GTx Inc. (GTXI, Financial) filed Quarterly Report for the period ended 2009-09-30.
Gtx Inc. has a market cap of $140.94 million; its shares were traded at around $3.87 with and P/S ratio of 10.42.
Total share-based compensation expense for the three months ended September 30, 2009 was $1.1 million, of which $413,000 and $715,000 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 September 30, 2008 was $995,000, of which $479,000 and $516,000 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 nine months ended September 30, 2009 was $3.3 million, of which $1.2 million and $2.1 million 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 nine months ended September 30, 2008 was $2.6 million, of which $1.2 million and $1.4 million 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 September 30, 2009 and 2008 is share-based compensation expense related to deferred compensation arrangements for our directors of $44,000 and $42,000, respectively, and $128,000 and $137,000 for the nine months ended September 30, 2009 and 2008, respectively. At September 30, 2009, the total compensation cost related to non-vested awards not yet recognized was approximately $12.5 million with a weighted average expense recognition period of 2.4 years.
Revenues. Revenues for the three months ended September 30, 2009 were $3.6 million, as compared to $3.0 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 September 30, 2009 and 2008, FARESTON® net product sales were $719,000 and $315,000, respectively, while cost of product sales were $344,000 and $192,000, respectively. FARESTON® net product sales for the three months ended September 30, 2009 increased from the same period in the prior year as a result of a price increase instituted in the fourth quarter of 2008, partially offset by a decrease of approximately 24% in sales volume of FARESTON® as compared to the three months ended September 30, 2008. The increase in cost of product sales was due to an increase in royalty expenses which was based on our net sales of FARESTON®. We expect FARESTON® sales volume to continue 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 September 30, 2009 and $2.7 million for the three months ended September 30, 2008. Collaboration revenue for the three months ended September 30, 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 September 30, 2008 consisted of approximately $1.5 million and approximately $1.3 million from the amortization of deferred revenue from Ipsen and Merck, respectively.
Interest Income. Interest income decreased to $29,000 for the three months ended September 30, 2009 from $568,000 for the three months ended September 30, 2008. The decrease was due to lower average interest rates and lower average cash balances during the three months ended September 30, 2009 as compared to the same period in 2008.
Revenues. Revenues for the nine month periods ended September 30, 2009 and 2008 were $11.1 million and $10.5 million, respectively. Revenues include net sales of FARESTON® marketed for the treatment of metastatic breast cancer and collaboration revenue from Ipsen and Merck. In the first nine months of 2009 and 2008, FARESTON® net product sales were $2.4 million and $846,000, respectively, while cost of product sales were $1.1 million and $482,000 respectively. FARESTON® net product sales for the nine months ended September 30, 2009 increased from the same period in the prior year as a result of a price increase instituted in the fourth quarter of 2008, partially offset by a decrease of approximately 21% in sales volume of FARESTON® as compared to the nine months ended September 30, 2008. The increase in cost of product sales was due to an increase in royalty expenses which was based on our net sales of FARESTON®. Collaboration revenue was $8.6 million for the nine months ended September 30, 2009, which consisted of approximately $4.4 million and approximately $4.2 million from the amortization of deferred revenue from Ipsen and Merck, respectively. Collaboration revenue was approximately $9.7 million for the nine months ended September 30, 2008, which consisted of approximately $4.4 million and approximately $3.8 million from the amortization of deferred revenue from Ipsen and Merck, respectively, and approximately $1.5 million from an earned milestone from Ipsen resulting from the achievement of the primary endpoint in the toremifene 80 mg ADT Phase III clinical trial during the first quarter of 2008.
Research and Development Expenses. Research and development expenses decreased by 28% to $24.2 million for the nine months ended September 30, 2009 from $33.6 million for the nine months ended September 30, 2008. The following table identifies the research and development expenses for each of our clinical product candidates, as well as research and development expenses pertaining to our other research and development efforts, for both of the periods presented. The decrease in research and development expenses during the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 was primarily due to the completion of the toremifene 80 mg Phase III clinical trial, a decreased number of subject visits in the toremifene 20 mg clinical trial due to a portion of the subjects having completed the trial prior to or during the current year, and the completion of the OstarineTM Phase II cancer cachexia clinical trial during 2008. This decrease was partially offset by research and development spending on our Phase I clinical trials for GTx-758.
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Gtx Inc. has a market cap of $140.94 million; its shares were traded at around $3.87 with and P/S ratio of 10.42.
