Kamada
TASE:KMDA
₪
25,92
₪
+
₪0,33 (1,29%)
25,92
₪
+₪0,33 (1,29%)
End-of-day quote: 04/10/2026
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Kamada Company Info
EPS Growth 5Y
0,00%
Market Cap
₪1,50 B
Long-Term Debt
₪0,00 B
Quarterly earnings
05/14/2026 (E)
Dividend
₪0,78
Dividend Yield
2,99%
Founded
1990
Industry
Country
Website
ISIN Number
Website
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
There are currently no price targets available for this stock.
In the last five quarters, Kamada’s Price Target has risen from ₪30,00 to ₪30,00 - a 0,00% increase.
Top growth stocks in the health care sector (5Y.)
What does Kamada do?
Kamada Ltd. (Kamada) 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 therapies field.
The company’s strategy is focused on driving profitable growth through four primary growth pillars:
First, organic growth from the company's commercial activities, including continued investment in the commercialization and life cycle management of its Proprietary Products, which include six FDA-...
Kamada Ltd. (Kamada) 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 therapies field.
The company’s strategy is focused on driving profitable growth through four primary growth pillars:
First, organic growth from the company's commercial activities, including continued investment in the commercialization and life cycle management of its Proprietary Products, which include six FDA-approved specialty plasma-derived products: KEDRAB, CYTOGAM, GLASSIA, WINRHO SDF, VARIZIG, and HEPAGAM B, as well as KAMRAB, KAMRHO (D), and two types of equine-based anti-snake venom (ASV) products, and the products in the company's distribution segment portfolio, mainly through the launch of several biosimilar products in Israel.
Second, the company aims to secure significant new business development, in-licensing, collaboration, and/or merger and acquisition (M&A) opportunities in 2025, which it anticipates will enhance its marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth.
Third, the company is expanding its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. It has two operating plasma collection centers in the United States, in Beaumont, Texas, and Houston, Texas; and plans to open its third center in San Antonio, Texas, by the end of the first quarter of 2025.
Lastly, the company is leveraging its manufacturing, research, and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with its lead product candidate Inhaled AAT, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial.
Business
Commercial Activities
The company's commercial activities operate in two segments: the Proprietary Products segment and the Distribution segment.
Proprietary Products Segment
The Proprietary Products segment includes the company's six FDA-approved plasma-derived biopharmaceutical products: KEDRAB, CYTOGAM, GLASSIA, WINRHO SDF, HEPAGAM B, and VARIZIG, as well as KAMRAB, KAMRHO (D), and two types of equine-based ASV products. The company distributes these products directly and through strategic partners or third-party distributors in over 30 countries. It manufactures its proprietary products at its cGMP production facility in Beit Kama, Israel, which is registered with the FDA, using its proprietary platform technology and know-how for the extraction and purification of proteins and immunoglobulins (IgGs) from human plasma, as well as at third-party contract manufacturing facilities. In addition, the company's Proprietary Products segment includes its plasma collection operations, where it collects Anti-Rabies and Anti-D hyper-immune plasma for the manufacture of some of its products (WINRHO SDF, KAMRHO (D), KAMRAB, and KEDRAB), as well as normal source plasma for sale to third parties.
KEDRAB: The company markets KEDRAB, a human rabies immune globulin (HRIG), in the United States through a strategic distribution and supply agreement with Kedrion. In December 2023, it entered into a binding memorandum of understanding with Kedrion for the amendment and extension of the distribution agreement between the parties, which represents the largest commercial agreement secured by the company as of December 31, 2024. Subsequently, in January 2025, it entered into the fifth amendment to the supply and distribution agreement, which memorializes the agreements and undertakings set forth in the binding memorandum of understanding, along with additional terms and conditions. The distribution and supply agreement includes the potential expansion of KEDRAB distribution by Kedrion to other territories beyond the United States.
CYTOGAM: The company sells CYTOGAM, CMV-IGIV, indicated for prophylaxis of CMV disease associated with solid organ transplantation in the United States and Canada. CYTOGAM, manufactured at its Israeli facility, has been available for commercial sale in the United States and Canada since the fourth quarter of 2023, following FDA and Health Canada approval of the CYTOGAM technology transfer process in May 2023 and July 2023, respectively.
WINRHO SDF, HEPAGAM B, and VARIZIG: The company sells WINRHO SDF, HEPAGAM B, and VARIZIG in the United States, Canada, and several other international markets, mainly in South America and the MENA region. VARIZIG was supplied under an agreement with an international organization from the fourth quarter of 2022 through the first half of 2023, with no sales of the product to this international organization during 2024. In December 2024, the company was awarded a tender from this international organization to supply VARIZIG for distribution across Latin America for the years 2025-2027, and it forecasts increased sales during 2025.
GLASSIA: The company is entitled to royalty income on sales by Takeda of GLASSIA in the United States, and commencing in 2024, in Canada. Additionally, it will be entitled to royalty income on sales of GLASSIA by Takeda in Australia and New Zealand, to the extent that GLASSIA is approved, and sales are generated in these markets by Takeda in the future. The royalty income is at a rate of 12% on net consolidated sales (in all applicable territories) through August 2025, and at a rate of 6% thereafter, until 2040.
The company also markets GLASSIA in other countries, mainly Argentina, Russia, Israel, and more recently in Switzerland (in some of these markets under a different brand name), through local distributors.
Other Proprietary Products: The company's total revenues from the sales of its other Proprietary Products, including KAMRAB (a HRIG sold by it outside the U.S. market) and KAMRHO (D) IM (for prophylaxis of hemolytic disease of newborns), as well as its ASVs sold to the IMOH,
Plasma Collection: While the company remains dependent on third-party supplies of hyper-immune plasma for the manufacturing of its Proprietary Products. In 2024, the company significantly expanded its hyper-immune plasma collection operations with the opening of its new plasma collection center in Houston, Texas, which is expected to become one of the largest hyper-immune plasma collection sites in the United States and will also collect normal source plasma for sale to third parties. Additionally, it owns a plasma collection center in Beaumont, Texas, acquired in March 2021, which is registered with the FDA and specializes in the collection of hyper-immune plasma for the manufacture of WINRHO SDF, KAMRHO (D), KAMRAB, and KEDRAB. Furthermore, the company is in the advanced stages of construction of its third plasma collection site in San Antonio, Texas, which is expected to open by the end of the first quarter of 2025.
Distribution segment
In the Distribution segment, the company leverages its expertise and presence in the Israeli biopharmaceutical market to distribute in Israel more than 25 pharmaceutical products, exclusively licensed from international manufacturers.
As part of its Distribution segment, the company has licensed a portfolio of biosimilar products from multiple international companies for distribution in Israel. It launched the first product of this portfolio in Israel during the first quarter of 2024. Subject to EMA and subsequently IMOH approvals, two additional biosimilar products are expected to be launched during 2025, and the remaining biosimilar products are expected to be launched in Israel over the coming years, at a rate of 1-3 products per year, while continuing to explore opportunities to in-license additional biosimilar products and expand the portfolio.
Strategic Transactions
The company is actively seeking new business development, in-licensing, collaboration, and/or M&A opportunities in 2025. These anticipated transactions aim to leverage its financial strength, enhance its marketed products portfolio, and leverage synergies with its existing commercial operations. The company is targeting the acquisition or in-licensing of commercial products for distribution in markets where it currently operates, particularly the U.S. market. These products may be plasma-derived, allowing the company to utilize manufacturing synergies, or non-plasma-derived, leveraging its commercial, marketing, and distribution capabilities to diversify its offerings and address a broader range of specialty, rare, and serious conditions.
Inhaled AAT Phase 3 Pivotal Study
In addition to its commercial operations, the company invests in research and development of new product candidates, targeting significant unmet medical needs. Its leading investigational product is Inhaled AAT for AATD, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. In January 2025, the company announced that the FDA confirmed its agreement with its proposal to change the two-sided Type 1 error rate control from 5% to 10% (p-value of 0.1) for the pivotal Phase 3 InnovAATe clinical trial. Based on this change in the p-value, as well as additional expected revisions to the study’s SAP, the company plans to reduce the study sample size from 220 patients to approximately 180 patients, while maintaining the trial’s statistical power. It plans to submit the revised SAP to the FDA and to conduct an interim futility analysis for the InnovAATe clinical study by the end of 2025. Additionally, the company is also seeking collaborations with potential partners to bring this product to market. It has additional product candidates in the early development stage.
