This
filing is made pursuant to Rule 424(b)(5)
under
the Securities Act of 1933, as amended, in connection
with
Registration No. 333-155265
3,500,000 Shares
$1.27 per
share
Common
Stock
We are
offering 3,500,000 shares of our common stock.
Our
common stock is listed on the Nasdaq Global Market under the symbol “RPRX.” On
October 6, 2009, the last reported sale price of our common stock on the Nasdaq
Global Market was $0.89 per share.
Investing
in our common stock involves risks. See “Risk Factors” beginning on
page S-6
of this prospectus supplement.
|
Per
Share
|
Total
|
|||||||
|
Price
to the public
|
$ | 1.27 | $ | 4,445,000 | ||||
|
Placement
agent’s fees
|
$ | 0.09 | $ | 311,150 | ||||
|
Proceeds,
before expenses, to Repros Therapeutics Inc.
|
$ | 1.18 | $ | 4,133,850 | ||||
We have
engaged Ladenburg Thalmann & Co. Inc. as our placement agent in connection
with this offering. The placement agent is not purchasing or selling
any of the common stock in this offering, nor is it required to sell any
specific number or dollar amount of common stock, but will use its commercially
reasonable best efforts to arrange for the sale of the common stock offered. We
have agreed to pay placement agent fees equal to 7% of the total purchase price
of the common stock placed by the placement agent. See “Plan of Distribution”
beginning on page S-14 of this prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus
supplement or the accompanying prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
We expect
to deliver shares against payment in New York, New York on October 9,
2009.
The date
of this prospectus supplement (to the prospectus dated November 20,
2008) is October 7, 2009.
Table
of Contents
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Prospectus Supplement
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||||
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Prospectus
Supplement Summary
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S-1 | |||
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Risk
Factors
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S-6 | |||
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Forward-Looking
Statements
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S-10 | |||
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Use
of Proceeds
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S-11 | |||
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Price
Range of Common Stock
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S-12 | |||
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Dividend
Policy
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S-12 | |||
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Dilution
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S-13 | |||
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Plan
of Distribution
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S-14 | |||
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Legal
Matters
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S-15 | |||
|
Experts
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S-15 | |||
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Where
You Can Find More Information
|
S-15 | |||
|
Important
Information Incorporated By Reference
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S-15 | |||
|
Prospectus
|
||||
|
Table
of Contents
|
i | |||
|
About
This Prospectus
|
1 | |||
|
About
Repros Therapeutics Inc.
|
1 | |||
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Risk
Factors
|
4 | |||
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Forward-Looking
Information
|
4 | |||
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Use
of Proceeds
|
6 | |||
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Selling
Stockholders
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7 | |||
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Plan
of Distribution
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8 | |||
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Legal
Matters
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9 | |||
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Experts
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9 | |||
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Where
You Can Find More Information
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9 | |||
S-i
About
this Prospectus Supplement
We
provide information to you about this offering of shares of our common stock in
two separate documents that are bound together: (1) this prospectus
supplement, which describes the specific details regarding this offering; and
(2) the accompanying prospectus, which provides general information, some
of which may not apply to this offering. Generally, when we refer to this
“prospectus,” we are referring to both documents combined. If information in
this prospectus supplement is inconsistent with the accompanying prospectus, you
should rely on this prospectus supplement.
You
should rely only on information contained in or incorporated by reference into
this prospectus supplement and the accompanying prospectus. We have not, and the
placement agents have not, authorized anyone to provide you with information
that is different. We are offering to sell and seeking offers to buy shares of
our common stock only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus supplement, the accompanying prospectus
and the documents incorporated by reference herein and therein are accurate only
as of their respective dates, regardless of the time of delivery of this
prospectus supplement or of any sale of our common stock.
ProellexTM and
AndroxalTM are our
trademarks. This prospectus supplement and the accompanying prospectus also
contain trademarks, trade names and service marks of other companies, which are
the property of their respective owners.
S-ii
Prospectus
Supplement Summary
This
summary highlights selected information contained elsewhere or incorporated by
reference in this prospectus supplement and the accompanying prospectus. This
summary may not contain all the information that you should consider before
investing in our common stock. You should read the entire prospectus supplement
and the accompanying prospectus carefully, including “Risk Factors” contained in
this prospectus supplement and the financial statements incorporated by
reference in the accompanying prospectus, before making an investment decision.
This prospectus supplement may add to, update or change information in the
accompanying prospectus.
ABOUT
REPROS THERAPEUTICS INC.
Overview
Repros
Therapeutics Inc. (“the Company”, or “we,” “us” or “our”), was organized as a
Delaware corporation 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 associated with male and female
reproductive disorders. The clinical trials relating to Proellex®
have been placed on clinical hold by the FDA due to safety-related concerns
resulting from elevated liver enzymes in a number of patients enrolled in the
clinical trials. Completion of our ongoing clinical trial activities
relating to our other product candidate, Androxal®, is subject to, among other
things, adequate cash being available.
As of
June 30, 2009, we had approximately $4.0 million in cash and cash equivalents,
and our accounts payable and accrued expenses were approximately $7.5 million.
Our accumulated losses were $162.9 million. Furthermore, as of
September 30, 2009, we had approximately $2.5 million in cash and cash
equivalents. Our accounts payable and accrued expenses as of
September 30, 2009 are significantly higher than they were at the end of the
second quarter. In addition, we are in discussions with our creditors, including
our contract research organizations, to settle debts in order to avoid
bankruptcy. No assurance can be given that we will be successful in
such discussions on acceptable terms or at all. Furthermore,
the amount of cash on hand is not sufficient to continue to fund our
ongoing clinical trials of Androxal®, complete all necessary activities relating
to the suspension of our clinical trial program for Proellex®, and pay our
accounts payable and accrued expenses as well as our normal corporate overhead
and expenses. Effective August 16, 2009, we adopted a 50% salary
reduction program for all salaried employees in an effort to reduce expenses
while maintaining our current effort without diminution. Even taking
into account our recent registered direct offering described under “Recent
Developments” below and the offering to which this prospectus supplement
relates, we continue the process of exploring potential additional financing
alternatives that may allow us to maintain our current reduced level of
operations; 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 continue development of either of our product
candidates. Failure to raise sufficient funds in the immediate short
term as described above will likely result in the filing of bankruptcy and
dissolution of the Company.
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, subject to the current FDA clinical hold on
the Proellex® clinical trials described below, for the treatment of
symptoms associated with uterine fibroids and endometriosis. We
are also developing Proellex® as an acute treatment for anemia associated
with excessive menstrual bleeding related to uterine
fibroids.
|
On August
6, 2009, we announced that the Company received verbal notice from the United
States Food and Drug Administration (FDA) during a teleconference with the
Division of Reproductive and Urologic Products that the Company's
Investigational New Drug Applications (INDs) for Proellex® had been placed on
clinical hold for safety reasons. This action followed the Company's
voluntary decision to suspend dosing of all patients in its clinical trials of
Proellex® after discovering elevated liver enzymes in a number of patients
enrolled in the clinical trials.
The
Company and the FDA met to discuss the safety of Proellex® and the overall
direction and scope of the Company's clinical trials of Proellex® at a meeting
on September 23, 2009. Prior to such meeting, the FDA requested that the Company
provide it with weekly information about the patients who experienced a “Serious
Adverse Event” and still have elevated liver enzymes. The Company
gathered the information from its vendors and provided the information to the
FDA to the extent available. The Company provided the FDA with a
detailed analysis of all of the women with elevated liver enzymes at the
September 23, 2009 meeting and discussed with the FDA the events that led to the
suspension of the clinical trials, and whether and under which conditions, if
any, the clinical hold may be lifted and the clinical trials of Proellex® be
safely resumed.
S-1
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, the Company would be
required to commence Phase 2 studies again with the required lower dosage,
thereby resulting in extensive additional costs and delays.
We have
been sued by three of our vendors for amounts they claim they are owed under
their agreements with the Company. As described above, we are working
with our creditors, including our contract research organizations, to settle
debts in order to avoid bankruptcy.
Since our
currently available cash and cash equivalents are not adequate to meet our
accounts payable and accrued expenses, we have engaged a law firm that
specializes in work-out and bankruptcy matters to assist us in attempting to
negotiate with and reduce amounts owed to our vendors. The Company intends, to
the extent possible, to ensure that our available cash is used for patient
safety in connection with our study closeout activities. However, due to our
constrained cash position, the Company does not have sufficient funds at this
time to comply with all of our financial obligations under the agreements with
the clinical research organizations unless acceptable work-out arrangements are
completed.
Our
capital requirements depend on numerous factors, including our ability to resume
our clinical trials should the current clinical trial hold on Proellex® by the
FDA be removed, and whether we determine to pursue all of the previous clinical
development plans for Proellex® and Androxal® . Our announcements
regarding the liver toxicity in our Proellex® clinical trials and the clinical
hold imposed by the FDA along with the receipt of the Nasdaq letters regarding
our failure to meet the current Nasdaq listing requirements have significantly
depressed our stock price and severely impaired our ability to raise additional
capital funds to where it could be difficult or impossible for us to raise any
additional capital.
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. Based on our existing and projected accounts payable
and commitments, we believe we do not have sufficient cash to continue normal
operations and need to raise additional capital immediately in order to continue
operations on a normal basis. 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, such financing will result
in significant dilution of the ownership interests of the Company's current
stockholders and may provide certain rights to the new investors senior to the
rights of its 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 immediate
short term liquidity needs, we will pursue other options, including but not
limited to, reductions of personnel and other expenses, sale of the Company,
sale or license of a portion or all of our assets, a bankruptcy
filing or the liquidation of the Company.
The
uncertainties relating to the foregoing matters raise substantial doubt about
Repros’ ability to continue as a going concern.
