e424b5
This filing is made pursuant to Rule 424(b)(5)
under the Securities Act of 1933, as amended, in connection
with Registration No. 333-137109
and Registration No. 333-153727
2,400,000 Shares
$6.50 per share
Common Stock
We are offering 2,400,000 shares of our common stock.
Our common stock is listed on the Nasdaq Global Market under the symbol RPRX. On September 26,
2008, the last reported sale price of our common stock on the Nasdaq Global Market was $6.08 per
share.
Investing in our common stock involves risks. See Risk Factors beginning on
page S-4 of this prospectus supplement.
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Per Share |
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Price to the public and
proceeds, before expenses, to Repros Therapeutics Inc. |
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6.50 |
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15,600,000 |
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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 or about October 3, 2008.
The date of this prospectus supplement (to the prospectus dated September 5, 2006) is September 29,
2008.
Table of Contents
Prospectus Supplement
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S-1 |
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S-4 |
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S-5 |
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S-7 |
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S-8 |
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S-8 |
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S-9 |
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S-10 |
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S-10 |
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S-10 |
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S-10 |
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S-10 |
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Prospectus
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Table of Contents |
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1 |
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About This Prospectus |
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About Repros Therapeutics Inc. |
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2 |
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Risk Factors |
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4 |
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Forward-Looking Information |
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Use of Proceeds |
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5 |
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Plan of Distribution |
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5 |
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Legal Matters |
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7 |
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Experts |
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7 |
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Where You Can Find More Information |
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7 |
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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 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-i
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.
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 |
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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Planned Phase 2b proof-of-concept trial to treat men with AIHH, with concomitant
plasma glucose elevations |
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 as soon as practicable in 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 the fourth quarter of 2009. 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 and then start enrollment in the second Open
Label Safety study.
The initiation of these Phase 3 clinical trials and Open Label Studies included awarding the
trials to three clinical research organizations, the process of identifying and contracting the
clinical sites to be used as well as other various activities required to complete these clinical
trials. During the second quarter of 2008 we implemented a centralized patient recruitment
advertisement campaign for our Phase 3 Proellex clinical trials and in July 2008 we have taken the
necessary steps to begin additional patient recruitment advertising for one of our 400 patient
Proellex Open Label Safety Studies.
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.
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 other human
clinical trials and animal safety studies
S-1
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 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. According to the Urology Channel,
recent estimates show that approximately 13 million men in the United States experience
testosterone deficiency.
During
the second half of 2008, pending input from the U.S. Food and Drug
Administration, or FDA, we intend to initiate a Phase 2b clinical trial in men with low
testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism, or AIHH, with concomitant
plasma glucose and lipid elevations, all of which are components of metabolic syndrome. Recent
published studies in older men show a link of low testosterone with higher incidences of insulin
resistance, diabetes and consequently mortality rates. Based on a retrospective review of our
previously completed six-month clinical trial with Androxal for the treatment of low testosterone
due to secondary hypogonadism, our findings showed that Androxal therapy resulted in a significant
reduction in mean glucose levels in men with a body mass index, or BMI, greater than 26 and glucose
levels greater than 104 md/dL, an outcome not seen in the placebo or AndroGel® arms of
this study. AndroGel® is the current leading therapy for testosterone replacement.
In addition to the clinical trials discussed above we are also conducting a long-term Open
Label Safety Study and animal safety studies with Androxal to support our future NDA submissions.
General
We continue to maintain our patent portfolio of our phentolamine-based products for the
treatment of sexual dysfunction.
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.
S-2
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The Offering |
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Common stock offered by Repros
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2,400,000 shares |
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Common stock to be outstanding after
this offering
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15,174,904 shares |
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Use of proceeds
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We intend to use the net
proceeds from this offering
for preclinical studies,
clinical trials and regulatory
submissions of our product
candidates, and for general
corporate purposes. |
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Nasdaq Global Market symbol
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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 June 30, 2008, which was 12,774,904 shares, and does not
include:
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1,663,565 shares of common stock issuable upon the exercise of outstanding options at a
weighted average exercise price of $5.02 per share; and |
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320,744 shares of common stock available for future issuance under our stock option plans. |
S-3
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, 2007, 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 the 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 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, 2008 to September 26, 2008, the
market price of our stock was as low as $5.31 per share and as high as $11.09 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. |
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.
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 12,774,904 shares of our common stock outstanding as of September 26, 2008. In
addition, as of June 30, 2008, there were options to purchase 1,663,565 shares of our common stock
issued and outstanding under all of our stock option plans at a weighted average exercise price of
$5.02, 266,326 additional shares of common stock issuable under our 2004 Stock Option Plan and
54,418 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.
S-4
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 17.8% of our common stock immediately prior to the
offering, and will own 27.2% of our common stock after this 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 more difficult a merger, tender offer or proxy contest
involving us that you may consider to be in your best interest. 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. |
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 for preclinical studies, clinical trials and
regulatory submissions of our product candidates and 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.
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 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. |
S-5
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 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-6
Use of Proceeds
We expect to receive approximately $15.5 million in net proceeds from the sale of the
2,400,000 shares of common stock offered by us in this offering based on the offering price of
$6.50 per share. Net proceeds is what we expect to receive after paying the expenses of this
offering.
We intend to use the net proceeds from this offering for preclinical studies, clinical trials and
regulatory submissions of our product candidates, and for general corporate purposes.
The timing and amount of our actual expenditures will be based on many factors, including the
timing and success of our clinical trials, whether we partner any of our internal programs and
whether we choose to curtail some of our research activities. Although we currently have no plans
to acquire any complementary businesses, we may use these proceeds for that purpose in the future.
As a result, we will retain broad discretion in determining how we will allocate the net proceeds
from this offering.
Until we use the net proceeds of this offering, we intend to invest the funds in short-term,
investment grade, interest-bearing securities.
S-7
Price Range of Common Stock
Our common stock is quoted on The Nasdaq Global Market under the symbol RPRX. The following table
shows the high and low sale prices per share of our common stock, as reported by The Nasdaq Capital
Market through August 20, 2006 and thereafter by the Nasdaq Global Market, during the periods
presented.
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Price Range |
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High |
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Low |
2006 |
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First Quarter |
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10.35 |
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$ |
4.50 |
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Second Quarter |
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14.27 |
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7.95 |
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Third Quarter |
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8.88 |
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7.26 |
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Fourth Quarter |
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13.23 |
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5.50 |
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2007 |
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First Quarter |
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$ |
14.67 |
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$ |
9.16 |
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Second Quarter |
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15.09 |
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9.51 |
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Third Quarter |
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14.38 |
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9.88 |
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Fourth Quarter |
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12.96 |
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6.99 |
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2008 |
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First Quarter |
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10.20 |
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$ |
8.11 |
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Second Quarter |
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11.09 |
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8.21 |
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Third Quarter (through September 26, 2008) |
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10.00 |
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5.31 |
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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 September 26, 2008, the last sale price of the common stock, as reported by the Nasdaq Global
Market, was $6.08 per share. On September 26, 2008, there were approximately 184 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-8
Dilution
Our unaudited net tangible book value as of June 30, 2008 was approximately $10.3 million, or
approximately $0.80 per share of common stock. Net tangible book value per share represents total
tangible assets less 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 2,400,000 shares of common stock in this offering at the
offering price of $6.50 per share and after deduction of estimated offering expenses payable by
us, our pro forma net tangible book value as of June 30, 2008 would have been approximately
$25.8 million, or
$1.69 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. |
The
following table illustrates the pro forma increase in net tangible
book value of $0.89 per
share and the dilution (the difference between the offering price per share and net tangible book
value per share) to new investors:
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Offering price per share |
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$ |
6.50 |
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Net tangible book value per share as of June 30, 2008 |
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$ |
0.80 |
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Increase per share attributable to new investors |
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0.89 |
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Pro forma net tangible book value per share as of June 30, 2008,
after giving effect to the offering |
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1.69 |
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Dilution per share to new investors |
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$ |
4.79 |
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The number of shares in the table above excludes as of June 30, 2008:
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1,663,565 shares of common stock issuable upon the exercise of outstanding options at a
weighted average exercise price of
$5.02 per share; and |
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320,744 shares of common stock available for future issuance under our stock option plans. |
S-9
Plan of Distribution
We are selling 2,400,000 shares of our common stock under this prospectus supplement directly to
certain investors at a price of $6.50 per share pursuant to separate purchase agreements. We
currently anticipate that the closing of the sale of such common shares under these agreements will
take place on or about October 3, 2008. 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.
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 and a director of Repros,
beneficially owned as of June 30, 2008, an aggregate of 11,424 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 managements assessment of the effectiveness of internal
control over financial reporting (which is included in Managements 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, 2007 have been so incorporated in reliance on the
report (which contains an explanatory paragraph relating to the Companys 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 SECs 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 SECs 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 SECs 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, 2007; |
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our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2008 and June 30, 2008; |
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our Current Reports on Form 8-K (other than information furnished rather than filed), filed
with the SEC 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 and August 21, 2008 (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 |
S-10
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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. |
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-11
PROSPECTUS
Up to 5,000,000 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.
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 August 31, 2006, the
last reported sale price of our common stock on the Nasdaq
Global Market was $8.24 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.
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, 2005, 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 September 5, 2006
Table of
Contents
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.
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.
We are a biopharmaceutical company focused on the development of
new drugs to treat hormonal and reproductive system disorders.