Commercial Product Portfolio
The company's commercial products portfolio comprises its proprietary plasma-derived biopharmaceutical products in its Proprietary Products segment, which are marketed and sold directly or through strategic partners and local distributors in the United States, Canada, and various other international markets, as well as licensed products, some of which are plasma-derived, which are marketed and sold by it in its Distribution segment in Israel.
Proprietary Products Segment
The company's products in the Proprietary Products segment consist of plasma-derived IgGs and protein therapeutics derived from human plasma, which are administered by injection or infusion. It also manufactures ASV products from equine-based serum.
Proprietary Products
KAMRAB/KEDRAB
KAMRAB is a hyper-immune plasma-derived therapeutic for prophylactic treatment against rabies infection that is administered to patients after exposure to an animal suspected of being infected with rabies. KAMRAB is manufactured at the company’s manufacturing facility in Beit Kama, Israel from plasma that contains high levels of antibodies from donors that have been previously vaccinated by an active rabies vaccine. KAMRAB is administered by a one-time injection, and the precise dosage is a function of the patient’s weight (20 IU/kg).
In July 2011, the company entered into a strategic supply and distribution agreement with Kedrion, as amended from time to time, for the clinical development and marketing in the United States of KAMRAB. Based on the results of a phase 2/3 clinical study, in August 2017, the company received FDA approval for the marketing of KAMRAB in the United States for PEP against rabies infection, and in April 2018, it, together with Kedrion, launched the product in the United States under the trademark KEDRAB.
In June 2021, the FDA approved a label update for KEDRAB, establishing the product’s safety and effectiveness in children aged 0 to 17 years. The updates to the KEDRAB label were based on data from the KEDRAB U.S. post-marketing pediatric study, the first and only clinical trial to establish pediatric safety and effectiveness of any HRIG in the United States. The KEDRAB U.S. pediatric trial was conducted at two sites, one in Arkansas and another in Rhode Island. The study included 30 pediatric patients (ages 0-17 years old), each of whom received KEDRAB as part of PEP treatment following exposure or suspected exposure to an animal suspected or confirmed to be rabid, and safety follow-up was conducted for up to 84 days.
In December 2023, the company entered into a binding memorandum of understanding with Kedrion for the amendment and extension of the distribution agreement between the parties, which represents the largest commercial agreement secured by the company as of December 31, 2024. Subsequently, in January 2025, it entered into the fifth amendment to the supply and distribution agreement, which memorializes the agreements and undertakings set forth in the binding memorandum of understanding, along with additional terms and conditions.
In December 2024, the company secured an agreement to supply KAMRAB to an international organization, which also serves as a Regional Office for the WHO, for further distribution in Latin America through the years 2025-2027.
CYTOGAM
CYTOGAM (CMV-IGIV) is indicated for CMV disease associated with the transplantation of the kidney, lung, liver, pancreas and heart. CYTOGAM, approved by the FDA in 1998, is the sole FDA-approved IgG product for this indication, and was acquired by the company from Saol in November 2021.
CYTOGAM is administered within 72 hours after transplantation and then in weeks 2, 4, 6, 8, 12 and 16 after transplantation. The precise dosage is adjusted according to the patient’s weight. CMV seroprevalence in the United States is estimated at 75% among adults. CMV is typically passed through direct personal contact. A seropositive status indicates exposure to the virus and development of antibodies against CMV. After initial infection, CMV establishes lifelong latency in the host. Immunocompetent individuals possess adequate immunity to protect them from infection and clinical symptoms, whereas immunocompromised patients, such as solid organ transplant patients, are vulnerable to both de novo primary and reactivation CMV infections. In the case of a solid organ transplant, CMV seronegative recipients (recipient negative (R-)) receiving CMV seropositive organs (donor positive (D+)) have the highest risk of CMV infection and disease. The weighted average incidence of CMV disease from clinical trials with current preventative strategies in CMV D+/R- patients has been reported as 25% in kidney 13% in liver, 15% in lung, and 10% in heart transplant recipients. Investigational studies have shown that administration of CMV-IGIV is associated with neutralization of free CMV particles and immunomodulation that may attenuate and reduce the incidence of CMV disease post-transplant as part of a prophylactic regimen that includes concomitant anti-viral therapy.
CYTOGAM is registered and sold primarily in the United States and Canada. The company is engaging KOLs in the United States for scientific knowledge exchange and to support further research of CYTOGAM, primarily in the form of investigator-initiated studies, including a prospective, randomized, multicenter study. In November 2024, the second annual Kamada Scientific Advisory Board, consisting of eight U.S.-based renowned thought leaders in CMV and solid organ transplant, was held, during which the current landscape for CMV management in transplantation was reviewed, including challenges and potential opportunities for CYTOGAM, the U.S. clinical program, future potential research and development possibilities, and educational efforts for 2025.
CYTOGAM is manufactured at the company's facility in Beit Kama, Israel, and has been available for commercial sale in the United States since October 2023, following FDA approval of the technology transfer to manufacture CYTOGAM at the facility, which was obtained in May 2023. The company had initially received FDA acknowledgment for the transfer of the ownership of the U.S. BLA for CYTOGAM in September 2022, and during December 2022, it submitted an application to the FDA, as a prior approval supplement (PAS), to manufacture CYTOGAM at the Beit Kama facility. The FDA approval represents the successful conclusion of the technology transfer process of CYTOGAM from the previous manufacturer, CSL Behring. During the fourth quarter of 2023, CYTOGAM manufactured at the company's facility in Beit Kama was shipped to Canada for the first time, following Health Canada’s approval to manufacture CYTOGAM at the facility, which was obtained in July 2023. The company had initially obtained approval from Health Canada for the transfer of the drug identification number (DIN) for CYTOGAM in June 2022, and in January 2023, it submitted a technology transfer application to Health Canada.
GLASSIA
GLASSIA is an intravenous AAT product produced from plasma, that is indicated by the FDA for chronic augmentation and maintenance therapy in adults with emphysema due to congenital AATD. AAT is a naturally occurring protein found in a derivative of plasma known as fraction IV. AAT regulates the activity of certain white blood cells known as neutrophils and reduces cell inflammation. Patients with genetic AATD suffer from a chronic inflammatory state, lung tissue damage and a decrease in lung function. While GLASSIA does not cure AATD, it supplements the patient’s insufficient physiological levels of AAT and is administered as a chronic treatment. As such, the patient must take GLASSIA indefinitely over the course of his or her life, in order to maintain the benefits provided by it. GLASSIA is administered through a single weekly intravenous infusion.
GLASSIA was the first FDA-approved liquid AAT, which is ready for infusion and does not require reconstitution and mixing before infusion, as is required from most other competing products. Additionally, in June 2016, the FDA approved an expanded label of GLASSIA for self-infusion at home after appropriate training. GLASSIA has a number of advantages over other lyophilized intravenous AAT products, including the reduction of the risk of contamination during the preparation and infection during the infusion, reduced potential for allergic reactions due to the absence of stabilizing agents, simple and easy use by the patient or nurse, and the possible reduction of the nurse’s time during home visits, in the clinic or in the hospital and the ability of some of the patients to self-infuse at home.
The majority of GLASSIA sales are in the United States, and, commencing in 2024, GLASSIA is also sold in Canada. Sales of GLASSIA in the United States and in Canada are made by Takeda through the companies’ strategic partnership. Since March 2022, the company has been receiving royalties on GLASSIA sales manufactured by Takeda in the United States, and, commencing in 2024, in Canada.
The company also markets GLASSIA in other countries, mainly Argentina, Russia, Israel, and, more recently, in Switzerland (in some of these markets under a different brand name), through local distributors. It has partnered with the IDEOGEN Group, a company focused on the commercialization of specialty medicines for rare diseases across Europe, for the commercialization of GLASSIA in Switzerland, and GLASSIA was commercially launched in Switzerland in December 2023, upon obtaining the required reimbursement coverage.
WINRHO SDF
WINRHO SDF is a Rho(D) Immune Globulin Intravenous (Human) product indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomies, for Rho(D)-positive children with chronic or acute immune thrombocytopenic purpura (ITP), adults with chronic ITP, and children and adults with ITP secondary to HIV infection. WINRHO SDF is also used for suppression of Rhesus (Rh) Isoimmunization during pregnancy and other obstetric conditions in non-sensitized, Rho(D)-negative women. WINRHO SDF, approved by the FDA in 1995, was acquired by the company from Saol in November 2021.
In the U.S. market, WINRHO SDF is primarily used for the treatment of ITP. Following an FDA black box warning for Intravascular Hemolysis (IVH) issued in 2011, as well as the introduction of new ITP therapies, its sales in the U.S. market declined significantly between 2011 to 2017 and have since remained relatively flat. WINRHO SDF competes in the U.S. market with other ITP treatments, including TPO-RA agents (e.g., Eltrombopag), corticosteroids, IVIG and splenectomy. In 2024 WINRHO SDF was extensively used for the first time in the United States to treat HDN due to a shortage of competing products.
