GTx, Inc. 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report: November 2, 2006
(Date of earliest event reported)
GTx, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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000-50549
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62-1715807 |
(State or other jurisdiction of
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(Commission
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(I.R.S. Employer |
incorporation or organization)
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File Number)
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Identification No.) |
3 N. Dunlap Street
Van Vleet Building
Memphis, Tennessee 38163
(901) 523-9700
(Address, including zip code, and telephone number,
including area code, of registrants principal executive offices)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
ITEM 2.02 Results of Operations and Financial Condition.
On November 2, 2006, GTx, Inc. issued an earnings release for the third quarter ended
September 30, 2006, a copy of which is furnished as Exhibit 99.1 to this Current Report.
This release is furnished by GTx pursuant to Item 2.02 of Form 8-K and is not to be
considered filed under the Exchange Act, and shall not be incorporated by reference into
any previous or future filing by the Registrant under the Securities Act or the Exchange
Act.
ITEM 9.01 Financial Statements and Exhibits.
(c) Exhibits
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Exhibit |
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Number |
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated November 2, 2006 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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GTx, INC.
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Date: November 2, 2006 |
By: |
/s/ Mark E. Mosteller
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Name: |
Mark E. Mosteller |
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Title: |
Vice President and Chief Financial Officer
(principal accounting and financial officer) |
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exv99w1
Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Manager, Corporate Communications & Financial Analysis
901-523-9700
GTX, INC. REPORTS THIRD QUARTER 2006 FINANCIAL RESULTS
MEMPHIS, TENN. November 2, 2006GTx, Inc. (NASDAQ: GTXI), the Mens Health Biotech Company,
today reported financial results for the third quarter of 2006. The net loss for the
third quarter and nine months ended September 30, 2006 was $10.9 million and $30.8 million,
respectively, compared with a net loss of $9.9 million and $29.0 million for the same periods in
2005. This performance is consistent with GTxs previously stated financial guidance.
We are proud of the significant progress GTx made in the third quarter. We achieved a major
milestone with the execution of our definitive agreement granting Ipsen exclusive European
development and marketing rights of ACAPODENE®, said Mitchell S. Steiner, M.D., Chief Executive
Officer of GTx. This partnership allows us to achieve three major corporate objectives.
Financially, the partnerships upfront payment yielded GTx sufficient cash to meet our projected
operating requirements through the first quarter of 2008, by which time we expect to have received
data from our two pivotal Phase III clinical trials. Second, GTx retains exclusive rights to
ACAPODENE® in the United States, where we intend to market the drug to physicians treating prostate
cancer patients. Third, the transaction places European commercialization of ACAPODENE® in the
hands of the partner most capable of successfully marketing prostate cancer drugs. Ipsen already
has a solid prostate cancer franchise in Europe with its lead product, Decapeptyl. ACAPODENE® for
the treatment of multiple side effects of ADT and ACAPODENE® for the prevention of prostate cancer
will further strengthen their product portfolio.
In the current quarter we will receive important data from our proof of concept Phase II clinical
trial of ostarine, Steiner said. The information from this trial we hope will show the potential
of SARMs to build muscle and bone in both men and women. We look forward to reporting top line
results toward the end of the year.
Revenues for the quarter and nine months ended September 30, 2006 were $1.1 million and $2.9
million, respectively, as compared to $0.6 million and $3.1 million for the third quarter and first
nine months of 2005. Revenues in all periods included net sales of FARESTON® (toremifene citrate
60 mg), marketed for the treatment of metastatic breast cancer, and collaboration revenue for
andarine from our partner, Ortho Biotech Products, LP, a subsidiary of Johnson & Johnson. Revenues
for the third quarter of 2006 also included collaboration revenue for the period September 7, 2006
through September 30, 2006 from our partner, Ipsen Group (Ipsen), which has acquired from GTx the
exclusive rights to develop and market ACAPODENE® (toremifene citrate) in the European Union,
Commonwealth of Independent States and certain other European countries (European Territory).
GTx is developing ACAPODENE® in two separate indications in men: ACAPODENE® 80 mg for the treatment
of multiple side effects of androgen deprivation therapy (ADT) for advanced prostate cancer, and
ACAPODENE® 20 mg for the prevention of prostate cancer in men with the precancerous lesion of the
prostate, high grade prostatic intraepithelial neoplasia (PIN).