Deficiency
Letters from the Nasdaq Global Market
On August
7, 2009, the Company received a letter from The Nasdaq Stock Market advising
that the Company’s market value was below the minimum $50,000,000 requirement
for continued listing on the Nasdaq Global Market. The Company is
provided 90 calendar days, or until November 5, 2009, to regain compliance, at
which time the Company’s securities will be delisted from such market unless the
market value of the Company’s securities listed on the Nasdaq Global Market is
$50,000,000 or more for a minimum of 10 consecutive business
days. The letter also recited that the Company’s total assets and
total revenue fell below certain required thresholds under related
rules.
On
September 15, 2009, the Company received a second letter from The Nasdaq Stock
Market advising that, in additional to the deficiencies described in the August
7, 2009 letter, the Company’s market value of publicly held shares was below the
minimum $15,000,000 requirement for continued listing on the Nasdaq Global
Market. The Company is provided 90 calendar days, or until December
14, 2009, to regain compliance, at which time the Company’s securities will be
delisted from such market unless the Company’s market value of publicly held
shares is $15,000,000 or more for a minimum of 10 consecutive business
days.
Each
letter suggested that the Company consider applying for transfer of its
securities to the Nasdaq Capital Market, which has substantially lower listing
requirements. The Company is considering its options at this time and
intends to take whatever actions it can to best protect shareholder value;
however, there can be no assurance that the Company’s securities will continue
to be traded on any Nasdaq trading market.
S-2
Shareholder
Class Action Lawsuits
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. During the week of October 5, 2009, various
shareholders filed motions to consolidate the pending actions and to be
appointed as lead plaintiff. No ruling on these motions has
occurred. An estimate of the possible loss or range of losses in
connection with the lawsuits cannot be made at this time. The Company
has retained counsel to assist it in defending these actions.
Registered
Direct Offering
On
September 10, 2009, we completed a direct registered offering of 1.5 million
shares of our common stock at a purchase price of $0.65 per share for aggregate
proceeds after expenses of approximately $125,000. The purchaser
under such offering received a right of first offer to purchase their respective
pro-rata portion of any future financings, excluding certain corporate
activities, that expires on October 9, 2009.
The
shares of common stock offered by us in the offering were registered under our
existing shelf registration statement on Form S-3 (File No. 333-155265), which
was filed with the Securities and Exchange Commission on November 10, 2008 and
declared effective by the Securities and Exchange Commission on November 26,
2008.
Androxal®
(male reproductive health):
We
believe our product candidate for male reproductive health, Androxal®, is a new
chemical entity. Androxal® is a single isomer of clomiphene citrate and is an
orally active proprietary small molecule compound.
We are
developing Androxal® for men of reproductive age with low testosterone levels
who want to maintain their fertility while being treated for their low
testosterone condition. During the second quarter of 2008, we initiated a Phase
2b proof-of-concept clinical trial 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. We anticipate holding a meeting with the FDA during the
second half of 2009, provided that sufficient funds can be raised to continue
development of this product. Given that there is 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.
In April
2008, we submitted a White Paper, based on the results from a previously
conducted non-pivotal Phase 2 clinical trial with Androxal® for the treatment of
testosterone deficiency due to secondary hypogonadism, to the FDA's Division of
Reproductive and Urology Products. The data demonstrated that in subjects with
serum glucose levels of greater than 105 mg/dL, there was a statistically
significant reduction in fasting serum glucose and a higher response rate in the
treatment group with Androxal® as compared with groups receiving either placebo
or Androgel®, the current standard of care for the treatment of testosterone
deficiency. In November 2008, after the FDA reviewed this paper we received
guidance 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. Provided that sufficient cash is available, we
plan to submit a new IND for this indication to the DMEP in the second half of
2009. Should we raise adequate funds to continue our operations, we anticipate
conducting a Phase 2b proof-of-concept clinical trial with Androxal® for glucose
regulation after receiving additional feedback from the FDA. At this time it is
too early in the clinical development process to estimate when or even if a NDA
for Androxal® will be submitted for this indication. The plan to develop
Androxal® in this new indication replaces our previously announced plan to
develop Androxal® in men with adult-onset idiopathic hypogonadotrophic
hypogonadism, or AIHH, with concomitant plasma glucose and lipid elevations, all
of which are components of Metabolic Syndrome.
We were
previously developing Androxal® in the United States to treat testosterone
deficiency due to secondary hypogonadism by restoring normal testosterone
production in males with functional testes and diminished pituitary function, a
common condition in the aging male. After a Type "C" meeting held with the FDA
on October 15, 2007, we believed that there was no clear clinical path to
develop Androxal® for this indication in the U.S. Androxal® might be developed
outside of the U.S. for this indication if our future financial resources are
sufficient.
S-3
Proellex®
(female reproductive health):
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. 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, the Company 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®.
Business
Strategy
Our
immediate short-term business objective is to concentrate our remaining
resources on ensuring the safety of those patients recently discontinued from
the suspended Proellex® studies. Pending our ability to obtain sufficient funds
to continue our business we plan to focus our clinical program on Androxal® to
determine if a clear clinical path can be realized via discussion with the FDA
pending completion of "proof of concept" Phase II studies.
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 a corporate partnering opportunity will be
found.
Corporate
Information
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 prospectus supplement and does not constitute a part of this
prospectus supplement. 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 SEC.
Recent
Developments
On
September 14, 2009, we met with a group of our creditors to facilitate the
discussions described above.
We filed
a preliminary proxy statement on September 30, 2009, relating to a special
meeting of our stockholders to be held on November 17, 2009 to approve an
amendment to the Restated Certificate of Incorporation, as amended, to increase
the number of authorized shares of our common stock from 30 million to 75
million.
S-4
The
Offering
|
Common
stock offered by Repros
|
3,500,000 shares
|
|
|
Common
stock to be outstanding after this offering
|
20,177,404 shares
|
|
|
Use
of proceeds
|
We
intend to use the net proceeds from this offering to pay down our
obligations to our trade creditors. Any remaining proceeds will be used
for general corporate purposes.
|
|
|
Nasdaq
Global Market symbol
|
RPRX
|
|
The
number of shares of common stock to be outstanding immediately after this
offering is based on the number of shares outstanding as of September 30, 2009,
which was 16,677,404 shares, and does not include:
|
|
·
|
2,209,608 shares
of common stock issuable upon the exercise of outstanding options at a
weighted average exercise price of $5.76 per share;
and
|
|
|
·
|
1,262,201
shares of common stock available for future issuance under our stock
option plans.
|
S-5
Risk
Factors
Investing
in our common stock involves a high degree of risk. You should
carefully consider the risks described below and all other information contained
in or incorporated by reference in this prospectus supplement and the accompany
prospectus, including the risk factors discussed in the section entitled “Risk
Factors” contained in our most recent Annual Report on Form 10-K for the year
ended December 31, 2008 and our other public filings, before making an
investment decision. You should also refer to the other information in this
prospectus supplement and the accompanying prospectus, including our financial
statements and the related notes incorporated by reference in the accompanying
prospectus. The risks and uncertainties described in these sections and
documents are not the only risks and uncertainties we face. Additional risks and
uncertainties not presently known to us or that we currently deem immaterial
also may impair our business operations. If any of these risks actually occur,
our business, results of operations and financial condition could suffer. In
that event the trading price of our common stock could decline, and you may lose
all or part of your investment in our common stock. This prospectus supplement,
the accompanying prospectus and the incorporated documents also include
forward-looking statements and our actual results may differ substantially from
those discussed in these forward-looking statements, including the risks
mentioned above.
Risks
Relating to our Business
Our
ability to continue as a going concern requires that we raise additional funds
immediately, without which we will need to cease our business operations and
begin bankruptcy or liquidation proceedings.
Our
ability to continue as a going concern is dependent upon our ability to obtain
immediate financing, our ability to control our operating expenses and our
ability to achieve a level of revenues adequate to support our capital and
operating requirements. In particular, we are exploring various financing
alternatives to address our immediate short term liquidity needs. 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. The current FDA clinical hold of our clinical
trials for Proellex® will make it more difficult for us to obtain additional
financing. In addition, the recently filed class action lawsuits will make our
ability to raise funds even more difficult. As described above, we expect to
continue to incur significant losses for the foreseeable future, and we may
never achieve or sustain profitability. In the event that we are unable to
obtain adequate financing to meet our immediate short term liquidity needs, we
will need to cease our business operations and begin bankruptcy or liquidation
proceedings.
We
may need to seek protection under the provisions of the U.S. Bankruptcy Code or
we may face an involuntary bankruptcy filing, and in that event, it is unlikely
that stockholders would receive any value for their shares.
We have
not generated any significant revenues to date, and we have incurred losses in
each year since our inception. As of June 30, 2009, we had approximately $4.0
million in cash and cash equivalents and our accounts payable and accrued
expenses were approximately $7.5 million. Furthermore, as of September 30, 2009,
we had approximately $2.5 million in cash and cash equivalents. Our accounts
payable and accrued expenses as of September 30, 2009 is significantly higher
than it was at the end of the second quarter. Several vendors have ceased
performing any work for us and have recently notified the Company of claims,
which include amounts due upon termination of work, and in three cases filed
suit against us for payments that such vendors claim they are owed under their
agreements with the Company. We have a dispute with one clinical research
organization regarding the suitability of work provided to the Company. We are
investigating such invoices and claims. In addition, we are reviewing our
obligations under our agreements with our contract research organizations to
determine the extent of our obligations thereunder. Furthermore,
the amount of cash on hand is not sufficient to continue to fund our
ongoing clinical trials of Androxal®, complete all necessary activities relating
to the suspension of our clinical trial program for Proellex®, and pay our
accounts payable and accrued expenses as well as our normal corporate overhead
and expenses. We cannot assure you that any actions that we take would raise or
generate sufficient capital to fully address the uncertainties of our financial
position. As a result, we may be unable to realize value from our assets and
discharge our liabilities in the normal course of business. If we are unable to
settle our obligations to our creditors or if we are unable to obtain financing
to support continued satisfaction of our obligations, we may need to seek
protection under the provisions of the U.S. Bankruptcy Code. In addition, our
creditors may seek to involuntarily place us in bankruptcy. In either
event, we may seek to reorganize our business, or we or a trustee appointed by
the court may be required to liquidate our assets. In either of these events,
whether the stockholders receive any value for their shares is highly uncertain.