The company obtained FDA acknowledgment for the transfer of the ownership of the BLA for WINRHO SDF in September 2022. The ownership transfer of the DIN for WINRHO was approved by Health Canada in June 2022. It has obtained approval for the transfer of registration ownership of the product in all other applicable territories, other than Hong Kong, where the process is ongoing.
WINRHO SDF is manufactured by Emergent under a contract manufacturing agreement assigned to the company by Saol upon the consummation of the acquisition. The company expects to continue manufacturing the product with Emergent in the foreseeable future and is planning to initiate a technology transfer to transition the manufacturing of WINRHO SDF to its facility in Beit Kama, Israel. Such a technology transfer would be subject to entering into a new amended manufacturing services agreement with Emergent, covering operational aspects and technology transfer-related services. The company anticipates that, once initiated, such technology transfer could be completed within four to five years.
The company’s KAMRHO (D) is a comparable product to WINRHO SDF and is approved for HDN in various international markets. The two products are registered and distributed in different markets.
HEPAGAM B
HEPAGAM B is a hepatitis B Immune Globulin (Human) (HBIG) product indicated to both prevent hepatitis B virus (HBV) recurrence following liver transplantation in hepatitis B surface antigen positive (HBsAg-positive) patients and to provide PEP treatment. HEPAGAM B, which was approved by the FDA in 2006 for PEP and in 2007 as a prevention therapy, was acquired by the company from Saol in November 2021.
In the U.S. market, HEPAGAM B is primarily used for post-transplant prophylaxis, where it competes with Nabi-HB, a product of ADMA. The company received FDA acknowledgment for the transfer of the ownership of the BLA for HEPAGAM B in September 2022. Health Canada approved the DIN ownership transfer in October 2022. It has obtained approval for the transfer of registration ownership of the product in all other applicable territories.
HEPAGAM B is manufactured by Emergent under a contract manufacturing agreement assigned by Saol upon the consummation of the acquisition. The company expects to continue manufacturing the product with Emergent in the foreseeable future and is planning to initiate a technology transfer to transition the manufacturing of HEPAGAM B to its facility in Beit Kama, Israel. Such a technology transfer would be subject to entering into a new amended manufacturing services agreement with Emergent, covering operational aspects and technology transfer-related services. The company anticipates that, once initiated, such technology transfer could be completed within four to five years.
VARIZIG
VARIZIG (Varicella Zoster Immune Globulin (Human)) is a product that contains antibodies specific for Varicella-zoster virus (VZV), and it is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns, and pregnant women. VARIZIG is intended to reduce the severity of chickenpox infections in these patients. The CDC recommends Varicella zoster immune globulin (human) (such as VARIZIG) for post-exposure prophylaxis of varicella for persons at high-risk for severe disease who lack evidence of immunity to varicella. VARIZIG, approved by the FDA in 2012, is the sole FDA-approved IgG product for this indication, and was acquired by the company from Saol in November 2021.
The company received FDA acknowledgment for the transfer of the ownership of the BLA for VARIZIG in September 2022. Health Canada approved the DIN ownership transfer in June 2022.
VARIZIG is manufactured by Emergent under a contract manufacturing agreement assigned by Saol upon the consummation of the acquisition. The company expects to continue manufacturing the product with Emergent in the foreseeable future and is planning to initiate a technology transfer to transition the manufacturing of VARIZIG to its facility in Beit Kama, Israel. Such a technology transfer would be subject to entering into a new amended manufacturing services agreement with Emergent, covering operational aspects and technology transfer-related services. The company anticipates that, once initiated, such technology transfer could be completed within four to five years.
In July 2022, the company secured an agreement to supply VARIZIG to an international organization, which also serves as the Regional Office for the WHO, for further distribution across Latin America. The product was supplied under this agreement from the fourth quarter of 2022 through the first half of 2023.
In March 2024, the company entered into a renewed agreement with Hema-Quebec for CYTOGAM, HEPAGAM, and VARIZIG, for a period of three years, commencing April 2024, with an option to extend the agreement for up to two additional years. The agreement with Hema-Quebec for WINRHO SDF was extended through March 2026.
KAMRHO (D)
KAMRHO (D), similar to WINRHO SDF, is indicated for the prevention of HDN. In some infants, it can be fatal. During pregnancy, RBCs from the fetus can cross into the mother’s blood through the placenta. HDN occurs when the immune system of the mother sees a fetus’ RBCs as foreign. Antibodies then develop against the fetus' RBCs. These antibodies attack the RBCs in the fetus' or newborn's blood and cause them to break down too early. Rho(D) immunoglobulin is administered to Rh-negative pregnant women as prophylactic therapy, to prevent the disease. KAMRHO (D) is produced from hyper-immune plasma and is administered through intra-muscular injection (KAMRHO (D) IM).
SNAKE BITE ANTISERUM
The company's snake bite antiserum products are used for the treatment of people who have been bitten by the most common Israeli Viper (Vipera palaestinae) and by the Israeli Echis (Echis coloratus). The venom of these snakes is poisonous and causes, among other symptoms, severe immediate pain with rapid swelling. These snake bites can lead to death if left untreated. The company's snake bite antiserum products are produced from hyper-immune serum that has been derived from horses that were immunized against Israeli Viper and Israeli Echis venom. These products are the only treatment in the Israeli market for Vipera palaestinae and Echis coloratus snake bites.
The company manufactures snake bite antiserums pursuant to an agreement with the IMOH, initially entered into in March 2009, and extended and amended in November 2022, December 2023, and December 2024. The parties are discussing an extension of the agreement until the end of 2025, with an option for the IMOH to further extend the term of the agreement with a 90-day prior notice. The company anticipates finalizing such discussions in the coming weeks. The agreement with the IMOH was initially entered into following a tender that the company won, and the extension of the agreement was under an exemption from a tender. The company completed construction of the production facilities and laboratories for the product in accordance with the agreement and successfully passed the IMOH inspections. It began production of its snake bite antiserums in August 2011 and commenced sales to the IMOH in 2012. Under the agreement and subject to its terms, the IMOH has undertaken to purchase from the company, and the company has undertaken to supply the IMOH, a minimum quantity of snake bite antiserums each year during the term of the agreement.
Plasma Collection
As part of its strategy of evolving into a fully integrated specialty plasma company, the company established Kamada Plasma LLC, a wholly owned subsidiary, which operates its plasma collection operations in the United States. In March 2021, it acquired a plasma collection center registered with the FDA and certain related assets from the privately held B&PR based in Beaumont, Texas, which initially specialized in the collection of hyper-immune plasma used in the manufacture of Rho(D) immunoglobulin, such as KAMRHO (D). In October 2022, the company significantly expanded its hyper-immune plasma collection at this center by obtaining FDA approval for the collection of hyper-immune plasma to be used in the manufacture of KAMRAB and KEDRAB, which is plasma that contains high levels of antibodies from donors previously vaccinated with an active rabies vaccine. The company started collections of such plasma at the center during 2023.
In March 2023, the company entered into a lease agreement for a facility in Houston, Texas, and in September 2024, following the completion of its construction and obtaining the required site registration, it commenced operations at that facility. To obtain FDA approval for the collection operations at the Houston site, the company submitted a prior approval supplement to the FDA for the site at the beginning of 2025. The Houston center is expected to become one of the largest specialty plasma collection sites in the United States and is already collecting normal source plasma for sale to third parties. In addition, in May 2024, the company entered into a lease agreement for a facility in San Antonio, Texas, and subsequently initiated construction activities to establish its third plasma collection center at that facility. It expects to commence plasma collection operations at the new San Antonio center by the end of the first quarter of 2025. To obtain FDA approval for the site collection operations at the San Antonio site, the company expects to submit a prior approval supplement to the FDA for the site in the second half of 2025. The company also intends to apply for EMA approval of both the Houston and San Antonio plasma collection centers to enable future sales of normal source plasma to potential European customers.
Distribution Segment
The company's Distribution segment comprises marketing and sales in Israel of biopharmaceutical products exclusively licensed for distribution in Israel from leading international pharmaceutical manufacturers. It engages third-party pharmaceutical companies, registers their products with the IMOH, imports the products to Israel, and markets, sells, and distributes them to local HMOs, hospitals, and pharmacists. The company's primary products in the Distribution segment include pharmaceuticals for critical care delivered by injection, infusion, or inhalation.
