Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced its financial results for the quarter ended June 30, 2014. “2014 has been a significant year for Anacor,” said Paul Berns, President and Chief Executive Officer of Anacor Pharmaceuticals. “The FDA approved our New Drug Application for KERYDIN TM to treat onychomycosis of the toenails, and we signed a strategically and financially significant agreement with Sandoz to commercialize KERYDIN in the United States through PharmaDerm, Sandoz’s branded dermatology division. In addition, we initiated our pivotal Phase 3 studies of AN2728 to treat mild-to-moderate atopic dermatitis, and are pleased with the current pace of enrollment, which we believe keeps us on track to report top-line data in the second half of 2015.” Recent Highlights and Developments
- On July 8, 2014, we announced that the U.S. Food and Drug Administration approved our New Drug Application for KERYDIN (tavaborole) topical solution, 5%. KERYDIN is the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today.
- On July 21, 2014, we announced that we had entered into an exclusive agreement with Sandoz Inc., a Novartis company, pursuant to which Sandoz will distribute and commercialize KERYDIN in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN.
- Our lead product candidate is AN2728, an investigational anti-inflammatory PDE-4 inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis. Atopic dermatitis is a chronic rash characterized by inflammation and itch. According to the National Eczema Association, almost 18 million people in the United States have atopic dermatitis, and approximately 8% - 18% of all infants and children are affected by the disease.
- We are continuing to enroll patients in the pivotal Phase 3 studies of AN2728 to treat patients with mild-to-moderate atopic dermatitis. We plan to enroll approximately 750 patients in each of two Phase 3 clinical trials.
- We expect data from the Phase 3 studies of AN2728 for mild-to-moderate atopic dermatitis in the second half of 2015.
|ANACOR PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development (1)||19,261||10,146||35,196||21,305|
|General and administrative (1)||7,095||5,086||15,423||9,802|
|Total operating expenses||26,356||15,232||50,619||31,107|
|Loss from operations||(23,425||)||(11,808||)||(43,530||)||(25,975||)|
|Loss on early extinguishment of debt||—||(1,381||)||—||(1,381||)|
|Net loss per common share — basic and diluted||$||(0.58||)||$||(0.36||)||$||(1.09||)||$||(0.78||)|
|Weighted-average number of common shares used in calculating net loss per common share — basic and diluted||41,921,329||39,273,330||41,830,803||37,569,275|
|(1) Includes the following noncash, stock-based compensation expenses:|
|Research and development expenses||$||1,249||$||741||$||2,334||$||1,166|
|General and administrative expenses||$||1,942||$||514||$||5,593||$||848|
|ANACOR PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|June 30,||December 31,|
|Cash, cash equivalents and investments (2)||$||130,532||$||166,815|
|Total stockholders’ equity||84,650||121,432|
|(1)||Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.|
|(2)||Investment balances at June 30, 2014 and December 31, 2013 include short-term and long-term investments, as well as $3.9 million and $4.6 million of restricted investments, respectively.|