Mails Letter to Shareholders Highlighting
Accelerated Growth Opportunity
Details Enhanced Market Position, Capital
Resources and Cost Savings to Deliver Enhanced and Sustained
Shareholder Value
Urges Shareholders to Vote “FOR” the Proposals
Relating to the Merger
Akebia Therapeutics, Inc. (Nasdaq: AKBA) today announced that it
and Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) filed a
definitive joint proxy statement with the U.S. Securities and
Exchange Commission (“SEC”) in connection with their respective
special meetings of shareholders that have been called to approve
shareholder proposals relating to the previously announced proposed
merger of Akebia and Keryx. Akebia is mailing a letter together
with its proxy materials to Akebia shareholders in connection with
the special meeting of Akebia shareholders (the “Special
Meeting”).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20181030006158/en/
The Special Meeting will be held at 11:00 a.m. Eastern Time on
December 11, 2018, at the offices of Latham & Watkins LLP,
which are located at 200 Clarendon Street, Boston, MA 02116.
Holders of record of Akebia common stock as of 5:00 p.m. Eastern
Time on October 22, 2018, will be entitled to vote at the Special
Meeting.
The Akebia Board of Directors unanimously recommends that
Akebia shareholders vote “FOR” the proposals relating to the
proposed merger with Keryx.
In connection with the filing of the definitive proxy statement,
Akebia will mail the following letter to shareholders:
Dear Fellow Akebia Shareholder:
As Chairperson of the Akebia Board of Directors, I am writing to
encourage you to vote in the upcoming Special Meeting of Akebia
shareholders to approve the shareholder proposals relating to the
combination of Akebia with Keryx Biopharmaceuticals. The Akebia
Board of Directors has been intensely focused on driving value for
our shareholders. The Board unanimously believes this combination
will provide substantial strategic, financial and operational
benefits to Akebia shareholders.
We believe that this transaction will lower Akebia’s risk
profile by providing it with a broader range of growth
opportunities to enhance our market position, capital resources and
operational efficiency, and increase the value of your investment
in the near-term, mid-term and long-term.
In the near-term, Akebia shareholders will gain access to
Auryxia® (ferric citrate), a U.S. Food and Drug Administration
(FDA)-approved medicine to treat dialysis dependent chronic kidney
disease (CKD) patients with hyperphosphatemia and non-dialysis
dependent CKD patients with iron deficiency anemia. In the
mid-term, Auryxia’s potential growth is expected to generate the
cash to fund pro forma operations and cover the majority of
Akebia’s capital needs beginning in 2020. In the long-term, Akebia
shareholders remain positioned to participate in the potential
benefits from vadadustat, an innovative Phase 3 product candidate
with the potential to compete in a complementary
multibillion-dollar market, subject to successful completion of its
development program and regulatory approval, with an established
commercial organization.
The Akebia Board of Directors recommends that all shareholders
vote “FOR” the proposals relating to the proposed merger for
the following reasons:
FULLY INTEGRATED RENAL COMPANY WITH A
COMPLEMENTARY PORTFOLIO
- The merger will create a fully
integrated renal company with a complementary portfolio comprising
Keryx’s FDA-approved Auryxia and Akebia’s product candidate,
vadadustat, which is in Phase 3 clinical trials
- Auryxia has substantial revenue growth
potential
- In the second quarter of 2018,
quarterly prescriptions for Auryxia doubled compared to the same
quarter last year
- Auryxia’s second quarter 2018 market
share was approximately 6% and has the potential for significant
market share gains over the next several years
See image one.
- Physicians express favorable perception
of Auryxia in iron deficiency anemia (IDA)
- Majority of physicians surveyed
recognize benefits of Auryxia’s profile5
- Majority of surveyed nephrologists
report satisfaction with Auryxia6
COMBINATION EXPECTED TO ENHANCE CAPITAL
RESOURCES AND CASH FLOW
- The combined company will have a strong
cash position with pro forma cash on hand as of June 30, 2018, of
$452 million (unaudited), enabling further development of
vadadustat while reducing the need for future share dilution
- Keryx’s ongoing revenue streams and
potential for growth are expected to enhance Akebia’s profitability
and cash flow as Auryxia’s revenues have the potential to continue
to increase
See image two.
EXPERIENCED RENAL MANAGEMENT TEAM AND
SUBSTANTIAL ORGANIZATIONAL SYNERGIES EXPECTED TO CREATE COST
SAVINGS AND LOWER RISK OF COMMERCIAL LAUNCH
- Together, Akebia and Keryx plan to
leverage Keryx’s existing renal commercial infrastructure,
eliminating the need for Akebia as a standalone to build its own
salesforce ahead of launch
- 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, including Chief Executive Officer, John P. Butler, who led
the renal business at Genzyme Corporation, growing the business
from $150 million to over $1 billion in revenue
- We plan to leverage our 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
- We estimate potential cost savings of
greater than $250 million to be realized within five years
following closing
VOTE FOR ENHANCED VALUE AND ACCELERATED
GROWTH OPPORTUNITYVOTE “FOR” THE PROPOSALS RELATING TO
AKEBIA – KERYX MERGER TODAY
The Akebia Board and management team have been – and continue to
be – highly focused on driving value for all our shareholders. We
undertook a robust strategic evaluation prior to entering into the
merger agreement with Keryx, and based on that evaluation, coupled
with the fairness opinions received from independent financial
advisors, we believe the merger is the optimal path for Akebia to
build value for Akebia shareholders over time.
Accordingly, we recommend that shareholders vote today
“FOR” the Akebia proposals set forth in the definitive proxy
statement, including “FOR” the proposal to issue shares of
Akebia common stock to Keryx shareholders in relation to the
proposed merger.
Your vote is extremely important, no matter how many shares you
own. Please take a moment to vote “FOR” the proposals set
forth on the enclosed proxy card today – by internet, telephone
toll-free or by signing, dating and returning the enclosed proxy
card in the postage-paid envelope provided.
If you have any questions or need assistance voting your shares,
please contact MacKenzie Partners, Inc., our proxy solicitor, by
calling toll-free at (800) 322-2885 (from the U.S. and Canada) or
(212) 929-5500 (call collect from other locations) or via email at
proxy@mackenziepartners.com.
On behalf of the Akebia Board of Directors, thank you for your
continued support of Akebia.
Sincerely,
Muneer A. SatterChairperson of the Akebia Board of Directors
About Akebia
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.
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 or about October 31, 2018.
BEFORE MAKING ANY VOTING DECISION, AKEBIA’S AND KERYX’S RESPECTIVE
SHAREHOLDERS 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 shareholders can
obtain a free copy of the joint proxy statement/prospectus and
other documents containing important information about Akebia and
Keryx filed with or furnished to 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 (in the “Investors”
section) and www.keryx.com, respectively (in the “Investors &
Media” section), copies of materials they file with, or furnish to,
the SEC.
Participants in the 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 shareholders
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
shareholders, 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 shareholders, which was filed with the
SEC on May 31, 2018. To the extent the holdings of Akebia’s
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
shareholders, 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 are included in the joint proxy
statement/prospectus relating to the proposed merger that was filed
with the SEC. These documents 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.
Forward Looking Statements
These materials contain 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
“believe,” “build,” “create,” “drive,” “enhance,” “estimate,”
“expect,” “goal,” “leverage,” “may,” “maximize,” “opportunity,”
“optimal,” “plan,” “position,” “potential” “will,” “would,” 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 ability of the parties to
complete the merger considering the various closing conditions; the
consummation of the merger; the potential benefits of the merger;
creating shareholder value; the growth potential of Auryxia and the
market potential of Auryxia and vadadustat 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,
including the recent changes to reimbursement coverage for Auryxia
that could have a material adverse effect on Auryxia sales and
profitability; (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, in the definitive joint proxy
statement/prospectus filed by Akebia and Keryx and other filings
with the SEC, which are available on the SEC’s website at
www.sec.gov. See in particular “Risk Factors” in the definitive
joint proxy statement/prospectus filed by Akebia and Keryx, Item 1A
of Akebia’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2018 under the heading “Risk Factors,” and Item 1A of
Keryx’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2018 under the heading “Risk Factors.” The risks and
uncertainties described above and in the definitive joint proxy
statement/prospectus filed by Akebia and Keryx, 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 these materials 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.
