A. History and Development of the Company Corporate Information We were incorporated under the laws of the State of Israel on December 13, 1990, under the name Kamada Ltd. In August 2005, we successfully completed an initial public offering on the TASE. In June 2013, we successfully completed an initial public offering in the United States on the Nasdaq. The address of our principal executive office is 2 Holzman St., Science Park, P.O. Box 4081, Rehovot 7670402, Israel, and our telephone number is +972 8 9406472. Our website address is https://www.kamada.com/. The reference to our website is intended to be an inactive textual reference and the information on, or accessible through, our website is not intended to be part of this Annual Report. The SEC maintains a website at https://www.sec.gov/search-filings that contains reports, proxy and information statements and other information regarding registrants like us that file electronically with the SEC. You can also inspect the Annual Report on that website. 53 We have irrevocably appointed Puglisi & Associates as our agent to receive service of process in any action against us in any United States federal or state court. The address of Puglisi & Associates is 850 Library Avenue, Suite 204, P.O. Box 885, Newark, Delaware 19715. Capital Expenditures For a discussion of our principal capital expenditures for the three years ended December 31, 2025, and for those currently in progress, see “Item 5. Operating and Financial Review and Prospects—Liquidity and Capital Resources.” B. Business Overview We are 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. Our strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth of our commercial portfolio, including continued investment in the commercialization and life cycle management of our Proprietary Products. Our Proprietary Products consist of six FDA-approved specialty plasma-derived products: KEDRAB®, GLASSIA®, CYTOGAM®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, and two types of equine-based anti-snake venom (“ASV”) products. Second, distribution of third-party pharmaceutical products in Israel through in-licensing partnerships, including the launch of several biosimilar products in Israel, as well as expansion, during 2026, of such distribution activities to the MENA region. Third, we are ramping up our plasma collection operations to support revenue growth through the sale of normal source plasma (“NSP”) to other plasma-derived manufacturers and to support our increasing demand for hyper-immune specialty plasma. We currently own three operating plasma collection centers in the United States, located in Beaumont, Texas; in Houston, Texas, which obtained FDA approval in August 2025; and in San Antonio, Texas, which commenced operations in March 2025 for which an FDA site audit was completed in February 2026 and we expect to receive FDA approval during the first half of 2026. We are in active discussions with potential customers to secure long-term sales agreements for NSP, and anticipate initiating sales of NSP during the second half of 2026. Fourth, we aim to secure new merger and acquisition (“M&A”), business development, in-licensing and/or collaboration opportunities during 2026. These anticipated transactions aim to leverage our financial strength, enhance our marketed products portfolio, and generate synergies with our existing commercial operations to drive long-term profitable growth. We are targeting the acquisition or in-licensing of commercial products. These products may be plasma-derived, allowing us to utilize manufacturing synergies, or non-plasma-derived, leveraging our commercial, marketing, and distribution capabilities to diversify our offerings and address a broader range of specialty, rare, and serious conditions. We may also explore manufacturing services agreements to manufacture plasma-derived products for other companies, which can provide additional revenue streams and leverage our expertise in plasma-derived biopharmaceuticals. Our Commercial Activities Our commercial activities operate in two segments: the Proprietary Products segment, which encompasses our portfolio of specialty plasma therapies and NSP, and the Distribution segment, which encompasses the commercialization of in-licensed third-party biopharmaceutical products. 54 Proprietary Products Segment The Proprietary Products segment includes our specialty plasma therapies product portfolio, which is comprised of six FDA-approved plasma-derived biopharmaceutical products: KEDRAB, GLASSIA, CYTOGAM, WINRHO SDF, VARIZIG and HEPAGAM B, as well as KAMRAB, KAMRHO (D) and two types of equine-based ASV products. We distribute these products directly and through strategic partners or third-party distributors in over 30 countries. We manufacture our Proprietary Products at our cGMP production facility in Beit Kama, Israel, which is registered with the FDA, using our 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, our Proprietary Products segment includes our plasma collection operations, where we collect Anti-Rabies and Anti-D hyper-immune plasma for the manufacture of some of our Proprietary Products (WINRHO SDF, KAMRAB and KEDRAB) as well as NSP for sale to third parties. Our Proprietary Products segment sales totaled $156.2 million, $141.4 million and $115.5 million for the years ended December 31, 2025, 2024, and 2023, respectively. Most revenues from the Proprietary Products segment are generated from sales in the United States 55%, 71% and 64% for the years ended December 31, 2025, 2024 and 2023, respectively). For more information regarding the geographical sales breakdown see “Item 5. Operating and Financial Review and Prospects.” We expect that KEDRAB, GLASSIA and CYTOGAM, which combined accounted for approximately 50% of our revenues and approximately 70% of our gross profitability in the year ended December 31, 2025, will continue to be our leading products in our existing Proprietary Products portfolio for the foreseeable future. Our revenues from sales of KEDRAB to Kedrion during 2025 totaled $53.6 million, compared to $50.0 million and $32.8 million during 2024 and 2023, respectively. The increase in 2025 sales compared to 2024 is related to increased demand for KEDRAB in the U.S. market as well as Kedrion’s inventory management and timing of product supply, while the increase between 2024 and 2023 reflects increased demand for KEDRAB in the U.S. market as well as improved financial terms under the fifth amendment to the supply and distribution agreement entered into in January 2025. KEDRAB’s in-market sales in the United States grew by approximately 14% between 2024 and 2025. Our total revenues from the sales of KAMRAB (our HRIG product, sold outside the U.S. market) during 2025 totaled $17.2 million, compared to $11.7 million and $12.5 million during 2024 and 2023, respectively. The increase in 2025 sales is associated with increased demand for the product in the various markets in which it is being distributed, as well as continued increase in average sale price in these markets. During 2025, total revenues derived from GLASSIA sales outside the U.S and Canadian markets, mainly Argentina, Russia, Israel and Switzerland (in some of these markets under a different brand name), increased to $19.4 million, compared to $15.2 million and $7.4 million during 2024 and 2023, respectively. The increase in GLASSIA revenue in these other markets in 2025, compared to 2024 and 2023, is mainly attributable to newly diagnosed AATD patients receiving GLASSIA treatment. During 2025, our revenues included approximately $1.2 million in income on account of an achieved sales milestone pursuant to our distribution agreement with our distributor in Russia. In 2025, we recognized $15.8 million in sales-based royalty income from GLASSIA sales in the United States and Canada by Takeda, compared to $16.9 million and $16.1 million in 2024 and 2023, respectively. While, based on information provided by Takeda, sales of GLASSIA in these markets increased between 2024 and 2025, our royalty income decreased during 2025 due to the reduction in the royalty rate from 12% to 6% of net consolidated sales (in both territories), commencing in August 2025. Based on current GLASSIA sales by Takeda, projected future growth, and the new royalty rate, we expect annual royalties on sales of GLASSIA by Takeda during 2026 to be approximately $10 million and in the range of $10 million to $20 million per year for 2027 to 2040. Pursuant to our licensing agreement with Takeda, we are entitled to a guaranteed minimum of $5 million in annual royalty income through 2040. Total revenues from sales of CYTOGAM for the years ended December 31, 2025, 2024 and 2023, were $17.1 million, $22.5 million and $17.2 million, respectively. We believe that the decline in CYTOGAM sales in 2025 compared to 2024 was primarily due to increased usage of antivirals such as letermovir and maribavir resulting from improvements in their market access coverage. CYTOGAM and the antivirals are used to prevent CMV infection, a common post-transplant infectious complication that remains a significant medical need despite recent advances in antiviral drug therapies. 55 Our promotional efforts for CYTOGAM are focused on enhancing awareness among the medical community of the benefits of using CYTOGAM in conjunction with the antivirals due to the complementary mechanisms of action of both treatments, as well as identifying specific solid organ transplant patient profiles that are at higher risk for CMV post-transplant and may benefit from additional CMV protection with CYTOGAM. We believe that our current promotional activities, supported by new clinical data, are expected to lead to increased demand for the product in the coming years. In 2025, we launched a post marketing research program in collaboration with leading KOLs, aimed at generating key data in support of the benefits of CYTOGAM. We believe that the program, which is directed at advancing CMV disease management through novel strategies focused on late-onset CMV prevention and mitigation of active CMV disease, exploring alternative dosing strategies, and investigating potential new applications of CYTOGAM, will provide updated clinical data that would support increasing physicians’ awareness of the product’s unique properties. As part of the research program, in November 2025 we initiated a post-marketing clinical trial of CYTOGAM to prevent late CMV infection titled “Strategic Help with Immunoglobulin to Enhance protection Against Late Disease (CMV),” or SHIELD. The SHIELD study is a prospective, randomized, controlled multicenter investigator-initiated study in CMV high-risk kidney transplant recipients, conducted together with leading experts and KOLs in CMV and organ transplantation: Camille Kotton, M.D., Infectious Disease Specialist and Clinical Director, Transplant and Immunocompromised Host Infectious Diseases at Massachusetts General Hospital, and David Wojciechowski, D.O., Medical Director of the Kidney Transplantation Program at the University of Texas Southwestern Medical Center. Both investigators are recognized experts in transplant-related infections. The SHIELD study will investigate the benefits of CYTOGAM administered at the conclusion of antiviral prophylaxis to reduce the risk of clinically significant late CMV in kidney transplant recipients who are CMV seronegative and have a CMV seropositive donor. These patients are at the highest risk of developing late-onset CMV infection, which is associated with worse transplant recipient health and outcomes. Total revenues from WINRHO SDF, VARIZIG and HEPAGAM B for the years ended December 31, 2025, 2024 and 2023, was $31.4 million, $22.3 million and $26.7 million, respectively. The increase in sales between 2025 and 2024 is associated with increased sales of all three products which was achieved through multiple actions, including increased awareness of the benefits of VARIZIG and HEPAGAM B in the U.S. market and the securing of supply tenders for WINRHO SDF in the MENA region and VARIZIG in Latin America. Our total revenues from the sales of our other Proprietary Products, including KAMRHO (D) IM (for prophylaxis of hemolytic disease of newborns), ASVs sold to the IMOH, as well as collected plasma were $1.7 million in 2025, compared to $2.8 million and $2.8 million during 2024 and 2023, respectively. Over the past several years, we have invested in the expansion of our plasma collection capabilities and believe these efforts will better support our hyper-immune plasma needs, potentially lower our raw material costs, and generate additional revenue through sales of collected NSP to third parties. During 2024 and 2025, we opened two new plasma collection centers in Houston, Texas (approved by the FDA in August 2025 for the collection of NSP) and in San Antonio, Texas (which was inspected by the FDA in February 2026). Each of the Houston and San Antonio collection centers, once fully operational, is expected to contribute annual revenues of approximately $8 million to $10 million in sales of normal source plasma. Additionally, we own 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, KEDRAB and KAMRAB. Distribution Segment In the Distribution segment, we leverage our expertise and presence in the Israeli biopharmaceutical and healthcare market to distribute in Israel more than 25 pharmaceutical products that we have exclusively licensed from international manufacturers. Sales generated by our Distribution segment during 2025 totaled $24.3 million, as compared to $19.5 million and $27.1 million during 2024 and 2023, respectively. The increase in revenues during 2025 compared to the prior year is primarily the result of the launch of two biosimilar products as well as increased demand for certain other products in our portfolio. 56 As part of our Distribution segment, we have licensed a portfolio of biosimilar products from multiple international companies for distribution in Israel. Through the end of 2025, we launched two products from this portfolio in Israel and generated $2.4 million in sales during 2025 associated with the sales of these products. Two additional biosimilar products are expected to be launched during 2026, and the remaining biosimilar products are expected to be launched in Israel over the coming years, at a rate of approximately 1-3 products per year, subject to the EMA and subsequently the IMOH approvals, while continuing to explore opportunities to in-license additional biosimilar products and expand the portfolio. We believe that sales generated by the launch of biosimilar products will serve as a major growth and profitability catalyst for our Distribution segment. We estimate that revenues from the sales of our existing biosimilar products portfolio in Israel will increase to between approximately $15 million and $20 million within the next four to five years and will continue to grow thereafter, subject to the continued launch of the entire portfolio as scheduled. We are currently expanding the distribution of our in-licensed products into the MENA region by engaging third-party pharmaceutical companies to register and distribute these products in the region. 