Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical
company focused on delivering innovative therapies to patients with
kidney disease through the biology of hypoxia-inducible factor
(HIF), today announced financial results for the second quarter
ended June 30, 2017.
“Akebia continues to maximize the potential of vadadustat
through value-enhancing deals and executing on our clinical
development program,” said John P. Butler, President and Chief
Executive Officer of Akebia. “Our agreement with Vifor Pharma
establishes vadadustat as its exclusive HIF product for
distribution to Fresenius Medical Care, the largest kidney dialysis
provider in the U.S., following FDA approval. In addition, we
initiated our Phase 2 FO2RWARD study in patients with renal anemia
who are hyporesponsive to erythropoiesis-stimulating agents, and
plan to start our Phase 3 TRILO2GY trial in the second half of the
year to confirm previous positive results of vadadustat
administered on a three-times-weekly basis. Topline data from both
of these studies are expected by the end of 2018, followed by
results from our global Phase 3 program for vadadustat.”
Mr. Butler added, “Substantial financial commitments from our
collaborators, together with our existing cash, position Akebia
well in advance of multiple value-creating events anticipated over
the next 12-18 months, including filing an IND for AKB-5169, our
HIF product candidate for inflammatory bowel disease, in the first
half of next year.”
Second Quarter 2017 and Recent Corporate Highlights
- Entered into an exclusive license
agreement with Vifor Pharma to sell vadadustat as its only HIF
product for distribution to Fresenius Medical Care in the U.S., a
kidney dialysis provider serving approximately 40% of dialysis
patients, following approval of vadadustat by the U.S. Food and
Drug Administration (FDA). The profit-sharing arrangement is based
on inclusion of vadadustat in a bundled reimbursement model, which
will generate a $20 million payment to Akebia from Vifor
Pharma. Separately, Vifor Pharma made a $50 million equity
investment in Akebia;
- Dosed the first patient in the
randomized, open-label Phase 2 FO2RWARD study of vadadustat in
dialysis-dependent chronic kidney disease patients who are
hyporesponsive to erythropoiesis-stimulating agents (ESAs). Akebia
expects to report data from FO2RWARD by the end of 2018;
- Prevailed in two additional European
Patent disputes in which the Opposition Division of the European
Patent Office revoked another FibroGen, Inc. HIF-related patent in
Europe, and another of their patents was significantly narrowed to
cover only an indication for which Akebia is not intending to
develop vadadustat;
- Appointed Rita Jain, M.D. as Senior
Vice President and Chief Medical Officer to lead the global
development program for vadadustat and the clinical development of
Akebia’s growing HIF pipeline;
- Raised approximately $67 million
through an underwritten public offering of common stock and full
exercise of the underwriters’ option to purchase additional shares;
and
- Otsuka Pharmaceutical Co. Ltd. waived
its option, in advance of its expiration, to convert its U.S.
arrangement with Akebia from a profit share to a right to receive
royalties.
Financial Results
Akebia reported a net loss of ($21.5) million, or ($0.53) per
share, for the second quarter of 2017 as compared to a net loss for
the second quarter of 2016 of ($35.8) million or ($0.95) per
share.
Collaboration revenue was $28.5 million for the second quarter
of 2017, which related to the Company’s agreements with Otsuka.
Collaboration revenue in connection with Akebia’s agreement with
Mitsubishi Tanabe Pharma Corporation is expected to commence in the
second half of 2017.
Research and development expenses were $43.8 million for the
second quarter of 2017 compared to $30.9 million for the second
quarter of 2016. The increase is primarily attributable to external
costs related to the global PRO2TECT and INNO2VATE Phase 3
programs, as well as the FO2RWARD and TRILO2GY studies. Research
and development expenses were further increased by headcount and
compensation-related costs.
General and administrative expenses were $6.9 million for the
second quarter of 2017 compared to $5.3 million for the second
quarter of 2016. The increase is primarily attributable to an
increase in costs to support the Company’s research and development
programs, including headcount and compensation-related costs and
associated facility costs.