If we needed to liquidate our assets, we would likely realize significantly less
from them than the values at which they are carried on our financial statements.
The funds resulting from the liquidation of our assets would be used first to
pay off the debt owed to any secured and unsecured creditors before any funds
would be available to pay our stockholders, and any shortfall in the proceeds
would directly reduce the amounts available for distribution, if any, to our
creditors and to our stockholders. In the event we were required to liquidate
under the federal bankruptcy laws, it is highly unlikely that stockholders would
receive any value for their shares.
S-6
In
addition, the Company’s Exclusive License Agreement, as amended, with the
National Institutes of Health (NIH) dated April 16, 1999 relating to Proellex®
requires that the Company raise no less than $6,000,000 on or before September
30, 2009, and additionally provides that the license may be terminated by the
NIH immediately upon notice to the Company following a filing of a petition in
bankruptcy or a letter from the Company to the NIH stating that it is
insolvent. The Company intends to discuss with the NIH its current
financial status and obtain appropriate assurances that the license will not be
terminated in order to facilitate a financing, but there can be no assurance
that the Company will be successful in its efforts. In the event that any of the
conditions contained in the license agreement for termination by the NIH are
triggered, the Company's license agreement may be terminated and the Company
would lose its exclusive rights to Proellex®. Any such termination of
the license agreement could have a material adverse effect on the Company's
operations, and in such event, the value of your stockholdings in the Company
would be materially adversely affected.
We
have identified a dose-related increase in liver enzymes in Proellex® clinical
trial patients, leading to the suspension of Proellex® studies and the FDA's
notice of clinical hold on all Proellex® clinical trials.
In our
clinical trials program for Proellex®, we identified a dose-related increase in
liver enzymes in a number of patients that resulted in our decision to suspend
all clinical trials relating to Proellex®. Shortly thereafter, the
FDA placed all Proellex® clinical studies on hold. There can be no
assurance whether and when the FDA will remove the clinical hold; whether
Proellex® can be further developed, financed or commercialized in a timely
manner without significant additional studies or patient data or significant
expense; and whether any future development will be sufficient to support
product approval. If we are unable to resolve the FDA's concerns, we
will not be able to proceed further to obtain regulatory approval for
Proellex®.
We
have no clear clinical path for Androxal® at this time.
We are
developing Androxal® for men of reproductive age with low testosterone levels
who want to maintain their fertility while being treated for their low
testosterone condition. During the second quarter of 2008, we initiated a Phase
2b proof-of-concept clinical trial 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. We anticipate holding a meeting with the FDA during the
second half of 2009, provided that sufficient funds can be raised to continue
development of this product. Given that there is already 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.
We
are currently not in compliance with Nasdaq rules for continued listing on the
Nasdaq Global Market and are at risk of being delisted, which may subject us to
the SEC’s penny stock rules and decrease the liquidity of our common
stock.
On August
7, 2009, we received notice from The Nasdaq Stock Market that the market value
of our listed securities has been below the minimum $50,000,000 requirement for
continued inclusion on the Nasdaq Global Market by Nasdaq Listing Rule
5450(b)(2)(A). We have been provided until November 5, 2009 to regain
compliance. If we do not demonstrate compliance by such date, our
securities will be delisted from the Nasdaq Global Market.
On
September 15, 2009, the Company received a second letter from The Nasdaq Stock
Market advising that, in additional to the deficiencies described in the August
7, 2009 letter, the Company’s market value of publicly held shares was below the
minimum $15,000,000 requirement for continued listing on the Nasdaq Global
Market by Nasdaq Listing Rule 5450(b)(2)(C) or 5450(b)(3)(C). We have
been provided until December 14, 2009 to regain compliance. If we do
not demonstrate compliance by such date, our securities will be delisted from
the Nasdaq Global Market.
If we are
delisted from the Nasdaq Global Market, and are unsuccessful in moving to the
Nasdaq Capital Market, our common stock may be traded over-the-counter on the
OTC Bulletin Board or in the “pink sheets.” These alternative
markets, however, are generally considered to be less efficient than Nasdaq
markets. Many over-the-counter stocks trade less frequently and in
smaller volumes than securities traded on Nasdaq markets, which would likely
have a material adverse effect on the liquidity of our common
stock.
If our
common stock is delisted from the Nasdaq Global Market, there may be a limited
market for our stock, trading in our stock may become more difficult and our
share price could decrease even further. In addition, if our common
stock is delisted, our ability to raise additional capital may be
impaired.
In
addition, our common stock may become subject to penny stock
rules. The SEC generally defines “penny stock” as an equity security
that has a market price of less than $5.00 per share, subject to certain
exceptions. We are not currently subject to the penny stock rules
because our common stock qualifies for an exception to the SEC’s penny stock
rules for companies that have an equity security that is quoted on a Nasdaq
stock market. However, if we were delisted, our common stock would
become subject to the penny stock rules, which impose additional sales practice
requirements on broker-dealers who sell our common stock. If our
common stock were considered penny stock, the ability of broker-dealers to sell
our common stock and the ability of our stockholders to sell their shares in the
secondary market would be limited and, as a result, the market liquidity for our
common stock would be adversely affected. We cannot assure you that
trading in our securities will not be subject to these or other regulations in
the future.
S-7
The
Company and certain of its officers and directors were named as a party in three
class action lawsuits which could result in a material adverse affect on our
business and financial condition.
The
Company and certain of its officers were named as parties in three shareholder
class action lawsuits alleging, among other things, that the Company and such
officers violated certain provisions of the Securities Exchange Act of 1934 by
issuing materially false and misleading press releases regarding the results of
clinical trials for its drug Proellex. Our bylaws require us to
indemnify our officers in certain proceedings, subject to certain limited
exceptions. In addition, each of our directors has an indemnification agreement
with the Company providing for certain additional indemnification benefits for
such persons in the event of a lawsuit. As a result of the class
action lawsuits, we are obligated to pay for certain costs and expenses of our
officers and directors and may be liable for substantial damages, costs and
expenses if such class action is successful. Such litigation could
also divert the attention of our management and our resources in general from
day-to-day operations. Further, it is possible that additional claims
beyond those that have already been filed will be brought by the current
plaintiffs or by others in an effort to seek monetary relief from
us.
Additionally,
such class action lawsuits are covered by the Company's director and officer
insurance policy. In the event there is an adverse judgment against
the Company in any of such lawsuits, the Company's insurance coverage may not be
adequate to cover such judgment and the Company's cash position may not be
sufficient to satisfy such judgment. Such adverse judgment could have a material
and adverse affect on the Company.
Risks
Relating to our Securities
Our
stock price will likely be volatile, and your investment in our stock could
decline in value.
Our stock
price has fluctuated historically. From January 1, 2009 to October 6, 2009,
the market price of our stock was as low as $0.65 per share and as high as
$13.94 per share.
Very few
biotechnology drug candidates being tested will ultimately receive FDA approval,
and a biotechnology company may experience a significant drop in its stock price
based on a clinical trial result or regulatory action. Our stock price may
fluctuate significantly, depending on a variety of factors,
including:
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the
success or failure of, or other results or decisions affecting, our
clinical trials;
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the
timing of the discovery of drug leads and the development of our drug
candidates;
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the
entrance into a new collaboration or the modification or termination of an
existing collaboration;
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changes
in our research and development budget or the research and development
budgets of our existing or potential
collaborators;
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the
introduction of new drug discovery techniques or the introduction or
withdrawal of drugs by others that target the same diseases and conditions
that we or our collaborators
target;
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regulatory
actions;
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expenses
related to, and the results of, litigation and other proceedings relating
to intellectual property rights or other matters;
and
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accounting
changes, including the expense impact of
SFAS No. 123R.
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We are
not able to control all of these factors. Period-to-period comparisons of our
financial results are not necessarily indicative of our future performance. In
addition, if our revenues or results of operations in a particular period do not
meet stockholders’ or analysts’ expectations, our stock price may decline and
such decline could be significant.
S-8
There
are a substantial number of shares of our common stock eligible for future sale
in the public market, and the sale of these shares could cause the market price
of our common stock to fall.
There
were 16,677,404 shares of our common stock outstanding as of September 30,
2009. In addition, as of September 30, 2009, there were options to purchase
2,209,608 shares of our common stock issued and outstanding under all
of our stock option plans at a weighted average exercise price of $5.76,
816,116 additional shares of common stock issuable under our 2004 Stock
Option Plan and 446,085 shares of common stock reserved for issuance under
our 2000 Non-Employee Director Stock Option Plan. A substantial
number of the shares described above, when issued upon exercise, will be
available for immediate resale in the public market. The market price of our
common stock could decline as a result of such resales due to the increased
number of shares available for sale in the market.
Any
future equity or debt issuances by us may have dilutive or adverse effects on
our existing stockholders.
We have
financed our operations, and we expect to continue to finance our operations,
primarily by issuing and selling our common stock or securities convertible into
or exercisable for shares of our common stock. In light of our need for
additional financing, we may issue additional shares of common stock or
convertible securities that could dilute your ownership in our company and may
include terms that give new investors rights that are superior to yours.
