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

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

Kamada宣布在得克萨斯州扩大血浆收集业务,在休斯顿开设新站点。
Kamada ·  09/23 00:00
  • 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
  • 休斯敦的新血浆收集中心现已开放,计划年收集能力约为5万升,满负荷预计年收入为800万至1000万美元
  • 该中心将收集普通来源血浆和特种血浆,例如抗狂犬病和抗D,预计将成为美国最大的特种血浆收集场所之一
  • 新中心支持镰田作为全球领先的垂直整合特种等离子体衍生公司的战略和发展
  • Kamada预计将于2025年上半年在德克萨斯州圣安东尼奥开设第三个血浆收集中心

REHOVOT, Israel, and HOBOKEN, NJ – September 23, 2024 – 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.

以色列雷霍沃特和新泽西州霍博肯——2024年9月23日——Kamada有限公司(纳斯达克股票代码:KMDA;TASE:KMDA.TA)是一家全球生物制药公司,其上市产品组合适用于罕见和严重情况,也是特种等离子体衍生领域的领导者。该公司今天宣布扩大其血浆收集业务,在德克萨斯州休斯敦开设新的血浆收集中心。这座占地12,000平方英尺的新中心由Kamada的全资子公司Kamada Plasma运营,计划为50多张捐赠床位提供支持,估计每年的总收集容量约为50,000升。

"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首席执行官阿米尔·伦敦说:“我们非常高兴地宣布,我们在休斯敦开设了最先进的新血浆采集中心。”“该中心的开业是镰田发展和垂直整合的重要里程碑,它将特种等离子体的收集能力扩展到了德克萨斯州博蒙特现有场地之外,供我们内部使用。休斯敦的新中心预计将成为美国最大的特种血浆收集场所之一,还将收集普通来源的血浆出售给第三方。我们特别感谢我们聘请了技术精湛且经验丰富的血浆采集专家团队来领导我们新中心的开发和运营。”

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.

镰田打算在2025年上半年向美国食品药品管理局提交Kamada Plasma现有的生物制剂许可申请(BLA)的事先批准补充文件,以批准休斯敦基地,以及向欧洲药品管理局(EMA)提交血浆主文件(PMF)。FDA和EMA获得血浆采集中心批准的监管程序包括现场检查。在审查过程中,该公司有权在该中心收集捐赠的血浆。Kamada目前预计将在提交后的9-12个月内做出批准决定。
除了新的休斯敦中心外,该公司还开始在德克萨斯州圣安东尼奥市建造其第三个血浆收集基地,预计将于2025年上半年开放。预计每个收集中心将为正常源血浆的满负荷销售贡献800万至1000万美元的年收入。

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.

关于镰田
Kamada Ltd.(以下简称 “公司”)是一家全球生物制药公司,其上市产品组合适用于罕见和严重的疾病,是特种血浆衍生领域的领导者,专注于治疗替代方案有限的疾病。该公司还在推进一项针对重大未满足医疗需求领域的创新开发管道。该公司的战略侧重于利用其重要的商用催化剂及其在等离子体衍生和生物制药领域的制造和开发专业知识来推动盈利增长。该公司的商业产品组合包括六种经美国食品药品管理局批准的血浆衍生生物制药产品:CytoGam、Kedrab、WINRHO SDF、VARIZIG、HepaGam b和GLASSIA,以及Kamrab、KAMRHO(D)和两种马类抗蛇毒(ASV)产品。该公司直接分销其商业产品组合,并通过战略合作伙伴或第三方分销商分销其商业产品组合,包括美国、加拿大、以色列、俄罗斯、阿根廷、巴西、印度、澳大利亚以及拉丁美洲、欧洲、中东和亚洲的其他国家。该公司利用其在以色列市场的专业知识和影响力,分销国际制造商提供的超过25种药品,供以色列使用。近年来,该公司在其以色列分销产品组合中增加了11种生物仿制药,这些产品有待欧洲药品管理局(EMA)和以色列卫生部的批准,预计将在2028年之前在以色列推出。该公司在得克萨斯州博蒙特拥有一家获得美国食品药品管理局许可的血浆采集中心,该中心目前专门收集用于制造KAMRHO(D)、Karab和KedRAB的超免疫血浆,最近在德克萨斯州休斯敦开设了一个新的血浆收集中心,计划在那里收集正常来源的血浆和特种血浆,例如抗狂犬病和抗D。除了公司的商业运营外,它还投资于新候选产品的研发。该公司领先的研究产品是用于治疗Aat缺乏症的吸入式Aat,该公司正在继续推进InnovaAte临床试验,这是一项随机、双盲、安慰剂对照的关键性3期试验。以色列领先的私募股权公司FIMI Opportunity Funds是该公司的控股股东,受益拥有约38%的已发行普通股。

