e424b5
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-148321
PROSPECTUS SUPPLEMENT
(To the Prospectus dated January 17, 2008)
14,285,715 Shares of Common Stock
We are offering up to 14,285,715 shares of our common stock.
Our
common stock is listed on The NASDAQ Global Market under the symbol GTXI. On October 26,
2010, the last reported sale price of our common stock was $3.19 per share.
Investing in our common stock involves significant risks. See Risk Factors beginning on page
S-5 of this prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the adequacy or accuracy of this
prospectus supplement. Any representation to the contrary is a criminal offense.
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Per Share |
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Total |
Public offering price |
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$ |
2.80 |
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$ |
40,000,002 |
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Underwriting discounts and commissions |
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$ |
0.14 |
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$ |
2,000,000 |
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Proceeds, before expenses, to us |
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$ |
2.66 |
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$ |
38,000,002 |
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We estimate the total expenses of this offering, excluding the underwriting discounts and
commissions, will be approximately $375,000. The underwriter may also purchase up to an additional 2,142,857
shares of our common stock from us at the public offering price, less underwriting discounts
and commissions, to cover over-allotments, if any, within 30 days of the date of this prospectus
supplement.
We anticipate that delivery of the shares of our common stock will be made through the
facilities of the Depository Trust Company on or about November 1, 2010, subject to customary
closing conditions.
Sole Book-Running Manager
Lazard Capital Markets
Prospectus supplement dated October 27, 2010
TABLE OF CONTENTS
Prospectus Supplement
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ABOUT THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus supplement, which describes
the specific terms of the offering and also adds to and updates information contained in the
accompanying prospectus and the documents incorporated by reference into this prospectus supplement
and the accompanying prospectus. The second part, the accompanying prospectus dated January 17,
2008, including the documents incorporated by reference, provides more general information.
Generally, when we refer to this prospectus, we are referring to both parts of this document
combined. To the extent there is a conflict between the information contained in this prospectus
supplement, on the one hand, and the information contained in the accompanying prospectus or in any
document incorporated by reference that was filed with the Securities and Exchange Commission, or
SEC, before the date of this prospectus supplement, on the other hand, you should rely on the
information in this prospectus supplement. If any statement in one of these documents is
inconsistent with a statement in another document having a later date for example, a document
incorporated by reference in the accompanying prospectus the statement in the document having the
later date modifies or supersedes the earlier statement. You should read this prospectus supplement
and the accompanying prospectus, including the information incorporated by reference and any free
writing prospectus that we have authorized for use in connection with this offering, in their
entirety before making an investment decision.
You should rely only on the information contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus, along with the information contained in any
free writing prospectus that we have
S-i
authorized for use in connection with this offering. If the description of the offering varies
between this prospectus supplement and the accompanying prospectus, you should rely on the
information in this prospectus supplement. We have not authorized anyone to provide you with
different or additional information. You should assume that the information appearing in this
prospectus supplement, the accompanying prospectus, the documents incorporated by reference in this
prospectus supplement and the accompanying prospectus, and in any free writing prospectus that we
have authorized for use in connection with this offering is accurate only as of the respective
dates of those documents. Our business, financial condition, results of operations and prospects
may have changed since those dates.
S-ii
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information about us, this offering and information appearing
elsewhere in this prospectus supplement, in the accompanying prospectus and in the documents we
incorporate by reference. This summary is not complete and does not contain all of the information
that you should consider before making an investment decision. To fully understand this offering
and its consequences to you, you should read this entire prospectus supplement and the accompanying
prospectus carefully, including the factors described under the headings Risk Factors in this
prospectus supplement beginning on page S-5, together with any free writing prospectus we have
authorized for use in connection with this offering and the financial statements and other
information incorporated by reference in this prospectus supplement and the accompanying
prospectus.
About GTx, Inc.
Our Business
We are a biopharmaceutical company dedicated to the discovery, development and
commercialization of small molecules that selectively target hormone pathways for the treatment and
prevention of cancer, the treatment of side effects of anticancer therapy, cancer supportive care,
and other serious medical conditions.
We are developing GTx-758, a selective estrogen receptor, or ER, alpha agonist for the
treatment of advanced prostate cancer. As a selective ER alpha agonist, GTx-758 has the potential
to achieve medical castration by feedback inhibition of the hypothalamic- pituitary-gonadal axis.
Because of the mechanism of action of GTx-758, castration is expected
to be achieved without concomitant bone loss
or the development of hot flashes. In 2009, we evaluated GTx-758 in healthy male volunteers in two
Phase I clinical trials. In a single ascending dose study in 96 subjects, GTx-758 was well
tolerated and demonstrated a pharmacokinetic profile compatible with daily oral dosing. In a 14 day
multiple ascending dose study in 50 subjects, GTx-758 was well tolerated and demonstrated the
ability to reduce testosterone and to increase sex hormone binding globulin, or SHBG. In September
2010, we announced that in a Phase II, open label, pharmacokinetic-pharmacodynamic clinical trial
in healthy male volunteers, GTx-758 suppressed serum total testosterone to castrate levels,
increased serum SHBG, and markedly reduced serum free testosterone, the form of testosterone which
is available to prostate cancer cells for growth. Medical castration (levels of serum total
testosterone <50 ng/dL) was achieved in subjects receiving both the 1000 mg and 1500 mg
treatment. The percentage of treatment compliant subjects receiving 1500 mg of GTx-758 who achieved
medical castration was comparable to rates of castration observed with luteinizing hormone
releasing hormone treatment, which, along with surgical bilateral orchiectomy, is current standard
of care. GTx-758 was well tolerated and no serious adverse events were reported in the study. In
2011, we are planning to initiate an additional clinical trial evaluating GTx-758 for first line
treatment in men with advanced prostate cancer.
Additionally, we are developing selective androgen receptor modulators, or SARMs, a new class
of drugs with the potential to treat cancer cachexia (cancer induced muscle loss), chronic
sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and
ability to perform activities of daily living, and other musculoskeletal wasting or muscle loss
conditions. In March 2010, we reacquired full rights to our SARM program, including ostarine, our
lead SARM, following the termination by us and Merck & Co., Inc., or Merck, of our exclusive
license and collaboration agreement for SARM compounds and related
SARM products.
We are currently preparing for an End of Phase II meeting with the U.S. Food and Drug
Administration, or FDA, that we anticipate will occur later this
year, to gain concurrence from the FDA
on the proposed late stage clinical development of ostarine for the treatment of cancer cachexia
in non-small cell lung cancer patients. Following the FDAs input, we plan to continue our pursuit
of a partnership or collaboration for the development and commercialization of SARMs, which
includes ostarine for the treatment of cancer cachexia, and/or to initiate a pivotal clinical
trial in 2011.
We are also developing toremifene 80 mg, a selective estrogen receptor modulator, or SERM, for
the reduction of fractures and treatment of other estrogen deficiency side effects of androgen
deprivation therapy, or ADT, in men with prostate cancer. In September 2006, we licensed to Ipsen
Biopharm Limited, or Ipsen, exclusive rights in the European Union, Switzerland, Norway, Iceland,
Lichtenstein and the Commonwealth of Independent States, which we collectively refer to as the
European Territory, to develop and commercialize toremifene in all indications that we have
licensed from Orion Corporation, or Orion, which include all indications in humans except the
treatment
S-1
and prevention of breast cancer outside of the United States. In December 2008, we submitted a
New Drug Application, or NDA, for toremifene 80 mg to reduce fractures in men with prostate cancer
on ADT to the FDA. In October 2009, we received a Complete Response Letter from the FDA regarding
our NDA for toremifene 80 mg notifying us that the FDA would not approve our NDA in its present
form as a result of certain clinical deficiencies identified in the Complete Response Letter.
In March 2010, we amended our collaboration and license agreement with Ipsen primarily to
expand our collaboration for the development and commercialization of toremifene 80 mg to reduce
fractures in men with prostate cancer and to potentially fund a second pivotal Phase III clinical
trial of toremifene 80 mg. In exchange for Ipsens commitment, subject to specified conditions, to
fund a second Phase III clinical trial of toremifene 80 mg, we granted Ipsen certain additional
rights, including an expansion of the territory in which Ipsen has the right to develop and
commercialize toremifene beyond the European Territory to include Australia and certain countries
in North Africa, the Middle East and Asia (excluding Japan), which we collectively refer to as the
Ipsen Territory. In addition, Ipsen received the right to co-promote our toremifene 80 mg product
candidate for the ADT indication in the United States or, at Ipsens election in lieu of
co-promotion, the right to receive a double digit royalty on net sales of our toremifene 80 mg
product candidate for the ADT indication in the United States, which declines as net sales increase
beyond an established base. Additionally, Ipsen was released of the obligation to pay certain
potential milestone payments totaling 18.0 million related to the European approval of toremifene
80 mg and pricing approvals and received a reduction in the royalty payable to us on aggregate net
sales of our toremifene 80 mg product candidate for the ADT indication. Ipsen also received the
right of first negotiation, subject to certain conditions, with respect to development, marketing,
sale and distribution in the Ipsen Territory of GTx-758.
In April 2010, we submitted a proposed protocol to the FDA for a second pivotal Phase III
clinical trial evaluating toremifene 80 mg to reduce fractures in men with prostate cancer on ADT
to address in a single clinical trial the deficiencies identified by the FDA in the Complete
Response Letter, which we refer to as the planned TREAT 2 trial. Based on our discussions with the
FDA to date, we believe that we have finalized the protocol for the planned TREAT 2 trial. Under
our amended agreement with Ipsen, Ipsen agreed to pay us up to 42.0 million in clinical
development milestones related to a second pivotal Phase III clinical trial evaluating toremifene
80 mg to reduce fractures in men with prostate cancer on ADT. However, our amended agreement with
Ipsen provides that if the projected third-party costs of such second pivotal Phase III clinical
trial of toremifene 80 mg (our planned TREAT 2 trial) exceed 42.0 million by a certain amount,
then we and Ipsen agreed to discuss whether to initiate such trial or to renegotiate the terms of
the collaboration. The projected third-party costs of the planned TREAT 2 trial exceed the
threshold in excess of 42.0 million established under our amended agreement with Ipsen, and Ipsen
has not agreed to the initiation and funding of the planned TREAT 2 trial. We and Ipsen are in
discussions with respect to whether to commence the planned TREAT 2 trial and, if so, the
renegotiation of the terms of our collaboration, including in particular each partys respective
funding commitments related to the planned TREAT 2 trial.
Although we continue to be engaged in discussions intended to resolve the matter, we cannot predict
the outcome, including whether we will be able to initiate the planned TREAT 2 trial or, if it is
initiated, what our respective funding commitments for the planned TREAT 2 trial would be. If we
and Ipsen are able to renegotiate the terms of our collaboration and we and Ipsen agree to initiate
the planned TREAT 2 trial as proposed, we expect to initiate the planned TREAT 2 trial in the first
quarter of 2011.
In May 2010, we announced that toremifene 20 mg failed to meet the primary efficacy endpoint
in a completed Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate
cancer in high risk men with high grade prostatic intraepithelial neoplasia, or high grade PIN. We
are reviewing all of the data from the Phase III clinical trial to better understand the trial
results and the ability of toremifene 20 mg to reduce cancer among high risk men, but we do not
currently expect to conduct additional clinical trials evaluating toremifene 20 mg for the
prevention of prostate cancer in high risk men with high grade PIN or to submit a NDA to the FDA
for this indication.
We
market FARESTON® (toremifene citrate) 60 mg tablets, approved
for the treatment of advanced
metastatic breast cancer in postmenopausal women in the United States. The active pharmaceutical
ingredient in FARESTON® is the same as in our toremifene 80 mg product candidate. In January 2005,
we acquired from Orion the right to market
S-2
FARESTON® tablets in the United States for the metastatic breast cancer
indication. We also acquired from Orion a license to toremifene for all indications in humans
worldwide, except breast cancer outside of the United States.
Recent Financial Results
While we have not finalized our full financial results for the three and nine months ended
September 30, 2010, we expect to report that we had $19.7 million of cash, cash equivalents and
short-term investments as of September 30, 2010, which does not include the final $5.0 million
research and development expense reimbursement payment from Merck that we will receive later this
year, and we also expect to report that our total costs and expenses were $9.9 million and $36.1
million for the three and nine months ended September 30, 2010, respectively.
Corporate Information
We were originally incorporated under the name Genotherapeutics, Inc. in Tennessee in
September 1997. We changed our name to GTx, Inc. in 2001, and we reincorporated in Delaware in
2003. Our principal executive office is located at 175 Toyota Plaza, Suite 700, Memphis, Tennessee,
and our telephone number is (901) 523-9700. Our website address is www.gtxinc.com. The information
contained in, or that can be accessed through, our website is not part of, and is not incorporated
into, this prospectus supplement or the accompanying prospectus and should not be considered a part
of this prospectus supplement or the accompanying prospectus.
Unless the context requires otherwise, references in this prospectus supplement and the
accompanying prospectus to GTx, the company, we, us and our refer to GTx, Inc. Service
marks, trademarks and trade names included or incorporated by reference in this prospectus
supplement or the accompanying prospectus are the property of their respective owners.
S-3
The Offering
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Common stock offered by us pursuant to
this prospectus supplement
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14,285,715 shares |
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Common stock to be outstanding
immediately after the offering
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50,706,616 shares |
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Use of proceeds
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We currently intend to use the
net proceeds from this offering
for clinical development and
other research and development
activities and for working
capital and general corporate
purposes. See Use of Proceeds
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NASDAQ Global Market symbol
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GTXI |
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Risk Factors
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Investing in our common stock
involves significant risks. See
Risk Factors beginning on page
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J.R. Hyde, III, the chairman of our board of directors and the beneficial owner of
approximately 33.2% of our common stock as of June 30, 2010, has agreed to purchase, directly or through his affiliates, 5,467,857 shares of common stock
in this offering at the price offered to the public.
The number of shares of common stock to be outstanding immediately after this offering as
shown above is based on 36,420,901 shares of common stock outstanding as of June 30, 2010. This
number excludes, as of June 30, 2010:
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4,536,539 shares of our common stock issuable upon the exercise of options outstanding,
having a weighted-average exercise price of $10.89 per share; |
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89,367 shares of our common stock credited to individual non-employee director stock
accounts under our Directors Deferred Compensation Plan; and |
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an aggregate of 8,283,075 shares of our common stock reserved for future issuance under
our stock option and equity incentive plans. |
Unless otherwise indicated, this prospectus supplement reflects and assumes no exercise by the
underwriter of its over-allotment option.
S-4
RISK FACTORS
Our business is subject to various risks, including those described below. You should consider
carefully the following risks, together with all of the other information included in this
prospectus supplement, the accompanying prospectus, the documents incorporated by reference in this
prospectus supplement and the accompanying prospectus, and any free writing prospectus that we have
authorized for use in connection with this offering, before making an investment decision. If any
of these risks actually occurs, our business, financial condition, results of operations and future
prospects would likely be materially and adversely affected. In these circumstances, the market
price of our common stock would likely decline, and you may lose all or part of your investment.
Risks Related to Our Financial Condition and Need for Additional Financing
We have incurred losses since inception, and we anticipate that we will incur continued losses
for the foreseeable future.
We have a limited operating history. As of June 30, 2010, we had an accumulated deficit of
$336.8 million. We have incurred losses in each year since our inception in 1997, including net
losses of $46.3 million and $51.8 million in 2009 and 2008, respectively. Due to the termination
of our collaboration with Merck & Co., Inc., or Merck, and the associated recognition in the first
quarter of 2010 of $49.9 million in deferred revenue and the final payment to be received from
Merck later in 2010 of $5.0 million of cost reimbursement for research and development activities,
we expect to report net income for the year ending December 31, 2010. However, while recognition of
this revenue is expected to result in net income for 2010, we expect to incur significant operating
losses in 2011 and for the foreseeable future. These losses have had and will continue to have an
adverse effect on our stockholders equity and working capital.
In October 2009, we received a Complete Response Letter from the U.S. Food and Drug
Administration, or FDA, regarding our New Drug Application, or NDA, for toremifene 80 mg to reduce
fractures in men with prostate cancer on ADT notifying us that the FDA would not approve our NDA in
its present form as a result of certain clinical deficiencies identified in the Complete Response
Letter. As a result, FDA approval of toremifene 80 mg, if it occurs, will be substantially delayed.
In addition, significant additional clinical development will be required in order to potentially
obtain FDA approval of toremifene 80 mg, including a second pivotal Phase III clinical trial of
toremifene 80 mg. We recently expanded our collaboration with Ipsen Biopharm Limited, or Ipsen,
pursuant to which Ipsen committed, subject to certain conditions, up to 42.0 million to fund a
second pivotal Phase III clinical trial of toremifene 80 mg. However, our amended agreement with
Ipsen provides that if the projected third-party costs of such second pivotal Phase III clinical
trial of toremifene 80 mg exceed 42.0 million by a certain amount, then we and Ipsen agreed to
discuss whether to initiate such trial or to renegotiate the terms of the collaboration. We believe
that we have finalized the protocol for a second pivotal Phase III clinical trial evaluating
toremifene 80 mg to reduce fractures in men with prostate cancer on ADT to address in a single
clinical trial the deficiencies identified by the FDA in the Complete Response Letter, which we
refer to as the planned TREAT 2 trial. The projected third-party costs of the planned TREAT 2 trial
exceed the threshold in excess of 42.0 million established under our agreement with Ipsen, and
Ipsen has not agreed to the initiation and funding of the planned TREAT 2 trial.
We and Ipsen are in discussions with respect to whether to commence the planned TREAT 2 trial and,
if so, the renegotiation of the terms of our collaboration, including in particular each partys
respective funding commitments related to the planned TREAT 2 trial. Although we continue to be
engaged in discussions intended to resolve the matter, we cannot predict the outcome, including
whether we will be able to initiate the planned TREAT 2 trial or, if it is initiated, what our
respective funding commitments for the planned TREAT 2 trial would be. If we and Ipsen determine
to initiate the planned TREAT 2 trial as proposed, the portion of the costs of such trial that we
would be required to fund could be substantial. Each of our other product candidates are in earlier-stage clinical development, and
significant additional clinical development and financial resources will be required to obtain
necessary regulatory approvals for our other product candidates, including ostarine and GTx-758,
and to develop them into commercially viable products. Accordingly, we do not expect to obtain FDA
or any other regulatory approvals to market any of our product candidates in the near future, if at
all.
S-5
Because of the numerous risks and uncertainties associated with developing and commercializing
small molecule drugs, we are unable to predict the extent of any future losses or when we will
become profitable, if at all. We have financed our operations and internal growth primarily
through public offerings and private placement of our common stock, as well as payments from our
current and former collaborators, including Merck and Ipsen. In March 2010, we and Merck agreed to
terminate our collaboration and, as a result, we will not receive any milestone payments or
royalties for the development or sale of selective androgen receptor modulators, or SARMs, from
Merck, although Merck remains obligated to make a final payment to us this year of $5.0 million
for the reimbursement of SARM research and development costs. FARESTON® is currently our only
commercial product and, until such time that we receive regulatory approval to market any of our
product candidates, if ever, we expect that FARESTON® will account for all of our product revenue.
For the six months ended June 30, 2010, we recognized $1.4 million in net revenues from the sale of
FARESTON®. If we, Ipsen, and/or any potential future collaborators are unable to develop and
commercialize any of our product candidates, if development is further delayed or eliminated, or if
sales revenue from any product candidate that receives marketing approval is insufficient, we may
never become profitable and we will not be successful.
We will need to raise substantial additional funding and may be unable to raise capital when
needed, which would force us to further delay, reduce or eliminate our product development programs
or commercialization efforts.
We will need to raise substantial additional capital to:
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continue our research and development; and |
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commercialize our product candidates, if any such product candidates receive regulatory
approval for commercial sale. |
We estimate that our current cash and cash equivalent balances, short-term investments,
interest income, product revenue from the sale of FARESTON®, and the final payment from Merck of
$5.0 million of cost reimbursement, together with the anticipated net proceeds from this offering,
will be sufficient to meet our projected operating requirements through the first quarter of 2012.
We have based this estimate on our current business plan and assumptions that may prove to be
wrong, and we could utilize our available capital resources sooner than we currently expect. In
addition, we will need to raise substantial additional capital prior to that time to fully finance
our currently-planned clinical trials that we anticipate will be ongoing at that time. Our future
funding requirements will depend on many factors, including:
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matters related to our collaborative arrangement with Ipsen, including a determination
as to whether we and Ipsen determine to conduct the planned TREAT 2 trial and, if so, the
costs that we will be required to bear with respect to the trial and any other continued
development, which costs are expected to be substantial; |
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the scope, rate of progress and cost of our, Ipsens and/or any potential future
collaborators clinical trials and other research and development activities; |
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future clinical trial results; |
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the terms and timing of any potential future collaborative, licensing and other
arrangements that we may establish; |
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the cost and timing of regulatory filings and/or approvals to commercialize our product
candidates and any related restrictions, limitations, and/or warnings in the label of an
approved product candidate; |
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potential future licensing fees, milestone payments and royalty payments, including the
amount and timing of any milestone payments that we may receive under our collaborative
arrangement with Ipsen, particularly with respect to any development milestone payments
for our planned TREAT 2 trial, if the trial is initiated; |
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the cost and timing of establishing medical education, sales, marketing and
distribution capabilities; |
S-6
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the cost of establishing clinical and commercial supplies of our product candidates and
any products that we, Ipsen, and/or any potential future collaborators may develop; |
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the effect of competing technological and market developments; |
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the cost of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights, and the cost of defending any other litigation claims; and |
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the extent to which we acquire or invest in businesses, products and technologies,
although we currently have no commitments or agreements relating to any of these types of
transactions. |
Until we can generate a sufficient amount of product revenue, which we may never do, we expect
to finance future cash needs through public or private equity offerings, debt financings or
collaboration and licensing arrangements, or a combination of the above, as well as through
interest income earned on the investment of our cash balances and short-term investments, and
revenues from the sale of FARESTON®. With the exception of payments that we may receive under our
collaboration with Ipsen, we do not currently have any commitments for future external funding. In
December 2009, we announced a reduction of approximately 26% of our workforce in order to reduce
our operating expenses in connection with the receipt of the Complete Response Letter regarding our
NDA for toremifene 80 mg and the associated delay in the potential regulatory approval of
toremifene 80 mg. If we are unable to raise additional funds when we need them, we may need to
further reduce our expenditures, perhaps significantly, to preserve our cash. The cost-cutting
measures that we may take in the future may not be sufficient to enable us to meet our cash
requirements, and they may negatively affect our business and growth prospects.
To the extent we raise additional funds by issuing equity securities, our stockholders may
experience dilution, and debt financing, if available, may involve restrictive covenants. Any debt
financing or additional equity that we raise may contain terms that are not favorable to us or our
stockholders. To the extent we raise additional funds through collaboration and licensing
arrangements, such as our arrangement with Ipsen, it may be necessary to relinquish rights to some
of our technologies or product candidates, or grant licenses on terms that are not favorable to us.