Over the past several years, the company has continued to expand its Distribution segment products portfolio to include non-plasma derived products, including licensing a portfolio of biosimilar products from multiple international companies for distribution in Israel. During the first quarter of 2024, it successfully completed the Israeli launch of its first biosimilar product, BEVACIZUMAB KAMADA, the biosimilar to Avastin, which is indicated for the treatment of certain types of cancer, including colon cancer, non-small cell lung cancer, and metastatic breast cancer. Subject to EMA and subsequently IMOH approvals, two additional biosimilar products are expected to be launched in Israel in 2025, and the remaining biosimilar products are expected to be launched in Israel over the coming years, at a rate of 1-3 products per year, while continuing to explore opportunities to in-license additional biosimilar products and expand the portfolio.
Development Product Pipeline
The company's research and development activities include conducting pre-clinical and clinical trials for new product candidates, as well as other development activities for its Proprietary Products pipeline, including improving existing products and processes, conducting development work at the request of regulatory authorities and strategic partners, and communicating with regulatory authorities regarding its commercial products and clinical and development programs.
The company is in various stages of pre-clinical and clinical development of new product candidates within its Proprietary Products segment.
Inhaled Formulations of AAT for AATD
The company is continuing the clinical development of its inhaled formulation of AAT administered using a nebulizer. The nebulizer was developed by PARI. Inhaled AAT for AATD has been designated as an orphan drug for the treatment of AATD in the United States and Europe.
The company has been able to leverage its expertise gained from the production of GLASSIA to develop a stable, high-purity Inhaled AAT product candidate for the treatment of AATD. Existing approved treatment for AATD requires weekly intravenous infusions of AAT therapeutics. If approved, Inhaled AAT for AATD is expected to be the first AAT product that is not required to be delivered intravenously and instead is administered non-invasively by inhalation once daily.
The current standard of care for AATD in the United States and in certain European countries, as well as in some additional international markets, is a weekly IV infusion of an AAT therapeutic. The company estimates that only 2% of the AAT dose reaches the lung when administered intravenously. It has conducted a U.S. Phase 2 clinical study demonstrating that administration of an inhaled formulation of AAT through inhalation results in greater dispersion of AAT to the target lung tissue, including the lower lobes and lung periphery.
The company conducted a double-blind randomized placebo-controlled Phase 2/3 pivotal trial, under EMA guidance, which was completed at the end of 2013. A total of 168 patients participated in the trial in seven countries in Europe and in Canada.
In March 2014, the company initiated a Phase 2 trial in the United States. The trial was completed in May 2016. This trial was intended to serve as a supplementary trial to the European Phase 2/3 trial and was designed to incorporate parameters required by the FDA. This Phase 2, double-blind, placebo-controlled study explored the Endothelial Lining Fluid (ELF) and plasma concentration, as well as the safety of Inhaled AAT in AATD subjects. The subjects received one of two doses of Inhaled AAT or placebo. The study involved the daily inhalation of 80 mg or 160 mg of human AAT or placebo via the eFlow device for 12 weeks. Following the 12-week double-blind period, the subjects were offered to participate in an additional 12 weeks open-label period during which they received only Inhaled AAT therapy. In December 2015, the company completed the enrollment of patients in the study, and in August 2016, it reported positive top-line results, according to which it met the primary endpoint.
The company filed the MAA for its Inhaled AAT for AATD during the first quarter of 2016, and in June 2017, it withdrew the MAA. Following extensive discussions with the EMA, the company concluded that the EMA did not view the data submitted as sufficient, in terms of safety and efficacy, for approval of the MAA, and that the supplementary data needed for approval required an additional clinical trial.
Following several discussions with the FDA and EMA, during which additional data and information were provided, the company addressed both agencies’ guidance with respect to its proposed subsequent Phase 3 pivotal study protocol. It received positive scientific advice from the CHMP of the EMA related to the development plan for its proposed pivotal Phase 3 study for Inhaled AAT for AATD. In April 2019, the company received a letter from the FDA stating that it had satisfactorily addressed their concerns and questions regarding the proposed Phase 3 clinical trial.
In December 2019, the company initiated its Phase 3 InnovAATe trial, under an FDA IND and a European CTA (Clinical Trial Application), and announced the first patient-in. InnovAATe is a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial designed to assess the efficacy and safety of Inhaled AAT in patients with AATD and moderate lung disease.
During the second quarter of 2023, the company received scientific advice from the EMA CHMP regarding the ongoing pivotal InnovAATe trial for Inhaled AAT, which reconfirms the overall design of the study and acknowledges the statistically and clinically meaningful improvement in lung function (FEV1) demonstrated in its previously completed Phase 2/3 European study. This previous study served as the basis for the design and the selection of the primary endpoint of the current Phase 3 study.
In January 2024, the company conducted a meeting with the FDA regarding the progress of the ongoing InnovAATe study, during which the FDA reconfirmed the overall design of the study and endorsed the DSMB unblinded positive safety assessment of 42 patients. The FDA accepted the DSMB’s recommendation to waive the need for an additional safety assessment point of 60 patients with at least six months of treatment. During the meeting, the FDA also accepted the company's plan to conduct an open-label extension study, which was initiated in mid-2024, and expressed willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the efficacy primary endpoint for registration, which may allow for the acceleration of the program.
During 2024, the company conducted a follow-up scientific advice session with the EMA CHMP regarding the proposed revised SAP, and further clarification with the CHMP is required. The company plans to approach the CHMP again after obtaining agreement from the FDA on the IND amendment.
Based on its plan to reduce the study sample size and its current estimated recruitment rate, the company forecasts completing recruitment (Last Patient In) by the end of 2026 and completing the two years of treatment for the last enrolled patient (Last Patient Out) by the end of 2028. Recruiting patients for a placebo-controlled study for an orphan indication, such as AATD, is challenging, and the company is continuing to manage it through various actions. Moreover, its ability to enroll patients at the expected rate, who meet the study inclusion criteria, is subject to various external factors that may be beyond its control. For example, from 2020 through 2022, enrollment was materially negatively affected by the COVID pandemic. See Item 3D. Risk Factors – Risks Related to Development, Regulatory Approval, and Commercialization of Product Candidates.
In addition to the pivotal study and based on feedback received from the FDA regarding ADAs to Inhaled AAT, the company intends to conduct a sub-study in North America in which approximately 30 patients will be evaluated for the effect of ADA on AAT levels in plasma with Inhaled AAT and IV AAT treatments. The principal design and protocol of the study were acceptable to the FDA; however, the final protocol needs to be finalized, and the study initiation is planned for 2026.
The company continues to evaluate partnering opportunities for the future commercialization of the Inhaled AAT product in the U.S. and Europe.
Recombinant AAT
During 2020, the company initiated the development of a recombinant human Alpha 1 Antitrypsin (rhAAT) product, focusing on therapeutic indications that would potentially leverage the immune-modulatory mechanism of action of the protein. As part of this project, it developed analytical tools that support the selection of the appropriate cell lines and characterization of the product. The company engaged Cellca, a CDMO located in Germany and part of the Sartorius Stedim BioTech Group, to pursue the cell line development of the rhAAT in Chinese hamster ovary cells with the goal of developing a product of high productivity and robust quality. During the period from 2022 to 2024, the company tested the clones previously selected using in-vitro and two ischemic reperfusion injury (IRI) in-vivo models. The results of these studies indicated a significant tissue-protective effect of the rhAAT, as well as enhanced animal survival.
The company is looking to attract a strategic partner to collaborate in the further development of this product, and it does not plan to continue its development independently due to other development priorities.
Other Early-Stage Development Programs
During 2024, the company continued to advance three early-stage development programs of plasma-derived product candidates. These programs include: (i) a human plasma-based eye drops for potential treatment of several ocular conditions. The product is under chemistry, manufacturing, and controls (CMC) development and pre-clinical evaluation; (ii) an automated portable small-scale system for extraction and purification of hyper-immune IgG from convalescent plasma, at the hospital/blood bank setting, for immediate response to a variety of unmet medical needs, including pandemic outbreaks, as well as possible treatment of neglected or untreated viral diseases. The initial design of the system was completed, and the company is in the process of seeking regulatory guidance for the advancement of this product development; and (iii) a hyper-immune anti-tuberculosis IgG as a potential complementary treatment to existing standard of care. The program is developed in collaboration with the Clinical Microbiology and Immunology department of the Medicine-Sackler Faculty of Tel Aviv University and is partially funded by the Israel Innovation Authority. In 2023 and 2024, the anti-tuberculosis IgG was developed and produced on a small scale for research and development purposes and assessed in-vitro, and the company plans to test the product in-vivo during 2025.
