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 second quarter ended June 30, 2014.
"Over the past few months, we have advanced our efforts to deliver a
novel, best-in-class therapy that harnesses the power of HIF biology for
the treatment of anemia secondary to chronic kidney disease, a
significant and growing patient population that remains severely
under-treated," stated John P. Butler, President and Chief Executive
Officer of Akebia. "We completed enrollment in the Phase 2b trial of
AKB-6548, strengthened our board with two key additions, and expanded
our management team to help drive growth and advance our programs. We
look forward to reporting top-line clinical trial results from the Phase
2b study in the fourth quarter of this year."
Second Quarter and Recent Corporate Highlights
Second Quarter 2014 Financial Results
Akebia reported a net loss and a net loss applicable to common
stockholders of $7.6 million, or ($0.39) per share, for the second
quarter of 2014. Net loss applicable to common stockholders for the
second quarter of 2013, which includes accretion on preferred stock of
$49.3 million, was $52.1 million or ($103.19) per share. 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 $5.5 million for the second
quarter of 2014 compared to $2.5 million for the second quarter of 2013.
The increase of $3.0 million in research and development expenses is
primarily attributable to increased clinical trial and other costs
related to AKB-6548, increased headcount related costs as well as
increased stock-based compensation expense of $1.0 million.
General and administrative expenses were $2.3 million for the second
quarter of 2014 compared to $0.7 million for the second quarter of 2013.
The increase of $1.6 million in general and administrative expenses is
primarily related to an increase in headcount and insurance related
costs, increased professional fees as well as increased stock-based
compensation expense of $0.5 million.
The increased stock-based compensation expense in both research and
development expenses and general and administrative expenses is
primarily a result of an 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 second quarter of 2014
was $6.7 million, an increase of $4.7 million from $2.0 million for the
same period of 2013. The Company ended the second quarter of 2014 with
cash, cash equivalents and investments of $124.2 million and expects its
existing cash resources to support operations through the first half of
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered
in Cambridge, Massachusetts, focused on harnessing the potential of
hypoxia-inducible factor (HIF) biology to develop and commercialize
novel, proprietary therapeutics to treat kidney disease. Akebia's lead
clinical program, AKB-6548, is a once-daily, oral therapy currently in
Phase 2b clinical development for the treatment of anemia related to
chronic kidney disease, a serious medical condition that leads to
increased morbidity and mortality if left untreated. For more
information on Akebia, please visit www.akebia.com.
This press release includes forward-looking statements. Such
forward-looking statements include those about Akebia's strategy, future
plans and prospects, including statements regarding the potential
indications and benefits of AKB-6548, the expected timing of the
announcement of data from the Phase 2b study, the growth of the chronic
kidney disease patient population and the projected use of Akebia's
existing cash resources. The words "anticipate," "appear," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue,"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. Each forward-looking statement is subject to risks
and uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement, including the risk
that existing preclinical and clinical data may not be predictive of the
results of ongoing or later clinical trials; the ability of Akebia to
successfully complete the clinical development of AKB-6548 or any other
product candidate; the funding required to develop Akebia's product
candidates and operate the Company, and the actual expenses associated
therewith; the content of decisions made by the FDA and other regulatory
authorities; the actual time it takes to complete the Phase 2b study and
analyze the data; the success of competitors in developing product
candidates for diseases for which Akebia is currently developing its
product candidates; the introduction or adoption of therapeutic
interventions that slow the progression of chronic kidney disease; and
Akebia's ability to obtain, maintain and enforce patent and other
intellectual property protection for AKB-6548 or any other product
candidates. Other risks and uncertainties include those identified under
the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for
the quarter ended June 30, 2014, and other filings that Akebia may make
with the Securities and Exchange Commission in the future. Akebia does
not undertake, and specifically disclaims, any obligation to update any
forward-looking statements contained in this press release.
June 30, 2014
Reconciliation of net loss to net loss applicable to common
Net loss per share applicable to common stockholders-basic and
Weighted-average number of common shares used in net loss per
share applicable to common stockholders'-basic and diluted
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