Sanofi to acquire Kadmon to further strengthen growth of transplant
business
Dear recipient,Please note this is a corrected french
version of the release which replaces the release sent on September
8 at 8.31 am Paris time where the word « … relutif» has been
replaced with « …dilutif». See below:
La transaction devrait avoir un effet légèrement dilutif sur le
BNPA de Sanofi en 2022.
Best regards, the Sanofi media team.
###
Sanofi to acquire
Kadmon to further strengthen growth of
transplant business
- Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class
treatment for adult and pediatric patients 12 years and older with
chronic graft-versus-host disease (cGVHD) after failure of at least
two prior lines of systemic therapy
PARIS and NEW YORK –
September 8,
2021 – Sanofi has entered into a
definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ:
KDMN) a biopharmaceutical company that discovers, develops, and
markets transformative therapies for disease areas of significant
unmet medical needs. The acquisition supports Sanofi’s strategy to
continue to grow its General Medicines core assets and will
immediately add Rezurock™(belumosudil) to its transplant portfolio.
Rezurock is a recently FDA-approved, first-in-class treatment for
chronic graft-versus-host disease (cGVHD) for adult and pediatric
patients 12 years and older who have failed at least two prior
lines of systemic therapy.
Shareholders of Kadmon common stock will receive
$9.50 per share in cash, which represents a total equity value of
approximately $1.9 billion (on a fully diluted basis). The Sanofi
and Kadmon Boards of Directors unanimously approved the
transaction.
“We are transforming and simplifying our General
Medicines business and have shifted our focus on differentiated
core assets in key markets,” said Olivier Charmeil, Executive Vice
President General Medicines. “We are thrilled to add Kadmon's
Rezurock to our well-established transplant portfolio. Our existing
scale, expertise, and relationships in transplant create an ideal
platform to achieve the full potential of Rezurock, which will
address the significant unmet medical needs of patients with
chronic graft-versus-host disease around the world.”
“We are excited that Sanofi has acknowledged the
value of Rezurock and the deep potential of our pipeline,” said
Harlan Waksal, M.D., President and Chief Executive Officer, Kadmon.
“By leveraging Sanofi’s global resources and long-standing
expertise in developing and commercializing innovative medicines,
Rezurock is now well positioned for global accessibility, faster. I
want to thank the entire Kadmon team, including management and the
Board of Directors, and the Sanofi organization, for their ongoing
commitment to patients and their caregivers.”
Sanofi’s transplant business mainly consists of
Thymoglobulin® (anti-thymocyte globulin), a polyclonal, anti-human
thymocyte antibody preparation that acts as a broad
immunosuppressive and immunomodulating agent and Mozobil®
(plerixafor), a hematopoietic stem cell mobilizer. Both products
are among General Medicines core assets and are currently
registered and marketed in more than 65 countries.
In July 2021, the FDA approved Rezurock for the
treatment of adult and pediatric patients 12 years and older with
cGVHD after the failure of at least two prior lines of systemic
therapy. Rezurock was launched in August in the United States. It
is the first and only approved small molecule therapy that inhibits
the Rho-associated coiled-coil kinase 2 (ROCK2), a signaling
pathway that modulates inflammatory response and fibrotic
processes. Sanofi will work closely with regulatory authorities
across different geographies to ensure that patients suffering from
cGVHD can benefit from belumosudil treatment as early as possible.
Kadmon is also developing Rezurock for the treatment of diffuse
cutaneous systemic sclerosis, with an open-label Phase 2 clinical
trial currently ongoing.
Kadmon’s pipeline includes drug candidates for
immune and fibrotic diseases as well as immuno-oncology
therapies.
The transaction is expected to be modestly dilutive to Sanofi’s
EPS in 2022.
Transaction Terms
Under the terms of the merger agreement, holders
of Kadmon’s common stock will receive $9.50 per share in an
all-cash transaction, reflecting a total equity value of Kadmon of
approximately $1.9 billion. The offer price represents a premium of
79% over the closing price on September 7, 2021 and a premium of
approximately 113% over the 60 trading days volume weighted average
price.
The consummation of the transaction is subject
to customary closing conditions, including the approval of holders
of a majority of the outstanding shares of Kadmon voting stock, the
expiration or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other
customary conditions. Following the successful completion of the
merger, a wholly owned subsidiary of Sanofi will merge with Kadmon
and the outstanding Kadmon shares will receive $9.50 per share in
cash. Sanofi plans to fund the transaction with available cash
resources. Subject to the satisfaction or waiver of customary
closing conditions, Sanofi expects to complete the acquisition in
the fourth quarter of 2021.
Weil, Gotshal & Manges LLP is acting as
legal counsel to Sanofi. Cantor Fitzgerald & Co. and Moelis
& Company LLC are acting as exclusive financial advisors to
Kadmon in the transaction, while DLA Piper LLP (US) is acting as
legal counsel.
About
Kadmon
Kadmon is a biopharmaceutical company that
discovers, develops, and delivers transformative therapies for
unmet medical needs. Rezurock™ (belumosudil), an oral, once-daily
tablet, is approved in the United States for the treatment of adult
and pediatric patients 12 years and older with chronic
graft-versus-host disease (cGVHD) after failure of at least two
prior lines of systemic therapy. Kadmon’s pipeline includes product
candidates for immune and fibrotic diseases as well as
immuno-oncology therapies. For more information, please visit
www.kadmon.com.
About Sanofi
Sanofi is dedicated to supporting people through
their health challenges. We are a global biopharmaceutical company
focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
the few who suffer from rare diseases and the millions with
long-term chronic conditions.
With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe.
Sanofi Media Relations
Contacts
Sandrine
Guendoul
Tel.: +33 (0)6 25 09 14
25
Sandrine.Guendoul@sanofi.com
Lisa Zobel
Tel.: + 1 (908) 967-4605
Lisa.Zobel@sanofi.com
Sanofi Investor Relations Contacts
Paris
Eva Schaefer-Jansen
Arnaud Delepine
Nathalie Pham
Sanofi Investor Relations Contact North
America
Felix Lauscher
Tel.: +33 (0)1 53 77 45
45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
Kadmon Investor Relations
Contact
Steven Meehan, Executive Vice President, Chief Financial
Officer
Tel.: +1 (833) 900-5366
Investors@kadmon.com
https://www.kadmon.com
Sanofi and Kadmon
Forward-Looking Statements
This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts and may include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans”, “will be” and similar expressions. Although
Sanofi’s and Kadmon’s management each believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi and Kadmon, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, risks related to Sanofi’s and Kadmon’s ability to complete
the transaction on the proposed terms or on the proposed timeline,
including the receipt of required regulatory approvals, the
possibility that competing offers will be made, other risks
associated with executing business combination transactions, such
as the risk that the businesses will not be integrated
successfully, that such integration may be more difficult,
time-consuming or costly than expected or that the expected
benefits of the acquisition will not be realized, risks related to
future opportunities and plans for the combined company, including
uncertainty of the expected financial performance and results of
the combined company following completion of the proposed
acquisition, disruption from the proposed acquisition making it
more difficult to conduct business as usual or to maintain
relationships with customers, employees, manufacturers, suppliers
or patient groups, and the possibility that, if the combined
company does not achieve the perceived benefits of the proposed
acquisition as rapidly or to the extent anticipated by financial
analysts or investors, the market price of Sanofi’s shares could
decline, as well as other risks related Sanofi’s and Kadmon’s
respective businesses, including the ability to grow sales and
revenues from existing products and to develop, commercialize or
market new products, competition, the uncertainties inherent in
research and development, including future clinical data and
analysis, regulatory obligations and oversight by regulatory
authorities, such as the FDA or the EMA, including decisions of
such authorities regarding whether and when to approve any drug,
device or biological application that may be filed for any product
candidates as well as decisions regarding labelling and other
matters that could affect the availability or commercial potential
of any product candidates, the absence of a guarantee that any
product candidates, if approved, will be commercially successful,
the future approval and commercial success of therapeutic
alternatives, Sanofi’s ability to benefit from external growth
opportunities and to complete related transactions and/or obtain
regulatory clearances, risks associated with Sanofi’s and Kadmon’s
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in exchange
rates and prevailing interest rates, volatile economic and market
conditions, cost containment initiatives and subsequent changes
thereto, and the impact that COVID-19 will have on Sanofi and
Kadmon and their respective customers, suppliers, vendors, and
other business partners, and the financial condition of any one of
them, as well as on Sanofi’s and Kadmon’s employees and on the
global economy as a whole. Any material effect of COVID-19 on any
of the foregoing could also adversely impact Sanofi and Kadmon.
This situation is changing rapidly and additional impacts may arise
of which Sanofi and Kadmon are not currently aware and may
exacerbate other previously identified risks. While the list of
factors presented here is representative, no list should be
considered a statement of all potential risks, uncertainties or
assumptions that could have a material adverse effect on companies’
consolidated financial condition or results of operations. The
foregoing factors should be read in conjunction with the risks and
cautionary statements discussed or identified in the public filings
with the U.S. Securities and Exchange Commission (the “SEC”) made
by Sanofi and Kadmon and the public filings with the AMF made by
Sanofi, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in Sanofi’s annual
report on Form 20-F for the year ended December 31, 2020, and
Kadmon’s annual report on Form 10-K for the year ended December 31,
2020, quarterly reports on Form 10-Q and current reports on Form
8-K filed with the SEC. The forward-looking statements speak only
as of the date hereof and, other than as required by applicable
law, Sanofi and Kadmon do not undertake any obligation to update or
revise any forward-looking information or statements.
Additional Information and Where to Find It
The proposed acquisition will be submitted to
stockholders of Kadmon Holdings, Inc. for their consideration. In
connection with the acquisition, Kadmon will file a proxy statement
and other materials with the SEC. This press release is not a
substitute for the proxy statement or any other document that
Kadmon may send to its stockholders in connection with the proposed
acquisition.
KADMON’S STOCKHOLDERS ARE ADVISED TO READ THE
PROXY STATEMENT FOR THE PROPOSED ACQUISITION WHEN IT IS FILED, AND
ANY AMENDMENT OR SUPPLEMENT THERETO THAT MAY BE FILED, WITH THE SEC
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT KADMON AND
THE ACQUISITION. All such documents, when filed, are available free
of charge at the SEC’s website (www.sec.gov) or upon request by
contacting Kadmon’s Investor Relations by telephone at
1-833-900-5366 or via email at Investors@kadmon.com. Kadmon’s
filings with the SEC are also available on Kadmon’s website at
www.kadmon.com
Participants in the Solicitation
Kadmon and its directors and executive officers
are deemed to be participants in any solicitation of Kadmon’s
stockholders in connection with the proposed acquisition.
Information about Kadmon’s directors and executive officers is
available in Kadmon’s definitive proxy statement, dated April 1,
2021, for its 2021 annual meeting of stockholders, and in Kadmon’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2020.
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