Transaction Brings RayzeBio’s
Differentiated Actinium-Based Radiopharmaceutical Platform,
Including Rich Pipeline of Multiple Drug Development Programs, to
Bristol Myers Squibb’s Leading Oncology Franchise
Lead Program, RYZ101, in Phase 3 Development
for Treatment of Gastroenteropancreatic Neuroendocrine Tumors and
Early-stage Development for Treatment of Small Cell Lung Cancer and
Potentially Other Tumor Types
Gains Robust IND Engine and State-of-the-Art
Radiopharmaceutical Manufacturing Capabilities
Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ:
RYZB) today announced a definitive merger agreement under which
Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in
cash, for a total equity value of approximately $4.1 billion, or
$3.6 billion net of estimated cash acquired. The transaction was
unanimously approved by both the Bristol Myers Squibb and RayzeBio
Boards of Directors.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231225781528/en/
RayzeBio is a clinical-stage radiopharmaceutical therapeutics
(“RPT”) company with an innovation-leading position in
actinium-based RPTs and a pipeline of potentially first-in-class
and best-in-class drug development programs. Current pipeline
programs are targeting the treatment of solid tumors, including
gastroenteropancreatic neuroendocrine tumors (GEP-NETs), small cell
lung cancer, hepatocellular carcinoma and other cancers. There
remains a high, unmet need for more effective treatments in solid
tumors, and RPTs enable a precision approach to patient treatment.
RPTs bind to tumor cells and deliver targeted radiation to induce
cancer cell death. Actinium-based RPTs offer potential advantages
over currently available RPTs since the high potency and short
firing range of the alpha-emitter create the possibility for
stronger efficacy and more targeted delivery.
“This transaction enhances our increasingly diversified oncology
portfolio by bringing a differentiated platform and pipeline, and
further strengthens our growth opportunities in the back half of
the decade and beyond,” said Christopher Boerner, Ph.D., Chief
Executive Officer of Bristol Myers Squibb. “Radiopharmaceutical
therapeutics are already transforming cancer care, and RayzeBio is
at the forefront of pioneering the application of this novel
modality. We look forward to supporting and accelerating RayzeBio’s
preclinical and clinical programs and advancing its highly
innovative radiopharmaceutical platform.”
“Acquiring RayzeBio’s differentiated actinium-based
radiopharmaceutical platform will establish Bristol Myers Squibb’s
presence in one of the most promising and fastest-growing new
modalities for the treatment of patients with solid tumors –
delivering radioactive payloads to cancer cells in a targeted
manner,” said Samit Hirawat, M.D., Executive Vice President, Chief
Medical Officer, Drug Development of Bristol Myers Squibb. “In
addition, RayzeBio’s platform has the potential to be a significant
IND engine, generating several therapeutic candidates in the future
by leveraging our global drug development capabilities and
infrastructure.”
Ken Song, M.D., President and CEO of RayzeBio, said, “Despite
therapeutic advances in recent years, the need for more effective
treatments in solid tumors persists, and radiopharmaceutical
therapeutics are positioned to be an important next wave of
innovation in oncology therapy. Bristol Myers Squibb’s
well-established presence in oncology and deep expertise in
developing, commercializing and manufacturing treatments on a
global scale makes it the ideal partner for RayzeBio at this
important moment in our evolution. I am excited to see what our
team achieves as part of Bristol Myers Squibb.”
RayzeBio’s portfolio includes:
- Lead program RYZ101 (225Ac-DOTATATE), targeting somatostatin
receptor 2 (SSTR2), which is over-expressed in GEP-NETs and
extensive stage small cell lung cancer (ES-SCLC). A Phase 3
clinical trial is currently enrolling patients to evaluate RYZ101
in patients with SSTR-positive GEP-NETs who have previously been
treated with lutetium-177 based somatostatin therapies. RayzeBio
previously reported the interim results of the Phase 1b portion of
the ACTION-1 clinical trial, suggesting encouraging efficacy and
tolerability. A Phase 1b clinical trial is also currently enrolling
patients to evaluate RYZ101 as a first-line treatment of ES-SCLC in
combination with standard-of-care therapy.
- RYZ801, RayzeBio’s novel proprietary peptide targeting
glypican-3 (GPC3) for delivery of actinium- based radioactivity for
the treatment of hepatocellular carcinoma (HCC). RYZ801 is
currently in IND-enabling studies.
- Pipeline also includes an asset targeting CA9, which is
expressed in renal cell cancer and is currently in IND-enabling
studies.
- Multiple first-in-class preclinical assets to treat solid
tumors.
RayzeBio is completing construction of a state-of-the-art
in-house manufacturing facility in Indianapolis, Indiana, and GMP
drug production is expected to begin in the first half of 2024.
The transaction is expected to be treated as a business
combination and to be dilutive to Bristol Myers Squibb’s non-GAAP
diluted earnings per share by approximately $0.13 in 2024. Bristol
Myers Squibb expects to finance the acquisition with primarily new
debt issuance. Bristol Myers Squibb’s cash flows and strong
financial profile enable continued commitment to strong
investment-grade credit ratings and investment for growth through
business development opportunities and distributions to
shareholders through ongoing dividends and share repurchases.
Transaction Terms and Financing
Under the terms of the merger agreement, Bristol Myers Squibb
will promptly commence a tender offer to acquire all of the
outstanding shares of RayzeBio common stock at a price of $62.50
per share in an all-cash transaction for a total equity value of
approximately $4.1 billion, or $3.6 billion net of estimated cash
acquired. RayzeBio’s Board of Directors unanimously recommends that
RayzeBio’s shareholders tender their shares in the tender
offer.
