UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the quarterly period ended March
31, 2010
or
¨
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the transition period from
____________ to ____________
Commission
file number: 001-15281
REPROS
THERAPEUTICS INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
(State
or other jurisdiction of
incorporation
or
organization)
|
2408
Timberloch Place, Suite B-7
The
Woodlands, Texas 77380
(Address
of principal executive offices
and
zip
code)
|
76-0233274
(IRS
Employer
Identification
No.)
|
|
(281)
719-3400
(Registrant's
telephone number,
including
area code)
|
|
Indicate by check mark whether the
registrant (1) has filed all reports required to be filed by Section 13 or 15(d)
of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90
days. Yes x No ¨
Indicate by check mark whether the
registrant has submitted electronically and posted on its corporate Web site, if
any, every Interactive Data File required to be submitted and posted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such
files). Yes ¨ No ¨
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer or smaller reporting company. See definition of "accelerated
filer", "large accelerated filer" and "smaller reporting company" in Rule 12b-2
of the Exchange Act. (Check one):
Large
accelerated filer ¨ Accelerated
filer x Non-accelerated
filer ¨ Smaller
reporting company ¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange
Act). Yes ¨ No x
As of May 5, 2010, there were
outstanding 31,723,046 shares of Common Stock, par
value $.001 per share, of the Registrant.
REPROS
THERAPEUTICS INC.
(A
development stage company)
For the
Quarter Ended March 31, 2010
INDEX
|
|
Page
|
FACTORS
AFFECTING FORWARD-LOOKING STATEMENTS
|
|
3
|
|
|
|
PART
I. FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1.
|
Financial
Statements (unaudited)
|
|
4
|
|
|
|
Unaudited
Condensed Consolidated Balance Sheets as of March 31, 2010 and December
31, 2009
|
|
5
|
Unaudited
Condensed Consolidated Statements of Operations for the three months ended
March 31, 2010 and 2009 and from Inception (August 20, 1987) through March
31, 2010
|
|
6
|
Unaudited
Condensed Consolidated Statements of Stockholders' Equity for the three
months ended March 31, 2010
|
|
7
|
Unaudited
Condensed Consolidated Statements of Cash Flows for the three months ended
March 31, 2010 and 2009 and from Inception (August 20, 1987) through March
31, 2010
|
|
8
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
|
9
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
14
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
25
|
Item
4.
|
Controls
and Procedures
|
|
25
|
|
|
|
PART
II. OTHER INFORMATION
|
|
|
Item
1.
|
Legal
Proceedings
|
|
26
|
Item
1A.
|
Risk
Factors
|
|
27
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
27
|
Item
3.
|
Defaults
Upon Senior Securities
|
|
27
|
Item
4.
|
(Removed
and Reserved)
|
|
27
|
Item
5.
|
Other
Information
|
|
27
|
Item
6.
|
Exhibits
|
|
28
|
|
|
|
SIGNATURES
|
|
29
|
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 Company's ability to continue as
a going concern and to continue to be able to raise additional capital on
acceptable terms or at all; its ability to successfully defend itself in the
recently filed class action lawsuits; its ability to maintain its
listing on the NASDAQ Capital Market; the removal of the current clinical hold
on further clinical trials for Proellex® by the Food and
Drug Administration, or FDA, and the
reestablishment of safe dosing in clinical trials for Proellex®; having available
funding for the continued development of Proellex® and Androxal®; uncertainty
related to the Company's ability to obtain approval of the Company's products by
the FDA and regulatory bodies in other jurisdictions; whether a clear clinical
path for Androxal® can be realized; uncertainty relating to the Company's patent
portfolio and license rights to such patents; and other risks and uncertainties
described in the Company's filings with the Securities and Exchange
Commission. For additional discussion of such risks, uncertainties
and assumptions, see "Part I. Financial Information - Item 2. Management's
Discussion and Analysis of Financial Condition and Results of Operations -
Liquidity and Capital Resources" included elsewhere in this quarterly report on
Form 10-Q and “Item 1A. Risk Factors” to Part I of Form 10-K for the fiscal year
ended December 31, 2009.
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 three-month period ended March 31,
2010 are not necessarily indicative of the results that may be expected for the
year ended December 31, 2010. For further information, refer to the
financial statements and footnotes thereto included in the Company's Annual
Report on Form 10-K for the year ended December 31, 2009.
REPROS
THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(unaudited
and in thousands except share and per share amounts)
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
974 |
|
|
$ |
1,886 |
|
Prepaid
expenses and other current assets
|
|
|
216 |
|
|
|
177 |
|
Total
current assets
|
|
|
1,190 |
|
|
|
2,063 |
|
Fixed assets,
net
|
|
|
8 |
|
|
|
12 |
|
Other assets,
net
|
|
|
925 |
|
|
|
885 |
|
Total
assets
|
|
$ |
2,123 |
|
|
$ |
2,960 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,696 |
|
|
$ |
2,043 |
|
Accrued
expenses
|
|
|
182 |
|
|
|
355 |
|
Total
current liabilities
|
|
|
1,878 |
|
|
|
2,398 |
|
|
|
|
|
|
|
|
|
|
Commitments
& Contingencies (note 5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
|
|
|
|
Undesignated
Preferred Stock, $.001 par value, 5,000,000
|
|
|
|
|
|
|
|
|
shares
authorized, none issued and outstanding
|
|
|
- |
|
|
|
- |
|
Common
Stock, $.001 par value, 75,000,000 shares authorized,
|
|
|
|
|
|
|
|
|
26,863,876
and 25,987,998 shares issued, respectively;
|
|
|
|
|
|
|
|
|
26,414,476
and 25,538,598 shares outstanding, respectively
|
|
|
27 |
|
|
|
26 |
|
Additional
paid-in capital
|
|
|
177,201 |
|
|
|
176,392 |
|
Cost
of treasury stock, 449,400 shares
|
|
|
(1,380 |
) |
|
|
(1,380 |
) |
Deficit
accumulated during the development stage
|
|
|
(175,603 |
) |
|
|
(174,476 |
) |
Total
stockholders' equity
|
|
|
245 |
|
|
|
562 |
|
Total
liabilities and stockholders' equity
|
|
$ |
2,123 |
|
|
$ |
2,960 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
REPROS
THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited
and in thousands except per share amounts)
|
|
|
|
|
|
|
|
From
Inception
|
|
|
|
|
|
|
|
|
|
(August
20, 1987)
|
|
|
|
|
|
|
|
|
|
through
|
|
|
|
Three Months Ended March
31,
|
|
|
March
31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
and other income
|
|
|
|
|
|
|
|
|
|
Licensing
fees
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
28,755 |
|
Product
royalties
|
|
|
- |
|
|
|
- |
|
|
|
627 |
|
Research
and development grants
|
|
|
- |
|
|
|
- |
|
|
|
1,219 |
|
Interest
income
|
|
|
- |
|
|
|
3 |
|
|
|
16,297 |
|
Gain
on disposal of fixed assets
|
|
|
- |
|
|
|
- |
|
|
|
102 |
|
Other
Income
|
|
|
- |
|
|
|
- |
|
|
|
582 |
|
Total
revenues and other income
|
|
|
- |
|
|
|
3 |
|
|
|
47,582 |
|
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
458 |
|
|
|
5,698 |
|
|
|
170,788 |
|
General
and administrative
|
|
|
669 |
|
|
|
1,060 |
|
|
|
42,666 |
|
Interest
expense and amortization of intangibles
|
|
|
- |
|
|
|
- |
|
|
|
388 |
|
Total
expenses
|
|
|
1,127 |
|
|
|
6,758 |
|
|
|
213,842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from continuing operations
|
|
|
(1,127 |
) |
|
|
(6,755 |
) |
|
|
(166,260 |
) |
Loss
from discontinued operations
|
|
|
- |
|
|
|
- |
|
|
|
(1,828 |
) |
Gain
on disposal of discontinued operation
|
|
|
- |
|
|
|
- |
|
|
|
939 |
|
Net
loss before cumulative effect of change in accounting
principle
|
|
|
(1,127 |
) |
|
|
(6,755 |
) |
|
|
(167,149 |
) |
Cumulative
effect of change in accounting principle
|
|
|
- |
|
|
|
- |
|
|
|
(8,454 |
) |
Net
loss
|
|
$ |
(1,127 |
) |
|
$ |
(6,755 |
) |
|
$ |
(175,603 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per share - basic and diluted
|
|
$ |
(0.04 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used in loss per share calculation:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
25,827 |
|
|
|
15,175 |
|
|
|
|
|
Diluted
|
|
|
25,827 |
|
|
|
15,175 |
|
|
|
|
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
REPROS
THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY
(unaudited
and in thousands except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
During the
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Treasury Stock
|
|
|
Development
|
|
|
Stockholders'
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Shares
|
|
|
Amount
|
|
|
Stage
|
|
|
Equity
|
|
Balance at December 31, 2009
|
|
|
25,987,998 |
|
|
$ |
26 |
|
|
$ |
176,392 |
|
|
|
449,400 |
|
|
$ |
(1,380 |
) |
|
$ |
(174,476 |
) |
|
$ |
562 |
|
Stock based option compensation
|
|
|
- |
|
|
|
- |
|
|
|
186 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
186 |
|
Issuance
of 352,459 shares of common stock at $0.72 to $1.10 per share, as
settlement with trade creditors
|
|
|
352,459 |
|
|
|
- |
|
|
|
335 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
335 |
|
Issuance
of 523,419 shares of common stock at a weighted average share price of
$0.75, net of offering costs of $103
|
|
|
523,419 |
|
|
|
1 |
|
|
|
288 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
289 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,127 |
) |
|
|
(1,127 |
) |
Balance
at March 31, 2010
|
|
|
26,863,876 |
|
|
$ |
27 |
|
|
$ |
177,201 |
|
|
|
449,400 |
|
|
$ |
(1,380 |
) |
|
$ |
(175,603 |
) |
|
$ |
245 |
|
The
accompanying notes are an integral part of these consolidated financial
statements.