Our ability to raise additional funds and the terms upon which we are able to raise such funds may
be adversely impacted by the uncertainty regarding our ability to gain FDA approval of toremifene
80 mg, the uncertainty regarding our ability to fully finance our currently-planned clinical
trials, and/or current economic conditions, including the effects of the disruptions to and
continuing volatility in the credit and financial markets in the United States and worldwide. As a
result of these and other factors, we cannot be certain that additional funding will be available
on acceptable terms, or at all. If adequate funds are not available when we need them, we may be
required to further delay, reduce the scope of or eliminate one or more of our research or
development programs, including our SARM and toremifene programs, conduct additional workforce or
other expense reductions, or obtain funds through collaborations with others that are on
unfavorable terms or that require us to relinquish rights to some of our technologies or product
candidates that we would otherwise seek to develop on our own.
Risks Related to Development of Product Candidates
We will not be able to commercialize our product candidates if our preclinical studies do not
produce successful results or if our or our collaborators clinical trials do not demonstrate
safety and efficacy in humans.
Preclinical and clinical testing is expensive, can take many years and has an uncertain
outcome. Success in preclinical testing and early clinical trials does not ensure that later
clinical trials will be successful, and interim results of a clinical trial do not necessarily
predict final results. Typically, the failure rate for development candidates is high.
Significant delays in clinical testing could materially impact our product development costs. We do
not know whether planned clinical trials will begin on time, will need to be restructured or will
be completed on schedule, if at all.
In clinical studies, the efficacy and/or safety results from the trial may be insufficient to
support the submission or approval of a NDA with the FDA. For example, we received a Complete
Response Letter in October 2009 from the FDA regarding our NDA for toremifene 80 mg to reduce
fractures in men with prostate cancer on ADT, notifying us that the FDA would not approve our NDA
in its present form as a result of certain clinical deficiencies identified in the Complete
Response Letter, which deficiencies may only be addressed by conducting an additional pivotal Phase
III clinical trial of toremifene 80 mg. In addition, in May 2010, we announced that toremifene 20
mg
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failed to meet its primary efficacy endpoint in our Phase III clinical trial of toremifene 20
mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial
neoplasia, or high grade PIN. As a result, we do not currently expect to conduct any additional
clinical development of toremifene 20 mg for the high grade PIN indication or to submit a NDA to
the FDA for this indication.
We, Ipsen, or any potential future collaborators may experience numerous unforeseen events
during, or as a result of, preclinical testing and the clinical trial process that could delay or
prevent our or our collaborators ability to commercialize our product candidates, including:
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regulators or institutional review boards may not authorize us, Ipsen, or any potential
future collaborators to commence a clinical trial or conduct a clinical trial at a
prospective trial site; |
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preclinical or clinical trials may produce negative or inconclusive results, which may
require us, Ipsen, or any potential future collaborators to conduct additional preclinical
or clinical testing or to abandon projects that we expect to be promising; |
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registration or enrollment in clinical trials may be slower than we currently
anticipate, resulting in significant delays; |
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we, Ipsen, or any potential future collaborators may suspend or terminate clinical
trials if the participating patients are being exposed to unacceptable health risks; |
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regulators or institutional review boards may suspend or terminate clinical research
for various reasons, including noncompliance with regulatory requirements; and |
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our product candidates may not have the desired effects or may include undesirable side
effects. |
If any of these events were to occur and, as a result, we, Ipsen, or any potential future
collaborators have significant delays in or termination of clinical trials, our costs could
increase and our ability to generate revenue could be impaired, which would adversely impact our
financial results.
If we, Ipsen, or any potential future collaborators observe serious or other adverse events
during the time our product candidates are in development or after our products are approved and on
the market, we, Ipsen, or any potential future collaborators may be required to perform lengthy
additional clinical trials, may be denied regulatory approval of such products, may be forced to
change the labeling of such products or may be required to withdraw any such products from the
market, any of which would hinder or preclude our ability to generate revenues.
Although the results from our completed Phase III clinical trial for toremifene 80 mg to
reduce fractures and treat other estrogen deficiency side effects of ADT in men with prostate
cancer showed that the drug was well tolerated and had a generally favorable safety profile, more
subjects experienced a venous thromboembolic event, or VTE, such as a deep vein thrombosis,
pulmonary embolism or heart attack, in the toremifene 80 mg treatment group, 17 (2.6%) compared to
7 (1.1%) in the placebo group. Even though the majority of VTEs recorded in the clinical trial
occurred in men who were at high risk for a VTE (including: age greater than 80 years, history of
VTEs, recent surgical procedure or immobilization) and data from the clinical trial showed that the
number of men without any of these independent risk factors for VTEs in whom a VTE occurred during
the clinical trial was 5 in the toremifene 80 mg treatment group versus 3 in the placebo group, the
FDA will consider the overall safety profile from our clinical trials when making its determination
whether to grant marketing approval and to require potential warnings in the label, if approval is
granted.
We have conducted a number of studies of toremifene in addition to our clinical trials,
including a Thorough QT study (toremifene 80 mg and toremifene 20 mg), a bioequivalence study
(toremifene 80 mg), a series of drug-drug interaction studies (toremifene 80 mg and toremifene 20
mg), and a semen quality study (toremifene 20 mg) to assess the effect of toremifene. The results
of the Thorough QT study of 250 healthy male volunteers, with 5 parallel cohorts receiving 20 mg,
80 mg or 300 mg doses of toremifene, moxifloxacin, or placebo, showed that toremifene prolonged the
QT interval in a dose dependent manner. The mean change in QTcB (a measurement of QT interval
corrected by Bazetts formula) from baseline relative to placebo for toremifene 20 mg was 5.79
milliseconds, for toremifene 80 mg, it was 22.43 milliseconds, and for moxifloxacin, it was 8.83
milliseconds. Since we market
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FARESTON® in the United States under a license agreement with Orion Corporation, or Orion, we
notified the FDA of the Thorough QT study results and have proposed modifications to the FARESTON®
label in the United States. FDA action on the proposed label changes is pending. Separately, Orion
recommended label changes to the European Medicines Agency, or EMEA. In January 2009, the EMEA
recommended that the FARESTON® label within the European Union reflect that toremifene should not
be given to patients at risk of prolonged QT intervals or other certain heart problems. The
results of these completed studies were included as a part of the NDA submission to the FDA for our
toremifene 80 mg product candidate to reduce fractures in men with prostate cancer on ADT and will
be included as part of any future NDA submission for our toremifene 80 mg product candidate we make
to the FDA if we and Ipsen determine to conduct the planned TREAT 2 trial and the results of such
trial are positive. In addition, the results of these completed studies will be used to update the
label for FARESTON®. The study results could lead to the inclusion of restrictions, limitations
and/or warnings in the label of FARESTON® or an approved toremifene 80 mg product candidate, which
may adversely affect the marketability of the product or limit the patients to whom the product is
prescribed.
In addition, in our Phase II clinical trial for ostarine for the treatment of cancer cachexia
(cancer induced muscle loss), we observed mild elevations of hepatic enzymes in a few patients, and
in our preclinical studies for ostarine, only at the highest doses, we observed expected selective
effects on the reproductive and other target organs in the male population consistent with the
stimulating and inhibiting effects on the androgen receptor which is located in these organs.
If the incidence of the events described above increases in number or severity, if a
regulatory authority believes that these or other events constitute an adverse effect caused by the
drug, or if other effects are identified during clinical trials that we, Ipsen, or any potential
future collaborators may conduct in the future or after any of our product candidates are approved
and marketed:
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we, Ipsen, or any potential future collaborators may be required to conduct additional
preclinical or clinical trials, make changes in labeling of any such approved products,
reformulate any such products, or implement changes to or obtain new approvals of our
contractors manufacturing facilities; |
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regulatory authorities may be unwilling to approve our product candidates or may
withdraw approval of our products; |
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we may experience a significant drop in the sales of the affected products; |
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our reputation in the marketplace may suffer; and |
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we may become the target of lawsuits, including class action suits. |
Any of these events could prevent approval or harm sales of the affected product candidates or
products, or could substantially increase the costs and expenses of commercializing and marketing
any such products.
Risks Related to Our Dependence on Third Parties
We are dependent upon our collaborative arrangement with Ipsen to further develop and
commercialize toremifene in Ipsens licensed territories. We may also be dependent upon additional
collaborative arrangements to complete the development and commercialization of some of our other
product candidates. These collaborative arrangements may place the development and
commercialization of our product candidates outside our control, may require us to relinquish
important rights or may otherwise be on terms unfavorable to us.
In September 2006, we entered into a collaboration agreement with Ipsen for the development
and commercialization of toremifene, which collaboration was amended in March 2010 to, among other
things, expand Ipsens licensed territory for the development and commercializing of toremifene
product candidates. Pursuant to the collaboration agreement, as recently amended, Ipsen committed
up to 42.0 million to fund a second pivotal Phase III clinical trial of toremifene 80 mg in
exchange for certain additional rights we granted to Ipsen, including an expansion of its licensed
territory, as well as a reduction in or, in some cases, an elimination of Ipsens potential future
milestone and royalty obligations to us under our original agreement with Ipsen. However, our
amended agreement with Ipsen provides that if the projected third-party costs of such second
pivotal Phase III clinical trial of
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toremifene 80 mg (our planned TREAT 2 trial) exceed 42.0 million by a certain amount, then we
and Ipsen agreed to discuss whether to initiate such trial or to renegotiate the terms of the
collaboration. If we do not to initiate the trial, Ipsen would not be obligated to provide any
additional funding for the development of toremifene 80 mg. The projected third-party costs of the
planned TREAT 2 trial exceed the threshold in excess of 42.0 million established under our
agreement with Ipsen, and Ipsen has not agreed to the initiation and funding of the planned TREAT 2
trial. We and Ipsen are in discussions with respect to whether to commence the planned TREAT 2
trial and, if so, the renegotiation of the terms of our collaboration, including in particular each
partys respective funding commitments related to the planned TREAT 2 trial.
Although we continue to be engaged in discussions intended to resolve the matter, we cannot predict
the outcome, including whether we will be able to initiate the planned TREAT 2 trial or, if it is
initiated, what our respective funding commitments for the planned TREAT 2 trial would be.
In the event we are unable to satisfactorily renegotiate the terms
of our agreement with Ipsen, we or Ipsen may determine not to initiate the planned TREAT 2 trial,
and Ipsen could elect to terminate our collaboration. The loss of Ipsen as a collaborator in the
development or commercialization of toremifene, any disputes over the terms of our collaboration
with Ipsen, or any other adverse developments in our relationship with Ipsen, including our
inability to satisfactorily renegotiate the terms of our collaboration, could materially harm our
business and would substantially increase our need for additional capital. For example, if we were
to lose Ipsen as a collaborator, we may not be able to obtain sufficient additional funding to
complete the development of toremifene 80 mg. In addition, Ipsen is obligated to initiate and
conduct appropriate clinical studies as required by the appropriate regulatory authorities in order
to obtain marketing approvals of toremifene in its licensed territory. Any failure on the part of
Ipsen to initiate these studies could delay the commercialization of toremifene in its licensed
territory. In addition, the receipt of the Complete Response Letter from the FDA in October 2009
has delayed Ipsens plans to seek marketing approval of toremifene 80 mg in its licensed territory.
Moreover, if we and Ipsen (or either of us individually) determines that clinical development of
toremifene 80 mg should be further delayed or discontinued, our potential future milestone payments
and potential future revenues from the commercialization of toremifene 80 mg would be reduced or
eliminated. In addition, we do not currently expect to conduct additional clinical development of
toremifene 20 mg for the high grade PIN indication, and we therefore do not currently expect to
receive any milestone payments or royalty payments from Ipsen associated with our toremifene 20 mg
product candidate.
We may not be successful in entering into additional collaborative arrangements with other
third parties, including as a result of any collaboration discussions we chose to pursue for
ostarine and GTx-758, and even if we do enter into collaborative arrangements with other parties,
such arrangements may not be successful. If we fail to enter into additional collaborative
arrangements on favorable terms, it could delay or impair our ability to develop and commercialize
our other product candidates and could increase our costs of development and commercialization.
Dependence on collaborative arrangements, including our collaborative arrangement with Ipsen
for the development and commercialization of toremifene subjects us to a number of risks,
including:
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we are not able to control either the amount and timing of resources that Ipsen devotes
to toremifene; |
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we may not be able to control the amount and timing of resources that our potential
future collaborators may devote to our other product candidates; |
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Ipsen or any potential future collaborations may experience financial difficulties or
changes in business focus; |
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we may be required to relinquish important rights such as marketing and distribution
rights; |
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under certain circumstances, Ipsen may not be required to commercialize toremifene in
its licensed territory if Ipsen determines that it is not commercially reasonable for it
to do so; |
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pricing reimbursement constraints in Europe, which is part of Ipsens licensed
territory, may diminish the prospects of our receiving royalty payments from Ipsen on
aggregate net sales of toremifene if approved for commercial sale in some or all of the
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should a collaborator fail to develop or commercialize one of our compounds or product
candidates, we may not receive any future milestone payments and will not receive any
royalties for the compound or product candidate; |
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business combinations or significant changes in a collaborators business strategy may
also adversely affect a collaborators willingness or ability to complete its obligations
under any arrangement; |
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under certain circumstances, a collaborator could move forward with a competing product
candidate developed either independently or in collaboration with others, including our
competitors; and |
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collaborative arrangements are often terminated or allowed to expire, such as our former
collaboration with Merck, which would delay the development and may increase the cost of
developing our product candidates. |
We may not realize the anticipated benefits from our collaborative arrangement with Ipsen,
and may not receive the anticipated benefits from any future collaboration arrangements that we
might establish.
We may never receive any of the clinical development milestone payments for our planned TREAT
2 trial provided for under our collaboration agreement with Ipsen if our negotiations with Ipsen
are not successful and we determine not to initiate the planned TREAT 2 trial or Ipsen otherwise
determines to terminate our collaboration. In addition, we do not currently expect to conduct
additional clinical development of toremifene 20 mg for the high grade PIN indication, and we
therefore do not currently expect to receive any milestone payments or royalty payments from Ipsen
associated with our toremifene 20 mg product candidate. Even if required regulatory approvals to
market toremifene are obtained, it is possible that Ipsen will not successfully market and sell any
toremifene products in which case we would not receive royalties to the extent that we currently
anticipate. Furthermore, our royalty rates under our collaboration and license agreement with
Ipsen are subject to a possible reduction if a generic version of toremifene achieves specified
sales levels in a major country within its licensed territory. Ipsen also may be entitled to
offset a portion of any royalties due to us if Ipsen licenses patent rights from a third party that
would otherwise be infringed by Ipsens use, manufacture, sale or import of toremifene compounds.
Moreover, we have agreed to grant Ipsen co-promotion rights in the United States with respect to
toremifene 80 mg for the ADT indication, which may, if toremifene 80 mg receives regulatory
approval and is commercialized, reduce the amount of product revenue that we would have otherwise
received had we commercialized toremifene 80 mg in the United States solely ourselves.
Under our agreement with Ipsen, we and Ipsen have agreed that neither party will seek to
commercialize, promote, market or sell certain products within its licensed territory for an
agreed period of time subsequent to the time of the first commercial launch of toremifene within
its licensed territory. We and Ipsen have also agreed to grant to the other a right of first
negotiation with respect to the development, marketing, sale and distribution of any new
SERM-based products for the field of the prevention and treatment of prostate cancer or related
side effects, or any other indication the parties agree on. We have also agreed to grant to Ipsen
a right of first negotiation, subject to certain conditions, with respect to the development,
marketing, sale and distribution of GTx-758 in Ipsens licensed territory. However, there can be
no assurance that we will be able to reach an agreement with Ipsen on reasonable terms, or at all,
for any new SERM-based products or GTx-758, as applicable.
Ipsen may terminate our collaboration agreement for our uncured breach, upon our bankruptcy,
with 12 months prior written notice for any reason and with 30 days prior written notice as a
result of legitimate and documented safety concerns, or in the event that either the UTRF license
for chemoprevention of prostate cancer or our license and supply agreement with Orion terminates
early. If our agreement with Ipsen is terminated, the anticipated future benefits to us from this
agreement would be eliminated and the development and commercialization of toremifene, including in
Ipsens licensed territory, would be delayed and could be abandoned. In any such or similar
events, we may not realize the anticipated benefits from our collaborative arrangement with Ipsen.
Besides Ipsen, we have in the past established and intend to continue to establish
collaborations with third parties to develop and commercialize some of our current and future
product candidates, and these collaborations may not be successful or we may otherwise not realize
the anticipated benefits from these collaborations. For example, in March 2010, following Mercks
determination to discontinue internal development of ostarine, we and Merck mutually agreed to
terminate our collaboration and, as a result, we will not receive any milestone
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payments or royalties for the development or sale of SARMs from Merck. In the future, we may
not be able to locate third-party collaborators to develop and market our product candidates, and
we may lack the capital and resources necessary to develop our product candidates alone.
If third parties do not manufacture our product candidates in sufficient quantities, in the
required timeframe, and at an acceptable cost, clinical development and commercialization of our
product candidates would be delayed.
We do not currently own or operate manufacturing facilities, and we rely, and expect to
continue to rely, on third parties for the production of clinical and commercial quantities of our
product candidates. Our current and anticipated future dependence upon others for the manufacture
of our product candidates may adversely affect our future profit margins, if any, and our ability
to develop product candidates and commercialize any product candidates on a timely and competitive
basis.
We have agreed to purchase from Orion our worldwide requirements of toremifene in a finished
tablet form at specified prices under a license and supply agreement. Similarly, Ipsen has agreed
to purchase from Orion toremifene tablets for clinical testing and commercial sale in its licensed
territory under an amended supply agreement with Orion. As such, both we and Ipsen rely on Orion
as the single source supplier of toremifene.
Orion may terminate its supply obligations at its election at any time as a result of our
failure to obtain regulatory approval of one of our toremifene product candidates in the United
States prior to December 31, 2009, although we have received no indication from Orion to date that
it intends to do so. If Orion elects to terminate its obligation to manufacture and supply us and
Ipsen with toremifene, any arrangements we make for an alternative supply would have to be made
with a qualified alternative supplier with appropriate FDA approval in order for us to obtain our
supply requirements for toremifene. In addition, although Orions composition of matter patents
have expired, and as such, neither we nor Ipsen would be prevented from manufacturing toremifene
within the United States or European Territory, there is no obligation on the part of Orion to
transfer its manufacturing technology to us or Ipsen or to assist us or Ipsen in developing
manufacturing capabilities to meet our respective supply needs. We and Ipsen have mutually agreed
to cooperate in the manufacture of toremifene in the event that Orion elects to terminate its
obligation to manufacture and supply us and Ipsen with toremifene. Although we and Ipsen have
agreed to cooperate with each other in the event either of our supply rights are terminated by
Orion for any reason, a disruption in the supply of toremifene could delay the development of and
impair our and Ipsens ability to commercialize toremifene. In addition, in the event of such a
termination by Orion, Ipsen could elect to exercise its right to terminate our collaboration
agreement on limited notice to us.
We also rely on Orion to cooperate with us in the filing and maintenance of regulatory filings
with respect to the manufacture of toremifene, and Orion may terminate its obligation to assist us
in obtaining and maintaining regulatory approval of toremifene at its election at any time. If
Orion terminates its obligation to cooperate in these activities, or does not cooperate with us or
otherwise does not successfully file or maintain these regulatory filings, we would be required to
make arrangements with a qualified alternative supplier, which could further delay or prevent
regulatory approval of toremifene.
Historically, we have relied on third party vendors for the manufacture of ostarine drug
substance. However, Merck assumed primary manufacturing responsibilities for ostarine under our
exclusive license and collaboration agreement with Merck, which agreement was terminated in March
2010. In connection with the termination of the agreement with Merck, Merck agreed to return to us
all remaining inventory of ostarine drug substance. If this supply of ostarine becomes unusable
or if the contract manufacturers that we are currently utilizing to meet our supply needs for
ostarine or our other SARM product candidates prove incapable or unwilling to continue to meet our
supply needs, we could experience a further delay in conducting any additional clinical trials of
ostarine or other SARM product candidates. In addition, we rely on third party contractors for
the manufacture of GTx-758 drug substance. We may not be able to maintain or renew our existing or
any other third-party manufacturing arrangements on acceptable terms, if at all. If we are unable
to continue our relationship with Orion for toremifene, or to do so at an acceptable cost, or other
suppliers fail to meet our requirements for GTx-758, or ostarine or our other SARM product
candidates for any reason, we would be required to obtain alternate suppliers. Any inability to
obtain alternate suppliers, including an inability to obtain approval from the FDA of an alternate
supplier, would delay or prevent the clinical development and commercialization of these product
candidates.
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Use of third-party manufacturers may increase the risk that we will not have adequate supplies
of our product candidates.
Reliance on third-party manufacturers entails risks, to which we would not be subject if we
manufactured product candidates or products ourselves, including:
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reliance on the third party for regulatory compliance and quality assurance; |
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the possible breach of the manufacturing agreement by the third party because of
factors beyond our control; |
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the possible termination or non-renewal of the agreement by the third party, based on
its own business priorities, at a time that is costly or inconvenient for us; |
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drug product supplies not meeting the requisite requirements for clinical trial use;
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the possible exercise by Orion of its right to terminate its obligation to supply us
with toremifene, which it may do at its election at any time. |
If we are not able to obtain adequate supplies of our product candidates, it will be more
difficult for us to develop our product candidates and compete effectively. Our product candidates
and any products that we, Ipsen and/or our potential future collaborators may develop may compete
with other product candidates and products for access to manufacturing facilities. For example,
the active pharmaceutical ingredient in our toremifene 80 mg product candidate is also the active
pharmaceutical ingredient in FARESTON®. Further, Orion has agreed to supply toremifene tablets to
Ipsen for clinical trials and commercial supply in its licensed territory. Orion also manufactures
toremifene for third parties for sale outside the United States for the treatment of metastatic
breast cancer in postmenopausal women.
Our present or future manufacturing partners may not be able to comply with FDA-mandated
current Good Manufacturing Practice regulations, other FDA regulatory requirements or similar
regulatory requirements outside the United States. Failure of our third-party manufacturers or us
to comply with applicable regulations could result in sanctions being imposed on us, including
fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval
of our product candidates, delays, suspension or withdrawal of approvals, license revocation,
seizures or recalls of product candidates or products, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect supplies of our product
candidates.
If third parties on whom we rely do not perform as contractually required or expected, we may
not be able to obtain regulatory approval for or successfully commercialize our product candidates.
