KMDA Kamada Ltd.

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1. 02 June 2021 Kedrion and Kamada Announce FDA Approval of KEDRAB® Label Update, Confirming Safety and Effectiveness in Children

   FORT LEE, N.J. and REHOVOT, Israel, June 2, 2021 /PRNewswire/ -- Kedrion Biopharma and Kamada Ltd. (NASDAQ:KMDA) and (TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has approved a label update for KEDRAB® (Rabies Immune Globulin [Human]), establishing the product's safety and effectiveness in children. 

   

   Label Expansion Differentiates KEDRAB® as First and Only Human Rabies Immune Globulin in U.S. to be Studied in Children

   KEDRAB, a human rabies immune globulin (HRIG), is now indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ages when given promptly following contact with a rabid or possibly rabid animal. The new updates to the KEDRAB label are based on data from the KEDRAB U.S. post marketing Pediatric Study, the first and only clinical trial to establish pediatric safety and effectiveness of any HRIG in the U.S.

   Additional evidence to support the use of KEDRAB in children comes from real world evidence. According to Centers for Disease Control and Prevention (CDC) data, no children in the U.S. treated with post-exposure prophylaxis have been reported to have had rabies between 2018 and April 2021.  

   Rabies is a life-threatening disease, but it is fully preventable if treated on time. It impacts approximately 40,000 people in the U.S. each year. According to the World Health Organization (WHO), up to 40 percent of people exposed to a suspected rabid animal are children under 15 years of age.

   "Improving the lives of people with rare and serious diseases is our most important mission at Kedrion Biopharma," said Kedrion Biopharma Chief Executive Officer, Val Romberg. "As the U.S. market's first and only human rabies immune globulin to be studied in children, KEDRAB is an excellent example of that dedication. Today's news will provide added peace of mind for physicians who choose KEDRAB in treating children who have possibly been exposed to rabies. We are especially proud of our partnership with Kamada, which has resulted in this significant step forward in global health."

   "Kamada is excited to have a HRIG that can treat people of all ages in the U.S. with the FDA-approved label expansion for KEDRAB," said Amir London, Chief Executive Officer of Kamada. "We believe that this label update may support an increase of KEDRAB's U.S. market share. We anticipate that sales of KEDRAB will continue to grow meaningfully in the U.S., capturing a significant portion of the estimated annual $150 million U.S. HRIG market."

   Kamada has been selling the HRIG product since 2003 in numerous territories outside of the U.S. under the brand name KAMRAB®.

   Kamada sold approximately 5 million ml of KamRAB to date, demonstrating significant clinical experience with the product. Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, Kamada holds the license for KEDRAB and Kedrion Biopharma has exclusive rights to commercialize the product in the U.S.

   About KEDRAB^®

   KEDRAB® [Rabies Immune Globulin (Human)] is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ages when given promptly after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. 

   KEDRAB was approved by the FDA in August, 2017. KEDRAB is supplied in single-dose vials containing 2 mL or 10 mL of ready-to-use solution with a nominal potency of 150 IU/mL.

   KEDRAB should be administered concurrently with a full course of rabies vaccine.

   Important Safety Information:

   • Severe hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.
   • KEDRAB is made from human plasma donors and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeld-Jacob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

   Please see KEDRAB full prescribing Information for complete prescribing details. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 

   About the KEDRAB^® U.S. Pediatric Clinical Study

   KEDRAB's safety and effectiveness have been established in children. KEDRAB was evaluated in a two-center, open-label clinical trial in 30 pediatric patients exposed or possibly exposed to rabies virus for whom post-exposure prophylaxis (PEP) was indicated. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population.

   The patients were treated with KEDRAB at a dose of 20 IU/kg on Day 0 and active rabies vaccine on Days 0, 3, 7, and 14 as per the Advisory Committee on Immunization Practices (ACIP) recommendations for rabies PEP. The patients ranged in age from 0.5 to 14.9 years; 46.7 percent were females, 6.7 percent were Asian, 23.3 percent were Black or African American and 70 percent were White.

   Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration. Participant safety was monitored for 84 days. No serious adverse reactions, rabies infections, or deaths were recorded through day 84.

   Of the 30 patients, 28 (93.3 percent) achieved a Day-14 RVNA titer ≥0.5 IU/mL, the World Health Organization recommended level. This secondary objective included the evaluation of antibody levels and effectiveness of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine, according to the rabies PEP guidelines recommended by ACIP.

   View the published U.S. Pediatric Clinical Study here.

   About Rabies

   Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. It is a serious and nearly always fatal infection. In the U.S., rabies in wild animals, especially raccoons, skunks, foxes and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. An acute, progressive viral encephalomyelitis, rabies carries the highest case fatality rate of any conventional etiological agent. Rabies is one of the oldest described infectious diseases, known for over 5,000 years.

   About Kedrion Biopharma

   Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as anti-hepatitis B, anti-tetanus and RhoGAM^® for prophylaxis against Rh sensitization and subsequent hemolytic disease of the fetus and newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in the United States to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States.

   Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,500 employees and a commercial presence in approximately 100 countries worldwide. Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at kedrion.com and kedrion.us.

   About Kamada

   Kamada Ltd. ("Kamada" or the "Company") is a global specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable growth from its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company's two leading commercial products are GLASSIA® and KEDRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited ("Takeda") and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) and an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21 percent of the outstanding ordinary shares.

   Cautionary Note Regarding Forward-Looking Statements

   This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) Estimation that rabies impacts approximately 40,000 people in the U.S. each year and that up to 40% of people exposed to a suspected rabid animal are children under 15 years of age, 2) the belief that sales of KEDRAB has the potential to continue to grow in the U.S. by capturing a significant share of the estimated annual $150 million U.S. HRIG market, and 3) the belief that the new label extension further differentiate KEDRAB from other currently available HRIGs in the U.S. market.  Forward-looking statements are based on Kamada's and Kedrion's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, competition within, and entry of new treatments for, the U.S. HRIG market, corporate events associated with Kamada, Kedrion and their respective partners in relation to KEDRAB and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement, Kamada and Kedrion undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

   CONTACTS:

   Kamada: Chaime Orlev Chief Financial Officer Bob Yedid LifeSci Advisors, LLC 646-597-6989

   Kedrion Biopharma: Sheila A. Burke Method Health Communications 484-667-6330

    

   View original content to download multimedia:http://www.prnewswire.com/news-releases/kedrion-and-kamada-announce-fda-approval-of-kedrab-label-update-confirming-safety-and-effectiveness-in-children-301303676.html

   SOURCE Kedrion Biopharma

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2. 02 June 2021 Kedrion and Kamada Announce FDA Approval of KEDRAB® Label Update, Confirming Safety and Effectiveness in Children

   • Label Expansion Differentiates KEDRAB® as the First and Only Human Rabies Immune Globulin (HRIG) Available in the U.S. to be Clinically Studied in Children
     
     
   • KEDRAB Product Label Now Includes Patients of All Ages
     
     
   • New FDA Approval Based on Safety and Effectiveness of KEDRAB in the Pediatric Population Demonstrated in a U.S. Post Marketing Clinical Trial
     
     
   • World Health Organization Estimates up to 40 Percent of People Exposed to a Suspected Rabid Animal are Children Under 15 Years of Age

   FORT LEE, N.J. and REHOVOT, Israel, June 02, 2021 (GLOBE NEWSWIRE) -- Kedrion Biopharma and Kamada Ltd. (NASDAQ & TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration…

   • Label Expansion Differentiates KEDRAB® as the First and Only Human Rabies Immune Globulin (HRIG) Available in the U.S. to be Clinically Studied in Children
     
     
     
     
   • KEDRAB Product Label Now Includes Patients of All Ages
     
     
     
     
   • New FDA Approval Based on Safety and Effectiveness of KEDRAB in the Pediatric Population Demonstrated in a U.S. Post Marketing Clinical Trial
     
     
     
     
   • World Health Organization Estimates up to 40 Percent of People Exposed to a Suspected Rabid Animal are Children Under 15 Years of Age

   FORT LEE, N.J. and REHOVOT, Israel, June 02, 2021 (GLOBE NEWSWIRE) -- Kedrion Biopharma and Kamada Ltd. (NASDAQ & TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has approved a label update for KEDRAB® (Rabies Immune Globulin [Human]), establishingthe product's safety and effectiveness in children.