-------------------------------------------------------------------------
Footnotes: 1. Keryx consolidated data based on data received from
IMS and specialty pharmacies (Fresenius Rx, DaVita Rx) 2.
Definitive Proxy Statement/Prospectus filed by Akebia Therapeutics,
Inc. with the U.S. Securities and Exchange Commission on October
30, 2018 (see “The Merger—Certain Akebia Management Unaudited
Prospective Financial Information – Akebia Management Keryx
Projections”). This estimate of peak sales is unaudited and was
based upon Akebia assumptions made in preparation for the June 28,
2018, merger announcement, including upon publicly filed financial
information of Keryx, certain financial information provided to
Akebia management by Keryx, and certain assumptions made by the
Akebia management, including estimates of revenue growth for U.S.
sales of Auryxia and associated operational costs, and has not been
updated since that time. Furthermore, this estimate of peak sales
was not adjusted for a number of critical risks, including the
recent changes to reimbursement coverage for Auryxia that could
have a material adverse effect on Auryxia sales and profitability.
See the Forward-Looking Statements section herein for additional
information regarding risks. 3. Akebia management internal
estimates based on market research. This Auryxia market share
estimate formed the basis of certain information included in the
Definitive Proxy Statement/Prospectus filed by Akebia Therapeutics,
Inc. with the U.S. Securities and Exchange Commission on October
30, 2018 (see “The Merger—Certain Akebia Management Unaudited
Prospective Financial Information – Akebia Management Keryx
Projections”) and was based upon Akebia assumptions made in
preparation for the June 28, 2018, merger announcement, including
upon publicly filed financial information of Keryx, certain
financial information provided to Akebia management by Keryx, and
certain assumptions made by the Akebia management, including
estimates of revenue growth for U.S. sales of Auryxia and
associated operational costs, and has not been updated since that
time. Furthermore, this market share estimate was not adjusted for
a number of critical risks, including the recent changes to
reimbursement coverage for Auryxia that could have a material
adverse effect on Auryxia sales and profitability. See the
Forward-Looking Statements section herein for additional
information regarding risks. 4. Prevention and Treatment of Chronic
Kidney Disease-Mineral and Bone Disorder (CKD_MBD); Vol. 7, Issue
1. July 2017 5. Reason Research Q3 Auryxia ATU 6. Spherix Global
Anemia 1Q Pulse (2018); aided awareness data 7. Definitive Proxy
Statement/Prospectus filed by Akebia Therapeutics, Inc. with the
U.S. Securities and Exchange Commission on October 30, 2018 (see
“The Merger—Certain Akebia Management Unaudited Prospective
Financial Information”). These cash balance estimates are unaudited
and were based upon Akebia assumptions made in preparation for the
June 28, 2018, merger announcement, including assumptions related
to timing for clinical trial completion and commercial launch,
estimated operational costs, including R&D, manufacturing and
general and administrative costs, and estimates of revenue growth
for U.S. sales of Auryxia, and have not been updated since that
time. Furthermore, these cash balance estimates are not adjusted
for a number of critical risks, including the risks and probability
of success of vadadustat, delays of any clinical trials or
commercial launch, the financial implications of Akebia’s
collaborations and other relationships with third parties, and the
recent changes to reimbursement coverage for Auryxia that could
have a material adverse effect on Auryxia sales and profitability.
See the Forward-Looking Statements section herein for additional
information regarding risks.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181030006158/en/
Akebia TherapeuticsJohn Garabo, 617-844-6130Director,
Corporate Communicationsjgarabo@akebia.com
Akebia Therapeutics (NASDAQ:AKBA)
Historical Stock Chart
From Apr 2024 to May 2024
Akebia Therapeutics (NASDAQ:AKBA)
Historical Stock Chart
From May 2023 to May 2024