The transaction is expected to close in the first half of 2024,
subject to customary closing conditions, including the tender of a
majority of the outstanding shares of RayzeBio’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 RayzeBio that are not tendered into
the tender offer through a second-step merger at the same price of
$62.50 per share.
Advisors
BofA Securities, Inc., is serving as financial advisor to
Bristol Myers Squibb, and Covington & Burling LLP is serving as
legal counsel. Centerview Partners LLC is serving as financial
advisor to RayzeBio, and Cooley 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 RayzeBio
RayzeBio is building a radiopharmaceutical therapeutics (RPT)
company to treat various cancers, with its lead program in a Phase
3 clinical trial. RayzeBio has created a pipeline of multiple drug
candidates in therapeutic areas with significant market
opportunities. Much like antibody drug conjugates emerged as a new
and transformative treatment modality in certain cancers, the
company sees an opportunity for innovative radiopharmaceutical
therapeutics to follow a similar path. RayzeBio believes its
strategic investments in building a robust product pipeline,
development capabilities, and manufacturing infrastructure position
the company to be an industry-leading pioneer in the broad
application of RPT for cancer.
Additional Information about the Tender
Offer and Where to Find It
The tender offer described 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 any shares of the common stock of RayzeBio or any other
securities, nor is it a substitute for the tender offer materials
that Bristol Myers Squibb and an acquisition vehicle to be formed
by Bristol Myers Squibb promptly following execution of the merger
agreement (“Merger Sub”) will file with the U.S. Securities and
Exchange Commission (“SEC”). At the time the tender offer is
commenced, Bristol Myers Squibb will cause Merger Sub to file a
tender offer statement on Schedule TO and RayzeBio will file a
recommendation statement on Schedule 14D-9. The offer to purchase
shares of RayzeBio common stock will only be made pursuant to the
offer to purchase, the letter of transmittal and related documents
filed as a part of the Schedule TO. RAYZEBIO’S STOCKHOLDERS AND
INVESTORS ARE URGED TO READ THE TENDER OFFER STATEMENT (INCLUDING
AN OFFER TO PURCHASE, LETTER OF TRANSMITTAL AND RELATED TENDER
OFFER DOCUMENTS) AND THE RELATED SOLICITATION/RECOMMENDATION
STATEMENT ON SCHEDULE 14D-9 TO BE FILED BY RAYZEBIO WITH THE SEC,
AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT
SHOULD BE CONSIDERED BY RAYZEBIO’S INVESTORS BEFORE ANY DECISION IS
MADE WITH RESPECT TO THE TENDER OFFER. RAYZEBIO’S STOCKHOLDERS AND
INVESTORS ARE ALSO URGED TO READ ANY OTHER DOCUMENTS FILED BY EACH
OF BRISTOL MYERS SQUIBB AND RAYZEBIO 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 these
tender offer materials and such other documents containing
important information about Bristol Myers Squibb and RayzeBio, once
such documents are filed with the SEC, through the website
maintained by the SEC at www.sec.gov, or by directing a request for
such materials to the information agent for the offer, which will
be named in the tender offer materials. Bristol Myers Squibb and
RayzeBio make available free of charge at Bristol Myers Squibb’s
website at www.bms.com/investors and RayzeBio’s website at
investors.rayzebio.com, respectively, copies of materials they file
with, or furnish to, the SEC.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains “forward-looking statements”
regarding, among other things, the proposed acquisition of RayzeBio
by Bristol Myers Squibb, the expected timetable for completing the
transaction, future opportunities for the combined businesses, the
expected benefits of Bristol Myers Squibb’s acquisition of RayzeBio
and the development and commercialization of RayzeBio’s product
candidates, including the therapeutic and commercial potential of
RYZ101 and RayzeBio’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, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them, that are difficult to predict,
may be beyond our control and could cause actual outcomes and
results to differ materially from those expressed in, or implied
by, the forward-looking statements. Actual results may differ
materially because of numerous risks and uncertainties including
with respect to (i) the timing of the tender offer and subsequent
merger, (ii) the number of shares of RayzeBio common stock that
will be tendered in the tender offer, (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 RayzeBio, (vi) the possibility that
various conditions to the consummation of the tender offer or the
acquisition may not be satisfied or waived, including that a
governmental entity may prohibit, delay or refuse to grant approval
for the consummation of the offer or the acquisition and (vii)
unanticipated difficulties or expenditures relating to the proposed
acquisition, including the response of business partners and
competitors to the announcement of the proposed acquisition or
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 press release. In addition, the compounds
described in this press release 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. No forward-looking statement can be
guaranteed. Forward-looking statements in this press release should
be evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2022, and its subsequent Quarterly
Reports on Form 10-Q, and RayzeBio’s business, particularly those
identified in the risk factors discussion in RayzeBio’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2023, as
well as other documents that may be filed by Bristol Myers Squibb
or RayzeBio from time to time with the SEC. Neither Bristol Myers
Squibb nor RayzeBio undertakes any obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise, except to the extent
required by law. The forward-looking statements made in this press
release relate only to events as of the date on which the
statements are made and readers are cautioned not to place undue
reliance on such statements.
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, Bristol Myers Squibb 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231225781528/en/
Bristol Myers Squibb
Media Inquiries: Media: media@bms.com Investors:
Investor Relations: investor.relations@bms.com
RayzeBio Contact: Arvind
Kush Email: info@rayzebio.com
RayzeBio (NASDAQ:RYZB)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
RayzeBio (NASDAQ:RYZB)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024