KYTHERA Biopharmaceuticals, Inc.
(NASDAQ: KYTH) today reported financial results for its quarter and year ended December 31, 2012.
“2012 was a transformational year for KYTHERA, during which we strengthened our capital position through the successful completion of our initial public offering with gross proceeds of $81 million,” said Keith Leonard, KYTHERA’s President and CEO. “We also made important advances in our clinical development program for ATX-101, an investigational injectable drug for the reduction of unwanted submental fat, commonly known as double chin. In April, we announced positive European Phase III clinical trial results in conjunction with Bayer, our collaborator outside of the U.S. and Canada. Additionally, in August, we completed enrollment in our pivotal U.S. and Canadian Phase III clinical trials and expect to report topline results in mid-2013. If approved, ATX-101 will be the first drug approved for the reduction of submental fat. Over the coming year we will continue to advance our development program for this potential first-in-class injectable drug.”
2012 Summary Financial Results
Cash and cash equivalents
totaled $79.3 million at December 31, 2012. This compares to $34.6 million at December 31, 2011. Based on current operating plans, the Company believes its existing cash and cash equivalents will allow it to fund its operating plan through at least the next 12 months.
Research and development expenses
totaled $14.4 million for the fourth quarter 2012 and $43.2 million for the full year 2012, compared to $6.2 million for the fourth quarter 2011 and $15.8 million for the full year 2011. The increase in research and development expenses in 2012 compared to the similar periods in 2011 is primarily attributable to the initiation of pivotal Phase III trials in the U.S. and Canada.
General and administrative expenses
totaled $3.4 million for the fourth quarter of 2012 and $10.5 million for the year ended December 31, 2012, compared to $1.9 million for the fourth quarter of 2011 and $6.9 million for the year ended December 31, 2011. The increase in general and administrative expenses in 2012 compared to the similar periods in 2011 is primarily attributable to increased personnel costs, increased marketing in preparation for a potential commercial launch of ATX-101 and services associated with the support of operations as a public company.
was $18.0 million for the fourth quarter of 2012 and $36.8 million for the year ended December 31, 2012, compared to $5.6 million for the fourth quarter of 2011 and $11.2 million for the year ended December 31, 2011.
Key 2012 and Recent Accomplishments
- In March 2013, announced the appointment of Frederick Beddingfield, III, MD, PhD, as Chief Medical Officer. He joins the company from Allergan, Inc., where he worked in an executive capacity across the entire aesthetics portfolio including Botox® Cosmetic, Juvederm® and Latisse®. Dr. Beddingfield most recently held the role of Allergan’s Vice President and Therapeutic Area Head, Dermatology and Aesthetics.
- In March 2013, four abstracts were presented at the 71st American Academy of Dermatology (AAD) Annual Meeting that evaluated the safety, efficacy and pharmacokinetics of ATX-101.
- In October 2012, completed its initial public offering of 5,060,000 shares of its common stock at an initial public offering price of $16.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 660,000 additional shares of common stock. The Company received net proceeds of approximately $72.5 million after deducting underwriting discounts, commissions and offering costs.
- In August 2012, completed enrollment in two pivotal U.S. and Canadian Phase III clinical trials of ATX-101.
- In April 2012, Bayer announced positive results from two pivotal European Phase III multi-center, randomized, double blind, placebo controlled trials of ATX-101. ATX-101 was found to be well tolerated and resulted in a statistically significant reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.
ATX-101 is a potential first-in-class injectable drug candidate under clinical investigation for the reduction of unwanted submental fat. ATX-101 is a proprietary synthetic formulation of deoxycholate, a well-characterized endogenous bile acid that is naturally occurring in the body and promotes the natural breakdown of dietary fat. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Based on clinical trials conducted to date, ATX-101 has exhibited significant, meaningful and durable results in the reduction of submental fat, which commonly presents as an undesirable “double chin.” These results correspond with subject satisfaction measures demonstrating meaningful improvement in perceived chin appearance.