Akebia ended the second quarter of 2017 with cash, cash
equivalents and marketable securities of $321.2 million, which
included a $50.0 million equity investment from Vifor Pharma. In
July 2017, the Company raised approximately $67.0 million from a
follow-on offering. The Company’s collaborators have committed up
to $373.0 million or more in license and cost-share funding, which
Akebia continues to receive on a quarterly prepaid basis. Akebia
expects existing cash resources, including net proceeds from the
July 2017 follow-on offering and the timing of committed research
and development funding from its collaborators to fund the
Company’s current operating plan into the second quarter of 2019.
Thereafter, committed research and development funding will
continue to be received from Otsuka on a prepaid, quarterly
basis.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company
headquartered in Cambridge, Massachusetts, focused on delivering
innovative therapies to patients with kidney disease through
hypoxia-inducible factor biology. Akebia's lead product candidate,
vadadustat, is an oral, investigational therapy in development for
the treatment of anemia related to chronic kidney disease in both
non-dialysis and dialysis patients. Akebia's global Phase 3 program
for vadadustat, which includes the PRO2TECT studies for
non-dialysis patients with anemia secondary to chronic kidney
disease and the INNO2VATE studies for dialysis-dependent patients,
is currently ongoing. In addition, the Company has initiated the
Phase 2 FO2RWARD study of vadadustat in dialysis-dependent chronic
kidney disease patients who are hyporesponsive to
erythropoiesis-stimulating agents (ESAs), and expects to commence
the Phase 3 TRILO2GY study to further evaluate a three-times-weekly
dosing regimen for vadadustat. For more information, please visit
our website at www.akebia.com.
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 expected timing of
clinical studies, the timing of the potential submission of an IND
for AKB-5169, anticipated financial contributions from Otsuka and
Mitsubishi Tanabe Pharma Corporation under Akebia’s collaboration
agreements, and the expected timing and 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 actual funding
required to develop Akebia's product candidates and operate the
company, and the actual expenses associated therewith; the actual
costs incurred in the clinical studies of vadadustat and the
availability of financing to cover such costs; early termination of
Akebia’s collaboration or license agreements; Akebia’s ability to
satisfy its obligations under its collaboration or license
agreements; the timing and content of decisions made by the FDA and
other regulatory authorities; the timing of any additional studies
initiated by Akebia or its collaborators for vadadustat; the rate
of enrollment in clinical studies of vadadustat; the actual time it
takes to initiate and complete research and clinical studies; the
success of competitors in developing product candidates for
diseases for which Akebia is currently developing its product
candidates; and Akebia's ability to obtain, maintain and enforce
patent and other intellectual property protection for vadadustat
and its other product candidates. Other risks and uncertainties
include those identified under the heading “Risk Factors” in
Akebia's Annual Report on Form 10-Q for quarter ended June 30,
2017, 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.
AKEBIA THERAPEUTICS,
INCConsolidated Statements of Operations(in thousands
except share and per share data)(unaudited)
Three Months Ended Six Months Ended June
30, 2017 June 30, 2016 June 30, 2017
June 30, 2016 Collaboration revenue $ 28,520 $ — $
49,385 $ — Operating expenses: Research and development 43,751
30,877 103,800 51,112 General and administrative 6,905
5,311 12,693 11,122
Total operating expenses 50,656 36,188
116,493 62,234 Operating loss
(22,136 ) (36,188 ) (67,108 ) (62,234 ) Other income, net
618 409 1,048 657
Net loss $ (21,518 ) $ (35,779 ) $ (66,060 ) $ (61,577 ) Net loss
per share - basic and diluted $ (0.53 ) $ (0.95 ) $ (1.66 ) $ (1.65
) Weighted-average number of common shares - basic and
diluted
40,819,957 37,811,056 39,795,282
37,342,324
AKEBIA THERAPEUTICS,
INC.Selected Balance Sheet Data(in
thousands)(unaudited)
June 30, 2017 December 31, 2016 Cash, cash
equivalents and available for sale securities $ 321,215 $ 260,343
Working capital 150,798 182,053 Total assets 336,822 300,216 Total
stockholders’ equity 56,998 68,120
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version on businesswire.com: http://www.businesswire.com/news/home/20170808006152/en/
Akebia:Theresa McNeely, 617-844-6113SVP, Corporate
Communications and Investor Relationstmcneely@akebia.com
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