GTx Inc. Reports Operating Results (10-Q)

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May 11, 2009
GTx Inc. (GTXI, Financial) filed Quarterly Report for the period ended 2009-03-31.

GTX Inc is a biopharmaceutical company dedicated to the discovery development and commercialization of therapeutics primarily related to the treatment of serious men's health conditions. GTx's drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens. GTx Inc. has a market cap of $353.5 million; its shares were traded at around $9.71 with and P/S ratio of 26.1.

Highlight of Business Operations:

Total share-based compensation expense for the three months ended March 31, 2009 was $1.1 million, of which $380,000 and $680,000 were recorded in the condensed statement of operations as research and development expenses and general and administrative expenses, respectively. Total share-based compensation expense for the three months ended March 31, 2008 was $781,000, of which $345,000 and $436,000 were recorded in the condensed statement of operations as research and development expenses and general and administrative expenses, respectively. Included in share-based compensation expense for the three months ended March 31, 2009 and 2008 is share-based compensation expense related to deferred compensation arrangements for our directors of $45,000 and $51,000, respectively. At March 31, 2009, the total compensation cost related to non-vested awards not yet recognized was approximately $13.7 million with a weighted average expense recognition period of 2.73 years.

Revenues. Revenues for the three months ended March 31, 2009 were $3.6 million, as compared to $4.5 million for the same period of 2008. Revenues included net sales of FARESTON® marketed for the treatment of metastatic breast cancer in postmenopausal women and collaboration revenue from Ipsen and Merck. During the three months ended March 31, 2009 and 2008, FARESTON® net product sales were $759,000 and $257,000, respectively, while cost of product sales were $348,000 and $135,000, respectively. FARESTON® net product sales for the three months ended March 31, 2009 increased from the same period in the prior year as a result of a price increase of 263% instituted in the fourth quarter of 2008, partially offset by a decrease of approximately 22% in sales volume of FARESTON® as compared to the three months ended March 31, 2008. We expect FARESTON® sales volume to decline in future periods, particularly as a result of aromatase inhibitors continuing to capture breast cancer market share

from SERMs, including FARESTON®. Collaboration revenue was $2.9 million for the three months ended March 31, 2009, and $4.2 million for the three months ended March 31, 2008. Collaboration revenue for the three months ended March 31, 2009 consisted of approximately $1.5 million and approximately $1.4 million from the amortization of deferred revenue from Ipsen and Merck, respectively. Collaboration revenue for the three months ended March 31, 2008 consisted of approximately $1.5 million and approximately $1.3 million from the amortization of deferred revenue from Ipsen and Merck, respectively, and approximately $1.5 million from an earned milestone from Ipsen with the achievement of the primary endpoint in the toremifene 80 mg ADT Phase III clinical trial.

General and Administrative Expenses. General and administrative expenses increased during the three months ended March 31, 2009 to $6.5 million from $4.3 million for the three months ended March 31, 2008. This increase was primarily the result of increased personnel and personnel related expenses of approximately $1.4 million, marketing expenses of approximately $190,000 in connection with the planned commercialization of our toremifene product candidates, medical education expenses of approximately $190,000, and changes in foreign currency of approximately $250,000 related to our receivable from Ipsen for the final license fee and expense reimbursement payment under our collaboration agreement.

At March 31, 2009, we had cash, cash equivalents and short-term investments of $81.7 million, compared to $97.7 million at December 31, 2008. Net cash used in operating activities was $15.3 million for the three months ended March 31, 2009 and resulted primarily from funding our net loss. Net cash provided by operating activities was $28.7 million for the three months ended March 31, 2008 and consisted primarily of the receipt of $40.0 million from Merck in conjunction with our exclusive license and collaboration agreement, offset by funding our net loss for the period.

Net cash used in investing activities was $93,000 and $697,000 for the three months ended March 31, 2009 and 2008, respectively. Net cash used in investing activities for the three months ended March 31, 2009 was primarily for the purchase of information technology equipment, software, and research and development equipment. Net cash used in investing activities for the three month period of 2008 was primarily for the purchase of furniture and fixtures and leasehold improvements related to the additional office space added in 2008, as well as the purchase of additional research and development equipment. We currently expect to make capital expenditures of approximately $1.2 million for the remainder of 2009.

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