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ICU Medical, Inc. and Otsuka Pharmaceutical Factory, Inc., a Subsidiary of Otsuka Holdings Co. Ltd., Announce Creation of a Joint Venture to Bolster IV Solutions Manufacturing and Innovation in North America

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ICU Medical and Otsuka Pharmaceutical Factory have announced a joint venture aimed at strengthening IV solutions manufacturing and innovation in North America. This partnership will create one of the largest global IV solutions manufacturing networks, producing an estimated 1.4 billion units annually. The joint venture will combine OPF's global manufacturing scale with ICU Medical's strong North American production and distribution capabilities, enhancing supply chain resiliency and accelerating new product development. ICU Medical will provide commercial services to ensure seamless operations. The venture is expected to become operational in early Q2 2025. Key economic terms include a $200 million upfront payment from OPF to ICU Medical, performance-based milestones by the end of 2026, and a put-call option in 2030 and beyond. This collaboration aims to address persistent supply chain challenges in the North American IV solutions market and deliver clinical and economic value to customers.

ICU Medical e Otsuka Pharmaceutical Factory hanno annunciato una joint venture mirata a rafforzare la produzione di soluzioni IV e l'innovazione in Nord America. Questa partnership creerà una delle più grandi reti di produzione di soluzioni IV a livello globale, producendo un volume stimato di 1,4 miliardi di unità all'anno. La joint venture unirà la scala di produzione globale di OPF con le forti capacità produttive e di distribuzione di ICU Medical in Nord America, migliorando la resilienza della catena di approvvigionamento e accelerando lo sviluppo di nuovi prodotti. ICU Medical fornirà servizi commerciali per garantire operazioni senza interruzioni. Si prevede che la joint venture diventi operativa all'inizio del secondo trimestre del 2025. I principali termini economici includono un pagamento iniziale di 200 milioni di dollari da OPF a ICU Medical, milestone basate sulle prestazioni entro la fine del 2026 e un'opzione put-call nel 2030 e oltre. Questa collaborazione mira ad affrontare le persistenti sfide della catena di approvvigionamento nel mercato nordamericano delle soluzioni IV e a fornire valore clinico ed economico ai clienti.

ICU Medical y Otsuka Pharmaceutical Factory han anunciado una empresa conjunta destinada a fortalecer la fabricación de soluciones IV y la innovación en América del Norte. Esta asociación creará una de las redes de fabricación de soluciones IV más grandes del mundo, produciendo un estimado de 1.4 mil millones de unidades anualmente. La empresa conjunta combinará la escala de fabricación global de OPF con las sólidas capacidades de producción y distribución de ICU Medical en América del Norte, mejorando la resiliencia de la cadena de suministro y acelerando el desarrollo de nuevos productos. ICU Medical proporcionará servicios comerciales para asegurar operaciones sin inconvenientes. Se espera que la empresa conjunta comience a operar a principios del segundo trimestre de 2025. Los principales términos económicos incluyen un pago inicial de 200 millones de dólares de OPF a ICU Medical, hitos basados en el rendimiento para finales de 2026 y una opción de put-call en 2030 y más allá. Esta colaboración tiene como objetivo abordar los desafíos persistentes de la cadena de suministro en el mercado de soluciones IV de América del Norte y ofrecer valor clínico y económico a los clientes.

ICU MedicalOtsuka Pharmaceutical Factory가 북미에서 IV 솔루션 제조와 혁신을 강화하기 위한 합작 회사를 발표했습니다. 이 파트너십은 연간 약 14억 개의 단위를 생산하는 세계 최대의 IV 솔루션 제조 네트워크 중 하나를 형성할 것입니다. 합작 투자기관은 OPF의 글로벌 제조 규모와 ICU Medical의 북미 생산 및 유통 능력을 결합하여 공급망 회복력을 강화하고 신제품 개발을 가속화할 것입니다. ICU Medical은 원활한 운영을 보장하기 위해 상업적 서비스를 제공할 것입니다. 이 합작 회사는 2025년 2분기 초에 가동될 것으로 예상됩니다. 주요 경제 조건으로는 OPF가 ICU Medical에 2억 달러의 선불금을 지급하고, 2026년 말까지 성과 기반 이정표를 설정하며, 2030년 이후에 풋-콜 옵션을 포함합니다. 이 협력은 북미 IV 솔루션 시장의 지속적인 공급망 문제를 해결하고 고객에게 임상적 및 경제적 가치를 제공하는 것을 목표로 합니다.