We do not have the ability to independently conduct clinical trials for our product
candidates, and we must rely on third parties, such as contract research organizations, medical
institutions, clinical investigators and contract laboratories to conduct our clinical trials. In
addition, we rely on third parties to assist with our preclinical development of product
candidates. If these third parties do not successfully carry out their contractual duties or
regulatory obligations or meet expected deadlines, if the third parties need to be replaced, or if
the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our
clinical protocols or regulatory requirements or for other reasons, our preclinical development
activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be
able to obtain regulatory approval for or successfully commercialize our product candidates.
Risks Related to Our Intellectual Property
If we lose our licenses from the University of Tennessee Research Foundation, or UTRF, we may
be unable to continue a substantial part of our business.
We have licensed intellectual property rights and technology from UTRF used in a substantial
part of our business. These license agreements may be terminated by UTRF if we are in breach of
our obligations under, or fail to perform any terms of, the agreement and fail to cure that breach.
If any of these agreements were terminated,
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then we may lose our rights to utilize the technology and intellectual property covered by
that agreement to market, distribute and sell our licensed products, which may prevent us from
continuing a substantial part of our business and may result in a serious adverse effect on our
financial condition, results of operations and any prospects for growth. Additionally, the
termination of our UTRF license for chemoprevention of prostate cancer could lead to a termination
of our license and collaboration agreement with Ipsen, which would result in a loss of any
potential milestone or royalty payments from Ipsen.
If some or all of our, or our licensors, patents expire or are invalidated or are found to be
unenforceable, or if some or all of our patent applications do not result in issued patents or
result in patents with narrow or unenforceable claims, or if we are prevented from asserting that
the claims of an issued patent cover a product of a third party, we may be subject to competition
from third parties with products in the same class of products as our
product candidates or products with the same active pharmaceutical ingredients as our product
candidates.
Our commercial success will depend in part on obtaining and maintaining patent and trade
secret protection for our product candidates, as well as the methods for treating patients in the
product indications using these product candidates. We will be able to protect our product
candidates and the methods for treating patients in the product indications using these product
candidates from unauthorized use by third parties only to the extent that we or our exclusive
licensors own or control such valid and enforceable patents or trade secrets. Additionally,
Ipsens ability to successfully market toremifene within a substantial portion of its licensed
territory may depend on having marketing and data exclusivity from the appropriate regulatory
authorities.
Our rights to certain patents and patent applications relating to SARM compounds that we have
licensed from UTRF are subject to the terms of UTRFs inter-institutional agreements with The Ohio
State University, or OSU, and our rights to future related improvements in some instances are
subject to UTRFs exercise of exclusive options under its agreements with OSU for such
improvements.
Even if our product candidates and the methods for treating patients for prescribed
indications using these product candidates are covered by valid and enforceable patents and have
claims with sufficient scope, disclosure and support in the specification, the patents will provide
protection only for a limited amount of time. For example, the patent that we have licensed from
Orion covering the composition of matter of toremifene has expired in the United States and abroad.
As a result, we will need to rely primarily on the protection afforded by method of use patents
relating to the use of toremifene for the relevant prescribed indications that have been issued or
may be issued from our owned or licensed patent applications. Also, within its licensed
territories, Ipsen may need to rely primarily on the protection afforded by marketing and data
exclusivity for the toremifene products that may be sold within the respective territory. To date,
many of our applications for method of use patents filed for toremifene outside of the United
States are still pending and have not yielded issued patents. Loss of marketing and data
exclusivity for any toremifene products that may be commercialized within the territories licensed
to Ipsen could adversely affect Ipsens ability to successfully commercialize these products.
Our and our licensors ability to obtain patents can be highly uncertain and involve complex
and in some cases unsettled legal issues and factual questions. Furthermore, different countries
have different procedures for obtaining patents, and patents issued in different countries provide
different degrees of protection against the use of a patented invention by others. Therefore, if
the issuance to us or our licensors, in a given country, of a patent covering an invention is not
followed by the issuance, in other countries, of patents covering the same invention, or if any
judicial interpretation of the validity, enforceability, or scope of the claims in, or the written
description or enablement in, a patent issued in one country is not similar to the interpretation
given to the corresponding patent issued in another country, our ability to protect our
intellectual property in those countries may be limited. Changes in either patent laws or in
interpretations of patent laws in the United States and other countries may materially diminish the
value of our intellectual property or narrow the scope of our patent protection.
Even if patents are issued to us or our licensors regarding our product candidates or methods
of using them, those patents can be challenged by our competitors who can argue such patents are
invalid or unenforceable, lack sufficient written description or enablement, or that the claims of
the issued patents should be limited or narrowly construed. Patents also will not protect our
product candidates if competitors devise ways of making or using these product candidates without
legally infringing our patents. The Federal Food, Drug, and Cosmetic Act and FDA regulations and
policies create a regulatory environment that encourages companies to challenge branded drug
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patents or to create non-infringing versions of a patented product in order to facilitate the
approval of abbreviated new drug applications for generic substitutes. These same types of
incentives encourage competitors to submit new drug applications that rely on literature and
clinical data not prepared for or by the drug sponsor, providing another less burdensome pathway to
approval.
We also rely on trade secrets to protect our technology, especially where we do not believe
that patent protection is appropriate or obtainable. However, trade secrets are difficult to
protect. Our employees, consultants, contractors, outside scientific collaborators and other
advisors may unintentionally or willfully disclose our confidential information to competitors, and
confidentiality agreements may not provide an adequate remedy in the event of unauthorized
disclosure of confidential information. Enforcing a claim that a third party illegally obtained
and is using our trade secrets is expensive and time-consuming, and the outcome is unpredictable.
Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
Failure to obtain or maintain trade secret protection could adversely affect our competitive
business position.
Off-label sale or use of third-party toremifene products could decrease sales of any
toremifene product candidates that we continue to develop and that are approved for commercial
sale, and could lead to pricing pressure if such products become available at competitive prices
and in dosages that are appropriate for the indications for which we and Ipsen may continue to
develop toremifene.
In all countries in which we hold or have licensed rights to patents or patent applications
related to toremifene, the composition of matter patents we license from Orion have expired. As a
result, we will need to rely primarily on the protection afforded by method of use patents. Our
method of use patents may not protect toremifene from the risk of off-label sale or use of other
toremifene products in place of any toremifene product candidates that we continue to develop and
that are approved for commercial sale. Physicians are permitted to prescribe legally available
drugs for uses that are not described in the drugs labeling and that differ from those uses tested
and approved by the FDA or its equivalent. Such off-label uses are common across medical
specialties and are particularly prevalent for cancer treatments. Any off-label sales of other
toremifene products may adversely affect our or Ipsens ability to generate revenue from the sale
of any toremifene product candidates that we continue to develop and that are approved for
commercial sale.
Even in the event that patents are issued from our pending method of use patent applications,
competitors could market and sell toremifene products for uses for which FARESTON® has already been
approved. Thus, physicians in such countries would be permitted to prescribe these other
toremifene products for indications that are protected by our method of use patents or method of
use patents issuing from pending patent applications, even though these other toremifene products
would not have been approved for those uses, and in most cases, the physician would not be liable
for contributing to the infringement of our patents or potential patents. Moreover, because Orion
has licensed and could further license other parties to market, sell and distribute toremifene for
breast cancer outside the United States, physicians in such countries could prescribe these
products sold pursuant to another Orion license off-label. This further increases the risk of
off-label competition developing for toremifene for the indications for which we and Ipsen may
continue to develop this product candidate. In addition, if no patents are issued with respect to
our pending method of use patent applications related to the use of toremifene in the countries
outside of the United States where these applications are currently pending, we would not have as
extensive patent coverage to prevent competitors from marketing and selling generic versions of
toremifene at doses and in formulations equivalent to our toremifene product candidates for the
indications covered by our pending method of use patent applications. Also, regulatory authorities
may not recognize marketing and data exclusivity for toremifene in the territory we licensed to
Ipsen under our collaboration for the treatment of prostate cancer and estrogen deficiency side
effects resulting from ADT. If generic versions of toremifene are able to be sold in countries
within the territory we licensed to Ipsen for the indications for which Ipsen could potentially
market toremifene, the royalties to be paid to us by Ipsen will be reduced if the total generic
sales exceed a certain threshold for a certain period of time.
Our license agreement with Orion excludes the use of toremifene in humans to treat breast
cancer outside the United States and may limit our ability to market toremifene for human uses
outside the United States.
Our exclusive license and supply agreement from Orion excludes the use of toremifene for the
treatment of metastatic breast cancer in postmenopausal women outside the United States. Orion has
licensed to other parties the right to market, sell and distribute toremifene for the treatment of
advanced breast cancer outside the United States
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and could license additional parties to market, sell and distribute toremifene for this
indication outside the United States.
Under the terms of our license agreement with Orion, Orion may require us and Ipsen to modify
our final toremifene development plans for specified major markets outside the United States if
those development plans could adversely affect Orions or Orions other licensees activities
related to FARESTON® for breast cancer outside the United States or toremifene-based animal health
products. Although we do not believe that our or Ipsens development plans adversely affect these
activities, any future modifications to our or Ipsens plans imposed by Orion may limit our and
Ipsens ability to maximize the commercial potential of toremifene.
If we infringe intellectual property rights of third parties, it may increase our costs or
prevent us from being able to commercialize our product candidates.
There is a risk that we are infringing the proprietary rights of third parties because
numerous United States and foreign issued patents and pending patent applications, which are owned
by third parties, exist in the fields that are the focus of our drug discovery, development, and
manufacture and process synthesis efforts. Others might have been the first to make the inventions
covered by each of our or our licensors pending patent applications and issued patents and might
have been the first to file patent applications for these inventions. In addition, because patent
applications can take many years to issue, there may be currently pending applications, unknown to
us or our licensors, which may later result in issued patents that cover the production,
manufacture, synthesis, commercialization, formulation or use of our product candidates. In
addition, the production, manufacture, synthesis, commercialization, formulation or use of our
product candidates may infringe existing patents of which we are not aware. Defending ourselves
against third-party claims, including litigation in particular, would be costly and time consuming
and would divert managements attention from our business, which could lead to delays in our
development or commercialization efforts. If third parties are successful in their claims, we
might have to pay substantial damages or take other actions that are adverse to our business.
As a result of intellectual property infringement claims, or to avoid potential claims, we
might:
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be prohibited from selling or licensing any product that we, Ipsen and/or any potential
future collaborators may develop unless the patent holder licenses the patent to us, which
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be required to pay substantial royalties or other amounts, or grant a cross license to
our patents to another patent holder; or |
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be required to redesign the formulation of a product candidate so that it does not
infringe, which may not be possible or could require substantial funds and time. |
In addition, under our collaboration and license agreement with Ipsen, Ipsen may be entitled
to offset a portion of any royalties due to us in any calendar year on account of product sales to
pay for costs incurred by Ipsen to obtain a license to any dominant intellectual property rights
that are infringed by the products at issue.
Risks Related to Regulatory Approval of Our Product Candidates
If we, Ipsen, or any potential future collaborators are not able to obtain required regulatory
approvals, we or such collaborators will not be able to commercialize our product candidates, and
our ability to generate revenue will be materially impaired.
Our product candidates and the activities associated with their development and
commercialization are subject to comprehensive regulation by the FDA, other regulatory agencies in
the United States and by comparable authorities in other countries. Failure to obtain regulatory
approval for a product candidate will prevent us or any collaborator from commercializing the
product candidate. We have not received regulatory approval to market any of our product
candidates in any jurisdiction, and we do not expect to obtain FDA or any other regulatory
approvals to market any of our product candidates in the near future, if at all. In addition, we
will not receive any clinical development milestone or royalty payments associated with our
toremifene 80 mg product candidate if we and/or Ipsen determine to discontinue the development of
toremifene 80 mg or, if such development continues, if Ipsen is
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unable to obtain the necessary regulatory approvals to commercialize toremifene 80 mg within
its licensed territory. The process of obtaining regulatory approvals is expensive, often takes
many years, if approval is obtained at all, and can vary substantially based upon the type,
complexity and novelty of the product candidates involved.
Changes in the regulatory approval policy during the development period, changes in or the
enactment of additional regulations or statutes, or changes in regulatory review for each submitted
product application, may cause delays in the approval or rejection of an application. For example,
the FDA announced in 2008 that, due to staffing and resource limitations, it has given its managers
discretion to miss certain timing goals for completing reviews of NDAs set forth under the
Prescription Drug User Fee Act, or PDUFA. Although the FDA has since publicly expressed a
recommitment to meeting PDUFA deadlines, it remains unclear whether and to what extent the FDA will
adhere to PDUFA deadlines in the future. If the FDA were to miss a PDUFA timing goal for one of
our product candidates, the development and commercialization of the product candidate could be
delayed. In addition, the Food and Drug Administration Amendments Act of 2007, or the FDA
Amendments Act, which was enacted in September 2007, expands the FDAs authority to regulate drugs
throughout the product life cycle, including enhanced authority to require post-approval studies
and clinical trials. Other proposals have been made to impose additional requirements on drug
approvals, further expand post-approval requirements and restrict sales and promotional activities.
This new legislation, and the additional proposals if enacted, may make it more difficult or
burdensome for us or our potential future collaborators to obtain approval of our product
candidates. Even if the FDA approves a product candidate, the approval may impose significant
restrictions on the indicated uses, conditions for use, labeling, advertising, promotion, marketing
and/or production of such product, and may impose ongoing requirements for post-approval studies,
including additional research and development and clinical trials. The approval may also impose
risk evaluation mitigation strategies, or REMS, on a product if the FDA believes there is a reason
to monitor the safety of the drug in the market place. REMS may include requirements for
additional training for health care professionals, safety communication efforts and limits on
channels of distribution, among other things. The sponsor would be required to evaluate and
monitor the various REMS activities and adjust them if need be. The FDA also may impose various
civil or criminal sanctions for failure to comply with regulatory requirements, including
withdrawal of product approval.
Furthermore, the approval procedure and the time required to obtain approval varies among
countries and can involve additional testing beyond that required by the FDA. Approval by one
regulatory authority does not ensure approval by regulatory authorities in other jurisdictions.
The FDA has substantial discretion in the approval process and may refuse to accept any
application or may decide that our data are insufficient for approval and require additional
preclinical, clinical or other studies. For example, in October 2009, we received a Complete
Response Letter from the FDA regarding our NDA for toremifene 80 mg to reduce fractures in men with
prostate cancer on ADT notifying us that the FDA would not approve our NDA in its present form as a
result of certain clinical deficiencies identified in the Complete Response Letter. As a result,
FDA approval of toremifene 80 mg, if it occurs, will be substantially delayed Additionally, if our
planned TREAT 2 trial of toremifene 80 mg to reduce fractures and treat other estrogen deficiency
side effects of ADT in men with prostate cancer is conducted, it could result in varying
interpretations of the data obtained from the clinical trial which could delay, limit or prevent
regulatory approval of the product candidate. Furthermore, even if we submit an application to the
FDA for marketing approval of a product candidate, it may not result in marketing approval from the
FDA.
We do not expect to receive regulatory approval for the commercial sale of any of our product
candidates that are in development, including toremifene 80 mg, in the near future, if at all.
Furthermore, it is not anticipated that Ipsen will receive the appropriate regulatory approvals to
market toremifene within its licensed territory any sooner than we will achieve regulatory approval
in the United States, and it likely will be thereafter. The inability to obtain FDA approval or
approval from comparable authorities in other countries for our product candidates would prevent
us, Ipsen, or any potential future collaborators from commercializing these product candidates in
the United States or other countries. See the section entitled Business Government Regulation
of our Annual Report on Form 10-K, filed with the SEC on March 15, 2010, for additional information
regarding risks associated with marketing approval, as well as risks related to post-approval
requirements.
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Risks Related to Commercialization
The commercial success of any products that we, Ipsen, and/or any potential future
collaborators may develop, including any toremifene products, will depend upon the market and the
degree of market acceptance among physicians, patients, healthcare payors and the medical
community.
Any products that we, Ipsen, and/or any potential future collaborators may develop may not
gain market acceptance among physicians, patients, health care payors and the medical community.
If these products do not achieve an adequate level of acceptance, we may not generate material
product revenues or receive royalties to the extent we currently anticipate, and we may not become
profitable. The degree of market acceptance of our product candidates, if approved for commercial
sale, will depend on a number of factors, including:
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efficacy and safety results in clinical trials; |
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the prevalence and severity of any side effects; |
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potential advantages over alternative treatments; |
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whether the products we commercialize remain a preferred course of treatment; |
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the ability to offer our product candidates for sale at competitive prices; |
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relative convenience and ease of administration; |
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the strength of marketing and distribution support; and |
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sufficient third-party coverage or reimbursement. |
We have conducted a number of studies of toremifene in addition to our clinical trials,
including a Thorough QT study (toremifene 80 mg and toremifene 20 mg), a bioequivalence study
(toremifene 80 mg), a series of drug-drug interaction studies (toremifene 80 mg and toremifene 20
mg), and a semen quality study (toremifene 20 mg) to assess the effect of toremifene. The results
of the Thorough QT study of 250 healthy male volunteers, with 5 parallel cohorts receiving 20 mg,
80 mg or 300 mg doses of toremifene, moxifloxacin, or placebo, showed that toremifene prolonged the
QT interval in a dose dependent manner. The mean change in QTcB (a measurement of QT interval
corrected by Bazetts formula) from baseline relative to placebo for toremifene 20 mg was 5.79
milliseconds, for toremifene 80 mg, it was 22.43 milliseconds, and for moxifloxacin, it was 8.83
milliseconds. Since we market FARESTON® in the United States under a license agreement with Orion,
we notified the FDA of the Thorough QT study results and have proposed modifications to the
FARESTON® label in the United States. FDA action on the proposed label changes is pending.
Separately, Orion recommended label changes to the EMEA. In January 2009, the EMEA recommended
that the FARESTON® label within the European Union reflect that toremifene should not be given to
patients at risk of prolonged QT intervals or other certain heart problems. The results of these
completed studies were included as a part of the NDA submission to the FDA for our toremifene 80 mg
product candidate to reduce fractures in men with prostate cancer on ADT and will be included as
part of any future NDA submission we make to the FDA for toremifene 80 mg if we and Ipsen determine
to conduct the planned TREAT 2 trial and the results of such trial are positive. In addition, the
results of these completed studies will be used to update the label for FARESTON®. The study
results could lead to the inclusion of restrictions, limitations and/or warnings in the label of
FARESTON® or an approved toremifene 80 mg product candidate, which may adversely affect the
marketability of the product or limit the patients to whom the product is prescribed.
Our only marketed product generating revenue is FARESTON®, which is subject to a number of
risks. These risks may cause sales of FARESTON® to continue to decline.
FARESTON® is currently our only marketed product. FARESTON® is indicated for the treatment of
metastatic breast cancer in postmenopausal women. FARESTON® competes against tamoxifen,
fulvestrant, and several aromatase inhibitors, including anastrozole, letrozole, and exemestane,
for hormonal treatment of breast cancer. Sales of pharmaceuticals for breast cancer in the SERM
class have declined in recent years as aromatase inhibitors have gained market share and we believe
this trend will continue. Further, the branded competitors have greater resources and generic
competitors are preferred by insurers. Continued sales of FARESTON® also could be impacted by many
other factors. The occurrence of one or more of the following risks may cause sales of FARESTON®
to decline more than we currently anticipate:
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the loss of the availability of Orions website to market FARESTON®, which is an
important source of advertising; |
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the loss of one or more of our three largest wholesale drug distributors, which
together accounted for approximately 96% of our product sales of FARESTON® for the six
months ended June 30, 2010; |
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any restrictions, limitations, and/or warnings added to the FARESTON® label as a result
of our studies of toremifene, including a Thorough QT study and drug interaction studies,
or otherwise; |
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the continued success of competing products, including aromatase inhibitors; |
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the loss of coverage or reimbursement for FARESTON® from Medicare and Medicaid, private
health insurers or other third-party payors; |
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exposure to product liability claims related to the commercial sale of FARESTON®, which
may exceed our product liability insurance; |
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the failure of Orion to maintain regulatory filings or comply with applicable FDA
requirements with respect to FARESTON®; |
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the introduction of generic toremifene products that compete with FARESTON® for the
treatment of breast cancer; and |
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the loss of Orion, upon which we rely as a single source, as our supplier of FARESTON®. |
If we are unable to expand our sales and marketing capabilities or establish and maintain
agreements with third parties to market and sell our product candidates, we may be unable to
generate product revenue from such candidates.
We have limited experience as a company in the sales, marketing and distribution of
pharmaceutical products, and in any event have only limited company personnel to undertake such
activities, and we therefore need to expand our sales and marketing capabilities or establish and
maintain agreements with third parties to market and sell our product candidates. We may be
unable to build our own sales and marketing capabilities and there are risks involved with entering
into arrangements with third parties to perform these services, which could delay the
commercialization of any of our product candidates if approved for commercial sale. For example,
we would be relying on Ipsen to market and distribute our toremifene product candidates if their
development continues and they are approved for commercial sale through Ipsens established sales
and marketing network within its licensed territory. If our collaboration and license agreement
with Ipsen is terminated for any reason, our ability to sell any of our toremifene product
candidates that may be approved for commercial sale in Ipsens licensed territory would be
adversely affected, and we may be unable to develop or engage an effective sales force to
successfully market and sell such toremifene product candidates in Ipsens licensed territory.
Currently, we do not have a partner outside of Ipsens licensed territory for our toremifene
product candidates, and our success in regions other than Ipsens licensed territory may be
dependent on our ability to find suitable partners in other regions of the world. In addition, to
the extent that we enter into arrangements with third parties to perform sales, marketing and
distribution services, our product revenues are likely to be lower than if we market and sell any
products that we develop ourselves.
If we, Ipsen, and/or any potential future collaborators are unable to obtain reimbursement or
experience a reduction in reimbursement from third-party payors for products we sell, our revenues
and prospects for profitability will suffer.
Sales of products developed by us, Ipsen, and/or any potential future collaborators are
dependent on the availability and extent of reimbursement from third-party payors. Changes in the
reimbursement policies of these third-party payors that reduce reimbursements for FARESTON® and any
other products that we, Ipsen and/or any potential future collaborators may develop and sell could
negatively impact our future operating and financial results.
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 established
comprehensive Medicare coverage and reimbursement of prescription drugs under Medicare Part D. The
prescription drug program
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established by this legislation may have the effect of reducing the prices that we, Ipsen, or
any potential future collaborators are able to charge for products we, Ipsen, and/or any potential
future collaborators develop and sell through the program. This legislation may also cause
third-party payors other than the federal government, including the states under the Medicaid
program, to discontinue coverage for products that we, Ipsen, and/or any potential future
collaborators may develop or to lower the amount that they pay. State Medicaid programs are
increasingly requesting manufacturers to pay supplemental rebates and requiring prior authorization
for use of drugs where supplemental rebates are not provided.