2026 Financial Guidance We currently expect to generate total revenues for the fiscal year 2026 in the range of $200 million to $205 million and adjusted EBITDA in the range of $50 million to $53 million. The midpoint of the projected 2026 revenue and adjusted EBITDA forecast represents a year-over-year increase of 13% in revenues and 23% in adjusted EBITDA. For details regarding the use of non-IFRS measures, see “Item 5. Operating and Financial Review and Prospects—Non-IFRS Financial Measures.” Proprietary Products The following tables list our Proprietary Products: Product Indication Active Ingredient KAMRAB/ KEDRAB Prophylaxis of rabies disease Anti-rabies immunoglobulin (Human) GLASSIA (or VENTIA/RESPIKAM in certain countries) Intravenous AATD Alpha-1 Antitrypsin (Human) CYTOGAM Prophylaxis of Cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and heart/lung transplants Cytomegalovirus Immunoglobulin Intravenous (Human) WINRHO SDF Immune thrombocytopenic purpura (ITP) and suppression of rhesus isoimmunization (RH) Rho(D) immunoglobulin (Human) VARIZIG Post-exposure prophylaxis of Varicella in high-risk individuals Varicella Zoster Immunoglobulin (Human) HEPAGAM B Prevention of Hepatitis B recurrence liver transplants and post-exposure prophylaxis Hepatitis B immunoglobulin (Human) KAMRHO (D) IM Prophylaxis of hemolytic disease of newborns Rho(D) immunoglobulin (Human) Echis coloratus Antiserum, Vipera palaestinae Antiserum Treatment of snake bites by the Vipera palaestinae and the Echis coloratus Anti-snake venom 57 KAMRAB/KEDRAB KAMRAB is a hyper-immune Human plasma-derived Rabies Immune Globulin (HRIG) 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 our manufacturing facility in Beit Kama, Israel from plasma that contains high levels of antibodies from donors that were 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). According to WHO, rabies is estimated to cause 59,000 human deaths annually in over 150 countries and each year more than 29 million people worldwide receive a post-bite rabies vaccination, which is estimated to prevent hundreds of thousands of rabies deaths annually. According to the U.S. Centers for Disease Control and Prevention (CDC), each year 1.4 million Americans receive healthcare for a possible rabies exposure, 100,000 receive post-exposure prophylaxis, and fewer than 10 die from rabies, thanks to effective prevention efforts. The CDC recommends that post-exposure prophylaxis (“PEP”) treatment for people who have never been vaccinated against rabies previously should always include administration of both HRIG and rabies vaccine. According to the CDC, the combination of HRIG and vaccination is recommended for both bite and non-bite exposures, regardless of the interval between exposure and initiation of treatment. We market KEDRAB in the United States through a strategic distribution and supply agreement with Kedrion that we entered into in July 2011 for the clinical development and marketing in the United States of KAMRAB. See “— Strategic Partnerships — Kedrion (KEDRAB and Other Products Distributed in Israel).” Based on the results of a phase 2/3 clinical study, in August 2017, we received FDA approval for the marketing of KAMRAB in the United States for PEP against rabies infection, and in April 2018 we, 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 84-day 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. No serious adverse events were observed during the study. No incidence of rabies disease or deaths were recorded throughout the study period. In December 2023, we 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 us to date. Subsequently, in January 2025, we 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. Under these agreements, Kedrion committed to purchasing minimum quantities of KEDRAB during the first four years (i.e., 2024 through 2027) of the eight-year term that began in January 2024, generating projected minimum aggregate revenues for us of approximately $180.0 million over such four-year period, of which a minimum of approximately $90.0 million is to be acquired during the remaining two years of such four-year period (i.e., 2026 through 2027). The distribution and supply agreement, as amended, includes the potential expansion of KEDRAB distribution by Kedrion to other territories beyond the United States. In December 2024, we secured an agreement to supply KAMRAB to an international organization, which also serves as Regional Office for the WHO, for further distribution in Latin America during the years 2025-2027. 58 GLASSIA GLASSIA is a plasma derived intravenous AAT product, 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, to maintain the benefits provided by it. GLASSIA is administered through a single weekly intravenous infusion. In the United States and Europe, we believe that AATD is currently significantly under-diagnosed and under-treated. Based on information published by the Alpha-1 Foundation, there are approximately 100,000 people with AATD in the United States and about the same number in Europe, and we estimate, based on medical literature, that less than 10% of all potential cases of AATD are treated. We believe that the primary reasons for this significant gap in the United States and Europe are under diagnosis of patients suffering from AATD, the absence of insurance reimbursement in various European countries, lengthy and complicated regulatory and reimbursement processes required to commence sales of AAT products in new markets. Similar reasons limit the diagnosis and usage of AATD treatment in other territories outside of the United States and Europe. We expect the number of patients treated for AATD to continue to increase going forward as awareness of AATD increases and given that several European countries have recently approved reimbursement for treatment of AATD, we believe that additional European countries will approve such reimbursement during the coming years. Based on a market analysis report published in 2023 by Cantor Fitzgerald, the global AATD augmentation therapy market is expected to grow at a compound annual growth rate of 7.2% at least through 2032. The estimated annual cost of treatment in the United States is between $80,000 and $120,000 per each AATD patient, depending on the patient’s body weight. In the United States, Canada, in some of the European countries and in Israel, Argentina and Russia we believe that most of the cost of treatment is covered by medical insurance programs. 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. GLASSIA obtained FDA approval in July 2010, and sales commenced in October 2010. As part of the approval, the FDA requested that we conduct post-approval Phase 4 clinical trials, as is common in the pharmaceutical industry, aimed at collecting additional safety and efficacy data for GLASSIA. According to our agreement with Takeda (See “— Strategic Partnerships — Takeda (Glassia)”), the Phase 4 clinical trials are financed and managed by Takeda, provided that if the cost of such Phase 4 clinical trials exceeds a pre-defined amount, we will participate in financing such trial up to a certain amount by offsetting such amounts from future royalties due from Takeda. The first Phase 4 safety study completed enrollment of a total of 30 subjects in the United States and Canada during 2020 and its clinical study report was completed and was submitted to the FDA in 2022. The second Phase 4 efficacy study was initiated during 2016 and was terminated two years after initiation based on the DSMB’s recommendation due to very low recruitment rates. In 2019, Takeda submitted a revised Phase 4 protocol to the FDA. Following several interactions with the FDA with respect to the Phase 4 efficacy study requirements, Takeda decided not to continue to pursue the study, however this matter remains unresolved pending the FDA’s approach to IV AAT cluster products. The majority of GLASSIA sales are in the United States (by Takeda) and, commencing in 2024, GLASSIA is also being sold by Takeda in Canada, through our companies’ strategic partnership. Since March 2022, we have been receiving royalties on GLASSIA sales manufactured by Takeda in the United States, and, commencing in 2024, in Canada. We will be entitled to royalty income on sales of GLASSIA by Takeda in Australia and New Zealand, to the extent that GLASSIA will be approved, and sales will be generated in these markets by Takeda in the future. The royalty income was 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, with a guaranteed minimum of $5 million annually from 2022 to 2040. Through 2021, we generated revenues from sales of GLASSIA, manufactured by us, to Takeda for further distribution in the United States. During 2021, Takeda completed the technology transfer of GLASSIA manufacturing to its facility in Belgium, received the required FDA approval, and began its own production of GLASSIA for the U.S. market. In addition, Takeda obtained marketing authorization approval for GLASSIA from Health Canada in 2021. In December 2023, Takeda announced that it entered into a two-year contract with the Canadian Blood Services (“CBS”) for the supply of GLASSIA, which commenced in early 2024. 59 We also market GLASSIA in other counties, mainly Argentina, Russia, Israel and Switzerland (in some of these markets under a different brand name), through local distributors. In May 2023, Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, granted marketing authorization for GLASSIA for AATD in Switzerland. We have 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. CYTOGAM CYTOGAM (CMV-IGIV), which we acquired from Saol in November 2021, is indicated for the prophylaxis of CMV disease associated with the transplantation of the kidney, lung, liver, pancreas and heart. Approved by the FDA in 1998, CYTOGAM is the sole FDA-approved plasma-derived IgG product for this indication. 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 to be 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. Based on the Organ Procurement and Transplantation Network, 49,064 solid organ transplant procedures were performed in the United States in 2025. Transplantation numbers have grown as a result of increasing and more effective usage of organs from less traditional donors, including older individuals and people who have died of cardiorespiratory failure. Several available antivirals (ganciclovir and valganciclovir) are being used and are considered standards of care for the prevention of CMV infection in high-risk patients. As CMV infection in immunocompromised solid organ transplant patients can be severe and life-threatening, we believe that administration of CYTOGAM together with available antivirals may provide additional protection in preventing CMV disease for certain high-risk transplant populations, such as lung transplant patients, due to its complementary mechanism of action to antiviral drug therapy. We believe there is under-utilization of CYTOGAM as CMV prophylaxis in specific CMV high-risk patient profiles across all organs (short-telomere syndrome in lung transplant patients or kidney transplant patients with delayed graft function and belatacept-based immunosuppression).We are currently advancing a comprehensive clinical program, which includes prospective investigator-initiated studies, aimed at generating data to support the ongoing use of CYTOGAM and identifying potential innovative applications. Through our continuous efforts to communicate new and existing clinical data for CYTOGAM, we aim to achieve increased utilization. 60 Over the past four years we have engaged KOLs in the United States to study and present their ongoing clinical experiences with CYTOGAM for scientific knowledge exchange and to support further research of CYTOGAM. At the American Transplant Congress in 2024, Jennifer Chow, MD, Transplant Infectious Diseases specialist at Tufts Medical Center, presented the results of an investigator-initiated study (“IIS”) analyzing the stored samples of a previously conducted placebo-controlled randomized controlled interventional study of CYTOGAM prophylaxis that demonstrates the potential anti-viral and disease attenuation effect of CYTOGAM in moderate to low CMV risk liver transplant patients. In April 2025, we presented the results of internal research comparing the functional properties of CYTOGAM and regular intravenous immune globulin (IVIG) against CMV and other common viruses at the International Society for Heart & Lung Transplantation 2025 Annual Meeting. The study demonstrates that CYTOGAM has 4-fold higher anti-CMV antibodies than regular IVIGs, while also highlighting the polyvalent characteristics of both hyperimmune globulins, such as CYTOGAM, and regular IVIGs, which are not well described in the literature. In July 2025, the results of an investigator-initiated, single-center, long-term follow-up (8 years) retrospective study were published in Clinical Transplantation. The study was conducted by Fernando Torres, M.D., Clinical Chief, Division of Pulmonary and Critical Care at University of Texas Southwestern Medical Center, and consisted of 324 lung-transplant patients, evaluating the real-world use of CYTOGAM in combination with anti-viral agents for the prevention of CMV disease in high-risk CMV mismatch lung transplant recipients (CMV seronegative patients receiving a lung from a seropositive donor). The authors concluded that the use of a proactive multimodality CMV prophylaxis consisting of antivirals and immune augmentation with CMV immunoglobulin attenuated the negative impact of CMV D+/R by enabling high-risk patients to achieve long-term survival and CLAD (Chronic Lung Allograft Dysfunction) outcomes similar to non-high-risk patient recipients. In May 2025, we launched a new post-marketing research program aimed at generating key data on the benefits of CYTOGAM in the management of CMV in solid organ transplantation. The program includes a total of ten studies that are being conducted in collaboration with leading U.S. physicians, primarily as investigator-initiated studies. Results from these studies are expected to be published and/or presented in peer-reviewed scientific journals and at major medical meetings over the coming years. The clinical program includes three prospective clinical studies that are actively screening patients for enrollment. In July 2025, the first patient was enrolled in a prospective, single-center clinical study regarding the prophylactic use of CYTOGAM for CMV infection or disease in solid organ transplant recipients. In November 2025, the first patient was enrolled in the SHIELD study, a prospective, randomized, controlled, multicenter, investigator-initiated clinical trial evaluating the role of CYTOGAM in reducing the risk of late CMV disease following completion of standard antiviral prophylaxis in high-risk kidney transplant recipients. In December 2025, the third annual Kamada Scientific Advisory Board meeting, consisting of six U.S.-based renowned thought leaders in neonatology, pediatric infectious disease, and CMV, was held. During the meeting, innovative investigator-initiated research regarding postnatal CMV in very preterm infants and potential opportunities for CYTOGAM was discussed. Additionally, the participants provided feedback regarding unmet needs related to congenital and postnatal CMV, including future potential research and development possibilities. CYTOGAM is registered and sold in the United States and Canada. CYTOGAM is manufactured at our facility in Beit Kama, Israel, and has been available for commercial sale in the United States since October 2023, following FDA approval in May 2023 for the technology transfer to manufacture CYTOGAM at our facility. The FDA approval marks the successful completion of the technology transfer process of CYTOGAM from the previous manufacturer, CSL Behring. In the fourth quarter of 2023, CYTOGAM manufactured at our facility in Beit Kama was shipped to Canada for the first time, following Health Canada’s approval in July 2023 to manufacture CYTOGAM at our facility. We believe that our ongoing clinical and medical affairs activities, which include collaborations with leading U.S.-based solid organ transplantation experts to generate and present new real-world data on the benefits of CYTOGAM, as well as planned prospective investigator-initiated studies evaluating the benefits and potential innovative uses of CYTOGAM, will continue to raise awareness of CYTOGAM. These efforts aim to explore new approaches to current clinical practices in CMV prevention in solid organ transplantation as well as innovative new applications for CYTOGAM, which are expected to support sustained sales growth. 61 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, which we acquired from Saol in November 2021. ITP is a blood disorder characterized by a decrease in the number of platelets – the cells that help blood clot. Findings published during 2019 suggest that nearly 20,000 children and adults are newly diagnosed with ITP each year in the United States. Rho(D) immunoglobulin is an effective option for rapidly increasing platelet counts in patients with symptomatic ITP. Hemolytic Disease of the Newborn (“HDN”) is a blood disorder in a fetus or newborn infant. In some infants, it can be fatal. During pregnancy, Red Blood Cells (“RBCs”) from the unborn baby can cross into the mother’s blood through the placenta. HDN occurs when the immune system of the mother identifies the baby’s RBCs as foreign. Antibodies then develop against the baby’s RBCs. These antibodies attack the RBCs in the baby’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. 