ICU Medical et Otsuka Pharmaceutical Factory ont annoncé un partenariat visant à renforcer la fabrication de solutions IV et l'innovation en Amérique du Nord. Ce partenariat créera l'un des plus grands réseaux mondiaux de fabrication de solutions IV, produisant environ 1,4 milliard d'unités par an. La coentreprise combinera l'échelle de fabrication mondiale d'OPF avec les solides capacités de production et de distribution d'ICU Medical en Amérique du Nord, améliorant ainsi la résilience de la chaîne d'approvisionnement et accélérant le développement de nouveaux produits. ICU Medical fournira des services commerciaux pour garantir des opérations fluides. La coentreprise devrait devenir opérationnelle au début du deuxième trimestre 2025. Les principaux termes économiques incluent un paiement initial de 200 millions de dollars de la part d'OPF à ICU Medical, des étapes basées sur la performance d'ici la fin de 2026, et une option de put-call en 2030 et au-delà. Cette collaboration vise à résoudre les défis persistants de la chaîne d'approvisionnement sur le marché des solutions IV en Amérique du Nord et à offrir une valeur clinique et économique aux clients.

ICU Medical und Otsuka Pharmaceutical Factory haben eine gemeinsame Unternehmung angekündigt, die darauf abzielte, die Herstellung von IV-Lösungen und Innovationen in Nordamerika zu stärken. Diese Partnerschaft wird ein Netzwerk für die größte globale Herstellung von IV-Lösungen schaffen, das jährlich voraussichtlich 1,4 Milliarden Einheiten produziert. Das Joint Venture wird die globale Fertigungskapazität von OPF mit den starken Produktions- und Vertriebskapazitäten von ICU Medical in Nordamerika verbinden, um die Resilienz der Lieferkette zu verbessern und die Entwicklung neuer Produkte zu beschleunigen. ICU Medical wird kommerzielle Dienstleistungen bereitstellen, um einen reibungslosen Betriebsablauf zu gewährleisten. Das Unternehmen wird voraussichtlich Anfang des zweiten Quartals 2025 betriebsbereit sein. Zu den wichtigsten wirtschaftlichen Bedingungen gehören eine Vorauszahlung von 200 Millionen Dollar von OPF an ICU Medical, leistungsbezogene Meilensteine bis Ende 2026 und eine Put-Call-Option im Jahr 2030 und darüber hinaus. Diese Zusammenarbeit zielt darauf ab, die anhaltenden Herausforderungen der Lieferkette im nordamerikanischen IV-Lösungsmarkt anzugehen und klinischen sowie wirtschaftlichen Nutzen für die Kunden zu bieten.

Positive
  • Creation of one of the largest global IV solutions manufacturing networks with an estimated 1.4 billion annual units.
  • Enhanced supply chain resiliency and accelerated new product development in North America.
  • ICU Medical to receive a $200 million upfront payment from OPF.
  • Performance-based milestones set for 2026, providing potential future financial benefits.
  • Put-call option in 2030, offering long-term strategic flexibility.
Negative
  • None.

Insights

This strategic joint venture represents a significant development for ICU Medical with substantial financial and operational implications. The $200 million upfront payment strengthens ICU Medical's balance sheet, while performance-based milestones and a put-call option in 2030 provide additional value potential. The combined production capacity of 1.4 billion annual units creates economies of scale that should improve margins.

The deal addresses critical supply chain vulnerabilities in the North American IV solutions market, particularly following recent hurricane disruptions. Otsuka's 16 production sites across Asia provide valuable geographic diversification and redundancy. The partnership also opens doors to innovative products like PVC-free technologies and advanced multi-chamber bags, potentially creating new revenue streams.

The formation of this joint venture represents a significant transformation in North American IV solutions manufacturing resilience. By integrating Otsuka's 16 Asian production facilities with ICU Medical's existing infrastructure, the partnership creates multiple supply nodes that can maintain continuous production even if individual facilities face disruptions. This addresses the vulnerabilities exposed by Hurricanes Maria and Helene.

The planned FDA approval of overseas manufacturing sites will create a more robust supply network, reducing dependency on regional facilities. This geographic diversification, combined with the massive 1.4 billion unit annual production capacity, should significantly enhance supply stability and market responsiveness.

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.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/icu-medical-inc-and-otsuka-pharmaceutical-factory-inc-a-subsidiary-of-otsuka-holdings-co-ltd-announce-creation-of-a-joint-venture-to-bolster-iv-solutions-manufacturing-and-innovation-in-north-america-302303077.html

SOURCE ICU Medical, Inc.

FAQ

What is the joint venture between ICU Medical (ICUI) and Otsuka Pharmaceutical Factory?

The joint venture aims to bolster IV solutions manufacturing and innovation in North America, creating one of the largest global IV solutions manufacturing networks.

When will the ICU Medical (ICUI) and Otsuka Pharmaceutical Factory joint venture become operational?

The joint venture is expected to become operational in early Q2 2025.

What are the financial terms of the ICU Medical (ICUI) and Otsuka Pharmaceutical Factory joint venture?

The terms include a $200 million upfront payment from OPF to ICU Medical, performance-based milestones by the end of 2026, and a put-call option in 2030 and beyond.

How will the ICU Medical (ICUI) and Otsuka Pharmaceutical Factory joint venture impact the North American IV solutions market?

The joint venture aims to enhance supply chain resiliency and accelerate new product development, addressing persistent supply chain challenges in the North American IV solutions market.

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