Bristol Myers Squibb to Acquire Mirati for
$58.00 Per Share, Representing $4.8 Billion Equity Value and Up to
$5.8 Billion Including the Contingent Value Right
Acquisition Brings KRAZATI® (adagrasib), a
Best-in-Class KRASG12C Inhibitor Approved by the U.S. FDA for the
Treatment of Patients with Advanced Non-Small Cell Lung Cancer
Harboring a KRASG12C Mutation and Who Have Received at Least One
Prior Systemic Treatment
KRAZATI is in Clinical Development in
Combination with a PD-1 Inhibitor as a First-Line Therapy for
Patients with Non-Small Cell Lung Cancer Harboring a KRASG12C
Mutation as well as in Other Indications
Mirati’s Promising Pipeline Includes a Potent
Selective PRMT5/MTA Inhibitor, MRTX1719, a Potential First-in-Class
and Best-in-Class Asset; and Early Clinical Pipeline Features a
KRAS and KRAS Enabling Program, including MRTX1133, and a SOS1
Inhibitor, MRTX0902
Bristol Myers Squibb (NYSE: BMY) and Mirati Therapeutics, Inc.®
(NASDAQ: MRTX) today announced that they have entered into a
definitive merger agreement under which Bristol Myers Squibb has
agreed to acquire Mirati for $58.00 per share in cash, for a total
equity value of $4.8 billion. Mirati stockholders will also receive
one non-tradeable Contingent Value Right (CVR) for each Mirati
share held, potentially worth $12.00 per share in cash,
representing an additional $1.0 billion of value opportunity. The
transaction was unanimously approved by both the Bristol Myers
Squibb and the Mirati Boards of Directors.
Mirati is a commercial stage targeted oncology company whose
mission is to discover, design and deliver breakthrough therapies
to transform the lives of patients with cancer and their loved
ones. Mirati’s assets are a strong fit with Bristol Myers Squibb’s
portfolio and innovative pipeline and represent an attractive
opportunity to grow Bristol Myers Squibb’s oncology franchise.
Through this acquisition, Bristol Myers Squibb will add KRAZATI, an
important lung cancer medicine, to its commercial portfolio. The
company gains access to several promising clinical assets that
complement its oncology pipeline and are strong candidates for
single agent development and combination strategies.
Mirati’s portfolio includes:
- KRAZATI (adagrasib), which was granted accelerated U.S. Food
and Drug Administration (FDA) approval for the treatment of adult
patients with KRASG12C-mutated locally advanced or metastatic
Non-Small Cell Lung Cancer (NSCLC) who have received at least one
prior systemic therapy. KRASG12C mutations represent one of the
most frequent alterations in NSCLC, accounting for approximately
14% of all NSCLC patients. KRAZATI also has several attributes that
position it favorably versus other KRASG12C inhibitors, including
its long half-life, and its demonstrated ability to be combined
with a PD-1 inhibitor in first-line treatment of NSCLC in Phase 1
and 2 clinical trials. Adagrasib has shown central nervous system
(CNS) penetration and intracranial responses in patients with
active and untreated brain metastases. Additionally, it has shown
strong efficacy data as a second- and third-line treatment for
patients with colorectal cancer in combination with cetuximab, and
as a monotherapy in previously treated pancreatic ductal
adenocarcinoma. Plans are underway to work with regulators to bring
adagrasib to patients in these treatment settings in the near
future;
- MRTX1719, a potential first-in-class MTA-cooperative PRMT5
inhibitor in Phase 1 development has shown encouraging early
efficacy data across several tumor types with MTAP deletion,
including NSCLC, cholangiocarcinoma (bile duct cancer) and
melanoma, with no evidence to date of meaningful hematologic
toxicities associated with non-selective PRMT5 inhibitors. MRTX1719
targets MTAP-deleted tumors that comprise approximately 10% of all
cancers. Phase 2 clinical trial initiation for MRTX1719 is expected
in the first half of 2024;
- A leading KRAS and KRAS enabling program, including MRTX1133
and MRTX0902. MRTX1133 targets the KRASG12D mutation, which is
implicated in key tumor types, such as pancreatic cancer, NSCLC and
colorectal cancer. MRTX0902 is a SOS1 inhibitor in Phase 1 clinical
development with the potential for combination use with other
agents targeting the MAPK/RAS pathway, including KRAZATI. The
KRASG12D mutation is implicated in over 30% of pancreatic cancer
patients, a disease with high unmet medical need.
“We are excited to add these assets to our portfolio and to
accelerate their development as we seek to deliver more treatments
for cancer patients,” said Giovanni Caforio, Chief Executive
Officer and Board Chair, Bristol Myers Squibb. “With a strong
strategic fit, great science and clear value creation opportunities
for our shareholders, the Mirati transaction is aligned with our
business development goals. Importantly, by leveraging our skills
and capabilities, including our global commercial infrastructure,
we will ensure patients globally can benefit from Mirati’s
portfolio of innovative medicines.”
“With multiple targeted oncology assets including KRAZATI,
Mirati is another important step forward in our efforts to grow our
diversified oncology portfolio and further strengthen Bristol Myers
Squibb’s pipeline for the latter half of the decade and beyond,”
said Chris Boerner, Ph.D., Executive Vice President and Chief
Operating Officer and Chief Executive Officer-Elect, Bristol Myers
Squibb. “Today’s news builds upon our long legacy of delivering
breakthrough therapies that transform the lives of people with
cancer. We are impressed with the science that the talented people
of Mirati have driven in service of patients, and we look forward
to welcoming them to Bristol Myers Squibb.”
Samit Hirawat, M.D., Chief Medical Officer and Head of Global
Drug Development, Bristol Myers Squibb, said, “Mirati strengthens
and complements our current portfolio by adding assets focused on
intrinsic tumor targets in the MTAP and MAPK pathways. We believe
Mirati’s assets have the potential to change the standard of care
in multiple cancers, both as standalone therapies and in
combination with Bristol Myers Squibb’s existing pipeline. We are
excited about the significant potential that this transaction
creates to transform patients’ lives through science around the
world.”
“Since our founding 10 years ago, Mirati has made significant
strides in transforming the lives of patients living with cancer
through the development of innovative therapies. Through our
discovery and development of next-generation targeted cancer
therapeutics, we have built a robust pipeline of potentially
best-in-class treatments that offer renewed hope for patients,”
said Charles Baum, M.D., Ph.D., Founder, President and Chief
Executive Officer, Mirati Therapeutics, Inc. “This transaction is a
testament to the potential of our platform and to our team’s hard
work and dedication to changing lives. Bristol Myers Squibb’s
global scale, resources and commitment to innovation will enable
Mirati’s therapeutics to benefit more patients, faster, and deliver
on our vision of unlocking the science behind the promise of a life
beyond cancer. We believe that this transaction is the best way to
benefit patients and maximize value for shareholders.”
The transaction is expected to be treated as a business
combination and to be dilutive to Bristol Myers Squibb’s non-GAAP
earnings per share by approximately $0.35 per share in the first 12
months after the transaction closes.
Transaction Terms and Financing
Under the terms of the merger agreement, Bristol Myers Squibb
through a subsidiary will acquire all of the outstanding shares of
Mirati common stock at a price of $58.00 per share in cash
representing a 52% premium to the 30-day VWAP as of the unaffected
October 4, 2023 close, for a total equity value of $4.8 billion
corresponding to an enterprise value of approximately $3.7 billion,
which accounts for approximately $1.1 billion of Mirati cash. Each
Mirati stockholder will also receive one non-tradeable CVR per
Mirati share, which will entitle its holder to receive a one-time
potential payment of $12.00 in cash, for a total value of
approximately $1.0 billion, upon acceptance by U.S. FDA of a new
drug application for MRTX1719 for the treatment of either locally
advanced or metastatic NSCLC in patients who have received no more
than two prior lines of systemic therapy within seven years after
the closing of the merger, subject to the terms and conditions
contained in a contingent value rights agreement detailing the
terms of the CVR.
The transaction is anticipated to close by the first half of
2024, subject to fulfillment of customary closing conditions,
including approval of Mirati’s stockholders and receipt of required
regulatory approvals.
Bristol Myers Squibb expects to finance the acquisition with a
combination of cash and debt.
Advisors
Evercore Inc. and Morgan Stanley & Co. LLC are serving as
financial advisors to Bristol Myers Squibb, and Kirkland &
Ellis LLP is serving as legal counsel. Centerview Partners LLC is
serving as financial advisor to Mirati, and Skadden, Arps, Slate,
Meagher & Flom LLP is serving as legal counsel.
