Mavacamten Is a Potential First-in-Class
Medicine with Compelling Data in the Treatment of Patients with
Symptomatic Obstructive Hypertrophic Cardiomyopathy
Mavacamten Will Be a Medium- and Long-Term
Growth Driver Presenting a Significant Commercial Opportunity upon
Approval
Promising Portfolio of Pipeline Candidates
Strengthens and Extends Bristol Myers Squibb’s Leading
Cardiovascular Franchise
Expected to be Accretive to Non-GAAP Earnings
Starting in 2023
Bristol Myers Squibb (NYSE: BMY) and MyoKardia, Inc. (Nasdaq:
MYOK) today announced a definitive merger agreement under which
Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or
$225.00 per share in cash. The transaction was unanimously approved
by both the Bristol Myers Squibb and MyoKardia Boards of Directors
and is anticipated to close during the fourth quarter of 2020.
MyoKardia is a clinical-stage biopharmaceutical company
discovering and developing targeted therapies for the treatment of
serious cardiovascular diseases. Through the transaction, Bristol
Myers Squibb gains mavacamten, a potential first-in-class
cardiovascular medicine for the treatment of obstructive
hypertrophic cardiomyopathy (“HCM”), a chronic heart disease with
high morbidity and patient impact. A New Drug Application (“NDA”)
for mavacamten for the treatment of symptomatic obstructive HCM –
based on data from the EXPLORER-HCM study – is expected to be
submitted to the U.S. Food and Drug Administration (“FDA”) in the
first quarter of 2021. Bristol Myers Squibb expects to explore the
full potential of mavacamten in additional indications, including
non-obstructive HCM, as well as develop MyoKardia’s promising
pipeline of novel compounds, including two clinical-stage
therapeutics: danicamtiv (formerly MYK-491) and MYK-224.
“The acquisition of MyoKardia further strengthens our portfolio,
pipeline and scientific capabilities, and is expected to add a
meaningful medium- and long-term growth driver,” said Giovanni
Caforio, M.D., Board Chair and Chief Executive Officer of Bristol
Myers Squibb. “We are further strengthening our outstanding
cardiovascular franchise through the addition of mavacamten, a
promising medicine with the potential to address a significant
unmet medical need in patients with cardiovascular disease. Our
companies share a commitment to innovation and bold science, and
our respective strengths will help us realize the value inherent in
this portfolio. We have long admired MyoKardia and what they have
done to revolutionize cardiovascular treatments through a precision
medicine approach. We look forward to welcoming their talented team
to our company.”
“MyoKardia was formed eight years ago with the aim of changing
the world for people with serious cardiovascular diseases through
bold and innovative science. Since then, MyoKardia’s dedicated
employees have established an unparalleled pipeline of targeted
therapeutics designed to change the course of disease and return
the heart to normal function,” said Tassos Gianakakos, Chief
Executive Officer of MyoKardia. “Bristol Myers Squibb shares our
vision for transforming the treatment of cardiovascular disease.
They value our team and the potential of our platform and, most
importantly, share our unwavering commitment to placing patients at
the center of everything we do. Together, our complementary
strengths and expanded resources and reach will further accelerate
the pace at which we can discover, develop and commercialize our
novel medicines for the benefit of people suffering from
cardiovascular disease around the world.”
Compelling Benefits
Bristol Myers Squibb expects the transaction, when complete,
to:
- Further strengthen the company’s outlook with the addition
of mavacamten, which has significant commercial potential in the
lead indication, obstructive HCM, and upside in additional future
indications, including non-obstructive HCM. With the
high unmet medical need in obstructive HCM, mavacamten can be a
significant medium- and long-term growth driver. Mavacamten
demonstrated clinically meaningful results in the pivotal Phase 3
EXPLORER-HCM trial, meeting the primary and all secondary
endpoints, and showed meaningful improvements in symptoms,
functional status and quality of life by reducing the obstruction
of blood flow from the heart. This potential first-in-class
medicine, for which an NDA is expected to be submitted to the FDA
in the first quarter of 2021, may help to change the course of the
disease.
