- Sociétés des Produits Nestlé S.A., part of Nestlé Health
Science, to acquire Aimmune for $34.50 per share in cash,
representing a total equity value of $2.6 Billion and a 174%
premium to Aimmune’s closing price on August 28, 2020
- Aimmune’s PALFORZIA® [Peanut (Arachis hypogaea) Allergen
Powder-dnfp] is the world’s first approved treatment for peanut
allergy
- Transaction expected to be completed in the fourth quarter of
2020
Aimmune Therapeutics Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing and commercializing treatments for potentially
life-threatening food allergies, today announced that it has
entered into a definitive agreement for Sociétés des Produits
Nestlé, S.A. to acquire Aimmune for $34.50 per share in an all-cash
transaction, implying a fully-diluted equity value of $2.6 billion.
Sociétés des Produits Nestlé, S.A. is a part of Nestlé Health
Science (NHSc) and a wholly owned subsidiary of Nestlé S.A. The
agreement was unanimously approved by all of the independent
members of the Board of Directors of Aimmune. Greg Behar, CEO of
Nestlé Health Sciences and an Aimmune Director, abstained due to
his position with Nestlé Health Science.
"The agreement with Nestlé recognizes the value created by years
of commitment and dedication to our mission by the team at Aimmune.
Delivering PALFORZIA, the world’s first treatment for food allergy,
is a game-changing proposition in the biopharmaceutical industry
and is transformative for the lives of millions of people living
with potentially life-threatening peanut allergy,” said Jayson
Dallas, MD, President and Chief Executive Officer of Aimmune. “This
acquisition provides strong value for our shareholders and ensures
a level of support for PALFORZIA and our pipeline that will further
enhance their potential for patients around the world living with
food allergies. Aimmune appreciates the continued strong
collaboration with Nestlé Health Science dating back to 2016
through their support as a shareholder and board member, as well as
through their consumer/nutrition strength and experience. Their
extensive capabilities and global reach, as well as their alignment
with our vision of pioneering treatments and solutions for food
allergies, are a strong fit for our company.”
“This transaction brings together Nestlé’s nutritional science
leadership with one of the most innovative companies in food
allergy treatment,” said Nestlé Health Science CEO Greg Behar.
“Together, we will be able to create a world leader in food allergy
prevention and treatment and offer a wide range of solutions that
can transform the lives of people around the world living with food
allergies.”
The transaction is expected to close in the fourth quarter of
2020, pending the satisfaction of all conditions to the completion
of the tender offer. Until that time, Aimmune will continue to
operate as a separate and independent company.
Aimmune’s financial advisors are J.P. Morgan Securities LLC and
Lazard. Latham & Watkins LLP is acting as legal counsel for
Aimmune.
Transaction Details
Under the terms of the merger agreement, Nestlé S.A.’s
wholly-owned subsidiary, Société des Produits Nestlé S.A. (SPN),
will commence a cash tender offer to acquire all outstanding shares
of Aimmune common stock that are not already owned by NHSc for
$34.50 per share in cash, and Aimmune agreed to file a
recommendation statement containing the unanimous recommendation of
the independent members of the Aimmune board that Aimmune
stockholders tender their shares to SPN. Following the completion
of the tender offer, Nestlé expects to promptly consummate a merger
of Aimmune with a subsidiary of SPN, in which shares of Aimmune
that have not been tendered in the tender offer will be acquired by
SPN and converted into the right to receive the same cash price per
share as paid in the tender offer.
The closing of the tender offer is subject to customary closing
conditions, including the tender of a majority of outstanding
Aimmune shares on a fully diluted basis which shall include the
shares of Aimmune common stock currently held by Nestlé and its
affiliates and the expiration or termination of the waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act and
antitrust approvals in Germany. The merger agreement includes
customary termination provisions for both Aimmune and Nestlé.
INDICATION
PALFORZIA is an oral immunotherapy indicated for the mitigation
of allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanut. PALFORZIA is approved for use in
patients with a confirmed diagnosis of peanut allergy. Initial Dose
Escalation may be administered to patients aged 4 through 17 years.
Up-Dosing and Maintenance may be continued in patients 4 years of
age and older.
PALFORZIA is to be used in conjunction with a peanut-avoidant
diet.
Limitations of Use: Not indicated for the emergency treatment of
allergic reactions, including anaphylaxis.
IMPORTANT SAFETY INFORMATION
Boxed WARNING:
PALFORZIA can cause anaphylaxis, which may be life
threatening and can occur at any time during PALFORZIA
therapy.
Prescribe injectable epinephrine, instruct and train patients
on its appropriate use, and instruct patients to seek immediate
medical care upon its use.
Do not administer PALFORZIA to patients with uncontrolled
asthma.
Dose modifications may be necessary following an anaphylactic
reaction.
Observe patients during and after administration of the
Initial Dose Escalation and the first dose of each Up-Dosing level,
for at least 60 minutes.
PALFORZIA is available only through a restricted program
called the PALFORZIA REMS.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled
asthma, or with a history of eosinophilic esophagitis and other
eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
Anaphylaxis
PALFORZIA can cause anaphylaxis, which may be life threatening.
PALFORZIA is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA
REMS because of the risk of anaphylaxis. Only prescribers,
healthcare settings, pharmacies, and patients certified and
enrolled in the REMS Program can prescribe, receive, dispense or
administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA
dosing, including Maintenance and in subjects who have undergone
recommended Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had
severe or life-threatening anaphylaxis within the previous 60 days.
PALFORZIA may not be suitable for patients with certain medical
conditions that may reduce the ability to survive anaphylaxis,
including but not limited to markedly compromised lung function,
severe mast cell disorder, or cardiovascular disease. In addition,
PALFORZIA may not be suitable for patients taking medications that
can inhibit or potentiate the effects of epinephrine.
All Initial Dose Escalation doses and the first dose of each
Up-Dosing level must be administered in a certified health care
setting.
Patients may be more likely to experience allergic reactions
following PALFORZIA administration in the presence of cofactors
such as exercise, hot water exposure, intercurrent illness (e.g.,
viral infection), or fasting. Other potential cofactors may include
menstruation, sleep deprivation, nonsteroidal anti-inflammatory
drug use, or uncontrolled asthma. Patients should be proactively
counseled about the potential for the increased risk of anaphylaxis
in the presence of these cofactors. If possible, adjust the time of
dosing to avoid these cofactors. If it is not possible to avoid
these cofactors, consider withholding PALFORZIA temporarily.
Asthma
Uncontrolled asthma is a risk factor for a serious outcome,
including death, in anaphylaxis. Ensure patients with asthma have
their asthma under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is
experiencing an acute asthma exacerbation. Following resolution of
the exacerbation, resumption of PALFORZIA should be undertaken
cautiously. Re-evaluate patients who have recurrent asthma
exacerbations and consider discontinuation of PALFORZIA.
Eosinophilic Gastrointestinal Disease
Discontinue PALFORZIA and consider a diagnosis of eosinophilic
esophagitis in patients who experience severe or persistent
gastrointestinal symptoms, including dysphagia, vomiting, nausea,
gastroesophageal reflux, chest pain, or abdominal pain.
Gastrointestinal Adverse Reactions
Gastrointestinal adverse reactions were commonly reported in
PALFORZIA-treated subjects, and dose modification should be
considered for patients who report these reactions. For severe or
persistent gastrointestinal symptoms consider a diagnosis of
eosinophilic esophagitis.
ADVERSE REACTIONS
The most common adverse events reported in subjects treated with
PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are abdominal
pain, vomiting, nausea, oral pruritus, oral paresthesia, throat
irritation, cough, rhinorrhea, sneezing, throat tightness,
wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and
ear pruritus.
Please see full Prescribing Information, including Boxed
WARNING, and Medication Guide at www.PALFORZIA.com.
For more information about PALFORZIA, please call 1-844-PALFORZ
(1-844-725-3679) or visit www.PALFORZIA.com.
About Aimmune
Aimmune Therapeutics, Inc. is a biopharmaceutical company
developing and commercializing treatments for potentially
life-threatening food allergies. With a mission to improve the
lives of people with food allergies, Aimmune is developing and
commercializing oral treatments for potentially life-threatening
food allergies. The Company’s Characterized Oral Desensitization
ImmunoTherapy (CODIT™) approach is intended to provide meaningful
levels of protection against allergic reactions resulting from
accidental exposure to food allergens by desensitizing patients
with defined, precise amounts of key allergens. Aimmune has one
FDA-approved medicine for peanut allergy and other investigational
therapies in development to treat other food allergies. For more
information, please visit www.aimmune.com.
Additional Information and Where to Find It
The tender offer described above has not yet commenced. This
communication is neither an offer to purchase nor a solicitation of
an offer to sell any securities of Aimmune Therapeutics, Inc.
