial review of our special protocol assessment (SPA) for a Phase III pivotal study of
efficacy was completed by the FDA. Unlike testosterone replacement therapies in which efficacy can
be shown through mere elevation of testosterone levels back to normal ranges, the FDA has noted
that Androxal must demonstrate a benefit over placebo on a relevant clinical endpoint. We intend
to comply with the FDAs request, develop a validated clinical test and revise our proposed Phase
III pivotal efficacy protocol to incorporate the FDAs other suggestions. We anticipate that this
study will begin in 2007, subject to available funding and timely and successful completion of our
initial Phase III study.
In February 2006, the Company announced results of an open-label study of Androxal in 13 men
with normal, borderline or low testosterone. This safety study was undertaken to determine if
treatment with Androxal could result in supra-normal levels of testosterone, as observed with some
currently available testosterone-replacement therapies. At the conclusion of the trial, following
administration of 25mg of Androxal for two weeks, all study subjects, including those that had
normal testosterone levels at the start of the study, exhibited average testosterone levels within
the normal range.
During 2004 we completed a 52 patient, 14-day duration, U.S. Phase II clinical study of
Androxal in men with secondary hypogonadism. In the study, Androxal exhibited positive effects on
inducing restoration of normal testicular function as evidenced by achievement of normal
testosterone levels. The drug was well tolerated over the course of the study.
Our Androxal product candidate is covered in the United States by seven pending patent
applications one of which has recently been allowed. Foreign coverage of our Androxal product
19
candidate includes two issued foreign patents and 21 foreign pending patent applications. The
issued patents and pending applications relate to methods and materials for treating certain
conditions including the treatment of testosterone deficiency in men. Androxal is purified from
clomiphene citrate. A third party 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 (the PTO) for re-examination of one of these patents based on prior
art. The third party amended the claims in the reexamination proceedings, which has since 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, among other things, additional prior art publications not yet
considered by the PTO which has granted our request for reexamination in light of a number of these
additional publications. We also believe that the second of these two patents is invalid in view
of published prior art not considered by the PTO and for other reasons. Nevertheless, there is no
assurance that either patent will ultimately be found invalid over the prior art. If such patents
are not invalidated, we may be required to obtain a license from the holder of such patents in
order to develop Androxal further. If such licenses were not available on acceptable terms or at
all, we may not be able to successfully commercialize Androxal.
Phentolamine Products
We are continuing our limited development assessment and out-licensing efforts relating to our
phentolamine-based product candidates, including VASOMAX®, which had previously been approved for
marketing in several countries in Latin America, for the treatment of male erectile dysfunction
(MED) under the brand name Z-Max. VASOMAX is currently on partial clinical hold in the United
States but is not on clinical hold in any other country. During the first quarter 2006, we met
with the Ministry of Health in Mexico regarding our second generation phentolamine-based products
for the treatment of erectile dysfunction: Bimexes, an oral therapy for men with mild to moderate
impotence, and ERxin, an injectable therapy for the treatment of severe erectile dysfunction.
Initial assessment of the outcome from this meeting suggests that both drugs could potentially be
approved in Mexico after completion of a successful single positive controlled registration trial
to the satisfaction of the Mexican Ministry of Health. A decision to proceed with Mexican approval
trials for Bimexes or ERxin is heavily dependent on having the necessary capital available.
Approval in Mexico can potentially lead to approvals in other Latin American countries. The
current Latin American market for erectile dysfunction therapies now exceeds $230 million.
All clinical trial results are subject to review by the FDA and the FDA may disagree with our
conclusions about safety and efficacy. 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.
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
20
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 development expenditures to increase and, in turn, have a material
adverse effect on our results of operations.
On February 1, 2005, we completed our follow-on public offering of 5,060,000 shares of our
common stock at $4.00 per share (which included the underwriters exercise of their over allotment
option for 660,000 shares). The shares offered by us were issued out of our then existing treasury
stock, and the offering resulted in net proceeds to us of approximately $18.2 million.
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.
Results of Operations
Three-Month and Nine-Month Periods Ended September 30, 2006 and 2005
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.
21
Revenues and other income. Total revenues and other income for the three-month period ended
September 30, 2006 decreased to $146,000 as compared to $175,000 for the same period in the prior
year and increased to $486,000 for the nine-month period ended September 30, 2006 as compared to
$460,000 for the same period in the prior year.
Research and development grant revenues for the nine-month period ended September 30, 2006
were zero as compared to $4,000 for the same period in the prior year. Grant revenue relates to an
$836,441 Phase II Small Business Innovative Research (SBIR) grant that was awarded to us in 2002
for the development of Proellex as an oral treatment for endometriosis. This SBIR grant has come
to its anticipated conclusion and is essentially depleted.
Interest income decreased 17% to $146,000 for the three-month period ended September 30, 2006,
as compared to $175,000 for the same period in the prior year and increased 7% to $486,000 for the
nine-month period ended September 30, 2006 as compared to $456,000 for the same period in the prior
year. The decrease in interest income for the three-month period ended September 30, 2006 as
compared to the same period in the prior year is primarily due to lower cash balances. The
increase in interest income for the nine-month period ended September 30, 2006 as compared to the same
period in the prior year is primarily due to an increase in interest rates.