   KEDRAB, a human rabies immune globulin (HRIG), is now indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ages when given promptly following contact with a rabid or possibly rabid animal. The new updates to the KEDRAB label are based on data from the KEDRAB U.S. post marketing Pediatric Study, the first and only clinical trial to establish pediatric safety and effectiveness of any HRIG in the U.S.

   Additional evidence to support the use of KEDRAB in children comes from real world evidence. According to Centers for Disease Control and Prevention (CDC) data,no children in the U.S. treated with post-exposure prophylaxis have been reported to have had rabies between 2018 and April 2021.

   Rabies is a life-threatening disease, but it is fully preventable if treated on time. It impacts approximately 40,000 people in the U.S. each year. According to the World Health Organization (WHO), up to 40 percent of people exposed to a suspected rabid animal are children under 15 years of age.

   "Improving the lives of people with rare and serious diseases is our most important mission at Kedrion Biopharma," said Kedrion Biopharma Chief Executive Officer, Val Romberg. "As the U.S. market's first and only human rabies immune globulin to be studied in children, KEDRAB is an excellent example of that dedication. Today's news will provide added peace of mind for physicians who choose KEDRAB in treating children who have possibly been exposed to rabies. We are especially proud of our partnership with Kamada, which has resulted in this significant step forward in global health."

   "Kamada is excited to have a HRIG that can treat people of all ages in the U.S. with the FDA-approved label expansion for KEDRAB," said Amir London, Chief Executive Officer of Kamada. "We believe that this label update may support an increase of KEDRAB's U.S. market share. We anticipate that sales of KEDRAB will continue to grow meaningfully in the U.S., capturing a significant portion of the estimated annual $150 million U.S. HRIG market."

   Kamada has been selling the HRIG product since 2003 in numerous territories outside of the U.S. under the brand name KAMRAB®. 

   Kamada sold approximately 5 million ml of KamRAB to date, demonstrating significant clinical experience with the product. Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, Kamada holds the license for KEDRAB and Kedrion Biopharma has exclusive rights to commercialize the product in the U.S.

   About KEDRAB^®
   
   KEDRAB® [Rabies Immune Globulin (Human)] is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ageswhen given promptly after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.

   KEDRAB was approved by the FDA in August, 2017. KEDRAB is supplied in single-dose vials containing 2 mL or 10 mL of ready-to-use solution with a nominal potency of 150 IU/mL.

   KEDRAB should be administered concurrently with a full course of rabies vaccine.

   Important Safety Information:

   • Severe hypersensitivity reactions, including anaphylaxis, may occur with KEDRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.
   • KEDRAB is made from human plasma donors and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeld-Jacob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

   Please see KEDRAB full prescribing Information for complete prescribing details. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

   About the KEDRAB^® U.S. Pediatric Clinical Study
   
   KEDRAB's safety and effectiveness have been established in children. KEDRAB was evaluated in a two-center, open-label clinical trial in 30 pediatric patients exposed or possibly exposed to rabies virus for whom post-exposure prophylaxis (PEP) was indicated. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population.

   The patients were treated with KEDRAB at a dose of 20 IU/kg on Day 0 and active rabies vaccine on Days 0, 3, 7, and 14 as per the Advisory Committee on Immunization Practices (ACIP) recommendations for rabies PEP. The patients ranged in age from 0.5 to 14.9 years; 46.7 percent were females, 6.7 percent were Asian, 23.3 percent were Black or African American and 70 percent were White.

   Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration. Participant safety was monitored for 84 days. No serious adverse reactions, rabies infections, or deaths were recorded through day 84.

   Of the 30 patients, 28 (93.3 percent) achieved a Day-14 RVNA titer ≥0.5 IU/mL, the World Health Organization recommended level. This secondary objective included the evaluation of antibody levels and effectiveness of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine, according to the rabies PEP guidelines recommended by ACIP.

   View the published U.S. Pediatric Clinical Study here.

   About Rabies
   
   Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. It is a serious and nearly always fatal infection. In the U.S., rabies in wild animals, especially raccoons, skunks, foxes and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. An acute, progressive viral encephalomyelitis, rabies carries the highest case fatality rate of any conventional etiological agent. Rabies is one of the oldest described infectious diseases, known for over 5,000 years.

   About Kedrion Biopharma
   
   Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as anti-hepatitis B, anti-tetanus and RhoGAM^® for prophylaxis against Rh sensitization and subsequent hemolytic disease of the fetus and newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in the United States to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States.

   Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,500 employees and a commercial presence in approximately 100 countries worldwide. Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at kedrion.com and kedrion.us.

   About Kamada
   
   Kamada Ltd. ("Kamada" or the "Company") is a global specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable growth from its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company's two leading commercial products are GLASSIA® and KEDRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited ("Takeda") and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) and an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21 percent of the outstanding ordinary shares.

   Cautionary Note Regarding Forward-Looking Statements
   
   This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) Estimation that rabies impacts approximately 40,000 people in the U.S. each year and that up to 40% of people exposed to a suspected rabid animal are children under 15 years of age, 2) the belief that sales of KEDRAB has the potential to continue to grow in the U.S. by capturing a significant share of the estimated annual $150 million U.S. HRIG market, and 3) the belief that the new label extension further differentiate KEDRAB from other currently available HRIGs in the U.S. market. Forward-looking statements are based on Kamada's and Kedrion's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, competition within, and entry of new treatments for, the U.S. HRIG market, corporate events associated with Kamada, Kedrion and their respective partners in relation to KEDRAB and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement, Kamada and Kedrion undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

   CONTACTS:

   Kamada: Chaime Orlev Chief Financial Officer Bob Yedid LifeSci Advisors, LLC 646-597-6989

   Kedrion Biopharma: Sheila A. Burke Method Health Communications 484-667-6330

    
   
   

   
   
   

   

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3. 12 May 2021 Kamada Reports First Quarter 2021 Financial Results, Recent Achievements and Corporate Development Activities

   • First Quarter 2021 Revenues were $24.9 Million, and Adjusted EBITDA was $3.7 Million
     
   • In Connection with the Transition of GLASSIA® Manufacturing, the Product's U.S. Biologics License Application will be Transferred to Takeda by the End of 2021 and Kamada will Receive a Payment of $2 Million; Kamada to Implement a Workforce Downsizing During Early Q3 2021 Resulting in an Approximately 10% Annual Labor Cost Reduction  
   • Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for Treatment of Alpha-1 Antitrypsin Deficiency Continues to Advance as Kamada Evaluates Strategic Partnering Opportunities
   • Continues to Supply its Plasma-Derived COVID-19 Immunoglobulin Investigational Product for COVID-19 Patients to the Israeli Ministry of Health
   • Completed Acquisition …

   • First Quarter 2021 Revenues were $24.9 Million, and Adjusted EBITDA was $3.7 Million
     
     
   • In Connection with the Transition of GLASSIA® Manufacturing, the Product's U.S. Biologics License Application will be Transferred to Takeda by the End of 2021 and Kamada will Receive a Payment of $2 Million; Kamada to Implement a Workforce Downsizing During Early Q3 2021 Resulting in an Approximately 10% Annual Labor Cost Reduction  
   • Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for Treatment of Alpha-1 Antitrypsin Deficiency Continues to Advance as Kamada Evaluates Strategic Partnering Opportunities
   • Continues to Supply its Plasma-Derived COVID-19 Immunoglobulin Investigational Product for COVID-19 Patients to the Israeli Ministry of Health
   • Completed Acquisition of a U.S. Plasma Collection Center and Actively Engaged in the Expansion of the Center Collection Capacity; Intends to Open Additional Centers
   • Continues to Explore Additional Business Development Opportunities that Utilize and Expand the Company's Core Plasma-Derived Development, Manufacturing and Commercialization Expertise, and Further its Strategic Objective of Evolving into a Fully Integrated Specialty Plasma Company

   REHOVOT, Israel, May 12, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced financial results for the three months ended March 31, 2021.

   "Our financial results for the first quarter of 2021 were in-line with our expectations and we continue to advance our business activities in multiple strategic directions," said Amir London, Kamada's Chief Executive Officer.

   "Our pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) is progressing, as we concurrently evaluate strategic opportunities to engage a commercialization partner for this key product candidate, in a market which is currently estimated at over one billion dollar and growing six to eight percent annually. In addition, we continue to supply our plasma-derived COVID-19 Immunoglobulin (IgG) investigational product to the Israeli Ministry of Health (IMOH) for the treatment of hospitalized patients, and during the first quarter of the year, we finalized the planned production ramp up of the product in anticipation of potential demand from additional international markets," continued Mr. London.

   "We are actively engaged in expanding the hyperimmune plasma collection capacity of our recently acquired Texas-based plasma collection center and initiated planning for the opening of additional U.S. centers by leveraging our U.S. Food and Drug Administration license. We are committed to growing our hyperimmune IgG portfolio and believe that expanding our plasma collection capabilities is a significant strategic step toward accomplishing this goal. In addition, we remain focused on evaluating new strategic business development opportunities that will utilize and expand our core expertise in the development, manufacturing and commercialization of plasma-derived therapeutics and will further advance our strategic objective of evolving into a fully integrated specialty plasma company. In order to leverage these opportunities, we intend to utilize our strong cash position of nearly $110 million," concluded Mr. London.

   Financial Highlights for the Three Months Ended March 31, 2021

   • Total revenues were $24.9 million in the first quarter of 2021, a 25% decrease from the $33.3 million recorded in the first quarter of 2020. Total revenues during the first quarter of 2021 included the final sales-based milestone from Takeda in the amount of $5 million.
   • Gross profit was $8.9 million in the first quarter of 2021, compared to $11.5 million reported in the first quarter of 2020. Gross profit in the first quarter of 2021 was affected by a one-time inventory write-off of approximately $1.5 million.
   • The anticipated reduction in revenues and profitability in 2021 is due to the transition of GLASSIA manufacturing to Takeda and the continued impact on the Company's operating environment created by the ongoing global COVID-19 pandemic.
   • As a result of the transition of GLASSIA manufacturing to Takeda, Kamada intends to implement a workforce downsizing during the early part of the third quarter of 2021, which is expected to result in an annualized reduction of approximately 10% in labor costs. As previously published, the Company, the Employees' Committee and the Histadrut - General Federation of Labor in Israel, entered into a special collective bargaining agreement with respect to severance remuneration for the employees who will be laid-off as part of such workforce downsizing plan.
   • Net income was $2.7 million, or $0.06 per share, in the first quarter of 2021, as compared to net income of $5.2 million, or $0.12 per share, in the first quarter of 2020.
   • Adjusted EBITDA, as detailed in the tables below, was $3.7 million in the first quarter of 2021, as compared to $6.3 million in the first quarter of 2020.
   • Cash provided by operating activities was $2.1 million in the first quarter of 2021, as compared to cash used in operating activities of $1.9 million in the first quarter of 2020.

   Balance Sheet Highlights
   
   As of March 31, 2021, the Company had cash, cash equivalents, and short-term investments of $109.5 million, as compared to $109.3 million on December 31, 2020. The slight increase was due to positive operational cash flow.

