The partnership creates one of the largest
global IV solutions manufacturing networks with combined production
of an estimated 1.4 billion annual units and aims to bring
additional supply chain resiliency and new innovation to the North
American IV solutions market.
- Joint venture becomes part of a global manufacturing network
with scale and redundancy
- Intends to add long-term supply resiliency and accelerate IV
solutions new product development in North America
- Combines Otsuka Pharmaceutical Factory, Inc.'s expertise and
global manufacturing scale with ICU Medical's strong North American
production and distribution
- ICU Medical to provide commercial services to the joint
venture
- Expected to become operationally effective in early Q2
2025
- Full presentation available for view here
SAN
CLEMENTE, Calif. and TOKUSHIMA, Japan, Nov. 12,
2024 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ:ICUI),
a worldwide leader in the development, manufacture and sale of
innovative medical devices, and Otsuka Pharmaceutical Factory, Inc.
(OPF), global IV solutions manufacturing subsidiary of Otsuka
Holdings Co., Ltd., together announce the creation of a joint
venture to provide additional supply chain resiliency and
innovation to the North American IV solutions market.
The joint venture brings together OPF's expertise and global
manufacturing scale—spanning 16 separate IV solutions production
sites across Asia—with ICU Medical's strong North American
production and distribution in the same category. OPF's history of
innovation and consistent investment in state-of-the-art IV
solutions manufacturing technologies combined with ICU Medical's
differentiated IV pumps and consumables will create a valuable
offering for North American customers across these complementary
infusion products.
Under the terms of the agreement, ICU Medical will provide
commercial services for the joint venture to ensure seamless
operations for North American customers. Key economic terms of the
joint venture include an upfront payment of approximately
$200 million from OPF to ICU Medical
at inception, performance-based milestones at the end of 2026, and
a backend put-call option in 2030 and beyond.
Shuichi Takagi, President and
Representative Director of OPF, commented, "Entering the North
American market has always been part of our long-term ambition, and
this joint venture with ICU Medical is the perfect way to do that."
Takagi added, "It will allow us to bring our innovative PVC-free
technologies—including admixtures, parenteral nutrition in advanced
multi-chamber bags, and premix IV antibiotics—to a market with an
established customer base."
"Otsuka's scale, experience with U.S. partnerships, and
demonstrated long-term investment horizon made them the ideal
partner," said Vivek Jain, ICU
Medical's Chief Executive Officer. "Their financial strength and
dedication to portfolio expansion will provide the stability and
choice the North American market needs," added Jain. "Through this
joint venture, we're committed to delivering clinical and economic
value for ICU Medical customers and giving this critical product
category the innovation and attention it deserves."
The North American IV solutions market has faced persistent
supply chain challenges, including disruptions from Hurricane Maria
in 2017 and Hurricane Helene in 2024, underscoring the urgent need
for action and geographic supply chain redundancy. By partnering in
this joint venture, ICU Medical and OPF will work together to
pursue long-term FDA approval of overseas manufacturing sites and
in the near term, seek import authorization if necessary for the
U.S. market while focusing on accelerating new product
development.
Investor Contacts:
Brian Bonnell, ICU Medical,
Inc.
949-366-2183
Brian.Bonnell@icumed.com
John Mills, ICR, Inc.
646-277-1254
John.Mills@icrinc.com
Media Contact:
Harrison Richards, ICU Medical,
Inc.
949-366-4261
Harrison.Richards@icumed.com
About Otsuka Holdings Co.,
Ltd.: The corporate philosophy of Otsuka
is "Otsuka-people creating new products for better health
worldwide." The Otsuka group of companies, whose origins date back
to 1921, strives daily to achieve the philosophy by creating
innovative products, improving human health, and contributing to
the lives of people worldwide. Otsuka has over 34,000 employees
across 168 group companies in 32 countries and regions.
About Otsuka Pharmaceutical Factory, Inc.
(OPF): OPF is the original company from
which the Otsuka Group has grown. The management vision of OPF is
"the best partner in clinical nutrition", and as a leading company
in clinical nutrition in Japan has
been developing, manufacturing, and selling IV solutions for over
75 years. Today, in addition to IV solutions, OPF provides a
variety of products that contribute to solving issues in the
healthcare setting.