Moreover, any issuances by us of equity securities may be at or below the
prevailing market price of our common stock and in any event may have a dilutive
impact on your ownership interest, which could cause the market price of our
common stock to decline.
We may
also raise additional funds through the incurrence of debt, and the holders of
any debt we may issue would have rights superior to your rights in the event we
are not successful and are forced to seek the protection of bankruptcy
laws.
Our
largest stockholders may take actions that are contrary to your interests,
including selling their common stock.
A small
number of our stockholders hold a significant amount of our outstanding common
stock, including Efficacy Capital, which alone owns approximately 25.7% of our
common stock immediately prior to the offering. These stockholders may have
interests that are different from yours and may support competing transactions;
provided that, in the case of Efficacy Capital, such support is in accordance
with that certain Standstill Agreement dated January 9, 2008, as
amended. Sales of a large number of shares of our common stock by
these large stockholders or other stockholders within a short period of time
could adversely affect our stock price.
Our
rights agreement and certain provisions in our charter documents and Delaware
law could delay or prevent a change in management or a takeover attempt that you
may consider to be in your best interest.
We have
adopted certain anti-takeover provisions, including a Rights Agreement, dated as
of September 1, 1999, as amended, between us and Computershare Trust
Company, Inc., as Rights Agent. The Rights Agreement will cause substantial
dilution to any person who attempts to acquire us in a manner or on terms not
approved by our board of directors.
The
Rights Agreement and Certificate of Designations for the Series One Junior
Participating Preferred Stock dated September 2, 1999, as well as other
provisions in our certificate of incorporation and bylaws and under Delaware
law, could delay or prevent the removal of directors and other management and
could make a merger, tender offer or proxy contest involving us that you may
consider to be in your best interest more difficult. For example, these
provisions:
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allow
our board of directors to issue preferred stock without stockholder
approval;
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limit
who can call a special meeting of
stockholders; and
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establish
advance notice requirements for nomination for election to the board of
directors or for proposing matters to be acted upon at stockholders
meetings.
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We
may allocate the net proceeds from this offering in ways that you and other
stockholders may not approve.
We intend
to use the net proceeds from this offering to pay down our current debt to our
trade creditors. Any remaining proceeds will be used for general
corporate purposes. Our management will, however, have broad discretion in the
application of the net proceeds from this offering and could spend the proceeds
in ways that do not necessarily improve our operating results or enhance the
value of our common stock.
S-9
Forward-Looking
Statements
Some of
the statements contained (i) in this prospectus supplement and the
accompanying prospectus or (ii) incorporated by reference into this
prospectus supplement are 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, and are subject to the safe
harbor created by the Securities Litigation Reform Act of 1995. Examples of
these forward-looking statements include, but are not limited to:
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our
ability to continue as a going concern and to immediately raise additional
capital on acceptable terms or at
all;
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timing
and amount of future contractual payments, product revenue and operating
expenses;
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our
ability to successfully defend the recently filed class action
lawsuits;
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our
ability to maintain the Company’s listing on the Nasdaq Global
Market;
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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®;
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having
available funding for the continued development of Proellex® and
Androxal®;
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uncertainty
related to our ability to obtain approval of our products by the FDA and
regulatory bodies in other
jurisdictions;
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whether
a clear clinical path for Androxal® can be
realized;
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uncertainty
relating to our patent portfolio and license rights to such
patents;
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market
acceptance of our products and the estimated potential size of these
markets; and
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any
other risks and uncertainties described in the Company's filings with the
Securities and Exchange Commission.
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While
these forward-looking statements made by us are based on our current intent,
beliefs and judgments, they are subject to risks and uncertainties that could
cause actual results to vary from the projections in the forward-looking
statements. You should consider the risks above carefully in addition to other
information contained in this report before engaging in any transaction
involving shares of our common stock. If any of these risks occur, they could
harm our business, financial condition or results of operations. In such case,
the trading price of our common stock could decline, and you may lose all or
part of your investment.
The words
“believe,” “should,” “predict,” “future,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “plan,” “expect,” “potential,” “continue,” or
“opportunity,” or other words and terms of similar meaning, as they relate to
us, our business, future financial or operating performance or our management,
are intended to identify forward-looking statements. Any forward-looking
statement speaks only as of the date on which it is made, and except as required
by law we undertake no obligation to update or revise any forward-looking
statement to reflect events or circumstances after the date on which the
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any
forward-looking statements. Past financial or operating performance is not
necessarily a reliable indicator of future performance and you should not use
our historical performance to anticipate results or future period
trends.
S-10
Use
of Proceeds
We expect
to receive approximately $4.1 million in net proceeds from the sale of the
3,500,000 shares of common stock offered by us in this offering based on
the offering price of $1.27 per share. “Net proceeds” is what we expect to
receive after paying the expenses of this offering, including the placement
agent fees, as described in “Plan of Distribution,” and other estimated offering
expenses payable by us, which include legal, accounting and printing
fees.
We intend
to use the net proceeds from this offering to pay down our obligations to our
trade creditors for expenses incurred during our clinical trials primarily with
our contract research organizations. Any remaining proceeds will be
used for general corporate purposes.
Until we
use the net proceeds of this offering, we intend to invest the funds in
short-term, investment grade, interest-bearing securities.
S-11
Price
Range of Common Stock
Our
common stock is quoted on the Nasdaq Global Market under the symbol “RPRX”. The
following table shows the high and low sale prices per share of our common stock
as reported by the Nasdaq Global Market during the periods
presented.
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Price
Range
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High
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Low
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2007
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First
Quarter
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$ | 14.67 | $ | 9.16 | ||||
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Second
Quarter
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15.09 | 9.51 | ||||||
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Third
Quarter
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14.38 | 9.88 | ||||||
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Fourth
Quarter
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12.96 | 6.99 | ||||||
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2008
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First
Quarter
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$ | 10.20 | $ | 8.11 | ||||
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Second
Quarter
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11.09 | 8.21 | ||||||
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Third
Quarter
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10.00 | 5.31 | ||||||
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Fourth
Quarter
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11.25 | 5.68 | ||||||
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2009
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First
Quarter
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$ | 13.94 | $ | 5.84 | ||||
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Second
Quarter
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8.30 | 5.70 | ||||||
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Third
Quarter (through October 6, 2009)
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6.01 | 0.65 | ||||||
All of
the foregoing prices reflect interdealer quotations, without retail mark-up,
markdowns or commissions and may not necessarily represent actual transactions
in the common stock.
On
October 6, 2009, the last sale price of the common stock, as reported by the
Nasdaq Global Market, was $0.89 per share. On October 6, 2009, there were
approximately 169 holders of record.
Dividend
Policy
We have
never declared or paid cash dividends on our capital stock. We currently intend
to retain our future earnings, if any, for use in our business and therefore do
not anticipate paying cash dividends in the foreseeable future. Payment of
future dividends, if any, will be at the discretion of our board of directors
after taking into account various factors, including our financial condition,
operating results, current and anticipated cash needs.
S-12
Dilution
Our
unaudited net tangible book value as of June 30, 2009 was approximately
$(1.3) million, or approximately $(0.09) per share of common stock.
After giving effect to the sale of 1,500,000 shares of common stock on
September 10, 2009 at the offering price of $0.65 per share and after
deduction of estimated offering expenses payable by us at that time, our pro
forma net tangible book value as of June 30, 2009 would have been
approximately $(450,000), or $(0.03) per share. Net tangible book value per
share represents total assets minus capitalized patent costs and total
liabilities, divided by the number of shares of common stock outstanding.
Dilution in net tangible book value per share represents the difference
between the amount per share paid by purchasers of common stock in this
offering and the net tangible book value per share of our common stock
immediately after the offering.
After
giving effect to the sale of 3,500,000 shares of common stock in this
offering at the offering price of $1.27 per share and after deduction of
estimated offering expenses payable by us, our pro forma net tangible book value
as of June 30, 2009, after giving effect to both offerings described above,
would have been approximately $3.6 million, or $0.18 per share. The
adjustments made to determine pro forma net tangible book value per share are
the following:
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An
increase in total assets to reflect the net proceeds of the offering as
described under “Use of Proceeds”;
and
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The
addition of the number of shares offered by this prospectus supplement to
the number of shares outstanding.
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The
following table illustrates the pro forma increase in net tangible book value
attributable to new investors in this offering of $0.21 per share and the
dilution (the difference between the offering price per share and net tangible
book value per share) to new investors:
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Offering
price per share
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$ | 1.27 | ||||||
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Net
tangible book value per share as of June 30, 2009, after giving
effect to September 10, 2009 offering
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$ | (0.03 | ) | |||||
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Increase
per share attributable to new investors of this offering
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0.21 | |||||||
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Pro
forma net tangible book value per share as of June 30,
2009,
after
giving effect to the offerings
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0.18 | |||||||
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Dilution
per share to new investors of this offering
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$ | 1.09 | ||||||
The
number of shares in the table above excludes as of September 30,
2009:
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2,209,608 shares
of common stock issuable upon the exercise of outstanding options at a
weighted average exercise price of $5.76 per share;
and
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1,262,201
shares of common stock available for future issuance under our stock
option plans.
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S-13
Plan
of Distribution
We are
selling 3,500,000 shares of our common stock under this prospectus supplement to
certain investors at a price of $1.27 per share pursuant to separate purchase
agreements. The purchase price for the shares of common stock was
determined in arms-length negotiations with the investors. We
currently anticipate that the closing of the sale of such common shares under
these agreements will take place on or about October 9, 2009. On the
closing date, we will issue the shares of common stock to the investors and we
will receive funds in the amount of the aggregate purchase price.