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 87% to approximately $3.1 million for the three-month period
ended September 30, 2006 as compared to approximately $1.6 million for the same period in the prior
year and increased 71% to $7.2 million for the nine-month period ended September 30, 2006 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 September 30, 2006 as compared to the same period in the prior year is
primarily due to an increase of $1.9 million in our current clinical activities offset by a
reduction in both preclinical activities of $376,000 and manufacturing costs of $212,000. The
increase in R&D expenses for the nine-month period ended September 30, 2006 as compared to the same
period in the prior year is primarily due to an increase of $3.6 million in our current clinical
activities, an increase in manufacturing activities associated with the development of a
commercially viable source of bulk Proellex in the amount of $537, 000 offset by a reduction of
$1.1 million in preclinical activities relating to the development programs for Proellex and
Androxal.
General and Administrative Expenses. General and administrative expenses increased 55% to
$713,000 for the three-month period ended September 30, 2006 as compared to $461,000 for the same
period in the prior year and increased 47% to approximately $2.0 million for the nine-month period
ended September 30, 2006 as compared to $1.4 million for the same period in the prior year. The
increase in expenses for the three-month period ended September 30, 2006 as compared to the same
period in the prior year is primarily due to an increase in non-cash stock compensation expense of
$161,000 due to the adoption of SFAS No. 123(R), an increase in investor relations costs of $74,000
and an increase of $31,000 in costs associated with meeting the requirements of Section 404 of the
Sarbanes-Oxley Act. The increase in expenses for the nine-month period ended September 30, 2006 as
compared to the same period in the prior year is primarily due to an increase in non-cash stock
compensation expense of $431,000 due to the adoption of SFAS No. 123(R), an increase in investor
relations costs of $194,000 and an increase of $31,000 in costs associated with meeting the requirements of Section 404 of the Sarbanes-Oxley
Act.
22
Liquidity and Capital Resources
We had cash, cash equivalents and marketable securities of approximately $9.9 million at
September 30, 2006 as compared to $16.8 million at December 31, 2005. This decrease in cash is
primarily due to an increase in costs related to our clinical development programs for Androxal and
Proellex and associated administrative costs.
Depending upon the timing of certain clinical activities, we
believe our cash resources will be sufficient until March 31,
2007. 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.
To allow us to raise capital, 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
that became effective on September 15, 2006 and will remain effective for three years.
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 approvals and
conduct long-term animal safety studies.
In addition to general operating obligations, as of September 30, 2006 the Company had open
purchase order commitments and potential future contractual obligations, which both span into and
through the year 2008, for the clinical development of Proellex and
Androxal in the amounts of $5.7 million and $3.9 million, respectively, generally cancelable on 30 days notice, although the
Company would be responsible for expenses incurred to the point of termination. Included in
purchase order commitments is the remaining $1.1 million of a $1.6 million agreement for the
commercial supply of the active pharmaceutical ingredient for our drug Proellex which was entered
into on April 26, 2006. The Company paid an up-front and non-refundable $500,000 payment of that
commitment at the time of signing. The Company may incur additional payments relating to this
contract before year-end 2006 depending on the success of the commercial supply agreement and
delivery of bulk compound.
23
The
Company amended its current facility lease effective April 1, 2006. This lease amendment increased the Companys obligations under its lease by approximately $20,000 per
year, for a total of $59,600 per year, for the remainder of the lease term which expires on June
30, 2010.
As of September 30, 2006, we had an accumulated deficit of $102.9 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 which include costs for VASOMAX, Androxal and Proellex 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 SBIR grants. We will require substantial additional capital to further develop
Proellex as an oral treatment for uterine fibroids and endometriosis and Androxal as an oral
treatment for testosterone deficiency due to secondary hypogonadism and to pursue commercialization
efforts of the Companys phentolamine products should the decision be made to do so.
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 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 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 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 $9.9 million at
September 30, 2006. 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.
24
Item 4. 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.
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, 2006 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
On September 21, 2005, the SEC extended the compliance dates related to Section 404 of the
Sarbanes-Oxley Act for non-accelerated filers. Under this extension a company that is not required
to file its annual and quarterly reports on an accelerated basis (non-accelerated filer) must begin
to comply with the internal control over financial reporting requirements for its first fiscal year
ending on or after July 15, 2007. We will become an accelerated filer at the end of fiscal 2006
and will be required to comply with these requirements for the year ending December 31, 2006.
25
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 registrants
Form 10-K for the fiscal year ended December 31, 2005 in response to Item 1A. to Part I of Form
10-K as updated in Part II. Other Information Item 1A. Risk Factors of the registrants Form 10-Q
for the quarter ended June 30, 2006.
Item 5. Other Information
None
Item 6. Exhibits
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31.1
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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). |
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31.2
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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). |
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32.1
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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). |
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32.2
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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). |
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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.
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REPROS THERAPEUTICS INC. |
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Date: November 13, 2006 |
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By:
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/s/ Joseph S. Podolski
Joseph S. Podolski
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President, Chief Executive Officer and Director |
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(Principal Executive Officer) |
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Date: November 13, 2006 |
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By:
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/s/ Louis Ploth, Jr.
Louis Ploth, Jr.
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Vice President Business Development, |
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Chief Financial Officer, Director and Secretary |
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(Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
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31.1
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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). |
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31.2
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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). |
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32.1
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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). |
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32.2
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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). |
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