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. Currently, 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 in the United States to treat HDN due to a shortage of competing products. This shortage was resolved by the fourth quarter of 2024, leading to a return of its primary use for ITP treatment. We obtained FDA acknowledgment for the transfer of the ownership of the BLA for WINRHO SDF in September 2022. The ownership transfer of the drug identification number (“DIN”) for WINRHO was approved by Health Canada in June 2022. We have 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 currently manufactured by Emergent under a contract manufacturing agreement assigned to us by Saol upon the consummation of the acquisition. We expect to continue manufacturing the product with Emergent in the foreseeable future and are planning to initiate a transition of the manufacturing of WINRHO SDF to our facility in Beit Kama, Israel. Such transition would require certain changes to manufacturing processes, potential amendments to the contract manufacturing agreement with Emergent, and the receipt of required regulatory approvals. We anticipate that such transition will be completed within four to five years. Our 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. 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, which we acquired from Saol in November 2021. 62 VZV causes varicella (chickenpox), a common childhood illness, and herpes zoster (shingles), which is caused by the reactivation of VZV. The incidence of herpes zoster increases with age or immunosuppression. Individuals at highest risk of developing severe or complicated varicella include immunocompromised individuals, preterm infants, and pregnant women. It has been demonstrated that administering VARIZIG post-exposure to VZV is associated with low rates of varicella in high-risk patients and reduces severity of varicella in immunocompromised children and adults. We received FDA acknowledgment for the transfer of the ownership transfer of the BLA for VARIZIG in September 2022. Health Canada approved the DIN ownership transfer in June 2022. In December 2024, we were awarded a tender to supply VARIZIG to an international organization, which also serves as the Regional Office for the WHO, for further distribution across Latin America for the years 2025-2027. VARIZIG is currently manufactured by Emergent under a contract manufacturing agreement assigned by Saol upon the consummation of the acquisition. We expect to continue manufacturing the product with Emergent in the foreseeable future and are planning to initiate a transition of the manufacturing of VARIZIG to our facility in Beit Kama, Israel. Such transition would require certain changes to manufacturing processes, potential amendments to the contract manufacturing agreement with Emergent, and the receipt of required regulatory approvals. We anticipate that such transition will be completed within four to five years. In October 2022, we were awarded an extension of a then-existing tender from CBS, which manages the supply of blood and plasma products across all Canadian provinces and territories, excluding Quebec, for the supply of the four IgG products: CYTOGAM, HEPAGAM, VARIZIG and WINRHO SDF, for three years, commencing on April 1, 2023, for an approximate total value of $22.0 million, securing the continued sales of these products in the Canadian market. In December 2025, the tender was extended, securing ongoing sales of approximately $5.0–$7.0 per year for the period from the second quarter of 2026 through the first quarter of 2028. In Quebec, we supply CYTOGAM, HEPAGAM, VARIZIG and WINRHO SDF under an agreement with Hema-Quebec, initially assigned to us from Saol. In March 2024, we entered into a renewed agreement with Hema-Quebec for CYTOGAM, HEPAGAM, and VARIZIG, for a period of three years, commencing April 2024, and have an option to extend the agreement for up to two additional years. The parties are currently discussing the extension of the agreement. Our revenues from sales of these products in Canada, under both the CBS and Hema-Quebec agreements, totaled $7.8 million for the year ended December 31, 2025, as compared to $7.5 million and $9.1 million during 2024 and 2023, respectively. 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 us from Saol in November 2021. Liver transplantation is the treatment of choice for patients with end-stage liver disease secondary to chronic hepatitis B. However, liver transplantation is complicated by the risk of recurrent HBV infection, which significantly impairs graft and patient survival. Prevention of HBV reinfection includes use of antiviral therapy, with the addition of HBIG. HBIG treatment is based upon the rationale that administered antibody will bind to and neutralize circulating virions, thereby preventing graft infection. In the U.S. market, HEPAGAM B is primarily used for post-transplant prophylaxis, where it competes with Nabi-HB, a product of ADMA. We believe that our ongoing registration and marketing activities in additional countries, will support the continued usage of HEPAGAM B in ex-U.S. markets. We 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. We have obtained approval for the transfer of registration ownership of the product in all other applicable territories. HEPAGAM B is currently manufactured by Emergent under a contract manufacturing agreement assigned by Saol upon the consummation of the acquisition. We expect to continue manufacturing the product with Emergent in the foreseeable future and are planning to initiate a transition of the manufacturing of HEPAGAM B to our facility in Beit Kama, Israel. Such transition would require certain changes to manufacturing processes, potential amendments to the contract manufacturing agreement with Emergent, and the receipt of required regulatory approvals. We anticipate that such transition will be completed within four to five years. 63 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). We manufactured and distributed the product through the end of 2024. Snake Bite Antiserum Our 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. Our 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. We manufacture snake bite antiserums pursuant to an agreement with the IMOH, initially entered into in March 2009 following a tender that we won. The agreement has been extended and amended several times since then, under exemption from a tender. The parties have finalized the extension of the agreement until mid-November 2026. Production of our snake bite antiserums began in August 2011, and sales to the IMOH commenced in 2012. Under the agreement, and subject to its terms, the IMOH has undertaken to purchase from us, and we have undertaken to supply to the IMOH, a minimum quantity of snake bite antiserums each year during the term of the agreement. Over the years we have successfully passed multiple IMOH inspections. Additionally, in 2025, we were audited by the WHO, which inspected the manufacturing of our snake bite antiserum products. This audit was conducted by the WHO to facilitate potential future distribution of these products through the WHO. To date, we have not entered into a supply agreement with the WHO covering these products. Plasma Collection As part of our strategy of evolving into a fully integrated specialty plasma company, we established Kamada Plasma LLC, a wholly owned subsidiary, which operates our plasma collection operations in the United States. We currently have three plasma collection centers in the United States. In March 2021, we acquired our first plasma collection center in Beaumont, Texas. The center is registered with the FDA and specializes in the collection of hyper-immune plasma for the manufacture of WINRHO SDF, KAMRAB and KEDRAB. The Beaumont plasma collection center successfully passed FDA inspections in January 2024 with no critical observations. In March 2023, we entered into a lease agreement for a facility in Houston, Texas, and in September 2024, after completing construction and obtaining the required site registration, we commenced plasma collection operations at the Houston center. In August 2025, we received FDA supplemental approval for NSP collection operations at the Houston center. In May 2024, we entered into a lease agreement for a facility in San Antonio, Texas, and in March 2025, after completing construction and obtaining the required site registration, we commenced plasma collection operations at the San Antonio center. We submitted a prior approval supplement to the FDA for the site in June 2025, the FDA site audit was completed during February 2026. We expect that our plasma collection site in San Antonio, Texas, will receive FDA approval during the first half of 2026. 64 The Houston and San Antonio plasma collection centers are expected to become two of the largest specialty plasma collection centers in the United States, while collecting NSP for sale to third parties. We also intend to apply for EMA approval of both the Houston and San Antonio plasma collection centers to enable future sales of NSP to potential European customers. We are ramping up plasma collection at our three collection centers and are in active discussions with potential customers to secure long-term supply agreements for NSP. Once at full collection capacity, each of the Houston and San Antonio collection centers is expected to contribute annual revenues of $8 million to $10 million in sales of NSP. While we remain dependent on third-party supplies of hyper-immune plasma for the manufacturing of our Proprietary Products, we believe that the expansion of our plasma collection capabilities will enable us to better support our hyper-immune plasma needs and lower manufacturing costs, as well as generate additional revenues through sales of collected NSP to third parties. Distribution Segment The Distribution segment encompasses the commercialization and distribution of third-party biopharmaceutical products. We leverage our expertise and presence in the Israeli biopharmaceutical market to distribute more than 25 pharmaceutical products in Israel, exclusively licensed for distribution in Israel from leading international pharmaceutical manufacturers. We engage third-party pharmaceutical companies, register their products with the IMOH, import the products to Israel, and market, sell and distribute them to local HMOs, hospitals and pharmacies. We are currently expanding the distribution operation of in-licensed products to the MENA region by engaging third-party pharmaceutical companies to register and distribute their products in the region. The primary products that we distribute in Israel include pharmaceuticals for critical care delivered by injection, infusion or inhalation. Sales generated by our Distribution segment during 2025 totaled $24.3 million, compared to $19.5 million and $27.1 million during 2024 and 2023, respectively. Such reported sales are only associated with distribution of products in the Israeli market, as distribution in the MENA region has not yet commenced. The increase in revenues during 2025 is due to the launch of biosimilar products, as well as continued growth in the distribution of our existing product portfolio. Over the past several years, we have continued to expand our Distribution segment product portfolio to non-plasma derived products, such as licensing a portfolio of biosimilar products from multiple international companies for distribution in Israel. In the first quarter of 2024, we successfully launched our first biosimilar product in Israel, BEVACIZUMAB KAMADA, a 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. Sales from the product totaled $2.4 million during 2025 and $1.5 million during 2024. In the fourth quarter of 2025, we successfully completed the launch, in Israel, of our second biosimilar product, PEGFILGRASTIM, a biosimilar to Neulasta, which is indicated for the treatment of neutropenia in patients treated with cytotoxic chemotherapy. Two additional biosimilar products are expected to be launched in Israel during 2026, 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, subject to EMA and subsequently IMOH approvals, while continuing to explore opportunities to in-license additional biosimilar products and expand the portfolio. We believe that sales generated by the launch of the biosimilar products will serve as a major growth and profitability catalyst for our Distribution segment. We estimate that revenues from the sales of our existing biosimilar product portfolio in Israel will increase to between approximately $15 million to $20 million within the next four to five years and will continue to grow thereafter, subject to the continued launch of the entire portfolio as scheduled. 65 The following table sets forth the products in our Distribution segment that are currently distributed by us in the Israeli market. Product Indication Active Ingredient Respiratory BRAMITOB Management of chronic pulmonary infection due to pseudomonas aeruginosa in patients six years and older with cystic fibrosis Tobramycin FOSTER Regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate Beclomethasone dipropionate, Formoterol fumarate TRIMBOW Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) with Asthma Maintenance treatment of asthma Beclomethasone dipropionate, Formoterol fumarate, Glycopyrronium as bromide PROVOCHOLINE Diagnosis of bronchial airway hyperactivity in subjects who do not have clinically apparent asthma Methacholine Chloride AEROBIKA OPEP device None RUPAFIN Symptomatic treatment of Allergic rhinitis and Urticaria Rupatadine RUPAFIN ORAL SOLUTION Symptomatic treatment of allergic rhinitis in children aged 2 to 11 years and urticaria in children aged 2 to 11 years Rupatadine SINTREDIUS Rheumatoid arthritis, systemic lupus erythematosus, mild-moderate juvenile dermatomyositis. Severe or debilitating allergic conditions, not treatable in a conventional manner such as: bronchial asthma in children, bronchial asthma in adults. Sarcoidosis in children and for maintenance therapy in adults. Acquired haemolytic anaemia. Prednisolone as Sodium Phosphate Immunoglobulins IVIG Treatment of various immunodeficiency-related conditions Gamma globulins (IgG) (human) VARITECT Preventive treatment after exposure to the virus that causes chicken pox and zoster herpes Varicella zoster immunoglobulin (human) ZUTECTRA Prevention of HBV re-infection in HBV-DNA negative patients 6 months after liver transplantation for hepatitis B induced liver failure Hepatitis B immunoglobulin (human) HEPATECT CP Prevent contraction of Hepatitis B by adults and children older than two years Hepatitis B immunoglobulin (human) MEGALOTECT CP Contains antibodies that neutralize CMV viruses and prevent their spread in immunologically impaired patients CMV immunoglobulin (human) Critical Care HEPARIN SODIUM INJECTION Treatment of thrombo-embolic disorders such as deep vein thrombosis, acute arterial embolism or thrombosis, thrombophlebitis, pulmonary embolism, fat embolism. Prophylaxis of deep vein thrombosis and thromboembolic events Heparin sodium 66 ALBUMIN and ALBUMIN Maintains a proper level in the patient’s blood plasma Human serum Albumin Coagulation Factors Factor VIII Treatment of Hemophilia Type A diseases Coagulation Factor VIII (human) Factor IX Treatment of Hemophilia Type B disease Coagulation Factor IX (human) COAGADEX Treatment specifically for hereditary factor X deficiency Coagulation factor X Vaccinations IXIARO Active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older Japanese encephalitis purified inactivated vaccine VIVOTIF Immunization against disease caused by Salmonella Typhi Typhoid vaccine live oral RABIPUR – Rabies Vaccine Active immunization against rabies for pre-exposure and post-exposure prophylaxis in all age groups Inactivated rabies virus (Flury LEP strain) grown in purified chick embryo cells (PCEC) Metabolic Disease PROCYSBI Nephropathic cystinosis in adults and children 1 year of age and older Cysteamine Biartrate LAMZEDE Treatment of alpha-mannosidosis Velmanase alfa RYPLAZIM Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia) Plasminogen, human-tvmh) Oncology ELIGARD Management of advanced prostate cancer Leuprolide acetate BIOSIMILARS BEVACIZUMAB KAMADA A monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease for cancer. It is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, and renal-cell carcinoma Bevacizumab PEGFILGASTRIM KAMADA Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing cytotoxic chemotherapy administered at intervals of 14 days or longer for malignancies, excluding chronic myeloid leukemia and myelodysplastic syndromes. PEGFILGRASTIM 67 Our Development Product Pipeline In addition to our commercial operation, we invest in research and development of new product candidates, targeting significant unmet medical needs. Our research and development activities include conducting pre-clinical and clinical trials for new product candidates, as well as other development activities for our 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 our commercial products and clinical