(“Aimmune”). The solicitation and the
offer to purchase shares of Aimmune’s common stock will only be
made pursuant to a tender offer statement on Schedule TO, including
an offer to purchase, a letter of transmittal and other related
materials that Sociétés des Produits Nestlé S.A., a société anonyme
organized under the laws of Switzerland (“Nestlé”) and SPN MergerSub, Inc., a Delaware
corporation (“Merger Sub”) intend to
file with the Securities and Exchange Commission (“SEC”). In addition, Aimmune will file with the SEC
a Solicitation/Recommendation Statement on Schedule 14D-9 and a
Schedule 13E-3 transaction statement, in each case with respect to
the tender offer. Once filed, investors will be able to obtain a
free copy of these materials and other documents filed by Nestlé,
Merger Sub and Aimmune with the SEC at the website maintained by
the SEC at www.sec.gov. Investors may also obtain, at no charge,
any such documents filed with or furnished to the SEC by Aimmune
under the “Investors & Media” section of Aimmune’s website at
www.aimmune.com. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ
THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE OFFER TO
PURCHASE AND THE SOLICITATION/RECOMMENDATION STATEMENT AND THE
SCHEDULE 13E-3 TRANSACTION STATEMENT OF AIMMUNE, AND ANY AMENDMENTS
THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER
OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN
THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO
WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY
CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS
OF THE TENDER OFFER.
Forward-Looking Statements
The statements included above that are not a description of
historical facts are forward-looking statements. Words or phrases
such as “believe,” “may,” “could,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would”
or similar expressions are intended to identify forward-looking
statements. These forward-looking statements include without
limitation statements regarding the planned completion of the
transactions contemplated by the Agreement and Plan of Merger dated
as of August 29, 2020 by and among Aimmune, Merger Sub and Nestlé.
Additional statements include, but are not limited to, statements
regarding: Aimmune’s expectations regarding the potential benefits
of PALFORZIA; Aimmune’s expectations regarding the potential
commercial launch of PALFORZIA; and Aimmune’s expectations
regarding potential applications of the CODIT approach to treating
life-threatening food allergies.
Risks and uncertainties that could cause results to differ from
expectations include: uncertainties as to the timing and completion
of the tender offer and the merger; uncertainties as to the
percentage of Aimmune stockholders tendering their shares in the
tender offer; the possibility that competing offers may be made;
the possibility that various closing conditions for the tender
offer or the merger may not be satisfied or waived, including that
a governmental entity may prohibit, delay or refuse to grant
approval for the consummation of the merger; the occurrence of any
event, change or other circumstance that could give rise to the
termination of the merger agreement; the effects of disruption
caused by the transaction making it more difficult to maintain
relationships with employees, collaborators, vendors and other
business partners; the risk that stockholder litigation in
connection with the tender offer or the merger may result in
significant costs of defense, indemnification and liability; and
risks and uncertainties pertaining to Aimmune’s business, including
the risks and uncertainties detailed in Aimmune’s public periodic
filings with the SEC, as well as the tender offer materials to be
filed by Merger Sub and Nestlé, the Solicitation/Recommendation
Statement and the Schedule 13E-3 transaction statement to be filed
by Aimmune in connection with the tender offer. Risks and
uncertainties that contribute to the uncertain nature of the
forward-looking statements regarding Aimmune’s business may
include: the expectation that Aimmune will need additional funds to
finance its operations; Aimmune’s dependence on the success of
PALFORZIA; Aimmune’s ability to build a commercial field
organization and distribution network; the degree of acceptance of
PALFORZIA among physicians, patients, healthcare payors, patient
advocacy groups and the general medical community; Aimmune’s
ability to obtain favorable coverage and reimbursement from
third-party payors for PALFORZIA; Aimmune’s reliance on third
parties for the manufacture of PALFORZIA; Aimmune’s ability to
implement and comply with the REMS for PALFORZIA; possible
regulatory developments in the United States and foreign countries;
and Aimmune’s ability to attract and retain senior management
personnel.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement and Aimmune undertakes no obligation to
revise or update these statements to reflect events or
circumstances after the date hereof, except as required by law.
This press release concerns PALFORZIA, which has been approved
for marketing by the FDA in the United States and has not been
approved for marketing by the EMA or Swissmedic. PALFORZIA in
Europe is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.
PALFORZIA®, AIMMUNE®, AIMMUNE THERAPEUTICS® and CODIT™ are
trademarks of Aimmune Therapeutics, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200830005025/en/
Investors: DeDe Sheel (917) 834-1494
dsheel@aimmune.com
Media: Jodi Sievers (650) 823-3253
jsievers@aimmune.com
Julie Normart (559) 974-3245 jnormart@w2ogroup.com
Aimmune Therapeutics (NASDAQ:AIMT)
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