In March 2010, the United States Congress enacted the Patient Protection and Affordable Care
Act and the Health Care and Education Reconciliation Act. This health care reform legislation will
increase the number of individuals who receive health insurance coverage and will close a gap in
drug coverage under Medicare Part D as established in 2003. However, the newly-enacted legislation
also implements cost containment measures that could adversely affect our revenues. These measures
include increased drug rebates under Medicaid starting in 2010 for brand name prescription drugs,
such as FARESTON®, and extension of these rebates to Medicaid managed care, which would reduce the
amount of net reimbursement received for FARESTON® or any other products that we, Ipsen, and/or any
potential future collaborators may develop and sell. Also effective for 2010, the legislation
extends 340B discounted pricing on outpatient drugs to childrens hospitals, critical access
hospitals, and rural health centers, which extension reduces the amount of reimbursement received
for drugs purchased by these new 340B-covered entities.
Additional provisions of the health care reform legislation, which become effective in 2011,
may negatively affect our revenues and prospects for profitability in the future. Along with other
pharmaceutical manufacturers and importers of brand name prescription drugs, we will be assessed a
fee based on our proportionate share of sales of brand name prescription drugs to certain
government programs, including Medicare and Medicaid. As part of the health care reform
legislations provisions closing a funding gap that currently exists in the Medicare Part D
prescription drug program (commonly known as the donut hole), we will also be required to provide
a 50% discount on brand name prescription drugs, including FARESTON®, sold to beneficiaries who
fall within the donut hole.
In the aftermath of the 2010 health care reform legislation, private health insurers and
managed care plans are likely to continue challenging the prices charged for medical products and
services, and many of these third-party payors may limit reimbursement for newly-approved health
care products. In particular, third-party payors may limit the indications for which they will
reimburse patients who use any products that we, Ipsen, and/or any potential future collaborators
may develop or sell. These cost-control initiatives could decrease the price we might establish
for products that we, Ipsen, or any potential future collaborators may develop or sell, which would
result in lower product revenues or royalties payable to us.
Similar cost containment initiatives exist in countries outside of the United States,
particularly in the countries of the European Union, where the pricing of prescription
pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with
governmental authorities can take six to twelve months or longer after the receipt of regulatory
marketing approval for a product. To obtain reimbursement or pricing approval in some countries,
we, Ipsen, or any potential future collaborators may be required to conduct a clinical trial that
compares the cost effectiveness of our product candidates or products to other available therapies.
The conduct of such a clinical trial could be expensive and result in delays in our, Ipsens or a
potential future collaborators commercialization efforts. Third-party payors are challenging the
prices charged for medical products and services, and many third-party payors limit reimbursement
for newly-approved health care products. In particular, third-party payors may limit the
indications for which they will reimburse patients who use any products that we, Ipsen, and/or any
potential future collaborators may develop or sell. Cost-control initiatives could decrease the
price we might establish for products that we, Ipsen, or any potential future collaborators may
develop or sell, which would result in lower product revenues or royalties payable to us.
Another development that could affect the pricing of drugs would be proposed congressional
action regarding drug reimportation into the United States. The Medicare Prescription Drug,
Improvement and Modernization Act of 2003 gives discretion to the Secretary of Health and Human
Services to allow drug reimportation into the United States under some circumstances from foreign
countries, including from countries where the drugs are sold at a lower price than in the United
States. Provisions allowing for the direct reimportation of drugs under certain
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circumstances were not included in the 2010 health care reform legislation, but could be
revisited in the future. If legislation or regulations were passed allowing the reimportation of
drugs, they could decrease the price we, Ipsen, or any potential future collaborators receive for
any products that we, Ipsen, and/or any potential future collaborators may develop, negatively
affecting our revenues and prospects for profitability.
Health care reform measures could hinder or prevent our product candidates commercial
success.
Among policy makers and payors in the United States and elsewhere, there is significant
interest in promoting health care reform, as evidenced by the recent enactment in the United States
of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation
Act. It is likely that federal and state legislatures within the United States and foreign
governments will continue to consider changes to existing health care legislation. These changes
adopted by governments may adversely impact our business by lowering the price of health care
products in the United States and elsewhere.
We operate in a highly regulated industry and new laws, regulations or judicial decisions, or
new interpretations or existing laws, regulations or decisions, related to health care
availability, method of delivery or payment for health care products and services, or sales,
marketing and pricing practices could negatively impact our business, operations and financial
condition.
If product liability lawsuits are brought against us, we may incur substantial liabilities and
may be required to limit commercialization of any products that we may develop.
We face an inherent risk of product liability exposure related to our commercial sale of
FARESTON® and the testing of our product candidates in human clinical trials and will face an even
greater risk if we commercially sell any product that we may develop. If we cannot successfully
defend ourselves against claims that our product candidates or products caused injuries, we will
incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may
result in:
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decreased demand for any product candidates or products; |
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injury to our reputation; |
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withdrawal of clinical trial participants; |
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costs to defend the related litigation; |
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substantial monetary awards to trial participants or patients; |
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loss of revenue; and |
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the inability to commercialize any products for which we obtain or hold marketing
approvals. |
We have product liability insurance that covers our clinical trials and commercial products
up to a $25 million annual aggregate limit. Insurance coverage is increasingly expensive. We may
not be able to maintain insurance coverage at a reasonable cost and we may not be able to obtain
insurance coverage that will be adequate to satisfy any liability that may arise.
If our competitors are better able to develop and market products than any products that we,
Ipsen, and/or any potential future collaborators may develop, our commercial opportunity will be
reduced or eliminated.
We face competition from commercial pharmaceutical and biotechnology enterprises, as well as
from academic institutions, government agencies and private and public research institutions. Our
commercial opportunities will be reduced or eliminated if our competitors develop and commercialize
products that are safer, more effective, have fewer side effects or are less expensive than any
products that we, Ipsen, and/or any potential future collaborators may develop. Competition could
result in reduced sales and pricing pressure on our product candidates, if approved, which in turn
would reduce our ability to generate meaningful revenue and have a negative impact on our results
of operations. In addition, significant delays in the development of our product candidates could
allow our competitors to bring products to market before us and impair any ability to commercialize
our product candidates.
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Various products are currently marketed or used off-label for some of the diseases and
conditions that we are targeting in our pipeline, and a number of companies are or may be
developing new treatments. These product uses, as well as promotional efforts by competitors and/or
clinical trial results of competitive products, could significantly diminish any ability to market
and sell any products that we, Ipsen, and/or any potential future collaborators may develop.
We are developing GTx-758 for the treatment of advanced prostate cancer. Currently, there are
several products approved to reduce testosterone levels in men with advanced prostate cancer that
may compete with GTx-758 if approved for commercial sale, including those marketed by Abbott
Laboratories (Lupron®), Sanofi-Aventis (Eligard ®), AstraZeneca (Zoladex®), Ferring Pharmaceuticals
(Firmagon®), Endo Pharmaceuticals (Vantas®) and Watson Pharmaceuticals (Trelstar®).
With respect to our SARM program, there are other SARM product candidates in development that
may compete with our SARM product candidates if approved. Pfizer Inc., Eli Lilly & Co., and Amgen
have myostatin inhibitors in development that may compete with ostarine if approved for commercial
sale. In addition, Cytokinetics, Inc. is developing a troponin activator with a muscle specific
mechanism in a Phase I study. Moreover, there are other categories of drugs in development,
including ghrelin receptor agonists and growth hormone secretagogues that may have some muscle
activity. Other appetite stimulants such as megestrol acetate and dronabinol are also used
off-label for cancer cachexia.
We are also developing toremifene 80 mg for the reduction of fractures and treatment of other
estrogen deficiency side effects of ADT. Although there are no products that have been approved by
the FDA to reduce fractures or treat estrogen deficiency related side effects of ADT, we are aware
of a number of drugs, including drugs marketed by Eli Lilly & Co. (Evista®), Merck (Fosamax®),
Sanofi-Aventis and Warner Chilcott (Actonel®), Pfizer Inc. (Effexor®), Boehringer Ingelheim
(Catapres®), Novartis (Zometa®) and generic megestrol acetate, that are prescribed to treat single
side effects of ADT; that external beam radiation and tamoxifen are used to treat breast pain and
enlargement, or gynecomastia. ProliaTM (denosumab), a monoclonal antibody developed by Amgen, is
approved in the United States, Europe and Australia for the treatment of osteoporosis in
postmenopausal women and additionally in Europe for the treatment of bone loss associated with
hormone ablation in men with prostate cancer at increased risk of fractures, and is under
regulatory review for cancer specific indications including prostate cancer.
Many of our competitors have significantly greater financial resources and expertise in
research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining
regulatory approvals and marketing approved products than we do. Smaller or early-stage companies
may also prove to be significant competitors, particularly through collaborative arrangements with
large and established companies. These third parties compete with us in recruiting and retaining
qualified scientific and management personnel, establishing clinical trial sites and patient
registration for clinical trials, as well as in acquiring technologies and technology licenses
complementary to our programs or advantageous to our business.
Risks Related to Employees and Growth
If we fail to attract and keep senior management and key scientific personnel, we may be
unable to successfully develop or commercialize our product candidates.
Our success depends on our continued ability to attract, retain and motivate highly qualified
management, clinical and scientific personnel and on our ability to develop and maintain important
relationships with leading academic institutions, clinicians and scientists. If we are not able to
attract and keep senior management and key scientific personnel, particularly Dr. Mitchell S.
Steiner, we may not be able to successfully develop or commercialize our product candidates. All
of our employees are at-will employees and can terminate their employment at any time. We do not
carry key person insurance covering members of senior management, other than $25 million of
insurance covering Dr. Steiner.
In December 2009, we announced a reduction of approximately 26% of our workforce in order to
reduce our operating expenses in connection with the receipt of the Complete Response Letter
regarding our NDA for
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toremifene 80 mg and the associated delay in the potential regulatory approval of toremifene
80 mg. This and any future workforce reductions may negatively affect our ability to retain or
attract talented employees.
We will need to hire additional employees in order to commercialize our product candidates in
the future. Any inability to manage future growth could harm our ability to commercialize our
product candidates, increase our costs and adversely impact our ability to compete effectively.
In order to commercialize our product candidates in the future, we will need to expand the
number of our managerial, operational, financial and other employees and the competition for
qualified personnel in the biotechnology field is intense.
Future growth will impose significant added responsibilities on members of management,
including the need to identify, recruit, maintain and integrate additional employees. Our future
financial performance and our ability to commercialize our product candidates and to compete
effectively will depend, in part, on our ability to manage any future growth effectively.
Risks Related to this Offering and Ownership of our Common Stock
Market volatility may cause our stock price and the value of your investment to decline.
The market prices for securities of biotechnology companies in general have been highly
volatile and may continue to be so in the future. The following factors, in addition to other risk
factors described in this section, may have a significant impact on the market price of our common
stock:
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developments with respect to our collaboration with Ipsen, including the results of our
negotiations with Ipsen with respect to the planned TREAT 2 trial, any changes to the terms
of our collaboration, and any determination by Ipsen to terminate the collaboration; |
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adverse results or delays in our clinical trials; |
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our ability to enter into additional collaborative arrangements with respect to our
product candidates; |
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the timing of achievement of, or failure to achieve, our, Ipsens and any potential
future collaborators clinical, regulatory and other milestones, such as the commencement
of clinical development, the completion of a clinical trial or the receipt of regulatory
approval; |
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announcement of FDA approval or non-approval of our product candidates or delays in the
FDA review process; |
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actions taken by regulatory agencies with respect to our product candidates or products,
our clinical trials or our sales and marketing activities, including regulatory actions
requiring or leading to restrictions, limitations and/or warnings in the label of FARESTON®
or an approved toremifene product candidate; |
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the commercial success of any product approved by the FDA or its foreign counterparts; |
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introductions or announcements of technological innovations or new products by us,
Ipsen, potential future collaborators, or our competitors, and the timing of these
introductions or announcements; |
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market conditions for equity investments in general, or the biotechnology or
pharmaceutical industries in particular; |
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the terms and timing of any future collaborative, licensing or other arrangements that
we may establish; |
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regulatory developments in the United States and foreign countries; |
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changes in the structure or reimbursement policies of health care payment systems; |
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any intellectual property infringement lawsuit involving us; |
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actual or anticipated fluctuations in our results of operations; |
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changes in financial estimates or recommendations by securities analysts; |
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sales of large blocks of our common stock; |
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sales of our common stock by our executive officers, directors and significant
stockholders; |
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changes in accounting principles; and |
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the loss of any of our key scientific or management personnel. |
The stock markets in general, and the markets for biotechnology stocks in particular, have
experienced significant volatility that has often been unrelated to the operating performance of
particular companies. Recently, the financial markets have faced almost unprecedented turmoil,
resulting in a decline in investor confidence and concerns about the proper functioning of the
securities markets, which decline in general investor confidence has resulted in depressed stock
prices for many companies notwithstanding the lack of a fundamental change in their underlying
business models or prospects. These broad market fluctuations may adversely affect the trading
price of our common stock.
In the past, class action litigation has often been instituted against companies whose
securities have experienced periods of volatility in market price. Any such litigation brought
against us could result in substantial costs, which would hurt our financial condition and results
of operations and divert managements attention and resources, which could result in delays of our
clinical trials or commercialization efforts.
Management will have broad discretion as to the use of the proceeds from this offering, and we
may not use the proceeds effectively.
Our management will have broad discretion in the application of the net proceeds from this
offering and could spend the proceeds in ways that do not improve our results of operations or
enhance the value of our common stock. Our failure to apply these funds effectively could have a
material adverse effect on our business, delay the development of our product candidates and cause
the price of our common stock to decline.
Our executive officers, directors and largest stockholders have the ability to control all
matters submitted to stockholders for approval.
As of June 30, 2010, our executive officers, directors and holders of 5% or more of our
outstanding common stock beneficially owned approximately 66.0% of our outstanding common stock,
and our executive officers and directors alone beneficially owned approximately 48.9% of our
outstanding common stock. As a result, these stockholders, acting together, may or will have the
ability to control all matters requiring approval by our stockholders, including the election of
directors and the approval of mergers or other business combination transactions. The interests of
this group of stockholders may not always coincide with our interests or the interests of other
stockholders.
Anti-takeover provisions in our charter documents and under Delaware law could make an
acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent
attempts by our stockholders to replace or remove our current management.
Provisions in our certificate of incorporation and our bylaws may delay or prevent an
acquisition of us or a change in our management. In addition, these provisions may frustrate or
prevent any attempts by our stockholders to replace or remove our current management by making it
more difficult for stockholders to replace members of our Board of Directors. Because our Board of
Directors is responsible for appointing the members of our management team, these provisions could
in turn affect any attempt by our stockholders to replace current members of our management team.
These provisions include:
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a classified Board of Directors; |
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a prohibition on actions by our stockholders by written consent; |
S-24
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the ability of our Board of Directors to issue preferred stock without stockholder
approval, which could be used to institute a poison pill that would work to dilute the
stock ownership of a potential hostile acquirer, effectively preventing acquisitions that
have not been approved by our Board of Directors; and |
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limitations on the removal of directors. |
Moreover, because we are incorporated in Delaware, we are governed by the provisions of
Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess
of 15% of our outstanding voting stock from merging or combining with us for a period of three
years after the date of the transaction in which the person acquired in excess of 15% of our
outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Finally, these provisions establish advance notice requirements for nominations for election to
our Board of Directors or for proposing matters that can be acted upon at stockholder meetings.
These provisions would apply even if the offer may be considered beneficial by some stockholders.
If there are substantial sales of our common stock, the market price of our common stock could
drop substantially, even if our business is doing well.
For the 12-month period ended June 30, 2010, the average daily trading volume of our common
stock on the NASDAQ Global Market was 406,412 shares. As a result, future sales of a substantial
number of shares of our common stock in the public market, or the perception that such sales may
occur, could adversely affect the then-prevailing market price of our common stock. As of June 30,
2010, we had 36,420,901 shares of common stock outstanding.
We, along with our executive officers and directors, have agreed, subject to certain
exceptions, to specified lock-up provisions with regard to future sales of our common stock for a
period of 90 days after the offering as described under UnderwritingNo Sales of Similar
Securities. The market price for shares of our common stock may drop significantly if
stockholders subject to these lock-up provisions sell a substantial number of shares when the
restrictions on resale lapse, or such shares are sold pursuant to specified exceptions, or if the
underwriter waives these lock-up provisions and allows these stockholders to sell some or all of
their shares. Based on information currently available to us, all of the shares to be outstanding
after this offering will be eligible for sale in the public market following expiration of these
lock-up provisions, subject in some cases to volume and other limitations under federal securities
laws.
Moreover, J.R. Hyde, III, and Oracle Investment Management, Inc., two of our largest
stockholders, and their affiliates, have rights, subject to some conditions, to require us to file
registration statements covering the approximately 10.8 million shares of common stock they hold in
the aggregate which are subject to registration rights or to include these shares in registration
statements that we may file for ourselves or other stockholders. If any of these large
stockholders were to sell large blocks of shares in a short period of time, the market price of our
common stock could drop substantially.
If you purchase shares of common stock in this offering, you will experience immediate
dilution in your investment. You will experience further dilution if we issue additional equity
securities in future fundraising transactions.
Purchasers of common stock in this offering will pay a price per share in this offering that
exceeds the net tangible book value per share of our common stock. After giving effect to the sale of 14,285,715
shares of our common stock in this offering at the public offering price of $2.80 per share,
and after deducting the underwriting discounts and commissions and estimated
offering expenses payable by us, you will experience immediate
dilution of $1.59 per share,
representing the difference between our as adjusted net tangible book value per share as of June
30, 2010 after giving effect to this offering and the public offering price. See the
section entitled Dilution below for a more detailed illustration of the dilution you would incur
if you purchase common stock in this offering.
If we issue additional common stock, or securities convertible into or exchangeable or
exercisable for common stock, our stockholders, including investors who purchase shares of common
stock in this offering, will experience
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additional dilution, and any such issuances may result in downward pressure on the price of
our common stock. We also cannot assure you that we will be able to sell shares or other securities
in any other offering at a price per share that is equal to or greater than the price per share
paid by investors in this offering, and investors purchasing shares or other securities in the
future could have rights superior to existing stockholders.
We have never paid dividends on our capital stock and we do not anticipate paying any cash
dividends in the foreseeable future.
We have never declared or paid cash dividends on our capital stock. We do not anticipate
paying any cash dividends on our capital stock in the foreseeable future. We currently intend to
retain all available funds and any future earnings to fund the development and growth of our
business. As a result, capital appreciation, if any, of our common stock will be our stockholders
sole source of gain for the foreseeable future.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The statements in this prospectus supplement, the accompanying prospectus, the documents
incorporated by reference and in any free writing prospectus that we have authorized for use in
connection with this offering contain forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, which we refer to as the Securities Act, and Section 21E
of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act. These
statements relate to future events or to our future financial performance and involve known and
unknown risks, uncertainties and other important factors that may cause our actual results,
performance or achievements to be materially different from any future results, performances or
achievements expressed or implied by the forward-looking statements. All statements, other than
statements of historical facts, are forward-looking statements for purposes of these provisions,
including without limitation any statements relating to:
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the anticipated progress of our research, development and clinical programs, including
whether any future clinical trials we conduct will achieve similar results to clinical
trials that we have successfully concluded; |
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the timing, scope and anticipated initiation and completion of any future clinical
trials that we may conduct; |
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the timing of regulatory submissions and the timing, scope and anticipated outcome of
related regulatory actions; |
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potential future licensing fees, milestone payments and royalty payments, including any
milestone payments or royalty payments that we may receive under our collaborative
arrangement with Ipsen; |
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our ability to maintain our collaborative arrangement with Ipsen and to establish and
maintain potential new collaborative arrangements for the development and commercialization
of our product candidates; |
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our and our current and potential future collaborators ability to obtain and maintain
regulatory approvals of our product candidates and any related restrictions, limitations,
and/or warnings in the label of an approved product candidate; |
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our and our current and potential future collaborators ability to market, commercialize
and achieve market acceptance for our product candidates or products that we may develop; |
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our ability to generate additional product candidates for clinical testing; |
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our ability to protect our intellectual property and operate our business without
infringing upon the intellectual property rights of others; and |
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our estimates regarding the sufficiency of our cash resources and our use of the net
proceeds from this offering. |
In some cases, you can identify forward-looking statements by terms such as anticipates,
believes, could, estimates, expects, intends, may, plans, potential, predicts,
projects, should, will, would and similar expressions intended to identify forward-looking
statements. Discussions containing these forward-looking statements may be found, among other
places, in the Business and Managements Discussion and Analysis of Financial Condition and
Results of Operations sections incorporated by reference from our most recent Annual Report on
Form 10-K, as well as any amendments thereto reflected in subsequent filings with the SEC, and in
Current Reports on Form 8-K filed with the SEC. Forward-looking statements reflect our current
views with respect to future events, are based on assumptions and are subject to risks,
uncertainties and other important factors. We discuss many of these risks, uncertainties and other
important factors in greater detail under the heading Risk Factors in this prospectus supplement.
Given these risks, uncertainties and other important factors, you should not place undue reliance
on these forward-looking statements. Also, these forward-looking statements represent our estimates
and assumptions only as of the date such forward-looking statements are made. You should carefully
read this prospectus supplement and the accompanying prospectus, together with the information
incorporated by reference as well as any free writing prospectus we have authorized for use in
connection with this offering, completely and with the understanding that our actual future results
may be materially different from what we expect. We hereby qualify all of our forward-looking
statements by these cautionary statements.
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Except as required by law, we assume no obligation to update any forward-looking statements
publicly, or to update the reasons actual results could differ materially from those anticipated in
any forward-looking statements, even if new information becomes available in the future.
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USE OF PROCEEDS
We estimate that the
net proceeds from the sale of 14,285,715 shares of common stock that we are offering hereby will be
approximately $37.6 million, or approximately
$43.3 million if the underwriter exercises in full its
over-allotment option to purchase additional shares of common stock, based on the public
offering price of $2.80 per share, and
after deducting the underwriting discounts and commissions and estimated offering expenses payable
by us.
We currently intend to use the net proceeds from this offering for clinical development and
other research and development activities and for working capital and general corporate purposes.
As of the date of this prospectus supplement, we cannot specify with certainty all of the
particular uses of the proceeds from this offering. Accordingly, we will retain broad discretion
over the use of such proceeds. Pending the use of the net proceeds from this offering as described
above, we intend to invest the net proceeds in investment-grade, interest-bearing instruments.
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DILUTION
Our net tangible book value as of June 30, 2010 was $23.5 million, or $0.65 per share of
common stock. Net tangible book value per share is calculated by subtracting our total liabilities
from our total tangible assets, and dividing this amount by the number of shares of common stock
outstanding.