REPROS
THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited
and in thousands)
|
|
|
|
|
|
|
|
From Inception
|
|
|
|
|
|
|
|
|
|
(August 20, 1987)
|
|
|
|
|
|
|
|
|
|
through
|
|
|
|
Three Months Ended March 31,
|
|
|
March 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows from Operating Activities
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,127 |
) |
|
$ |
(6,755 |
) |
|
$ |
(175,603 |
) |
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
|
|
|
- |
|
|
|
- |
|
|
|
2,614 |
|
Noncash
other income
|
|
|
|
|
|
|
|
|
|
|
(547 |
) |
Noncash
decrease in accounts payable
|
|
|
- |
|
|
|
- |
|
|
|
(1,308 |
) |
Depreciation
and amortization
|
|
|
18 |
|
|
|
17 |
|
|
|
3,972 |
|
Noncash
stock-based compensation
|
|
|
186 |
|
|
|
334 |
|
|
|
6,827 |
|
Common
stock issued for agreement not to compete
|
|
|
- |
|
|
|
- |
|
|
|
200 |
|
Series
B Preferred Stock issued for consulting services
|
|
|
- |
|
|
|
- |
|
|
|
18 |
|
Changes
in operating assets and liabilities (net effects of purchase of businesses
in 1988 and 1994):
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
in receivables
|
|
|
- |
|
|
|
- |
|
|
|
(199 |
) |
Increase
in inventory
|
|
|
- |
|
|
|
- |
|
|
|
(4,447 |
) |
(Increase)
decrease in prepaid expenses and other current assets
|
|
|
(39 |
) |
|
|
(848 |
) |
|
|
86 |
|
Increase
(decrease) in accounts payable and accrued expenses
|
|
|
(185 |
) |
|
|
323 |
|
|
|
9,853 |
|
Net
cash used in operating activities
|
|
|
(1,147 |
) |
|
|
(6,929 |
) |
|
|
(154,842 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
in trading marketable securities
|
|
|
- |
|
|
|
- |
|
|
|
(191 |
) |
Capital
expenditures
|
|
|
- |
|
|
|
- |
|
|
|
(2,371 |
) |
Purchase
of technology rights and other assets
|
|
|
(54 |
) |
|
|
(139 |
) |
|
|
(4,326 |
) |
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) provided by investing activities
|
|
|
(54 |
) |
|
|
(139 |
) |
|
|
(4,485 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stock, net of offering costs
|
|
|
289 |
|
|
|
- |
|
|
|
156,294 |
|
Exercise
of stock options
|
|
|
- |
|
|
|
- |
|
|
|
372 |
|
Proceeds
from a shareholder transaction
|
|
|
- |
|
|
|
- |
|
|
|
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
|
|
|
289 |
|
|
|
- |
|
|
|
160,301 |
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
(912 |
) |
|
|
(7,068 |
) |
|
|
974 |
|
Cash
and cash equivalents at beginning of period
|
|
|
1,886 |
|
|
|
19,470 |
|
|
|
- |
|
Cash
and cash equivalents at end of period
|
|
$ |
974 |
|
|
$ |
12,402 |
|
|
$ |
974 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
REPROS
THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March
31, 2010
(Unaudited)
NOTE
1 — Organization, Operations and Liquidity
Repros
Therapeutics Inc. ("the Company", "Repros," or "we," "us" or "our"), was
organized on August 20, 1987. We are a development stage
biopharmaceutical company focused on the development of oral small molecule
drugs for major unmet medical needs that treat male and female reproductive
disorders.
Our
portfolio of products includes:
|
·
|
Androxal®,
a single isomer of clomiphene citrate, is being developed for men of
reproductive age with low testosterone levels who want to maintain their
fertility while being treated for low
testosterone.
|
|
·
|
Proellex®,
a new chemical entity that acts as a selective blocker of the progesterone
receptor, is being developed for the treatment of symptoms associated with
uterine fibroids and endometriosis, subject to the current FDA clinical
hold on the Proellex® clinical trials; however, we have recently filed for
a limited removal of the clinical hold in order to commence certain
clinical trials of Proellex® at a 12 mg or lower
dose level. On April 29, 2010 a teleconference was held with
the FDA to review the clinical hold status of Proellex®. During
the teleconference the FDA noted that it felt that not all of their
concerns were fully answered but opined that if the Company was willing to
modify the trial from a parallel design to an escalating dose design the
FDA would consider lifting the full clinical hold and place Proellex® on
partial clinical hold to allow the low dose trial to be conducted. The
Company agreed to modify the protocol and submitted the new design to the
Agency on April 30, 2010.
|
As of
March 31, 2010, we had accumulated losses of $175.6 million, approximately
$974,000 in cash and cash equivalents, and our accounts payable and accrued
expenses were approximately $1.9 million. As of April 30, 2010, we
had cash and cash equivalents of approximately $4.0 million. The
amount of cash on hand is not sufficient to fund our future clinical trials of
Androxal® and, if the current FDA clinical hold on Proellex® is removed,
Proellex®, and pay our accounts payable and accrued expenses as well as our
normal corporate overhead and expenses. The foregoing and other matters
raise substantial doubt about our ability to continue as a going
concern. We continue to explore potential additional financing alternatives
that would provide sufficient funds to enable us to continue to develop our two
product candidates through completion of clinical trials; however, there can be
no assurance that we will be successful in raising any such additional funds on
a timely basis or at all. Significant additional capital will be
required for us to complete development of either of our product
candidates.
We also
continue to maintain our patent portfolio of our phentolamine-based products for
the treatment of sexual dysfunction and in order to create value from these
assets in various ways which includes product out-licensing.
NOTE 2 — Patents
and Patent Applications
As of
March 31, 2010, the Company had approximately $925,000 in capitalized patent and
patent application costs reflected on its balance sheet. This entire
amount relates to patent and patent application costs for
Androxal®.
Should
the Company not continue development of Androxal® or should the Company not
continue as a going concern, the remaining capitalized patent and patent
application costs may not be recoverable, which would result in charges to
operating results in future periods.
