DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, and owner of exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, announced today financial results for the third quarter ended September 30, 2012 in its Quarterly Report on Form 10-Q.
For the three months ended September 30, 2012, DARA reported a net loss attributable to common stockholders of $1,983,372, or ($0.16) per share as compared to a net loss of $921,478, or ($0.18) per share for the same period in 2011. The increase in loss was primarily a result of the costs incurred in establishment of a sales and marketing infrastructure to support the promotion of the Company's oncology and oncology supportive care products as well as an increase in general and administrative expenses. As of September 30, 2012, cash and cash equivalents totaled $8,259,476 and marketable securities totaled $788,574.
Third Quarter and Recent Corporate Highlights:
- In October, DARA launched Soltamox®(tamoxifen citrate) oral liquid solution in the United States with initial shipments of product to wholesalers and certain specialty pharmacy providers. Soltamox is a new treatment option for breast cancer patients who are prescribed tamoxifen therapy. DARA has exclusive U.S. rights to Soltamox from Rosemont Pharmaceuticals, Ltd, UK. Prior to DARA's launch of Soltamox, tamoxifen was only available in the U.S. as a solid oral tablet.
- In September, DARA completed a series of agreements with a number of specialty pharmacy providers, leading group purchasing organizations (GPOs), retail partners, reimbursement experts, and an industry-leading third-party logistics provider, providing DARA comprehensive commercial coverage across the national oncology market. As part of an integrated national network with annual sales of over $1 billion in cancer therapeutics, DARA significantly enhanced its commercial scale and capabilities. Its distribution network now consists of more than 45,000 retail pharmacies, mail order pharmacies, and long-term care facilities. This network provides DARA with established reimbursement and logistics expertise, with more than 300 sales and marketing personnel uniquely focused on oncology and oncology support products, and further provides the company with additional partnering opportunities.
- In September, DARA entered into an exclusive agreement with the Helsinn Group of Switzerland for U.S. commercial rights to Gelclair ® . Gelclair is an FDA-cleared, bioadherent oral protective gel product indicated for the treatment of oral mucositis, a painful inflammation and ulceration of the surface of the mouth and throat, which can result from a variety of cancer treatments. DARA plans to launch Gelclair late in the first quarter of 2013.
- In September, DARA reported that investors from the Company's April 2012 public offering had voluntarily elected to exercise warrants to purchase approximately 1.2 million shares of the Company's common stock at $1 per share whereby the Company realized net proceeds of approximately $1.2 million.
- In July and August, DARA added two new directors to its board of directors:
- Stephen O. Jaeger – Mr. Jaeger has more than 35 years of experience across a range of industries, including tenure at companies in the healthcare sector. He has served as director on boards including Savient Pharmaceuticals, Arlington Tankers LTD, eBT International Inc., Clinical Communications Group (a medical education company) and Hougton Mifflin. Mr. Jaeger also formerly served as chief executive officer of eBT International Inc.; and chief financial officer of Clinical Communications Group, Houghton Mifflin and Applera (a life sciences and instrument company).
- Timothy J. Heady - Mr. Heady retired in 2011 as CEO of UnitedHealthcare Pharmacy, a unit of UnitedHealthcare ( UNH) representing more than $11 billion in annual prescription drug spending. In that role, he was responsible for all aspects of the business, including pharmaceutical rebate contracting, retail pharmacy network development, customer and member services, operations, and financial performance. UnitedHealthcare Pharmacy provides pharmacy benefits and management for employers, both commercial and government, representing more than 14 million individuals.
- During the quarter, DARA completed work to improve the formulation of KRN 5500 and took steps to manufacture clinical material for anticipated clinical trials. DARA has also been engaged during the quarter in partnering discussions to advance ongoing development of the drug.
DARA CEO, David J. Drutz, MD, stated, “We have had a number of important achievements since the beginning of the third quarter, many of which represent critical steps toward realizing our goal of becoming a leading oncology and oncology supportive care company in the United States. I am confident we now have an extraordinary team in place and that we are positioned to effectively execute against our business plan and strategy."