Highlight of Business Operations:
Our net loss for the nine months ended September 30, 2009 was $35.4 million. Our net loss included FARESTON® net product sales of $2.4 million and the recognition of collaboration revenue of $8.6 million. We have financed our operations and internal growth primarily through public offerings and private placements of our common stock and preferred stock, as well as proceeds from our collaborations. We expect to continue to incur net losses as we continue our clinical development and research and development activities, apply for and address issues related to potential regulatory approvals, expand our sales and marketing capabilities and grow our operations.Total share-based compensation expense for the three months ended September 30, 2009 was $1.1 million, of which $413,000 and $715,000 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 September 30, 2008 was $995,000, of which $479,000 and $516,000 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 nine months ended September 30, 2009 was $3.3 million, of which $1.2 million and $2.1 million 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 nine months ended September 30, 2008 was $2.6 million, of which $1.2 million and $1.4 million 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 September 30, 2009 and 2008 is share-based compensation expense related to deferred compensation arrangements for our directors of $44,000 and $42,000, respectively, and $128,000 and $137,000 for the nine months ended September 30, 2009 and 2008, respectively. At September 30, 2009, the total compensation cost related to non-vested awards not yet recognized was approximately $12.5 million with a weighted average expense recognition period of 2.4 years.
Revenues. Revenues for the three months ended September 30, 2009 were $3.6 million, as compared to $3.0 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 September 30, 2009 and 2008, FARESTON® net product sales were $719,000 and $315,000, respectively, while cost of product sales were $344,000 and $192,000, respectively. FARESTON® net product sales for the three months ended September 30, 2009 increased from the same period in the prior year as a result of a price increase instituted in the fourth quarter of 2008, partially offset by a decrease of approximately 24% in sales volume of FARESTON® as compared to the three months ended September 30, 2008. The increase in cost of product sales was due to an increase in royalty expenses which was based on our net sales of FARESTON®. We expect FARESTON® sales volume to continue 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 September 30, 2009 and $2.7 million for the three months ended September 30, 2008. Collaboration revenue for the three months ended September 30, 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 September 30, 2008 consisted of approximately $1.5 million and approximately $1.3 million from the amortization of deferred revenue from Ipsen and Merck, respectively.
Interest Income. Interest income decreased to $29,000 for the three months ended September 30, 2009 from $568,000 for the three months ended September 30, 2008. The decrease was due to lower average interest rates and lower average cash balances during the three months ended September 30, 2009 as compared to the same period in 2008.
Revenues. Revenues for the nine month periods ended September 30, 2009 and 2008 were $11.1 million and $10.5 million, respectively. Revenues include net sales of FARESTON® marketed for the treatment of metastatic breast cancer and collaboration revenue from Ipsen and Merck. In the first nine months of 2009 and 2008, FARESTON® net product sales were $2.4 million and $846,000, respectively, while cost of product sales were $1.1 million and $482,000 respectively. FARESTON® net product sales for the nine months ended September 30, 2009 increased from the same period in the prior year as a result of a price increase instituted in the fourth quarter of 2008, partially offset by a decrease of approximately 21% in sales volume of FARESTON® as compared to the nine months ended September 30, 2008. The increase in cost of product sales was due to an increase in royalty expenses which was based on our net sales of FARESTON®. Collaboration revenue was $8.6 million for the nine months ended September 30, 2009, which consisted of approximately $4.4 million and approximately $4.2 million from the amortization of deferred revenue from Ipsen and Merck, respectively. Collaboration revenue was approximately $9.7 million for the nine months ended September 30, 2008, which consisted of approximately $4.4 million and approximately $3.8 million from the amortization of deferred revenue from Ipsen and Merck, respectively, and approximately $1.5 million from an earned milestone from Ipsen resulting from the achievement of the primary endpoint in the toremifene 80 mg ADT Phase III clinical trial during the first quarter of 2008.
Research and Development Expenses. Research and development expenses decreased by 28% to $24.2 million for the nine months ended September 30, 2009 from $33.6 million for the nine months ended September 30, 2008. The following table identifies the research and development expenses for each of our clinical product candidates, as well as research and development expenses pertaining to our other research and development efforts, for both of the periods presented. The decrease in research and development expenses during the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 was primarily due to the completion of the toremifene 80 mg Phase III clinical trial, a decreased number of subject visits in the toremifene 20 mg clinical trial due to a portion of the subjects having completed the trial prior to or during the current year, and the completion of the OstarineTM Phase II cancer cachexia clinical trial during 2008. This decrease was partially offset by research and development spending on our Phase I clinical trials for GTx-758.
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