After giving effect to the sale of 14,285,715 shares of our common stock in this offering at the public
offering price of $2.80 per share, and
after deducting the underwriting discounts and commissions and estimated offering expenses payable
by us, our as adjusted net tangible book value as of June 30, 2010 would have been approximately
$61.2 million, or $1.21 per share. This represents an immediate increase in net tangible book value
of $0.56 per share to existing stockholders and immediate dilution in net tangible book value of
$1.59 per share to new investors purchasing our common stock in this offering at the public
offering price. The following table illustrates this dilution on a per share basis:
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Public offering price per share |
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2.80 |
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0.65 |
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Increase per share attributable to investors participating in this offering |
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0.56 |
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As adjusted net tangible book value per share after this offering |
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1.21 |
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Dilution per share to investors participating in this offering |
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1.59 |
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If the underwriter exercises in full its over-allotment option to purchase 2,142,857 additional shares of common stock at the public offering price of $2.80 per
share, the as adjusted net tangible book value after this offering
would be $1.26 per share,
representing an increase in net tangible book value of $0.61 per share to existing stockholders and
immediate dilution in net tangible book value of $1.54 per share to new investors purchasing our
common stock in this offering at the public offering price.
The above discussion and table are based on 36,420,901 shares of our common stock outstanding
on June 30, 2010. This number excludes, as of June 30, 2010:
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4,536,539 shares of our common stock issuable upon the exercise of options outstanding,
having a weighted-average exercise price of $10.89 per share; |
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89,367 shares of our common stock credited to individual non-employee director stock
accounts under our Directors Deferred Compensation Plan; and |
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an aggregate of 8,283,075 shares of our common stock reserved for future issuance under
our stock option and equity incentive plans. |
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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS
The following summary describes the material U.S. federal income and estate tax consequences
of the acquisition, ownership and disposition of our common stock acquired in this offering by a
Non-U.S. Holder (as defined below). This discussion does not address all aspects of U.S. federal
income and estate taxes and does not deal with foreign, state and local consequences that may be
relevant to Non-U.S. Holders in light of their particular circumstances. Special rules may apply to
certain Non-U.S. Holders that are subject to special treatment under the Internal Revenue Code of
1986, as amended, or the Code, such as financial institutions, insurance companies, tax-exempt
organizations, broker-dealers and traders in securities, U.S. expatriates, controlled foreign
corporations, passive foreign investment companies, corporations that accumulate earnings to
avoid U.S. federal income tax, persons that hold our common stock as part of a straddle, hedge,
conversion transaction, synthetic security or integrated investment, partnerships and other
pass-through entities, and investors in such pass-through entities. Such Non-U.S. Holders are urged
to consult their own tax advisors to determine the U.S. federal, state, local and other tax
consequences that may be relevant to them. Furthermore, the discussion below is based upon the
provisions of the Code, and Treasury regulations, rulings and judicial decisions thereunder as of
the date hereof, and such authorities may be repealed, revoked or modified, perhaps retroactively,
so as to result in U.S. federal income and estate tax consequences different from those discussed
below. This discussion assumes that the Non-U.S. Holder holds our common stock as a capital asset.
The following discussion is for general information only and is not tax advice. Persons
considering the purchase of our common stock should consult their own tax advisors concerning the
U.S. federal income and estate tax consequences in light of their particular situations as well as
any consequences arising under the laws of any other taxing jurisdiction, including any state,
local or foreign tax consequences.
Except as otherwise described in the discussion of estate tax below, a Non-U.S. Holder is a
beneficial holder of our common stock that is not a U.S. Holder or an entity treated as a
partnership for U.S. tax purposes. A U.S. Holder means a beneficial holder of our common stock
that is for U.S. federal income tax purposes (i) an individual who is a citizen or resident of the
United States, (ii) a corporation or other entity treated as a corporation created or organized in
or under the laws of the United States or any political subdivision thereof, (iii) an estate the
income of which is subject to U.S. federal income taxation regardless of its source or (iv) a trust
if it (x) is subject to the primary supervision of a court within the United States and one or more
U.S. persons have the authority to control all substantial decisions of the trust or (y) has a
valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
If a partnership (including any entity or arrangement treated as a partnership for U.S.
federal income tax purposes) acquires our common stock, the tax treatment of a partner in the
partnership will generally depend upon the status of the partner and the activities of the
partnership. Persons who are partners of partnerships holding our common stock are urged to consult
their tax advisors.
Distributions
Subject to the discussion below, distributions, if any, made to a Non-U.S. Holder of our
common stock out of our current or accumulated earnings and profits generally will constitute
dividends for U.S. tax purposes and will be subject to withholding tax at a 30% rate or such lower
rate as may be specified by an applicable income tax treaty. To obtain a reduced rate of
withholding under a treaty, a Non-U.S. Holder generally will be required to provide us with a
properly-executed IRS Form W-8BEN, or other appropriate form, certifying the Non-U.S. Holders
entitlement to benefits under that treaty. Treasury regulations provide special rules to determine
whether, for purposes of determining the applicability of a tax treaty, dividends paid to a
Non-U.S. Holder that is an entity should be treated as paid to the entity or to those holding an
interest in that entity. If a Non-U.S. Holder holds stock through a financial institution or other
agent acting on the holders behalf, the holder will be required to provide appropriate
documentation to such agent. The holders agent will then be required to provide certification to
us or our paying agent, either directly or through other intermediaries.
We generally are not required to withhold tax on dividends paid to a Non-U.S. Holder that
are effectively connected with the Non-U.S. Holders conduct of a trade or business within the
United States if a properly-executed IRS Form W-8ECI, stating that the dividends are so connected
(and are not exempt from net U.S. federal income tax
under a treaty as described below), is filed with us. Effectively connected dividends will be
subject to net U.S.
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federal income tax, generally in the same manner and at the regular rate as if
the Non-U.S. Holder were a U.S. citizen or resident alien or a domestic corporation, as the case
may be, unless a specific treaty exemption applies. If the Non-U.S. Holder is eligible for the
benefits of a tax treaty between the United States and the holders country of residence, any
effectively connected dividends would generally be subject to net U.S. federal income tax only if
they are also attributable to a permanent establishment maintained by the holder in the United
States. A corporate Non-U.S. Holder receiving effectively connected dividends may also be subject
to an additional branch profits tax, which is imposed, under certain circumstances, at a rate of
30% (or such lower rate as may be specified by an applicable treaty) of the corporate Non-U.S.
Holders effectively connected earnings and profits, subject to certain adjustments. If you are
eligible for a reduced rate of withholding tax pursuant to a tax treaty, you may generally obtain a
refund of any excess amounts currently withheld if you timely file an appropriate claim for refund
with the IRS.
To the extent distributions on our common stock, if any, exceed our current and accumulated
earnings and profits, they will constitute a return of capital and will first reduce your basis in
our common stock, but not below zero, and then will be treated as gain from the sale of stock.
Gain on disposition of common stock
A Non-U.S. Holder generally will not be subject to U.S. federal income tax with respect to
gain realized on a sale or other disposition of our common stock unless (i) the gain is effectively
connected with a trade or business of such holder in the United States, (ii) in the case of
Non-U.S. Holders who are nonresident alien individuals, such individuals are present in the United
States for 183 or more days in the taxable year of the disposition and certain other conditions are
met, or (iii) we are or have been a United States real property holding corporation within the
meaning of Code Section 897(c)(2) at any time within the shorter of the five-year period preceding
such disposition or such holders holding period. In general, we would be a United States real
property holding corporation if interests in U.S. real estate comprised at least half of our
business assets. We believe that we are not, and do not anticipate becoming, a United States real
property holding corporation. Even if we are treated as a United States real property holding
corporation, gain realized by a Non-U.S. Holder on a disposition of our common stock will not be
subject to U.S. federal income tax so long as (1) the Non-U.S. Holder owned directly, indirectly
and constructively, no more than five percent of our common stock at all times within the shorter
of (a) the five year period preceding the disposition or (b) the holders holding period and (2)
our common stock is regularly traded on an established securities market. There can be no assurance
that our common stock will continue to qualify as regularly traded on an established securities
market.
If you are a Non-U.S. Holder described in (i) above, you will be required to pay tax on the
net gain derived from the sale at generally applicable United States federal income tax rates,
subject to an applicable income tax treaty providing otherwise, and corporate Non-U.S. Holders
described in (i) above may be subject to the branch profits tax at a 30% rate or such lower rate as
may be specified by an applicable income tax treaty. If you are an individual Non-U.S. Holder
described in (ii) above, you will be required to pay a flat 30% tax (or a reduced rate under an
applicable income tax treaty) on the gain derived from the sale, which tax may be offset by U.S.
source capital losses if you have timely filed tax returns with respect to such losses (even though
you are not considered a resident of the United States).
Information reporting and backup withholding
Generally, we must report to the IRS the amount of dividends paid, the name and address of the
recipient, and the amount, if any, of tax withheld. A similar report is sent to the holder.
Pursuant to tax treaties or certain other agreements, the IRS may make its reports available to tax
authorities in the recipients country of residence. Backup withholding will generally not apply to
payments of dividends made by us or our paying agents to a Non-U.S. Holder if the holder has
provided its federal taxpayer identification number, if any, or the required certification that it
is not a U.S. person (which is generally provided by furnishing a properly-executed IRS Form
W-8BEN), unless the payer otherwise has knowledge or reason to know that the payee is a U.S.
person. The backup withholding rate is currently 28% and scheduled to rise to 31% after December
31, 2010. Backup withholding is generally not required on payments to corporations, whether
domestic or foreign.
Under current U.S. federal income tax law, information reporting and backup withholding will
apply to the proceeds of a disposition of our common stock effected by or through a U.S. office of
a broker unless the disposing
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holder certifies as to its non-U.S. status or otherwise establishes
an exemption. The certification procedures for claiming benefits under a tax treaty described in
Distributions above will satisfy the certification requirements to avoid backup withholding as
well. Generally, U.S. information reporting and backup withholding will not apply to a payment of
disposition proceeds where the transaction is effected outside the United States through a non-U.S.
office of a non-U.S. broker. Backup withholding will apply to a payment of disposition proceeds if
the broker has actual knowledge or reason to know that the holder is a U.S. person.
Backup withholding is not an additional tax. Rather, the tax liability of persons subject to
backup withholding will be reduced by the amount of tax withheld. If withholding results in an
overpayment of taxes, a refund may generally be obtained, provided that the required information is
timely furnished to the IRS.
New legislation relating to foreign accounts
Newly enacted legislation may impose withholding taxes on certain types of payments made to
foreign financial institutions (as specifically defined in this new legislation) and certain
other non-U.S. entities (including financial intermediaries). Under this legislation, the failure
to comply with additional certification, information reporting and other specified requirements
could result in withholding tax being imposed on payments of dividends and sales proceeds to
foreign intermediaries and certain Non-U.S. Holders. The legislation imposes a 30% withholding tax
on dividends, or gross proceeds from the sale or other disposition of, common stock paid to a
foreign financial institution or to a foreign non-financial entity, unless (i) the foreign
financial institution undertakes certain diligence and reporting obligations or (ii) the foreign
non-financial entity either certifies it does not have any substantial United States owners or
furnishes identifying information regarding each substantial United States owner. If the payee is a
foreign financial institution, it must enter into an agreement with the United States Treasury
requiring, among other things, that it undertake to identify accounts held by certain United States
persons or United States-owned foreign entities, annually report certain information about such
accounts, and withhold 30% on payments to account holders whose actions prevent it from complying
with these reporting and other requirements. The legislation applies to payments made after
December 31, 2012. Prospective investors should consult their tax advisors regarding this
legislation.
Federal estate tax
An individual who at the time of death is not a citizen or resident of the United States and
who is treated as the owner of, or has made certain lifetime transfers of, an interest in our
common stock will be required to include the value thereof in his or her taxable estate for U.S.
federal estate tax purposes, and may be subject to U.S. federal estate tax unless an applicable
estate tax treaty provides otherwise. The U.S. federal estate tax was automatically repealed
effective January 1, 2010, for the estates of decedents dying in the year 2010. Accordingly, at
present, there is no U.S. federal estate tax. However, Congress could pass a law reinstating the
estate tax that has retroactive effect. In addition, unless Congress acts to make the current
repeal permanent, the estate tax will be reinstated with respect to decedents who die after
December 31, 2010. The test for whether an individual is a resident of the United States for
federal estate tax purposes differs from the test used for U.S. federal income tax purposes. Some
individuals, therefore, may be Non-U.S. Holders for U.S. federal income tax purposes, but not for
U.S. federal estate tax purposes, and vice versa.
THE PRECEDING DISCUSSION OF U.S. FEDERAL INCOME TAX CONSIDERATIONS IS FOR GENERAL INFORMATION
ONLY. IT IS NOT TAX ADVICE. EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS OWN TAX ADVISOR REGARDING
THE TAX CONSEQUENCES OF PURCHASING, HOLDING AND DISPOSING OF OUR COMMON STOCK, INCLUDING THE
CONSEQUENCES OF ANY PROPOSED CHANGE IN APPLICABLE LAW.
S-33
UNDERWRITING
Under the terms and subject to the conditions in an underwriting agreement dated the date of
this prospectus supplement, the underwriter named below has agreed to purchase, and we have agreed
to sell to it, the number of shares of our common stock at the public offering price, less the
underwriting discounts and commissions, as set forth on the cover page of this prospectus
supplement as indicated below:
|
|
|
|
|
|
|
Number of |
|
Underwriter |
|
Shares |
|
Lazard Capital Markets LLC |
|
|
14,285,715 |
|
|
|
|
|
Total |
|
|
14,285,715 |
|
|
|
|
|
The underwriter is offering the shares of common stock subject to its acceptance of the shares
from us and subject to prior sale. The underwriting agreement provides that the obligations of the
underwriter to pay for and accept delivery of the shares offered by this prospectus supplement are
subject to certain conditions precedent, including the absence of any material adverse change in
our business and the approval of certain legal matters by its counsel and the receipt of customary
legal opinions, letters and certificates and to other conditions. The underwriter is obligated to
take and pay for all of the shares of common stock offered by this prospectus supplement if any
such shares are taken.
The
underwriter has an option to buy up to 2,142,857 additional shares of common stock from
us to cover sales of shares by the underwriter which exceed the number of shares specified in the
table above. The underwriter may exercise this option at any time and from time to time during the
30-day period from the date of this prospectus supplement. If any additional shares of common
stock are purchased, the underwriter will offer the additional shares of common stock on the same
terms as those on which the shares are being offered.
The underwriter initially proposes to offer the shares of common stock directly to the public
at the public offering price listed on the cover page of this prospectus supplement. After the
initial offering of the shares, the offering price and other selling terms may from time to time be
varied by the underwriter.
Commissions and Discounts
The following table summarizes the public offering price, underwriting discount and proceeds
before expenses to us assuming both no exercise and full exercise of the underwriters option to
purchase additional shares of common stock:
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|
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|
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|
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|
|
|
|
|
|
|
|
|
Total |
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|
|
|
|
|
Without |
|
With |
|
|
Per Share |
|
Over-Allotment |
|
Over-Allotment |
Public offering price
|
|
$ |
|
2.80 |
|
$ |
|
40,000,002 |
|
$ |
|
46,000,002 |
Underwriting discounts and commissions |
|
|
|
0.14 |
|
|
|
2,000,000 |
|
|
|
2,300,000 |
Proceeds, before expenses, to us |
|
|
|
2.66 |
|
|
|
38,000,002 |
|
|
|
43,700,002 |
The expenses of the offering, not including the underwriting discount and commissions, payable
by us are estimated to be $375,000.
The relationship between Lazard Frères & Co. LLC and Lazard Capital Markets LLC is governed by
a business alliance agreement between their respective parent companies. Pursuant to such
agreement, Lazard Frères & Co. LLC referred this offering to Lazard Capital Markets LLC and will
receive a referral fee from Lazard Capital Markets LLC in connection therewith; however, such
referral fee is not in addition to the fee paid by us to Lazard Capital Markets LLC described
above.
S-34
Quotation on the NASDAQ Global Market
Our common stock is listed on The NASDAQ Global Market under the symbol GTXI. Our registrar
and transfer agent for our common stock is Computershare Trust Company, N.A., located at 150 Royall
Street, Canton, MA 02021.
Indemnification
We and the underwriter have agreed to indemnify each other, and we have also agreed to
indemnify Lazard Frères & Co. LLC, against certain liabilities, including liabilities under the
Securities Act and liabilities arising from breaches of representations and warranties contained in
the underwriting agreement. We have also agreed to contribute to payments the underwriter and
Lazard Frères & Co. LLC may be required to make in respect of such liabilities.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers or persons controlling the registrant pursuant to the foregoing
provisions, the registrant has been informed that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act and is therefore
unenforceable.
No Sales of Similar Securities
We and each of our executive officers and directors have agreed with the underwriter, subject
to certain exceptions, not to dispose of or hedge any of our shares of common stock or securities
convertible into or exercisable or exchangeable for common stock for 90 days after the date of this
prospectus supplement without first obtaining the written consent of Lazard Capital Markets LLC.
Exceptions to these lock-up agreements with our directors and executive officers include the
following: (i) transfers to any member of the immediate family of the party to the lock-up from or
by a grantor retained (or like-kind) annuity trust which exists as of the date of this prospectus
supplement and was established for the direct or indirect benefit of the undersigned and/or any
member of the immediate family of the undersigned pursuant to the terms of such trust, (ii)
transfers in the event of a default under a pledge which exists as of the date hereof as security
for a margin or loan account pursuant to the terms of such account, (iii) transfers pursuant to any
Rule 10b5-1 trading plans in effect as of the date of the date of this offering, and (iv) from and
after the date that is 45 days following the date of this prospectus supplement, open market sales
of up to, in the aggregate, 10,000 shares of our common stock for each of our directors and
executive officers. Exceptions to the lock-up agreement with us include our ability to issue shares
of our common stock or securities convertible into or exercisable or exchangeable for our common
stock at any time in connection with strategic transactions involving us and other entities. The
90-day lock-up period during which we and our executive officers and directors are restricted from
engaging in transactions in our common stock or securities convertible into or exercisable or
exchangeable for common stock is subject to extension in the event that either (i) during the last
17 days of the lock-up period, we issue an earnings or financial results release or material news
or a material event relating to us occurs, or (ii) prior to the expiration of the lock-up period,
we announce that we will release earnings or financial results during the 16-day period beginning
on the last day of the lock-up period, then in either case the expiration of the lock-up period
will be extended until the expiration of the 18-day period beginning on the issuance of the
earnings or financial results release or the occurrence of the material news or material event, as
applicable, unless Lazard Capital Markets LLC waives, in writing, such an extension.
Price Stabilization, Short Positions
In order to facilitate the offering of the shares of common stock, the underwriter may engage
in transactions that stabilize, maintain or otherwise affect the price of our common stock.
Specifically, the underwriter may sell more shares of common stock than it is obligated to purchase
under the underwriting agreement, creating a short position. The underwriter must close out any
short position by purchasing shares of common stock in the open market. A short position may be
created if the underwriter is concerned that there may be downward pressure on the price of the
common stock in the open market after pricing that could adversely affect investors who purchased
in this offering. As an additional means of facilitating this offering, the underwriter may bid
for, and purchase, shares of our common stock in the open market to stabilize the price of the
common stock. These activities may raise or maintain the market price of our common stock above
independent market levels or prevent or slow a decline in the market price of our common stock. The
underwriter is not required to engage in these activities, and may end any of these activities at
any time.
S-35
A prospectus in electronic format may be made available on websites maintained by the
underwriter. Internet distributions will be allocated by the underwriter on the same basis as
other allocations.
United Kingdom
This document is only being distributed to and is only directed at (i) persons who are outside
the United Kingdom or (ii) to investment professionals falling within Article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order) or (iii)
high net worth entities, and other persons to whom it may lawfully be communicated, falling within
Article 49(2)(a) to (e) of the Order (all such persons together being referred to as relevant
persons). The shares of common stock are only available to, and any invitation, offer or
agreement to subscribe, purchase or otherwise acquire such shares will be engaged in only with,
relevant persons. Any person who is not a relevant person should not act or rely on this document
or any of its contents.
Each underwriter has represented and agreed that:
|
(a) |
|
it has only communicated or caused to be communicated and will only communicate or
cause to be communicated an invitation or inducement to engage in investment activity
(within the meaning of Section 21 of the Financial Services and Markets Act 2000 or FSMA)
received by it in connection with the issue or sale of the shares in circumstances in which
Section 21(1) of the FSMA does not apply to us, and |
|
|
(b) |
|
it has complied with, and will comply with all applicable provisions of FSMA with
respect to anything done by it in relation to the shares in, from or otherwise involving
the United Kingdom. |
European Economic Area
To the extent that the offer of the shares of common stock are made in any Member State of the
European Economic Area that has implemented the Prospectus Directive before the date of publication
of a prospectus in relation to the shares of common stock which has been approved by the competent
authority in the Member State in accordance with the Prospectus Directive (or, where appropriate,
published in accordance with the Prospectus Directive and notified to the competent authority in
the Member State in accordance with the Prospectus Directive), the offer (including any offer
pursuant to this document) is only addressed to qualified investors in that Member State within the
meaning of the Prospectus Directive or has been or will be made otherwise in circumstances that do
not require us to publish a prospectus pursuant to the Prospectus Directive.
In relation to each Member State of the European Economic Area which has implemented the
Prospectus Directive (each, a Relevant Member State), each underwriter has represented and agreed
that with effect from and including the date on which the Prospectus Directive is implemented in
that Relevant Member State (the Relevant Implementation Date) it has not made and will not make
an offer of shares to the public in that Relevant Member State prior to the publication of a
prospectus in relation to the shares which has been approved by the competent authority in that
Relevant Member State or, where appropriate, approved in another Relevant Member State and notified
to the competent authority in that Relevant Member State, all in accordance with the Prospectus
Directive, except that it may, with effect from and including the Relevant Implementation Date,
make an offer of shares to the public in that Relevant Member State at any time:
|
(a) |
|
to legal entities which are authorized or regulated to operate in the financial markets
or, if not so authorized or regulated, whose corporate purpose is solely to invest in
securities, |
|
|
(b) |
|
to any legal entity which has two or more of (1) an average of at least 250 employees
during the last financial year; (2) a total balance sheet of more than 43,000,000 and (3)
an annual net turnover of more than 50,000,000, as shown in its last annual or
consolidated accounts, or |
|
|
(c) |
|
in any other circumstances which do not require the publication by us of a prospectus
pursuant to Article 3 of the Prospectus Directive. For the purposes of this provision, the
expression an offer of shares to the public in relation to any shares in any Relevant
Member State means the communication in any form and by any means of sufficient information
on the terms of the offer and the shares to be offered so as to enable an investor to
decide to purchase or subscribe the shares, as the same may be varied in that Relevant
Member State by any measure implementing the Prospectus Directive in that Relevant Member
State and |
S-36
|
|
|
the expression Prospectus Directive means Directive 2003/71/EC and includes any relevant
implementing measure in each Relevant Member State. |
The EEA selling restriction is in addition to any other selling restrictions set out below. In
relation to each Relevant Member State, each purchaser of shares of common stock (other than the
underwriter) will be deemed to have represented, acknowledged and agreed that it will not make an
offer of shares of common stock to the public in any Relevant Member State, except that it may,
with effect from and including the date on which the Prospectus Directive is implemented in the
Relevant Member State, make an offer of shares of common stock to the public in that Relevant
Member State at any time in any circumstances which do not require the publication by us of a
prospectus pursuant to Article 3 of the Prospectus Directive, provided that such purchaser agrees
that it has not and will not make an offer of any shares of common stock in reliance or purported
reliance on Article 3(2)(b) of the Prospectus Directive. For the purposes of this provision, the
expression an offer of Shares to the public in relation to any shares of common stock in any
Relevant Member State has the same meaning as in the preceding paragraph.