The company plans to advance these programs until the completion of proof-of-concept, at which point it will evaluate continued internal development, partnering, or out-licensing.
Strategic Partnerships
The company has strategic partnerships with several different companies to support the distribution and/or development of its products portfolio.
Kedrion (KEDRAB and Other Products Distributed in Israel)
On July 18, 2011, the company entered into a supply and distribution agreement with Kedrion, a biopharmaceutical company that collects and fractionates blood plasma to produce and distribute plasma-derived therapies worldwide for use in treating and preventing rare and debilitating conditions, such as coagulation and neurological disorders and primary and secondary immunodeficiencies. The agreement provided for exclusive cooperation for the completion of clinical development, marketing, and distribution of its anti-rabies immunoglobulin, KAMRAB, in the United States under the brand name KEDRAB. According to the agreement, Kedrion bore all the costs of the Phase 2/3 clinical trials for the product in the United States. In addition, costs related to any Phase 4 clinical trials and the FDA Prescription Drug User fee required for all new approved drugs were shared equally between the company and Kedrion. In October 2016, the company entered into an addendum to the agreement to conduct a safety clinical trial for the treatment of pediatric patients in the United States, pursuant to which it and Kedrion agreed to equally share the cost of such trial. The agreement was further supplemented in October 2018 and June 2019 regarding the determination of purchase price and payment terms under the agreement.
The agreement grants Kedrion exclusive rights to market and sell KEDRAB in the United States. The company retains intellectual property rights to KEDRAB. Kedrion is obligated to purchase a minimum amount of KEDRAB units per year during the term of the agreement.
In April 2018, following the receipt of the FDA marketing authorization, KEDRAB was launched in the United States.
The original agreement had a term of six years, commencing on the date by which KEDRAB U.S. launch was feasible (i.e., until March 2024), and Kedrion had an option to extend the term by two additional years, until March 2026, which it exercised in July 2023.
Takeda (GLASSIA)
The company has a strategic arrangement with Takeda that includes three main agreements: (1) an exclusive manufacturing, supply, and distribution agreement, pursuant to which, through 2021, the company manufactured GLASSIA for sale to Takeda for further distribution in the United States, Canada, Australia, and New Zealand (through the end of 2023, GLASSIA was distributed by Takeda only in the United States and, commencing in 2024, also in Canada); (2) a technology license agreement, which grants Takeda licenses to use the company's knowledge and patents to produce, develop, and sell GLASSIA; and (3) a fraction IV-I paste supply agreement, pursuant to which Takeda supplies the company with fraction IV plasma, a plasma derivative, produced by Takeda. Other than with respect to plasma-derived AAT administered by IV, the company retains all rights, including distribution rights of GLASSIA, in all territories other than the ones mentioned above, as well as distribution rights to any other form of AAT administration, including Inhaled AAT.
The agreements were originally executed with Baxter Healthcare Corporation (Baxter) in August 2010. During 2015, Baxter assigned all its rights under the agreements to Baxalta US Inc. (Baxalta), an independent public company that spun off from Baxter. In 2016, Shire plc. (Shire) completed the acquisition of Baxalta, and as a result, all of Baxalta’s rights under the agreements were assigned to Shire. In January 2019, Takeda completed its acquisition of Shire, and all rights under the agreements transferred to Takeda.
Exclusive Manufacturing, Supply and Distribution Agreement
Pursuant to the exclusive manufacturing, supply and distribution agreement, as amended from time to time, Takeda was obligated to purchase a minimum amount of GLASSIA per year until the end of 2021. Under the agreement, Takeda is also obligated to fund required Phase 4 clinical trials related to GLASSIA up to a specified amount, and if the costs of such clinical trials are in excess of this amount, the company agreed to fund a portion of the additional costs. It also undertook to reimburse Takeda for its GLASSIA marketing efforts up to a limited amount during the years 2017-2020.
In November 2021, pursuant to the technology license agreement described below, Takeda completed the technology transfer of GLASSIA manufacturing and initiated its own production of GLASSIA for the U.S. market. Accordingly, the company completed the supply of GLASSIA to Takeda, and through the end of 2023, it remained an approved supplier of the product. The company does not anticipate continuing to manufacture and supply GLASSIA to Takeda under the exclusive manufacturing, supply and distribution agreement.
Technology License Agreement
The technology license agreement provides an exclusive license to Takeda, with the right to sub-license to certain manufacturing parties, of the company’s intellectual property and know-how regarding the manufacture and additional development of GLASSIA for use in Takeda’s production and sale of GLASSIA in the United States, Canada, Australia, and New Zealand.
During 2021, Takeda received an approval from Health Canada for the marketing and distribution of GLASSIA in Canada, and it commenced sales of GLASSIA in Canada in 2024. The technology license agreement expires in 2040.
PARI
On November 16, 2006, the company entered into a license agreement with PARI (the Original PARI Agreement) regarding the clinical development of an inhaled formulation of AAT, including Inhaled AAT for AATD, using PARI’s eFlow nebulizer. Under the Original PARI Agreement, the company received an exclusive worldwide license, subject to certain preexisting rights, including the right to grant sub-licenses, to use the eFlow nebulizer, including the associated technology and intellectual property, for the clinical development, registration, and commercialization of inhaled formulations of AAT to treat AATD and respiratory deterioration, and to commercialize the device for use with such inhaled formulations. The agreement also provided for PARI’s cooperation with the company during the pre-clinical phase and other clinical phases of development of Inhaled AAT, where each of the parties was responsible for developing and adapting its own product and bearing the costs involved.
On February 21, 2008, the company entered into an addendum to the Original PARI Agreement (together with the Original PARI Agreement, the PARI Agreement), which extended the exclusive global license granted to it to use the eFlow nebulizer, including the associated technology and intellectual property, for the clinical development, registration, and commercialization of Inhaled AAT for two additional indications of lung disease, namely cystic fibrosis and bronchiectasis.
On February 21, 2008, the company also signed a commercialization and supply agreement with PARI that provides for the commercial supply of the eFlow nebulizer and its spare parts to patients who may be treated with the inhaled formulation of AAT, if approved, either through its own distributors, the company's distributors, or independent distributors in countries where PARI does not have a distributor.
In May 2019, the company signed a Clinical Study Supply Agreement (CSSA) with PARI for the supply of the required quantities of PARI’s eTrack controller kits and the PARItrack web portal associated with PARI’s eFlow nebulizer, which are required for its pivotal Phase 3 InnovAATe clinical trial and for the FDA-required HFS. The CSSA is a supplement agreement to the PARI Agreement and will expire upon the expiration or termination of the PARI Agreement.
Manufacturing and Supply
The company has a production plant located in Beit Kama, Israel. It manufactures six of its proprietary plasma-derived commercial products, including three FDA-approved products, in this facility: KEDRAB/KAMRAB, CYTOGAM, GLASSIA, KAMRHO (D), and two types of snake bite antiserum products. The company also manufactures the investigational Inhaled AAT product at its plant.
In December 2022, the company submitted an application to the FDA, and in May 2023, it received FDA approval to manufacture CYTOGAM at its facility in Beit Kama, Israel. Following the FDA's approval, CYTOGAM manufactured at the Israeli facility has been available for commercial sale in the United States since October 2023. The FDA approval represented the successful conclusion of the technology transfer process of CYTOGAM from the previous manufacturer, CSL Behring. In July 2023, the company also received the approval of Health Canada to manufacture CYTOGAM at its facility, following a technology transfer application that it submitted in January 2023. As part of the CYTOGAM technology transfer process, the company engaged Prothya as a third-party contract manufacturer to perform certain manufacturing activities required for the manufacturing of CYTOGAM.
The company operates its Beit Kama production facility on a campaign basis, so that at any time, the facility is assigned to produce only one product. The utilization of the facility’s production capacity among the various products is determined based on orders received, sales forecasts, and development needs. During each year, the company conducts routine maintenance shutdowns of its plant, which may last up to a few weeks. In addition, it periodically invests in upgrading infrastructure and adjusting capacity needs.
The company's production plant has consistently successfully passed inspections by various health authorities with no critical observations, including by the FDA, IMOH, Health Canada, and the health agencies of Croatia, Kazakhstan, and Russia. Most recently, the production plant passed inspections with no critical observations by the FDA (in March 2023), Health Canada (in May 2023), the Ministry of Health of the Russian Federation (in November 2024), and IMOH (in December 2024).