NOTE 3 — Accrued
Expenses
Accrued
expenses consist of the following (in thousands):
|
|
March 31, 2010
|
|
|
December 31, 2009
|
|
|
|
|
|
|
|
|
Personnel
related costs
|
|
$ |
113 |
|
|
$ |
181 |
|
Other
|
|
|
46 |
|
|
|
159 |
|
Patent
costs
|
|
|
23 |
|
|
|
15 |
|
Total
|
|
$ |
182 |
|
|
$ |
355 |
|
NOTE
4 — 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.
The
following table presents information necessary to calculate loss per share for
the three-month periods ended March 31, 2010 and 2009 (in thousands, except per
share amounts):
|
|
Three Months Ended March 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$ |
(1,127 |
) |
|
$ |
(6,755 |
) |
Average
common shares outstanding
|
|
|
25,827 |
|
|
|
15,175 |
|
Basic
and diluted loss per share
|
|
$ |
(0.04 |
) |
|
$ |
(0.45 |
) |
Other
potential common stock of 1,806,545 and 3,430,617 common shares underlying stock
options for the periods ended March 31, 2010 and 2009, respectively, were
excluded from the above calculation of diluted loss per share because they were
not dilutive.
NOTE
5 — Commitments and Contingencies
Therapeutic
uses of our Androxal® product candidate are covered in the United States by two
issued U.S. patents and six pending patent applications. In April,
2010, we were issued a Notice of Allowance by the U.S. Patent and Trademark
Office, or PTO, for our pending U.S. patent application directed to the
treatment of secondary hypogonadism. Foreign coverage of therapeutic
uses of our Androxal® product candidate includes 37 issued foreign patents and
87 foreign pending patent applications. The issued patents and
pending applications relate to methods 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 PTO for re-examination of one of these patents based on prior
art. The third party amended the claims in the re-examination
proceedings, which led the PTO to determine that the amended claims are
patentable in view of those publications under consideration and a
re-examination certificate was issued. However, we believe that the
amended claims are invalid based on additional prior art publications, and our
request for re-examination by the PTO in light of a number of these additional
publications and other publications cited by the PTO, was granted. All of the
claims have been finally rejected in the re-examination and the patent holder
has appealed the rejections to the PTO Board of Patent Appeals and Interferences
(“the Board”). A decision has been rendered by the Board affirming
the rejection of all of the claims. The patent holder has filed a
request for rehearing. If the Board maintains the rejections on
rehearing or the request for rehearing is denied, the patent holder will have
the opportunity to appeal the rejections to the United States Court of Appeals
for the Federal Circuit. 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 or out-license Androxal®.
On August
7, 2009, R.M. Berry filed a putative class action lawsuit naming the Company,
Joseph Podolski, Paul Lammers, and Louis Ploth, Jr. as
defendants. The lawsuit is pending in the United States District
Court for the Southern District of Texas, Houston Division. The
lawsuit, styled R.M. Berry, on Behalf of Himself and all Others Similarly
Situated v. Repros Therapeutics, Inc., Joseph Podolski, Paul Lammers, and Louis
Ploth, Jr., alleges that the defendants made certain misleading statements
related to the Company’s Proellex® drug. Among other claims, the
lawsuit contends that the defendants misrepresented the side effects of the drug
related to liver function, and the risk that these side effects could cause a
suspension of clinical trials of Proellex®. The lawsuit seeks to establish a
class of shareholders allegedly harmed by the misleading statements, and asserts
causes of action under the Securities Exchange Act of 1934. On August
14, 2009, a lawsuit making similar allegations and naming the same defendants
was also filed in the United States District Court for the Southern District of
Texas. This suit is styled Josephine Medina, Individually and On
Behalf of all Others Similarly Situated v. Repros Therapeutics, Inc., Joseph
Podolski, Paul Lammers, and Louis Ploth, Jr. On September 25, 2009, a
lawsuit also making allegations similar to those in the Berry action, and naming
the same defendants, was filed in the United States District Court for the
Southern District of Texas. That lawsuit is styled Shane Simpson,
Paul Frank and Clayton Scobie, on Behalf of Themselves and all Others Similarly
Situated v. Repros Therapeutics, Inc., Joseph Podolski, Paul Lammers, and Louis
Ploth, Jr. The lawsuits have now been consolidated, and
lead plaintiffs appointed. On January 27, 2010, the lead plaintiffs
filed a Consolidated Class Action Complaint styled In re Repros Therapeutics,
Inc. Securities Litigation, Civil Action No. 09 Civ. 2530 (VDG). The
lawsuit names Repros Therapeutics, Inc., Joseph Podolski, Paul Lammers, and
Louis Ploth, Jr. as defendants. The allegations in the Consolidated
Class Action Complaint are substantially the same as those contained in the
prior complaints, and focus on the claim that the defendants deliberately
withheld information concerning the negative side-effects of Proellex® related
to liver function. Plaintiffs seek to establish a class action for
all persons who “purchased or otherwise acquired Repros common stock between
July 1, 2009, and August 2, 2009.” No discovery has yet
occurred in the matter. Defendants filed a motion to dismiss the
Consolidated Class Action Complaint on March 15, 2010. Briefing
related to the motion is expected to be completed on May 10, 2010. An
estimate of the possible loss or range of losses in connection with the lawsuits
cannot be made at this time.
On November 13, 2009, a vendor filed a
lawsuit naming the company as a defendant. The lawsuit claimed the
Company owed it $93,698 in accordance with the terms of its agreement with the
Company. On February 1, 2010, the Company entered into a
confidential settlement agreement with this vendor which resolved the
lawsuit.
On March 1, 2010, we were served with a
lawsuit where we were named as a co-defendant along with one of our clinical
regulatory service providers (“CRO”) relating to the Proellex® clinical trial
study. The lawsuit was filed in the State of Tennessee, 30th Judicial
District Chancery Court at Memphis by an investigator and claims that the CRO
did not pay it amounts owing to it relating to the Proellex® study. We
did not engage the investigator and under our agreement with the CRO, we
believe the CRO is responsible for any such costs or damages regarding such
lawsuit. Pursuant to the October Settlement Agreement, such CRO, on behalf
of itself and its agents, released us from all claims which could be asserted by
them against us. We believe such release covers the claims set forth in
this lawsuit. The CRO failed to respond to the lawsuit, and a default
judgment was entered against it in the amount of $172,901.29. We
intend to vigorously defend any and all claims asserted by the
investigator. An estimate of the possible costs or expenses to defend
ourselves in this matter or risk of exposure under the litigation cannot be made
at this time.
NOTE
6 — Other Recent Events, Including Subsequent
Events
Between
November 30, 2009 and March 31, 2010, we entered into settlement agreements and
mutual releases (the “Prior Settlement Agreements”) with certain of our
creditors, pursuant to which we issued an aggregate of 352,459 shares of common
stock and paid an aggregate of $140,572 in cash as payment in full for our
then-outstanding liabilities to such creditors. On April 8,
2010, we entered into an additional settlement agreement and mutual release
(together with the Prior Settlement Agreements, the “Settlement Agreements”)
with a creditor, pursuant to which we issued 34,885 shares of common stock
(together with the shares issued under the Prior Settlement Agreements, the
“Settlement Shares”) and paid $8,721 in cash as payment in full for our
then-outstanding liability to such creditor. The Settlement Shares
were issued by the Company pursuant to Section 4(2) and /or Rule 506 of
Regulation D promulgated under the Securities Act of 1933, as
amended. Pursuant to the Settlement Agreements, we agreed to use our
best efforts to prepare and file a registration statement to register the
Settlement Shares as soon as possible following the date of each Settlement
Agreement, to use our best efforts to have such registration statement declared
effective as soon as possible and to maintain such registration statement until
all such Settlement Shares registered thereunder to such creditors have been
sold or for a period of one year, whichever comes first.
