Third-quarter revenues of $1.2 million reflect the first quarter of Abstral® (fentanyl) sublingual tablet sales, prior to the company’s official launch and commencement of promotional efforts in the fourth quarter. Net loss for the quarter was $0.11 per basic and diluted share, versus a net loss of $0.09 per basic and diluted share as reported for the comparable quarter of 2012.
Abstral® is the company’s FDA-approved treatment option for breakthrough cancer pain. Galena in March 2013 acquired Abstral®, and in May 2013 completed a debt financing of $15 million to fund the purchase and launch of the product, of which $10 million was drawn immediately and $5 million remains available. Abstral® was officially launched in the U.S. in October.
“Our commercial success to date with Abstral® has been very encouraging and we are excited to report initial revenues ahead of schedule. With our sales force and commercial organization fully deployed, we continue to make significant strides with physicians, payors and patients—and expect continuing strength with the launch,” Mark J. Ahn, Ph.D., president and CEO of Galena stated in the news release. “We are also making steady progress in advancing our NeuVax™ and FBP cancer immunotherapy pipeline.”
For the nine-month period, Galena reported a net loss of $0.34 per basic and diluted share, versus a net loss (including both continued operations and discontinued operations) of $ $0.52 per basic and diluted share for the first nine months of 2012.
As of September 30, 2013, Galena had cash, cash equivalents, marketable securities and net accounts receivable of $55.8 million, compared with $35.6 million as of December 31, 2012.
The company also provide a brief look at its third-quarter and recent achievements, including the commercial launch of Abstral®. Galena also noted:
• Appointment of Dr. Brian Hamilton, M.D., Ph.D. to serve as executive vice president and chief medical officer.
• Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) trial, under an SPA, enrolling at approximately 130 sites globally.
• Phase 2b NeuVax plus Herceptin® (trastuzumab; Genentech/Roche) 300 patient randomized, combination trial is enrolling at nine sites in the U.S.
• Results from the phase 1 portion of the Folate Binding Protein (FBP) trial will be presented at the Society for Immunotherapy of Cancer (SITC) conference taking place November 7-10, 2013. Expanded NeuVax™ Intellectual Property With European Allowance.
• NeuVax Oral presentation at the American College of Surgeons Clinical Congress.
• Secured $40 million in financing to significantly strengthen its balance sheet.
For more information visit www.galenabiopharma.com
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