Research and development expenses for the third quarter and first nine months of 2006 were $9.6
million and $26.5 million, respectively, compared to $8.5 million and $24.4 million for the same
periods in 2005. The increase in research and development spending was primarily the result of the
Companys continued investment in its clinical programs, including increased spending for the
development of ostarine in an ongoing Phase II clinical trial.
General and administrative expenses for the quarter and nine months ended September 30, 2006 were
$2.9 million and $8.5 million, respectively, compared to $2.3 million and $7.4 million for the same
periods in 2005.
At October 7, 2006, with the receipt of the upfront license fee and expense reimbursement from our
collaboration with Ipsen, GTx had approximately $70.9 million in cash and cash equivalents.
Third quarter 2006 Corporate Highlights
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In September, GTx and Ipsen entered into a definitive agreement under which
Ipsen has been granted exclusive rights to develop and market in the European |
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Territory ACAPODENE® for the prevention of prostate cancer in high risk men and for the
treatment of multiple side effects of ADT. Ipsen agreed to pay GTx 23 million Euros as a license fee and
expense reimbursement. In addition, GTx is entitled to receive milestone payments from
Ipsen of approximately 39 million Euros for ACAPODENE®, subject to the successful
development and European launch of ACAPODENE® for both the ADT and PIN indications. Ipsen
will pay all clinical development, regulatory, and launch expenses, in addition to bulk
drug product supply and packaging costs, to commercialize ACAPODENE® in the European
Territory, and Ipsen may pay a portion of GTxs ACAPODENE® development costs in the U.S. if
certain conditions are met. Ipsen has agreed to pay GTx a royalty equal to a graduating
percentage of aggregate net sales of ACAPODENE® in the European Territory in the mid-teens,
which could reach the mid-twenties based on certain sales price thresholds being met. GTx
is responsible for paying upstream royalties for ACAPODENE®. |
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In August, an independent drug safety monitoring board conducted a per
protocol interim review of safety data of more than 2,700 patients enrolled in our two
pivotal Phase III clinical trials of ACAPODENE® and recommended that GTx continue the two
clinical development programs as planned. |
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In July, GTx completed recruitment of its proof of concept Phase II clinical
trial of its first-in-class drug candidate, ostarine, a selective androgen receptor
modulator (SARM). GTx initiated the Phase II clinical trial of ostarine in May 2006. The
three month placebo controlled clinical trial is evaluating multiple doses of ostarine in
60 elderly men and 60 postmenopausal women. The trial is designed to evaluate the activity
of ostarine on building muscle and promoting bone as well as to assess safety in both
elderly men and postmenopausal women. GTx expects to report the data from the trial in the
fourth quarter of 2006. Based on ostarines Phase II clinical data profile, GTx will
select specific acute and chronic muscle wasting and/or bone loss diseases for further
development. GTx plans to initiate a Phase IIb or Phase III clinical trial in 2007. |
Conference Call
There will be a conference call today at 9 a.m. Eastern Time today to discuss GTxs third quarter
financial results and to provide a company update. To listen to the conference call, please dial:
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800-638-4930 from the United States and Canada or |
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617-614-3944 (International)
The access code for the call is 60274409. |
A playback of the call will be available beginning today at 11:00 a.m., Eastern Time through
November 16, and may be accessed by dialing:
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888-286-8010 from the United States and Canada or |
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617-801-6888 (International)
The reservation number for the replay is 83047883. |
Additionally, you may access the live and subsequently archived webcast of the conference call from
the Investor Relations section of the companys website at http://www.gtxinc.com.
About GTx
GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics for cancer and serious conditions related to
mens health. GTxs lead drug discovery and development programs are focused on small molecules
that selectively modulate the effects of estrogens and androgens, two essential classes of
hormones. GTx is 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 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 high grade PIN. GTx has licensed to Ipsen Group exclusive rights in
Europe to develop and commercialize ACAPODENE® for the prevention of prostate cancer in high risk
men and for the treatment of multiple side effects of androgen deprivation therapy. GTx is
developing ostarine, a selective androgen receptor modulator, or SARM, for muscle wasting and bone
loss indications. Ostarine is currently being evaluated in a Phase II clinical trial in 120 elderly
men and postmenopausal women. GTx expects to have data from the Phase II ostarine trial in the
fourth quarter of 2006. GTx has licensed to Ortho Biotech Products, L.P., a subsidiary of Johnson &
Johnson, another of its SARMs, andarine, under a joint collaboration and license agreement.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTxs current expectations.