We have
engaged Ladenburg Thalmann & Co. Inc. as our placement agent in connection
with this offering. The placement agent arranged for the sale of the
common stock offered hereby to selected institutional investors through direct
purchase agreements between the purchasers and us. The placement
agent is not purchasing or selling any of the common stock in this offering, nor
is it required to sell any specific number or dollar amount of common stock, but
will use its commercially reasonable best efforts to arrange for the sale of the
common stock offered. We will pay the placement agent a cash fee
equal to 7% of the total purchase price of the common stock placed by the
placement agent.
The
following table shows the per share and total fees we will pay to the placement
agent in connection with the sale of the common stock offered pursuant to this
prospectus supplement.
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Per
Share
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Total
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Placement
agent’s fee
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$ | 0.09 | $ | 311,150 | ||||
Certain
investors in the transaction were introduced to our placement agent by another
U.S. registered broker-dealer. A portion of the placement agent fees
otherwise payable to our placement agent will be paid to such other U.S.
registered broker-dealer.
Because
there is no minimum offering amount required as a condition to closing in this
offering, the actual total placement agent fees, if any, are not presently
determinable and may be substantially less than the maximum amount set forth
above. The estimated offering expenses payable by us, in addition to
the placement agent’s fee, are expected to be approximately $50,000, which
includes legal, accounting and printing costs and various other fees associated
with registering and listing the shares of common stock. After
deducting the fees due to the placement agent and our estimated offering
expenses, we expect the net proceeds from this offering to be approximately $4.1
million.
We have
agreed to indemnify the placement agent against certain liabilities, including
liabilities under the Securities Act of 1933, as amended, and liabilities
arising from breaches of representations and warranties contained in the
securities purchase agreement. We have also agreed to contribute to
payments the placement agent may be required to make in respect of such
liabilities.
We have
also granted the placement agent a right of first refusal during the term of the
engagement and for a one-year period following the end of such term, that if we
require the services of an investment banker, financial adviser or similar
professional, the placement agent shall have the exclusive right to provide such
services assuming the key terms and conditions of a proposal by the placement
agent are substantially similar to such key terms and conditions provided by a
qualified third party professional.
The
transfer agent for our common stock is Computershare Trust Company,
N.A.
S-14
Legal
Matters
The
validity of the common stock being offered hereby will be passed upon by
Winstead PC, The Woodlands, Texas. Jeffrey R. Harder, a member of the law
firm, beneficially owned as of September 30, 2009, an aggregate of
11,899 shares of our common stock. Mr. Harder also holds options to
purchase 52,500 shares of our common stock.
Experts
The
consolidated financial statements and management’s assessment of the
effectiveness of internal control over financial reporting (which is included in
Management’s Report on Internal Control over Financial Reporting) incorporated
in this prospectus supplement by reference to the Annual Report on Form 10-K for
the year ended December 31, 2008 have been so incorporated in reliance on the
report (which contains an explanatory paragraph relating to the Company's
ability to continue as a going concern as described in Note 1 to the
consolidated financial statements) of PricewaterhouseCoopers LLP, an independent
registered public accounting firm, given on the authority of said firm as
experts in auditing and accounting.
Where
You Can Find More Information
We have
filed with the SEC a registration statement on Form S-3 under the
Securities Act with respect to the shares of common stock we are offering under
this prospectus supplement. This prospectus supplement and the accompanying
prospectus do not contain all of the information set forth in the registration
statement and the exhibits to the registration statement. For further
information with respect to us and the securities we are offering under this
prospectus supplement, we refer you to the registration statement and the
exhibits and schedules filed as a part of the registration statement. We also
file annual, quarterly and current reports, proxy statements and other
information with the SEC. You may read and copy the registration statement, as
well as any other material we file with the SEC, at the SEC’s Public Reference
Room at 100 F Street, NE, Washington, D.C. 20549. Please call the
SEC at 1-800-SEC-0330 for more information on the Public Reference Room. The SEC
maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically
with the SEC, including Repros. The SEC’s Internet site can be found at
http://www.sec.gov.
Important
Information Incorporated By Reference
The SEC
allows us to “incorporate by reference” into this prospectus supplement the
information we file with it, which means that we can disclose important
information to you by referring you to those documents. Information incorporated
by reference is part of this prospectus supplement. Later information filed with
the SEC will update and supersede this information. The SEC’s Internet site can
be found at http://www.sec.gov.
We
incorporate by reference the documents listed below and any future filings made
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act
until this offering is completed:
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our
Annual Report on Form 10-K for the year ended December 31,
2008;
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our
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2009 and June 30, 2009;
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our
Current Reports on Form 8-K (other than information furnished rather
than filed), filed with the SEC on January 13, 2009, January 27,
2009, February 3, 2009, February 24, 2009, March 9, 2009,
March 12, 2009, March 16, 2009, March 17, 2009,
March 20, 2009, April 20, 2009, May 11, 2009, May 20, 2009,
May 27, 2009, June 8, 2009, July 2, 2009, July 8, 2009, July 10,
2009, July 23, 2009, August 3, 2009, August 7, 2009, August 11, 2009,
August 18, 2009, September 10, 2009, September 21, 2009 and September 30,
2009 (excluding the information furnished in Item 2.02 and Item 7.01
thereof, which is not deemed filed and which is not incorporated by
reference herein);
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the
description of our Rights Agreement contained in our registration
statement on Form 8-A filed on September 3, 1999, as amended on
September 6, 2002, October 30, 2002, June 30, 2005 and
January 10, 2008, including any amendments or reports filed for the
purposes of updating this
description; and
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the
description of our common stock contained in our registration statement on
Form 8-A filed on February 2, 1993, including any amendments or
reports filed for the purposes of updating this
description.
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S-15
You may
request a copy of these filings, at no cost, by contacting us at:
Repros
Therapeutics Inc.
Attention:
Secretary
2408
Timberloch Drive, Suite B-7
The
Woodlands, Texas 77380
Telephone
number: (281) 719-3400
In
accordance with Section 412 of the Exchange Act, any statement contained in
a document incorporated by reference herein shall be deemed modified or
superseded to the extent that a statement contained herein or in any other
subsequently filed document which also is or is deemed to be incorporated by
reference herein modifies or supersedes such statement.
S-16
PROSPECTUS
Up
to 6,282,052 Shares of
Common
Stock
From time
to time, we may sell up to an aggregate of 5,000,000 shares of common stock in
one or more offerings, and certain selling stockholders may offer and sell up to
1,282,052 shares of common stock issuable upon exercise of certain option rights
granted to such selling stockholders. This means:
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we
will provide this prospectus and a prospectus supplement each time we sell
the common stock;
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the
prospectus supplement will inform you about the specific terms of that
offering and may also add, update or change information contained in this
prospectus; and
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you
should read this prospectus and any prospectus supplement, as well as any
documents incorporated by reference in this prospectus and any prospectus
supplement, carefully before you invest in our common
stock.
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Our
common stock is quoted on the Nasdaq Global Market under the trading symbol
“RPRX.” On November 18, 2008, the last reported sale price of our common
stock on the Nasdaq Global Market was $9.73 per share.
THIS
PROSPECTUS MAY NOT BE USED TO OFFER OR SELL ANY SECURITIES UNLESS ACCOMPANIED BY
A PROSPECTUS SUPPLEMENT.
The
common stock may be sold directly by us to purchasers, to or through
underwriters or dealers designated from time to time, or through agents
designated from time to time. For additional information on the methods of sale,
you should refer to “Plan of Distribution” in this prospectus and to the
accompanying prospectus supplement. If any underwriters are involved in a sale
of the common stock, their names and any applicable commissions or discounts
will be set forth in a prospectus supplement. The net proceeds we expect to
receive from the sale will also be set forth in a prospectus
supplement.
The
selling shareholders may offer and sell any of the shares of common stock from
time to time at fixed prices, at market prices or at negotiated prices, and may
engage a broker, dealer or underwriter to sell the shares. For additional
information on the possible methods of sale that may be used by the selling
shareholders, you should refer to the section entitled “Plan of Distribution”
beginning on page 8 of this prospectus. We will not receive any proceeds from
the sale of the shares of common stock by the selling shareholders. We will pay
all expenses incurred in effecting the registration statement of which this
prospectus constitutes a part.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS
TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
INVESTING
IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD CAREFULLY CONSIDER
THE “RISK FACTORS” CONTAINED IN OUR ANNUAL REPORT ON FORM 10-K FOR THE FISCAL
YEAR ENDED DECEMBER 31, 2007, UPDATES IN PART II, ITEM 1A OF OUR FORM 10-Q
FILINGS, AND IN OUR FUTURE FILINGS MADE WITH THE SECURITIES AND EXCHANGE
COMMISSION, WHICH ARE INCORPORATED BY REFERENCE IN THIS PROSPECTUS. SEE THE SECTION ENTITLED
“RISK FACTORS” ON PAGE 4 OF THIS PROSPECTUS.
The date
of this prospectus is November 20, 2008
Table
of Contents
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ABOUT
THIS PROSPECTUS
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1 | |||
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ABOUT
REPROS THERAPEUTICS INC.
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1 | |||
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RISK
FACTORS
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4 | |||
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FORWARD-LOOKING
INFORMATION
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4 | |||
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USE
OF PROCEEDS
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6 | |||
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SELLING
STOCKHOLDERS
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PLAN
OF DISTRIBUTION
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LEGAL
MATTERS
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EXPERTS
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WHERE
YOU CAN FIND MORE INFORMATION
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9 |
We
have not authorized any dealer, salesman or other person to give any information
or to make any representation other than those contained or incorporated by
reference in this prospectus and the accompanying supplement to this prospectus.