S-37
LEGAL MATTERS
Cooley LLP, Palo Alto, California will pass upon the validity of the issuance of the common
stock offered by this prospectus supplement and the accompanying prospectus. Certain legal matters
will be passed upon for the underwriter by Proskauer Rose LLP, New York, New York.
EXPERTS
The financial statements of GTx, Inc. appearing in GTx, Inc.s Annual Report (Form 10-K) for
the year ended December 31, 2009, and the effectiveness of GTx, Inc.s internal control over
financial reporting as of December 31, 2009, have been audited by Ernst & Young LLP, independent
registered public accounting firm, as set forth in their reports thereon, included therein, and
incorporated herein by reference. Such financial statements are, and audited financial statements
to be included in subsequently filed documents will be, incorporated herein in reliance upon the
reports of Ernst & Young LLP pertaining to such financial statements and the effectiveness of our
internal control over financial reporting as of the respective dates (to the extent covered by
consents filed with the SEC) given on the authority of such firm as experts in accounting and
auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the reporting requirements of the Exchange Act and we file annual, quarterly
and special reports, proxy statements and other information with the SEC. You may read and copy any
document we file at the SECs Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for more information about the operation of 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 GTx, Inc. The SECs Internet site can be found at www.sec.gov. Our common stock is listed
on The NASDAQ Global Market, and you can read and inspect our filings at the offices of The NASDAQ
Stock Market at 1735 K Street, Washington, D.C. 20006. We maintain a website at www.gtxinc.com. The
information contained on our website is not incorporated by reference in this prospectus supplement
and the accompanying prospectus and you should not consider it a part of this prospectus supplement
and the accompanying prospectus.
You should rely only on the information contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus, along with the information contained in any
free writing prospectus that we have authorized for use in connection with this offering. We have
not authorized anyone to provide you with different or additional information. We are not making an
offer of these securities in any state where the offer is not permitted. You should assume that the
information appearing in this prospectus supplement, the accompanying prospectus, the documents
incorporated by reference in this prospectus supplement and the accompanying prospectus, and in any
free writing prospectus that we have authorized for use in connection with this offering is
accurate only as of the respective dates of those documents. Our business, financial condition,
results of operations and prospects may have changed since those dates.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference information from other documents 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 considered to be part of this prospectus
supplement and the accompanying prospectus. Information contained in this prospectus supplement and
the accompanying prospectus and information that we file with the SEC in the future and incorporate
by reference in this prospectus supplement and the accompanying prospectus will automatically
update and supersede this information. We incorporate by reference the documents listed below and
any future filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K
and exhibits filed on such form that are related to such items) we make with the SEC under Sections
13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, after the date of the
prospectus supplement and prior to the termination of the offering of the common stock covered by
this prospectus supplement (Commission File No. 0-50549):
|
|
|
our Annual Report on Form 10-K for the year ended December 31, 2009, filed with the SEC
on March 15, 2010; |
S-38
|
|
|
the information specifically incorporated by reference into our Annual Report on Form
10-K for the year ended December 31, 2009 from our definitive proxy statement on Schedule
14A for our 2010 Annual Meeting of Stockholders, filed with the SEC on March 18, 2010; |
|
|
|
|
our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010 and June 30,
2010, filed with the SEC on May 4, 2010 and August 9, 2010, respectively; |
|
|
|
|
our Current Reports on Form 8-K filed with the SEC on February 19, 2010, March 9, 2010,
March 15, 2010 (except for the information furnished under Item 2.02 and the related
exhibit), March 23, 2010, March 26, 2010, May 4, 2010 (except for the information
furnished under Item 2.02 and the related exhibit), May 26, 2010, June 9, 2010, June 21,
2010, September 15, 2010, October 26, 2010 and October 27, 2010; and |
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|
|
|
the description of our common stock contained in our registration statement on Form 8-A
filed with the SEC on January 13, 2004, including all amendments and reports filed for the
purpose of updating such information. |
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 GTx, Inc., Attention: Corporate Secretary, 175 Toyota Plaza, Suite
700, Memphis, Tennessee 38103. Our phone number is (901) 523-9700.
S-39
PROSPECTUS
$100,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
From time to time, we may offer up to $100,000,000 of any combination of the securities
described in this prospectus, either individually or in units. We may also offer common stock or
preferred stock upon conversion of debt securities, common stock upon conversion of preferred
stock, or common stock, preferred stock or debt securities upon the exercise of warrants.
We will provide the specific terms of these offerings and securities in one or more
supplements to this prospectus. We may also authorize one or more free writing prospectuses to be
provided to you in connection with these offerings. The prospectus supplement and any related free
writing prospectus may also add, update or change information contained in this prospectus. You
should carefully read this prospectus, the applicable prospectus supplement and any related free
writing prospectus, as well as any documents incorporated by reference, before buying any of the
securities being offered.
Our
common stock is traded on the NASDAQ Global Market under the symbol
GTXI. On December 24, 2007, the last reported sale price of our common stock on the NASDAQ Global Market was
$15.23. The applicable prospectus supplement will contain information, where applicable, as to any
other listing, if any, on the NASDAQ Global Market or any securities market or other exchange of
the securities covered by the applicable prospectus supplement.
Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties
described under the heading Risk Factors contained in the applicable prospectus supplement and any related free
writing prospectus, and under similar headings in the other documents that are incorporated by reference into this
prospectus.
This prospectus may not be used to consummate a sale of any securities unless accompanied by a
prospectus supplement.
The securities may be sold directly by us to investors, through agents designated from time to
time or to or through underwriters or dealers, on a continuous or delayed basis. For additional
information on the methods of sale, you should refer to the section entitled Plan of Distribution
in this prospectus. If any agents or underwriters are involved in the sale of any securities with
respect to which this prospectus is being delivered, the names of such agents or underwriters and
any applicable fees, commissions, discounts and over-allotment options will be set forth in a
prospectus supplement. The price to the public of such securities and the net proceeds that we
expect to receive from such 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.
The
date of this prospectus is January 17, 2008.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement on Form S-3 that we filed with the
Securities and Exchange Commission utilizing a shelf registration process. Under this shelf
registration process, we may offer shares of our common stock and preferred stock, various series
of debt securities and/or warrants to purchase any of such securities, either individually or in
units, in one or more offerings, up to a total dollar amount of $100,000,000. This prospectus
provides you with a general description of the securities we may offer. Each time we offer a type
or series of securities under this prospectus, we will provide a prospectus supplement that will
contain more specific information about the terms of those securities. We may also authorize one
or more free writing prospectuses to be provided to you that may contain material information
relating to these offerings. We may also add, update or change in the prospectus supplement (and
in any related free writing prospectus that we may authorize to be provided to you) any of the
information contained in this prospectus or in the documents that we have incorporated by reference
into this prospectus. We urge you to carefully read this prospectus, any applicable prospectus
supplement and any related free writing prospectus, together with the information incorporated
herein by reference as described under the heading Where You Can Find Additional Information,
before buying any of the securities being offered. THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A
SALE OF SECURITIES UNLESS IT IS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT.
You should rely only on the information that we have provided or incorporated by reference in
this prospectus, any applicable prospectus supplement and any related free writing prospectus that
we may authorize to be provided to you. We have not authorized anyone to provide you with
different information. No dealer, salesperson or other person is authorized to give any
information or to represent anything not contained in this prospectus, any applicable prospectus
supplement or any related free writing prospectus that we may authorize to be provided to you. You
must not rely on any unauthorized information or representation. This prospectus is an offer to
sell only the securities offered hereby, but only under circumstances and in jurisdictions where it
is lawful to do so. You should assume that the information in this prospectus, any applicable
prospectus supplement or any related free writing prospectus is accurate only as of the date on the
front of the document and that any information we have incorporated by reference is accurate only
as of the date of the document incorporated by reference, regardless of the time of delivery of
this prospectus, any applicable prospectus supplement or any related free writing prospectus, or
any sale of a security.
This prospectus contains summaries of certain provisions contained in some of the documents
described herein, but reference is made to the actual documents for complete information. All of
the summaries are qualified in their entirety by the actual documents. Copies of some of the
documents referred to herein have been filed, will be filed or will be incorporated by reference as
exhibits to the registration statement of which this prospectus is a part, and you may obtain
copies of those documents as described below under the heading Where You Can Find Additional
Information.
1
This prospectus and the information incorporated herein by reference includes trademarks,
service marks and trade names owned by us or other companies. All trademarks, service marks and
trade names included or incorporated by reference into this prospectus, any applicable prospectus
supplement or any related free writing prospectus are the property of their respective owners.
Unless otherwise mentioned or unless the context requires otherwise, all references in this
prospectus to GTx, we, our or similar references mean GTx, Inc.
GTx, INC.
We are a biopharmaceutical company dedicated to the discovery, development and
commercialization of small molecules that selectively target hormone pathways to treat cancer,
osteoporosis and bone loss, muscle wasting and other serious medical conditions. We are developing
ACAPODENE (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate
clinical programs in men: first, a pivotal Phase III clinical trial for the treatment of multiple
serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, a
pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with
precancerous prostate lesions called high grade prostatic intraepithelial neoplasia. We have
licensed to Ipsen Limited exclusive rights in the European Union, Switzerland, Norway, Iceland,
Lichtenstein and the Commonwealth of Independent States to develop and commercialize ACAPODENE and
other products containing toremifene in all indications that we have licensed from Orion
Corporation, which include all indications in humans except the treatment and prevention of breast
cancer outside of the United States. We are also developing Ostarine, a selective androgen receptor
modulator, or SARM, which is currently being evaluated in a
Phase II clinical trial for the treatment of muscle loss in
patients with cancer. We have entered into an exclusive license and collaboration agreement with Merck & Co.,
Inc., or Merck, governing our and Mercks joint research, development and global commercialization
of SARMs with the potential to treat age-related muscle loss
(sarcopenia) as well as other musculoskeletal conditions. We also have an extensive preclinical pipeline generated from our own discovery
program. We are evolving into a selective nuclear hormone receptor modulator company that develops
small molecules to target hormone pathways to address a myriad of unmet medical needs in men and
women.
We plan to build specialized sales and marketing capabilities to promote our product
candidates to urologists and medical oncologists in the United States and to seek additional
partners to commercialize our product candidates in broader markets in the United States and in the
rest of the world. We currently market FARESTON (toremifene citrate 60 mg) tablets, which have
been approved by the U.S. Food and Drug Administration, or FDA, for the treatment of metastatic
breast cancer in postmenopausal women in the United States. The active pharmaceutical ingredient in
FARESTON is the same as in ACAPODENE, but at a different dose.
We have a limited operating history and may not be able to attain profitability. We have
financed our operations and internal growth primarily through private placements of preferred stock
and our public offerings of common stock. We have incurred losses in each year since our inception
in 1997 and we expect to continue to incur net losses over the next several years as we continue
our clinical development and research and development activities, apply for regulatory approvals,
expand our sales and marketing capabilities and grow our operations.
We were originally incorporated under the name Genotherapeutics, Inc. in Tennessee in
September 1997. We changed our name to GTx, Inc. in 2001, and we reincorporated in Delaware in
2003. Our principal executive office is located at 3 N. Dunlap Street, Van Vleet Building, Memphis,
Tennessee, and our telephone number is (901) 523-9700. Our website address is www.gtxinc.com. The
information contained in, or that can be accessed through, our website is not part of this
prospectus.
RISK FACTORS
Investing in our securities involves a high degree of risk. You should carefully review the
risks and uncertainties described under the heading Risk Factors contained in the applicable
prospectus supplement and any related free writing prospectus, and under similar headings in the
other documents that are incorporated by reference into this prospectus. Additional risks not
presently known to us or that we currently believe are immaterial may also significantly impair our
business operations.
FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference contain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. These statements involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or achievements to be
2
materially different from any future results, performances or achievements expressed or
implied by the forward-looking statements. Forward-looking statements include statements about:
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the anticipated progress of our and our collaborators research, development
and clinical programs, including whether future clinical trials will achieve similar
results to clinical trials that we have successfully concluded; |
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potential future licensing fees, milestone payments and royalty payments, including any
milestone payments or royalty payments that we may receive under our collaborative
arrangements with Ipsen Limited and Merck & Co., Inc.; |
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our and our collaborators ability to market, commercialize and achieve market
acceptance for our product candidates or products that we and/or our collaborators may
develop; |
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our and our collaborators ability to generate additional product candidates for
clinical testing; |
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our ability to protect our intellectual property and operate our business without
infringing upon the intellectual property rights of others; and |
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our estimates regarding the sufficiency of our cash resources. |
In some cases, you can identify forward-looking statements by terms such as anticipates,
believes, could, estimates, expects, intends, may, plans, potential, predicts,
projects, should, will, would and similar expressions intended to identify forward-looking
statements. Forward-looking statements reflect our current views with respect to future events, are
based on assumptions and are subject to risks, uncertainties and other important factors. We
discuss many of these risks, uncertainties and other important factors in greater detail under the
heading Risk Factors contained in the applicable prospectus supplement and any related free
writing prospectus, and in our most recent annual report on Form 10-K and in our most recent
quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings
with the SEC. Given these risks, uncertainties and other important factors, you should not place
undue reliance on these forward-looking statements. Also, these forward-looking statements
represent our estimates and assumptions only as of the date such forward-looking statements are
made. You should carefully read this prospectus, the applicable prospectus supplement and any
related free writing prospectus, together with the information incorporated herein by reference as
described under the heading Where You Can Find Additional Information, completely and with the
understanding that our actual future results may be materially different from what we expect.
Except as required by law, we assume no obligation to update any forward-looking statements
publicly, or to update the reasons why actual results could differ materially from those
anticipated in any forward-looking statements, even if new information becomes available in the
future.
THE SECURITIES WE MAY OFFER
We may offer shares of our common stock and preferred stock, various series of debt securities
and/or warrants to purchase any of such securities, either individually or in units, with a total
value of up to $100,000,000 from time to time under this prospectus at prices and on terms to be
determined by market conditions at the time of any offering. This prospectus provides you with a
general description of the securities we may offer. Each time we offer a type or series of
securities under this prospectus, we will provide a prospectus supplement that will describe the
specific amounts, prices and other important terms of the securities, including, to the extent
applicable:
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designation or classification; |
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aggregate principal amount or aggregate offering price; |
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maturity, if applicable; |
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original issue discount, if any; |
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rates and times of payment of interest or dividends, if any; |
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redemption, conversion, exercise, exchange or sinking fund terms, if any; |
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ranking; |
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restrictive covenants, if any; |
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voting or other rights, if any; |
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conversion prices, if any; and |
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important United States federal income tax considerations. |
The prospectus supplement and any related free writing prospectus that we may authorize to be
provided to you may also add, update or change information contained in this prospectus or in
documents we have incorporated by reference. However, no prospectus supplement or free writing
prospectus will offer a security that is not registered and described in this prospectus at the
time of the effectiveness of the registration statement of which this prospectus is a part.
THIS PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF SECURITIES UNLESS IT IS ACCOMPANIED
BY A PROSPECTUS SUPPLEMENT.
We may sell the securities directly to investors or to or through agents, underwriters or
dealers. We, and our agents or underwriters, reserve the right to accept or reject all or part of
any proposed purchase of securities. If we do offer securities to or through agents or
underwriters, we will include in the applicable prospectus supplement:
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the names of those agents or underwriters; |
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applicable fees, discounts and commissions to be paid to them; |
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details regarding over-allotment options, if any; and |
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the net proceeds to us. |
Common Stock. We may issue shares of our common stock from time to time. The holders of our
common stock are entitled to one vote for each share held of record on all matters submitted to a
vote of stockholders and do not have cumulative voting rights. Subject to preferences that may be
applicable to any outstanding shares of preferred stock, the holders of our common stock are
entitled to receive ratably such dividends as may be declared by our board of directors out of
legally available funds. Upon our liquidation, dissolution or winding up, holders of our common
stock are entitled to share ratably in all assets remaining after payment of liabilities and the
liquidation preferences of any outstanding shares of preferred stock.
Preferred Stock. We may issue shares of our preferred stock from time to time, in one or more
series. Our board of directors will determine the designations, voting powers, preferences and
rights of the preferred stock, as well as the qualifications, limitations or restrictions thereof,
including dividend rights, conversion rights, preemptive rights, terms of redemption or repurchase,
liquidation preferences, sinking fund terms and the number of shares constituting any series or the
designation of any series. Convertible preferred stock will be convertible into our common stock or
exchangeable for our other securities. Conversion may be mandatory or at your option and would be
at prescribed conversion rates.
If we sell any series of preferred stock under this prospectus, we will fix the designations,
voting powers, preferences and rights of such series of preferred stock, as well as the
qualifications, limitations or restrictions thereof, in the certificate of designation relating to
that series. We will file as an exhibit to the registration statement of which this prospectus is a
part, or will incorporate by reference from reports that we file with the SEC, the form of any
certificate of designation that describes the terms of the series of preferred stock that we are
offering before the issuance of the related series of preferred stock. We urge you to read the
applicable prospectus supplement (and any free writing prospectus that we may authorize to be
provided to you) related to the series of preferred stock being offered, as well as the complete
certificate of designation that contains the terms of the applicable series of preferred stock.
Debt Securities. We may issue debt securities from time to time, in one or more series, as
either senior or subordinated debt or as senior or subordinated convertible debt. The senior debt
securities will rank equally with any other unsecured and unsubordinated debt. The subordinated
debt securities will be subordinate and junior in right of payment, to the extent and in the manner
described in the instrument governing the debt, to all of our senior indebtedness. Convertible debt
securities will be convertible into or exchangeable for our common stock or our other securities.
Conversion may be mandatory or at your option and would be at prescribed conversion rates.
4
The debt securities will be issued under one or more documents called indentures, which are
contracts between us and a national banking association or other eligible party, as trustee. In
this prospectus, we have summarized certain general features of the debt securities. We urge you,
however, to read the applicable prospectus supplement (and any free writing prospectus that we may
authorize to be provided to you) related to the series of debt securities being offered, as well
as the complete indentures that contain the terms of the debt securities. Forms of indentures have
been filed as exhibits to the registration statement of which this prospectus is a part, and
supplemental indentures and forms of debt securities containing the terms of the debt securities
being offered will be filed as exhibits to the registration statement of which this prospectus is a
part or will be incorporated by reference from reports that we file with the SEC.
Warrants. We may issue warrants for the purchase of common stock, preferred stock and/or debt
securities in one or more series. We may issue warrants independently or together with common
stock, preferred stock and/or debt securities, and the warrants may be attached to or separate from
these securities. In this prospectus, we have summarized certain general features of the warrants.
We urge you, however, to read the applicable prospectus supplement (and any free writing prospectus
that we may authorize to be provided to you) related to the particular series of warrants being
offered, as well as the complete warrant agreements and warrant certificates that contain the terms
of the warrants. Forms of the warrant agreements and forms of warrant certificates containing the
terms of the warrants being offered have been filed as exhibits to the registration statement of
which this prospectus is a part, and supplemental warrant agreements and forms of warrant
certificates will be filed as exhibits to the registration statement of which this prospectus is a
part or will be incorporated by reference from reports that we file with the SEC.
We will evidence each series of warrants by warrant certificates that we will issue. Warrants
may be issued under an applicable warrant agreement that we enter into with a warrant agent. We
will indicate the name and address of the warrant agent, if applicable, in the prospectus
supplement relating to the particular series of warrants being offered.
Units. We may issue, in one or more series, units consisting of common stock, preferred
stock, debt securities and/or warrants for the purchase of common stock, preferred stock and/or
debt securities in any combination. In this prospectus, we have summarized certain general features
of the units. We urge you, however, to read the applicable prospectus supplement (and any free
writing prospectus that we may authorize to be provided to you) related to the series of units
being offered, as well as the complete unit agreement that contains the terms of the units. We will
file as exhibits to the registration statement of which this prospectus is a part, or will
incorporate by reference from reports that we file with the SEC, the form of unit agreement and any
supplemental agreements that describe the terms of the series of units we are offering before the
issuance of the related series of units.
We will evidence each series of units by unit certificates that we will issue. Units may be
issued under a unit agreement that we enter into with a unit agent. We will indicate the name and
address of the unit agent, if applicable, in the prospectus supplement relating to the particular
series of units being offered.
RATIO OF EARNINGS TO FIXED CHARGES
Our earnings were insufficient to cover fixed charges for each of the periods presented.
Accordingly, the following table sets forth the deficiency of earnings to fixed charges for each of
the periods presented. Because of the deficiency, ratio information is not applicable. Amounts
shown are in thousands.
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Nine Months Ended |
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Year Ended December 31, |
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September 30, 2007 |
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2005 |
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2004 |
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2003 |
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2002 |
Deficiency of earnings available to cover fixed charges |
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$ |
(27,569 |
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(35,510 |
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(36,839 |
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$ |
(22,348 |
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$ |
(14,194 |
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$ |
(11,866 |
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For purposes of computing the deficiency of earnings available to cover fixed charges, fixed
charges represent that portion of rental expense that is considered by us to be representative of
interest. Earnings consists of loss before income taxes plus fixed charges.
USE OF PROCEEDS
Except as described in any prospectus supplement or in any related free writing prospectus
that we may authorize to be provided to you, we currently intend to use the net proceeds from the
sale of the securities offered hereby for research and development and general corporate purposes.
We may also use a portion of the net proceeds to acquire or invest in businesses, products and
technologies that are complementary to our own, as well as for capital expenditures. Pending these
uses, we expect to invest the net proceeds in short-term, investment-grade securities.
5
DESCRIPTION OF CAPITAL STOCK
General
Our authorized capital stock consists of 60,000,000 shares of common stock, $0.001 par value
per share, and 5,000,000 shares of preferred stock, $0.001 par value per share. As of December 18,
2007, there were 36,216,263 shares of our common stock outstanding and no shares of preferred stock
outstanding.
The following summary description of our capital stock is based on the provisions of our
certificate of incorporation and bylaws and the applicable provisions of the Delaware General
Corporation Law. This information is qualified entirely by reference to the applicable provisions
of our certificate of incorporation, bylaws and the Delaware General Corporation Law. For
information on how to obtain copies of our certificate of incorporation and bylaws, which are
exhibits to the registration statement of which this prospectus is a part, see Where You Can Find
Additional Information.