- Accelerate the expansion of Bristol Myers Squibb’s
cardiovascular portfolio. Bristol Myers Squibb has established
Eliquis® (apixaban) as the #1 oral anticoagulant globally with a
best-in-class profile, driven by leading commercial execution.
Mavacamten will be a fully owned asset that fits well into Bristol
Myers Squibb’s existing portfolio, given the company’s broad
expertise in cardiovascular disease. Through this acquisition,
Bristol Myers Squibb gains MyoKardia’s critical talent and
capabilities on the U.S. West Coast, which will support fully
realizing the opportunity in obstructive HCM and exploring the full
potential of mavacamten in additional indications. Bristol Myers
Squibb will also be well positioned to advance the global
development of MyoKardia’s portfolio of clinical- and early-stage
pipeline candidates, while continuing to advance its existing
Factor XIa inhibitor program.
- Deliver significant financial benefits. The transaction
is expected to add a significant growth driver during the medium-
to long-term. It is expected to be minimally dilutive to Bristol
Myers Squibb’s non-GAAP earnings per share (EPS) in 2021 and 2022
and accretive beginning in 2023. Bristol Myers Squibb reaffirms its
existing 2021 non-GAAP EPS guidance range. There is no reliable
estimable comparable GAAP measure as described below.
Transaction Terms and Financing
Under the terms of the merger agreement, a subsidiary of Bristol
Myers Squibb will promptly commence a tender offer to acquire all
of the outstanding shares of MyoKardia’s common stock for $225.00
per share in cash. MyoKardia’s Board of Directors unanimously
recommends that MyoKardia shareholders tender their shares in the
tender offer.
The transaction is subject to customary closing conditions,
including the tender of a majority of the outstanding shares of
MyoKardia’s common stock and the expiration or termination of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976. Following the successful closing of the tender offer,
Bristol Myers Squibb will acquire all remaining shares of MyoKardia
that are not tendered into the tender offer through a second-step
merger at the same price of $225.00 per share.
Bristol Myers Squibb expects to finance the acquisition with a
combination of cash and debt.
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy, or HCM, is a chronic, progressive
disease in which excessive contraction of the heart muscle and
reduced ability of the left ventricle to fill can lead to the
development of debilitating symptoms and cardiac dysfunction. HCM
is estimated to affect one in every 500 people.
The most frequent cause of HCM is mutations in the heart muscle
proteins of the sarcomere. In approximately two-thirds of HCM
patients, the path followed by blood exiting the heart, known as
the left ventricular outflow tract (LVOT), becomes obstructed by
the enlarged and diseased muscle, restricting the flow of blood
from the heart to the rest of the body (obstructive HCM). In other
patients, the thickened heart muscle does not block the LVOT, and
their disease is driven by diastolic impairment due to the enlarged
and stiffened heart muscle (non-obstructive HCM). In either
obstructive or non-obstructive HCM patients, exertion can result in
fatigue or shortness of breath, interfering with a patient’s
ability to participate in activities of daily living. HCM has also
been associated with increased risks of atrial fibrillation,
stroke, heart failure and sudden cardiac death.
There are currently approximately 160,000 to 200,000 people
diagnosed with symptomatic obstructive HCM across the U.S. and EU,
with no existing effective treatment options beyond limited
symptomatic relief. Patients are typically diagnosed in their 40s
or 50s and the treatment is expected to be chronic. It is estimated
that only approximately 25 percent of individuals with obstructive
HCM and only approximately 10 percent of individuals with
non-obstructive HCM have received a diagnosis.
Conference Call
At 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time today,
Bristol Myers Squibb will host a conference call and a simultaneous
webcast to discuss the transaction. A live webcast of the call can
be accessed at Bristol Myers Squibb’s Investors page at
bms.com/investors. Please connect to the website at least 15
minutes prior to the start of the call to allow adequate time for
any software download that may be required. Alternatively, please
call (877) 658-9096 (U.S.) or (602) 563-8733 (international) and
dial the conference ID 9697843 to access the call.
Telephone replay will be available approximately three hours
after the call until 11:30 a.m. ET on October 19, 2020. To access
the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406
(international) and dial the conference ID 9697843. The webcast
will be archived on bms.com/investors.