   Recent Corporate Highlights

   • Reported positive top-line results from Phase 1/2 clinical trial of plasma-derived IgG treatment for Coronavirus Disease (COVID-19).
   • Entered into an amendment to the Glassia technology license agreement with Takeda, pursuant to which, upon completion of the transition of GLASSIA manufacturing to Takeda, expected by the end of 2021, Kamada will transfer to Takeda the GLASSIA U.S. Biologics License Application (BLA). In consideration for the BLA transfer, Kamada will receive a $2 million payment from Takeda. In addition, the terms of the final sales-based milestone of $5 million due to Kamada under the agreement were amended.

   Conference Call
   
   Kamada management will host an investment community conference call on Wednesday, May 12, 2021, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1-809-406-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13719388. The call will also be webcast live on the Internet at http://public.viavid.com/index.php?id=144748.

   About Kamada
   
   Kamada Ltd. (the "Company") is a global specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable growth from its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company's two leading commercial products are GLASSIA® and KEDRRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited ("Takeda") and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) and an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added nine biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel between the years 2022 and 2025. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.

   Cautionary Note Regarding Forward-Looking Statements
   
   This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) anticipation to receive a $2 million payment from Takeda by the end of 2021 upon completion of the transition of GLASSIA manufacturing to Takeda, and the transfer to Takeda of the GLASSIA BLA, 2) plans to affect a workforce downsizing during early third quarter of 2021, which may result in potential annual labor costs savings of approximately 10%, 3) continue advancement of the pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) and evaluation of strategic opportunities to engage commercialization partner for this key product candidate, 4) statement regarding the size and annual growth rate of the AATD market, 5) continuation of supply of the plasma-derived COVID-19 IgG investigational product to the IMOH for the treatment of hospitalized patients, and anticipation of potential demand for the product from additional international markets, 6) expansion of the hyperimmune plasma collection capacity of the recently acquired Taxes based plasma collection center and initiation of planning for the opening of additional centers in the U.S. by leveraging our FDA license, 7) commitment to growing the hyperimmune IgG portfolio, 8) focus on exploring new strategic business development opportunities that will utilize and expand our core expertise in the development, manufacturing and commercialization of plasma-derived therapeutics and advance will further our strategic objective to evolve into a fully integrated specialty plasma company, 9) leveraging these business development opportunities by the intention to utilize the strong cash position of nearly $110 million, and 10) anticipated reduction in revenues and profitability during 2021 driven by the transition of GLASSIA® manufacturing to Takeda and the continued effect on the Company's operating environment created by the ongoing global COVID-19 pandemic. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the continued evolvement of the COVID-19 pandemic, its scope, effect and duration, availability of sufficient raw materials required to maintain manufacturing plans, the effects of the COVID-19 pandemic and related government mandates on the availability of adequate levels of work-force required to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, impact of the workforce downsizing plan, continued demand for Kamada's products, including GLASSIA and KEDRAB, in the U.S. market and its Distribution segment related products in Israel, financial conditions of the Company's customer, suppliers and services providers, ability to reap the benefits of the recent acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies, including plasma-derived IgG treatment for COVID-19 and the level of demand for such product, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

   CONTACTS:
   
   Chaime Orlev
   
   Chief Financial Officer
   
   

   Bob Yedid
   
   LifeSci Advisors, LLC
   
   646-597-6989
   
   

   
   
   

   
   
   

   CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

   		As of March 31,								As of December 31,
   		2021				2020				2020
   		Unaudited								Audited
   		U.S. Dollars in thousands
   Assets
   Current Assets
   Cash and cash equivalents		$	61,436			$	49,288			$	70,197
   Short-term investments			48,038				47,124				39,069
   Trade receivables, net			20,367				26,266				22,108
   Other accounts receivables			4,091				1,736				4,524
   Inventories			41,155				41,787				42,016
   Total Current Assets			175,087				166,201				177,914
   Non-Current Assets
   Property, plant and equipment, net			25,492				24,379				25,679
   Right-of-use assets			3,479				3,800				3,440
   Other long term assets			3,175				1,053				1,573
   Contract assets			3,295				421				2,059
   Deferred taxes			-				939				-
   Total Non-Current Assets			35,441				30,592				32,751
   Total Assets		$	210,528			$	196,793			$	210,665
   Liabilities
   Current Liabilities
   Current maturities of bank loans		$	127			$	465			$	238
   Current maturities of lease liabilities			1,092				928				1,072
   Trade payables			15,076				18,440				16,110
   Other accounts payables			5,682				4,875				7,547
   Deferred revenues			-				649				-
   Total Current Liabilities			21,977				25,357				24,967
   Non-Current Liabilities
   Bank loans			20				138				36
   Lease liabilities			3,417				3,663				3,593
   Deferred revenues			2,525				569				2,025
   Employee benefit liabilities, net			1,369				1,251				1,406
   Total Non-Current Liabilities			7,331				5,621				7,060
   Shareholder's Equity
   Ordinary shares			11,713				11,647				11,706
   Additional paid in capital  net			209,859				204,702				209,760
   Capital reserve due to translation to presentation currency			(3,490	)			(3,490	)			(3,490	)
   Capital reserve from hedges			30				264				357
   Capital reserve from share-based payments			4,674				8,903				4,558
   Capital reserve from employee benefits			(320	)			(356	)			(320	)
   Accumulated deficit			(41,246	)			(55,855	)			(43,933	)
   Total Shareholder's Equity			181,220				165,815				178,638
   Total Liabilities And Shareholder's Equity		$	210,528			$	196,793			$	210,665

   
   
   

   
   
   

   CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

   		Three months period ended								Year ended
   		March 31,								December 31,
   		2021				2020				2020
   		Unaudited								Audited
   		U.S. Dollars in thousands
   Revenues from proprietary products		$	20,870			$	25,317			$	100,916
   Revenues from distribution			4,030				7,973				32,330
   Total revenues			24,900				33,290				133,246
   Cost of revenues from proprietary products			12,468				14,947				57,750
   Cost of revenues from distribution			3,501				6,892				27,944
   Total cost of revenues			15,969				21,839				85,694
   Gross profit			8,931				11,451				47,552
   Research and development expenses			2,628				3,347				13,609
   Selling and marketing expenses			1,123				940				4,518
   General and administrative expenses			2,809				2,312				10,139
   Other expense			7				2				49
   Operating income			2,364				4,850				19,237
   Financial income			110				317				1,027
   Income in respect of securities measured at fair value, net			-				102				102
   Income (expense) in respect of currency exchange differences and derivatives instruments, net			266				432				(1,535	)
   Financial expense			(53	)			(77	)			(266	)
   Income before tax on income			2,687				5,624				18,565
   Taxes on income			-				406				1,425
   Net Income		$	2,687			$	5,218			$	17,140
   Other Comprehensive Income (loss) :
   Amounts that will be or that have been reclassified to profit or loss when specific conditions are met
   Gain (loss) from securities measured at fair value through other comprehensive income			-				(188	)			(188	)
   Gain on cash flow hedges			(73	)			241				876
   Net amounts transferred to the statement of profit or loss for cash flow hedges			(254	)			34				(528	)
   Items that will not be reclassified to profit or loss in subsequent periods:
   Remeasurement gain (loss) from defined benefit plan			-				-				64
   Tax effect			-				27				19
   Total comprehensive income		$	2,360			$	5,332			$	17,383
   Earnings per share attributable to equity holders of the Company:
   Basic income per share		$	0.06			$	0.12			$	0.39
   Diluted income per share		$	0.06			$	0.12			$	0.38

   
   
   

   
   
   

