V-Wave’s Novel and Minimally Invasive
Interatrial Shunt is Designed to Treat Heart Failure and Addresses
Significant Treatment Gap
Device Further Strengthens Johnson &
Johnson MedTech’s Position in Cardiovascular
Johnson & Johnson1 (NYSE: JNJ) today announced that it has
entered into a definitive agreement to acquire V-Wave Ltd., a
privately-held company focused on developing innovative treatment
options for patients with heart failure. Under the terms of the
agreement, Johnson & Johnson will acquire V-Wave for an upfront
payment of $600 million, subject to customary adjustments, with the
potential for additional regulatory and commercial milestone
payments up to approximately $1.1 billion. V-Wave will join Johnson
& Johnson as part of Johnson & Johnson MedTech.
The planned acquisition of V-Wave will extend Johnson &
Johnson MedTech’s position as an innovation leader in addressing
cardiovascular disease. It will further accelerate its shift into
high-growth and high-opportunity markets and will deepen its
relationships with structural interventional cardiologists and
heart failure specialists.
Heart failure is a global health burden associated with impaired
quality of life, frequent hospitalizations, increasing health-care
costs, and high rates of premature death.2 V-Wave’s cardiovascular
implant technology specifically targets heart failure with reduced
ejection fraction (HFrEF). In HFrEF, a patient’s heart muscle has
insufficient ability to pump blood containing oxygen and nutrients
to the body. V-Wave’s Ventura® Interatrial Shunt (IAS) is a novel
implantable device designed to decrease elevated left atrial
pressure seen in congestive heart failure by creating a shunt
between the left and right atrium, thereby reducing cardiovascular
events and heart failure hospitalizations. More specifically, the
device:
- Is placed in the heart through a minimally invasive
catheter-based procedure and has the potential to fill a
significant treatment gap between guideline directed medical
therapies (GDMT) as a first line therapy and highly invasive
cardiac replacement therapies, including left ventricular assist
devices (LVADs) and heart transplantation.
- Received FDA Breakthrough Device Designation in 2019 and CE
mark in 2020 and has the potential to be the first device of its
kind to market.
- Addresses an unmet need for approximately 800,000 patients who
experience HFrEF in the U.S every year, representing a market
opportunity for significant sustainable growth and meaningful
impact.3
Tim Schmid, Executive Vice President and Worldwide Chairman of
Johnson & Johnson MedTech, said, “We are excited to welcome
V-Wave to Johnson & Johnson MedTech and to take another
meaningful step toward transforming the standard of care for
cardiovascular disease. We recognize the importance of identifying
more diverse and effective treatments for heart failure, and our
recent track record demonstrates our focus on accelerating our
impact on the most urgent and pressing unmet needs. We know V-Wave
well, with our relationship dating back to our original investment
in the company in 2016, and we have a deep understanding of the
technology and science, as well as the company’s commitment to
patients. We look forward to working with the V-Wave team at this
pivotal stage of its evolution to bring the Ventura® Interatrial
Shunt technology to patients.”
“At V-Wave, we are dedicated to achieving our vision to help
patients around the world – and we know Johnson & Johnson
MedTech shares this mission,” said Dr. Neal Eigler, Chief Executive
Officer of V-Wave. “We are confident that Johnson & Johnson
MedTech is well-positioned to ensure V-Wave’s breakthrough ideas
and technology reach patients in need as quickly and effectively as
possible. I couldn’t be prouder of the V-Wave team, and the
commitment it has taken to achieve this milestone. We look forward
to continuing to build a world where cardiovascular disease is
prevented, treated, and cured.”
Transaction Details, Path to Completion, and Financial
Impact
Under the terms of the agreement, Johnson & Johnson will
acquire V-Wave for an upfront payment of $600 million, subject to
customary adjustments, with the potential for additional regulatory
and commercial milestone payments up to approximately $1.1 billion.
The transaction is expected to close before the end of 2024,
subject to the receipt of applicable regulatory approvals and other
customary closing conditions.