Advisors
Gordon Dyal & Co., LLC is serving as exclusive financial
advisor to Bristol Myers Squibb, and Kirkland & Ellis LLP is
serving as legal counsel. Centerview Partners LLC and Guggenheim
Securities are acting as joint financial advisors to MyoKardia and
Goodwin Procter LLP is serving as legal counsel.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook, and
Instagram.
About MyoKardia
MyoKardia is a clinical-stage biopharmaceutical company
discovering and developing targeted therapies for the treatment of
serious cardiovascular diseases. The company is pioneering a
precision medicine approach to its discovery and development
efforts by 1) understanding the biomechanical underpinnings of
disease; 2) targeting the proteins that modulate a given condition;
3) identifying patient populations with shared disease
characteristics; and 4) applying learnings from research and
clinical studies to inform and guide pipeline growth and product
advancement. MyoKardia’s initial focus is on small molecule
therapeutics aimed at the proteins of the heart that modulate
cardiac muscle contraction to address diseases driven by excessive
contraction, impaired relaxation, or insufficient contraction.
Among its discoveries are three clinical-stage therapeutics:
mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and
MYK-224.
MyoKardia’s mission is to change the world for people with
serious cardiovascular disease through bold and innovative
science.
Additional Information and Where to Find It
The tender offer referred to in this document 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, nor is it a substitute for the tender offer
materials that Bristol Myers Squibb and its acquisition subsidiary
will file with the U.S. Securities and Exchange Commission (the
“SEC”). At the time the tender offer is commenced, Bristol Myers
Squibb will cause its acquisition subsidiary to file with the SEC a
tender offer statement on Schedule TO and MyoKardia will file a
solicitation/recommendation statement on Schedule 14D-9. INVESTORS
AND MYOKARDIA STOCKHOLDERS ARE STRONGLY ADVISED TO READ THE TENDER
OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER
OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE RELATED
SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 THAT WILL
BE FILED BY MYOKARDIA WITH THE SEC BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION THAT SHOULD BE CONSIDERED BY MYOKARDIA’S
INVESTORS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER
OFFER. Both the tender offer statement and the
solicitation/recommendation statement will be available at no
charge on the SEC’s website: www.sec.gov. In addition, a copy of
the offer to purchase, letter of transmittal and certain other
related tender offer documents (once they become available) may be
obtained free of charge at www.bms.com or by directing a request to
Bristol Myers Squibb, Office of the Corporate Secretary, 430 East
29th Street, 14th Floor, New York, New York 10154-0037. A copy of
the tender offer statement and the solicitation/recommendation
statement will be made available to all stockholders of MyoKardia
free of charge at www.myokardia.com or by contacting MyoKardia at
ir@myokardia.com, telephone number 650-351-4690.
In addition to the offer to purchase, the related letter of
transmittal and certain other offer documents, as well as the
solicitation/recommendation statement, Bristol Myers Squibb and
MyoKardia file annual, quarterly and special reports, proxy
statements and other information with the SEC. You may read and
copy any reports, statements or other information filed by Bristol
Myers Squibb or MyoKardia 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. Bristol Myers Squibb’s and MyoKardia’s filings with the SEC
are also available to the public from commercial document-retrieval
services and at the website maintained by the SEC at www.sec.gov.
INVESTORS AND MYOKARDIA’S STOCKHOLDERS ARE ADVISED TO READ THE
SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR
SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS
FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY
DECISION WITH RESPECT TO THE TENDER OFFER, BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND
THE PARTIES THERETO.
Cautionary Statement Regarding Forward Looking
Statements
This report contains “forward-looking statements” relating to
the acquisition of MyoKardia by Bristol Myers Squibb and the
development and commercialization of certain biological compounds.
Such forward-looking statements are generally identified by
terminology such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential” or
“continue” or the negative of these terms or other similar words.