On
February 12, 2010, we entered into an Equity Distribution Agreement (the “Equity
Distribution Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg”),
pursuant to which we may issue and sell from time to time through Ladenburg, as
sales agent and/or principal, shares of our common stock having an aggregate
offering price of up to $10 million (the “ATM Shares”). Ladenburg is
not required to sell on our behalf any specific number or dollar amount of the
ATM Shares, but Ladenburg, upon acceptance of written instructions from us,
agreed to use its commercially reasonable efforts consistent with its customary
trading and sales practices, to sell the ATM Shares up to the amount specified,
and otherwise in accordance with the terms of a placement notice delivered to
Ladenburg. We have no obligation to sell any ATM Shares under the Equity
Distribution Agreement, and may at any time suspend sales under the Equity
Distribution Agreement, provided that such suspension shall not affect either
party’s obligations with respect to the ATM Shares sold prior to the receipt of
notice of such suspension. Ladenburg receives a commission of 4% of
the gross sales price of all ATM Shares sold through it under the Equity
Distribution Agreement. The ATM Shares are issued pursuant to our shelf
registration statement on Form S-3, as amended (File No.
333-163648). As of March 31, 2010, we have sold 523,419 ATM Shares at
a weighted average share price of $0.75,
for proceeds of approximately $289,000, net of
expenses. Between April 1, 2010 and May 7, 2010, we have sold
5,551,177 ATM Shares at a weighted average share price of $0.78,
for additional net proceeds of approximately $4.2
million.
On April
15, 2010, we announced that we believe that we have regained compliance with the
minimum stockholders' equity requirement for continued listing on the Nasdaq
Capital Market due primarily to the sale of ATM Shares (as defined
above). We continue to have until June 14, 2010 to maintain the
required minimum bid price for continued listing. During our annual
stockholders' meeting to be held on May 17, 2010, our stockholders will vote on
a proposal to grant our board of directors the authority to effect a reverse
split of its common stock within one year of such annual meeting on a basis not
to exceed one share of common stock for up to five shares of common stock
outstanding, if necessary, in the sole discretion of our board of directors, for
purposes of maintaining its listing on the Nasdaq Capital
Market. There can be no assurance that the stockholders of the
Company will approve this proposal or that the Company will be able to maintain
its listing on the Nasdaq Capital Market. If we cannot demonstrate
compliance with the required minimum bid price by June 14, 2010, our shares will
be subject to immediate delisting. If necessary, the Company may
appeal Nasdaq’s decision to delist its securities.
Item
2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
The
following discussion contains forward-looking statements, within the meaning of
Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and
Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange
Act") that involve risk and uncertainties. Any statements contained
in this quarterly report that are not statements of historical fact may be
forward-looking statements. When we use the words "may," "anticipates,"
"believes," "plans," "expects" and similar expressions, we are identifying
forward-looking statements. Forward-looking statements involve risks and
uncertainties which may cause our actual results, performance or achievements to
be materially different from those expressed or implied by forward-looking
statements. The following discussion of financial condition should be read in
conjunction with the accompanying consolidated financial statements and related
notes.
Repros
Therapeutics Inc.
Repros
Therapeutics Inc. ("the Company", "RPRX," “Repros”, or "we," "us" or "our") was
organized on August 20, 1987. We are a development stage
biopharmaceutical company focused on the development of oral small molecule
drugs for major unmet medical needs. As of March 31, 2010, we had
accumulated losses of $175.6 million, approximately $974,000 in cash and cash
equivalents, and our accounts payable and accrued expenses were approximately
$1.9 million. As of April 30, 2010, we had cash and cash equivalents
of approximately $4.0 million. The amount of cash on hand is not
sufficient to fund our future clinical trials of Androxal® and, if the current
FDA clinical hold on Proellex® is removed, Proellex®, and pay our accounts
payable and accrued expenses as well as our normal corporate overhead and
expenses. The foregoing and other matters raise substantial doubt about our
ability to continue as a going concern. We continue to explore
potential additional financing alternatives that would provide sufficient funds
to enable us to continue to develop our two product candidates through
completion of clinical trials; however, there can be no assurance that we will
be successful in raising any such additional funds on a timely basis or at
all. Significant
additional capital will be required for us to complete development of either of
our product candidates.
Our
current product pipeline (with the respective status of development) consists of
the following:
Androxal® (male reproductive
health):
|
¨
|
Completed
Phase 2b proof-of-concept trial in men being treated for low testosterone
levels who want to improve or maintain their fertility and/or sperm number
and function; and
|
|
¨
|
Our
Investigational New Drug Application, or IND, for the study of oral
Androxal® in the treatment of hypogonadal men with type 2 diabetes was
accepted by the FDA and, thus, we may initiate a Phase 2
trial.
|
Proellex® (female reproductive
health): All ongoing clinical trial activities for Proellex® have been put on hold by
the FDA; however, we have recently filed for a limited removal of the clinical
hold in order to commence certain clinical trials of Proellex® at a 12 mg or lower dose
level, following discussions with the FDA. On April 29, 2010 a teleconference
was held with the FDA to review the clinical hold status of
Proellex®. During the teleconference the FDA noted that it felt that not
all of their concerns were fully answered but opined that if the Company was
willing to modify the trial from a parallel design to an escalating dose design
the FDA would consider lifting the full clinical hold and place Proellex® on
partial clinical hold to allow the low dose trial to be conducted. The Company
agreed to modify the protocol and submitted the new design to the Agency on
April 30, 2010. There can be no assurances however that the FDA will find the
new design acceptable or that they will lift the full clinical
hold.
We also
continue to maintain our patent portfolio of our phentolamine-based products for
the treatment of sexual dysfunction and in order to create value from these
assets in various ways which includes product out-licensing.
Androxal®
Product
Overview
Our
primary product candidate, Androxal® (the trans isomer of clomiphene),
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 addition, we submitted 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. On February 1,
2010, we received confirmation from the DMEP that our new IND was accepted and,
as a result, we may initiate a Phase 2 trial, subject to available funding.Our
findings from a retrospective review of the clinical data from our
200 patient non-pivotal U.S. Phase 3 clinical trial showed that
Androxal® therapy resulted in a significant reduction in mean glucose levels in
men with glucose levels >104 mg/dL, an outcome not seen in the placebo or
AndroGel® arms of this study. There can be no assurance that clinical
trials performed for this new indication will be successful.
We
believe Androxal® may have advantages over current therapies for the treatment
of low testosterone due to secondary hypogonadism because it is designed as an
oral therapy that acts centrally to restore testicular function and hence normal
testosterone in the body, as compared to currently approved products that
simply replace diminished testosterone either through injections, nasal spray or
the application of a gel or cream containing testosterone over a percentage of
body area.
We
believe Androxal® will be superior to the existing administration of exogenous
testosterone products used to normalize testosterone as only Androxal® has the
property of restoring both LH and FSH levels. LH and FSH are the pituitary
hormones that stimulate testicular testosterone and sperm production,
respectively.
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 United States
experience testosterone deficiency. The leading therapy is AndroGel®, a
commercially available testosterone replacement cream marketed by Solvay
Pharmaceuticals for the treatment of low testosterone, which we believe has had
and continues to have significant sales in North America.
Based on
our own clinical trial screening data, we believe over 70% of men that have low
testosterone suffer from secondary hypogonadism, caused by failure of the
pituitary to provide appropriate hormone signaling to the testes, which we
believe causes testosterone levels to drop to the point where pituitary
secretions fall under the influence of estrogen. In this state, we also
believe that 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 undergo the full regulatory approval process. We must
still meet additional clinical requirements including pre-clinical, Phase 1,
Phase 2, pivotal Phase 3 trials and long-term Open Label Safety Studies as well
as other requirements. Although Androxal® is considered a new chemical
entity for purposes of requirements for approval, it is closely related
chemically to the drug, Clomid®, which is approved for use in women to treat
certain infertility disorders. The FDA has indicated that testicular
tumors, gynecomastia and adverse ophthalmologic events, which have been reported
in males taking Clomid®, are potential risks that should be included in informed
consent forms for our Androxal® clinical trials. We do not believe that
Androxal® will present with the same adverse events given its reduced half-life
in the human body as compared to Clomid®. In our preclinical studies and
our clinical trials to date, we have observed no evidence of any of these events
except for certain ophthalmologic events in our preclinical dog study at doses
significantly higher than those administered in the clinical
trials.
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
the results discussed herein are based on data from non-pivotal trials and that
our Phase 2 trials, pivotal Phase 3 and long-term Open Label Safety Trial data
may not agree with these results which will be based upon significantly larger
and more diverse patient populations treated for longer periods of
time.
Secondary
Hypogonadism with Fertility Maintenance/Improvement
During
the second quarter of 2008, we initiated a 24-patient Phase 2b proof-of-concept
clinical trial (ZA-201) for a new indication in which we are monitoring the
effects of Androxal® on male fertility and testicular function in patients being
treated for low testosterone as compared to Testim®, a popular marketed topical
testosterone medication. On October 6, 2009 we announced that Androxal® was
able to maintain sperm counts in men being treated for their low testosterone
levels. Testim® resulted in suppressed sperm levels while men were being treated
with that topical gel. We requested a meeting with the FDA to discuss such
results. In correspondence leading up to such meeting, the FDA stated that
it could not agree with such proposed indication for Androxal® at that time
because the patient population had not been adequately defined and that it was
not aware of certain data to support our position. On January 25, 2010, we
participated in a teleconference with the FDA relating to the future clinical
path for Androxal®. During such teleconference, the FDA requested that we
(i) propose a label that better defines the population of individuals for whom
we believe will benefit from the use of Androxal® and (ii) conduct a
literature review of the incidence of infertility associated with the use of
exogenous testosterone as supportive of our data. The FDA suggested that if
it finds the submission appropriate, no additional clarifying meeting regarding
this indication for Androxal® may be required. On February 8, 2010, we
announced that we submitted the requested information to the FDA and we are
currently awaiting the FDA’s response to such submissions. Given that there
is currently an acceptable treatment regimen for men with low testosterone,
there is significant uncertainty as to whether or not an additional approach
such as Androxal® would be approved by the FDA or accepted in the
market. At this time it is too early in the clinical development process to
estimate when or even if an NDA for Androxal® will be submitted for this
indication.
Type
2 Diabetes
In April
2008, we submitted a White Paper, based on the results from a previously
conducted non-pivotal Phase 2 clinical trial (ZA-003) with Androxal® for the
treatment of testosterone deficiency due to secondary hypogonadism, to the
Division of Reproductive and Urology Products. The data we believe
demonstrated that in subjects with a serum glucose of greater than or equal to
105mg/dL, there was a statistically significant reduction in fasting serum
glucose and a higher response rate to treatment in the Androxal®-group than the
placebo or Androgel® groups. In November 2008, after the FDA reviewed this paper
we received guidance from them suggesting that we open a new IND with the
Division of Metabolic and Endocrine Products, or DMEP, for the investigation of
Androxal® as a potential treatment for type 2 diabetes in mellitus. In
December 2009, we submitted a new IND to the DMEP for the investigation of
Androxal® for such purpose. On February 1, 2010, we received confirmation from
the DMEP that our new IND was accepted and, as a result, we may initiate a Phase
2 trial, subject to available funding.
Proellex®
Proellex®,
our product candidate for female reproductive health, is a new chemical entity
that acts as a selective blocker of the progesterone receptor and is being
developed for the treatment of symptoms associated with uterine fibroids and
endometriosis. However, as a result of the recent liver toxicity exhibited by
Proellex® in our previous Phase 2 and 3 clinical trials to endometriosis and
uterine fibroids, respectively, all ongoing clinical trial activities have been
put on hold by the FDA. There is currently no FDA-approved orally
administered drug treatment for the long-term treatment of uterine fibroids or
endometriosis.
Our
estimates regarding the timing of our Proellex® clinical development program are
completely on hold at this time in light of the FDA clinical hold and our recent
discontinuation of ongoing clinical trials. In addition, any future development
efforts are totally dependent on our ability to raise sufficient capital or find
an appropriate partner to proceed and on decisions by the FDA regarding the
current clinical hold on Proellex® clinical trials. On April 5, 2010, we
announced that we requested that the clinical hold be lifted to conduct a single
study to determine the potential for developing a “low dose” oral anti-progestin
therapy based on telapristone acetate or Proellex®. On April 29, 2010 a
teleconference was held with the FDA to review the clinical hold status of
Proellex®. During the teleconference the FDA noted that it felt that not
all of their concerns were fully answered but opined that if the Company was
willing to modify the trial from a parallel design to an escalating dose design
the FDA would consider lifting the full clinical hold and place Proellex® on
partial clinical hold to allow the low dose trial to be conducted. The Company
agreed to modify the protocol and submitted the new design to the Agency on
April 30, 2010. If the FDA were to lift the clinical hold on Proellex®, and
if the FDA requires a lower dosage of Proellex® to be used for future clinical
trials, we would be required to commence Phase 2 studies again with the required
lower dosage, thereby resulting in extensive additional costs and delays. The
length of time required to complete Phase 1, Phase 2 and Phase 3 clinical trials
and long-term open label safety trials may vary substantially according to
factors relating to the particular trial, such as the type and intended use of
the drug candidate, the clinical trial design and the ability to enroll suitable
patients. We have also, in the past, had difficulty recruiting patients into our
Proellex® clinical trials primarily due to the various test procedures that are
required, including multiple endometrial biopsies. Recruiting patients would
likely be even more difficult due to the recent liver toxicity exhibited by
Proellex®.
Other
Products
We
continue limited out-licensing efforts for 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 under the brand name, Z-Max. VASOMAX® is currently on partial
clinical hold in the U.S.
Business
Strategy
Provided
we are able to obtain sufficient funds to continue our business, we plan to
initially focus our clinical program on Androxal®. Should the FDA permit the
resumption of the Proellex® clinical trials, we will assess whether there are
sufficient funds available to continue development ourselves of such product
candidate or whether such program would be more appropriately funded by a
corporate partner. Therefore, we will continue to explore corporate
partnering opportunities for assistance in the clinical development funding and
commercialization of our products, as appropriate; however, there can be no
assurance that an acceptable corporate partnering opportunity will be
found.
Risks
Affecting Us
Our
business is subject to numerous risks as discussed more fully in “Item 1A. Risk
Factors" in our annual report on Form 10-K for the year ended December 31, 2009
and the section entitled "Risk Factors” in this quarterly report. We
plan to continue to utilize the current Equity Distribution Agreement with
Ladenburg to provide us with capital to fund our immediate and short term needs
and to explore other various financing alternatives. No assurance can be given
that we will be successful in obtaining financing on acceptable terms or at
all. We anticipate that if we are able to secure financing, that such
financing will result in significant dilution of the ownership interests of our
current stockholders and may provide certain rights to the new investors senior
to the rights of our current stockholders, including but not limited to voting
rights and rights to proceeds in the event of a sale or liquidation of the
Company. In the event that we are unable to obtain adequate financing
to meet our future needs, we will pursue other options, including but not
limited to, reductions of expenses, sale of the Company, sale or license of a
portion or all of our assets or the liquidation of the Company.
In
addition, we have not received regulatory approval for any of our product
candidates, have not successfully earned any significant commercial revenues
from any of our product candidates and may never launch either of our product
candidates. If we do not successfully commercialize any of our
product candidates, we will be unable to achieve our business
objectives. In addition, the reported results of our clinical trials
completed to date may not be indicative of results that will be achieved in
later-stage clinical trials involving larger and more diverse patient
populations. As of March 31, 2010, we had accumulated losses of
$175.6 million, approximately $974,000 in cash and cash equivalents, and our
accounts payable and accrued expenses were approximately $1.9 million. The
amount of cash on hand is not sufficient to fund our future clinical trials of
Androxal® and, if the current FDA clinical hold on Proellex® is removed,
Proellex®, and pay our accounts payable and accrued expenses as well as our
normal corporate overhead and expenses. The foregoing and other matters
raise substantial doubt about our ability to continue as a going concern and we
expect to continue to incur significant losses over the next several years, and
we may never become profitable. Our financial statements do not
include any adjustments that might result from the outcome of these
uncertainties.
Corporate
Information
We were
organized as a Delaware corporation in August 1987. Our principal
executive offices are located at 2408 Timberloch Place, Suite B-7, The
Woodlands, Texas, 77380, and our telephone number is (281) 719-3400. We maintain
an internet website at www.reprosrx.com. The information on our
website or any other website is not incorporated by reference into this
quarterly report and does not constitute a part of this quarterly report. Our
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports
on Form 8-K and all amendments to such reports are made available free of charge
through the Investor Relations section of our website as soon as reasonably
practicable after they have been filed or furnished with the Securities and
Exchange Commission.
