On November 2, 2015 DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment,reported its third quarter 2015 results (Filing, 8-K, Dara Biosciences, NOV 2, 2015, View Source [SID:1234507887]).
Third Quarter 2015 Financial Snapshot
DARA reported net revenues of $1.181 million for the third quarter ended September 30, 2015 based on gross product sales in excess of $1.5 million, as compared to net revenues of $597.8 thousand for the third quarter ended September 30, 2014, a year over year increase of 98%. The increase in revenues was primarily attributable to the expanded commercial sales organization and ongoing success in generating interest and prescriptions across DARA’s oncology supportive care product portfolio.
DARA reported a loss attributable to controlling interest of approximately $2.7 million or ($0.14) per share for the third quarter ended September 30, 2015 as compared to a loss attributable to controlling interest of approximately $2.1 million, or ($0.11) per share for the third quarter ended September 30, 2014. Sales and marketing costs for the quarter increased $463.8 thousand over the same period last year, primarily as a result of increased personnel costs, including an increase in incentive based field sales compensation driven by higher sales achievement. An increase in general and administrative expenses of $559.2 thousand was primarily driven by increased professional services costs related to DARA’s proposed merger with Midatech Pharma PLC. Research and development expenses decreased by $46.2 thousand, primarily as a result of reduced personnel costs. As of September 30, 2015, cash and cash equivalents totaled approximately $4.7 million.
"Our third quarter results illustrate continued growth from our commercial portfolio as our products continue to be accepted and utilized to support oncology patients and oncology health care providers nationwide," stated Christopher G. Clement, President and CEO of DARA BioSciences. Our continued momentum in the business and prescription increases for our key products Gelclair and Soltamox on a year to date basis support our full year estimates of net revenues for these two products to reach $3.7 million for 2015, excluding any net revenue contribution from our recent national launch of Oravig .
Clement continued, "We are excited regarding the continued strong performance of our commercial business and look forward to sustained success as we finalize our merger agreement with Midatech Pharma PLC. As of today the timelines for the close of the transaction with Midatech remain on track and we believe that this will take place prior to the end of 2015. Midatech has received clearance from the SEC on their Form F-4 registration statement and from Nasdaq on the listing of American Depositary Receipts representing Midatech Ordinary Shares. A DARA shareholder meeting to approve the merger has been set for December 2, 2015. "
DARA believes that its currently available funds, together with projected sales of Gelclair, an FDA-approved bioadherent oral rinse gel for treating the painful symptoms of oral mucositis (OM), Soltamox, (tamoxifen citrate oral liquid solution), Oravig, the first and only orally-dissolving buccal tablet approved for oral thrush, and the Mission Pharmacal products Ferralet 90 (for anemia) and Aquoral (for cancer-related dry mouth), will enable DARA to fund its current operations and to meet its obligations into the first quarter of 2016.
Third Quarter 2015 Operational Highlights and Recent Key Events
DARA made significant progress during the third quarter of 2015 in executing its strategy as well as expanding the commercial opportunity for its flagship oncology and oncology supportive care products, as follows:
· Quarterly net revenues increased 98% from Q3 FY’14 to $1.181 million, based on continued increases in prescriptions for our oncology supportive care portfolio.
· The merger agreement with Midatech Pharma PLC, a UK based specialty pharmaceutical company, is expected to close during the fourth quarter of 2015.
· Launched Oravig into both the oncology and the primary care markets.
· Oravig has been stocked and is available for both retail and institutional customers throughout the national wholesale distribution network
· Oravig is being supported by DARA’s retail prescription savings program available at over 40,000 pharmacies nationwide
· Gelclair continues to be the leading gel barrier prescribed in the U.S. retail market, per Symphony Prescription data, leading the nearest competitor by a 3 to 1 margin of prescriptions written in September and continues to outperform the overall gel barrier retail prescription market with consistent quarter over quarter prescription growth
· Q3 showed continued strong growth of over 200% in Gelclair prescriptions through DARA’s HUB pharmacy vs Q2 of this year.
· DARA has provided Gelclair to over 800 uninsured or underinsured patients, through DARA’s HUB program, providing health care providers a dependable option for prescribing Gelclair to all of their appropriate patients.
· Soltamox continues to show sequential quarterly sales growth
· DARA initiated a full service specialty pharmacy patient support program for Aquoral through its HUB program
· DARA’s telesales program has and continues to make calls on the top 300 high volume prescribing practitioners in "white space" areas
· The FDA provided formal agreement with DARA’s proposed development plan for KRN as well as proposed bridging studies for the new formulation.
· The US Patent and Trademark Office granted a significant extension of patent protection for DARA’s KRN 5500 developmental asset through a recently issued formulation patent, which DARA believes is strengthening potential opportunities to partner KRN 5500 and bringing newly-interested parties into discussions.
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Based on our current trends and continued growth DARA continues to support our previous guidance of $3.7 million for Gelclair and Soltamox net sales for the full year 2015, excluding any net revenue contribution from the launch of Oravig later in the year.