Forward-looking statements involve risks and uncertainties. GTxs actual results and the timing of
events could differ materially from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without limitation, the risks that (i) GTx
will not be able to commercialize its product candidates if clinical trials do not demonstrate
safety and efficacy in humans; (ii) GTx may not able to obtain required regulatory approvals to
commercialize its product candidates; (iii) GTxs clinical trials may not be completed on schedule,
or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its available
cash resources sooner than it currently expects and may be unable to raise capital when needed,
which would force GTx to delay, reduce or eliminate its product development programs or
commercialization efforts. You should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release. GTxs quarterly report on form 10-Q filed
with the U.S. Securities and Exchange Commission on August 9, 2006, contains a more comprehensive
description of these and other risks to which GTx is subject. GTx expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are based.
GTx, Inc.
CONDENSED BALANCE SHEETS
(in thousands, except share data)
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September 30, |
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December 31, |
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2006 |
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2005 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
44,551 |
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$ |
74,014 |
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Accounts receivable |
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121 |
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153 |
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Inventory |
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236 |
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135 |
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Receivable from collaboration partner |
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27,898 |
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Prepaid expenses and other current assets |
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1,330 |
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1,702 |
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Total current assets |
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74,136 |
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76,004 |
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Property and equipment, net |
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1,556 |
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1,746 |
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Purchased intangible assets, net |
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4,810 |
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4,978 |
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Receivable from collaboration partner, less current portion |
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1,189 |
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Other assets |
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37 |
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83 |
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Total assets |
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$ |
81,728 |
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$ |
82,811 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,344 |
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$ |
1,407 |
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Accrued expenses |
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3,987 |
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3,230 |
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Deferred revenue current portion |
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7,189 |
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1,337 |
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Total current liabilities |
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12,520 |
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5,974 |
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Deferred revenue, less current portion |
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24,972 |
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2,958 |
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Other long term liability |
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319 |
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280 |
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Capital lease obligation |
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16 |
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20 |
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Commitments and contingencies
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Stockholders equity: |
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Common stock, $0.001 par value: 60,000,000 shares authorized; 31,005,717
shares issued and outstanding at September 30, 2006 and
30,993,967shares issued and outstanding at December 31, 2005 |
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31 |
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31 |
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Deferred stock compensation |
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(1,725 |
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Additional paid-in capital |
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268,936 |
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269,542 |
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Accumulated deficit |
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(225,066 |
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(194,269 |
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Total stockholders equity |
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43,901 |
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73,579 |
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Total liabilities and stockholders equity |
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$ |
81,728 |
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$ |
82,811 |
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GTx, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Product sales, net |
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$ |
348 |
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$ |
288 |
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$ |
1,512 |
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$ |
2,133 |
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Collaboration revenue |
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724 |
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334 |
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1,393 |
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1,003 |
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Total revenues |
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1,072 |
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622 |
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2,905 |
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3,136 |
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Costs and expenses: |
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Cost of product sales |
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118 |
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185 |
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755 |
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1,350 |
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Research and development expenses |
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9,614 |
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8,454 |
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26,499 |
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24,419 |
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General and administrative expenses |
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2,867 |
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2,271 |
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8,509 |
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7,433 |
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Total costs and expenses |
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12,599 |
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10,910 |
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35,763 |
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33,202 |
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Loss from operations |
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(11,527 |
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(10,288 |
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(32,858 |
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(30,066 |
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Interest income |
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638 |
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345 |
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2,061 |
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1,023 |
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Net loss |
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$ |
(10,889 |
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$ |
(9,943 |
) |
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$ |
(30,797 |
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$ |
(29,043 |
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Net loss per share: |
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Basic |
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$ |
(0.35 |
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$ |
(0.40 |
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$ |
(0.99 |
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$ |
(1.18 |
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Diluted |
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$ |
(0.35 |
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$ |
(0.40 |
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$ |
(0.99 |
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$ |
(1.18 |
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Weighted average shares used in computing net loss per share: |
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Basic |
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31,005,717 |
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24,664,950 |
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31,001,292 |
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24,664,794 |
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Diluted |
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31,005,717 |
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24,664,950 |
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31,001,292 |
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24,664,794 |
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