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.

关于前瞻性陈述的警示说明
本新闻稿包括经修订的1934年《美国证券交易法》第21E条和1995年《美国私人证券诉讼改革法》的安全港条款所指的前瞻性陈述。前瞻性陈述是非历史事实的陈述,包括以下方面的陈述:1) 休斯敦新血浆采集中心的年总收集能力估计约为5万升,预计年收入为800万至1000万美元;2) 该中心将收集正常来源的血浆和抗狂犬病和Anti-D等特种血浆,预计将成为最大的基地之一特种血浆采集美国;3) Kamada预计将于2025年上半年在圣安东尼奥开设第三个血浆采集中心;4) 新中心计划为50多张捐赠床位提供支持;5) 该公司计划向美国食品药品管理局提交Kamada Plasma生物制剂许可证申请(BLA)的事先批准补充文件,以供休斯敦工厂批准,并向欧洲药品管理局(EMA)提交血浆主文件(PMF)以供其批准,在2025年上半年,目前预计将在提交后的9-12个月内做出此类批准决定;6)每次收集该中心预计将从正常来源等离子体的满负荷销售中贡献800万至1000万美元的年收入。前瞻性陈述基于Kamada当前的知识及其目前对未来可能事件的信念和预期,并受风险、不确定性和假设的影响。由于多种因素,实际结果和事件发生时间可能与这些前瞻性陈述中的预期存在重大差异,包括但不限于中东冲突不断变化的性质以及此类冲突对以色列、中东和世界其他地区的影响,这些冲突对市场状况以及以色列、美国和全球总体经济、工业和政治状况的影响,入境和出境国际交付路线的延续,持续的需求为了镰田的产品、公司客户、供应商和服务提供商的财务状况、Kamada将新产品组合整合到其当前产品组合中的能力、Kamada增加其新产品组合收入以及利用和扩大其国际分销网络的能力、从收购血浆收集中心中受益的能力,包括开设更多美国血浆中心以及收购美国食品药品管理局批准的血浆衍生超免疫商用产品的能力继续关键的3期InnovaATE临床试验的注册、临床研究的意外结果、Kamada管理运营支出的能力、Kamada竞争市场的额外竞争、监管延误,包括与血浆采集中心相关的BLA和PMF批准、当前市场状况以及美国、以色列或其他地区总体经济、行业或政治状况的影响,以及Kamada向美国证券公司提交的文件中详述的其他风险和交易委员会(“SEC”),包括中讨论的内容其最新的20-F表年度报告以及任何后续的6-k表报告中,每份报告均已存档或已向美国证券交易委员会提供,可在美国证券交易委员会网站www.sec.gov上查阅。除非法律另有要求,否则本文中的前瞻性陈述仅代表截至本公告发布之日,Kamada没有义务公开更新此类前瞻性陈述以反映随后的事件或情况。

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

联系人:
Chaime Orlev
首席财务官
R@kamada.com

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

布莱恩·里奇
LifeSci 顾问有限公司
212-915-2578
britchie@LifeSciAdvisors.com

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