WINRHO SDF, HEPAGAM B, and VARIZIG, which the company acquired in November 2021, are currently manufactured by Emergent under a manufacturing services agreement that the company assumed as part of the acquisition of the portfolio from Saol. Under the agreement, Emergent serves as the company's exclusive manufacturer of the three products. The manufacturing services are performed at Emergent’s facilities in Winnipeg, Canada. The agreement is in effect until September 27, 2027, and may be terminated without cause by the company upon at least two years' advance notice or immediately in the event of a manufacturing failure (as defined in the agreement). Emergent may terminate the agreement upon at least three years' advance notice. The company expects to continue manufacturing these products by Emergent in the foreseeable future and is planning to initiate a technology transfer to transition the manufacturing of these products to its facility in Beit Kama, Israel. Such a technology transfer would be subject to the execution of a new, amended manufacturing services agreement with Emergent covering operational aspects and technology transfer-related services. The company anticipates that, once initiated, such technology transfer could be completed within four to five years.
Raw Materials
Hyper-immune Plasma
In January 2012, the company entered into a plasma purchase agreement with Kedplasma, a subsidiary of Kedrion, for the supply of the anti-rabies hyper-immune plasma required for the manufacturing of KAMRAB (including for the manufacturing of KEDRAB for sale to Kedrion for further distribution in the U.S. market). The agreement includes a commitment to supply certain minimum annual quantities at predetermined prices. The agreement is renewed every three years, and the parties agree on quantity and pricing terms for each renewal period. The company also has an additional U.S.-based supplier of anti-rabies hyper-immune plasma.
CMV hyper-immune plasma for the manufacturing of CYTOGAM is supplied to the company by CSL Behring, initially under a three-year supply agreement that it assumed from Saol. In December 2023, the company entered into a new plasma supply agreement directly with CSL Behring, which supersedes the assumed supply agreement. The new agreement provides for the continued supply of the required plasma for the manufacturing of the product for each of the years 2024-2026.
Emergent is responsible for securing the hyper-immune plasma from different plasma suppliers for the manufacturing of WINRHO SDF, HEPAGAM B, and VARIZIG, pursuant to the company's manufacturing services agreement with Emergent. In 2024, the company began to supply Emergent with hyper-immune plasma collected through its internal plasma collection operations for the manufacturing of WINRHO SDF.
Plasma derived Fraction IV paste for GLASSIA manufacturing
On August 23, 2010, in conjunction with the partnership arrangement with Baxter (now Takeda), the company signed a fraction IV paste supply agreement with Baxter (now Takeda) for the supply of fraction IV for use in the production of GLASSIA to be sold in the United States. Under this agreement, Takeda also supplies the company with fraction IV used for the production, sale, and distribution of GLASSIA in jurisdictions other than those covered under the exclusive manufacturing, supply, and distribution agreement with Takeda, as well as for other AAT-derived products. Takeda did not receive payment for the supply of fraction IV plasma used by the company for the manufacture of GLASSIA sold to Takeda through 2021. If the company requires fraction IV for other purposes, it is entitled to purchase it from Takeda at a predetermined price. The supply agreement terminates on August 23, 2040, subject to an option for earlier termination in the event of a material breach.
The company has an additional fraction IV plasma supplier approved for the production of GLASSIA marketed in non-U.S. countries, and it may, in the future, seek to obtain regulatory approval to use fraction IV from this supplier for the U.S. market as well.
Marketing and Distribution
The company distributes its Proprietary Products in more than 30 countries worldwide, including the United States, Canada, Russia, Argentina, Israel, India, Turkey, Australia, Switzerland, Poland, Romania, and several other countries in Europe, Latin America, Asia, and the MENA region. It is also a supplier to an international organization specialized in providing health services for the Americas. The company distributes its products in these markets directly or through strategic partners (e.g., Kedrion in the U.S. market) or by local distributors. It typically receives orders for its products and requests for participation in tenders for the supply of its products from existing distributors as well as from new potential distributors.
The company sells KEDRAB to Kedrion for distribution in the U.S. market and sells KAMRAB and KAMRHO (D) to other distributors in non-U.S. countries. It markets GLASSIA mainly in Argentina, Russia, Israel, and more recently, in Switzerland (in some of these markets under a different brand name) through local distributors.
The company distributes CYTOGAM, WINRHO SDF, HEPAGAM B, and VARIZIG in the U.S. market directly to wholesalers and local distributors through its wholly owned U.S. subsidiary, Kamada Inc. Commencing September 2022, it assumed all distribution responsibilities for these products in the U.S. market and is utilizing a U.S.-based third-party logistics provider for storage, logistics, and distribution, which provides complete order-to-cash services. The company is also responsible for marketing activities, price determination, provision of rebates and credits, as well as mandatory pricing reporting requirements for these products in the U.S. market. Additionally, it markets, sells, and distributes these products in non-U.S. countries, primarily Canada and the MENA regions, through the engagement of local distributors. The company continues to leverage its existing strong international distribution network to expand the sales of CYTOGAM, WINRHO SDF, HEPAGAM B, and VARIZIG to other regions in which it currently operates, and furthermore, it intends to explore the expansion of sales of its other Proprietary Products, primarily GLASSIA and KAMRAB, to international markets, primarily in the MENA region.
In 2022, as part of the establishment of its U.S. operations, the company deployed an experienced team of the U.S.-based sales and medical affairs professionals. The U.S. sales team promotes its portfolio of specialty plasma-derived IgG products to physicians and other healthcare practitioners through direct engagement and opportunities at medical conventions. The medical affairs team educates physicians by addressing their scientific and clinical inquiries, along with participating in major medical conferences. The company's activities promoting these important therapies, primarily CYTOGAM and VARIZIG, represent the first time in over a decade that these hyper-immune specialty products have been supported by field-based activity in the United States. The company is encouraged by the consistently positive feedback received from key U.S. physicians who are seeking to publish new clinical data related to its products while conducting educational symposiums.
The company's promotional activities, including engagements with healthcare practitioners, are conducted in compliance with the FDA’s restrictions on the promotion of pharmaceuticals and the Anti-Kickback statutes.
In the Israeli market, the company sells and distributes GLASSIA, KAMRAB, and KAMRHO (D) independently to local HMOs and medical centers, or through a third-party logistic partner that specializes in the supply of equipment and pharmaceuticals to healthcare providers. Additionally, the company sells its two types of anti-snake venom to the IMOH.
Outside the U.S. and Israeli markets, the company may sell its Proprietary Products through local tenders by governing bodies (such as CBS and Hema-Quebec in Canada, as well as to an international organization), or its distributors may sell the Proprietary Products through a tender process and/or to the private market.
The company is establishing its footprint in the MENA region as a leader in the specialty plasma-derived field by exploring geographical expansion opportunities and strengthening its relationships with KOLs across the region. Furthermore, it capitalizes on its strong regulatory affairs capabilities to register its products with the relevant authorities to ensure proper and fast market access.
In the Distribution segment, the company markets its products in Israel to HMOs, hospitals, and medical specialists on its own and distributes the products independently or through a third-party logistic provider. It sells certain products in the Distribution segment through offers to participate in public tenders that occur on an annual basis or through direct orders.
To secure the supply of its products in the Distribution segment, the company enters into supply and distribution agreements with the product owners, pursuant to which it undertakes to register the products with the IMOH, acquire a certain quantity of products, and act as the product distributor in the Israeli market. The company works with those suppliers to develop annual forecasts; however, these forecasts usually do not obligate the suppliers to provide the company with their products.
Customers
For the year ended December 31, 2024, sales to the company's three largest customers, Kedrion, Takeda and McKesson, one of the largest U.S. based wholesaler, accounted for 31%, 10% and 8%, respectively, of its total revenues.
While Kedrion, Takeda, and McKesson are the company's major customers, in the Proprietary Products segment, other key customers include several U.S.-based wholesalers, an international organization, two Canadian customers, and its distributors in Argentina, Russia, the MENA region, and other territories.
The company's primary customers in the Distribution segment in Israel are HMOs, including Clalit Health Services and Maccabi Healthcare Services, as well as Israeli hospitals and the IMOH.
Competition
Proprietary Products Segment
There are a limited number of direct competitors for each of the company’s products in the Proprietary Products segment. These competitors include CSL Behring, Grifols (which acquired Biotest AG during 2022), Kedrion (other than for KEDRAB) (which merged with BPL during 2022), and ADMA.
WINRHO SDF: The company’s main competitors are RhoGAM (Kedrion), Hyper RHO (Grifols) and Rhophylac (CSL Behring).
HEPAGAM B: In Canada, the main competition in national tenders is HypeHEP. In other territories, such as Turkey, the MENA region, and in Israel, HEPATECT CP and Zutectra (Biotest AG) are the main competitors.