General
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
recent clinical hold put on our clinical trials relating to Proellex® by the
FDA, 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. Any failure by us to reestablish safe dosing in the
clinical trials of Proellex®, 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.
As with
most biotechnology companies with drug candidates in development, the path to
marketing approval by the FDA, and comparable foreign agencies for each such
candidate, is long and uncertain. The regulatory process, both domestically and
abroad, is a multi-year process with no certainty when and if a drug candidate
will be approved for commercial use. The development path for a particular drug
candidate typically includes a variety of clinical trials. While we have a
general estimate of the timeframe for our clinical trials, the actual
anticipated completion dates for each of our drug candidates are uncertain. The
length of time for a clinical trial may vary substantially according to factors
relating to the particular clinical trial, such as the type and intended use of
the drug candidate, the clinical trial design and the ability to enroll suitable
patients. A product may be put on clinical hold by the FDA in order
for them to assess the safety of the product, similar to that which has happened
with respect to Proellex®, with the result that previous estimates for clinical
trial completion and related NDA filings get missed. In addition, it
may be necessary to undertake additional unanticipated clinical trials during
the development path, particularly with respect to the recent findings relating
to the increase in liver enzymes observed in our Proellex® clinical
trials. Alternatively, many products that are placed on clinical hold
by the FDA may never be released from such hold.
We will
not receive any revenue from commercial sales unless we, or a potential partner,
complete the clinical development process, obtain regulatory approval, and
successfully commercialize one or more of our product
candidates. Similarly, we do not have a reasonable basis to predict
when or if material net cash inflows from the commercialization and sale of our
drug candidates will occur. To date, we have not commercialized any
of our drug candidates to any material extent and in fact may never do
so.
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 any
particular period and/or fiscal year.
For a
discussion of the risks and uncertainties associated with the timing and costs
of completing the development and commercialization of the Company's drug
candidates, see the section titled "Item 1A. Risk Factors" in this
quarterly report.
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 ongoing and planned clinical
programs, we will have spent our existing cash and cash equivalents by the end
of the third quarter of 2010 and will need to raise additional capital under our
Equity Distribution Agreement with Ladenburg or otherwise in order to continue
our development activities. It is possible that our current planned 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. We believe that we will secure
sufficient capital to continue our ongoing and planned clinical programs
assuming that the results of our current ongoing clinical trials with
Androxal® are favorable.
If the results of these trials are unfavorable, there can be no assurance that
the Company will be successful in obtaining additional capital in amounts
sufficient to continue to fund its operations, which outcome would have a
material adverse effect on the Company. The uncertainties relating to the
foregoing matters raise substantial doubt about our ability to continue as a
going concern. Our financial statements do not include any adjustments that
might result from the outcome of these uncertainties.
We have 5
full time employees. We 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. The 50% salary reduction program we adopted during 2009
could have a negative impact on our ability to retain our
employees. However, this salary reduction program will be revised for
all employees other than the CEO, to only a 25% reduction in salary, when the
Company is successful in raising additional funding in 2010 in an amount at
least equal to $5 million. We are substantially dependent on our
various contract groups to adequately perform the activities required to obtain
regulatory approval of our products.
We have
accumulated net operating losses through March 31, 2010 and the value of the tax
asset associated with these accumulated net operating losses can be
substantially diminished in value due to various tax regulations, including
change in control provisions in the tax code. The Company’s
public offerings completed on February 5, 2007, October 2, 2008, September 11,
2009, October 13, 2009, the sale and issuance of the ATM Shares and the issuance
of unregistered shares as part of the settlement agreements we have entered into
with certain of our creditors since October of 2009 may have created a change of
ownership for Federal Income tax purposes. The Company has not
undertaken a study to determine if this has occurred. A change in
ownership for Federal Income tax purposes may result in a limitation on the use
of net operating loss and tax credit carryforwards in future
periods.
Losses
have resulted principally from costs incurred in conducting clinical trials for
our 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. There can be no assurance that we
will be able to successfully complete the transition from a development stage
company to the successful introduction of commercially viable
products. Our ability to achieve profitability will depend, among
other things, on successfully completing the clinical development of our
products in a reasonable time frame and at a reasonable cost, obtaining
regulatory approvals, establishing marketing, sales and manufacturing
capabilities or collaborative arrangements with others that possess such
capabilities, our and, if applicable, our partners' ability to realize value
from our research and development programs through the commercialization of
those products and raise sufficient funds to finance our
activities. There can be no assurance that we will be able to achieve
profitability or that profitability, if achieved, can be sustained.
Critical
Accounting Policies and the Use of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the condensed consolidated financial statements and the reported amounts of
revenues and expenses during the reporting period. Actual results
could differ from those estimates.
Capitalized
Patent and Patent Application Costs
We
capitalize the cost associated with building our patent library for
Androxal®. As of March 31, 2010, other assets consist of capitalized
patent and patent application costs in the amount of $925,000. Patent
costs, which include legal and application costs related to the patent
portfolio, are being amortized over 20 years, or the lesser of the legal or the
estimated economic life of the patent. Amortization of patent costs
was $14,000 and $12,000 for the three month period ended March 31, 2010 and
2009, respectively. The entire $925,000 in capitalized patents and
patent applications relates to Androxal®.
We review
capitalized patent and patent application costs for impairment whenever events
or changes in circumstances indicate that the carrying amount of an asset may
not be recoverable. An impairment exists when estimated
undiscounted cash flows expected to result from the patent are less than its
carrying amount. The impairment loss recognized represents the excess
of the patent cost as compared to its estimated fair value. We
believe that our remaining capitalized patent and patent application costs are
not impaired as of March 31, 2010.
Should
the Company not continue development of Androxal® or should the Company not
continue as a going concern, capitalized patent and patent application costs may
not be recoverable, which would result in a charge to operating results in
future periods.
Accrued
Expenses
We
estimate accrued expenses as part of our process of preparing financial
statements. Examples of areas in which subjective judgments may be required
include costs associated with services provided by contract organizations for
clinical trials, preclinical development and manufacturing of clinical
materials. We accrue for costs incurred as the services are being
provided by monitoring the status of the trials or services provided and the
invoices received from our external service providers. In the case of
clinical trials, a portion of the estimated cost normally relates to the
projected cost to treat a patient in our trials, and we recognize this cost over
the estimated term of the study based on the number of patients enrolled in the
trial on an ongoing basis, beginning with patient enrollment. As
actual costs become known to us, we adjust our accruals. To date, our
estimates have not differed significantly from the actual costs
incurred. Due to the clinical hold on Proellex® and our current
financial condition, any further development of our product candidates is
dependent on our ability to raise additional capital. As a result, we
anticipate that our estimated accruals for clinical services will be
significantly reduced in future periods. However, subsequent changes
in estimates may result in a material change in our accruals, which could also
materially affect our balance sheet and results of operations.
R&D
Expense
Research
and development, or R&D, expenses include salaries and related employee
expenses, contracted regulatory affairs activities, insurance coverage for
clinical trials and prior product sales, contracted research and consulting
fees, facility costs, amortization of capitalized patent costs and internal
research and development supplies. We expense research and
development costs in the period they are incurred. These costs
consist of direct and indirect costs associated with specific projects as well
as fees paid to various entities that perform research on our
behalf.
Share-Based
Compensation
We had
two stock-based compensation plans at March 31, 2010, the 2000 Non-Employee
Directors' Stock Option Plan, or 2000 Director Plan and the 2004 Stock Option
Plan, or 2004 Plan. Accounting for stock based compensation 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. We use the Black-Scholes option pricing model to
estimate the fair value of our stock options. 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 option's expected
term.
Income
Taxes
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. We have recorded a deferred tax
asset for our net operating losses (“NOL”); however, 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 Company’s public offerings completed on
February 5, 2007, October 2, 2008, September 11, 2009, October 13, 2009, the
sale and issuance of the ATM Shares and the issuance of unregistered shares as
part of the settlement agreements we entered into with certain of our creditors
since October of 2009 may have created a change of ownership for Federal Income
tax purposes. The Company has not undertaken a study to determine if
this has occurred. A change in ownership for Federal Income tax
purposes may result in a limitation on the use of net operating loss and tax
credit carryforwards in future periods.
