Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device
company with a mission to treat and transform the lives of patients
suffering from venous and other diseases, today announced that it
has entered into a definitive agreement to acquire LimFlow, S.A., a
privately held pioneer in limb salvage for patients with chronic
limb-threatening ischemia (CLTI). Under the terms of the agreement,
Inari will pay $250 million in cash at closing and LimFlow will be
eligible to receive additional cash payments based on certain
commercial and reimbursement milestones. The transaction is
expected to close in the fourth quarter of 2023.
LimFlow is transforming the treatment of CLTI, an advanced stage
of peripheral artery disease that is associated with increased
mortality, risk of amputation and impaired quality of life. CLTI is
a large and underpenetrated market, impacting more than 1.5 million
patients each year globally, approximately 560,000 of which are in
the United States. CLTI represents one of the most significant
unmet needs in vascular medicine. The minimally-invasive LimFlow
System is designed to bypass blocked arteries in the leg and
deliver oxygenated blood back into the foot via the veins in
no-option CLTI patients, those who are facing major amputation and
have exhausted all other therapeutic options.
LimFlow recently received FDA approval for its Transcatheter
Arterialization of Deep Veins (TADV) system based upon the strength
of the results of the PROMISE II study which were published in the
New England Journal of Medicine. LimFlow has already trained and
deployed an initial team of sales representatives in targeted U.S.
markets who are executing the launch of the LimFlow therapy. Inari
anticipates continuing to expand this team as a focused, dedicated
sales force separate from Inari’s existing VTE sales
organization.
“The acquisition of LimFlow is closely aligned with our mission
to address significant unmet patient needs and adds another highly
differentiated growth platform into our portfolio,” said Drew
Hykes, CEO of Inari. “We see the CLTI market as poised for durable
growth, driven by compelling technology, outstanding clinical
results, and multiple opportunities for expansion. As a minority
investor and board observer in LimFlow since early 2022, we have
seen firsthand the life-changing impact this technology has on
patients, as well as how complementary our two businesses are.”
“I am incredibly proud of the LimFlow team and our clinical
investigators who have developed our novel solution that can
provide a better life to CLTI patients,” said LimFlow CEO Dan Rose.
“By joining with Inari and benefitting from their exceptional
resources and capabilities, we expect to be well-positioned to
increase access to our technology and advance our shared mission of
creating better outcomes for patients.”
Compelling Strategic BenefitsInari believes the
LimFlow acquisition provides several strategic benefits,
including:
- Aligns with Inari’s mission to address unmet patient
needs: As a mission-driven company, Inari is compelled by
the opportunity to deliver improved outcomes for no-option CLTI
patients. LimFlow provides an innovative offering to patients who
suffer in unimaginable ways and deserve better options and
outcomes.
- Brings clinically differentiated CLTI
solution: LimFlow received FDA approval for its LimFlow
System in September 2023, and is the first and only FDA-approved
system for no-option CLTI. In March 2023, results from LimFlow’s
PROMISE II U.S. pivotal trial were published in the New England
Journal of Medicine, demonstrating that the LimFlow System achieved
70% improvement in amputation-free survival over the current
standard-of-care. LimFlow has generated compelling clinical
evidence across multiple clinical trials, demonstrating the safety
and efficiency of the LimFlow System as a treatment option for CLTI
patients.
- Enhances avenues for growth: As its commercial
launch matures, Inari expects LimFlow to become a meaningful
contributor to revenue growth with robust gross margins at scale.
LimFlow enriches Inari’s portfolio and adds new capabilities in a
large and underpenetrated market. Of the approximately 560,000
patients suffering from CLTI in the United States each year, Inari
conservatively estimates that approximately 55,000 patients
currently have no treatment options other than amputation. Inari
believes that these patients represent a $1.5 billion annual
opportunity for LimFlow’s device in the United States alone, and
that there is significant potential for expansion by targeting
patients with less severe disease and by commercializing LimFlow’s
device internationally.
- Leverages Inari’s core competencies: Inari has
a proven track record of performance in the VTE space, including
training and education, development of a novel procedural
technique, building awareness among non-interventionalist
stakeholders, patient pathway and program development, clinical
evidence generation, and refinement of a purpose-built toolkit.
Inari plans to leverage these same capabilities to successfully
commercialize the LimFlow System in the United States.
Transaction Details
- Total upfront consideration is $250 million paid in cash upon
closing.