About KRASG12C in NSCLC
Lung cancer is one of the most common cancers worldwide,
accounting for 2.21 million new cases and 1.8 million deaths
worldwide in 2020.1 Lung cancer consists of NSCLC in approximately
85% of cases and small cell lung cancer (SCLC) in approximately 15%
of cases.2 KRASG12C is the most common KRAS mutation in NSCLC,
present in approximately 14% of patients with lung adenocarcinoma,
and is a biomarker mutation of poor prognosis.3,4
KRAZATI (adagrasib) U.S. Indication
KRAZATI is indicated for the treatment of adult patients with
KRASG12C-mutated locally advanced or metastatic non-small cell lung
cancer (NSCLC), as determined by an FDA-approved test, who have
received at least one prior systemic therapy.
This indication is approved under accelerated approval based on
objective response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon
verification and description of a clinical benefit in a
confirmatory trial(s).
KRAZATI (adagrasib) Important Safety Information
WARNINGS AND PRECAUTIONS
Gastrointestinal Adverse Reactions
- In the pooled safety population, serious gastrointestinal
adverse reactions observed were gastrointestinal obstruction in
1.6%, including 1.4% grade 3 or 4, gastrointestinal bleeding in
0.5% of patients, including 0.5% grade 3, and colitis in 0.3%,
including 0.3% grade 3. In addition, nausea, diarrhea, or vomiting
occurred in 89% of 366 patients, including 9% grade 3. Nausea,
diarrhea, or vomiting led to dosage interruption or dose reduction
in 29% of patients and permanent discontinuation of KRAZATI in
0.3%
- Monitor and manage patients using supportive care, including
antidiarrheals, antiemetics, or fluid replacement, as indicated.
Withhold, reduce the dose, or permanently discontinue KRAZATI based
on severity
QTc Interval Prolongation
- KRAZATI can cause QTc interval prolongation, which can increase
the risk for ventricular tachyarrhythmias (eg, torsades de pointes)
or sudden death
- In the pooled safety population, 6% of 366 patients with at
least one post-baseline electrocardiogram (ECG) assessment had an
average QTc ≥501 ms, and 11% of patients had an increase from
baseline of QTc >60 msec. KRAZATI causes concentration-dependent
increases in the QTc interval
- Avoid concomitant use of KRAZATI with other products with a
known potential to prolong the QTc interval. Avoid use of KRAZATI
in patients with congenital long QT syndrome and in patients with
concurrent QTc prolongation
- Monitor ECGs and electrolytes prior to starting KRAZATI, during
concomitant use, and as clinically indicated in patients with
congestive heart failure, bradyarrhythmias, electrolyte
abnormalities, and in patients who are taking medications that are
known to prolong the QT interval. Withhold, reduce the dose, or
permanently discontinue KRAZATI, depending on severity
Hepatotoxicity
- KRAZATI can cause hepatotoxicity
- In the pooled safety population, hepatotoxicity occurred in
37%, and 7% were grade 3 or 4. A total of 32% of patients who
received KRAZATI had increased alanine aminotransferase
(ALT)/increased aspartate aminotransferase (AST); 5% were grade 3
and 0.5% were grade 4. Increased ALT/AST leading to dose
interruption or reduction occurred in 11% of patients. KRAZATI was
discontinued due to increased ALT/AST in 0.5% of patients
- Monitor liver laboratory tests (AST, ALT, alkaline phosphatase,
and total bilirubin) prior to the start of KRAZATI, and monthly for
3 months or as clinically indicated, with more frequent testing in
patients who develop transaminase elevations. Reduce the dose,
withhold, or permanently discontinue KRAZATI based on severity
Interstitial Lung Disease /Pneumonitis
- KRAZATI can cause interstitial lung disease (ILD)/pneumonitis,
which can be fatal. In the pooled safety population,
ILD/pneumonitis occurred in 4.1% of patients, 1.4% were grade 3 or
4, and 1 case was fatal. The median time to first onset for
ILD/pneumonitis was 12 weeks (range: 5 to 31 weeks). KRAZATI was
discontinued due to ILD/pneumonitis in 0.8% of patients
- Monitor patients for new or worsening respiratory symptoms
indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold
KRAZATI in patients with suspected ILD/pneumonitis and permanently
discontinue KRAZATI if no other potential causes of ILD/pneumonitis
are identified
Adverse Reactions
- The most common adverse reactions (≥25%) are nausea, diarrhea,
vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal
impairment, edema, dyspnea, decreased appetite
Females and Males of Reproductive Potential
- Infertility: Based on findings from animal studies, KRAZATI may
impair fertility in females and males of reproductive
potential
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 Mirati Therapeutics
Mirati Therapeutics, Inc. is a commercial stage biotechnology
company whose mission is to discover, design and deliver
breakthrough therapies to transform the lives of patients with
cancer and their loved ones. The company is relentlessly focused on
bringing forward therapies that address areas of high unmet need,
including lung cancer, and advancing a pipeline of novel
therapeutics targeting the genetic and immunological drivers of
cancer. Unified for patients, Mirati’s vision is to unlock the
science behind the promise of a life beyond cancer. For more
information about Mirati, visit us at Mirati.com or follow us on
Twitter, LinkedIn and Facebook.