Common Stock
The holders of our common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of stockholders. The holders of our common stock do not have cumulative
voting rights in the election of directors. Subject to preferences that may be applicable to any
outstanding shares of preferred stock, the holders of common stock are entitled to receive ratably
such dividends as may be declared by our board of directors out of legally available funds. Upon
our liquidation, dissolution or winding up, holders of our common stock are entitled to share
ratably in all assets remaining after payment of liabilities and the liquidation preferences of any
outstanding shares of preferred stock. Holders of common stock have no preemptive rights and no
right to convert their common stock into any other securities. There are no redemption or sinking
fund provisions applicable to our common stock.
The rights of the holders of our common stock are subject to, and may be adversely affected
by, the rights of holders of shares of any preferred stock that we may designate and issue in the
future.
Preferred Stock
Pursuant to our certificate of incorporation, our board of directors has the authority,
without further action by the stockholders (unless such stockholder action is required by
applicable law or NASDAQ rules), to designate and issue up to 5,000,000 shares of preferred stock
in one or more series, to establish from time to time the number of shares to be included in each
such series, to fix the designations, voting powers, preferences and rights of the shares of each
wholly unissued series, and any qualifications, limitations or restrictions thereof, and to
increase or decrease the number of shares of any such series, but not below the number of shares of
such series then outstanding.
We will fix the designations, voting powers, preferences and rights of the preferred stock of
each series, as well as the qualifications, limitations or restrictions thereof, in the certificate
of designation relating to that series. We will file as an exhibit to the registration statement of
which this prospectus is a part, or will incorporate by reference from reports that we file with
the SEC, the form of any certificate of designation that describes the terms of the series of
preferred stock we are offering before the issuance of that series of preferred stock. This
description will include:
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the title and stated value; |
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the number of shares we are offering; |
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the liquidation preference per share; |
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the purchase price; |
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the dividend rate, period and payment date and method of calculation for dividends; |
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whether dividends will be cumulative or non-cumulative and, if cumulative, the date from
which dividends will accumulate; |
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the procedures for any auction and remarketing, if any; |
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the provisions for a sinking fund, if any; |
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the provisions for redemption or repurchase, if applicable, and any restrictions on our
ability to exercise those redemption and repurchase rights; |
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any listing of the preferred stock on any securities exchange or market; |
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whether the preferred stock will be convertible into our common stock, and, if
applicable, the conversion price, or how it will be calculated, and the conversion period; |
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whether the preferred stock will be exchangeable into debt securities, and, if
applicable, the exchange price, or how it will be calculated, and the exchange period; |
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voting rights, if any, of the preferred stock; |
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preemptive rights, if any; |
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restrictions on transfer, sale or other assignment, if any; |
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whether interests in the preferred stock will be represented by depositary shares; |
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a discussion of any material United States federal income tax considerations applicable
to the preferred stock; |
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the relative ranking and preferences of the preferred stock as to dividend rights and
rights if we liquidate, dissolve or wind up our affairs; |
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any limitations on the issuance of any class or series of preferred stock ranking senior
to or on a parity with the series of preferred stock as to dividend rights and rights if we
liquidate, dissolve or wind up our affairs; and |
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any other specific terms, preferences, rights or limitations of, or restrictions on, the
preferred stock. |
The General Corporation Law of the State of Delaware, the state of our incorporation, provides
that the holders of preferred stock will have the right to vote separately as a class (or, in some
cases, as a series) on an amendment to our certificate of incorporation if the amendment would
change the par value or, unless the certificate of incorporation provided otherwise, the number of
authorized shares of the class or change the powers, preferences or special rights of the class or
series so as to adversely affect the class or series, as the case may be. This right is in addition
to any voting rights that may be provided for in the applicable certificate of designation.
Our board of directors may authorize the issuance of preferred stock with voting or conversion
rights that could adversely affect the voting power or other rights of the holders of our common
stock. Preferred stock could be issued quickly with terms designed to delay or prevent a change in
control of our company or make removal of management more difficult. Additionally, the issuance of
preferred stock may have the effect of decreasing the market price of our common stock.
Registration Rights
J.R. Hyde, III, and Oracle Partners, L.P., two of our largest stockholders, and their
affiliates, are entitled to certain rights with respect to the registration of approximately 10.9
million shares of our common stock under the Securities Act of 1933, based on shares held as of
December 18, 2007. If we propose to register any of our securities under the Securities Act, either
for our own account or for the account of others, the holders of these shares are entitled to
notice of the registration and are entitled to include, at our expense, their shares of common
stock in the registration and any related underwriting, provided, among other conditions, that the
underwriters may limit the number of shares to be included in the registration. These holders have
waived these registration rights in connection with the filing of, and any offerings that might be
made pursuant to, the registration statement of which this prospectus is a part. In addition, the
holders of these shares may require us, at our expense and subject to certain limitations, to file
a registration statement under the Securities Act with respect to their shares of our common stock.
We have also entered into a registration rights agreement with Merck & Co., Inc., or Merck,
pursuant to which we agreed to file and keep effective a shelf registration statement under the
Securities Act registering the resale from time to time thereunder of the 1,285,347 shares of
common stock that we issued to Merck in December 2007.
Anti-Takeover Effects of Provisions of Delaware Law and Our Charter Documents
Delaware Takeover Statute. We are subject to the provisions of Section 203 of the Delaware
General Corporation Law. In general, the statute prohibits a publicly-held Delaware corporation
such as us from engaging in a business combination with an interested stockholder for a period of
three years after the date of the transaction in which the person became an interested stockholder,
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unless the business combination is approved in a prescribed manner. For purposes of
Section 203, a business combination includes a merger, asset or stock sale or other transaction
resulting in a financial benefit to the interested stockholder, and an interested stockholder is a
person who, together with affiliates and associates, owns, or within three years prior, did own,
15% or more of our voting stock. Section 203 of the Delaware General Corporation Law will generally
have an anti-takeover effect for transactions not approved in advance by our board of directors,
including discouraging attempts that might result in a premium over the market price for the shares
of common stock held by our stockholders.
Charter Documents. Our certificate of incorporation and bylaws provide that our board of
directors be divided into three classes of directors, with each class serving a staggered
three-year term. The classification system of electing directors may tend to discourage a third
party from making a tender offer or otherwise attempting to obtain control of us and may maintain
the composition of our current board of directors, as the classification of the board of directors
generally increases the difficulty of replacing a majority of directors. In addition, our
certificate of incorporation and bylaws:
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provide that any action required or permitted to be taken by our stockholders must be
effected at a duly called annual or special meeting of stockholders and may not be effected
by any consent in writing; |
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establish advance notice requirements for nominations for election to our board of
directors or for proposing matters that can be acted upon at a stockholder meeting; |
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provide that the authorized number of directors may be changed only by resolution of the
board of directors; and |
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provide that special meetings of our stockholders may be called only by the chairman of
our board of directors, our chief executive officer or our board of directors pursuant to a
resolution adopted by a majority of the total number of authorized directors. |
The Delaware corporate law statute provides generally that the affirmative vote of a majority
of the shares entitled to vote is required to amend a corporations bylaws, unless a corporations
certificate of incorporation requires a greater percentage or also confers the power upon the
corporations directors. Our bylaws may be amended or repealed by:
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the affirmative vote of a majority of our directors then in office; or |
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the affirmative vote of the holders of at least 66-2/3% of the voting power of all
then-outstanding shares of our capital stock entitled to vote generally in the election of
directors. |
The provisions described in the preceding paragraph that are included in our certificate of
incorporation may only be amended or repealed by the affirmative vote of a majority of our
directors and the affirmative vote of the holders of at least 66-2/3% of the voting power of all
then-outstanding shares of our capital stock entitled to vote generally in the election of
directors.
These and other provisions contained in our certificate of incorporation and bylaws could
delay or discourage some types of transactions involving an actual or potential change in our
control or change in our management, including transactions in which stockholders might otherwise
receive a premium for their shares over then current prices, and may limit the ability of
stockholders to remove current management or approve transactions that stockholders may deem to be
in their best interests and, therefore, could adversely affect the price of our common stock.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Computershare Trust Company, N.A. Its
address is 150 Royall Street, Canton, MA 02021. The transfer agent for any series of preferred
stock that we may offer under this prospectus will be named and described in the prospectus
supplement for that series.
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities, in one or more series, as either senior or subordinated debt or
as senior or subordinated convertible debt. While the terms we have summarized below will apply
generally to any debt securities that we may offer under this prospectus, we will describe the
particular terms of any debt securities that we may offer in more detail in the applicable
prospectus supplement. The terms of any debt securities offered under a prospectus supplement may
differ from the terms described below. Unless the context
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requires otherwise, whenever we refer to the indentures, we also are referring to any
supplemental indentures that specify the terms of a particular series of debt securities.
We will issue the senior debt securities under the senior indenture that we will enter into
with the trustee named in the senior indenture. We will issue the subordinated debt securities
under the subordinated indenture that we will enter into with the trustee named in the subordinated
indenture. The indentures will be qualified under the Trust Indenture Act of 1939. We use the term
debenture trustee to refer to either the trustee under the senior indenture or the trustee under
the subordinated indenture, as applicable. We have filed forms of indentures to the registration
statement of which this prospectus is a part, and supplemental indentures and forms of debt
securities containing the terms of the debt securities being offered will be filed as exhibits to
the registration statement of which this prospectus is a part or will be incorporated by reference
from reports that we file with the SEC.
The following summaries of material provisions of the senior debt securities, the subordinated
debt securities and the indentures are subject to, and qualified in their entirety by reference to,
all of the provisions of the indenture applicable to a particular series of debt securities. We
urge you to read the applicable prospectus supplements and any related free writing prospectuses
related to the debt securities that we may offer under this prospectus, as well as the complete
indentures that contains the terms of the debt securities. Except as we may otherwise indicate, the
terms of the senior indenture and the subordinated indenture are identical.
General
We will describe in the applicable prospectus supplement the terms of the series of debt
securities being offered, including:
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the title; |
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the principal amount being offered, and if a series, the total amount authorized and the
total amount outstanding; |
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any limit on the amount that may be issued; |
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whether or not we will issue the series of debt securities in global form, the terms and
who the depositary will be; |
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the maturity date; |
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whether and under what circumstances, if any, we will pay additional amounts on any debt
securities held by a person who is not a United States person for tax purposes, and whether
we can redeem the debt securities if we have to pay such additional amounts; |
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the annual interest rate, which may be fixed or variable, or the method for determining
the rate and the date interest will begin to accrue, the dates interest will be payable and
the regular record dates for interest payment dates or the method for determining such
dates; |
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whether or not the debt securities will be secured or unsecured, and the terms of any
secured debt; |
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the terms of the subordination of any series of subordinated debt; |
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the place where payments will be payable; |
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restrictions on transfer, sale or other assignment, if any; |
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our right, if any, to defer payment of interest and the maximum length of any such
deferral period; |
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the date, if any, after which, and the price at which, we may, at our option, redeem the
series of debt securities pursuant to any optional or provisional redemption provisions and
the terms of those redemption provisions; |
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the date, if any, on which, and the price at which we are obligated, pursuant to any
mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the
holders option to purchase, the series of debt securities and the currency or currency
unit in which the debt securities are payable; |
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whether the indenture will restrict our ability and/or the ability of our subsidiaries
to: |
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incur additional indebtedness; |
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issue additional securities; |
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create liens; |
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pay dividends and make distributions in respect of our capital stock and the capital
stock of our subsidiaries; |
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redeem capital stock; |
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place restrictions on our subsidiaries ability to pay dividends, make distributions
or transfer assets; |
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make investments or other restricted payments; |
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sell or otherwise dispose of assets; |
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enter into sale-leaseback transactions; |
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engage in transactions with stockholders and affiliates; |
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issue or sell stock of our subsidiaries; or |
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effect a consolidation or merger; |
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whether the indenture will require us to maintain any interest coverage, fixed charge,
cash flow-based, asset-based or other financial ratios; |
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a discussion of any material United States federal income tax considerations applicable
to the debt securities; |
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information describing any book-entry features; |
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provisions for a sinking fund purchase or other analogous fund, if any; |
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the applicability of the provisions in the indenture on discharge; |
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whether the debt securities are to be offered at a price such that they will be deemed
to be offered at an original issue discount as defined in paragraph (a) of Section 1273
of the Internal Revenue Code; |
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the denominations in which we will issue the series of debt securities, if other than
denominations of $1,000 and any integral multiple thereof; |
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the currency of payment of debt securities if other than U.S. dollars and the manner of
determining the equivalent amount in U.S. dollars; and |
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any other specific terms, preferences, rights or limitations of, or restrictions on, the
debt securities, including any additional events of default or covenants provided with
respect to the debt securities, and any terms that may be required by us or advisable under
applicable laws or regulations. |
Conversion or Exchange Rights
We will set forth in the prospectus supplement the terms on which a series of debt securities
may be convertible into or exchangeable for our common stock or our other securities. We will
include provisions as to whether conversion or exchange is mandatory, at the option of the holder
or at our option. We may include provisions pursuant to which the number of shares of our common
stock or our other securities that the holders of the series of debt securities receive would be
subject to adjustment.
Consolidation, Merger or Sale
Unless we provide otherwise in the prospectus supplement applicable to a particular series of
debt securities, the indentures will not contain any covenant that restricts our ability to merge
or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our
assets. However, any successor to or acquirer of such assets must assume all of our obligations
under the indentures or the debt securities, as appropriate. If the debt securities are convertible
into or exchangeable for our other securities or securities of other entities, the person with whom
we consolidate or merge or to whom we sell all of our property must make provisions for the
conversion of the debt securities into securities that the holders of the debt securities would
have received if they had converted the debt securities before the consolidation, merger or sale.
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Events of Default Under the Indenture
Unless we provide otherwise in the prospectus supplement applicable to a particular series of
debt securities, the following are events of default under the indentures with respect to any
series of debt securities that we may issue:
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if we fail to pay interest when due and payable and our failure continues for 90 days
and the time for payment has not been extended or deferred; |
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if we fail to pay the principal, premium or sinking fund payment, if any, when due and
payable and the time for payment has not been extended or delayed; |
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if we fail to observe or perform any other covenant contained in the debt securities or
the indentures, other than a covenant specifically relating to another series of debt
securities, and our failure continues for 90 days after we receive notice from the
debenture trustee or holders of at least 25% in aggregate principal amount of the
outstanding debt securities of the applicable series; and |
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if specified events of bankruptcy, insolvency or reorganization occur. |
If an event of default with respect to debt securities of any series occurs and is continuing,
other than an event of default specified in the last bullet point above, the debenture trustee or
the holders of at least 25% in aggregate principal amount of the outstanding debt securities of
that series, by notice to us in writing, and to the debenture trustee if notice is given by such
holders, may declare the unpaid principal of, premium, if any, and accrued interest, if any, due
and payable immediately. If an event of default specified in the last bullet point above occurs
with respect to us, the principal amount of and accrued interest, if any, of each issue of debt
securities then outstanding shall be due and payable without any notice or other action on the part
of the debenture trustee or any holder.
The holders of a majority in principal amount of the outstanding debt securities of an
affected series may waive any default or event of default with respect to the series and its
consequences, except defaults or events of default regarding payment of principal, premium, if any,
or interest, unless we have cured the default or event of default in accordance with the indenture.
Any waiver shall cure the default or event of default.
Subject to the terms of the indentures, if an event of default under an indenture shall occur
and be continuing, the debenture trustee will be under no obligation to exercise any of its rights
or powers under such indenture at the request or direction of any of the holders of the applicable
series of debt securities, unless such holders have offered the debenture trustee reasonable
indemnity. The holders of a majority in principal amount of the outstanding debt securities of any
series will have the right to direct the time, method and place of conducting any proceeding for
any remedy available to the debenture trustee, or exercising any trust or power conferred on the
debenture trustee, with respect to the debt securities of that series, provided that:
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the direction so given by the holder is not in conflict with any law or the applicable
indenture; and |
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subject to its duties under the Trust Indenture Act of 1939, the debenture trustee need
not take any action that might involve it in personal liability or might be unduly
prejudicial to the holders not involved in the proceeding. |
A holder of the debt securities of any series will have the right to institute a proceeding
under the indentures or to appoint a receiver or trustee, or to seek other remedies only if:
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the holder has given written notice to the debenture trustee of a continuing event of
default with respect to that series; |
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the holders of at least 25% in aggregate principal amount of the outstanding debt
securities of that series have made written request, and such holders have offered
reasonable indemnity to the debenture trustee to institute the proceeding as trustee; and |
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the debenture trustee does not institute the proceeding, and does not receive from the
holders of a majority in aggregate principal amount of the outstanding debt securities of
that series other conflicting directions within 90 days after the notice, request and
offer. |
These limitations do not apply to a suit instituted by a holder of debt securities if we
default in the payment of the principal, premium, if any, or interest on, the debt securities.
We will periodically file statements with the debenture trustee regarding our compliance with
specified covenants in the indentures.
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Modification of Indenture; Waiver
We and the debenture trustee may change an indenture without the consent of any holders with
respect to specific matters:
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to fix any ambiguity, defect or inconsistency in the indenture; |
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to comply with the provisions described above under Description of Debt
SecuritiesConsolidation, Merger or Sale; |
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to comply with any requirements of the SEC in connection with the qualification of any
indenture under the Trust Indenture Act of 1939; |
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to add to, delete from or revise the conditions, limitations, and restrictions on the
authorized amount, terms, or purposes of issue, authentication and delivery of debt
securities, as set forth in the indenture; |
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to provide for the issuance of and establish the form and terms and conditions of the
debt securities of any series as provided under Description of Debt SecuritiesGeneral to
establish the form of any certifications required to be furnished pursuant to the terms of
the indenture or any series of debt securities, or to add to the rights of the holders of
any series of debt securities; |
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to evidence and provide for the acceptance of appointment hereunder by a successor
trustee; |
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to provide for uncertificated debt securities in addition to or in place of certificated
debt securities and to make all appropriate changes for such purpose; |
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to add to our covenants such new covenants, restrictions, conditions or provisions for
the protection of the holders, and to make the occurrence, or the occurrence and the
continuance, of a default in any such additional covenants, restrictions, conditions or
provisions an event of default; or |
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to change anything that does not materially adversely affect the interests of any holder
of debt securities of any series. |
In addition, under the indentures, the rights of holders of a series of debt securities may be
changed by us and the debenture trustee with the written consent of the holders of at least a
majority in aggregate principal amount of the outstanding debt securities of each series that is
affected. However, unless we provide otherwise in the prospectus supplement applicable to a
particular series of debt securities, we and the debenture trustee may make the following changes
only with the consent of each holder of any outstanding debt securities affected:
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extending the fixed maturity of the series of debt securities; |
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reducing the principal amount, reducing the rate of or extending the time of payment of
interest, or reducing any premium payable upon the redemption of any debt securities; or |
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reducing the percentage of debt securities, the holders of which are required to consent
to any amendment, supplement, modification or waiver. |
Discharge
Each indenture provides that we can elect to be discharged from our obligations with respect
to one or more series of debt securities, except for specified obligations, including obligations
to:
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register the transfer or exchange of debt securities of the series; |
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replace stolen, lost or mutilated debt securities of the series; |
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maintain paying agencies; |
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hold monies for payment in trust; |
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recover excess money held by the debenture trustee; |
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compensate and indemnify the debenture trustee; and |
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appoint any successor trustee. |
In order to exercise our rights to be discharged, we must deposit with the debenture trustee
money or government obligations sufficient to pay all the principal of, any premium, if any, and
interest on, the debt securities of the series on the dates payments are due.
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Form, Exchange and Transfer
We will issue the debt securities of each series only in fully registered form without coupons
and, unless we provide otherwise in the applicable prospectus supplement, in denominations of
$1,000 and any integral multiple thereof. The indentures provide that we may issue debt securities
of a series in temporary or permanent global form and as book-entry securities that will be
deposited with, or on behalf of, The Depository Trust Company or another depositary named by us and
identified in a prospectus supplement with respect to that series. See Legal Ownership of
Securities for a further description of the terms relating to any book-entry securities.
At the option of the holder, subject to the terms of the indentures and the limitations
applicable to global securities described in the applicable prospectus supplement, the holder of
the debt securities of any series can exchange the debt securities for other debt securities of the
same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject to the terms of the indentures and the limitations applicable to global securities set
forth in the applicable prospectus supplement, holders of the debt securities may present the debt
securities for exchange or for registration of transfer, duly endorsed or with the form of transfer
endorsed thereon duly executed if so required by us or the security registrar, at the office of the
security registrar or at the office of any transfer agent designated by us for this purpose. Unless
otherwise provided in the debt securities that the holder presents for transfer or exchange, we
will impose no service charge for any registration of transfer or exchange, but we may require
payment of any taxes or other governmental charges.
We will name in the applicable prospectus supplement the security registrar, and any transfer
agent in addition to the security registrar, that we initially designate for any debt securities.
We may at any time designate additional transfer agents or rescind the designation of any transfer
agent or approve a change in the office through which any transfer agent acts, except that we will
be required to maintain a transfer agent in each place of payment for the debt securities of each
series.
If we elect to redeem the debt securities of any series, we will not be required to:
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issue, register the transfer of, or exchange any debt securities of that series during a
period beginning at the opening of business 15 days before the day of mailing of a notice
of redemption of any debt securities that may be selected for redemption and ending at the
close of business on the day of the mailing; or |
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register the transfer of or exchange any debt securities so selected for redemption, in
whole or in part, except the unredeemed portion of any debt securities we are redeeming in
part. |
Information Concerning the Debenture Trustee
The debenture trustee, other than during the occurrence and continuance of an event of default
under an indenture, undertakes to perform only those duties as are specifically set forth in the
applicable indenture. Upon an event of default under an indenture, the debenture trustee must use
the same degree of care as a prudent person would exercise or use in the conduct of his or her own
affairs. Subject to this provision, the debenture trustee is under no obligation to exercise any of
the powers given it by the indentures at the request of any holder of debt securities unless it is
offered reasonable security and indemnity against the costs, expenses and liabilities that it might
incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of
the interest on any debt securities on any interest payment date to the person in whose name the
debt securities, or one or more predecessor securities, are registered at the close of business on
the regular record date for the interest.
We will pay principal of and any premium and interest on the debt securities of a particular
series at the office of the paying agents designated by us, except that unless we otherwise
indicate in the applicable prospectus supplement, we will make interest payments by check that we
will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the
applicable prospectus supplement, we will designate the corporate trust office of the debenture
trustee in the City of New York as our sole paying agent for payments with respect to debt
securities of each series. We will name in the applicable prospectus supplement any other paying
agents that we initially designate for the debt securities of a particular series. We will maintain
a paying agent in each place of payment for the debt securities of a particular series.