Results
of Operations
Comparison
of the three-month periods ended March 31, 2010 and 2009
Revenues
and Other Income
Total
revenues and other income, which was comprised of interest income for the three
month periods ended March 31, 2010 and 2009, decreased 100% to zero for the
three month period ended March 31, 2010 as compared to $3,000 for the same
period in the prior. The decrease for the three month period ended
March 31, 2010 was primarily due to lower combined cash and cash equivalents
balances and reduced interest rate yields.
Research
and Development Expenses
Research
and development, or R&D, expenses include contracted services relating to
our clinical product development activities which include preclinical studies,
clinical trials, regulatory affairs and bulk manufacturing scale-up activities
and bulk active ingredient purchases for preclinical and clinical trials
primarily relating to our two products in clinical development, which are
Androxal® and Proellex®. Research and development expenses also
include internal operating expenses relating to our general research and
development activities. R&D expenses decreased 92% or
approximately $5.2 million to $458,000 for the three month period ended March
31, 2010 as compared to $5.7 million for the same period in the prior
year. Our primary R&D expenses for the three month periods ended
March 31, 2010 and 2009 are shown in the following table (in
thousands):
Research and Development
|
|
Three-months
ended
March 31, 2010
|
|
|
Three-months
ended
March 31, 2009
|
|
|
Variance
|
|
|
Change
(%)
|
|
Operating
and occupancy
|
|
$ |
177 |
|
|
$ |
218 |
|
|
$ |
(41 |
) |
|
|
(19 |
)% |
Payroll
and benefits
|
|
|
120 |
|
|
|
416 |
|
|
|
(296 |
) |
|
|
(71 |
)% |
Androxal®
clinical development
|
|
|
14 |
|
|
|
347 |
|
|
|
(333 |
) |
|
|
(96 |
)% |
Proellex®
clinical development
|
|
|
147 |
|
|
|
4,717 |
|
|
|
(4,570 |
) |
|
|
(97 |
)% |
Total
|
|
$ |
458 |
|
|
$ |
5,698 |
|
|
$ |
(5,240 |
) |
|
|
(92 |
)% |
The decrease in R&D expenses is
primarily due to the decreased clinical development expenses related to
Proellex® as a result of the discontinuation of all clinical trials due to the
FDA’s clinical hold on Proellex®. R&D expenses were further
decreased by the decreased clinical development expenses related to Androxal®
due to the completion of a Phase 2b proof-of-concept clinical trial in
2009. Additionally, payroll and benefits expenses decreased due
to reduced headcount and the 50% salary reduction program put in place in August
2009.
To date
through March 31, 2010 we have incurred approximately $14.4 million for the
development of Androxal® and approximately $55.3 million for the development of
Proellex®. These accumulated costs exclude any internal operating
expenses. We are currently developing Androxal® as a treatment for
men with low testosterone that want to maintain their fertility. In
addition, we have received confirmation from the DMEP that our new IND was
accepted for the investigation of Androxal® as a potential treatment for type 2
diabetes. As a result, we may initiate a Phase 2 trial, subject to
available funding. Before the clinical hold on further Proellex®
development in August 2009, we were developing Proellex® for three indications
which included a pre-surgical treatment of anemia associated with uterine
fibroids, a chronic treatment of symptoms associated with uterine fibroids and
as a chronic treatment of symptoms associated with endometriosis.
General
and Administrative Expenses
General
and administrative expenses, or G&A, decreased 37% to approximately $669,000
for the three month period ended March 31, 2010 as compared to $1.1 million for
the same period in the prior year. Our primary G&A expenses for
the three month period ended March 31, 2010 and 2009 are shown in the following
table (in thousands):
General and Administrative
|
|
Three-months
ended
March 31, 2010
|
|
|
Three-months
ended
March 31, 2009
|
|
|
Variance
|
|
|
Change
(%)
|
|
Payroll
and benefits
|
|
$ |
153 |
|
|
$ |
475 |
|
|
$ |
(322 |
) |
|
|
(68 |
)% |
Operating
and occupancy
|
|
|
516 |
|
|
|
585 |
|
|
|
(69 |
) |
|
|
(12 |
)% |
Total
|
|
$ |
669 |
|
|
$ |
1,060 |
|
|
$ |
(391 |
) |
|
|
(37 |
)% |
G&A
payroll and benefits expense include salaries, bonuses, relocation expense,
severance costs, non-cash stock option compensation expense and fringe
benefits. Included in payroll and benefits expense is a charge for
non-cash stock option expense of $74,000 for the three month period ended March
31, 2010 as compared to $192,000 for the same period in the prior
year. Additionally, salaries for the three month period ended March
31, 2010 were $63,000 as compared to $238,000 for the same period in the prior
year. The decrease in salaries is primarily due to a decrease in
headcount and the 50% salary reduction program put in place in August
2009.
G&A
operating and occupancy expenses, which include expenses to operate as a public
company, decreased 12% to $516,000 for the three month period ended March 31,
2010 as compared to $585,000 for the same period in the prior
year. The decrease is primarily due to a decrease in travel
expenses.
Off-Balance
Sheet Arrangements
As of
March 31, 2010, the only off-balance sheet arrangement we have is the operating
lease relating to our facility.
Liquidity
and Capital Resources
Since our
inception, we have financed our operations primarily with proceeds from private
placements and public offerings of equity securities and with funds received
under collaborative agreements.
On
February 12, 2010, we entered into an Equity Distribution Agreement (the “Equity
Distribution Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg”),
pursuant to which we may issue and sell from time to time through Ladenburg, as
sales agent and/or principal, shares of our common stock having an aggregate
offering price of up to $10 million (the “ATM
Shares”). Ladenburg is not required to sell on our behalf any
specific number or dollar amount of the ATM Shares, but Ladenburg, upon
acceptance of written instructions from us, agreed to use its commercially
reasonable efforts consistent with its customary trading and sales practices, to
sell the ATM Shares up to the amount specified, and otherwise in accordance with
the terms of a placement notice delivered to Ladenburg. We have no obligation to
sell any ATM Shares under the Equity Distribution Agreement, and may at any time
suspend sales under the Equity Distribution Agreement, provided that such
suspension shall not affect either party’s obligations with respect to the ATM
Shares sold prior to the receipt of notice of such
suspension. Ladenburg receives a commission of 4% of the gross sales
price of all ATM Shares sold through it under the Equity Distribution Agreement.
The ATM Shares are issued pursuant to our shelf registration statement on Form
S-3, as amended (File No. 333-163648). As of March 31, 2010, we
have sold 523,419 ATM Shares at a weighted average share price of $0.75,
for proceeds of approximately $289,000, net of
expenses. Between April 1, 2010 and May 7, 2010, we have sold
5,551,177 ATM Shares at a weighted average share price of $0.78,
for additional net proceeds of approximately $4.2 million.
Our
primary use of cash to date has been in operating activities to fund research
and development, including preclinical studies and clinical trials, and general
and administrative expenses. We had cash and cash equivalents of
approximately $974,000 as of March 31, 2010 as compared to $1.9 million as of
December 31, 2009. As of April 30, 2010 we had cash and cash
equivalents of approximately $4.0 million.
Net cash
of approximately $1.5 million and $6.9 million was used in operating activities
during the three month period ended March 31, 2010 and 2009,
respectively. The major use of cash for operating activities during
the first quarter of 2010 was to fund our operations and pay down our accounts
payable and accrued expenses.
We have
experienced negative cash flows from operations since inception. 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. Based on our current planned
clinical activities, we will need to raise additional capital by the end of the
third quarter of 2010 under our Equity Distribution Agreement with Ladenburg, or
seek additional funding in the public or private capital markets through
corporate collaborations or other financing vehicles in order to continue our
development activities. 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. It is 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. Our capital requirements will depend on many factors, which
are discussed in detail in “Item 1A. Risk Factors” to Part I of Form 10-K for
the fiscal year ended December 31, 2009. The uncertainties relating to the
foregoing matters raise substantial doubt about our ability to continue as a
going concern.
