Press Release
Akebia Announces Fourth Quarter and Full-Year 2016 Financial Results
-- Company to Host Conference Call at
"Over the last year, we continued to advance our global Phase 3
development program for vadadustat," said
2016 Full-Year and Recent Corporate Highlights
- Initiated the global Phase 3 INNO2VATE program to evaluate vadadustat in dialysis-dependent patients with anemia associated with chronic kidney disease (CKD);
-
Entered into a collaboration with
Otsuka Pharmaceutical Co., Ltd in which the companies equally share the costs of developing and commercializing vadadustat in theU.S. and the profits from sales of vadadustat after approval by the U.S. Food and Drug Administration. This includes$265 million or more in committed capital and up to$765 million in potential development and commercial milestone payments from Otsuka;
-
Signed an exclusive agreement with
Janssen Pharmaceutica, NV , a Johnson & Johnson company, to license HIF product candidates and access an extensive library of HIF compounds that may have applications across multiple therapeutic areas. The lead compound, a differentiated, oral, non-absorbed preclinical compound for the treatment of inflammatory bowel disease, is poised for IND submission in 12-18 months; -
Prevailed in two patent disputes in which the
European Patent Office confirmed that none of FibroGen, Inc.'s patent claims met the requirements for patentability and, as a result, revoked the patents; and -
Published positive Phase 2b study results in non-dialysis dependent
chronic kidney disease patients in
Kidney International . Additional data was presented at several scientific meetings further demonstrating the potential of vadadustat including encouraging results in dialysis-dependent chronic kidney disease patients, and a drug-drug interaction study suggesting that vadadustat should have no impact on the metabolism of any of the major statins, which are commonly prescribed medications for CKD patients.
Financial Results
The company reported a net loss of
The company reported a net loss for the full year of 2016 of
Collaboration revenue was
Research and development expenses were
General and administrative expenses were
The company ended 2016 with cash, cash equivalents and available for
sale securities of
In other news today, Akebia announced that on
Conference Call and Webcast
Akebia management will host a conference call to discuss the financial
results for the year ended
To access the conference call, follow these instructions:
Dial: (877) 458-0977 (
Conference
ID: 77605143
About
Forward-Looking Statements
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
commercialization of vadadustat if approved by regulatory authorities,
the potential indications and benefits of vadadustat and Akebia's other
product candidates, the research and development plan for the portfolio
of HIF compounds licensed from Janssen, anticipated collaboration
revenue, and the timing of the potential filing of an IND for AKB-5169.
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 funding required to develop Akebia's product
candidates and operate the company, and the actual expenses associated
therewith; the actual costs incurred in the Phase 3 studies of
vadadustat and the availability of financing to cover such costs; early
termination of Akebia's collaboration or license agreements; the timing
and content of decisions made by the
Consolidated Statements of Operations (in thousands except share and per share data) (unaudited) |
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Three Months Ended | Twelve Months Ended | |||||||||||||||
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|
|
|
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Collaboration revenue |
$ |
1,535 |
— |
$ |
1,535 |
$ |
— |
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Operating expenses: | ||||||||||||||||
Research and development | 33,435 | 14,244 | 115,785 | 43,016 | ||||||||||||
General and administrative | 6,144 | 5,806 | 22,210 | 18,497 | ||||||||||||
Total operating expenses | 39,579 | 20,050 | 137,995 | 61,513 | ||||||||||||
Operating loss | (38,044) | (20,050) | (136,460) | (61,513) | ||||||||||||
Other income, net | 182 | 193 | 713 | 797 | ||||||||||||
Net loss | $ | (37,862) | $ | (19,857) | $ | (135,747) | $ | (60,716) | ||||||||
Net loss per share applicable to common stockholders—basic and diluted | $ | (0.99) | $ | (0.66) | $ | (3.60) | $ | (2.29) | ||||||||
Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted | 38,277,100 | 30,309,251 | 37,716,949 | 26,469,170 | ||||||||||||
Selected Balance Sheet Data (in thousands) (unaudited) |
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Cash, cash equivalents and available for sale securities | $ | 260,343 | $ | 138,454 | |||
Working capital | 182,053 | 129,149 | |||||
Total assets | 300,216 | 142,940 | |||||
Total stockholders' equity | 68,120 | 130,998 | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170306005419/en/
Akebia
SVP, Corporate
Communications and Investor Relations
tmcneely@akebia.com
Source:
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Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax