Novo Nordisk and Forma Therapeutics, Holdings Inc. (Nasdaq:
FMTX) today announced that they have entered into a definitive
agreement under which Novo Nordisk will acquire Forma Therapeutics
for $20 per share in cash, which represents a total equity value of
$1.1 billion. Forma Therapeutics is a clinical-stage
biopharmaceutical company focused on transforming the lives of
patients with sickle cell disease (SCD) and rare blood
disorders.
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The acquisition of Forma Therapeutics, including its lead
development candidate, etavopivat, is aligned with Novo Nordisk’s
strategy to complement and accelerate its scientific presence and
pipeline in hemoglobinopathies, a group of disorders in which there
is abnormal production or structure of the hemoglobin protein in
the red blood cells.
“Novo Nordisk has worked for more than 40 years to develop and
deliver transformative medicines to patients around the world with
rare and devastating diseases. By adding Forma’s differentiated
approach to address unmet needs for patients, we are taking a step
forward in enhancing our sickle cell disease pipeline,” said
Ludovic Helfgott, executive vice president and head of Rare Disease
at Novo Nordisk. “We have an ambition to build a leading portfolio
with standalone and combination treatments to tackle the
complications and underlying causes of sickle cell disease.”
Etavopivat, an investigational oral, once-daily, selective
pyruvate kinase-R (PKR) activator, is being developed to improve
anemia and red blood cell health in people with SCD, a seriously
debilitating, life-threatening and life shortening disease.
Etavopivat is currently being evaluated in a global phase 2/3
clinical trial (Hibiscus) in patients with SCD, and in a phase 2
trial (Gladiolus) in patients with transfusion-dependent SCD and
another inherited hemoglobinopathy called thalassemia.
“Today’s announcement is an exciting milestone that accelerates
Forma’s purpose to transform the lives of patients with sickle cell
disease and other serious hematological diseases,” said Frank D.
Lee, president and chief executive officer of Forma. “Novo Nordisk
will partner closely with the sickle cell community to amplify our
impact for patients around the world who urgently need new
treatment options. We look forward to working together with Novo
Nordisk to serve as a trusted partner to our communities and to
advance innovation, access and health equity for patients.”
The transaction will not impact Novo Nordisk’s previously
communicated operating profit outlook for 2022 or the ongoing share
buy-back program. Novo Nordisk will fund the acquisition from
financial reserves.
About the transaction Under the terms of the agreement,
Novo Nordisk will initiate a tender offer to acquire all
outstanding shares of Forma Therapeutics’ common stock at a price
of $20 per share in cash (or aggregated value of $1.1 billion) and
a premium of 92% to Forma Therapeutics’ volume-weighted average
price per share over the past 30 days ended August 31, 2022.
The transaction has been unanimously approved by the Forma
Therapeutics Board of Directors. The closing of the tender offer
will be subject to certain conditions, including the tender of
shares representing a majority of Forma Therapeutics’ outstanding
shares, receipt of applicable regulatory approvals and other
customary conditions. Upon the successful completion of the tender
offer, Novo Nordisk’s acquisition subsidiary will merge into Forma
Therapeutics, and any shares of common stock of Forma Therapeutics
not tendered into the offer will receive the same USD per share
price payable in the tender offer. The transaction is expected to
close in the fourth quarter of 2022.
In addition, certain affiliates of RA Capital Management, L.P.,
which collectively own approximately 19% of Forma Therapeutics’
outstanding shares, have entered into a support agreement pursuant
to which they committed to tender their shares in the tender
offer.
Novo Nordisk is represented by Moelis & Company UK LLP as
financial advisor and Davis Polk & Wardwell LLP as legal
advisor. Forma Therapeutics is represented by Centerview Partners
LLC as financial advisor and Goodwin Procter LLP as legal
advisor.
About sickle cell disease Sickle cell disease (SCD) is a
chronic and progressive inherited disorder associated with a
decrease in the health and lifespan of red blood cells. People
living with SCD have red blood cells that are crescent shaped,
rendering them inflexible, fragile, and unable to effectively
deliver oxygen. The health of these sickle red blood cells is
impaired and characterized by reduced cellular energy, poor
deformability, decreased membrane repair, and increased
adhesion.
Around 17 million people worldwide live with SCD, including
approximately 100,000 people in the United States, as well as
approximately 30,000 in France, Germany, Italy, Spain, and the
United Kingdom. SCD can cause serious health problems, including
anemia, fatigue, episodes of pain known as vaso-occlusive crises
(VOCs), and chronic, progressive end-organ damage. Despite recent
advances in treatment, most patients with SCD still suffer from
pain crises, lifelong disability, reduced quality of life, and
shortened life expectancy.
About etavopivat Etavopivat is an investigational,
once-daily, selective pyruvate kinase-R (PKR) activator designed to
be a disease-modifying therapy with the potential to improve red
blood cell health and transform the lives of people living with
SCD. Employing a multimodal approach, etavopivat works by
activating the red blood cell’s natural PKR activity to decrease
levels of the metabolite 2,3-DPG, allowing sickle hemoglobin to
hold on to oxygen longer, resulting in decreased polymerization,
hemolysis, and sickling. Etavopivat-mediated PKR activation also
increases adenosine triphosphate (ATP) levels, to improve red blood
cell function, which can lead to improved deformability, capacity
for membrane repair, red blood cell health, and lifespan. Together,
these effects are anticipated to improve the health of sickle red
blood cell and lead to a reduction in anemia, hemolysis,
vaso-occlusive crises, and end organ damage.
In a phase 1 trial, etavopivat improved anemia and red blood
cell health and appeared to have a safe and well-tolerated profile,
demonstrating a potential to improve the lives of patients with
SCD, including increases in hemoglobin, improvements in red blood
cell health, and decreases in vaso-occlusive crises (VOCs).
The U.S. Food and Drug Administration (FDA) has granted
etavopivat Fast Track, Rare Pediatric Disease and Orphan Drug
designations. Additionally, etavopivat was granted Orphan Drug
designation from the European Commission based on a positive
opinion from the Committee for Orphan Medicinal Products of the
European Medicines Agency for the treatment of patients with
SCD.
About Forma Therapeutics Forma Therapeutics is a
clinical-stage biopharmaceutical company focused on the research,
development and commercialization of novel therapeutics to
transform the lives of patients with rare hematologic diseases and
cancers. Forma Therapeutics R&D engine combines deep biology
insight, chemistry expertise and clinical development capabilities
to create drug candidates with differentiated mechanisms of action
focused on indications with high unmet need. Our work has generated
a broad proprietary portfolio of programs with the potential to
provide profound patient benefit. For more information, please
visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc
and LinkedIn.
About Novo Nordisk Novo Nordisk is a leading global
healthcare company, founded in 1923 and headquartered in Denmark.
Our purpose is to drive change to defeat diabetes and other serious
chronic diseases such as obesity and rare blood and endocrine
disorders. We do so by pioneering scientific breakthroughs,
expanding access to our medicines, and working to prevent and
ultimately cure disease. Novo Nordisk employs about 50,800 people
in 80 countries and markets its products in around 170 countries.
For more information, visit novonordisk.com, Facebook, Twitter,
LinkedIn and YouTube.
Cautionary Note Regarding Forward-Looking Statements This
communication relates to Novo Nordisk A/S (“Novo Nordisk”), Forma
Therapeutics Holdings, Inc. (“Forma”) and the acquisition of Forma
by Novo Nordisk and includes express or implied forward-looking
statements about the proposed acquisition of Forma by Novo Nordisk,
etavopivat, its therapeutic benefits and its regulatory development
pathway, and the operations of the combined company that involve
risks and uncertainties relating to future events and the future
performance of Novo Nordisk and Forma. Actual events or results may
differ materially from these forward-looking statements. Words such
as “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target,” variations of such
words, and similar expressions are intended to identify such
forward-looking statements, although not all forward-looking
statements contain these identifying words. Examples of such
forward-looking statements include, but are not limited to, express
or implied: statements regarding the business combination and
related matters, closing conditions, prospective performance and
opportunities, post-closing operations and the outlook for the
companies’ businesses; statements of targets, plans, objectives or
goals for future operations, including those related to Novo
Nordisk’s and Forma’s products, product research, product
development, product introductions and product approvals as well as
cooperation in relation thereto; statements containing projections
of or targets for revenues, costs, income (or loss), earnings per
share, capital expenditures, dividends, capital structure, net
financials and other financial measures; statements regarding
future economic performance, future actions and outcome of
contingencies such as legal proceedings; and statements regarding
the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and
projections. By their very nature, forward-looking statements
involve inherent risks and uncertainties, both general and
specific. A number of important factors, including those described
in this communication, could cause actual results to differ
materially from those contemplated in any forward-looking
statements. Factors that may affect future results and may cause
these forward-looking statements to be inaccurate include, without
limitation: uncertainties as to the timing of the tender offer and
merger; uncertainties as to how many of Forma’s stockholders will
tender their stock in the offer; the possibility that competing
offers will be made; the possibility that various closing
conditions for the proposed transaction may not be satisfied or
waived, including that a governmental entity may prohibit, delay,
or refuse to grant approval for the consummation of the transaction
(or only grant approval subject to adverse conditions or
limitations); the difficulty of predicting the timing or outcome of
regulatory approvals or actions, if any; the possibility that the
proposed transaction may not be completed in the time frame
expected by Novo Nordisk and Forma, or at all; failure to realize
the anticipated benefits of the proposed transaction in the time
frame expected, or at all; the effects of the proposed transaction
on relationships with employees, other business partners or
governmental entities; potential adverse reactions or changes to
business relationships resulting from the announcement or
completion of the proposed transaction; significant or unexpected
costs, charges or expenses resulting from the proposed transaction;
negative effects of this announcement or the consummation of the
proposed acquisition on the market price of Novo Nordisk’s or
Forma’s common stock and/or Novo Nordisk’s or Forma’s operating
results; unknown liabilities; the risk of litigation and/or
regulatory actions related to the proposed acquisition; global as
well as local political and economic conditions, including interest
rate and currency exchange rate fluctuations; delay or failure of
projects related to research and/or development; unplanned loss of
patents; interruptions of supplies and production, product recalls,
unexpected contract breaches or terminations; government-mandated
or market-driven price decreases for Novo Nordisk’s or Forma’s
products; introduction of competing products; reliance on
information technology; Novo Nordisk’s or Forma’s ability to
successfully market current and new products; Novo Nordisk’s,
Forma’s, and their collaborators’ ability to continue to conduct
research and clinical programs; exposure to product liability and
legal proceedings and investigations; changes in governmental laws
and related interpretation thereof, including on reimbursement,
intellectual property protection and regulatory controls on
testing, approval, manufacturing and marketing; perceived or actual
failure to adhere to ethical marketing practices; investments in
and divestitures of domestic and foreign companies; unexpected
growth in costs and expenses; failure to recruit and retain the
right employees; failure to maintain a culture of compliance; and
epidemics, pandemics or other public health crises and their impact
on Novo Nordisk’s and Forma’s respective businesses, operations,
supply chain, patient enrollment and retention, clinical trials,
strategy, goals and anticipated milestones. A more complete
description of these and other material risks can be found in Novo
Nordisk’s and Forma’s filings with the SEC, including annual
reports on Form 20-F and Form 10-K, as applicable, for the year
ended December 31, 2021 and other documents that may be filed from
time to time with the U.S. Securities and Exchange Commission (the
“SEC”), as well as, the Schedule TO and related tender offer
documents to be filed by Novo Nordisk and its indirect wholly owned
subsidiary, NNUS New Dev, Inc. (“Purchaser”), and the Schedule
14D-9 to be filed by Forma.