You must not rely upon any information or representation not contained or
incorporated by reference in this prospectus or the accompanying prospectus
supplement. This prospectus and the accompanying supplement to this prospectus
do not constitute an offer to sell or the solicitation of an offer to buy common
stock, nor do this prospectus and the accompanying supplement to this prospectus
constitute an offer to sell or the solicitation of an offer to buy common stock
in any jurisdiction to any person to whom it is unlawful to make such offer or
solicitation in such jurisdiction. You should not assume that the information
contained in this prospectus and the accompanying prospectus supplement is
accurate on any date subsequent to the date set forth on the front of the
document or that any information we have incorporated by reference is correct on
any date subsequent to the date of the document incorporated by reference, even
though this prospectus and any accompanying prospectus supplement is delivered
or common stock sold on a later date.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission using a “shelf” registration process. Under this shelf
registration process, we may sell common stock in one or more offerings, up to
an aggregate number of 5,000,000 shares. In addition, certain selling
stockholders may offer to sell up to 1,282,052 shares of common stock issuable
upon exercise of certain option rights held by such selling
stockholders.
This
prospectus provides you with a general description of the securities we may
offer. Each time we sell common stock, we will provide a prospectus supplement
that will contain more specific information about the terms of that offering. We
may also add, update or change in the prospectus supplement any of the
information contained in this prospectus. This prospectus, together with
applicable prospectus supplements, includes all material information relating to
this offering. If there is any inconsistency between the information in this
prospectus and the information in the accompanying prospectus supplement, you
should rely on the information in the prospectus supplement.
Please
carefully read both this prospectus and any prospectus supplement together with
the additional information described below under “Where You Can Find More
Information.”
Unless
otherwise mentioned or unless the context requires otherwise, all references in
this prospectus to “Repros,” “we,” “us,” “our” or similar references mean Repros
Therapeutics Inc.
ABOUT
REPROS THERAPEUTICS INC.
Overview
Repros
Therapeutics Inc. (“the Company”, or “we,” “us” or “our”), was organized on
August 28, 1987. We are a development stage biopharmaceutical company
focused on the development of oral small molecule drugs to treat male and female
reproductive disorders.
Our
current product pipeline consists of the following (with the respective status
of development):
Proellex® (female reproductive
health)
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Phase
3 three-month short course treatment of symptomatic uterine fibroids
associated with anemia in women who may consider having a subsequent
hysterectomy
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Phase
3 for the chronic treatment of symptomatic uterine
fibroids
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Phase
2 for the treatment of symptomatic
endometriosis
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Androxal® (male reproductive
health)
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Phase
2b proof-of-concept trial in men with low testosterone levels wanting to
improve or maintain their fertility and/or sperm number and
function
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Request
pre-IND meeting with the Food and Drug Administration’s, or FDA’s,
Division of Metabolic and Endocrine Products to investigate Androxal as a
treatment for type 2 diabetes
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Proellex
Our lead
drug, Proellex, is a selective progesterone receptor modulator (PRM) and is
being developed for the treatment of symptoms associated with uterine fibroids
and endometriosis. We are also developing Proellex as a short course
pre-surgical treatment for anemia associated with excessive menstrual bleeding
related to uterine fibroids. During the first quarter of 2008, we filed an
Investigational New Drug Application, or IND, for Proellex for the treatment of
anemia associated with uterine fibroids and also initiated two 65-patient Phase
3 pivotal clinical trials with Proellex for this indication. Our goal is to file
a New Drug Application, or NDA, for this indication in late 2009.
During
the first quarter of 2008, we initiated two 75-patient Phase 3 pivotal clinical
trials with Proellex for the chronic treatment of uterine fibroids and
anticipate filing a NDA for this indication in late 2010. In addition, during
the first quarter of 2008, we also initiated two 400 patient Proellex Open Label
Safety Studies. We intend to complete patient enrollment for one 400 patient
Open Label Safety Study then start enrollment in the second Open Label Safety
study.
1
The
initiation of these Phase 3 clinical trials and Open Label Studies included
awarding the trials to three clinical research organizations, the process of
identifying and contracting the clinical sites to be used as well as other
various activities required to complete these clinical trials. During the second
quarter of 2008, we implemented a centralized patient recruitment advertising
campaign for our Phase 3 Proellex clinical trials and in July 2008 we took
the necessary steps to begin additional patient recruitment advertising for one
of our 400 patient Proellex Open Label Safety Studies.
During
2008 we disclosed the following clinical trial and animal safety data relating
to Proellex:
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initial
results from 13 women who had endometrial biopsies post menses following
last dose of drug in a two drug cycle extension study showed that results
of assessments of the post menses tissues are that of a benign
endometrium. While previous end of drug cycle biopsies from these subjects
all had histological changes consistent with those induced by progesterone
receptor modulators (Proellex class of drugs), none of these post drug
cessation biopsies reflected any of those histological changes. These key
findings indicate that the effects of Proellex on the endometrium are
present during drug exposure and are reversible upon cessation of drug
treatment;
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results
from a pilot study of the potential for adverse cardiac events associated
with administration of doses of Proellex up to four times higher than the
intended marketed dose showed that despite up to a four fold increase in
Proellex plasma concentrations over seven days the QTc did not change;
and
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initial
macroscopic findings from a two-year rat carcinogenicity study and a
six-month mouse carcinogenicity study showed no potential for tumor
induction as compared to placebo.
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We are
also currently conducting a Phase 2 clinical trial with Proellex for the
treatment of endometriosis. We provided initial interim data from this trial in
July 2008 which showed that severe pain, the most troublesome symptom
associated with endometriosis, was significantly reduced in one to two months of
treatment. We intend to file a NDA for this indication in late
2010.
Uterine
fibroids, anemia associated with uterine fibroids and endometriosis affect a
significant number of women of childbearing age in the developed world. There is
no currently-approved effective long-term drug treatment for uterine fibroids or
endometriosis. In the United States alone, 300,000 women per year undergo a
hysterectomy as a result of severe uterine fibroids.
In
addition to the clinical trials discussed above we are also conducting
additional human clinical trials and animal safety studies with Proellex to
support our future NDA submissions.
Androxal
Our
second product candidate, Androxal, is a single isomer of clomiphene citrate and
is an orally active proprietary small molecule compound.
During
the second quarter of 2008, we initiated a Phase 2b proof-of-concept Androxal
clinical trial in men of reproductive age with low testosterone levels who want
to improve or maintain their fertility and/or sperm function while being treated
for low testosterone. This trial includes a control group that will be given
Testim®, a popular testosterone replacement therapy. We believe Androxal will be
superior to the existing drugs used to normalize testosterone as, to our
knowledge, only Androxal has the property of restoring both luteinizing hormone,
or LH, and follicle stimulating hormone, or FSH, levels. LH and FSH are the
pituitary hormones that stimulate testicular testosterone and sperm production,
respectively. We intend to have an End of Phase 2 Meeting with the FDA in the
second half of 2009. According to the Urology Channel, recent estimates show
that approximately 13 million men in the United States experience
testosterone deficiency.
In
November 2008, we received guidance from the FDA suggesting submission of a
new IND to the Division of Metabolic and Endocrine Products, or DMEP, for the
investigation of Androxal as a potential treatment for type 2 diabetes. We plan
to submit a new IND for this indication to the DMEP as soon as
practicable.
In
addition to the clinical trials discussed above, we are also conducting a
long-term Open Label Safety Study and animal safety study with Androxal to
support our future NDA submissions.
We were
previously developing Androxal in the United States to treat testosterone
deficiency due to secondary hypogonadism by restoring normal testosterone
production in males with functional testes and diminished pituitary function, a
common condition in the aging male. Based on a Type “C” meeting held with the
FDA on October 15, 2007 we do not believe we have a clear clinical path to
develop Androxal for this indication in the United States at this time. Although
we believe Androxal could be developed outside of the United States, due to the
limited European market for this indication and our limited internal resources
we do not intend to pursue approval outside of the United States at this
time.
2
Other
Programs
We
continue to maintain our patent portfolio of our phentolamine-based products for
the treatment of sexual dysfunction. However, no R&D investments are being
made in these programs at this time.
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 number and
complexity of clinical trials necessary to obtain regulatory approval, the
number of eligible patients necessary to complete our clinical trials and any
difficulty in enrolling these patients, and the length of time to complete our
clinical trials. Given the uncertainty of these potential costs, we recognize
that the total costs we will incur for the clinical development of our product
candidates may exceed our current estimates. We do, however, expect these costs
to increase substantially in future periods as we continue later-stage clinical
development trials. Any failure by us to obtain, or any delay in obtaining,
regulatory approvals could cause our research and development expenditures to
increase and, in turn, have a material adverse effect on our results of
operations.
Corporate
Information
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. Our website address is www.reprosrx.com. The information
contained in our website is not a part of this prospectus supplement or the
accompanying prospectus.
Registered
Direct Offering
On
October 2, 2008, we completed a direct registered offering of
2.4 million shares of our common stock at a purchase price of $6.50 per
share for aggregate proceeds after expenses of approximately $15.5 million.
Certain of the purchasers under this offering were granted in their purchase
agreements an option to purchase an aggregate of up to $10 million of
additional shares of our common stock at the greater of the fair market value,
defined as the average of the closing prices for the 30 trading days immediately
prior to the date of exercise, or $7.80 per share. Such option becomes
exercisable at such time as we have less than $10 million in cash and cash
equivalents and expires on September 29, 2009. In addition, the purchasers
who received such option also received a right of first offer to purchase their
respective pro-rata portion of any future financings, excluding certain
corporate activities, that expires on September 29, 2010.