About ICU Medical: ICU Medical Inc.
(Nasdaq: ICUI) offers clinically essential medical devices that
connect patients and caregivers through life-enhancing, innovative
technology, and services that provide meaningful clinical value.
The organization's robust portfolio features medical delivery
systems and consumable products for infusion therapy, emergency
medicine, general and regional anesthesia, home care, NICU/PICU,
oncology, pain management, and respiratory care. More information
about ICU Medical Inc. can be found at www.icumed.com.
Cautionary Note on Forward-Looking Statements:
This
press release 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.
These statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995 and may often
be identified by the use of words such as "will", "may", "could",
"should", "would,", "project", "believe", "anticipate", "expect",
"plan", "estimate", "forecast", "potential", "intend", "continue",
"target", "build", "expand" or the negative thereof or comparable
terminology, and may include (without limitation) information
regarding the company's expectations, goals or intentions regarding
the future, including, but not limited to, the proposed joint
venture between the company and Otsuka Pharmaceutical Factory
America, Inc. ("Otsuka"), the expected timetable for completing the
proposed transaction, benefits and synergies of the proposed
transaction, future opportunities for the company and products and
any other statements regarding the company's and the proposed joint
venture's future operations, anticipated business levels, future
earnings, planned activities, anticipated growth, market
opportunities, strategies, competition, and other expectations and
targets for future periods.
These forward-looking statements are based on management's
current expectations, estimates, forecasts and projections about
the company and the proposed transaction and assumptions management
believes are reasonable, all of which are subject to risks and
uncertainties that could cause actual results and events to differ
materially from those stated in the forward-looking statements.
These risks and uncertainties include, but are not limited to, the
parties' ability to consummate the transaction, including Otsuka's
ability to terminate the transaction under certain conditions; the
regulatory approvals required for the transaction not being
obtained, or not being obtained on the terms expected or on the
anticipated schedule; the other conditions to the completion of the
transaction not being obtained; decreased demand for the products
of the company or the proposed joint venture; decreased free cash
flow; the inability to recapture conversion delays or part/resource
shortages on anticipated timing, or at all; changes in product mix;
increased competition from competitors; lack of continued growth or
improving efficiencies; unexpected changes in the company's
arrangements with its largest customers; the parties' ability to
meet expectations regarding the timing, completion and accounting
and tax treatments of the transaction; changes in relevant tax and
other laws; inherent uncertainties involved in the estimates and
judgments used in the preparation of financial statements, and the
providing of estimates of financial measures, in accordance with
GAAP and related standards or on an adjusted basis; the completion
of the joint venture being more difficult, time-consuming or costly
than expected; operating costs, customer loss and business
disruption (including, without limitation, difficulties in
maintaining relationships with employees, customers, clients or
suppliers) being greater than expected following the transaction;
the retention of certain key employees of the business being
difficult; the company's and the proposed joint venture business's
expected or targeted future financial and operating performance and
results; the scope, timing and outcome of any ongoing legal
proceedings and the impact of any such proceedings on the company's
and the proposed joint venture business's consolidated financial
condition, results of operations or cash flows; the company's and
the proposed joint venture business's ability to protect their
intellectual property and preserve their intellectual property
rights; the effect of any changes in customer and supplier
relationships and customer purchasing patterns; the ability to
attract and retain key personnel; changes in third-party
relationships; the impacts of competition; changes in economic and
financial conditions of the company's business or the proposed
joint venture's business; uncertainties and matters beyond the
control of management; and the possibility that the company may be
unable to achieve expected synergies and operating efficiencies in
connection with the transaction within the expected time-frames or
at all.
For more detailed information on the risks and uncertainties
associated with the company's business activities, see the risks
described in the company's Annual Report on Form 10-K for the year
ended December 31, 2023, filed with
the Securities and Exchange Commission (the "SEC") and in any
subsequent filings with the SEC. You can access the company's Form
10-K and other filings through the SEC website at www.sec.gov, and
the company strongly encourages you to do so. The company
undertakes no obligation to update any statements herein for
revisions or changes after the date of this communication.
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SOURCE ICU Medical, Inc.