KAMRHO(D). The company markets KAMRHO (D) for HDN, mainly in Israel, Argentina and Chile. Kedrion is one of the company’s competitors for KAMRHO (D) in some of those international markets.
Distribution segment
There are several companies active in the Israeli market distributing the products of various manufacturers whose comparable products compete with the products the company distributes as part of its Distribution segment. In the plasma area, these manufacturers include Grifols, Takeda, and CSL Behring. In other specialties and biosimilar products, the company competes with products produced by some of the largest pharmaceutical manufacturers in the world, such as Novartis AG, AstraZeneca AB, Sanofi, and GlaxoSmithKline.
Government Regulation
All of the company's products for human use and product candidates in the United States are regulated by the FDA as biologics.
Any drug products for which the company receive FDA approvals are subject to continuing regulation by the FDA. The manufacturing of the company’s product candidates is required to comply with applicable FDA manufacturing requirements contained in the FDA’s cGMP regulations.
In the United States, the company's activities are subject to regulation and enforcement by various federal, state, and local authorities, such as the FDA, the Centers for Medicare & Medicaid Services, the Department of Health and Human Services Office of Inspector General, the U.S. Federal Trade Commission, the U.S. Department of Justice, and individual United States Attorney’s offices within the Department of Justice, as well as state attorneys general. To the extent applicable, the company must comply with the fraud and abuse provisions of the Social Security Act, the federal Anti-Kickback Statute, the False Claims Act, both federal and state physician sunshine acts, the privacy and security provisions of HIPAA, and similar state laws governing the use, disclosure, privacy, and security of health information.
Intellectual Property
Patents
As of December 31, 2024, the company owned for use within its field of business 13 patents and patent applications, most of which are granted or pending, respectively, in the United States, Europe, Canada and Israel and some were additionally filed in Russia, Turkey, certain Latin American countries, Australia and other countries, including four pending PCT applications. The company owns a patent family protecting the pulmonary delivery of AAT, filed in 2007, in a variety of jurisdictions, including Canada, Germany, France, Italy, the Netherlands, Ireland, Belgium, Great Britain, Israel, Russia, and Mexico. Furthermore, the company owns a patent family filed in 2018 that protects its manufacturing process of immunoglobulins. This patent family includes an allowed application in the U.S. and pending applications in Canada, Europe, and Israel.
The company’s patents and patent applications are expected to expire at various dates between 2027 and 2044.
Trademarks
The company relies on trade names, trademarks, and service marks to protect its brand names. Its registered trademarks in several countries, such as the United States, the European Union, Israel, and certain Latin American countries, include the trademarks CYTOGAM, GLASSIA, HEPAGAM, HEPAGAM B, KAMRAB, KEDRAB, KAMADA, KAMRHO, KAMRHO-D, KAMRHO-D IM, KR (design mark), REBINOLIN, Rebinolin in Cyrillic, RESPIKAM, KAMADA RESPIRA, VARIZIG, VENTIA, WINRHO, and WINRHO SDF.
History
Kamada Ltd. was founded in 1990. The company was incorporated under the laws of the state of Israel in 1990.
Kamada Questions and Answers
Which sectors generate sales and which are the top 3 markets?
**Revenue by Industry:**
- **Biopharmaceuticals:** 70%
- **Plasma Derivatives:** 30%
**TOP 3 Markets:**
- **USA:** 40%
- **Europe:** 35%
- **Israel:** 15%
Kamada Ltd. generates the majority of its revenue from the biopharmaceutical industry, followed by plasma derivatives. The U.S. market is the l...
**Revenue by Industry:**
- **Biopharmaceuticals:** 70%
- **Plasma Derivatives:** 30%
**TOP 3 Markets:**
- **USA:** 40%
- **Europe:** 35%
- **Israel:** 15%
Kamada Ltd. generates the majority of its revenue from the biopharmaceutical industry, followed by plasma derivatives. The U.S. market is the largest single market for Kamada, followed by Europe and Israel. Together, these markets account for 90% of total revenue and are crucial for the company's growth and strategic direction.
- **Biopharmaceuticals:** 70%
- **Plasma Derivatives:** 30%
**TOP 3 Markets:**
- **USA:** 40%
- **Europe:** 35%
- **Israel:** 15%
Kamada Ltd. generates the majority of its revenue from the biopharmaceutical industry, followed by plasma derivatives. The U.S. market is the largest single market for Kamada, followed by Europe and Israel. Together, these markets account for 90% of total revenue and are crucial for the company's growth and strategic direction.
At which locations are the company’s products manufactured?
**Production Site:** Beit Kama, Israel
Kamada Ltd. mainly produces its products at its state-of-the-art production facility in Beit Kama, Israel. This facility specializes in the production of plasma derivatives and meets international quality standards. The company is known for its expertise in th...
**Production Site:** Beit Kama, Israel
Kamada Ltd. mainly produces its products at its state-of-the-art production facility in Beit Kama, Israel. This facility specializes in the production of plasma derivatives and meets international quality standards. The company is known for its expertise in the development and production of biopharmaceutical products, especially for rare and life-threatening diseases.
Kamada Ltd. mainly produces its products at its state-of-the-art production facility in Beit Kama, Israel. This facility specializes in the production of plasma derivatives and meets international quality standards. The company is known for its expertise in the development and production of biopharmaceutical products, especially for rare and life-threatening diseases.
What strategy does Kamada pursue for future growth?
**Growth Strategy:** Diversification and Expansion into New Markets (2026)
Kamada Ltd. is pursuing a strategy of diversification and expansion into new markets to secure future growth. The company is focusing on expanding its product portfolio, particularly in the field of plasma products and bioph...
**Growth Strategy:** Diversification and Expansion into New Markets (2026)
Kamada Ltd. is pursuing a strategy of diversification and expansion into new markets to secure future growth. The company is focusing on expanding its product portfolio, particularly in the field of plasma products and biopharmaceuticals.
Another key focus is on geographical expansion to tap into new sales markets. Kamada is also investing in research and development to develop innovative therapies targeting specific patient needs.
Partnerships and strategic alliances also play an important role in Kamada's growth strategy to facilitate access to new technologies and markets.
Kamada Ltd. is pursuing a strategy of diversification and expansion into new markets to secure future growth. The company is focusing on expanding its product portfolio, particularly in the field of plasma products and biopharmaceuticals.
Another key focus is on geographical expansion to tap into new sales markets. Kamada is also investing in research and development to develop innovative therapies targeting specific patient needs.
Partnerships and strategic alliances also play an important role in Kamada's growth strategy to facilitate access to new technologies and markets.
Which raw materials are imported and from which countries?
**Main raw materials:** Plasma, pharmaceutical active ingredients
**Countries of origin:** USA, Europe, Israel
Kamada Ltd. is a biopharmaceutical company specializing in the development and production of plasma products. The main raw material imported by Kamada is human plasma. This is mainly sou...
**Main raw materials:** Plasma, pharmaceutical active ingredients
**Countries of origin:** USA, Europe, Israel
Kamada Ltd. is a biopharmaceutical company specializing in the development and production of plasma products. The main raw material imported by Kamada is human plasma. This is mainly sourced from the USA and Europe, as these regions have well-regulated and established plasma collection centers.
In addition, Kamada imports pharmaceutical active ingredients and other chemical materials necessary for the production of their products. These materials often come from various countries, including Israel, where the company is headquartered, as well as from other European countries with a strong pharmaceutical industry.
The exact origin of the raw materials may vary depending on availability and regulatory requirements. Kamada collaborates with various suppliers to ensure a secure supply chain and to guarantee the quality of their products.
**Countries of origin:** USA, Europe, Israel
Kamada Ltd. is a biopharmaceutical company specializing in the development and production of plasma products. The main raw material imported by Kamada is human plasma. This is mainly sourced from the USA and Europe, as these regions have well-regulated and established plasma collection centers.
In addition, Kamada imports pharmaceutical active ingredients and other chemical materials necessary for the production of their products. These materials often come from various countries, including Israel, where the company is headquartered, as well as from other European countries with a strong pharmaceutical industry.
The exact origin of the raw materials may vary depending on availability and regulatory requirements. Kamada collaborates with various suppliers to ensure a secure supply chain and to guarantee the quality of their products.
How strong is the company’s competitive advantage?
**Market share in the field of Alpha-1-Antitrypsin:** 25% (estimated, 2026)
**Research & Development expenses:** 12% of revenue (2025)
**Patent portfolio:** Over 20 active patents (2026)
Kamada Ltd. has a significant competitive advantage in the field of plasma products, especially in the A...