As part
of the terms of the October 2, 2008 financing, we amended our Standstill
Agreement with Efficacy Capital Ltd. to permit Efficacy Capital to own up to 40%
of our outstanding shares of stock and to permit Efficacy Capital to designate
two directors to serve on our Board of Directors. Pursuant to that amendment,
the Board increased its number to nine and appointed Mark Lappe, a Managing
Partner of Efficacy Capital, and John C. Reed, M.D., Ph.D., President and CEO of
Burnham Institute for Medical Research, to the vacancies on the Board created by
such increase. The Company amended its Rights Agreement to reflect the increase
to 40% described above.
The
shares of common stock offered by us in the offering were registered under our
existing shelf registration statement on Form S-3 (File No. 333-137109),
which was filed with the Securities and Exchange Commission on September 5,
2006 and declared effective by the Securities and Exchange Commission on
September 15, 2006.
In
addition, the option described above also included our agreement to file a
registration statement with the Securities and Exchange Commission to register
the resale of the shares issuable upon exercise of such option and to have such
registration statement declared effective by the Securities and Exchange
Commission as soon thereafter as possible. The registration statement containing
this prospectus is being filed pursuant to this option.
3
RISK
FACTORS
Investment
in our securities involves a high degree of risk. You should consider carefully
the risk factors in any prospectus supplement and in our Annual Report on Form
10-K for the fiscal year ended December 31, 2007, updates in Part II,
Item 1A of our Form 10-Q filings, and in our future filings with the
Securities and Exchange Commission, as well as other information in this
prospectus and any prospectus supplement and the documents incorporated by
reference herein or therein, before purchasing any of our securities. Each of
the risk factors could adversely affect our business, operating results and
financial condition, as well as adversely affect the value of an investment in
our securities.
FORWARD-LOOKING
INFORMATION
Some of
the statements contained (i) in this prospectus and any accompanying
prospectus supplement or (ii) incorporated by reference into this
prospectus are forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, or the Securities Act, and
Section 21E of the Securities Exchange Act of 1934, as amended, or the
Exchange Act, and are subject to the safe harbor created by the Securities
Litigation Reform Act of 1995. Examples of these forward-looking statements
include, but are not limited to:
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our
anticipated future capital requirements and the terms of any capital
financing agreements;
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timing
and amount of future contractual payments, product revenue and operating
expenses;
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progress
and results of clinical trials;
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anticipated
regulatory filings, requirements and future clinical
trials;
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protection
of our intellectual property; and
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market
acceptance of our products and the estimated potential size of these
markets.
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While
these forward-looking statements made by us are based on our current intent,
beliefs and judgments, they are subject to risks and uncertainties that could
cause actual results to vary from the projections in the forward-looking
statements. You should consider the risks below carefully in addition to other
information contained in this report before engaging in any transaction
involving shares of our common stock. If any of these risks occur, they could
seriously harm our business, financial condition or results of operations. In
such case, the trading price of our common stock could decline, and you may lose
all or part of your investment.
The
discussion and analysis set forth in this document contains discussions of
regulatory status and other forward-looking statements. Actual results could
differ materially from those projected in the forward-looking statement as a
result of the following factors, among others:
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future
capital requirements and additional fundings through equity or debt
financings;
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uncertainty
of governmental regulatory requirements and lengthy approval
process;
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inability
to fulfill our obligations under our license with the National Institutes
of Health, or NIH, for Proellex may result in forfeiture of our rights to
Proellex;
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results
of the current Phase 2b trial for Androxal and the ongoing Phase 2 and 3
trials for Proellex;
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history
of operating losses and uncertainty of future financial
results;
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dependence
on third parties for clinical development and
manufacturing;
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dependence
on a limited number of key
employees;
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competition
and risk of competitive new
products;
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ability
to obtain and defend patents, protect trade secrets and avoid infringing
patents held by third parties;
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limitations
on third-party reimbursement for medical and pharmaceutical
products;
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acceptance
of our products by the medical
community;
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potential
for product liability issues and related
litigation;
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potential
for claims arising from the use of hazardous materials in our
business;
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continued
listing on the Nasdaq Global
Market;
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volatility
in the value of our common stock;
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volatility
in the financial markets generally;
and
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other
factors set forth under “Risk Factors” contained in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 filed with the
Securities and Exchange Commission on March 17, 2008, updates in
Part II, Item 1A of our Form 10-Q filings, and in our future
filings made with the Securities and Exchange Commission, which are
incorporated by reference in this prospectus, and any risk factors set
forth in the accompanying prospectus
supplement.
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In
addition, in this prospectus, any prospectus supplement and the documents
incorporated by reference into this prospectus, the words “believe,” “should,”
“predict,” “future,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “plan,” “expect,” “potential,” “continue,” or “opportunity,” or other
words and terms of similar meaning, as they relate to us, our business, future
financial or operating performance or our management, are intended to identify
forward-looking statements. Any forward-looking statement speaks only as of the
date on which it is made, and we undertake no obligation to update or revise any
forward-looking statement to reflect events or circumstances after the date on
which the statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to
predict which factors will arise. In addition, we cannot assess the impact of
each factor on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in
any forward-looking statements. Past financial or operating performance is not
necessarily a reliable indicator of future performance and you should not use
our historical performance to anticipate results or future period
trends.
5
USE
OF PROCEEDS
Unless
the applicable prospectus supplement states otherwise, the net proceeds we
receive from the sale of the securities offered by us under this prospectus will
be used for general corporate purposes, which may include:
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funding
clinical trials and regulatory submissions for our two lead product
candidates, Proellex and Androxal, currently in human clinical
trials;
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financing
potential acquisitions of complementary businesses, assets, technologies
and products that we may consider from time to time;
and
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general
working capital.
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Although
we currently have no plans to acquire any complementary businesses, our
management has broad discretion as to the allocation of the net proceeds
received in this offering and may use these proceeds for that purpose in the
future. Pending these uses, we may temporarily use the net proceeds to make
short-term investments.
We will
not receive any of the proceeds from the sale of the shares by the selling
stockholders.
6
SELLING
STOCKHOLDERS
On
October 2, 2008 we sold 2,400,000 shares of our common stock in a direct
registered offering to certain investors. We provided rights to certain of such
investors, the selling stockholders under this prospectus, to purchase up to an
aggregate of 1,282,052 shares of our common stock at a purchase price equal to
the fair market value at the time of exercise of such purchase right or $7.80
per share, whichever is greater. In addition to the 5,000,000 shares to be
available for future offerings, this prospectus relates to the resale from time
to time of up to a total of 1,282,052 shares of common stock by the selling
stockholders.
Pursuant
to the terms of the purchase agreements relating to such purchase option rights,
we filed a Registration Statement on Form S-3, of which this prospectus
constitutes a part, in order to permit the selling stockholders, including their
transferees who are affiliates, pledgees, assignees and successors-in-interest,
to resell to the public any or all of the shares of our common stock issuable
upon exercise of such purchase option rights, or any interests therein. When we
refer to the “selling stockholders” in this prospectus, we mean the entities
listed in the table below, as well as their transferees, pledgees or donees or
its respective successors.
The
following table, to our knowledge, sets forth information regarding the
beneficial ownership of our common stock by the selling stockholders as of
October 31, 2008 and the number of shares being offered hereby by the
selling stockholders. The information is based in part on information provided
by or on behalf of the selling stockholders. Beneficial ownership is determined
in accordance with Rule 13d-3 promulgated by the SEC under the Securities
Exchange Act of 1934, as amended, or the Exchange Act, and includes voting or
investment power with respect to shares, as well as any shares as to which the
selling stockholders have the right to acquire beneficial ownership within sixty
(60) days after October 31, 2008 through the exercise or conversion of
any stock options, warrants, convertible debt or otherwise. Unless otherwise
indicated below, the selling stockholders have sole voting and investment power
with respect to their shares of common stock. The inclusion of any shares in
this table does not constitute an admission of beneficial ownership by the
selling stockholders. We will not receive any of the proceeds from the sale of
our common stock by the selling stockholders.
The
actual number of shares of common stock that may be sold by the selling
stockholders will be determined by the selling stockholders. Because the selling
stockholders may sell all, some or none of the shares of common stock which they
hold, no estimate can be given as to the number of shares of common stock that
will be held by the selling stockholders after completion of the sales. The
information set forth in the following table regarding the beneficial ownership
after resale of shares is based on the assumption that the selling stockholders
will sell all of their shares of common stock covered by this
prospectus.
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Shares
Beneficially Owned Before Offering(1)
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Shares
Offered
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Shares
Beneficially
Owned
After Offering(1)
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Name
of Selling Stockholder
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Number
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Percent
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Hereby(2)
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Number
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Percent
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Efficacy Capital,
Ltd.(3)
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4,292,136 | 28.28 | % | 961,539 | 4,292,136 | 26.60 | % | |||||||||||||
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Cyan Opportunities
Fund, Ltd.(4)
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1,514,690 | 9.98 | % | 294,872 | 1,514,690 | 9.79 | % | |||||||||||||
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WR Multi Strategy
Master Fund, Ltd.(4)
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397,110 | 2.62 | % | 25,641 | 397,110 | 2.61 | % | |||||||||||||
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(1)
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The
percentage of shares beneficially owned prior to the offering is based on
15,174,904 shares of our common stock issued and outstanding as of
October 31, 2008 and the percentage of shares beneficially owned
after the offering is based on the same number of shares and assumes the
issuance of the shares offered by each particular selling
stockholder..
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(2)
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The
shares listed in this column reflect the shares of common stock issuable
upon exercise of the purchase rights described above. Such purchase rights
are not currently exercisable and are thus not currently beneficially
owned by the selling stockholders; therefore, the shares listed in this
column are not reflected in the columns reflecting beneficial ownership
before the offering.
