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 third quarter
ended September 30, 2018.
“In the third quarter, we continued to drive our vadadustat
Phase 3 development program, while working diligently to close our
proposed merger transaction with Keryx Biopharmaceuticals by the
end of 2018. The combination is expected to create a
fully-integrated kidney disease therapeutics company, with a
strengthened financial profile, positioned to deliver substantial
long-term value to shareholders,” said John P. Butler, President
and Chief Executive Officer of Akebia Therapeutics. “In addition,
we look forward to the Phase 3 clinical trial readouts in Japan
from our collaboration partner, Mitsubishi Tanabe Pharma
Corporation, expected next year. This will be the first time Phase
3 data has been reported for our product candidate, vadadustat,
which is an important milestone.”
Third Quarter 2018 and Recent Corporate Highlights
Merger Integration Planning:
- Following the definitive merger
agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)
announced June 28, 2018, Akebia has been actively engaged in
integration planning and expects to close the transaction by the
end of 2018;
- The combination offers potential
operating and product portfolio synergies and the opportunity to
create significant value and accelerate the growth potential beyond
what either company would achieve separately;
- The combined company will have an
expanded and highly complementary nephrology portfolio, with
Auryxia® (ferric citrate), a U.S. Food and Drug Administration
(FDA)-approved product in two indications with significant growth
opportunity, and vadadustat, an investigational late-stage
hypoxia-inducible factor prolyl hydroxylase inhibitor, which has
the potential to provide a new oral standard of care to patients
with anemia due to chronic kidney disease (CKD);
- The combined company will have an
established renal development, manufacturing and commercial
organization, positioning it as a partner of choice for the renal
community and for companies developing renal products; and
- The combined company plans to leverage
its leadership’s extensive expertise in the commercial renal market
with the goal of maximizing sales of Auryxia while driving launch
momentum for vadadustat in the United States, subject to FDA
approval.
Clinical Development:
- Akebia continued to enroll subjects in
its Phase 3 INNO2VATE program, with top-line results expected in
the first quarter of 2020, subject to the accrual of major adverse
cardiovascular events (MACE). U.S. enrollment in the Phase 3
INNO2VATE Conversion study completed last quarter, as announced in
Akebia’s second quarter 2018 earnings press release;
- Akebia continued to enroll subjects in
its Phase 3 PRO2TECT program, with top-line results anticipated in
mid-2020, subject to the accrual of MACE; and
- Akebia received a recommendation from
the Independent Data Monitoring Committee, which held another
meeting in the quarter, for Akebia’s global Phase 3 PRO2TECT and
INNO2VATE programs to continue without modification.
Other Business:
- This past quarter, Akebia appointed
Cynthia Smith to its Board of Directors. With more than 20 years of
broad leadership experience within the healthcare industry,
including serving as a Chief Commercial Officer, Cynthia brings
expertise that is particularly relevant to Akebia as it prepares
for the commercialization of vadadustat, subject to regulatory
approval, and works to maximize the value of Auryxia, subject to
the consummation of Akebia’s merger with Keryx
Biopharmaceuticals.
Financial Results
Akebia reported a net loss of $26.0 million, or ($0.46) per
share, for the third quarter of 2018 as compared to a net loss for
the third quarter of 2017 of $23.1 million or ($0.49) per
share.
Collaboration revenue was $53.2 million for the third quarter of
2018 compared to $41.3 million for the third quarter of 2017.
Collaboration revenue recognized in the third quarter of 2018
related primarily to revenue recognized under both the U.S.
collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or
Otsuka, and the collaboration agreement with Otsuka related to
Europe, China and certain other regions, or the Otsuka
International Agreement. Collaboration revenue recognized in the
third quarter of 2017 also related to the Otsuka U.S. Agreement and
the Otsuka International Agreement, which were consummated in
December 2016 and April 2017, respectively.
Research and development expenses were $70.6 million for the
third quarter of 2018 compared to $58.7 million for the third
quarter of 2017. The increase was 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 $10.4 million for the
third quarter of 2018 compared to $6.7 million for the third
quarter of 2017. The increase was primarily attributable to an
increase in legal and other professional fees related to our
proposed merger with Keryx Biopharmaceuticals, and an increase in
costs to support the company’s research and development programs,
including headcount and compensation-related costs.
Akebia ended the third quarter of 2018 with cash, cash
equivalents and available for sale securities of $390.1 million.
The company also generally receives cost-share funding from its
collaboration agreements with Otsuka on a prepaid quarterly basis.
Akebia expects its existing cash resources, including the prepaid
quarterly committed cost-share funding from its collaborators, to
fund its current operating plan through the first quarter of
2020.