Our
results of operations may vary significantly from quarter to quarter and year to
year, and depend on, among other factors, 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.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
Interest Rate Risk. We had
cash and cash equivalents of approximately $974,000 at March 31, 2010 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 Accounting 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”), were effective as of March 31, 2010.
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 quarter ended
March 31, 2010 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
On August
7, 2009, R.M. Berry filed a putative class action lawsuit naming the Company,
Joseph Podolski, Paul Lammers, and Louis Ploth, Jr. as
defendants. The lawsuit is pending in the United States District
Court for the Southern District of Texas, Houston Division. The
lawsuit, styled R.M. Berry, on Behalf of Himself and all Others Similarly
Situated v. Repros Therapeutics, Inc., Joseph Podolski, Paul Lammers, and Louis
Ploth, Jr., alleges that the defendants made certain misleading statements
related to the Company’s Proellex® drug. Among other claims, the
lawsuit contends that the defendants misrepresented the side effects of the drug
related to liver function, and the risk that these side effects could cause a
suspension of clinical trials of Proellex®. The lawsuit seeks to establish a
class of shareholders allegedly harmed by the misleading statements, and asserts
causes of action under the Securities Exchange Act of 1934. On August
14, 2009, a lawsuit making similar allegations and naming the same defendants
was also filed in the United States District Court for the Southern District of
Texas. This suit is styled Josephine Medina, Individually and On
Behalf of all Others Similarly Situated v. Repros Therapeutics, Inc., Joseph
Podolski, Paul Lammers, and Louis Ploth, Jr. On September 25, 2009, a
lawsuit also making allegations similar to those in the Berry action, and naming
the same defendants, was filed in the United States District Court for the
Southern District of Texas. That lawsuit is styled Shane Simpson,
Paul Frank and Clayton Scobie, on Behalf of Themselves and all Others Similarly
Situated v. Repros Therapeutics, Inc., Joseph Podolski, Paul Lammers, and Louis
Ploth, Jr. The lawsuits have now been consolidated, and lead
plaintiffs appointed. On January 27, 2010, the lead plaintiffs filed
a Consolidated Class Action Complaint styled In re Repros Therapeutics, Inc.
Securities Litigation, Civil Action No. 09 Civ. 2530 (VDG). The
lawsuit names Repros Therapeutics, Inc., Joseph Podolski, Paul Lammers, and
Louis Ploth, Jr. as defendants. The allegations in the Consolidated
Class Action Complaint are substantially the same as those contained in the
prior complaints, and focus on the claim that the defendants deliberately
withheld information concerning the negative side-effects of Proellex® related
to liver function. Plaintiffs seek to establish a class action for
all persons who “purchased or otherwise acquired Repros common stock between
July 1, 2009, and August 2, 2009.” No discovery has yet
occurred in the matter. Defendants filed a motion to dismiss the
Consolidated Class Action Complaint on March 15, 2010. Briefing
related to the motion is expected to be completed on May 10, 2010. An
estimate of the possible loss or range of losses in connection with the lawsuits
cannot be made at this time.
On
November 13, 2009, a vendor filed a lawsuit naming the company as a
defendant. The lawsuit claimed the Company owed it $93,698 in
accordance with the terms of its agreement with the Company. On
February 1, 2010, the Company entered into a confidential settlement agreement
with this vendor which resolved the lawsuit.
On March
1, 2010, we were served with a lawsuit where we were named as a co-defendant
along with one of our clinical regulatory service providers (“CRO”) relating to
the Proellex® clinical trial study. The lawsuit was filed in the
State of Tennessee, 30th
Judicial District Chancery Court at Memphis by an investigator and claims that
the CRO did not pay it amounts owing to it relating to the
Proellex® study. We did not engage the investigator and under
our agreement with the CRO, we believe the CRO is responsible for any such
costs or damages regarding such lawsuit. Pursuant to the October
Settlement Agreement, such CRO, on behalf of itself and its agents, released us
from all claims which could be asserted by them against us. We
believe such release covers the claims set forth in this
lawsuit. The CRO failed to respond
to the lawsuit, and a default judgment was entered against it in the
amount of $172,901.29. We intend to vigorously defend any and all
claims asserted by the investigator. An estimate of the
possible costs or expenses to defend ourselves in this matter or risk of
exposure under the litigation cannot be made at this
time.
Therapeutic
uses of our Androxal® product candidate are covered in the United States by two
issued U.S. patents and six pending patent applications. In April,
2010, we were issued a Notice of Allowance by the U.S. Patent and Trademark
Office, or PTO, for our pending U.S. patent application directed to the
treatment of secondary hypogonadism. Foreign coverage of therapeutic
uses of our Androxal® product candidate includes 37 issued foreign patents and
87 foreign pending patent applications. The issued patents and
pending applications relate to methods 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 PTO for re-examination of one of these patents based on prior
art. The third party amended the claims in the re-examination
proceedings, which led the PTO to determine that the amended claims are
patentable in view of those publications under consideration and a
re-examination certificate was issued. However, we believe that the
amended claims are invalid based on additional prior art publications, and our
request for re-examination by the PTO in light of a number of these additional
publications and other publications cited by the PTO, was granted. All of the
claims have been finally rejected in the re-examination and the patent holder
has appealed the rejections to the PTO Board of Patent Appeals and Interferences
(“the Board”). A decision has been rendered by the Board affirming
the rejection of all of the claims. The patent holder has filed a
request for rehearing. If the Board maintains the rejections on
rehearing or the request for rehearing is denied, the patent holder will have
the opportunity to appeal the rejections to the United States Court of Appeals
for the Federal Circuit. 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 or out-license Androxal®.
Item
1A. Risk Factors
There
were no material changes from the risk factors previously disclosed in the
registrant’s Form 10-K for the fiscal year ended December 31, 2009 in response
to “Item 1A. Risk Factors” to Part I of Form 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
See the
first paragraph in Note 6 to Item 1 to Part I of this quarterly
report.
Item
3. Defaults Upon Senior Securities.
None
Item
4. (Removed and Reserved).
Item
5. Other Information
None
Item
6. Exhibits
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3.1(a)
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Restated
Certificate of Incorporation (incorporated by reference to Exhibit 3.3 to
the Company's Registration Statement on Form SB-2 (No. 33-57728-FW), as
amended ("Registration
Statement")).
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3.1(b)
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Certificate
of Amendment to the Company's Restated Certificate of Incorporation, dated
as of May 2, 2006 (incorporated by reference to Exhibit 3.1 to the
Company's Current Report on Form 8-K as filed with the Securities and
Exchange Commission (the "Commission") on May 2,
2006).
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3.1(c)
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Certificate
of Amendment to the Company's Restated Certificate of Incorporation, as
amended, dated as of December 16, 2008 (incorporated by reference to
Exhibit 3.1(d) to the Company's Current Report on Form 8-K as filed with
the Commission on December 23,
2008).
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3.1(d)
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Certificate
of Designation of Series One Junior Participating Preferred Stock dated
September 2, 1999 (incorporated by reference to Exhibit A to Exhibit 4.1
to the Company's Registration Statement on Form 8-A as filed with the
Commission on September 3,
1999).
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3.2
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Restated
Bylaws of the Company (incorporated by reference to Exhibit 3.4 to the
Registration Statement).
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10.1
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Equity
Distribution Agreement dated February 12, 2010 between the Company and
Ladenburg Thalmann & Co. Inc. (incorporated by reference to Exhibit
10.1 to the Company’s Current Report on Form 8-K as filed with the
Commission on February 19, 2010).
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10.2
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Fourth
Amendment to Employment Agreement effective March 10, 2010 between the
Company and Joseph S. Podolski (incorporated by reference to Exhibit 10.1
to the Company’s Current Report on Form 8-K as filed with the Commission
on March 11, 2010).
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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 Accounting
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*
|
Certification
furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Accounting
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: May
10, 2010
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By:
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/s/ Joseph S. Podolski
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Joseph
S. Podolski
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Chief
Executive Officer and Director
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(Principal
Executive Officer)
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Date: May
10, 2010
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By:
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/s/ Katherine A.
Anderson
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Katherine
A. Anderson
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Chief
Accounting Officer
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(Principal
Financial Officer)
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