– Recent Collaboration Agreements Position Vadadustat Global
Phase 3 Development Program for Success, Offer Strong Financial and
Commercial Support, and Drive Significant Value Creation –
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 first quarter
ended March 31, 2017.
“Our team at Akebia continues to execute on our goals in 2017,
as we advance the Phase 3 program for vadadustat and expand our
pipeline,” said John P. Butler, President and Chief Executive
Officer of Akebia. “We established two major collaborations with
Otsuka Pharmaceutical in the last four months that support our
global development program for vadadustat and drive long-term value
for Akebia. The Otsuka agreements, coupled with an earlier
collaboration with Mitsubishi Tanabe, provide for $573 million or
more in committed capital and a total potential deal value of $2.2
billion plus royalties ranging from mid-single digit to tiered
double digit. We believe that the strength of our collaborations is
a testament to the potential of vadadustat to change the standard
of care for patients with anemia associated with chronic kidney
disease. With cash plus committed development funding of over $600
million, Akebia is in a very strong financial position.”
First Quarter 2017 and Recent Corporate Highlights
- Expanded relationship with Otsuka for
vadadustat from a profit share agreement in the U.S. to include a
collaboration and license agreement for Europe, China and other
territories, excluding Latin America. This agreement provides for
committed capital and potential milestone payments from Otsuka of
up to $865 million, including $208 million or more in upfront and
development funding and up to $657 million in milestone
payments;
- Signed an exclusive agreement with
Johnson & Johnson Innovation to in-license HIF product
candidates and access an extensive library of HIF compounds,
including AKB-5169, a differentiated, oral, non-absorbed
preclinical compound for the treatment of inflammatory bowel
disease, which is poised for IND submission in the second half of
2018;
- Published positive Phase 2a study
results in the American Journal of Nephrology, demonstrating that
vadadustat increased hemoglobin levels in a dose-dependent manner
and improved iron mobilization in non-dialysis chronic kidney
disease (CKD) patients; and
- The Independent Data Monitoring
Committee for Akebia’s global Phase 3 PRO2TECT and INNO2VATE
programs met and recommended continuing the studies without
modification.
Financial Results
The company reported a net loss of ($44.5) million, or ($1.15)
per share, for the first quarter of 2017 as compared to a net loss
for the first quarter of 2016 of ($25.8) million or ($0.70) per
share.
Collaboration revenue was $20.9 million for the first quarter of
2017, which related to the Company’s agreement with Otsuka.
Collaboration revenue in connection with our agreement with
Mitsubishi Tanabe Pharma Corporation is expected to commence in the
second half of 2017.
Research and development expenses were $60.0 million for the
first quarter of 2017 compared to $20.2 million for the first
quarter of 2016. The increase is primarily attributable to external
costs related to the global PRO2TECT and INNO2VATE Phase 3
programs. Research and development expenses were further increased
by headcount and compensation-related costs.
General and administrative expenses were $5.8 million for both
the first quarters of 2017 and 2016 due to offsetting increases and
decreases in associated costs.
The company ended the first quarter of 2017 with cash, cash
equivalents and marketable securities of $251.8 million. The
company is also entitled to receive $373.0 million or more in
committed capital from collaborators, which is expected to be
received over the course of the global development program for
vadadustat, of which $73.0 million was received in April 2017 in
connection with the expanded collaboration with Otsuka. Based on
the timing of payments from collaborators, Akebia expects existing
and committed cash resources to fund the company’s current
operating plan into the first quarter of 2019. However, the
remaining committed research and development funding will continue
to be received from Otsuka on a prepaid, quarterly basis up to an
estimated aggregate of $60.0 million.
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 associated with chronic kidney
disease and the INNO2VATE studies for dialysis-dependent patients,
is currently ongoing. 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, anticipated financial
contributions from Otsuka Pharmaceutical and Mitsubishi Tanabe
under Akebia’s collaboration agreements, 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; Akebia’s ability to satisfy
its obligations under its collaboration and license agreements; the
timing and content of decisions made by the FDA and other
regulatory authorities; the actual time it takes to initiate and
complete research and development; 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 March 31, 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, INC
Consolidated Statements of Operations (in thousands
except share and per share data) (unaudited)
Three Months Ended March 31, 2017 March 31,
2016 Collaboration revenue $ 20,865 $ — Operating expenses:
Research and development 60,049 20,235 General and administrative
5,788 5,811 Total operating expenses
65,837 26,046 Operating loss (44,972 )
(26,046 ) Other income, net 429 248 Net
loss $ (44,543 ) $ (25,798 ) Net loss per share - basic and
diluted
$ (1.15 ) $ (0.70 ) Weighted-average number of common shares -
basic and diluted 38,759,221 36,873,594
AKEBIA THERAPEUTICS, INC. Selected
Balance Sheet Data (in thousands) (unaudited)
March 31, 2017 December 31, 2016 Cash, cash
equivalents and available for sale securities $ 251,805 $ 260,343
Working capital 121,590 182,053 Total assets 259,256 300,216 Total
stockholders’ equity 30,617 68,120
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AkebiaTheresa McNeely, 617-844-6113SVP, Corporate
Communications and Investor Relationstmcneely@akebia.com
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