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. For more information,
please visit our website at www.akebia.com, which does not
form a part of this release.
Forward-Looking Statements
Statements in this press release regarding Akebia’s strategy,
plans, prospects, expectations, beliefs, intentions and goals are
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995, as amended, including but
not limited to statements regarding the expected benefits of the
pending merger with Keryx, including but not limited to expected
synergies, value creation, growth potential, and the combined
company’s portfolio; the closing of the pending merger with Keryx,
including the timing thereof; the competitive position of the
combined company following completion of the merger with Keryx,
including but not limited to being a partner of choice for the
renal community and for companies developing renal products; plans
and goals for the combined company following completion of the
merger with Keryx; the potential for vadadustat to provide a new
oral standard of care to patients with anemia due to CKD; the rate
and timing of enrollment of our clinical trials; the anticipated
timing of the availability and presentation of clinical trial data
and results; the benefits, including the potential effect on
commercial position, of the designs of our studies; the potential
characterization and differentiation information we believe will
result from the designs of our studies; potential and anticipated
payments from our collaborators, including the timing thereof;
expectations regarding financial position, including the period of
time our cash resources and committed funding from our
collaborators will fund our current operating plan. The terms
“anticipate,” “create,” “expect,” “goal,” “look forward,” “may,”
“opportunity,” “plan,” “position,” “potential,” “target,” “will,”
and similar references 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 that Akebia or Keryx may be unable to obtain
stockholder approval as required for the pending merger; conditions
to the closing of the pending merger may not be satisfied; the
pending merger may involve unexpected costs, liabilities or delays;
the effect of the announcement of the pending merger on the ability
of Akebia or Keryx to retain and hire key personnel and maintain
relationships with customers, suppliers and others with whom Akebia
or Keryx does business, or on Akebia’s or Keryx’s operating results
and business generally; Akebia’s or Keryx’s respective businesses
may suffer as a result of uncertainty surrounding the pending
merger and disruption of management’s attention due to the pending
merger; the outcome of any legal proceedings related to the pending
merger; Akebia or Keryx may be adversely affected by other
economic, business, and/or competitive factors, including the
receipt by Keryx of notice letters on October 31, 2018, and
November 6, 2018, regarding abbreviated new drug applications
submitted to the FDA requesting approval to market, sell and use a
generic version of the Auryxia; the occurrence of any event, change
or other circumstances that could give rise to the termination of
the merger agreement; risks that the pending merger disrupts
current plans and operations and the potential difficulties in
employee retention as a result of the pending merger; the risk that
Akebia or Keryx may be unable to obtain governmental and regulatory
approvals required for the transaction, or that required
governmental and regulatory approvals may delay the transaction or
result in the imposition of conditions that could reduce the
anticipated benefits from the proposed transaction or cause the
parties to abandon the proposed transaction; the impact of
legislative, regulatory, competitive and technological changes,
including the recent changes to reimbursement coverage for Auryxia
that could have a material adverse effect on Auryxia sales and
profitability; risks that the anticipated benefits of the pending
merger or other commercial opportunities may otherwise not be fully
realized or may take longer to realize than expected; other risks
to the consummation of the merger, including the risk that the
merger will not be consummated within the expected time period or
at all; rate of enrollment in clinical studies of vadadustat; the
rate of major adverse cardiovascular events in PRO2TECT
and INNO2VATE; the risk that clinical trials may not be
successful; the risk that existing preclinical and clinical data
may not be predictive of the results of ongoing or later clinical
trials; manufacturing risks; the quality and manner of the data
that will result from clinical studies of vadadustat; the actual
funding required to develop and commercialize 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; the risk that clinical studies are discontinued or
delayed for any reason, including for safety, tolerability,
enrollment, manufacturing or economic reasons; early termination of
any of Akebia’s collaborations; Akebia’s and its collaborators’
ability to satisfy their obligations under Akebia’s collaboration
agreements; the timing and content of decisions made by regulatory
authorities; the timing of any additional studies initiated for
vadadustat; the actual time it takes to initiate and complete
preclinical and clinical studies; the success of competitors
in developing product candidates for diseases for which Akebia is
currently developing its product candidates; the scope, timing, and
outcome of any ongoing legal, regulatory and administrative
proceedings; changes in the economic and financial conditions of
the businesses of Akebia and its partners; and Akebia’s ability to
obtain, maintain and enforce patent and other intellectual property
protection for vadadustat and 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
quarterly period ended September 30, 2018, and other filings
that Akebia may make with the U.S. Securities and Exchange
Commission (the “SEC”) in the future. These forward-looking
statements (except as otherwise noted) speak only as of the date of
this press release, and Akebia does not undertake, and specifically
disclaims, any obligation to update any forward-looking statements
contained in this press release.
Additional Information and Where to Find It
In connection with the proposed merger, Akebia has filed with
the SEC a Registration Statement on Form S-4, which, as amended,
includes a final prospectus with respect to the shares of Akebia’s
common stock to be issued in the proposed merger and a definitive
joint proxy statement of Keryx and Akebia with respect to the
proposed merger. The Registration Statement was declared effective
by the SEC on October 30, 2018 and the definitive joint proxy
statement was mailed or otherwise made available to Keryx’s and
Akebia’s respective stockholders on October 31, 2018. BEFORE MAKING
ANY VOTING DECISION, KERYX’S AND AKEBIA’S RESPECTIVE STOCKHOLDERS
ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS IN ITS
ENTIRETY AND ANY OTHER DOCUMENTS FILED BY EACH OF AKEBIA AND KERYX
WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED
BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE
PROPOSED TRANSACTION. Investors and stockholders can obtain a free
copy of the joint proxy statement/prospectus and other documents
containing important information about Akebia and Keryx, once such
documents are filed with the SEC, through the website maintained by
the SEC at www.sec.gov. Akebia and Keryx make available free of
charge at www.akebia.com and www.keryx.com, respectively (in the
“Investors” section), copies of materials they file with, or
furnish to, the SEC.
Participants in the Merger Solicitation
Akebia, Keryx and their respective directors, executive officers
and certain employees and other persons may be deemed to be
participants in the solicitation of proxies from the stockholders
of Akebia and Keryx in connection with the proposed merger.
Information regarding the interests of such individuals in the
proposed merger, by security holdings or otherwise, is included in
the joint proxy statement/prospectus relating to the proposed
merger that has been filed with the SEC. In addition, security
holders may obtain information regarding the names, affiliations
and interests of Akebia’s directors and officers in Akebia’s Annual
Report on Form 10-K for the fiscal year ended December 31,
2017, which was filed with the SEC on March 12, 2018, and its
definitive proxy statement for the 2018 annual meeting of
stockholders, which was filed with the SEC on April 30, 2018,
and information regarding the names, affiliations and interests of
Keryx’s directors and officers in Keryx’s Annual Report on Form
10-K for the fiscal year ended December 31, 2017, which was
filed with the SEC on February 21, 2018, and the Amendment
No. 1 on Form 10-K/A, which was filed with the SEC on
April 30, 2018, and its definitive proxy statement for the
2018 annual meeting of stockholders, which was filed with the SEC
on May 31, 2018. To the extent the holdings of Akebia
securities by Akebia’s directors and executive officers or the
holdings of Keryx securities by Keryx’s directors and executive
officers have changed since the amounts set forth in the joint
proxy statement/prospectus, such changes have been or will be
reflected on Statements of Change in Ownership on Form 4 filed with
the SEC. These documents (when available) may be obtained free of
charge from the SEC’s website at www.sec.gov, Akebia’s website at
www.akebia.com and Keryx’s website at www.keryx.com.
This document does not constitute a
solicitation of proxy, an offer to purchase or a solicitation of an
offer to sell any securities.
Tables Follow
AKEBIA THERAPEUTICS,
INC.Consolidated Statements of Operations(in
thousands except share and per share data)(unaudited)
Three Months Ended Nine Months Ended
September 30, 2018 September 30, 2017
September 30, 2018 September 30, 2017
Collaboration revenue $ 53,169 $ 41,283 $ 147,892 $ 90,668
Operating expenses: Research and development 70,634 58,711 203,955
162,511 General and administrative 10,378
6,748 31,940 19,441 Total operating
expenses 81,012 65,459 235,895
181,952 Operating loss (27,843) (24,176) (88,003)
(91,284) Other income, net 1,796 1,042
4,469 2,090 Net loss $ (26,047) $
(23,134) $ (83,534) $ (89,194) Net loss per share -
basic and diluted $ (0.46) $ (0.49) $ (1.54) $
(2.11) Weighted-average number of common shares - basic and
diluted
57,027,598 46,938,618 54,207,973
42,202,560
AKEBIA THERAPEUTICS, INC.Selected
Balance Sheet Data(in thousands)(unaudited)
September 30, 2018 December 31, 2017 Cash,
cash equivalents and available for sale securities $ 390,144 $
317,792 Working capital 220,127 217,250 Total assets 403,826
364,247 Total stockholders' equity 142,541 122,574
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version on businesswire.com: https://www.businesswire.com/news/home/20181108005692/en/
Akebia TherapeuticsJohn Garabo, 617-844-6130Director, Corporate
Communicationsjgarabo@akebia.com
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