Durect Corp. Reports Operating Results (10-Q)

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May 06, 2011
Durect Corp. (DRRX, Financial) filed Quarterly Report for the period ended 2011-03-31.

Durect Corp. has a market cap of $274.9 million; its shares were traded at around $3.15 with and P/S ratio of 8.7. Durect Corp. had an annual average earning growth of 1% over the past 5 years.

Highlight of Business Operations:

Since our inception in 1998, we have had a history of operating losses. At March 31, 2011, we had an accumulated deficit of $343.1 million and our net loss was $6.4 million for the three months ended March 31, 2011. Our net losses were $22.9 million, $30.3 million and $43.9 million for the years ended December 31, 2010, 2009 and 2008, respectively. These losses have resulted primarily from costs incurred to research and develop our product candidates and to a lesser extent, from selling, general and administrative costs associated with our operations and product sales. We expect our research and development expenses to increase in the near future as we expect to continue to expand our clinical trials, nonclinical studies and other research and development activities. We expect selling, general and administrative expenses to remain comparable to recent quarters in the near future. We do not anticipate meaningful revenues from our pharmaceutical systems, should they be approved, for at least the next twelve months. Therefore, we expect to incur continuing losses and negative cash flow from operations for the foreseeable future.

We also received a $20.0 million upfront fee in connection with the development and license agreement signed with Alpharma (acquired by King which was subsequently acquired by Pfizer) in September 2008 relating to ELADUR. The $20.0 million upfront fee is recognized as collaborative research and development revenue ratably over the term of our continuing involvement with Alpharma with respect to ELADUR.

We also received a $14.0 million upfront fee in connection with the development and license agreement signed with Nycomed in November 2006 relating to POSIDUR. The $14.0 million upfront fee is recognized as collaborative research and development revenue ratably over the term of our continuing involvement with Nycomed with respect to POSIDUR.

A portion of our revenues is derived from our product sales, which include our ALZET mini pump product line, our LACTEL biodegradable polymer product line and certain excipients that are included in Remoxy. Net product revenues were $3.1 million and $3.9 million in the three months ended March 31, 2011 and 2010, respectively. The decrease in the three months ended March 31, 2011 was primarily attributable to lower product revenue from the sale of certain excipients included in Remoxy to Pfizer, partially offset by higher product revenue from our ALZET mini pump product line and our LACTEL polymer product line as a result of higher units sold in the three months ended March 31, 2011 compared to the corresponding period in 2010. Revenues in the 2010 period included $551,000 related to a price settlement for shipments to Pfizer that occurred in 2008 and the first quarter of 2009 pursuant to the long term supply agreement executed in the third quarter of 2009 as well as $410,000 of product revenue related to the shipment of another excipient that is included in Remoxy in the first quarter of 2010.

Cost of product revenues. Cost of product revenues was $1.4 million for each of the three months ended March 31, 2011 and 2010. The comparable cost of product revenue in the three months ended March 31, 2011 was primarily the result of higher units sold from our ALZET mini pump product line and from our LACTEL polymer product line, offset by lower cost of goods sold related to the sale of certain excipients to Pfizer as we had no revenue from that source in the first quarter of 2011. Cost of product revenue and gross profit margin will fluctuate from period to period depending upon the product mix in a particular period. Stock-based compensation expense recognized related to cost of product revenues was $85,000 and $84,000 for the three months ended March 31, 2011 and 2010, respectively.

Research and development. Research and development expenses are primarily comprised of salaries, benefits, stock-based compensation and other compensation cost associated with research and development personnel, overhead and facility costs, preclinical and non-clinical development costs, clinical trial and related clinical manufacturing costs, contract services, and other outside costs. Research and development expenses were $9.9 million and $9.4 million for the three months ended March 31, 2011 and 2010, respectively. The increase in the three months ended March 31, 2011 was primarily attributable to higher development costs associated with POSIDUR as well as ORADUR-ADHD, TRANSDUR-Sufentanil, our biologics programs and other research programs, partially offset by lower development costs associated with Remoxy and ELADUR compared to the corresponding period in 2010 as more fully discussed below. Stock-based compensation expense recognized related to research and development personnel was $1.1 million and $1.3 million for the three months ended March 31, 2011 and 2010, respectively.

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