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Kamada Announces Expansion of Plasma Collection Operations in Texas with the Opening of New Site in Houston

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Kamada (NASDAQ: KMDA; TASE: KMDA.TA) has expanded its plasma collection operations by opening a new center in Houston, TX. The 12,000 square foot facility, operated by Kamada Plasma, is designed to support over 50 donor beds with an estimated annual collection capacity of 50,000 liters. It will collect both normal source plasma and specialty plasma, such as Anti-Rabies and Anti-D, and is expected to be one of the largest specialty plasma collection sites in the U.S.

The company plans to submit regulatory applications to the FDA and EMA in the first half of 2025 for approval of the Houston site. Kamada is also constructing a third plasma collection center in San Antonio, TX, set to open in the first half of 2025. Each center is projected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at full capacity.

Kamada (NASDAQ: KMDA; TASE: KMDA.TA) ha espanso le sue operazioni di raccolta di plasma aprendo un nuovo centro a Houston, TX. La struttura di 1.100 metri quadrati, gestita da Kamada Plasma, è progettata per supportare oltre 50 letti per donatori con una capacità di raccolta annuale stimata di 50.000 litri. Raccoglierà sia plasma normale che plasma specialistico, come Anti-Rabbia e Anti-D, e si prevede che sarà uno dei più grandi centri di raccolta di plasma specialistico negli Stati Uniti.

L'azienda prevede di presentare domande di autorizzazione alla FDA e all'EMA nella prima metà del 2025 per ottenere l'approvazione del sito di Houston. Kamada sta anche costruendo un terzo centro di raccolta di plasma a San Antonio, TX, che dovrebbe aprire nella prima metà del 2025. Ogni centro è destinato a contribuire entrate annuali di 8 milioni a 10 milioni di dollari dalle vendite di plasma normale a piena capacità.

Kamada (NASDAQ: KMDA; TASE: KMDA.TA) ha expandido sus operaciones de recolección de plasma al abrir un nuevo centro en Houston, TX. La instalación de 1,100 metros cuadrados, operada por Kamada Plasma, está diseñada para soportar más de 50 camas para donantes con una capacidad de recolección anual estimada de 50,000 litros. Recolectará tanto plasma de origen normal como plasma especializado, como Anti-Rábico y Anti-D, y se espera que sea uno de los sitios de recolección de plasma especializado más grandes en EE.UU.

La compañía planea presentar solicitudes regulatorias a la FDA y EMA en la primera mitad de 2025 para la aprobación del sitio de Houston. Kamada también está construyendo un tercer centro de recolección de plasma en San Antonio, TX, que se espera que abra en la primera mitad de 2025. Cada centro está proyectado para contribuir ingresos anuales de 8 millones a 10 millones de dólares en ventas de plasma de origen normal a plena capacidad.

카마다(NASDAQ: KMDA; TASE: KMDA.TA)는 휴스턴, TX에 혈장 수집 작업을 확장했습니다. 1,100 평방 미터 규모의 시설인 카마다 플라즈마가 운영하며, 50개 이상의 기증자 침대를 지원할 수 있도록 설계되었으며, 연간 50,000리터의 수집 용량이 예상됩니다. 일반 혈장과 안티-광견병 및 안티-D와 같은 전문 혈장을 수집할 예정이며, 미국에서 가장 큰 전문 혈장 수집 장소 중 하나가 될 것으로 예상됩니다.

회사는 휴스턴 사이트에 대한 FDA 및 EMA의 승인 신청서를 2025년 상반기에 제출할 계획입니다. 카마다는 또한 2025년 상반기에 개장할 샌안토니오, TX에 세 번째 혈장 수집 센터를 건설하고 있습니다. 각 센터는 최대 용량으로 정상 혈장 판매로 연간 800만 달러에서 1,000만 달러의 수익을 기여할 것으로 예상됩니다.

Kamada (NASDAQ: KMDA; TASE: KMDA.TA) a élargi ses opérations de collecte de plasma en ouvrant un nouveau centre à Houston, TX. L'établissement de 1.100 mètres carrés, opéré par Kamada Plasma, est conçu pour soutenir plus de 50 lits pour donneurs avec une capacité de collecte annuelle estimée à 50 000 litres. Il collectera à la fois du plasma normal et du plasma spécialisé, comme l'Anti-Rage et l'Anti-D, et devrait être l'un des plus grands sites de collecte de plasma spécialisé aux États-Unis.

L'entreprise prévoit de soumettre des demandes réglementaires à la FDA et à l'EMA dans la première moitié de 2025 pour l'approbation du site de Houston. Kamada construit également un troisième centre de collecte de plasma à San Antonio, TX, qui devrait ouvrir dans la première moitié de 2025. Chaque centre devrait contribuer des revenus annuels de 8 millions à 10 millions de dollars grâce aux ventes de plasma normal à pleine capacité.

Kamada (NASDAQ: KMDA; TASE: KMDA.TA) hat seine Plasma-Sammeloperationen erweitert, indem es ein neues Zentrum in Houston, TX eröffnet hat. Die 1.100 Quadratmeter große Einrichtung, betrieben von Kamada Plasma, wurde so konzipiert, dass sie über 50 Spenderbetten unterstützt, mit einer geschätzten jährlichen Sammlungskapazität von 50.000 Litern. Es wird sowohl normales Spenderplasma als auch Spezialplasma, wie Anti-Tollwut und Anti-D, gesammelt und soll eine der größten Spezialplasma-Sammelstellen in den USA werden.