These statements are only predictions, and such forward-looking
statements are based on current expectations and involve inherent
risks and uncertainties, including factors that could delay, divert
or change any of them, and could cause actual outcomes and results
to differ materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks are (i) that there
can be no guarantee that the acquisition will be completed, or if
it is completed, that it will close within the anticipated time
period or that the expected benefits of the acquisition will be
realized, (ii) the outcome of any legal proceedings that may be
instituted against the parties and others related to the merger
agreement and (iii) unanticipated difficulties or expenditures
relating to the proposed transaction, the response of business
partners and competitors to the announcement of the proposed
transaction and/or potential difficulties in employee retention as
a result of the announcement and pendency of the proposed
transaction. The actual financial impact of this transaction may
differ from the expected financial impact described in this report.
In addition, the compounds described in this report are subject to
all the risks inherent in the drug development process, and there
can be no assurance that the development of these compounds will be
commercially successful. Forward-looking statements in this report
should be evaluated together with the many uncertainties that
affect Bristol Myers Squibb’s business, particularly those
identified in the cautionary factors discussion in Bristol Myers
Squibb’s Annual Report on Form 10-K for the year ended December 31,
2019, and its subsequent Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K and in MyoKardia’s most recent Annual Report on
Form 10-K for the year ended December 31, 2019 and subsequent
quarterly reports filed on Form 10-Q with the SEC, as well as other
documents that may be filed by MyoKardia from time to time with the
SEC. Neither Bristol Myers Squibb nor MyoKardia undertakes any
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise.
The forward-looking statements made in this communication relate
only to events as of the date on which the statements are made.
Use of Non-GAAP Financial Information and Financial
Guidance
This release contains non-GAAP financial guidance, which is
adjusted to exclude certain costs, expenses, gains and losses and
other specified items that are evaluated on an individual basis.
These non-GAAP items are adjusted after considering their
quantitative and qualitative aspects and typically have one or more
of the following characteristics, such as being highly variable,
difficult to project, unusual in nature, significant to the results
of a particular period or not indicative of future operating
results. Similar charges or gains were recognized in prior periods
and will likely reoccur in future periods. Non-GAAP information is
intended to portray the results of the company’s baseline
performance, supplement or enhance management, analysts and
investors overall understanding of the company’s underlying
financial performance and facilitate comparisons among current,
past and future periods. For example, non-GAAP earnings and EPS
information are indications of the company’s baseline performance
before items that are considered by us to not be reflective of the
company’s ongoing results. In addition, this information is among
the primary indicators that we use as a basis for evaluating
performance, allocating resources, setting incentive compensation
targets and planning and forecasting for future periods. This
information is not intended to be considered in isolation or as a
substitute for net earnings or diluted EPS prepared in accordance
with GAAP and may not be the same as or comparable to similarly
titled measures presented by other companies due to possible
differences in method and in the items being adjusted. We encourage
investors to review our financial statements and publicly-filed
reports in their entirety and not to rely on any single financial
measure. There is no reliable or reasonably estimable comparable
GAAP measure for this non-GAAP financial guidance because we are
not able to reliably predict the impact of specified items beyond
2020. As a result, reconciliation of this non-GAAP measure to the
most directly comparable GAAP measure is not available without
unreasonable effort. In addition, the company believes such a
reconciliation would imply a degree of precision and certainty that
could be confusing to investors. The variability of the specified
items may have a significant and unpredictable impact on our future
GAAP results.
In addition, the non-GAAP financial guidance in this release
excludes the impact of any potential additional future strategic
acquisitions and divestitures and any specified items that have not
yet been identified and quantified. The guidance also excludes
macro-economic effects due to the COVID-19 pandemic that are not
yet quantifiable. The financial guidance is subject to risks and
uncertainties applicable to all forward-looking statements as
described elsewhere in this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20201005005381/en/
Bristol Myers Squibb
Media: media@bms.com 609-252-3345
Investors: Tim Power, 609-252-7509, timothy.power@bms.com Nina
Goworek, 908-673-9711, nina.goworek@bms.com
MyoKardia
Michelle Corral Executive Director, Corporate Communications and
Investor Relations MyoKardia, Inc. 650-351-4690
ir@myokardia.com
Hannah Deresiewicz (investors) Stern Investor Relations, Inc.
212-362-1200 hannah.deresiewicz@sternir.com
Julie Normart (media) W2O 628-213-3754 jnormart@w2ogroup.com
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