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DARA - Reports 2013 Fourth Quarter and Full Year Financial Results and Commercial Business Update

link: http://finance.yahoo.com/news/dara-reports-2013-fourth-quarter-121000608.html

RALEIGH, NC--(Marketwired - February 04, 2014) - DARA BioSciences, Inc. (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, announced today its financial results for the fourth quarter and full year ended December 31, 2013. The Company also provided a business update on its fourth quarter 2013 operational and commercial highlights.

Fourth Quarter 2013 Financial Snapshot
For the year ended December 31, 2013, DARA reported a net loss attributable to controlling interest of ($9,965,014), or ($0.39) per share as compared to a net loss attributable to controlling interest of ($7,311,033), or ($0.60) per share for the year ended December 31, 2012. The increase in loss was primarily a result of the costs incurred in the establishment of a sales and marketing infrastructure to support the promotion of the Company's oncology and oncology supportive care products as well as a related increase in general and administrative expenses as the Company continued its transition from what had been solely a research and development company. As of December 31, 2013, cash and cash equivalents and available for sale investments totaled approximately $3,425,543.

DARA believes that its currently available funds, together with projected sales of Soltamox®, (tamoxifen citrate) oral liquid solution, Gelclair®, an FDA-approved bioadherent oral rinse gel for treating the painful symptoms of oral mucositis (OM), Bionect®, (hyaluronic acid sodium salt, 0.2%) a topical treatment for skin irritation and burns associated with radiation therapy and the Mission Pharmacal products, Ferralet® 90 (for anemia), BINOSTO® (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis), and Aquoral® (for cancer-related dry mouth), will enable the Company to fund its planned operations and to meet its obligations through the first quarter of 2014.

On December 23, 2013, DARA filed an S-1 Registration Statement with the U.S. Securities and Exchange Commission (SEC) announcing its intention to raise additional capital to extend its cash runway to fund operations to execute on its business plan.

David J. Drutz, MD, DARA's Chief Executive Officer and Chief Medical Officer, stated, "We are seeing encouraging sales performance in the fourth quarter based on our refined commercial strategy announced in the second quarter of 2013. The focus has been placed on increasing our share of voice targeting high-prescribing oncology practitioners."

The Company expanded its sales force and complemented its synergistic oncology supportive care product portfolio through a strategic partnership with Mission Pharmacal and its subsidiary, Alamo Pharma Services.

As of January 2, the Company's new commercial force provided through Alamo has been hired, professionally trained and is in the field selling the Company's synergistic product portfolio to the highest prescribing oncology offices nationwide.

Dr. Drutz continued, "Further, an important driver of our strategy is to continue to work closely with oncology market leaders in pursuit of contracts that will optimize the utilization of our product portfolio, similar to our recent agreements with Memorial Sloan Kettering Cancer Center and RainTree Oncology. Finally, we intend to further expand our oncology supportive care product portfolio and are actively looking to in-license or acquire additional products. I believe executing on these key initiatives will have a significant, positive impact on DARA's performance in 2014."

FOURTH QUARTER 2013 OPERATIONAL HIGHLIGHTS AND RECENT KEY EVENTS

The Company made significant progress during the fourth quarter of 2013 in executing its strategy as well as expanding the commercial opportunity for its flagship oncology and oncology supportive care products. The Company:

Continued execution of refined commercial strategy, implemented at the end of Q2 2013, focused on increasing sales call frequency to targeted high volume customers, resulting in increased aggregate Soltamox and Gelclair revenues of approximately 31 percent over Q3 2013;
Entered into an agreement to increase the Company's national field sales organization from five to 20 representatives, through Alamo Pharma Services, an experienced and successful contract sales organization, to continue to drive product momentum and provide the necessary scope and coverage of high prescribing oncologists maximizing the potential of DARA's product portfolio;
Signed a shared sales force agreement expanding DARA's presence in oncology supportive care with Mission Pharmacal for the Alamo sales team to carry DARA's products as well as three Mission Pharmacal products : Ferralet 90, BINOSTO, and Aquoral;
Through the Company's partnership with Alamo, interviewed, hired and trained 20 sales representatives for nationwide field force deployment on January 2, 2014;
Completed CAPTURE (Compliance and Preference for Tamoxifen Registry); 17 leading oncology centers enrolling a total of 626 women who had been prescribed and were taking tamoxifen therapy for breast cancer completed the CAPTURE survey, providing investigators with valuable insight into adherence to prescribed tamoxifen treatment; patient preference for a liquid formulation of tamoxifen; and prevalence of difficulties in swallowing among breast cancer patients taking tamoxifen tablets. Results expected to be reported in the first quarter of 2014;
Submitted CAPTURE clinical abstract to National Comprehensive Cancer Network® (NCCN) for presentation and anticipate presenting these data at upcoming oncology conferences in 2014;
Signed agreement with Memorial Sloan Kettering, a well-recognized worldwide, leading cancer institution for the exclusive placement of Gelclair on its formulary;
Signed a pharmacy supply agreement with RainTree Oncology Services, the nation's leading community oncology alliance, for both Gelclair and Soltamox to be accessible to RainTree's Nationwide Oncology Membership; and
Provided U.S. Food and Drug Administration (FDA), on November 19, 2013, with additional information requested in support of DARA's request for orphan drug designation for the Company's Phase 2 development asset, KRN5500, for the treatment of painful, treatment-refractory, chronic chemotherapy-induced peripheral neuropathy ("CCIPN").
Dr. Drutz concluded, "Oncology supportive care remains a unique market niche and growth opportunity for DARA, and we believe our product portfolio meaningfully addresses unmet needs for patients suffering from cancer and the side effects of their treatments. We are singularly focused on oncology/supportive care, and we believe we provide a comprehensive offering of these types of products in the market place. Our goal is to be the leader in the oncology/supportive care market with a comprehensive and growing portfolio of synergistic products to offer physicians and their patients. DARA has made substantial progress over the past two quarters. The recent expansion of our sales organization, marketing campaigns and product portfolio supports this vision and sets the stage for an exciting 2014 for DARA and our shareholders."

A summary of key financial highlights for the three and twelve months ended December 31, 2013 and 2012 is as follows ($ in thousands):

For the three
months ended
December 31,
2013 For the three
months ended
December 31,
2012 For the year ended
December 31,
2013 For the year ended
December 31,
2012

Net Product Revenues $182.3 $53.6 $419.3 $53.6

Costs and Expenses 2,587.9 3,618.8 10,908.7 9,690.7

Net Loss Attributed to Controlling Interest
(2,354.1 )
(1,871.3 )
(9,965.0 )
(7,311.0 )




As of December 31, 2013
As of December 31, 2012
Cash and Cash Equivalents
$3,425.5
$6,496.5

Current Assets 3,888.6 7,044.8

Current Liabilities 1,675.0 2,038.9

Working Capital 2,213.6 5,005.9