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All money we pay to a paying agent or the debenture trustee for the payment of the principal
of or any premium or interest on any debt securities that remains unclaimed at the end of two years
after such principal, premium or interest has become due and payable will be repaid to us, and the
holder of the debt security thereafter may look only to us for payment thereof.
Governing Law
The indentures and the debt securities will be governed by and construed in accordance with
the laws of the State of New York, except to the extent that the Trust Indenture Act of 1939 is
applicable.
Subordination of Subordinated Debt Securities
The subordinated debt securities will be unsecured and will be subordinate and junior in
priority of payment to certain of our other indebtedness to the extent described in a prospectus
supplement. The subordinated indenture does not limit the amount of subordinated debt securities
that we may issue, nor does it limit us from issuing any other secured or unsecured debt.
DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of common stock, preferred stock and/or debt securities
in one or more series. We may issue warrants independently or together with common stock, preferred
stock and/or debt securities, and the warrants may be attached to or separate from these
securities. While the terms summarized below will apply generally to any warrants that we may
offer, we will describe the particular terms of any series of warrants in more detail in the
applicable prospectus supplement. The terms of any warrants offered under a prospectus supplement
may differ from the terms described below.
We have filed forms of the warrant agreements and forms of warrant certificates containing the
terms of the warrants being offered as exhibits to the registration statement of which this
prospectus is a part. We will file as exhibits to the registration statement of which this
prospectus is a part, or will incorporate by reference from reports that we file with the SEC, the
form of warrant agreement, including a form of warrant certificate, that describes the terms of the
particular series of warrants we are offering before the issuance of the related series of
warrants. The following summaries of material provisions of the warrants and the warrant agreements
are subject to, and qualified in their entirety by reference to, all the provisions of the warrant
agreement and warrant certificate applicable to the particular series of warrants that we may offer
under this prospectus. We urge you to read the applicable prospectus supplements related to the
particular series of warrants that we may offer under this prospectus, as well as any related free
writing prospectuses, and the complete warrant agreements and warrant certificates that contain the
terms of the warrants.
General
We will describe in the applicable prospectus supplement the terms of the series of warrants
being offered, including:
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the offering price and aggregate number of warrants offered; |
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the currency for which the warrants may be purchased; |
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if applicable, the designation and terms of the securities with which the warrants are
issued and the number of warrants issued with each such security or each principal amount
of such security; |
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if applicable, the date on and after which the warrants and the related securities will
be separately transferable; |
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in the case of warrants to purchase debt securities, the principal amount of debt
securities purchasable upon exercise of one warrant and the price at, and currency in
which, this principal amount of debt securities may be purchased upon such exercise; |
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in the case of warrants to purchase common stock or preferred stock, the number of
shares of common stock or preferred stock, as the case may be, purchasable upon the
exercise of one warrant and the price at which these shares may be purchased upon such
exercise; |
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the effect of any merger, consolidation, sale or other disposition of our business on
the warrant agreements and the warrants; |
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the terms of any rights to redeem or call the warrants; |
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any provisions for changes to or adjustments in the exercise price or number of
securities issuable upon exercise of the warrants; |
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the dates on which the right to exercise the warrants will commence and expire; |
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the manner in which the warrant agreements and warrants may be modified; |
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a discussion of any material or special United States federal income tax consequences of
holding or exercising the warrants; |
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the terms of the securities issuable upon exercise of the warrants; and |
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any other specific terms, preferences, rights or limitations of or restrictions on the
warrants. |
Before exercising their warrants, holders of warrants will not have any of the rights of
holders of the securities purchasable upon such exercise, including:
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in the case of warrants to purchase debt securities, the right to receive payments of
principal of, or premium, if any, or interest on, the debt securities purchasable upon
exercise or to enforce covenants in the applicable indenture; or |
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in the case of warrants to purchase common stock or preferred stock, the right to
receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or
to exercise voting rights, if any. |
Exercise of Warrants
Each warrant will entitle the holder to purchase the securities that we specify in the
applicable prospectus supplement at the exercise price that we describe in the applicable
prospectus supplement. Holders of the warrants may exercise the warrants at any time up to the
specified time on the expiration date that we set forth in the applicable prospectus supplement.
After the close of business on the expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the warrants by delivering the warrant certificate
representing the warrants to be exercised together with specified information, and paying the
required amount to the warrant agent in immediately available funds, as provided in the applicable
prospectus supplement. We will set forth on the reverse side of the warrant certificate and in the
applicable prospectus supplement the information that the holder of the warrant will be required to
deliver to the warrant agent.
Upon receipt of the required payment and the warrant certificate properly completed and duly
executed at the corporate trust office of the warrant agent or any other office indicated in the
applicable prospectus supplement, we will issue and deliver the securities purchasable upon such
exercise. If fewer than all of the warrants represented by the warrant certificate are exercised,
then we will issue a new warrant certificate for the remaining amount of warrants. If we so
indicate in the applicable prospectus supplement, holders of the warrants may surrender securities
as all or part of the exercise price for warrants.
Governing Law
Unless we provide otherwise in the applicable prospectus supplement, the warrants and warrant
agreements will be governed by and construed in accordance with the laws of the State of New York.
Enforceability of Rights by Holders of Warrants
Each warrant agent will act solely as our agent under the applicable warrant agreement and
will not assume any obligation or relationship of agency or trust with any holder of any warrant. A
single bank or trust company may act as warrant agent for more than one issue of warrants. A
warrant agent will have no duty or responsibility in case of any default by us under the applicable
warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at
law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent
of the related warrant agent or the holder of any other warrant, enforce by appropriate legal
action its right to exercise, and receive the securities purchasable upon exercise of, its
warrants.
DESCRIPTION OF UNITS
We may issue, in one more series, units consisting of common stock, preferred stock, debt
securities and/or warrants for the purchase of common stock, preferred stock and/or debt securities
in any combination. While the terms we have summarized below
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will apply generally to any units that we may offer under this prospectus, we will describe
the particular terms of any series of units in more detail in the applicable prospectus supplement.
The terms of any units offered under a prospectus supplement may differ from the terms described
below.
We will file as exhibits to the registration statement of which this prospectus is a part, or
will incorporate by reference from reports that we file with the SEC, the form of unit agreement
that describes the terms of the series of units we are offering, and any supplemental agreements,
before the issuance of the related series of units. The following summaries of material terms and
provisions of the units are subject to, and qualified in their entirety by reference to, all the
provisions of the unit agreement and any supplemental agreements applicable to a particular series
of units. We urge you to read the applicable prospectus supplements related to the particular
series of units that we may offer under this prospectus, as well as any related free writing
prospectuses and the complete unit agreement and any supplemental agreements that contain the terms
of the units.
General
Each unit will be issued so that the holder of the unit is also the holder of each security
included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder
of each included security. The unit agreement under which a unit is issued may provide that the
securities included in the unit may not be held or transferred separately, at any time or at any
time before a specified date.
We will describe in the applicable prospectus supplement the terms of the series of units
being offered, including:
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the designation and terms of the units and of the securities comprising the units,
including whether and under what circumstances those securities may be held or transferred
separately; |
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any provisions of the governing unit agreement that differ from those described below;
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any provisions for the issuance, payment, settlement, transfer or exchange of the units
or of the securities comprising the units. |
The provisions described in this section, as well as those described under Description of
Capital Stock, Description of Debt Securities and Description of Warrants will apply to each
unit and to any common stock, preferred stock, debt security or warrant included in each unit,
respectively.
Issuance in Series
We may issue units in such amounts and in such numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act solely as our agent under the applicable unit agreement and will not
assume any obligation or relationship of agency or trust with any holder of any unit. A single bank
or trust company may act as unit agent for more than one series of units. A unit agent will have no
duty or responsibility in case of any default by us under the applicable unit agreement or unit,
including any duty or responsibility to initiate any proceedings at law or otherwise, or to make
any demand upon us. Any holder of a unit may, without the consent of the related unit agent or the
holder of any other unit, enforce by appropriate legal action its rights as holder under any
security included in the unit.
Title
We, and any unit agent and any of their agents, may treat the registered holder of any unit
certificate as an absolute owner of the units evidenced by that certificate for any purpose and as
the person entitled to exercise the rights attaching to the units so requested, despite any notice
to the contrary. See Legal Ownership of Securities below.
LEGAL OWNERSHIP OF SECURITIES
We can issue securities in registered form or in the form of one or more global securities. We
describe global securities in greater detail below. We refer to those persons who have securities
registered in their own names on the books that we or any applicable
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trustee, depositary or warrant agent maintain for this purpose as the holders of those
securities. These persons are the legal holders of the securities. We refer to those persons who,
indirectly through others, own beneficial interests in securities that are not registered in their
own names, as indirect holders of those securities. As we discuss below, indirect holders are not
legal holders, and investors in securities issued in book-entry form or in street name will be
indirect holders.
Book-Entry Holders
We may issue securities in book-entry form only, as we will specify in the applicable
prospectus supplement. This means securities may be represented by one or more global securities
registered in the name of a financial institution that holds them as depositary on behalf of other
financial institutions that participate in the depositarys book-entry system. These participating
institutions, which are referred to as participants, in turn, hold beneficial interests in the
securities on behalf of themselves or their customers.
Only the person in whose name a security is registered is recognized as the holder of that
security. Securities issued in global form will be registered in the name of the depositary or its
participants. Consequently, for securities issued in global form, we will recognize only the
depositary as the holder of the securities, and we will make all payments on the securities to the
depositary. The depositary passes along the payments it receives to its participants, which in turn
pass the payments along to their customers who are the beneficial owners. The depositary and its
participants do so under agreements they have made with one another or with their customers; they
are not obligated to do so under the terms of the securities.
As a result, investors in a book-entry security will not own securities directly. Instead,
they will own beneficial interests in a global security, through a bank, broker or other financial
institution that participates in the depositarys book-entry system or holds an interest through a
participant. As long as the securities are issued in global form, investors will be indirect
holders, and not holders, of the securities.
Street Name Holders
We may terminate a global security or issue securities in non-global form. In these cases,
investors may choose to hold their securities in their own names or in street name. Securities
held by an investor in street name would be registered in the name of a bank, broker or other
financial institution that the investor chooses, and the investor would hold only a beneficial
interest in those securities through an account he or she maintains at that institution.
For securities held in street name, we will recognize only the intermediary banks, brokers and
other financial institutions in whose names the securities are registered as the holders of those
securities, and we will make all payments on those securities to them. These institutions pass
along the payments they receive to their customers who are the beneficial owners, but only because
they agree to do so in their customer agreements or because they are legally required to do so.
Investors who hold securities in street name will be indirect holders, not holders, of those
securities.
Legal Holders
Our obligations, as well as the obligations of any applicable trustee and of any third parties
employed by us or a trustee, run only to the legal holders of the securities. We do not have
obligations to investors who hold beneficial interests in global securities, in street name or by
any other indirect means. This will be the case whether an investor chooses to be an indirect
holder of a security or has no choice because we are issuing the securities only in global form.
For example, once we make a payment or give a notice to the holder, we have no further
responsibility for the payment or notice even if that holder is required, under agreements with
depositary participants or customers or by law, to pass it along to the indirect holders but does
not do so. Similarly, we may want to obtain the approval of the holders to amend an indenture, to
relieve us of the consequences of a default or of our obligation to comply with a particular
provision of the indenture or for other purposes. In such an event, we would seek approval only
from the holders, and not the indirect holders, of the securities. Whether and how the holders
contact the indirect holders is up to the holders.
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Special Considerations For Indirect Holders
If you hold securities through a bank, broker or other financial institution, either in
book-entry form or in street name, you should check with your own institution to find out:
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how it handles securities payments and notices; |
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whether it imposes fees or charges; |
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how it would handle a request for the holders consent, if ever required; |
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whether and how you can instruct it to send you securities registered in your own name
so you can be a holder, if that is permitted in the future; |
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how it would exercise rights under the securities if there were a default or other event
triggering the need for holders to act to protect their interests; and |
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if the securities are in book-entry form, how the depositarys rules and procedures will
affect these matters. |
Global Securities
A global security is a security that represents one or any other number of individual
securities held by a depositary. Generally, all securities represented by the same global
securities will have the same terms.
Each security issued in book-entry form will be represented by a global security that we
deposit with and register in the name of a financial institution or its nominee that we select. The
financial institution that we select for this purpose is called the depositary. Unless we specify
otherwise in the applicable prospectus supplement, The Depository Trust Company, New York, New
York, known as DTC, will be the depositary for all securities issued in book-entry form.
A global security may not be transferred to or registered in the name of anyone other than the
depositary, its nominee or a successor depositary, unless special termination situations arise. We
describe those situations below under Special Situations When a Global Security Will Be
Terminated. As a result of these arrangements, the depositary, or its nominee, will be the sole
registered owner and holder of all securities represented by a global security, and investors will
be permitted to own only beneficial interests in a global security. Beneficial interests must be
held by means of an account with a broker, bank or other financial institution that in turn has an
account with the depositary or with another institution that does. Thus, an investor whose security
is represented by a global security will not be a holder of the security, but only an indirect
holder of a beneficial interest in the global security.
If the prospectus supplement for a particular security indicates that the security will be
issued in global form only, then the security will be represented by a global security at all times
unless and until the global security is terminated. If termination occurs, we may issue the
securities through another book-entry clearing system or decide that the securities may no longer
be held through any book-entry clearing system.
Special Considerations For Global Securities
The rights of an indirect holder relating to a global security will be governed by the account
rules of the investors financial institution and of the depositary, as well as general laws
relating to securities transfers. We do not recognize an indirect holder as a holder of securities
and instead deal only with the depositary that holds the global security.
If securities are issued only in the form of a global security, an investor should be aware of
the following:
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an investor cannot cause the securities to be registered in his or her name, and cannot
obtain non-global certificates for his or her interest in the securities, except in the
special situations we describe below; |
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an investor will be an indirect holder and must look to his or her own bank or broker
for payments on the securities and protection of his or her legal rights relating to the
securities, as we describe above; |
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an investor may not be able to sell interests in the securities to some insurance
companies and to other institutions that are required by law to own their securities in
non-book-entry form; |
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an investor may not be able to pledge his or her interest in a global security in
circumstances where certificates representing the securities must be delivered to the
lender or other beneficiary of the pledge in order for the pledge to be effective; |
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the depositarys policies, which may change from time to time, will govern payments,
transfers, exchanges and other matters relating to an investors interest in a global
security; |
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we and any applicable trustee have no responsibility for any aspect of the depositarys
actions or for its records of ownership interests in a global security, nor do we or any
applicable trustee supervise the depositary in any way; |
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the depositary may, and we understand that DTC will, require that those who purchase and
sell interests in a global security within its book-entry system use immediately available
funds, and your broker or bank may require you to do so as well; and |
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financial institutions that participate in the depositarys book-entry system, and
through which an investor holds its interest in a global security, may also have their own
policies affecting payments, notices and other matters relating to the securities. |
There may be more than one financial intermediary in the chain of ownership for an investor.
We do not monitor and are not responsible for the actions of any of those intermediaries.
Special Situations When a Global Security Will Be Terminated
In a few special situations described below, the global security will terminate and interests
in it will be exchanged for physical certificates representing those interests. After that
exchange, the choice of whether to hold securities directly or in street name will be up to the
investor. Investors must consult their own banks or brokers to find out how to have their interests
in securities transferred to their own name, so that they will be direct holders. We have described
the rights of holders and street name investors above.
Unless we provide otherwise in the applicable prospectus supplement, the global security will
terminate when the following special situations occur:
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if the depositary notifies us that it is unwilling, unable or no longer qualified to
continue as depositary for that global security and we do not appoint another institution
to act as depositary within 90 days; |
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if we notify any applicable trustee that we wish to terminate that global security; or |
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if an event of default has occurred with regard to securities represented by that global
security and has not been cured or waived. |
The prospectus supplement may also list additional situations for terminating a global
security that would apply only to the particular series of securities covered by the applicable
prospectus supplement. When a global security terminates, the depositary, and not we or any
applicable trustee, is responsible for deciding the names of the institutions that will be the
initial direct holders.
PLAN OF DISTRIBUTION
We may sell the securities from time to time pursuant to underwritten public offerings,
negotiated transactions, block trades or a combination of these methods. We may sell the securities
to or through underwriters or dealers, through agents, or directly to one or more purchasers. We
may distribute securities from time to time in one or more transactions:
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at a fixed price or prices, which may be changed; |
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at market prices prevailing at the time of sale; |
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at prices related to such prevailing market prices; or |
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at negotiated prices. |
A prospectus supplement or supplements will describe the terms of the offering of the
securities, including:
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the name or names of the underwriters, if any; |
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the purchase price of the securities and the proceeds we will receive from the sale; |
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any over-allotment options under which underwriters may purchase additional securities
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 public offering price; |
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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 securities may be listed. |
Only underwriters named in the prospectus supplement will be underwriters of the securities
offered by the prospectus supplement.
If underwriters are used in the sale, they will acquire the securities for their own account
and may resell the securities from time to time in one or more 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 securities will be subject to the conditions set forth in the
applicable underwriting agreement. We may offer the securities 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 of the securities offered by
the prospectus supplement, other than securities covered by any over-allotment option. 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 securities directly or through agents we designate from time to time. We will name
any agent involved in the offering and sale of securities and we will describe any commissions we
will pay the agent in the prospectus supplement. Unless the prospectus supplement states otherwise,
our agent will act on a best-efforts basis for the period of its appointment.
We may authorize agents or underwriters to solicit offers by certain types of institutional
investors to purchase securities 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 civil liabilities,
including liabilities under the Securities Act, or contribution with respect to payments that the
agents or underwriters may make with respect to these liabilities. Agents and underwriters may
engage in transactions with, or perform services for, us in the ordinary course of business.
All securities we may offer, other than common stock, will be new issues of securities with no
established trading market. Any underwriters may make a market in these securities, but will not be
obligated to do so and may discontinue any market making at any time without notice. We cannot
guarantee the liquidity of the trading markets for any securities.
Any underwriter may engage in over-allotment, stabilizing transactions, short-covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act.
Over-allotment involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing
bids do not exceed a specified maximum price. Syndicate-covering or other short-covering
transactions involve purchases of the securities, either through exercise of the over-allotment
option or 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 securities
originally sold by the dealer are purchased in a stabilizing or covering transaction to cover short
positions. Those activities may cause the price of the securities to be higher than it would
otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
Any underwriters that are qualified market makers on the NASDAQ Global Market may engage in
passive market making transactions in the common stock on the NASDAQ Global Market in accordance
with Regulation M under the Exchange Act, during the business day prior to the pricing of the
offering, before the commencement of offers or sales of the common stock. 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. Passive market making may stabilize the market price of the
securities at a level above that which might otherwise prevail in the open market and, if
commenced, may be discontinued at any time.
In compliance with guidelines of the Financial Industry Regulatory Authority, or FINRA, the
maximum consideration or discount to be received by any FINRA member or independent broker dealer
may not exceed 8% of the aggregate amount of the securities offered pursuant to this prospectus and
any applicable prospectus supplement.
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LEGAL MATTERS
The validity of the securities being offered by this prospectus will be passed upon by Cooley
Godward Kronish LLP, Palo Alto, California.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our financial
statements included in our Annual Report on Form 10-K for the year ended December 31, 2006, and
managements assessment of the effectiveness of our internal control over financial reporting as of
December 31, 2006, as set forth in their reports, which are incorporated by reference in this
prospectus and elsewhere in the registration statement. Our financial statements and managements
assessment are incorporated by reference in reliance on Ernst & Young LLPs reports, given on their
authority as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We file annual, quarterly and special reports, proxy statements and other information with the
SEC. You may read and copy any document we file at the SECs Public Reference Room at 100 F Street,
N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for more information about the
operation of 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 GTx, Inc. The SECs Internet site can be found at www.sec.gov.
The SEC allows us to incorporate by reference the information we file with it, which means
that we can disclose important information to you by referring you to another document that we have
filed separately with the SEC. You should read the information incorporated by reference because it
is an important part of this prospectus. We incorporate by reference the following information or
documents that we have filed with the SEC (Commission File No. 0-50549):
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our current report on Form 8-K filed with the SEC on February 26, 2007; |
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our annual report on Form 10-K for the year ended December 31, 2006 filed with the SEC
on March 9, 2007 (the 2006 10-K); |
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the information specifically incorporated by reference into our 2006 Form 10-K from our
definitive proxy statement on Schedule 14A filed with the SEC on March 14, 2007; |
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our current report on Form 8-K filed with the SEC on April 17, 2007; |
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our quarterly report on Form 10-Q for the quarter ended March 31, 2007 filed with the
SEC on May 7, 2007; |
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our current report on Form 8-K filed with the SEC on July 3, 2007; |
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our current report on Form 8-K filed with the SEC on July 12, 2007; |
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our current report on Form 8-K filed with the SEC on July 26, 2007; |
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our current report on Form 10-Q for the quarter ended June 30, 2007 filed with the SEC
on August 1, 2007; |
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our current reports on Form 8-K filed with the SEC on November 6, 2007 (except for the
information furnished under Item 2.02 or any related exhibit); |
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our current report on Form 10-Q for the quarter ended September 30, 2007 filed with the
SEC on November 9, 2007; |
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our current report on Form 8-K filed with the SEC on December 13, 2007; |
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our current report on Form 8-K filed with the SEC on December 18, 2007; and |
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the description of our common stock, which is registered under Section 12 of the
Exchange Act, in our registration statement on Form 8-A, filed with the SEC on January 13,
2004, including any amendments or reports filed for the purpose of updating such
description. |
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Any information in any of the foregoing documents will automatically be deemed to be modified
or superseded to the extent that information in this prospectus or in a later filed document that
is incorporated or deemed to be incorporated herein by reference modifies or replaces such
information.
We also incorporate by reference any future filings (other than current reports furnished
under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such
items) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, until
we file a post-effective amendment that indicates the termination of the offering of the securities
made by this prospectus. Information in such future filings updates and supplements the information
provided in this prospectus. Any statements in any such future filings will automatically be deemed
to modify and supersede any information in any document we previously filed with the SEC that is
incorporated or deemed to be incorporated herein by reference to the extent that statements in the
later filed document modify or replace such earlier statements.
We will provide to each person, including any beneficial owner, to whom a prospectus is
delivered, without charge upon written or oral request, a copy of any or all of the documents that
are incorporated by reference into this prospectus but not delivered with the prospectus, including
exhibits which are specifically incorporated by reference into such documents. Requests should be
directed to: GTx, Inc., Attention: Corporate Secretary, 3 N. Dunlap Street, Van Vleet Building,
Memphis, TN 38163, telephone (901) 523-9700.
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14,285,715 Shares
Common Stock
PROSPECTUS SUPPLEMENT
Sole Book-Running Manager
Lazard Capital Markets
October 27, 2010