In accordance with U.S. GAAP, the transaction will be accounted
for as an asset acquisition, resulting in a non-tax deductible
in-process research and development charge of approximately $600
million in the period the transaction closes. Johnson & Johnson
expects the transaction to dilute adjusted earnings per share (EPS)
by approximately $0.24 in 2024 and approximately $0.06 in 2025.
Johnson & Johnson will provide an update to its full-year
financial outlook when it reports third quarter 2024 results on
October 15, 2024.
Following the completion of the transaction, V-Wave will be part
of Johnson & Johnson MedTech, and financials will be reported
within Johnson & Johnson MedTech’s Cardiovascular portfolio.
Michael Bodner, Group President, Heart Recovery & Intravascular
Lithotripsy, will assume responsibility for the V-Wave team upon
close.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/.
About V-Wave
V-Wave is a privately held medical device company that was
established in 2009 and is focused on developing innovative
treatment options for people living with heart failure and
cardiovascular disease. The company was built on a foundation of
science, engineering, and medicine and has decades of experience in
these fields. The company has offices in Israel and the U.S. For
more information, please visit www.vwavemedical.com or V-Wave on
LinkedIn.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements regarding
the acquisition of V-Wave. The reader is cautioned not to rely on
these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Johnson & Johnson. Risks and
uncertainties include, but are not limited to: the potential that
the expected benefits and opportunities of the acquisition may not
be realized or may take longer to realize than expected; challenges
inherent in product research and development, including uncertainty
of clinical success and obtaining regulatory approvals; uncertainty
of commercial success for new products; manufacturing difficulties
and delays; product efficacy or safety concerns resulting in
product recalls or regulatory action; economic conditions,
including currency exchange and interest rate fluctuations; the
risks associated with global operations; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; changes to applicable laws and
regulations, including tax laws and global health care reforms;
adverse litigation or government action; changes in behavior and
spending patterns or financial distress of purchasers of health
care services and products; and trends toward health care cost
containment. In addition, there will be risks and uncertainties
related to the ability of the Johnson & Johnson family of
companies to successfully integrate the products and
employees/operations and clinical work of V-Wave, as well as the
ability to ensure continued performance or market growth of
V-Wave’s products. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the sections captioned “Cautionary
Note Regarding Forward-Looking Statements” and “Item 1A. Risk
Factors,” and in Johnson & Johnson’s subsequent Quarterly
Reports on Form 10-Q, and other filings by Johnson & Johnson
with the SEC. Copies of these filings are available online at
www.sec.gov, at www.jnj.com or on request from Johnson &
Johnson. Johnson & Johnson does not undertake to update any
forward-looking statement as a result of new information or future
events or developments, except as required by law.
Non-GAAP Financial Measures
This press release includes Adjusted EPS, which represents a
non-GAAP financial measure. The Company believes that providing
this non-GAAP financial measure enhances the Company’s and
investors’ understanding of our financial performance. Non-GAAP
financial measures should not be considered a substitute for, or
superior to, financial measures determined or calculated in
accordance with GAAP. The Company’s definitions of its non-GAAP
financial measures may not be comparable to similarly titled
measures reported by other companies. The most directly comparable
GAAP measure to Adjusted EPS is earnings per share, or EPS. The
Company is not providing a reconciliation of Adjusted EPS to EPS,
however, because Johnson & Johnson does not provide GAAP
financial measures on a forward-looking basis as the Company is
unable to predict with reasonable certainty the ultimate outcome of
adjusted items, such as legal proceedings, unusual gains and
losses, acquisition-related expenses, and purchase accounting fair
value adjustments without unreasonable effort. These items are
uncertain, depend on various factors, and could be material to
Johnson & Johnson's results computed in accordance with
GAAP.
1 Legal entity, Biosense Webster (Israel) Ltd.
2 Khan, M.S., Shahid, I., Bennis, A. et al. Global epidemiology
of heart failure. Nat Rev Cardiol (2024).
https://doi.org/10.1038/s41569-024-01046-6
3 Market size derived from internal market analysis and analyst
estimates
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version on businesswire.com: https://www.businesswire.com/news/home/20240820275047/en/
Media Ryan Carbain media-relations@its.jnj.com
Investor Tracy Menkowski investor-relations@its.jnj.com
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