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Anacor: Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

Recognized $21.1 million in total KERYDIN

revenue in the third quarter of 2015 under the Sandoz Agreement, representing a sequential increase of 18.8% over the second quarter of 2015

Top-line results from the long-term safety study of crisaborole topical ointment, 2%, in patients with mild-to-moderate atopic dermatitis demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months

Anacor expects to submit a New Drug Application for crisaborole topical ointment, 2%, to the U.S. Food and Drug Administration in the first quarte r of 2016

Palo Alto, CA November 3, 2015

Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced its financial results for the quarter ended September 30, 2015.

We continue to make significant progress in developing and commercializing innovative new products derived from our boron chemistry platform. In the third quarter, we announced positive top-line results from our two Phase 3 pivotal studies of crisaborole for the potential treatment of mild-to-moderate atopic dermatitis in children and adults, and last week we announced the top-line results from our long-term safety study of crisaborole that demonstrated a safety profile consistent with that seen in our Phase 3 pivotal studies. With this study data now in hand, and the completion of our pre-NDA submission meeting with the FDA in September 2015, we anticipate that we will file our NDA for crisaborole in the first quarter of 2016. In addition, we continue to prepare for the potential commercial launch of crisaborole in 2017. If approved, we believe crisaborole could offer an important treatment option to patients with mild-to-moderate atopic dermatitis, said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. Turning to our first approved product, we were pleased with the continued prescription growth of KERYDIN in the third quarter, as PharmaDerm, the branded dermatology division of Sandoz Inc. responsible for the commercialization of KERYDIN in the U.S., initiated its direct-to-consumer television advertisements and other consumer-directed commercialization activities pursuant to the amendment we executed in the second quarter.

Third Quarter and Recent Highlights and Developments

On October 29, 2015, we announced the top-line results from the long-term safety study of crisaborole topical ointment, 2% (formerly known as AN2728), a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In the long-term safety study, crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months. No treatment-related serious adverse events were reported and most adverse events were graded as mild in severity, and transient. The most common treatment-related adverse events reported by at least 2% of subjects were atopic dermatitis (3.1%) and application site pain (2.3%).

In July 2015, we announced the positive top-line results from our two Phase 3 pivotal studies of crisaborole. In both studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies.

Selected Financial Results for the Quarter Ended September 30, 2015

Distribution and commercialization agreement revenue

for the third quarter of 2015 was $21.1 million, representing a sequential increase of 18.8% from the second quarter of 2015. In the quarter ended September 30, 2015, we recognized $19.1 million of gross profit sharing revenue under our distribution and commercialization agreement (the Sandoz Agreement) with Sandoz Inc. (Sandoz), a Novartis company, based upon gross profits on sales of KERYDIN, as reported to us by Sandoz. In addition, for the three months ended September 30, 2015 and 2014, we recognized $0.8 million and $0.6 million, respectively, of the $40.0 million in total upfront payments made to us during the third quarter of 2014 under the Sandoz Agreement, and $1.3 million and $0.4 million, respectively, from product sales of KERYDIN to Sandoz.

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