- Contingent consideration of up to $165 million in additional
cash payments are subject to the achievement of certain commercial
and reimbursement milestones. The earliest potential payment would
be due in 2025.
- The acquisition is subject to customary closing conditions and
is expected to be completed in the fourth quarter of 2023.
- Financing of the transaction at closing is expected to be with
cash on hand and borrowings under existing credit facilities.
Inari Third Quarter 2023 Financial ResultsIn a
separate press release issued today, Inari announced financial
results for its third quarter ended September 30, 2023. Inari’s
third quarter 2023 earnings press release can be found on Inari’s
investor relations website at ir.inarimedical.com.
AdvisorsBofA Securities is serving as financial
advisor to Inari, and Latham & Watkins LLP is serving as legal
counsel.
Webcast and Conference Call InformationInari
Medical will host a conference call to discuss its third quarter
2023 financial results and acquisition of LimFlow after market
close on Wednesday, November 1, 2023 at 1:30 p.m. Pacific Time /
4:30 p.m. Eastern Time. The conference call can be accessed live by
dialing (844) 825-9789 for domestic callers or (412) 317-5180 for
international callers. The live webinar and presentation may be
accessed by visiting the Events Section of the Inari investor
relations website at ir.inarimedical.com.
About Inari Medical, Inc.Patients first. No
small plans. Take care of each other. These are the guiding
principles that form the ethos of Inari Medical. We are committed
to improving lives in extraordinary ways by creating innovative
solutions for both unmet and underrecognized health needs. In
addition to our purpose-built products, we leverage our
capabilities in education, clinical research, and program
development to improve patient outcomes. We are passionate about
our mission to establish our treatments as the standard of care for
venous thromboembolism and beyond. We are just getting started.
About LimFlow and the LimFlow SystemLimFlow SA
is a private, venture-backed medical device company, transforming
the treatment of CLTI, a severe condition, for which there is a
growing clinical need in light of high mortality rates. The
minimally-invasive LimFlow System is designed to bypass blocked
arteries in the leg and deliver oxygenated blood back into the foot
via the veins in CLTI patients who are facing major amputation and
have exhausted all other therapeutic options.
The LimFlow System received the CE Mark in October 2016 and FDA
PMA approval in September 2023. For more information, please visit:
https://limflow.com/.
Forward Looking StatementsStatements in this
press release may contain “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to substantial risks and uncertainties.
Forward-looking statements contained in this press release may be
identified by the use of words such as “may,” “will,” “should,”
“expect,” “plan,” “anticipate,” “could,” “intend,” “target,”
“project,” “contemplate,” “believe,” “estimate,” “predict,”
“potential” or “continue” or the negative of these terms or other
similar expressions. Forward-looking statements include, among
others, anticipated closing of the LimFlow acquisition, potential
strategic benefits of the LimFlow acquisition, and potential
operating performance of LimFlow, and are based on Inari’s current
expectations, forecasts, and assumptions, are subject to inherent
uncertainties, risks and assumptions that are difficult to predict,
and actual outcomes and results could differ materially due to a
number of factors, including: if we fail to complete the LimFlow
Acquisition; if we fail to successfully integrate the business and
operations or effect the commercial launch of LimFlow's product in
the expected timeframe or at all; if we continue to incur,
substantial expenses related to the LimFlow Acquisition and the
related integration of the LimFlow Acquisition, if consummated; if
we underestimated certain liabilities of LimFlow or failed to
discover certain liabilities in the course of performing our due
diligence investigation of LimFlow; if, as a private company,
LimFlow may not have in place an adequate system of internal
control over financial reporting that we will need to manage that
business effectively as part of a public company; and if we
write-off certain intangible assets, such as goodwill. These and
other risks and uncertainties include those described more fully in
the section titled “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operation” and
elsewhere in its Annual Report on Form 10-K for the period ended
December 31, 2022, and in its other reports filed with the U.S.
Securities and Exchange Commission. Forward-looking statements
contained in this announcement are based on information available
to Inari as of the date hereof and are made only as of the date of
this release. Inari undertakes no obligation to update such
information except as required under applicable law. These
forward-looking statements should not be relied upon as
representing Inari’s views as of any date subsequent to the date of
this press release. In light of the foregoing, investors are urged
not to rely on any forward-looking statement in reaching any
conclusion or making any investment decision about any securities
of Inari.
Investor Contact:John Hsu, CFAVP, Investor
Relations949-658-3889IR@inarimedical.com
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