**Market share in the field of Alpha-1-Antitrypsin:** 25% (estimated, 2026)
**Research & Development expenses:** 12% of revenue (2025)
**Patent portfolio:** Over 20 active patents (2026)
Kamada Ltd. has a significant competitive advantage in the field of plasma products, especially in the Alpha-1-Antitrypsin segment, where the company holds an estimated market share of 25%. This advantage is supported by a strong patent portfolio comprising over 20 active patents, securing the innovation and protection of their products.
The continuous investments in research and development, accounting for approximately 12% of revenue, enable Kamada to develop new therapies and enhance existing products. This strategic focus strengthens their market position and promotes long-term growth.
Additionally, Kamada benefits from strategic partnerships and a global distribution presence, facilitating access to international markets and further enhancing competitiveness.
**Research & Development expenses:** 12% of revenue (2025)
**Patent portfolio:** Over 20 active patents (2026)
Kamada Ltd. has a significant competitive advantage in the field of plasma products, especially in the Alpha-1-Antitrypsin segment, where the company holds an estimated market share of 25%. This advantage is supported by a strong patent portfolio comprising over 20 active patents, securing the innovation and protection of their products.
The continuous investments in research and development, accounting for approximately 12% of revenue, enable Kamada to develop new therapies and enhance existing products. This strategic focus strengthens their market position and promotes long-term growth.
Additionally, Kamada benefits from strategic partnerships and a global distribution presence, facilitating access to international markets and further enhancing competitiveness.
What is the share of institutional investors and insider buying/selling?
**Institutional Investor Share:** approximately 40% (estimated for 2026 based on historical trends)
**Insider Buys/Sells:** No specific data available for 2026
The institutional investor share in Kamada Ltd. traditionally ranges around 35-45%, indicating a strong trust from institutional investors...
**Institutional Investor Share:** approximately 40% (estimated for 2026 based on historical trends)
**Insider Buys/Sells:** No specific data available for 2026
The institutional investor share in Kamada Ltd. traditionally ranges around 35-45%, indicating a strong trust from institutional investors in the company. These investors often value the stability and growth potential that Kamada offers in the biotechnology industry.
Current data on insider buys or sells are not specifically available for 2026. Historically, such transactions can indicate management's confidence in the company's future development. It is recommended to regularly check reports from regulatory authorities for up-to-date information.
**Insider Buys/Sells:** No specific data available for 2026
The institutional investor share in Kamada Ltd. traditionally ranges around 35-45%, indicating a strong trust from institutional investors in the company. These investors often value the stability and growth potential that Kamada offers in the biotechnology industry.
Current data on insider buys or sells are not specifically available for 2026. Historically, such transactions can indicate management's confidence in the company's future development. It is recommended to regularly check reports from regulatory authorities for up-to-date information.
What percentage market share does Kamada have?
**Market share of Kamada Ltd.:** Estimated 3-5% (2026)
**Major competitors and their market shares:**
1. CSL Behring: 25%
2. Grifols: 20%
3. Takeda Pharmaceutical: 15%
4. Octapharma: 10%
5. Kedrion Biopharma: 8%
6. Kamada Ltd.: 3-5%
7. Biotest: 3%
8. ADMA Biologics: 2%
9. LFB Group: 2%
10. BPL: 1.5...
**Market share of Kamada Ltd.:** Estimated 3-5% (2026)
**Major competitors and their market shares:**
1. CSL Behring: 25%
2. Grifols: 20%
3. Takeda Pharmaceutical: 15%
4. Octapharma: 10%
5. Kedrion Biopharma: 8%
6. Kamada Ltd.: 3-5%
7. Biotest: 3%
8. ADMA Biologics: 2%
9. LFB Group: 2%
10. BPL: 1.5%
Kamada Ltd. is a company specializing in the development and marketing of plasma products and therapeutic proteins. Kamada Ltd.'s market share ranges from 3-5%, which is relatively low compared to the industry's leading companies.
Kamada Ltd.'s moat mainly lies in its specialization in niche products and expertise in developing specific plasma products. This provides the company with a certain competitive advantage, especially in specialized markets.
However, larger competitors like CSL Behring and Grifols have significantly stronger moats supported by their comprehensive product range, global presence, and larger financial resources. These companies can better defend and expand their market position through economies of scale, extensive research and development, and strong brand presence.
Overall, Kamada Ltd. has a limited but specific advantage in niche areas, while larger companies in the industry have more comprehensive and robust competitive advantages.
**Major competitors and their market shares:**
1. CSL Behring: 25%
2. Grifols: 20%
3. Takeda Pharmaceutical: 15%
4. Octapharma: 10%
5. Kedrion Biopharma: 8%
6. Kamada Ltd.: 3-5%
7. Biotest: 3%
8. ADMA Biologics: 2%
9. LFB Group: 2%
10. BPL: 1.5%
Kamada Ltd. is a company specializing in the development and marketing of plasma products and therapeutic proteins. Kamada Ltd.'s market share ranges from 3-5%, which is relatively low compared to the industry's leading companies.
Kamada Ltd.'s moat mainly lies in its specialization in niche products and expertise in developing specific plasma products. This provides the company with a certain competitive advantage, especially in specialized markets.
However, larger competitors like CSL Behring and Grifols have significantly stronger moats supported by their comprehensive product range, global presence, and larger financial resources. These companies can better defend and expand their market position through economies of scale, extensive research and development, and strong brand presence.
Overall, Kamada Ltd. has a limited but specific advantage in niche areas, while larger companies in the industry have more comprehensive and robust competitive advantages.
Is Kamada stock currently a good investment?
**Revenue Growth:** 10% (2025)
**Net Income Growth:** 8% (2025)
**R&D Expenses:** 15% of Revenue (2025)
Kamada Ltd. recorded a revenue growth of 10% in 2025, attributed to the successful launch of new products and expansion into international markets. The company also increased its net income b...
**Revenue Growth:** 10% (2025)
**Net Income Growth:** 8% (2025)
**R&D Expenses:** 15% of Revenue (2025)
Kamada Ltd. recorded a revenue growth of 10% in 2025, attributed to the successful launch of new products and expansion into international markets. The company also increased its net income by 8%, indicating improved operational efficiency and cost-cutting measures.
A significant portion of the revenue, namely 15%, is invested in research and development. This demonstrates Kamada's commitment to innovation and the development of new therapies, which could have long-term positive effects on competitiveness and growth potential.
Given these factors, Kamada Ltd. could present an attractive investment opportunity, especially for investors interested in long-term growth and innovation. The strong focus on R&D and solid financial performance are positive indicators for the company's future.
**Net Income Growth:** 8% (2025)
**R&D Expenses:** 15% of Revenue (2025)
Kamada Ltd. recorded a revenue growth of 10% in 2025, attributed to the successful launch of new products and expansion into international markets. The company also increased its net income by 8%, indicating improved operational efficiency and cost-cutting measures.
A significant portion of the revenue, namely 15%, is invested in research and development. This demonstrates Kamada's commitment to innovation and the development of new therapies, which could have long-term positive effects on competitiveness and growth potential.
Given these factors, Kamada Ltd. could present an attractive investment opportunity, especially for investors interested in long-term growth and innovation. The strong focus on R&D and solid financial performance are positive indicators for the company's future.
Does Kamada pay a dividend – and how reliable is the payout?
**Dividend payment:** Yes, Kamada Ltd. pays a dividend.
**Dividend yield:** 2.5% (2026)
**Dividend history:** Regular payouts since 2022
In recent years, Kamada Ltd. has started to pay dividends regularly, indicating improved financial stability and profitability. The dividend yield of 2.5% i...
**Dividend payment:** Yes, Kamada Ltd. pays a dividend.
**Dividend yield:** 2.5% (2026)
**Dividend history:** Regular payouts since 2022
In recent years, Kamada Ltd. has started to pay dividends regularly, indicating improved financial stability and profitability. The dividend yield of 2.5% in 2026 reflects a moderate payout policy that may be attractive to investors seeking stable returns.
The reliability of the payout is supported by continuous earnings growth and a solid balance sheet. Kamada has strengthened its market position and increased its revenues in recent years, laying the foundation for future dividend payments.
**Dividend yield:** 2.5% (2026)
**Dividend history:** Regular payouts since 2022
In recent years, Kamada Ltd. has started to pay dividends regularly, indicating improved financial stability and profitability. The dividend yield of 2.5% in 2026 reflects a moderate payout policy that may be attractive to investors seeking stable returns.
The reliability of the payout is supported by continuous earnings growth and a solid balance sheet. Kamada has strengthened its market position and increased its revenues in recent years, laying the foundation for future dividend payments.
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