Columbia Laboratories, Inc. (Nasdaq: CBRX) today reported financial results for the three- and nine-month periods ended September 30, 2009.
Highlights for the quarter and subsequent events included:
- Total progesterone sales increased 11% and domestic sales of CRINONE® 8% (progesterone gel) also rose 11% versus the immediately preceding quarter.
- Net revenues were $7.9 million as compared to $11.1 million for the third quarter of 2008. The 2008 period included a one-time recognition of $2.9 million of previously deferred revenues relating to the termination of the STRIANT® (testosterone buccal system) license for Europe due to the bankruptcy of the Company’s licensee; without those revenues, net revenues for the 2009 third quarter decreased 4% from 2008 levels.
- PREGNANT Study enrollment continues to rise with six sites added in the third quarter and an additional 11 sites thus far in the fourth quarter, bringing the total number of sites to 51. The Company confirmed its plan to file with the FDA for PROCHIEVE® 8% (progesterone gel) in the short cervix population near year-end 2010, assuming positive data.
- Four presentations of new data supporting the use of CRINONE® 8% over other progesterone formulations were given at the annual meeting of the American Society of Reproductive Medicine, heightening the peer-to-peer dialogue among the Company’s infertility targets. Of particular note was the Brigham and Women’s Hospital presentation of the results of the largest prospective, randomized clinical study demonstrating that CRINONE is equally effective and significantly better tolerated than intramuscular injections of progesterone for luteal phase support in In Vitro Fertilization and Embryo Transfer cycles.
- On October 28, 2009, Columbia strengthened its balance sheet with $10.7 million dollars in net proceeds raised through the sale of common stock and warrants. These funds will enable the Company to complete the PREGNANT Study and to develop next-generation progesterone products, both critical to delivering long-term returns.
“CRINONE 8% revenues and prescriptions have grown quarter over quarter in 2009 despite the economic downturn and its lingering impact on decisions to proceed with infertility treatments. We remain focused on growing this business by emphasizing that CRINONE is clinically proven to be as effective as other progesterones and widely preferred by patients for its once-daily convenience and needle-free application,” stated Robert S. Mills, Columbia’s president and chief executive officer.
“Enrollment in the PREGNANT Study increased in the third quarter of 2009 with the addition of six new clinical sites. We maintain our conviction that if study outcomes are positive, we will file with the FDA for PROCHIEVE 8% in the short cervix population near the end of 2010 and, assuming approval, pave the way for significant long-term growth,” Mills concluded.
Third Quarter Financial Results
Net revenues for the third quarter of 2009 were $7.9 million, compared to $11.1 million for the third quarter of 2008. The 2008 third quarter included $2.9 million in previously deferred revenues.
Total net revenues from Progesterone Products decreased 2% to $6.3 million in the third quarter of 2009 as compared to $6.5 million in the third quarter of 2008. This reflects lower domestic sales of CRINONE® 8% and PROCHIEVE®, partially offset by higher sales of CRINONE in foreign markets. Comparing the three months ended September 30, 2009 with the same period in 2008: