Expects to Capture Significant Operating and
Product Portfolio Synergies,Accelerating Revenue Growth and
Creating Shareholder Value
Consolidates an FDA-Approved Oral CKD Product
and an Investigational, Phase 3 Oral CKDProduct Candidate Under
Combined Experienced Renal Leadership Team
Largest Keryx Shareholder, The Baupost Group,
Agrees to Convert Outstanding Notes Prior to Close;Enters
Shareholder Voting Agreement in Support of Transaction
John P. Butler to Be President and Chief
Executive Officer of Combined Company; Keryx to Appoint Chairperson
of the Board
Companies to Host Investor Conference Call
Today at 8:00 a.m. ET
Akebia Therapeutics, Inc. (NASDAQ:AKBA) and Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that the
companies signed, and the boards of directors of both companies
have unanimously approved, a definitive merger agreement under
which the companies will combine in an all-stock merger. The
transaction will create a fully integrated biopharmaceutical
company focused on chronic kidney disease (CKD), with an implied
pro forma equity value of approximately $1.3 billion, assuming full
conversion of Keryx’s outstanding convertible notes, based on the
closing prices of Keryx and Akebia on June 27, 2018. The combined
company will be named Akebia Therapeutics, Inc.
Under the terms of the agreement, Keryx shareholders will
receive 0.37433 common shares of Akebia for each share of Keryx
they own. The exchange results in implied equity ownership in the
combined company of 49.4 percent for Akebia shareholders and 50.6
percent for Keryx shareholders on a fully-diluted basis. John P.
Butler, President and Chief Executive Officer of Akebia, is
expected to lead the combined company, and Keryx will appoint the
Chairperson of the Board of Directors of the combined company.
Additionally, Jason A. Amello, Akebia’s Chief Financial Officer, is
expected to serve in the same capacity on the management team of
the combined company.
The Baupost Group, L.L.C., which owns approximately 21.4 percent
of the outstanding Keryx common stock prior to any conversion of
its convertible notes, has agreed to convert its outstanding
convertible notes of Keryx into shares of Keryx common stock prior
to closing and has entered into a voting agreement in support of
the transaction. Muneer A. Satter, Chairperson of the Akebia Board
of Directors and a shareholder who owns approximately 5.3 percent
of outstanding Akebia common stock, has also agreed to support the
transaction by entering into a voting agreement.
The merger of Akebia and Keryx creates a renal-focused company
committed to developing and delivering innovative therapeutic
products. Keryx’s Auryxia® (ferric citrate) is a U.S. Food and Drug
Administration (FDA)-approved medicine to treat dialysis dependent
CKD patients for hyperphosphatemia and non-dialysis dependent CKD
patients for iron deficiency anemia (IDA). Akebia’s vadadustat is
an investigational Phase 3 oral hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI) with the potential to advance the
treatment of patients with anemia due to CKD, many of whom are
currently receiving injectable erythropoietin-stimulating agents
(ESAs). The companies believe that Auryxia and vadadustat, if
FDA-approved, have the potential to deliver an all-oral treatment
approach for patients with anemia due to CKD. More broadly, the
combined company has the potential to offer therapeutic options to
patients across all stages of CKD, including non-dialysis dependent
and dialysis dependent patients, and to become a partner of choice
for the renal community and for companies developing renal
products.
John P. Butler, President and Chief Executive Officer of Akebia,
said: “The strategic and financial drivers of this merger are
compelling. The combined company will have an expanded and highly
complementary nephrology portfolio, with Auryxia, a product with
significant growth opportunity, and vadadustat, an investigational
late-stage HIF-PHI that has the potential to provide a new oral
standard of care to patients with anemia due to CKD. Combining
Akebia and Keryx creates a leading renal company and provides it
with the infrastructure to maximize the market potential of Auryxia
and build launch momentum for vadadustat in the United States,
subject to FDA approval. I look forward to leading the talented
teams of both Akebia and Keryx as we work to establish new
standards of renal care and unlock growth potential for
shareholders.”
Jodie Morrison, Interim Chief Executive Officer of Keryx, said:
“Bringing Keryx together with Akebia represents a unique,
value-enhancing opportunity for stakeholders of both companies.
Akebia shareholders gain access to the only oral iron tablet
approved in the United States to treat dialysis dependent CKD
patients for hyperphosphatemia and non-dialysis dependent CKD
patients for iron deficiency anemia. Keryx shareholders gain access
to an innovative Phase 3 product candidate with the potential to
compete in a complementary multi-billion-dollar market upon
successful completion of its development program. Importantly,
Keryx shareholders also gain a seasoned executive with decades of
experience in the renal field to lead our organization. I look
forward to working with our management team during this transition
period to continue to deliver on our mission to bring innovative
medicines to people living with kidney disease.”
“Akebia and Keryx bring together assets and capabilities that
should lead to new business opportunities and substantial
realizable synergies,” said Greg Ciongoli, Partner, The Baupost
Group. “The combined company will be well positioned for future
growth.”
Strategic Rationale
The merger offers potential operating and product portfolio
synergies, with the opportunity to create significant value and
accelerate the growth potential beyond what either company would
achieve separately.
Establishes a Leading Renal Company with Enhanced Position
and Large Market Opportunity
Combining Akebia and Keryx is expected to create a sustainable,
kidney disease-focused, therapeutic leader that is well positioned
to be a partner of choice throughout the renal community and for
companies with products for patients with kidney disease. The
merger creates a fully integrated renal company with a
complementary portfolio comprising Keryx’s FDA-approved Auryxia and
Akebia’s product candidate, vadadustat.
Auryxia is a phosphate binder indicated for the control of serum
phosphorus levels in adult patients with CKD on dialysis, and an
iron replacement product indicated for the treatment of iron
deficiency anemia in adult patients with CKD who are not on
dialysis. The approval and commercialization of Auryxia provides a
new prescription oral treatment option for the millions of CKD
patients with either hyperphosphatemia or iron deficiency
anemia.
Vadadustat is a once-daily, oral investigational drug being
studied in large-scale global Phase 3 clinical trials in both
non-dialysis dependent and dialysis dependent patients with anemia
due to CKD. Vadadustat’s mechanism of action is designed to mimic
the physiologic effect of altitude on oxygen availability.
Vadadustat has the potential to become a new standard of care for
patients with anemia due to CKD who currently rely on injectable
ESAs, a multi-billion-dollar market.
The combined company will have the opportunity to provide
nephrologists with a portfolio of renal products, subject to
vadadustat’s FDA approval, that can address the needs of an
estimated 1.7 million patients who are non-dialysis dependent and
500,000 dialysis-dependent patients in the United States, across
the continuum of CKD.
Creates Potential for Accelerated Growth and Organizational
Synergies
The combined company brings together Keryx, a commercial
organization, with Akebia, a leader in the development of HIF-PHI
therapeutics for patients with kidney disease. The combined company
will have an established renal development, manufacturing and
commercial organization, and 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 its regulatory
approval. Keryx’s established U.S. sales and marketing organization
and its medical affairs team have built strong awareness within the
nephrology community to address the needs of patients with CKD, and
will drive the launch preparation and execution for vadadustat in
the United States, subject to its regulatory approval.
Combines Experienced Renal Management Teams
The combined company will be led by a management team with a
long track record of success developing, launching and
commercializing products for patients with kidney disease. John P.
Butler, who will lead the combined company as Chief Executive
Officer, has nearly two decades of executive experience in the
commercial renal therapeutic field, including as the leader of
Genzyme Corporation’s renal business, which grew from $150 million
in revenue to over $1 billion under his leadership.
Strengthens Financial Profile
The combined company will have $453 million in cash on its
balance sheet (unaudited pro forma cash balance as of March 31,
2018), which, along with the expected cost synergies of greater
than $250 million to be realized five years following closing, and
the potential for increasing revenues from Auryxia, are expected to
provide the combined company with significant financial strength
and flexibility to enable continued growth.
Combined Company Board of Directors
The Board of Directors of the combined company is expected to
consist of nine directors, four of whom are Akebia directors and
four of whom are Keryx directors. Keryx will appoint the
Chairperson of the Board of Directors of the combined company.
Timing and Approvals
The transaction is expected to close by the end of 2018, subject
to the satisfaction of customary closing conditions, including
clearance by antitrust authorities and approval by the shareholders
of both companies.
Advisors
Evercore Group L.L.C. and J.P. Morgan Securities L.L.C. are
serving as financial advisors to Akebia and Latham & Watkins
L.L.P. is serving as legal advisor to Akebia.
MTS Health Partners L.P. and Perella Weinberg Partners are
serving as financial advisors to Keryx and Goodwin Procter L.L.P.
is serving as legal advisor to Keryx.
Conference Call and Webcast Details
The companies will host a joint conference call and webcast
today at 8:00 a.m. ET to discuss the combination.
The conference call can be accessed by dialing 877-458-0977
within the United States and 484-653-6724 for all other locations.
The confirmation code is 3887937. Participants should dial in 10
minutes prior to the scheduled start time.
A live webcast of the conference call and associated
presentation materials will be available in the investor relations
section of each company’s website at www.akebia.com and
www.keryx.com.
A replay of the conference call will be available approximately
two hours after completion of the conference call through July 4,
2018, and can be accessed by dialing 855-859-2056 from the United
States or 404-537-3406 from outside the United States. The replay
confirmation code is 3887937. The webcast will be archived in the
investor relations section of each company’s website.
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI) currently in global Phase 3
development for the treatment of anemia due to chronic kidney
disease. Vadadustat’s mechanism of action is designed to mimic the
physiologic effect of altitude on oxygen availability. At higher
altitudes, the body responds to lower oxygen availability with
increased production of HIF, which coordinates the interdependent
processes of iron mobilization and erythropoietin production to
increase red blood cell production and, ultimately, improve oxygen
delivery. Vadadustat is an investigational therapy and is not
approved by the U.S. Food and Drug Administration (FDA) or any
regulatory authority.
About Auryxia (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug
Administration (FDA) on September 5, 2014, for the control of serum
phosphorus levels in adult patients with chronic kidney disease on
dialysis and approved by the FDA on November 6, 2017, for the
treatment of iron deficiency anemia in adult patients with chronic
kidney disease not on dialysis. Auryxia tablets were designed to
contain 210 mg of ferric iron, equivalent to 1 gram of ferric
citrate, and offers convenient mealtime dosing. For more
information about Auryxia and the U.S. full prescribing
information, please visit www.auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric
citrate)
Contraindication: Patients with iron overload syndrome,
e.g., hemochromatosis, should not take AURYXIA® (ferric
citrate).
Iron Overload: Iron absorption from AURYXIA may lead to
increased iron in storage sites. Iron parameters should be
monitored prior to and while on AURYXIA. Patients receiving
concomitant intravenous (IV) iron may require a reduction in dose
or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental
Ingestion: Accidental overdose of iron containing products is a
leading cause of fatal poisoning in children under 6 years of age.
Keep AURYXIA away from children. Call a poison control center or
your physician in case of an accidental overdose in a child.
Adverse Events: The most common adverse events occurring
in at least 5% of patients treated with AURYXIA were, diarrhea,
constipation, nausea, vomiting, cough, abdominal pain, and high
levels of potassium in the blood.
AURYXIA contains iron and may cause dark stools, which is
considered normal with oral medications containing iron.
Please click here to see full prescribing information for
Auryxia.
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.
About Keryx Biopharmaceuticals
Keryx Biopharmaceuticals, Inc., headquartered in Boston,
Massachusetts, is focused on the development and commercialization
of innovative medicines that provide unique and meaningful
advantages to people with kidney disease. The Keryx team works with
passion to advance the care of people with this complex disease.
This dedication has resulted in two FDA-approved indications for
Keryx’s first medicine, Auryxia (ferric citrate) tablets. For more
information about Keryx, please visit www.keryx.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the federal securities law. Such statements are
based upon current plans, estimates and expectations that are
subject to various risks and uncertainties. The inclusion of
forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Words such as “anticipate,” “expect,” “project,”
“intend,” “believe,” “may,” “will,” “should,” “plan,” “could,”
“target,” “contemplate,” “estimate,” “predict,” “potential,”
“opportunity,” “creates” and words and terms of similar substance
used in connection with any discussion of future plans, actions or
events identify forward-looking statements. All statements, other
than historical facts, including statements regarding the expected
management team; the potential benefits of Auryxia; the potential
benefits of vadadustat; the market potential of Auryxia; the market
potential of vadadustat; the expected timing of the closing of the
merger; the ability of the parties to complete the merger
considering the various closing conditions; the expected benefits
of the merger, such as efficiencies, cost savings, synergies,
revenue growth, creating shareholder value, growth potential,
market profile, enhanced competitive position, building launch
momentum for vadadustat, and financial strength and flexibility;
the competitive ability and position of the combined company; and
any assumptions underlying any of the foregoing, are
forward-looking statements. Important factors that could cause
actual results to differ materially from Akebia’s and Keryx’s
plans, estimates or expectations could include, but are not limited
to: (i) Akebia or Keryx may be unable to obtain stockholder
approval as required for the merger; (ii) conditions to the closing
of the merger may not be satisfied; (iii) the merger may involve
unexpected costs, liabilities or delays; (iv) the effect of the
announcement of the 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; (v) Akebia’s or Keryx’s respective businesses may suffer
as a result of uncertainty surrounding the merger and disruption of
management’s attention due to the merger; (vi) the outcome of any
legal proceedings related to the merger; (vii) Akebia or Keryx may
be adversely affected by other economic, business, and/or
competitive factors; (viii) the occurrence of any event, change or
other circumstances that could give rise to the termination of the
merger agreement; (ix) risks that the merger disrupts current plans
and operations and the potential difficulties in employee retention
as a result of the merger; (x) 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; (xi) risks that the anticipated benefits of the merger
or other commercial opportunities may otherwise not be fully
realized or may take longer to realize than expected; (xii) the
impact of legislative, regulatory, competitive and technological
changes; (xiii) expectations for future clinical trials, the timing
and potential outcomes of clinical studies and interactions with
regulatory authorities; and (xiv) 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. Additional
factors that may affect the future results of Akebia and Keryx are
set forth in their respective filings with the SEC, including each
of Akebia’s and Keryx’s most recently filed Annual Report on Form
10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other filings with the SEC, which are available on the
SEC’s website at www.sec.gov. See in particular Item 1A of Akebia’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
under the heading “Risk Factors” and Item 1A of Keryx’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2018, under the
heading “Risk Factors.” The risks and uncertainties described above
and in Akebia’s most recent Quarterly Report on Form 10-Q and
Keryx’s most recent Quarterly Report on Form 10-Q are not exclusive
and further information concerning Akebia and Keryx and their
respective businesses, including factors that potentially could
materially affect their respective businesses, financial condition
or operating results, may emerge from time to time. Readers are
urged to consider these factors carefully in evaluating these
forward-looking statements, and not to place undue reliance on any
forward-looking statements. Readers should also carefully review
the risk factors described in other documents that Akebia and Keryx
file from time to time with the SEC. The forward-looking statements
in this press release speak only as of the date of these materials.
Except as required by law, Akebia and Keryx assume no obligation to
update or revise these forward-looking statements for any reason,
even if new information becomes available in the future.
Additional Information and Where to Find It
In connection with the proposed merger, Akebia and Keryx plan to
file with the SEC and mail or otherwise provide to their respective
stockholders a joint proxy statement/prospectus regarding the
proposed transaction. BEFORE MAKING ANY VOTING DECISION, AKEBIA’S
AND KERYX’S RESPECTIVE STOCKHOLDERS ARE URGED TO READ THE JOINT
PROXY STATEMENT/PROSPECTUS IN ITS ENTIRETY WHEN IT BECOMES
AVAILABLE 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 will be able to
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
This document does not constitute a solicitation of proxy, an
offer to purchase or a solicitation of an offer to sell any
securities. 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. 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. Security holders may obtain 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 Akebia’s or
Keryx’s respective proxy statement for its 2018 annual meeting of
stockholders, such changes have been or will be reflected on
Statements of Change in Ownership on Form 4 filed with the SEC.
Additional information regarding the interests of such individuals
in the proposed merger will be included in the joint proxy
statement/prospectus relating to the proposed merger when it is
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180628005572/en/
Akebia Therapeutics ContactJohn Garabo,
617-844-6130Director, Corporate
Communicationsjgarabo@akebia.comorKeryx Biopharmaceuticals
ContactAmy Sullivan, 617-466-3519Senior Vice President,
Corporate Affairsinvestors@keryx.commedia@keryx.com
Grafico Azioni Keryx Biopharmaceuticals, Inc. (delisted) (NASDAQ:KERX)
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