and development programs. We incurred approximately $13.0 million, $15.2 million and $13.9 million in research and development expenses in the years ended December 31, 2025, 2024 and 2023, respectively. We are currently in various stages of pre-clinical and clinical development of new product candidates within our Proprietary Products segment, and are in the process of performing mandatory close-out activities for the Inhaled AAT study following our decision to discontinue the program. Inhaled Formulation of AAT for AATD We pursued the development of an inhaled AAT therapy as a potential alternative to the current standard of care for AATD patients of weekly intravenous (IV) infusions, with the objective of enhancing patient convenience and achieving targeted pulmonary delivery. Leveraging our proprietary expertise from the development and commercialization of GLASSIA, we formulated and advanced a high-purity inhaled formulation of GLASSIA through multiple clinical phases, including a European Phase 2/3 trial and U.S. Phase 2 studies. These studies established the safety profile and pharmacokinetic advantages of the formulation; however, the results from these studies were not sufficient to obtain regulatory approval for the product, as the European Phase 2/3 study failed to meet its predefined efficacy endpoints. In 2019, we commenced a global, randomized, double-blind, placebo-controlled Phase 3 InnovAATe pivotal study under the guidance of the FDA and the EMA. In December 2025, we announced that the independent Data and Safety Monitoring Board (DSMB) advised us that, based on a prespecified interim futility analysis, the Phase 3 InnovAATe trial is unlikely to demonstrate a statistically significant benefit in its primary endpoint—lung function measured by FEV1. Based on the futility analysis outcome, we announced our decision to discontinue the trial. The discontinuation was solely due to the low likelihood of achieving the efficacy outcome and was not reflective of any safety concerns. Following our announcement, we took appropriate steps to inform all participating sites and other stakeholders of our decision to discontinue the study, and we are currently carrying out the discontinuation process in an organized and efficient manner. In connection with the discontinuation of the InnovAATe clinical trial, we will also terminate our agreements with PARI. Prior to conducting the futility analysis, we entered into an exclusivity letter with an international biopharmaceutical company in connection with the potential out-licensing of the distribution rights of the Inhaled AAT product. In consideration for the terms of the exclusivity letter, we received a non-refundable payment of $3.0 million. Following the decision to discontinue the InnovAATe clinical trial, such exclusivity letter was terminated and the payment received was recorded as an offset to our 2025 research and development expenses associated with the clinical trial. For detailed information regarding the Inhaled AAT development project, see “Item 4B. Information on the Company — Business Overview — Our Development Product Pipeline — Inhaled Formulations of AAT for AATD” of our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on March 5, 2025. 68 Recombinant AAT During 2020, we initiated the development of a recombinant human Alpha 1 Antitrypsin (“rhAAT”) product, focusing on therapeutic indications which would potentially leverage the immune-modulatory mechanism of action of the protein. As part of this project, we developed analytical tools that support the selection of the appropriate cell lines and characterization of the product. We engaged Cellca, a CDMO located in Germany, part of 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 of 2022 to 2024, we tested the clones previously selected using in-vitro and two ischemic reperfusion injury (“IRI”) in-vivo models. The results of these studies indicated significant tissue-protective effect of the rhAAT, as well as enhanced animal survival. We continue to seek a strategic partner to collaborate in the further development of this product, and we do not plan to continue its development independently. Early-stage development programs During 2025, we continued to advance two early-stage development programs of plasma derived product candidates. These programs include: (i) human plasma-based eye drops for potential treatment of several ocular conditions, which is currently under pre-clinical evaluation, and (ii) a hyper-immune anti-tuberculosis IgG as a potential complementary treatment to the 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 we plan to complete in-vivo testing of the product during 2026. We plan to advance these programs until completion of proof-of-concept, at which point we plan to evaluate continued internal development, partnering or out-licensing. Investigators initiated studies We are actively supporting IIS related to our commercial products. These studies are clinical trials that are conceived, developed, and conducted by independent researchers or institutions, rather than by pharmaceutical companies. Unlike regular industry-sponsored studies, in IIS, the investigator acts as both the sponsor and the principal investigator, taking full responsibility for the study’s design, implementation, and management. These studies offer both clinical and commercial value. Clinically, IIS generate real-world data on drug effectiveness and safety, addressing questions that arise in day-to-day medical practice. Commercially, they provide us with a cost-effective source of clinical data while maintaining a hands-off approach. IIS can explore new therapeutic indications for existing drugs, compare different treatment options, or evaluate cost-effectiveness, often focusing on areas that may not be commercially viable for pharmaceutical companies to pursue directly. By supporting IIS, we can gain valuable insights into our product’s performance across diverse clinical settings without incurring the full responsibilities and costs associated with sponsoring the research. In connection with our support of IIS, in May 2025, we announced the launch of a new post-marketing research program aimed at generating key data in support of the benefits of CYTOGAM. The research program, developed in collaboration with leading KOLs, is directed at advancing CMV disease management through novel strategies focused on late-onset CMV prevention and mitigation of active CMV disease, exploring alternative dosing strategies, and investigating potential new applications of CYTOGAM. The program also includes research aimed at enhancing the understanding of CYTOGAM’s mechanism of action and its functional properties against CMV and other viruses. Health economic studies to analyze the cost burden of CMV in solid organ transplantation are also planned, along with a clinical practice study to better understand the nuances of current CMV management in lung transplantation. Strategic Partnerships We currently have strategic partnerships with several companies to support the distribution and/or development of our products portfolio. Certain strategic partnerships relating to our Proprietary Products segment are discussed below. 69 Kedrion (KEDRAB for the U.S and Other Products Distributed by Kamada in Israel) On July 18, 2011, we entered into a supply and distribution agreement with Kedrion, a biopharmaceutical company that collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies 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 our 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 our 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 us and Kedrion. In October 2016, we 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 we 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. We retain 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. For more information about the product, see above “Item 4B. Information on the Company —Business Overview — Proprietary Products Segment — Our Commercial Product Portfolio — Proprietary Products — KAMRAB/KEDRAB”. 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, which it exercised in July 2023. In December 2023, we 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 us to date. Subsequently, in January 2025, we entered into an amendment to the distribution agreement, which supersedes and memorializes the agreements and undertakings set forth in the binding memorandum of understanding, along with additional terms and conditions. Under these agreements, the distribution agreement was extended until December 31, 2031, and Kedrion has the right to extend the agreement for an additional two years, until December 31, 2033, by providing written notice no later than December 31, 2030. Under the terms of the amended distribution agreement, Kedrion committed to purchasing minimum quantities of KEDRAB during the first four years (i.e., 2024 through 2027) of the eight-year term that began in January 2024, generating projected minimum aggregate revenues for us of approximately $180.0 million over such four-year period, of which a minimum of approximately $90.0 million is to be acquired during the remaining two years of such four-year period (i.e., 2026 through 2027). In addition, the parties agreed on a mechanism to be used in determining the minimum purchase commitments for 2028 through the end of the term of the agreement. KEDRAB’s in-market sales in the United States grew significantly in 2023 and continued to grow at lower double-digit rates during 2024 and 2025, reflecting increased demand for KEDRAB in the U.S. market. In addition, the parties agreed to explore the potential expansion of KEDRAB distribution by Kedrion to other territories beyond the United States. In addition to customary termination provisions (including the right of either party to terminate the agreement if the other party fails to perform or violates any provision of the agreement in any material respect and the failure continues unremedied for a defined period), Kedrion has the right to terminate the agreement, upon prior written notice, (i) for any reason after receipt of FDA approval, (ii) in the event that the FDA BLA is suspended or revoked and cannot be reinstated within a certain period of time, or (iii) a major regulatory change occurs that materially and adversely increases the clinical trial costs. We have the right to terminate the agreement in the event that (i) a major regulatory change occurs that materially and adversely increases the manufacturing costs of KEDRAB, (ii) a major regulatory change occurs that poses considerable difficulties on submission of an application for FDA approval, or (iii) clinical trials are not initiated within a certain time after either receipt by Kedrion of enough product or FDA approval to begin clinical trials. Upon termination or expiration of the agreement, Kedrion’s exclusive rights to market and sell KEDRAB in the U.S. market will be canceled, at which point we may elect to market and sell the product in the U.S. market on our own or otherwise engage a different distributor. 70 For information related to a plasma purchase agreement with Kedplasma, a subsidiary of Kedrion, for the supply of anti-rabies hyper-immune plasma required for the manufacturing of KAMRAB/KEDRAB see “Raw Materials” section below. Takeda (GLASSIA) We have a strategic arrangement with Takeda comprised of three main agreements: (1) an exclusive manufacturing, supply and distribution agreement, pursuant to which through 2021, we 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 our knowledge and patents to produce, develop and sell GLASSIA; and (3) a fraction IV-I paste supply agreement, pursuant to which Takeda supplies us with fraction IV plasma, a plasma derivative, produced by Takeda, as further discussed under “— Manufacturing and Supply — Raw Materials — Plasma derived Fraction IV paste for GLASSIA manufacturing.” Other than with respect to plasma-derived AAT administrated by IV, we retain 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. 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 which 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. We undertook to reimburse Takeda for its GLASSIA marketing efforts up to a limited amount during the years 2017-2020. 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, we agreed to fund a portion of the additional costs. 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, we completed the supply of GLASSIA to Takeda, and through the end of 2023, we remained an approved supplier of the product. We do not anticipate resuming the manufacturing and supply of 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 our 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. Pursuant to the technology license agreement, following the initiation of sales of GLASSIA manufactured by Takeda, Takeda is required to pay us royalties at a rate of 12% on net sales through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually, for each of the years from 2022 to 2040. During the first quarter of 2022, Takeda began to pay us royalties on sales of GLASSIA manufactured by it in the United States. 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. For the years ended December 31, 2025, 2024 and 2023, we accounted for $15.8 million, $16.9 million and $16.1 million, respectively, of sales-based royalty income from Takeda. 71 Pursuant to the technology license agreement, the intellectual property rights for any improvements on the manufacturing process or formulations belong to the party that develops the improvements, with each party agreeing to cross-license the developed improvements to the other party. We retain an option to license any intellectual property developed by Takeda under the agreement that is not considered an improvement on the licensed technology. Additionally, Takeda owns any intellectual property it develops using the licensed technology for new indications for the intravenous AAT product, for which we retain an option to license at rates to be negotiated. Any technology related to new indications for the intravenous AAT product developed by us during the royalty payments period will be part of the licensed technology covered by the technology license agreement. The technology license agreement expires in 2040. Either party may terminate the agreement, in whole or solely with respect to one or more countries covered by the distribution agreement, pursuant to customary termination provisions. Takeda also has the right to terminate the agreement, upon prior written notice, in the event that: (i) our manufacturing process technology for GLASSIA is determined to materially infringe upon a third party’s intellectual property rights, and we have not obtained a license to such third party’s intellectual property or provided an alternative non-infringing manufacturing process; (ii) there are certain decreases in GLASSIA sales in the United States unless such decreases are due to transfers to Inhaled AAT for AATD; or (iii) the regulatory approval process in the United States has been withdrawn or rejected as a result of our inaction or lack of diligent effort, provided such withdrawal or rejection was not primarily caused by a breach by Takeda of its obligations. We have the right to terminate the agreement, upon prior written notice: (i) if Takeda contests or infringes upon our intellectual property; (ii) if regulatory approval in one or more countries covered by the technology license agreement is withdrawn or rejected and not reversed, provided it was not primarily caused by the breach by us of our obligations; or (iii) in the event that GLASSIA produced by Takeda, other than as a result of our manufacturing process technology, is determined to materially infringe upon a third party’s intellectual property rights, provided that the termination right is limited only to the country in which such judgment is binding. Following any termination, other than expiration of the agreement, all licensed rights will revert to us. Upon expiration of the agreement, Takeda will be entitled to a non-exclusive, perpetual, royalty free license. Pursuant to the exclusive manufacturing, supply and distribution agreement and the technology license agreement, we were entitled to receive an upfront payment and certain payments for the achievement of certain development-based milestones related to the transfer of technology to Takeda and sales-based milestones. To date, we received all such payments under these agreements in the total aggregate amount of $45 million. PARI In connection with the clinical development of our Inhaled AAT product, we entered into several agreements with PARI for the supply its “eFlow” nebulizer during the clinical phase of the program and, if commercialized, for potential commercialization. Following our decision to discontinue the InnovAATe clinical trial, we are in the process of terminating our agreements with PARI. Manufacturing and Supply We have a production plant located in Beit Kama, Israel. We currently manufacture five of our proprietary plasma-derived commercial products, including three FDA approved products, in this facility: KEDRAB/KAMRAB, GLASSIA, CYTOGAM and two types of snake bite antiserum product. In December 2022, we submitted an application to the FDA, and in May 2023, we received FDA’s approval to manufacture CYTOGAM at our facility in Beit Kama, Israel. Following FDA’s approval, CYTOGAM manufactured at our 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, we also received the approval of Health Canada to manufacture CYTOGAM at our facility, following a technology transfer application that we submitted in January 2023. As part of the CYTOGAM technology transfer process, we engaged Prothya as a third-party contract manufacturer to perform certain manufacturing activities required for the manufacturing of CYTOGAM. 