Additional Information and Where to
Find it
In connection with the proposed acquisition of Mirati by Bristol
Myers Squibb, Mirati intends to file a preliminary and definitive
proxy statement. The definitive proxy statement and proxy card will
be delivered to the stockholders of Mirati in advance of the
special meeting relating to the proposed acquisition. This document
is not a substitute for the proxy statement or any other document
that may be filed by Mirati with the SEC. MIRATI’S STOCKHOLDERS AND
INVESTORS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS
ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY
EACH OF BRISTOL MYERS SQUIBB AND MIRATI WITH THE SEC IN CONNECTION
WITH THE PROPOSED ACQUISITION OR INCORPORATED BY REFERENCE THEREIN
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
ACQUISITION AND THE PARTIES TO THE PROPOSED ACQUISITION. Investors
and security holders will be able to obtain a free copy of the
proxy statement and such other documents containing important
information about Bristol Myers Squibb and Mirati, once such
documents are filed with the SEC, through the website maintained by
the SEC at www.sec.gov. Bristol Myers Squibb and Mirati make
available free of charge at Bristol Myers Squibb’s website at
www.bms.com/investors and Mirati’s website at www.ir.mirati.com,
respectively, copies of materials they file with, or furnish to,
the SEC.
Participants in the
Solicitation
This document does not constitute a solicitation of proxy, an
offer to purchase or a solicitation of an offer to sell any
securities. Bristol Myers Squibb, Mirati and their respective
directors, executive officers and certain employees may be deemed
to be participants in the solicitation of proxies from the
stockholders of Mirati in connection with the proposed acquisition.
Information regarding Bristol Myers Squibb’s directors and
executive officers is contained in Bristol Myers Squibb’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2022,
which was filed with the SEC on February 14, 2023, and its
definitive proxy statement for the 2023 annual meeting of
stockholders, which was filed with the SEC on March 23, 2023.
Information regarding Mirati’s directors and executive officers is
contained in Mirati’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2022, which was filed with the SEC on
February 28, 2023, and its definitive proxy statement for the 2023
annual meeting of stockholders, which was filed with the SEC on
April 6, 2023. To the extent holdings of Bristol Myers Squibb’s or
Mirati’s securities by their respective directors or executive
officers have changed since the amounts set forth in such 2023
proxy statements, such changes have been or will be reflected on
Initial Statements of Beneficial Ownership on Form 3 or Statements
of Beneficial Ownership on Form 4 filed with the SEC. Additional
information regarding the identity of potential participants, and
their direct or indirect interests, by security holdings or
otherwise, will be included in the definitive proxy statement
relating to the proposed acquisition when it is filed with the SEC.
These documents (when available) may be obtained free of charge
from the SEC’s website at www.sec.gov, Bristol Myers Squibb’s
website at www.bms.com and Mirati’s website at www.mirati.com.
Cautionary Statement Regarding
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, regarding, among other things, the acquisition of Mirati
by Bristol Myers Squibb, potential contingent consideration, and
the development and commercialization of certain biological
compounds, including the therapeutic and commercial potential of
KRAZATI® (adagrasib), sitravatinib (TAM receptor inhibitor),
MRTX1719 (MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1
inhibitor), MRTX1133 (selective KRASG12D inhibitor), and Mirati’s
other technologies and products in development. These statements
may be identified by the fact they use words such as “should,”
“could,” “expect,” “anticipate,” “estimate,” “target,” “may,”
“project,” “guidance,” “intend,” “plan,” “believe,” “will” and
other words and terms of similar meaning and expression in
connection with any discussion of future operating or financial
performance, although not all forward-looking statements contain
such terms. All statements that are not statements of historical
facts are, or may be deemed to be, forward-looking statements.
