Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced its financial results for the quarter ended March 31, 2015. "We continue to work with our partner Sandoz to optimize the commercial opportunity for KERYDIN ® and believe, based on the continued growth in prescriptions, that we are making good progress," said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. "In addition, we recently completed enrollment in both of our pivotal Phase 3 studies of AN2728 in patients with mild-to-moderate atopic dermatitis and continue to expect to announce top-line data in the third quarter of 2015. Pending the results of these studies, we expect to submit an NDA to the FDA in the first half of 2016." Recent Highlights and Developments
- We received a launch payment of $25.0 million in January 2015 from our partner, Sandoz Inc. ("Sandoz"), a Novartis company, pursuant to the distribution and commercialization agreement we entered into in July 2014. Under the agreement, we are entitled to 50% of the gross profits accrued by Sandoz on sales of KERYDIN, except that, for 2016, we are entitled to cumulative minimum gross profit sharing payments of $45.0 million and, in 2015, we start receiving gross profit-sharing payments after the first $50.0 million of gross profits have been accrued by Sandoz.
- We recently completed enrollment in both of our pivotal Phase 3 studies of our lead product development candidate, AN2728, an investigational non-steroidal topical PDE-4 inhibitor for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. Atopic dermatitis is a chronic rash characterized by inflammation and itch. Approximately 18 to 25 million people in the United States have atopic dermatitis, and approximately 8% to 18% of all infants and children are affected by the disease. Based on our market research, we believe there is a significant unmet medical need for a non-steroidal topical treatment for mild-to-moderate atopic dermatitis with the target product profile of AN2728.
- We continue to expect to announce top-line data from our pivotal Phase 3 studies of AN2728 in the third quarter of this year.
- In January 2015, we announced that we completed two two-year rodent carcinogenicity studies for AN2728 and that neither study identified any evidence of AN2728-related malignancies.
|ANACOR PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data)|
|Three Months Ended March 31,|
|Distribution and commercialization agreement||$||12,069||$||—|
|Cost of goods sold (1)||754||—|
|Research and development (1)||18,161||15,935|
|Selling, general and administrative (1)||8,145||8,328|
|Total operating expenses||27,060||24,263|
|Loss from operations||(11,796||)||(20,105||)|
|Net loss per share - basic and diluted||$||(0.30||)||$||(0.51||)|
|Weighted-average number of shares used in calculating net loss per share - basic and diluted||43,432,034||41,739,272|
|(1) Includes the following stock-based compensation expenses:|
|Cost of goods sold||$||63||$||—|
|Research and development expenses||$||1,550||$||1,085|
|Selling, general and administrative expenses||$||2,368||$||3,651|
|ANACOR PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEET DATA (in thousands)|
|March 31, 2015||December 31, 2014|
|Cash, cash equivalents and investments (1)||$||199,570||$||191,635|
|Convertible senior notes, net (2)||60,808||59,969|
|Total stockholders' equity||72,591||78,832|
|(1)||Balances at March 31, 2015 and December 31, 2014 included cash and cash equivalents of $22.1 million and $16.0 million, short-term and long-term investments of $175.2 million and $171.9 million and restricted investments of $2.3 million and $3.7 million, respectively.|
|(2)||The Company separately accounts for the debt and equity components of the 2.00% Convertible Senior Notes due 2021. At March 31, 2015, the net carrying amount of the liability component was $60.8 million, and the unamortized discount on the liability component was $29.7 million. The aggregate outstanding principal amount of the Convertible Senior Notes was $90.5 million.|