Das Unternehmen plant, in der ersten Hälfte von 2025 regulatorische Anträge bei der FDA und EMA zur Genehmigung des Standortes Houston einzureichen. Kamada baut auch ein drittes Plasma-Sammelzentrum in San Antonio, TX, das in der ersten Hälfte von 2025 eröffnet werden soll. Jedes Zentrum soll jährliche Einnahmen von 8 Millionen bis 10 Millionen Dollar aus dem Vertrieb normalen Spenderplasmas bei voller Auslastung beitragen.

Positive
  • New plasma collection center in Houston with 50,000 liters annual capacity
  • Expected annual revenue contribution of $8-$10 million per center at full capacity
  • Expansion of specialty plasma collection capabilities
  • Third plasma collection center planned in San Antonio for 2025
  • Vertical integration strategy advancement
Negative
  • Regulatory approvals for the new center pending FDA and EMA review
  • 9-12 month estimated timeline for regulatory approvals
  • New Plasma Collection Center in Houston Now Open, with Planned Annual Collection Capacity of Approximately 50,000 Liters and an Estimated Annual Revenue Contribution of $8 Million to $10 Million at its Full Capacity
  • Center Will Collect Normal Source Plasma and Specialty Plasma, such as Anti-Rabies and Anti-D, and is Anticipated to be One of the Largest Sites for Specialty Plasma Collection in the U.S.
  • The New Center Supports Kamada's Strategy and Development as a Leading Global Vertically-Integrated Specialty Plasma-Derived Company
  • Kamada Expects to Open its Third Plasma Collection Center in San Antonio, TX, During the First Half of 2025

REHOVOT, Israel and HOBOKEN, N.J., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced the expansion of its plasma collection operations with the opening of a new plasma collection center in Houston, TX. The new 12,000 square foot center is operated by Kamada's wholly owned subsidiary, Kamada Plasma, and is planned to support over 50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually.

"We are extremely pleased to announce the opening of our new state-of-the-art plasma collection center in Houston," said Amir London, Chief Executive Officer of Kamada. "The opening of this center is an important milestone in Kamada's development and vertical integration, expanding the collection capacity of specialty plasma for our internal use beyond our existing site in Beaumont, TX. The new center in Houston is expected to be one of the largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties. We are especially grateful for the skilled and experienced team of plasma collection experts we have hired to lead the development and operations of our new center."

Kamada intends to submit to the FDA a prior approval supplement to Kamada Plasma's existing Biologics License Application (BLA) for the approval of the Houston site, as well as a plasma master file (PMF) to the European Medicines Agency (EMA), during the first half of 2025. The FDA and EMA’s regulatory process for obtaining approval for plasma collection centers includes onsite inspection. During the review process, the company is authorized to collect plasma donations at the center. Kamada currently anticipates approval decisions within 9-12 months of submissions.

In addition to the new Houston center, the company has begun construction of its third plasma collection site in San Antonio, TX, which is expected to open during the first half of 2025. Each collection center is expected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its full capacity.

About Kamada
Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, the Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D), KARAB and KEDRAB and recently opened a new plasma collection center in Houston, Texas in which it plans to collect normal source plasma and specialty plasma, such as Anti-Rabies and Anti-D. In addition to the Company’s commercial operation, it invests in research and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.

Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) an estimated total annual collection capacity of approximately 50,000 liters and an estimated annual revenue contribution of $8 to $10 million of the new plasma collection center in Houston from sales of normal source plasma at its full capacity; 2) the center will collect normal source plasma to be sold to third parties and specialty plasma such as Anti-Rabies and Anti-D, and is expected to be one of the largest sites for specialty plasma collection in the U.S; 3) Kamada expects to open its third plasma collection center in San Antonio during the first half of 2025; 4) the new center is planned to support over 50 donor beds; 5) the company plans to submit with the FDA a prior approval supplement to Kamada Plasma's Biologics License Application (BLA) for the approval of the Houston site and submit with the European Medicines Agency (EMA) a plasma master file (PMF) for its approval, during the first half of 2025 and currently anticipates such approvals decision within 9-12 months of submission; and 6) each collection center is expected to contribute annual revenues of $8 to $10 million from sales of normal source plasma at its full capacity. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, continuation of inbound and outbound international delivery routes, continued demand for Kamada’s products, financial conditions of the Company’s customer, suppliers and services providers, Kamada’s ability to integrate the new product portfolio into its current product portfolio, Kamada’s ability to grow the revenues of its new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies, Kamada’s ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, including the BLA and PMF approvals related to the plasma collection centers, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, and other risks detailed in Kamada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com


FAQ

What is the annual collection capacity of Kamada's new Houston plasma center?

The new plasma collection center in Houston has an estimated annual collection capacity of approximately 50,000 liters.

How much revenue is each Kamada plasma collection center expected to generate?

Each plasma collection center is expected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its full capacity.

When does Kamada (KMDA) plan to open its third plasma collection center?

Kamada expects to open its third plasma collection center in San Antonio, TX, during the first half of 2025.

What types of plasma will Kamada's new Houston center collect?

The new center in Houston will collect normal source plasma and specialty plasma, such as Anti-Rabies and Anti-D.

When will Kamada (KMDA) submit regulatory applications for the Houston plasma center?

Kamada intends to submit regulatory applications to the FDA and EMA for the approval of the Houston site during the first half of 2025.

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