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. Actual results may differ materially
from current expectations because of numerous risks and
uncertainties including with respect to (i) the approval of
Mirati’s stockholders for the proposed acquisition, which may be
delayed or may not be obtained, (ii) whether the contingent
consideration under the CVR will become payable, (iii) the risk
that the expected benefits or synergies of the acquisition will not
be realized, (iv) the risk that legal proceedings may be instituted
related to the merger agreement, (v) any competing offers or
acquisition proposals for Mirati, (vi) the possibility that various
conditions to the consummation of the acquisition may not be
satisfied or waived, including that a governmental entity may
prohibit, delay or refuse to grant approval for the acquisition and
(vii) unanticipated difficulties or expenditures relating to the
proposed acquisition, the response of business partners and
competitors to the announcement of the proposed acquisition and/or
potential difficulties in employee retention as a result of the
announcement and pendency of the proposed acquisition. The actual
financial impact of this transaction may differ from the expected
financial impact described in this communication. In addition, the
compounds described in this communication 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
communication 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, 2022, and Mirati's business, particularly those
identified in the cautionary factors discussion in Mirati’s Annual
Report on Form 10-K for the year ended December 31, 2022, as well
as other documents that may be filed by Bristol Myers Squibb or
Mirati from time to time with the SEC. Neither Bristol Myers Squibb
nor Mirati 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
In discussing financial guidance, Bristol Myers Squibb refers to
financial measures that are not in accordance with U.S. Generally
Accepted Accounting Principles (GAAP). The non-GAAP financial
measures are provided as supplemental information to the financial
measures presented in this communication that are calculated and
presented in accordance with GAAP and are presented because
management has evaluated the company’s financial results both
including and excluding the adjusted items or the effects of
foreign currency translation, as applicable, and believes that the
non-GAAP financial measures presented 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 trends and facilitate
comparisons among current, past and future periods.
Non-GAAP earnings and related EPS information are adjusted to
exclude certain costs, expenses, gains and losses and other
specified items that are evaluated on an individual basis 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 past or future operating results. These items are excluded from
non-GAAP earnings and related EPS information because Bristol Myers
Squibb believes they neither relate to the ordinary course of
Bristol Myers Squibb’s business nor reflect Bristol Myers Squibb’s
underlying business performance. Similar charges or gains were
recognized in prior periods and will likely reoccur in future
periods.
Because the non-GAAP financial measures are not calculated in
accordance with GAAP, they should not be considered superior to or
as a substitute for the related financial measures that are
prepared in accordance with GAAP and are not intended to be
considered in isolation 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.
A reconciliation of the forward-looking non-GAAP measures
presented in this communication is not provided due to the inherent
difficulty in forecasting and quantifying items that are necessary
for such reconciliation. Namely, we are not able to reliably
predict the impact of specified items such as unwind of inventory
purchase price adjustments, accelerated depreciation and impairment
of property, plant and equipment and intangible assets and stock
compensation resulting from acquisition-related equity awards, or
currency exchange rates beyond the next twelve months. As a result,
the reconciliation of these non-GAAP measures to the most directly
comparable GAAP measures 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
communication 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
financial guidance is subject to risks and uncertainties applicable
to all forward-looking statements as described elsewhere in this
communication.
Citations
- Lung cancer statistics. WCRF International.
https://www.wcrf.org/cancer-trends/lung-cancer-statistics/.
Published April 14, 2022.
- Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small
cell lung cancer: epidemiology, risk factors, treatment, and
survivorship. Mayo Clin Proc. 2008;83(5):584-94.
- Jänne PA, Riely GJ, Gadgeel SM, et al. Adagrasib in
Non-Small-Cell Lung Cancer Harboring a KRASG12C Mutation. N Engl J
Med. 2022;387(2):120-131.
- Haigis KM. KRAS alleles: the devil is in the detail. Trends
Cancer. 2017;3(10):686-697.
corporatefinancial-news
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231008963771/en/
Bristol Myers Squibb
Media Inquiries: media@bms.com
Investors: investor.relations@bms.com
Mirati Therapeutics
Media Inquiries: media@mirati.com
Investors: ir@mirati.com
Mirati Therapeutics (NASDAQ:MRTX)
Graphique Historique de l'Action
De Déc 2024 à Jan 2025
Mirati Therapeutics (NASDAQ:MRTX)
Graphique Historique de l'Action
De Jan 2024 à Jan 2025