72 We operate our 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 we conduct routine maintenance shutdowns of our plant, which may last up to a few weeks. In addition, we periodically invest in upgrading infrastructure and adjusting capacity needs. Our production plant has consistently 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, our 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). In 2025, we were audited by the WHO, which inspected the manufacturing of our snake bite antiserum products. This audit was conducted by the WHO to facilitate potential future distribution of these products through the WHO. To date, we have not entered into a supply agreement with the WHO covering these products. Most changes in our production processes related to our Proprietary Products segment must be approved by the FDA and/or similar authorities in other jurisdictions. From time to time, we make certain required modifications to our manufacturing process and are required to make certain filings to report such changes to the FDA and/or other similar authorities. During 2025, we commenced a project to acquire and install a new state-of-the-art filling line and construct a new filling suite in our Beit Kama Facility. In parallel, we initiated a project to implement a new IgG purification process utilizing caprylic acid. Both projects aim to increase overall manufacturing capacity and efficiency by enhancing yield per batch, reducing manufacturing costs, and supporting our long-term competitiveness and business continuity. These projects are intended to be advanced in parallel and are expected to be completed and approved by the relevant regulatory authorities, including the FDA, by 2030. This initiative demonstrates our ongoing commitment to improving operational efficiency and gross profit while enabling scalable, cost-effective production of our plasma-derived products. WINRHO SDF, VARIZIG and HEPAGAM B, which we acquired in November 2021, are currently manufactured by Emergent under a manufacturing services agreement that we assumed as part of the acquisition of the portfolio from Saol. Under the agreement, Emergent serves as our exclusive manufacturer for these three products. The manufacturing services are performed at Emergent’s facilities in Winnipeg, Canada. The current agreement is in effect until September 27, 2027. We expect to continue manufacturing these products with Emergent while planning to transition their production to our facility in Beit Kama, Israel, utilizing the new caprylic acid purification process. Such transition would require certain changes to manufacturing processes, potential amendments to the contract manufacturing agreement with Emergent, and the receipt of required regulatory approvals. We anticipate that such transition would be completed within four to five years. Raw Materials The main raw materials in our Proprietary Products segment are hyper-immune plasma and fraction IV derived from NSP. We also use other raw materials, including both natural and synthetic materials. We purchase raw materials from suppliers who are regulated by the FDA, EMA and other regulatory authorities. Our suppliers are approved in their countries of origin and by the IMOH. The raw materials must comply with strict regulatory requirements. We require our raw materials suppliers to comply with the cGMP regulations, and we audit our suppliers from time to time. We are dependent on the regular supply and availability of raw materials in our Proprietary Products segment. We maintain relationships with several suppliers to ensure availability and reduce reliance on specific suppliers. We are dependent, however, on several suppliers who supply specialty ancillary products prepared for the production process, such as specific gels and filters. See “Item 3. Key Information — D. Risk Factors — We could become supply-constrained, and our financial performance could suffer, if we were unable to obtain adequate quantities of source plasma, plasma derivatives or specialty ancillary products that meet the regulatory requirements of the FDA, the EMA, Health Canada or the regulatory authorities in Israel, or if our suppliers were to fail to modify their operations to meet regulatory requirements or if prices of source plasma or plasma derivatives were to rise significantly.” 73 In the years ended December 31, 2025, 2024 and 2023, we incurred $23.6 million, $22.2 million and $23.7 million of expenses, respectively, for the purchase of raw materials for the manufacturing of our Proprietary Products. The changes in the costs associated with the purchase of raw materials are driven by our inventory management and manufacturing plan. Hyper-immune Plasma Hyper-immune plasma is used for the manufacturing of KEDRAB/KAMRAB, CYTOGAM, WINRHO SDF, VARIZIG and HEPAGAM B. We have several suppliers in the United States for hyper-immune plasma with whom we have long-term supply agreements. Under such long-term supply agreements, we work to secure availability of hyper-immune plasma on an annual basis by providing forecasts to our suppliers based on our customers’ actual and forecasted demand. In January 2012, we 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 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. We have an additional U.S.-based supplier of anti-rabies hyper-immune plasma. CMV hyper-immune plasma for the manufacturing of CYTOGAM is supplied to us by CSL Behring, initially under a three-year supply agreement that we assumed from Saol, and in December 2023, we 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 required plasma for the manufacturing of the product for each of the years 2024-2026. We are currently negotiating an extension to such supply agreement for an additional four year period of 2027-2030. Emergent is currently responsible for securing the hyper-immune plasma from different plasma suppliers for the manufacturing of WINRHO SDF, HEPAGAM B and VARIZIG, pursuant to our manufacturing services agreement with Emergent (see above— “Manufacturing and Supply”). In 2024, we began supplying to Emergent hyper-immune plasma collected through our internal plasma collection operations for the manufacturing of WINRHO SDF. While we continue to pursue new long-term supply agreements for hyper-immune plasma with additional plasma-collection companies, we aim to reduce our dependencies on third-party suppliers by increasing our own supply of hyper-immune plasma, specifically for the manufacturing of KEDRAB/KAMRAB and WINRHO SDF, through our plasma collection operations at our centers in Beaumont, Houston and San Antonio. For information related to our internal plasma collection capabilities, see above “Plasma Collection.” Plasma derived Fraction IV paste for GLASSIA manufacturing On August 23, 2010, in conjunction with the partnership arrangement with Baxter (now Takeda), we 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 us with fraction IV used for the production, sale and distribution of GLASSIA in jurisdictions other than those which are covered under the exclusive manufacturing, supply and distribution agreement with Takeda as well as for other AAT derived products. If we require fraction IV for other purposes, we are entitled to purchase it from Takeda at a predetermined price and adjustment mechanism. The supply agreement terminates on August 23, 2040, subject to an option for earlier termination in the event of a material breach. We have an additional fraction IV plasma supplier, approved for production of GLASSIA marketed in non-U.S. countries, and we may, in the future, seek to obtain regulatory approval to use fraction IV from this supplier for the U.S. market as well. 74 Marketing and Distribution We distribute our Proprietary Products in more than 30 countries worldwide, including the United States, Argentina, Canada, Israel, Russia, Turkey, Sweden, Australia, Poland, Switzerland, South Korea, Romania and additional countries in Latin America, the MENA region and Asia. We are also a supplier to an international organization specializing in providing health services for the Americas. We distribute our products in these markets directly or through strategic partners (e.g., Kedrion in the U.S. market) or by local distributers. We typically receive orders for our products and receive requests for participation in tenders for the supply of our products from our existing distributors as well as from new potential distributors. We sell KEDRAB to Kedrion for distribution in the U.S. market and sell KAMRAB to other distributors in non-U.S. countries. We market GLASSIA mainly in Argentina, Russia, Israel and Switzerland (in some of these markets under a different brand name) through local distributors. We distribute CYTOGAM, WINRHO SDF, VARIZIG and HEPAGAM B in the U.S. market directly to wholesalers and local distributors, through our wholly owned U.S. subsidiary, Kamada Inc. Commencing September 2022, we assumed all distribution responsibilities for these products in the U.S. market and are utilizing a U.S.-based third-party logistics provider for storage, logistics and distribution, which provides complete order to cash services. We are 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. We also market, sell and distribute these products in non-U.S. countries, primarily in Canada and other countries in the MENA region, through the engagement of local distributors. We continue to leverage our existing strong international distribution network to expand the sales of CYTOGAM, WINRHO SDF, VARIZIG and HEPAGAM B to other regions in which we currently operate and furthermore, we intend to explore the expansion of sales of our other Proprietary Products, primarily GLASSIA and KAMRAB, to international markets, primarily in the MENA region. In 2022, as part of the establishment of our U.S. operations, we deployed an experienced team of U.S.-based sales and medical affairs professionals. The U.S. sales team promotes our 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. We are encouraged by the consistently positive feedback received from key U.S. physicians who are seeking to publish new clinical data related to our products, while conducting educational symposiums that we believe will have a positive impact on the understanding of these medicines, contributing to continued growth in demand. Our promotional activities, including engagements with healthcare practitioners, are conducted in compliance with the FDA’s restrictions on promotion of pharmaceuticals, and the Anti-Kickback statutes. In the Israeli market, we currently sell and distribute GLASSIA and KAMRAB 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, and in addition we sell our two types of anti-snake venom to the IMOH. Outside the U.S. and Israel, we sell our Proprietary Products through local tenders by governing bodies (such as CBS and Hema-Quebec in Canada, as well as to an international organization), or our distributors may sell our Proprietary Products through a tender process and/or to the private market. The tender process is conducted on a regular basis by the distributors, sometimes on an annual basis. For existing distributors, our existing relationship does not guarantee additional orders in these tenders. The decisive parameter is generally the price proposed in the tender. The distributor purchases products from us and sells them to its customers (either directly or by means of sub-distributors). In most cases, we do not enter into contractual arrangements with the end users, and as such, we do not determine the price to the end user or its terms of payment and are not exposed to credit risks of the end users. In most cases, our agreements with the local distributors award the various distributors exclusivity in the distribution of our products in the relevant country, if permitted. The distribution agreements are usually made for a specific initial period and are subsequently renewed for certain agreed periods, where the parties have the right to cancel or renew the agreements with prior notice of several months. In these markets, we do not actively participate in the marketing to the end users, except for supplying marketing assistance where the cost is negligible or in some cases, reimburse the local distributor for an agreed amount of its actual marketing expenses. We are establishing our footprint in the MENA region as a leader in the specialty plasma-derived field by exploring geographical expansion opportunities and strengthening our relationships with KOLs across the region. 75 Most of the sales of our Proprietary Products segment outside of Israel are made against open credit and some in documentary credit or advance payment. Most of our sales in Israel are made against open credit or cash. The credit given to some of our customers abroad (except for sales in documentary credit or advanced payment) is mostly secured by means of a credit insurance policy and in certain cases with bank guarantees. In the Distribution segment, we market our products in Israel to HMOs, hospitals and medical specialists on our own and we distribute the products independently or through a third-party logistic provider. We sell certain of our Distribution segment products through offers to participate in public tenders that occur on an annual basis or through direct orders. The public tender process involves HMOs and hospitals soliciting bids from several potential suppliers, including us, and selecting the winning bid based on several attributes, primarily price and availability. The annual public tender process is also used by our existing Distribution segment products customers to determine their suppliers. As a result, our existing relationship with customers in our Distribution segment does not guarantee additional orders from such customers year-over-year. To secure supply of our products in the Distribution segment, we enter into supply and distribution agreements with the product owners, pursuant to which we undertake to register the products with the IMOH, acquire certain quantity of products and act as the product distributor in the Israeli market. We work closely with those suppliers to develop annual forecasts, but these forecasts usually do not oblige our suppliers to provide us with their products. Customers For the year ended December 31, 2025, sales to our three largest customers, Kedrion, Takeda and Clalit Health Services, an Israeli based HMO, accounted for 30%, 9% and 7%. For the year ended December 31, 2024, sales to our three largest customers, Kedrion, Takeda and McKesson, one of the largest U.S.