Akebia Therapeutics reports net loss of $9.7 million for Q1 2014

Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development of novel, proprietary therapeutics based on hypoxia-inducible factor (HIF) biology and the commercialization of these products for patients with kidney disease, today announced financial results for the first quarter ended March 31, 2014.

"We have made important progress since the beginning of 2014 in several key areas of our corporate strategy," said John P. Butler, President and Chief Executive Officer of Akebia. "We completed enrollment in a Phase 2b study of our lead therapeutic candidate, AKB-6548, executed a highly successful initial public offering, and announced a key addition to our Board. We are in a strong position to rapidly advance our goal of delivering a novel, best-in-class therapy that harnesses the power of HIF biology for the treatment of anemia secondary to CKD, a significant and growing patient population that remains severely under-treated and may be exposed to safety risk with current treatment options."

First Quarter and Recent Corporate Highlights

• Completed enrollment in the Company's Phase 2b clinical study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis
• Completed an initial public offering raising approximately $104.4 million, net of underwriting discounts, commissions and offering expenses
• Strengthened the Board of Directors with the addition of Michael S. Wyzga, formerly the President and Chief Executive Officer of Radius Health, Inc. and, prior to that, the Executive Vice President, Finance and Chief Financial Officer at Genzyme Corporation

First Quarter 2014 Financial Results

Akebia reported a net loss of $9.7 million for the first quarter of 2014, compared to a net loss of $0.6 million for the first quarter of 2013. Net loss applicable to common stockholders, which includes accretion on preferred stock of $86.9 million, was $96.6 million for the first quarter of 2014, or ($43.37) per share. This compares to a net loss applicable to common stockholders of $1.5 million for the first quarter of 2013, which included accretion on preferred stock of $0.9 million, or ($3.09) per share. The first quarter 2013 net loss and net loss applicable to common stockholders also included a $2.4 million gain on the extinguishment of debt related to the 2012 Series X preferred stock. In connection with the closing of the Company's initial public offering on March 25, 2014, all of the Company's outstanding shares of preferred stock were converted into shares of common stock.

Research and development expenses were $6.2 million for the first quarter of 2014 compared to $1.9 million for the first quarter of 2013. The increase of $4.3 million in research and development expenses is primarily attributable to increased clinical trial and other costs related to AKB-6548 as well as increased stock-based compensation expense of $1.0 million.

General and administrative expenses were $3.8 million for the first quarter of 2014 compared to $0.7 million for the first quarter of 2013. The increase of $3.1 million in general and administrative expenses is primarily related to an increase in professional fees related to the Company's initial public offering as well as increased stock-based compensation expense of $1.4 million.

The increased stock-based compensation expense in both research and development expenses and general and administrative expenses is primarily a result of the increase in the value of the Company's common stock due to the Company's initial public offering.

The Company's cash used in operations during the first quarter of 2014 was $6.0 million, an increase of $4.5 million from $1.5 million for the same period of 2013. The Company ended the first quarter of 2014 with cash, cash equivalents and short-term investments of $132.2 million and expects its existing cash resources to support operations through the first half of 2016.