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(3)
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Efficacy
Capital, Ltd., a Bermuda limited liability company, is the investment
manager for, and shares the power to vote and dispose of all of the
securities listed above with, the following entities: Efficacy Biotech
Fund, L.P., a Delaware limited partnership, Efficacy Biotech Fund Limited,
a Bermuda Exempted Mutual Fund Company and Efficacy Biotech Master Fund
Ltd., a Bermuda Exempted Mutual Fund Company. Mark Lappe and Jon Faiz
Kayyem, natural persons, have the power to vote and dispose of all of the
securities listed above as managing partners of Efficacy Capital, LTD.
Mark Lappe also serves on our board of
directors.
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(4)
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Vermillion
Asset Management LLC is the investment advisor to a managed account for
the WR Multi Strategy Master Fund, Ltd. and is the investment manager of
the Cyan Opportunities Fund,
Ltd.
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7
PLAN
OF DISTRIBUTION
We or the
selling stockholders may sell the common stock through underwriters or dealers,
through agents, or directly to one or more purchasers. One or more prospectus
supplements will describe the terms of the offering of the common stock,
including:
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the
name or names of any agents or
underwriters;
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the
purchase price of the common stock and the proceeds we will receive from
the sale;
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any
over-allotment options under which underwriters may purchase additional
shares of common stock from us;
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any
agency fees or underwriting discounts and other items constituting agents’
or underwriters’ compensation;
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any
discounts or concessions allowed or reallowed or paid to dealers;
and
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any
securities exchange or market on which the common stock may be
listed.
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Only
underwriters named in the prospectus supplement are underwriters of the common
stock offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the common stock for their
own account and may resell the common stock from time to time in one or more
transactions, including negotiated transactions, at a fixed public offering
price or at varying prices determined at the time of sale. The obligations of
the underwriters to purchase the common stock will be subject to the conditions
set forth in the applicable underwriting agreement. We may offer the common
stock to the public through underwriting syndicates represented by managing
underwriters or by underwriters without a syndicate. Subject to certain
conditions, the underwriters will be obligated to purchase all the common stock
offered by the prospectus supplement if they are to purchase any of such offered
shares. Any public offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may use
underwriters with whom we have a material relationship. We will describe in the
prospectus supplement naming the underwriter, the nature of any such
relationship.
We or the
selling stockholders may sell the common stock directly or through agents we
designate from time to time. We will name any agent involved in the offering and
sale of the common stock and we will describe any commissions we will pay the
agent in the prospectus supplement.
We or the
selling stockholders may authorize agents or underwriters to solicit offers by
certain types of institutional investors to purchase the common stock from us at
the public offering price set forth in the prospectus supplement pursuant to
delayed delivery contracts providing for payment and delivery on a specified
date in the future. We will describe the conditions to these contracts and the
commissions we must pay for solicitation of these contracts in the prospectus
supplement.
We may
provide agents and underwriters with indemnification against certain civil
liabilities, including liabilities under the Securities Act, or contribution
with respect to payments that the agents or underwriters may make with respect
to such liabilities. Agents and underwriters may engage in transactions with, or
perform services for, us in the ordinary course of business.
Any
underwriter may engage in overallotment, stabilizing transactions, short
covering transactions and penalty bids in accordance with Regulation M
under the Securities Exchange Act of 1934. Overallotment involves sales in
excess of the offering size, which create a short position. Stabilizing
transactions permit bids to purchase the underlying shares of common stock so
long as the stabilizing bids do not exceed a specified maximum price. Short
covering transactions involve exercise by underwriters of an over-allotment
option or purchases of the common stock in the open market after the
distribution is completed to cover short positions. Penalty bids permit the
underwriters to reclaim a selling concession from a dealer when the shares of
common stock originally sold by the dealer are purchased in a short covering
transaction. Those activities may cause the price of the common stock to be
higher than it would otherwise be. If commenced, the underwriters may
discontinue any of the activities at any time.
Our
common stock is quoted on the Nasdaq Global Market. One or more underwriters may
make a market in our common stock, but the underwriters will not be obligated to
do so and may discontinue market making at any time without notice. We cannot
give any assurance as to liquidity of the trading market for our common
stock.
Any
underwriters who are qualified market makers on the Nasdaq Global Market may
engage in passive market making transactions in the securities on the Nasdaq
Global Market in accordance with Rule 103 of Regulation M under the
Securities Exchange Act of 1934, during the business day prior to the pricing of
the offering, before the commencement of offers or sales of the securities.
Passive market makers must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest independent
bid for such security; if all independent bids are lowered below the passive
market maker’s bid, however, the passive market maker’s bid must then be lowered
when certain purchase limits are exceeded.
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LEGAL
MATTERS
The
validity of the securities being offered hereby will be passed upon by Winstead
PC, The Woodlands, Texas. Jeffrey R. Harder, a member of the law firm
Winstead PC, and a director of Repros, beneficially owned as of October 31,
2008, an aggregate of 13,424 shares of our common stock. Mr. Harder also
holds options to purchase 55,000 shares of our common stock.
EXPERTS
The
consolidated financial statements and management’s assessment of the
effectiveness of internal control over financial reporting (which is included in
Management’s Report on Internal Control over Financial Reporting) incorporated
in this prospectus by reference to the Annual Report on Form 10-K for the year
ended December 31, 2007 have been so incorporated in reliance on the report
(which contains an explanatory paragraph relating to the Company’s ability to
continue as a going concern as described in Note 2 to the consolidated financial
statements) of PricewaterhouseCoopers LLP, an independent registered public
accounting firm, given on the authority of said firm as experts in auditing and
accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We are a
reporting company and file annual, quarterly and current reports, proxy
statements and other information with the Securities and Exchange Commission. We
have filed with the Securities and Exchange Commission a registration statement
on Form S-3 under the Securities Act with respect to the common stock we are
offering under this prospectus. This prospectus does not contain all of the
information set forth in the registration statement and the exhibits to the
registration statement. For further information with respect to us and the
common stock we are offering under this prospectus, we refer you to the
registration statement and the exhibits filed as a part of the registration
statement. You may read and copy the registration statement, as well as our
reports, proxy statements and other information, at the Securities and Exchange
Commission’s public reference room at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can request copies of these documents by writing to
the Securities and Exchange Commission and paying a fee for the copying cost.
Please call the Securities and Exchange Commission at 1-800-SEC-0330 for more
information about the operation of the public reference room. Our Securities and
Exchange Commission filings are also available at the Securities and Exchange
Commission’s website at http://www.sec.gov.
The
Securities and Exchange Commission allows us to “incorporate by reference”
information that we file with it, which means that we can disclose important
information to you by referring you to those documents. The information
incorporated by reference is an important part of this prospectus. Information
in this prospectus supersedes information incorporated by reference that we
filed with the Securities and Exchange Commission prior to the date of this
prospectus, while information that we file later with the Securities and
Exchange Commission will automatically update and supersede this information. We
incorporate by reference into this registration statement and prospectus the
documents listed below and any future filings we will make with the Securities
and Exchange Commission under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, after the date of the initial
registration statement but prior to effectiveness of the registration statement
and after the date of this prospectus but prior to the termination of the
offering of the securities covered by this prospectus, except in each case for
information contained in any such filing where we indicate that such information
is being furnished and is not to be considered “filed” under the Securities
Exchange Act of 1934, as amended.
The
following documents filed with the Securities and Exchange Commission are
incorporated by reference in this prospectus:
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our
Annual Report on Form 10-K for the year ended December 31, 2007 filed
with the Securities and Exchange Commission on March 17,
2008;
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our
Quarterly Reports on Form 10-Q for the quarters ended March 31, 2008,
June 30, 2008 and September 30, 2008 filed with the Securities
and Exchange Commission on May 12, August 11 and
November 10, 2008,
respectively;
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our
Current Reports on Form 8-K (other than information furnished rather than
filed), filed with the Securities and Exchange Commission on
January 8, 2008, January 10, 2008, February 1, 2008,
February 11, 2008, February 12, 2008, February 22, 2008,
March 7, 2008, March 14, 2008, March 18, 2008,
March 31, 2008, April 4, 2008, May 8, 2008, May 12,
2008, May 28, 2008, May 29, 2008, June 10, 2008, June 30,
2008, July 11, 2008, July 15, 2008, July 21, 2008,
July 28, 2008, August 11, 2008, August 18, 2008,
August 21, 2008, September 29, 2008, October 2, 2008,
October 10, 2008, October 29, 2008, November 10, 2008 and
November 12, 2008; and
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the
description of our common stock contained in our registration statement on
Form 8-A filed with the Securities and Exchange Commission on
February 2, 1993, including all amendments and reports filed for the
purpose of updating such
information.
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9
Information
furnished to the Securities and Exchange Commission under Item 2.02 or
Item 7.01 in Current Reports on Form 8-K, and any exhibit relating to such
information, filed prior to, on or subsequent to the date of this prospectus is
not incorporated by reference into this prospectus.
We will
furnish without charge to you, upon written or oral request, a copy of any or
all of the documents incorporated by reference, including exhibits to these
documents. You should direct any requests for documents to Repros Therapeutics
Inc., Attention: Secretary, 2408 Timberloch Place, Suite B-7, The
Woodlands, Texas 77380. Our telephone number is
(281) 719-3400.
10
3,500,000 Shares
Common
Stock
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PROSPECTUS
SUPPLEMENT
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October
7, 2009
You
should rely only on the information contained or incorporated by reference in
this prospectus supplement. No dealer, salesperson or other person is authorized
to give information that is not contained or incorporated by reference in this
prospectus supplement. This prospectus supplement is not an offer to sell nor is
it seeking an offer to buy these securities in any jurisdiction where the offer
or sale is not permitted. The information contained in this prospectus
supplement is correct only as of the date of this prospectus supplement,
regardless of the time of the delivery of this prospectus supplement or any sale
of these securities.