-based wholesalers, accounted for 31%, 10% and 8%, respectively, of our total revenues. For the year ended December 31, 2023, sales to our three largest customers, Kedrion, Takeda and Clalit Health Services accounted for 23%, 11% and 7%, respectively, of our total revenues. While Kedrion, Takeda, Clalit Health Services and McKesson are currently our major customers in the Proprietary Products segment, other key customers include several U.S. based wholesalers, an international organization, two Canadian customers and our distributors in Argentina, Russia, the MENA region and other territories. These arrangements are further described above under “— Marketing and Distribution.” Our primary customers in the Distribution segment in Israel are HMOs, including Clalit Health Services and Maccabi Healthcare Services, Israeli hospitals and the IMOH. Seasonality We have experienced in the past, and may experience in the future, certain fluctuations in our quarterly revenues. Competition The worldwide market for pharmaceuticals in general, and biopharmaceutical and plasma derived products, in particular, has, in recent years, undergone a process of consolidation through mergers and acquisitions. This trend has led to a reduction in the number of competitors and the strengthening of the remaining companies, particularly in the plasma-derived sector. Proprietary Products Segment There are a limited number of direct competitors for each of our 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. Most of these companies are multinational corporations that specialize in plasma derived protein therapeutics and distribute plasma derived pharmaceutical products worldwide. We have not seen significant changes in the activities of our competitors in recent years. Additionally, our strategic alliance with Kedrion in the United States has strengthened our KEDRAB competitive positioning in the market. The acquisition of Biotest AG by Grifols and the merger between Kedrion and BPL might impact the markets that we operate in. In some international markets, such as India, Thailand and Russia, we also have local competitors for KAMRAB. 76 In addition, we face potential competition from other biopharmaceutical companies that develop and market non-plasma derived products that are approved for similar indications to those in our Proprietary Products segment. In cases of existing competition, our competitors usually have advantages in the market because of their size, financial resources, plasma-collection capacity, and the duration of their activities and experience in the relevant market, especially in the United States and countries of the European Union. The following describes details known to us about our most significant competitors for each of our main Proprietary Products segment products. KEDRAB/KAMRAB. We believe that there are two main competitors for this anti-rabies IgG product worldwide: Grifols, whose product we estimate accounts for approximately 50% of the anti-rabies IgG market in the United States, and CSL Behring, which sells its anti-rabies product in Europe and other international markets. Sanofi Pasteur, the vaccines division of Sanofi S.A., exited the U.S. anti-rabies IgG market as well as some additional international markets during 2022. We believe that such departure, among other things, contributed to the increase in demand for KEDRAB in the United States since 2023. BPL, which has an anti-Rabies IgG product for the UK market, has developed it also for the U.S. market, including performing a clinical trial; however, it did not complete the product development and has not submitted a BLA for FDA approval. There are several local producers in other countries that make anti-rabies IgG products, mostly based on equine serum, which we believe results in inferior products, as compared to products made from human plasma. Over the past several years, several companies have made attempts, and some are still in the process of developing monoclonal antibodies for anti-rabies treatment. The first monoclonal antibody product was approved and is available in India, and the second monoclonal antibody product was approved and is available in China and to our understanding, is intended to be submitted for marketing authorization in other countries, including the U.S. market. These products may be as effective as the currently available plasma derived anti-rabies immunoglobulin and may potentially be cheaper, and as such may result in the future in increased competition and potential loss of market share of KEDRAB/KAMRAB. GLASSIA. There are several competing products for GLASSIA. Grifols, CSL Behring and Takeda have competing plasma derived AAT products approved for AATD that are marketed in the United States, as well as in some European countries and Canada. We estimate that Prolastin, Grifols’ AAT infusion product for the treatment of AATD, accounts for at least 50% market share in the United States and more than 70% of sales worldwide. In September 2017, Grifols announced FDA approval of a liquid formulation of Prolastin. To the best of our knowledge, Grifols’s liquid product is currently sold in the U.S. market. In addition, Grifols launched its liquid product in Argentina during 2025, and may in the future expand its sales of this product to other ex-U.S. markets. Grifols is also a producer of an additional AAT product, Trypsone, which is marketed in Spain and in some Latin American countries, including Brazil. CSL Behring’s AAT by IV product, Zemaira, is mainly sold in the United States, and during 2015 received centralized marketing authorization approval in the European Union. CSL Behring launched the product in a few selected EU markets during 2016 under the brand name Respreeza. Takeda, our strategic partner for sales of GLASSIA in the United States and Canada, also serves existing patients in the United States with its own proprietary AAT product, Aralast. As far as we know, Takeda is selling both products in the United States and maintaining existing patients on Aralast. Laboratoire Français du Fractionnement et des Biotechnologies, S.A. (LFB) is a producer of an AAT product distributed only in the French market. We do not believe that new plasma derived AAT products are expected to enter the U.S. or European markets in the near future. There are several other competitors in pre-clinical and clinical stages, such as Sanofi, Beam Therapeutics and Wave Therapeutics, and potentially others, all of which have clinical stage development programs for new medications for treatment of AATD lung disease. Additional companies have pre-clinical stage development programs, such as AlveoGene, and Regeneron/Tessera Thrapeutics, all of which include gene editing technologies. Preclinical phase programs do not always progress to advanced clinical development stages. These product candidates, if approved, may have an adverse effect on the AATD market size and reduce or eliminate the need for the currently approved plasma derived AAT augmentation therapy, and thus may potentially affect our ability to continue to generate revenues and earnings from GLASSIA. 77 CYTOGAM. To our knowledge, CYTOGAM is the only plasma derived CMV IgG product approved in the United States and Canada. In Europe and other international markets Cytotec CP/Megalotect (Biotest AG), a plasma derived competing product, is available. Standard IVIG (polyvalent IgG) preparations are sometimes used as an alternative to plasma-derived hyperimmune products like CYTOGAM, due to lower costs, and therefore remain a market competitor in certain settings. Based on available public information, the FDA approved the following non-plasma derived antiviral drugs for the prevention of CMV infection and disease: letermovir (Prevymis), distributed by Merck& Co., and for treatment of refractory/resistant infection or disease maribavir (Livtencity), developed by Takeda. Since their launch, these products have resulted in a significant loss of market share for CYTOGAM. Currently, treatment guidelines state that combination therapy with standard antiviral can be considered for certain solid organ transplant recipients. The most used antivirals are Ganciclovir (Cytovene-IV Roche) and valganciclovir (Valcyte Roche). Patients treated with such antivirals agents for a long time can develop resistance and will require second-line treatment such as foscarnet (Foscavir Pfizer) or Cidofovir (Gilead Sciences). Despite the introduction of newer antiviral therapies for CMV in solid organ transplantation, like letermovir and maribavir, there remains a need to determine the optimal approach to CMV management considering all therapies, including CYTOGAM. This is due to the ongoing risk of CMV developing antiviral drug resistance, specific patient populations at higher risk for CMV, adverse drug event concerns, and market access concerns. WINRHO SDF. WINRHO SDF, an Anti-D IgG product (also called Rhₒ(D) IgG), which is registered in the United States, competes with corticosteroids (oral prednisone or high-dose dexamethasone) and IVIG as first or second line treatment for acute ITP. Grifols, CSL Behring, Takeda, Kedrion and Octapharma are the main IVIG manufacturers and suppliers in the United States. IVIG or WINRHO SDF are recommended for pediatric patients in whom corticosteroids are contraindicated. Rhophylac, a competing Anti-D IgG from CSL Behring, is also approved for ITP treatment. Outside the United States, WINRHO SDF is used for HDN indication. The market in ex-U.S. countries is usually led by tenders, where key indicators are registration status and price. Our main competitors in those countries are RhoGAM (Kedrion), Hyper RHO (Grifols) and Rhophylac (CSL Behring). VARIZIG. To our knowledge, VARIZIG is the only plasma derived Varicella-Zoster IgG product approved in the United States and Canada. In Europe and other international markets, VARITECT (Biotest AG) and additional plasma derived competing products are available. In the United States, incidence of VZV infection has significantly decreased since the introduction of the varicella vaccine in 1995. While the vaccine has lowered the occurrence of chickenpox, the virus has not been eradicated, and the incidence of Herpes Zoster, also caused by VZV, is rising among adults in the United States. Suboptimal vaccination rates contribute to outbreaks and increased risk of VZV exposure. Immunocompromised individuals and other patient groups are at high risk for severe varicella and complications after being exposed to VZV. VARIZIG is recommended by the CDC for post-exposure prophylaxis of varicella in persons at high risk for severe varicella and complications who lack evidence of immunity to varicella. If VARIZIG is unavailable, the CDC recommends IVIG, and some experts recommend Acyclovir or Valacyclovir, although published data on their benefits as post-exposure prophylaxis among immunocompromised individuals are limited. HEPAGAM B. To our knowledge, HEPAGAM B is the only approved HBIG in the United States with an on-label indication for liver transplants. To our understanding, HEPAGAM B holds the majority market share for the indication, although another HBIG, Nabi-HB (manufactured and supplied by ADMA) is used off-label by some medical centers for the indication. New generation antivirals are considered effective for preventing HBV reactivation post-transplant, thereby reducing HBIG use. PEP indication in the United States is covered almost totally by Nabi-HB (ADMA) and HyperHEP (Grifols). 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. Government Regulation Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, cGMP requirements, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as those we sell and are developing. Except for compassionate use or non-registered named-patient cases, any pharmaceutical candidate that we develop must be approved by the FDA before it may be legally marketed in the United States and by the appropriate regulatory agencies of other countries before it may be legally marketed in such other countries. In addition, any changes or modifications to an approved biological product that has the potential to have an adverse effect on the product’s safety or effectiveness may require approval or review from regulatory authorities in the United States and/or in other countries. Preclinical studies, clinical trials and the process of obtaining such approvals or submitting required notifications can be expensive, time consuming and uncertain. 78 U.S. Drug Development Process In the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act and other laws, including, in the case of biologics, the Public Health Service Act and their respective implementing regulations. All of our products for human use and product candidates in the United States, are regulated by the FDA as biologics. Biologics require the submission of a biologics license application (“BLA”) and approval by the FDA prior to being marketed in the United States. Manufacturers of biologics may also be subject to state regulation. Failure to comply with regulatory requirements, both before and after product approval, may subject us and/or our partners, contract manufacturers and suppliers to administrative or judicial sanctions, including FDA delay or refusal to approve applications, issuance of a clinical hold, injunctions, restitution, disgorgement, warning letters, product recalls, product seizures, import restrictions, total or partial suspension of production or distribution, fines and/or criminal prosecution. The steps required before a biologic drug may be approved for marketing for an indication in the United States generally include: 1. completion of preclinical in-vitro and potentially also in-vivo tests in accordance with applicable regulations, including FDA’s good laboratory practice (“GLP”) requirements; 2. submission to the FDA of an investigational new drug (“IND”) application for human clinical testing, including required chemistry manufacturing and controls (“CMC”) sections, which must become effective before human clinical trials may commence; 3. performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the product; 4. submission to the FDA of a BLA, with all the required information; 5. a satisfactory completion of FDA pre-approval inspection of the drug product’s manufacturing facilities to ensure compliance with cGMP requirements; and 6. FDA review and approval of the BLA. Preclinical studies include laboratory evaluation and in-vitro studies, and may include in vivo animal studies, which assess the potential safety and efficacy of the product candidate. Preclinical safety tests must be conducted in compliance with FDA regulations regarding GLP requirements. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND which must become effective before human clinical trials may be commenced. The IND will automatically become effective 30 days after receipt by the FDA, unless the FDA before that time raises concerns about the drug candidate or the conduct of the trials as outlined in the IND. The IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can proceed. There can be no assurance that submission of an IND will result in FDA authorization to commence clinical trials or that, once commenced, other concerns will not arise, that could lead to a delay or a hold on the clinical trials. Clinical trials involve the administration of the investigational product to healthy volunteers or to patients, under the supervision of qualified principal investigators. Each clinical study at each clinical site must be reviewed and approved by an independent IRB, prior to the recruitment of subjects. Numerous requirements apply including, but not limited to, GCP regulations, privacy regulations, and requirements related to the protection of human subjects, such as informed consent. 79 Clinical trials are typically conducted in three sequential phases, but the phases may overlap, and different trials may be initiated with the same drug candidate within the same phase of development in similar or differing patient populations. ● Phase 1 studies may be conducted in a limited number of patients but are usually conducted in healthy volunteer subjects. The drug is usually tested for safety and, as appropriate, for absorption, metabolism, distribution, excretion, pharmacodynamics and pharmacokinetics. ● Phase 2 usually involves studies in a larger, but still limited, patient population to evaluate preliminarily the efficacy of the drug candidate for specific, targeted indications; to determine dosage tolerance and optimal dosage; and to identify possible short-term adverse effects and safety risks. ● Phase 3 trials are undertaken to further evaluate clinical efficacy of a specific endpoint and to test further for safety within an expanded patient population at geographically dispersed clinical study sites. Phase 1, Phase 2 or Phase 3 testing may not be completed successfully within any specific time period, if at all, with respect to any of our product candidates. Results from one trial are not necessarily predictive of results from later trials. The FDA may require additional testing or a larger pool of subjects beyond what we proposed as the clinical development process proceeds, thereby requiring more time and resources to complete the trials. Furthermore, the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk, or may not allow the importation of the clinical trial materials if there is non-compliance with applicable laws. The results of the preclinical studies and clinical trials, together with other detailed information, including information on the manufacture and composition of the product, are submitted to the FDA as part of a BLA requesting approval to market the product candidate for a proposed indication. Under the Prescription Drug User Fee Act, as amended, the fees payable to the FDA for reviewing a BLA, as well as annual fees for commercial manufacturing establishments and for approved products, can be substantial. The BLA review fee alone can exceed $4,300,000, subject to certain limited deferrals, waivers and reductions that may be available. Each BLA submitted to the FDA for approval is typically reviewed for administrative completeness and reviewability within 45 to 60 days following submission of the application. If found complete, the FDA will “file” the BLA, thus triggering a full review of the application. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission. The FDA’s established goals are to review and act on 90% of priority BLA applications and priority original efficacy supplements within six months of the 60-day filing date and receipt date, respectively. The FDA’s goals are to review and act on 90% of standard BLA applications and standard original efficacy supplements within 10 months of the 60-day filing date and receipt date, respectively. The FDA, however, may not be able to approve a drug within these established goals, and its review goals are subject to change from time to time. Further, the outcome of the review, even if generally favorable, may not be an actual approval but an “action letter” that describes additional work that must be done before the application can be approved. Before approving a BLA, the FDA may inspect the facilities at which the product is manufactured or facilities that are significantly involved in the product development and distribution process and will not approve the product unless cGMP compliance is satisfactory. The FDA may deny approval of a BLA if applicable statutory or regulatory criteria are not satisfied, or may require additional testing or information, which can delay the approval process. FDA approval of any application may include many delays or never be granted. If a product is approved, the approval will impose limitations on the indicated uses for which the product may be marketed, will require that warning statements be included in the product labeling, may impose additional warnings to be specifically highlighted in the labeling (e.g., a Black Box Warning), which can significantly affect promotion and sales of the product, will likely require that additional studies be conducted following approval as a condition of the approval, may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a risk management plan, or otherwise limit the scope of any approval. To market a product for other uses, or to make certain manufacturing or other changes requires prior FDA review and approval of a BLA Supplement or new BLA. Further post-marketing testing and surveillance to monitor the safety or efficacy of a product is required. Also, product approvals may be withdrawn if compliance with regulatory standards is not maintained or if safety or manufacturing problems occur following initial marketing. In addition, new government requirements may be established that could delay or prevent regulatory approval of our product candidates under development. 80 As part of the Patient Protection and Affordable Care Act (the “healthcare reform law”), Public Law No. 111-148, under the subtitle of Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a statutory pathway has been created for licensure, or approval, of biological products that are biosimilar to, and possibly interchangeable with, earlier biological products approved by the FDA for sale in the United States. Also, under the BPCIA, innovator manufacturers of original reference biological products are granted 12 years of exclusivity before biosimilars can be approved for marketing in the United States, which protects an innovator from competitors using the innovator’s own clinical data to gain approval of a competing product. There have been proposals to shorten this period from 12 years to five years. The objectives of the BPCI are conceptually similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the “Hatch-Waxman Act,” which established abbreviated pathways for the approval of drug products. A biosimilar is defined in the statute as a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency. Under this approval pathway, biological products can be approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product. If we obtain approval of a BLA, the approval of a biologic product biosimilar to one of our products could have a significant impact on our business. The biosimilar product may be significantly less costly to bring to market and may be priced significantly lower than our products. Both before and after the FDA approves a product, the manufacturer and the holder or holders of the BLA for the product are subject to comprehensive regulatory oversight. For example, quality control and manufacturing procedures must conform, on an ongoing basis, to cGMP requirements, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continue to spend time, money and effort to maintain cGMP compliance. In addition, a BLA holder must comply with post-marketing requirements, such as reporting of certain adverse events. Such reports can present liability exposure, as well as increase regulatory scrutiny that could lead to additional inspections, labeling restrictions, or other corrective action to minimize further patient risk. Special Development and Review Programs Orphan Drug Designation The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making the drug for this type of disease or condition will be recovered from sales in the United States. In the United States, orphan drug designation must be requested before submitting a BLA. In the European Union, orphan designation is granted by the European Commission following an opinion from the EMA’s Committee for Orphan Medicinal Products to promote the development of medicines intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition. A product may qualify if (i) the condition affects not more than five in 10,000 persons in the European Union at the time of application, or (ii) without incentives, it is unlikely that marketing of the product would generate sufficient return to justify the necessary investment. In addition, it must be established that there is no satisfactory authorized method of diagnosis, prevention or treatment in the European Union, or, if such a method exists, that the product will be of significant benefit to those affected. We have received orphan designations in the United States and the European Union for multiple indications. Inhaled AAT has been granted orphan designation for the treatment of AATD in both the United States and the European Union. The inhaled formulation of AAT has also received orphan designation for the treatment of cystic fibrosis in both regions, and for the treatment of bronchiectasis in the United States. In addition, GLASSIA has been granted orphan designation in the United States for the treatment of newly diagnosed Type 1 Diabetes. AAT has also received orphan designation for the treatment of Graft versus Host Disease in both the United States and the European Union, as well as for the prophylactic treatment of Graft versus Host Disease in the United States. 81 In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and waivers for BLA/NDA FDA application user fees. In addition, if a product and its active ingredients receive the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity. Orphan drug designation itself does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. In addition, the FDA may rescind orphan drug designation and, even with designation, may decide not to grant orphan drug exclusivity even if a marketing application is approved. Furthermore, the FDA may approve a competitor product intended for a non-orphan indication, and physicians may prescribe the drug product for off-label uses, which can undermine exclusivity and hurt orphan drug sales. There has also been litigation that has challenged the FDA’s interpretation of the orphan drug exclusivity regulatory provisions, which could potentially affect our ability to obtain exclusivity in the future. In the European Union, orphan drug designation may entitle the sponsor to financial incentives such as reduction of fees or fee waivers. If the orphan designation is maintained at the time of marketing authorization, the product is granted 10 years of orphan market exclusivity for the authorized orphan indication. This period may be reduced to six years if, at the end of the fifth year, it is established that the orphan criteria are no longer met, including where the product is sufficiently profitable not to justify maintenance of market exclusivity. During orphan market exclusivity, authorization of a similar medicinal product for the same therapeutic indication is generally not permitted unless one of the Article 8(3) derogations applies (clinical superiority, including major contribution to patient care, consent of the Marketing Authorization Holder, or inability to supply) In the European Union, an application for marketing authorization may be submitted while orphan designation is still under evaluation; however, orphan fee incentives apply only if the Commission decision granting orphan designation has been adopted and the designation is held at the time of marketing authorization application submission. Post-Approval Requirements Any drug products for which we receive FDA approvals are subject to continuing regulation by the FDA. Certain requirements include, among other things, changes to product testing or manufacturing, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information on an annual basis or more frequently for specific events, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements. These promotion and advertising requirements include, among others, standards for direct-to-consumer advertising, prohibitions against promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling (known as “off-label use”), and other promotional activities. We are also required to ensure that non-promotional scientific exchanges concerning our products are truthful and non-misleading. Failure to comply with FDA requirements can have negative consequences, including the immediate discontinuation of noncomplying materials, adverse publicity, warning letters from or other enforcement by the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties. Such enforcement may also lead to scrutiny and enforcement by other government and regulatory bodies. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not encourage, market or promote such off-label uses. 82 The manufacturing of our product candidates is required to comply with applicable FDA manufacturing requirements contained in the FDA’s cGMP regulations. Our product candidates are either manufactured at our production plant in Beit Kama, Israel, or, for products where we have entered into a strategic partnership with a third party to cooperate on the development of a product candidate, at a third-party manufacturing facility. These regulations require, among other things, quality control and quality assurance, as well as the corresponding maintenance of comprehensive records and documentation. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are also required to register their establishments and list any products they make with the FDA and to comply with related requirements in certain states. These entities are further subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in serious and extensive restrictions on a product, manufacturer or holder of an approved new drug application (NDA) or BLA, as well as lead to potential market disruptions. These restrictions may include suspension of a product until the FDA is assured that quality standards can be met, product seizure or detention, continuing oversight of manufacturing by the FDA under a “consent decree,” which frequently includes the imposition of costs and continuing inspections over a period of many years, as well as possible withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval, including possible user fees. The FDA also may require a Boxed Warning (e.g., a specific warning in the label to address a specific risk, sometimes referred to as a “Black Box Warning”), which has marketing restrictions, and post-marketing testing, or Phase 4 testing, as well as a Risk Evaluation and Minimization Strategy (REMS) plans and surveillance to monitor the effects of an approved product or place conditions on an approval that could otherwise restrict the distribution or use of the product. Other U.S. Healthcare Laws and Compliance Requirements In the United States, our 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, and state attorneys general. To the extent applicable, we 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. Pricing and rebate programs must comply with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care Act (“VHCA”), each as amended. Certain pricing and rebate provisions of the IRA may require additional pricing disclosure and discount obligations for our products. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Under the VHCA, drug companies are required to offer certain pharmaceutical products at a reduced price to a number of federal agencies, including the United States Department of Veterans Affairs and United States Department of Defense, the Public Health Service and certain private Public Health Service-designated entities in order to participate in other federal funding programs including Medicare and Medicaid. Under the TRICARE Retail Pharmacy Program, drug manufacturers must pay rebates to the United States Department of Defense for drugs provided by TRICARE retail network pharmacies to program beneficiaries. Participation under the VHCA requires submission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations. Furthermore, the FCPA prohibits any U.S. individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA presents unique challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions. The failure to comply with laws governing international business practices may result in substantial penalties, including civil and criminal penalties. 83 In order to distribute products commercially, we must comply with federal and state laws and regulations that require the registration of manufacturers and wholesale distributors of pharmaceutical products. In certain states, manufacturers and distributors that ship products into the state may have to be licensed, even if such manufacturers or distributors have no place of business within the state. Certain federal and state laws also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including the use of technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, register their sales representatives, as well as prohibit certain other sales and marketing practices. Additionally, the federal Physician Payments Sunshine Act and implementing regulations promulgated pursuant to Section 6002 of the healthcare reform law requires the tracking and reporting of certain transfers of value made to certain healthcare practitioners and teaching hospitals as well as ownership by a physician or a physician’s family member in a pharmaceutical manufacturer. Physician Payments Sunshine Act requirements were expanded in January 2021 to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives as covered recipients. Finally, all of our activities are potentially subject to federal and state consumer protection and unfair competition laws. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state, and federal authorities. Europe/Rest of World Government Regulation In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our products. Regardless of whether FDA approval is obtained, we must obtain the required local clinical trial authorizations before initiating clinical studies and marketing authorizations before commercializing any product in each country. For example, in the European Union, clinical trial applications (“CTA”) for medicinal products are submitted via the Clinical Trials Information System (CTIS) under the clinical trial regulation (EU) no. 536/2014. CTIS provides a single submission portal and coordinated assessment, while authorization remains at Member State level, with each Member State issuing a single decision before trial initiation in that country. The CTA must be approved by the national health authority and the independent ethics committee prior to the commencement of a clinical trial in the member state. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. In all cases, clinical trials are conducted in compliance with GCP and the applicable EU and national regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. In the United Kingdom, following BREXIT, a separate CTA is required, and approval for clinical trials must be obtained from the Medicines and Healthcare products Regulatory Agency in the United Kingdom (“MHRA”) and the appropriate ethics committee. To obtain marketing approval of a drug in the European Union, marketing authorization applications may be submitted via the centralized, mutual recognition, decentralized or national procedures, depending on product characteristics and legal scope. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union. The centralized procedure is compulsory for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, and products with a new active substance indicated for the treatment of certain diseases, and optional for those products that are highly innovative or for which a centralized process is in the interest of patients. For our products and product candidates that have received or will receive orphan designation in the European Union, they will qualify for this centralized procedure, under which each product’s marketing authorization application will be submitted to the EMA. Under the centralized procedure in the European Union, the CHMP opinion is adopted within a standard active evaluation timeframe of up to 210 days, excluding clock stops for the applicant to respond to CHMP questions. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major public health interest particularly from the point of view of therapeutic innovation which is assessed on a case-by-case basis. In this circumstance, the EMA ensures that the opinion of the CHMP is given within 150 days without the clock stops. 84 The decentralized procedure provides possibility for approval by several member states following the assessment of an application performed by one member state, known as the reference member state. Under this procedure, an applicant submits an application, or dossier, and related materials, including a draft summary of product characteristics, and draft labeling and package leaflet, to the reference member state and concerned member states. The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report and related materials. If a member state cannot approve the assessment report and related materials on the grounds of potential serious risk to public health, the disputed points may eventually be referred to the EMA. The European Commission, based on the EMA’s report, will then issue a decision that is binding on all member states. Currently, following BREXIT, the UK is regulated by the MHRA as the regulatory leading body, which necessitates the submission of an individual marketing authorization. The MHRA also offers recognition/reliance routes for certain marketing authorizations under defined pathways. Additionally, the EU GDPR and UK GDPR, which may apply to our clinical development operations and other personal data we process, imposes strict requirements for processing personal data. For other countries outside of the European Union, such as the UK, Israel, and countries in, Eastern Europe, Latin America and Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordance with GCPs and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. Additionally, these countries also impose privacy and data security requirements relevant to the processing of clinical trial and other personal data with which we are required to comply. If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of product candidates for which we obtain regulatory approval. In the United States and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the coverage and reimbursement decisions made by payors. In the United States, third-party payors include government health administrative authorities, managed care providers, private health insurers and other organizations. The process for determining whether a payor will provide coverage for a drug product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the drug product. Payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drug products for a particular indication. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. Several significant laws have been enacted in the United States which affect the pharmaceutical industry and additional federal and state laws have been proposed in recent years. For example, the IRA includes several provisions to lower prescription drug costs for people with Medicare and reduce drug spending by the federal government, including allowing Medicare to negotiate prices for certain prescription drugs, requiring drug manufacturers to pay a rebate to the federal government if prices for single-source drugs and biologicals covered under Medicare Part B and nearly all covered drugs under Part D increase faster than the rate of inflation (CPI-U), and limiting out of pocket spending for Medicare Part D enrollees. Additionally, the current administration has issued several executive orders aimed at lowering prescription drug costs, including an executive order aimed at reforming the Medicare drug pricing negotiation program under the IRA. It is difficult to predict whether or how any of the current executive orders will lead to legislative changes. These federal, as well as state reform efforts, including other legislative efforts, present uncertainty around restrictions that may be imposed on pricing for our products, as well as regulatory compliance issues. Federal, state and local governments in the United States continue to consider legislation to limit the growth of healthcare costs, including the cost of prescription drugs. Future legislation and regulation could further limit payments for pharmaceuticals such as the product candidates that we are developing. In addition, court decisions have the potential to affect coverage and reimbursement for prescription drugs. It is unclear whether future legislation, regulations or court decisions will affect the demand for our product candidates once commercialized. 85 Different pricing and reimbursement schemes exist in other countries. In the European Union, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of benefit assessments of medicinal products that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. The downward pressure of healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country. The marketability of any drug candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased, as well as certain government efforts to reduce the costs of drug prices in the United States, and we expect will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Intellectual Property Our success depends, at least in part, on our ability to protect our proprietary technology and intellectual property, and to operate without infringing or violating the proprietary rights of others. We rely on a combination of patent, trademark, trade secret and copyright laws, know-how, intellectual property licenses and other contractual rights (including confidentiality and invention assignment agreements) to protect our intellectual property rights. Patents As of December 31, 2025, we owned for use within our field of business 14 patents and patent applications families, 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, certain far East countries, Australia and other countries, including two pending PCT applications. We own a patent family protecting pulmonary delivery of AAT, filed in 2007, in a variety of jurisdictions, including Canada, Germany, France, Italy, Netherlands, Ireland, Belgium, Great Britain, Israel, Russia and Mexico. Furthermore, we own a patent family filed in 2018, protecting our manufacturing process of immunoglobulins. This patent family includes an allowed application in the U.S. and Israel, pending applications in Canada and Europe. Our patents generally relate to the separation and purification of proteins and their respective pharmaceutical compositions. Our patents and patent applications further relate to the use of our products for a variety of clinical indications, and their delivery methods. Our patent applications further relate to the production of recombinant AAT and uses thereof for clinical indications. Our patent applications further relate to the system and method for purification of immunoglobulins from a biological sample, and to the use of acellular plasma for various indications. Our patents and patent applications are expected to expire at various dates between 2027 and 2044. We also rely on trade secrets to protect certain aspects of our separation and purification technology. The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions. Our ability to maintain and solidify our proprietary position for our technology will depend on our success in obtaining effective claims and enforcing those claims once granted. We do not know whether any of our patent applications or any patent applications that we license will result in the issuance of any patents and there is no guarantee that patent applications that were filed with the patent offices, which are still pending, will be eventually granted and will be registered. Additionally, our issued patents and those that may be issued in the future may be challenged, opposed, narrowed, circumvented or found to be invalid or unenforceable, which could limit our ability to stop competitors from marketing related products or the length of term of patent protection that we may have for our products. We cannot be certain that we were the first to file the inventions claimed in our owned patents or patent applications. In addition, our competitors or other third parties may independently develop similar technologies that do not fall within the scope of the technology protected under our patents, or duplicate any technology developed by us, and the rights granted under any issued patents may not provide us with any meaningful competitive advantages against these competitors. Furthermore, because of the extensive time required for research and development, testing and regulatory review of a potential product until authorization for marketing, it is possible that, before any of our products can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby reducing any advantage of the patent. 86 Trademarks We rely on trade names, trademarks to protect our name brands. Our registered trademarks in several countries, such as United States and the European Union, Israel, and certain Latin American countries, include the trademarks CYTOGAM, GLASSIA, HEPAGAM, HEPAGAM B, KAMRAB, KEDRAB, KAMADA, Kamada Each Life Is Unique, KAMRHO, KAMRHO-D, KAMRHO-D IM, KR (design mark), REBINOLIN, РЕБИНОЛИН (Rebinolin in Cyrillic), RESPIKAM, KAMADA RESPIRA, VARIZIG, VENTIA, WINRHO and WINRHO SDF. Trade Secrets and Confidential Information We rely on, among other things, confidentiality and invention assignment agreements to protect our proprietary know-how and other intellectual property that may not be patentable, or that we believe is best protected by means that do not require public disclosure. For example, we require our employees, consultants and service providers to execute confidentiality agreements in connection with their engagement with us. Under such agreement, they are required, during the term of the commercial relationship with us and thereafter, to disclose and assign to us inventions conceived in connection with their services to us. However, there can be no assurance that these agreements will be fulfilled or shall be enforceable, or that these agreements will provide us with adequate protection. See “Item 3. Key Information — D. Risk Factors — In addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how.” For the risks related to intellectual property, see “Item 3. Key Information — D. Risk Factors — Risks Related to Intellectual Property.” Environmental We believe that our operations comply in material respects with applicable laws and regulations concerning the environment. While it is impossible to predict accurately the future costs associated with environmental compliance and potential remediation activities, compliance with environmental laws is not expected to require significant capital expenditures and has not had, and is not expected to have, a material adverse effect on our earnings or competitive position. For more information see “Item 3. Key Information —D. Risk Factors — Risks Related to Our Operations and Industry – We are subject to extensive environmental, health and safety, and other laws and regulations.” We are committed to business practices that promote socially and environmentally responsible economic growth. In 2025, we continued to make meaningful progress on our sustainability strategy and finalized our first Sustainability Report. A copy of the report is available on request by contacting us through our website. C. Organizational Structure Our subsidiaries are set forth below. All subsidiaries are either wholly owned by us or controlled by us. All companies are incorporated and registered in the country in which they operate as listed below: Legal Name Jurisdiction KI Biopharma LLC Delaware, USA Kamada Inc. Delaware, USA Kamada Plasma LLC Delaware, USA (wholly owned by Kamada Inc.) Kamada Assets (2001) Ltd. Israel Kamada Ireland Limited Ireland 87 D. Property, Plants and Equipment Our production plant located in Beit Kama, Israel, was built on land that Kamada Assets (2001) Ltd. (“Kamada Assets”), our 74%-owned Israeli subsidiary, leases from the Israel Land Administration pursuant to a capitalized long-term lease. Kamada Assets subleases the property to us. The property originally covered an area of approximately 16,880 square meters. The initial sublease expires in 2058, and we have an option to extend the sublease for an additional term of 49 years. On November 1, 2021, pursuant to a new area outline approved by the Israel Lands Administration, the covered area was reduced to 14,880 square meters. The production plant includes our manufacturing facility, manufacturing support systems, packaging, warehousing and logistics areas and laboratory facilities, as well as office buildings. In addition, we lease approximately 2,200 square meters of office and laboratory facility at a building located in the Kiryat Weizmann Science Park in Rehovot, Israel. This property houses our corporate office, research and development laboratory and additional departments such as clinical operations, medical, regulatory affairs, compliance, sales and marketing and business development. The current lease agreement is in effect until January 2032. We own a 237 square meters facility in Beaumont, TX that we acquired in March 2021, which serves as an FDA registered plasma collection center. On March 7, 2023, our U.S. subsidiary Kamada Plasma LLC entered into a lease agreement for a 12,000 square foot premises in Houston, Texas to be used as a plasma collection center. The lease is in effect for an initial period of ten years commencing on February 16, 2024. We have the option to extend the lease for two consecutive periods of five years each, upon six months prior written notice. During 2024, we completed the construction of the new plasma collection center in this facility and commenced plasma collection activities after obtaining the required site registration. In 2025, we received FDA approval for collection operations at the Houston site. In addition, on May 2, 2024, our U.S. subsidiary Kamada Plasma LLC entered into a lease agreement for a 11,100 square foot premises in San Antonio, Texas for our third plasma collection center. The lease is in effect for an initial period of ten years. We have the option to extend the lease for three additional periods of five years each, upon four months prior written notice. During 2025, we completed the construction of the new plasma collection center in this facility and commenced plasma collection activities after obtaining the required site registration. We submitted a prior approval supplement to the FDA for the site in June 2025 and the FDA site audit was completed in February 2026 and we expect to receive FDA approval during the first half of 2026. Furthermore, our U.S. subsidiary Kamada Inc. leases approximately 1,500 square feet of office space within a shared office facility in Hoboken, NJ. The lease is based on a month-to-month agreement which automatically renews and may be terminated at any time by a one-month prior written notice.