Our lead product candidate,
Proellextm,
is an orally available small molecule compound that we are
developing for the treatment of uterine fibroids and
endometriosis. We are developing Proellex under an exclusive,
worldwide license from the National Institutes of Health, or
NIH. Proellex is being developed to alleviate adverse symptoms
associated with both uterine fibroids and endometriosis by
selectively blocking the progesterone receptor in women. We
believe it may have advantages over the current standards of
care for the treatment of uterine fibroids and endometriosis,
which include surgery and treatment with gonadotropin releasing
hormone agonists, or GnRH agonists, such as
Lupron®.
Unlike Proellex, GnRH agonists create a low estrogen,
menopausal-like state in women, and estrogen is necessary for
the maintenance of bone mineral density. Therefore, GnRH
agonists tend to promote bone loss and cannot be used for more
than six months at a time. When women cease treatment with GnRH
agonists, fibroids rapidly regenerate and symptoms associated
with endometriosis quickly reappear. We believe Proellex may
have advantages over treatment with GnRH agonists based on
research that has been done to date, which includes data
collected from our three-month European human Phase 1b
clinical study and our
9-month
primate study, Proellex does not appear to induce a low estrogen
state and therefore should not promote bone loss, which could
make Proellex a better treatment option for patients prior to
surgery. In addition, we believe Proellex may provide an
attractive alternative to surgery because of its potential to
treat these conditions in a chronic fashion resolving the
symptoms that most commonly lead to surgical treatment.
Our second product candidate is
Androxaltm,
an orally available small molecule compound being developed for
the treatment of testosterone deficiency in men. Androxal, our
proprietary compound, is designed to restore normal testosterone
production in males with functional testes and diminished
pituitary function, a common condition in the aging male. We
believe Androxal may have advantages over current therapies
because it is being designed as an oral therapy that acts
centrally to restore normal testosterone function in the body,
rather than simply replacing diminished testosterone. The
administration of replacement testosterone has been linked to
numerous potential adverse effects, including shrinkage of the
testes. We believe that Androxal will not cause these adverse
effects to the extent that such other replacement therapies do.
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We also continue to maintain our patent portfolio on our
phentolamine-based products for the treatment of sexual
dysfunction. These products were placed on clinical hold in the
United States in 1999 after a New Drug Application was filed
with the U.S. Food and Drug Administration
(FDA) due to brown fat proliferations being
discovered in a two-year rat carcinogenicity study. The United
States is the only country where phentolamine-based products to
treat sexual dysfunction are on partial clinical hold. We
continue to explore opportunities to create value from these
assets through product out-licensing or partnering.
We were incorporated in the State of Delaware in August 1987. On
May 2, 2006, we effected a name change to our current name
from our former name, Zonagen, Inc. 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 or any
prospectus supplement.
Service marks, trademarks and trade names referred to in this
prospectus are the property of their respective owners.
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, 2005, 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 NIH
for Proellex may result in forfeiture of our rights to Proellex;
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results of the current Phase III trial for Androxal and the
ongoing Phase II 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; 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, 2005 filed with the
Securities and Exchange Commission on March 13, 2006,
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.
USE OF
PROCEEDS
Unless the applicable prospectus supplement states otherwise,
the net proceeds we receive from the sale of the securities
offered by 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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funding the development and regulatory approval of our
phentolamine-based products;
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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.
PLAN OF
DISTRIBUTION
We 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 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 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
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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 makers bid, however, the passive market
makers bid must then be lowered when certain purchase
limits are exceeded.
LEGAL
MATTERS
The validity of the securities being offered hereby will be
passed upon by Winstead Sechrest & Minick P.C.,
The Woodlands, Texas. Jeffrey R. Harder, a member of the law
firm Winstead Sechrest & Minick P.C., and a
director of Repros, beneficially owned as of August 31,
2006, an aggregate of 5,424 shares of the our Common Stock.
Mr. Harder also holds options to purchase
45,000 shares of our Common Stock.
EXPERTS
The financial statements incorporated in this Prospectus by
reference to the Annual Report on
Form 10-K
for the year ended December 31, 2005 have been so
incorporated in reliance on the report 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 Commissions 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 Commissions
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.
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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, 2005 filed with the
Securities and Exchange Commission on March 13, 2006;
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our Quarterly Reports on
Form 10-Q
for the quarters ended March 31, 2006 and June 30,
2006 filed with the Securities and Exchange Commission on
May 1 and August 3, 2006, respectively;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on
January 10, 2006;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on
February 8, 2006;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on
March 15, 2006;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on May 2,
2006;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on
May 24, 2006;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on
August 4, 2006;
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our Current Report on
Form 8-K
filed with the Securities and Exchange Commission on
August 18, 2006; 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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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.
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2,400,000 Shares
Common Stock
September 29, 2008
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.