Any forward-looking statements speak only as of the date of this
communication and are made based on the current beliefs and
judgments of Novo Nordisk’s and Forma’s management, and the reader
is cautioned not to rely on any forward-looking statements made by
Novo Nordisk or Forma. Unlisted factors may present significant
additional obstacles to the realization of forward-looking
statements. Unless required by law, neither Novo Nordisk nor Forma
is under no duty and undertakes no obligation to update or revise
any forward-looking statement after the distribution of this
document, whether as a result of new information, future events or
otherwise.
Additional Information and Where to Find It
The tender offer referenced in this communication has not yet
commenced. This communication is for informational purposes only
and is neither an offer to purchase nor a solicitation of an offer
to sell securities of Forma, nor is it a substitute for the tender
offer materials that Forma, Novo Nordisk or Purchaser will file
with the SEC. The solicitation and offer to buy Forma stock will
only be made pursuant to an Offer to Purchase and related tender
offer materials that Novo Nordisk intends to file with the SEC. At
the time the tender offer is commenced, Novo Nordisk and Purchaser
will file a Tender Offer Statement on Schedule TO and thereafter
Forma will file a Solicitation/Recommendation Statement on Schedule
14D-9 with the SEC with respect to the tender offer. FORMA’S
STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE
TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED
LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND
THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE
THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF FORMA
SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE MAKING ANY
DECISION REGARDING WITH RESPECT TO THE TENDER OFFER. The Offer to
Purchase, the related Letter of Transmittal, certain other tender
offer documents, as well as the Solicitation/Recommendation
Statement will be made available to all stockholders of Forma at no
expense to them and will also be made available for free at the
SEC’s website at www.sec.gov. Additional copies may be obtained for
free by contacting either Novo Nordisk or Forma. Copies of the
documents filed with the SEC by Forma will be available free of
charge on Forma’s website at https://ir.formatherapeutics.com or by
contacting Forma’s Investor Relations Department at 617-679-1970.
Copies of the documents filed with the SEC by Novo Nordisk will be
available free of charge on Novo Nordisk’s website at
https://novonordisk.com/investors or by contacting Novo Nordisk’s
Investor Relations Department at +45 4444 8888.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, Forma files annual,
quarterly and current reports and other information with the SEC
and Novo Nordisk files annual reports, reports of foreign issuers
and other information with the SEC. You may read and copy any
reports or other information filed by Novo Nordisk or Forma at the
SEC public reference room at 100 F Street, N.E., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for further
information on the public reference room. Novo Nordisk’s and
Forma’s filings with the SEC are also available for free to the
public from commercial document-retrieval services and at the
website maintained by the SEC at http://www.sec.gov.
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Further information Media Novo Nordisk: Ambre
Brown Morley, +45 3079 9289, abmo@novonordisk.com Natalia Salomao
Abrahao (US), +1 848 304 1027, niaa@novonordisk.com Media Forma
Therapeutics: Jamie Moser (Joele Frank, Wilkinson Brimmer
Katcher), +1 212 355 4449 Greg Klassen (Joele Frank, Wilkinson
Brimmer Katcher), +1 212 355 4449 Investors Novo Nordisk:
Daniel Muusmann Bohsen, +45 3075 2175, dabo@novonordisk.com David
Heiberg Landsted, +45 3077 6915, dhel@novonordisk.com Jacob Martin
Wiborg Rode, +45 3075 5956, jrde@novonordisk.com Mark Joseph Root
(US), +1 848 213 3219, mjhr@novonordisk.com Investors Forma
Therapeutics: Adam Bero, Ph.D. (Kendell Investor Relations),
abero@kendallir.com
Forma Therapeutics (NASDAQ:FMTX)
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Forma Therapeutics (NASDAQ:FMTX)
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