SEC Letter
October 23, 2006
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
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Re:
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GTx, Inc. |
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Form 10-K for the Fiscal Year Ended December 31, 2005 |
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File No. 000-50549 |
Dear Mr. Rosenberg:
We received verbal comments from Amy Bruckner, Staff Accountant, on September 6, 2006, in
response to our letter to you dated August 8, 2006. Please find below GTx, Inc.s response to Ms.
Bruckners comments.
In future filings beginning with its 10-Q for the quarter ended September 30, 2006, the
Company will expand its Critical Accounting Policies and Significant Judgments and Estimates
discussion in Managements Discussion and Analysis of Financial Condition and Results of Operations
as follows to more specifically address what information is obtained from external sources and how
it is used to estimate the Companys accrual for product returns as well as to enhance the
Companys disclosure about historical product returns:
Revenue Recognition
We recognize net product sales revenue from the sale of FARESTON® less deductions for
estimated sales discounts and sales returns. We recognize revenue from product sales when
the goods are shipped and title and risk of loss pass to the customer and the other criteria
of Staff Accounting Bulletin (SAB) No.101, Revenue Recognition in Financial Statements
as amended by SAB No. 104 (together, SAB 104) and Statements of Financial Accounting
Standards No. 48, Revenue Recognition When Right of Return Exists, are satisfied. We
account for rebates to certain governmental agencies as a reduction of revenue. We allow
customers to return product within a specified time period prior to and subsequent to the
products labeled expiration date. As a result, we estimate an accrual for product returns
based on factors which include historical product returns and estimated product in the
distribution channel which is expected to exceed its expiration date. We retained
substantially the same wholesale customers of, and the distribution channel that was used by
another pharmaceutical company that distributed FARESTON® for six years prior to our
obtaining the rights to market FARESTON® in January 2005. We also obtained
United States Securities and Exchange Commission
October 23, 2006
historical product return trend information that we continue to update with our own product
return data. We estimate the amount of product in the distribution channel which is
expected to exceed its expiration date and be returned by the customer by receiving
information from our three largest wholesale customers about the levels of FARESTON®
inventory held by these customers. These three largest customers accounted for 94% of the total sales of
FARESTON® for the nine month period ended September 30, 2006. Based on this information,
which we have not independently verified, we estimate the number of months of product on
hand. At September 30, 2006 and December 31, 2005, our accrual for product returns was
$162,000 and $274,000, respectively. If actual future results are different than our
estimates, we may need to adjust our estimated accrual for product returns, which could have
a material effect on earnings in the period of the adjustment.
The Company provides sales rebates to the Department of Veteran Affairs and to State Medicaid
rebate programs. Total year to date rebate expense through September 30, 2006 was approximately
$25,000. As rebate expense is immaterial to the Companys financial condition and results of
operations, the Company did not disclose more detailed information about its rebate program in its
discussion of Critical Accounting Policies and Significant Judgments and Estimates in Managements
Discussion and Analysis of Financial Condition and Result of Operations in Form 10-Q for the
quarterly period ended June 30, 2006. In future periods as the Companys rebate expense becomes
material to its financial condition or results of operations, the Company will provide more
detailed disclosure about its rebate program in its Managements Discussion and Analysis of
Financial Condition and Result of Operations in future SEC filings.
In our response letter to you dated August 8, 2006, we provided a roll-forward of the
Companys FARESTON® product return accrual for the year ended December 31, 2005 and for the quarter
ended March 31, 2006. The Company did not include the roll-forward of the product return accrual
in its discussion of Critical Accounting Policies and Significant Judgments and Estimates in
Managements Discussion and Analysis of Financial Condition and Result of Operations in Form 10-Q
for the quarterly period ended June 30, 2006, as estimated product returns and actual product
returns are not material as compared to the Companys financial condition or results of operations.
As of September 30, 2006, the Companys year to date net loss was $30.8 million, its year to date
change in accrual for estimated product returns was $29,000 and year to date actual product returns
were $142,000. At such time that actual or estimated product returns in the future are material as
compared to the Companys financial condition or results of operations, the Company commits that it
will include a roll-forward of its product return accrual in Managements Discussion and Analysis
of Financial Conditions and Results of Operations in future SEC filings.
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United States Securities and Exchange Commission
October 23, 2006
We hope that the responses provided above will be sufficient to address Ms. Bruckners
comments. Please let us know if you require any additional information.
Best Regards,
/s/ Mark E. Mosteller
Mark E. Mosteller
Vice President and Chief Financial Officer
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