   CONSOLIDATED STATEMENTS OF CASH FLOWS

   		Three months period Ended								Year Ended
   		March 31,								December 31,
   		2021				2020				2020
   		Unaudited								Audited
   		U.S. Dollars in thousands								U.S. Dollars in thousands
   Net income		$	2,687			$	5,218			$	17,140
   Adjustments to reconcile net income to net cash provided by operating activities:
   Adjustments to the profit or loss items:
   Depreciation and impairment			1,147				1,192				4,897
   Financial expenses (income), net			(323	)			(774	)			672
   Cost of share-based payment			215				257				977
   Taxes on income			-				406				1,425
   Loss (gain) from sale of property and equipment			-				-				(7	)
   Change in employee benefit liabilities, net			(37	)			(18	)			201
   			1,002				1,063				8,165
   Changes in asset and liability items:
   Decrease (increase) in trade receivables, net			1,585				(3,016	)			1,332
   Decrease (increase) in other accounts receivables			(14	)			1,513				115
   Decrease (increase)  in inventories			1,045				1,386				1,157
   (Increase) decrease  in deferred expenses			(1,153	)			(421	)			(3,085	)
   (Decrease) Increase in trade payables			(1,484	)			(7,216	)			(9,560	)
   Increase (decrease) in other accounts payables			(2,145	)			(1,180	)			1,736
   Increase in deferred revenues			500				397				1,204
   			(1,666	)			(8,537	)			(7,101	)
   Cash received (paid) during the year for:
   Interest paid			(48	)			(55	)			(209	)
   Interest received			141				451				1,211
   Taxes paid			(14	)			(61	)			(101	)
   			79				335				901
   Net cash provided by (used in) operating activities		$	2,102			$	(1,921	)		$	19,105

   
   
   

   
   
   

   CONSOLIDATED STATEMENTS OF CASH FLOWS

   		Three months period Ended								Year Ended
   		March 31,								December 31,
   		2021				2020				2020
   		Unaudited								Audited
   		U.S. Dollars in thousands								U.S. Dollars in thousands
   Cash Flows from Investing Activities
   Investment in short term investments, net		$	(9,000	)		$	(15,646	)		$	(7,646	)
   Purchase of property and equipment and intangible assets			(131	)			(896	)			(5,488	)
   Proceeds from sale of property and equipment			-				-				7
   Acquisition of subsidiary, net of cash (Appendix A below)			(1,404	)			-				-
   Net cash used in investing activities			(10,535	)			(16,542	)			(13,127	)
   Cash Flows from Financing Activities
   Proceeds from exercise of share base payments			7				5				64
   Repayment of lease liabilities			(289	)			(278	)			(1,103	)
   Repayment of long-term loans			(121	)			(123	)			(492	)
   Proceeds from issuance of ordinary shares, net			-				24,895				24,895
   Net cash provided by (used in) financing activities			(403	)			24,499				23,364
   Exchange differences on balances of cash and cash equivalent			75				590				(1,807	)
   Increase (decrease) in cash and cash equivalents			(8,761	)			6,626				27,535
   Cash and cash equivalents at the beginning of the year			70,197				42,662				42,662
   Cash and cash equivalents at the end of the year		$	61,436			$	49,288			$	70,197
   Significant non-cash transactions
   Purchase of property and equipment through capital lease		$	302			$	58			$	539
   Purchase of property and equipment		$	670			$	579			$	722

   
   
   

   Appendix A
   Acquisition of a subsidiary that was first consolidated
   Current Assets (exclusive of cash and cash equivalents)			(184	)
   Non Current Assets			(1,500	)
   Current Liabilities			280
   			(1,404	)

   
   
   

   
   
   

   KAMADA LTD.

   Adjusted EBITDA
   		Three months period Ended								Year ended
   		March 31,								December 31,
   		2021				2020				2020
   		U.S. Dollars in thousands
   Net income (loss)		$	2,687			$	5,218			$	17,140
   Taxes on income			-				406				1,425
   Financial expense (income), net			(323	)			(774	)			672
   Depreciation and amortization expense			1,147				1,192				4,897
   Cost of share - based payments			215				257				977
   Adjusted EBITDA		$	3,726			$	6,299			$	25,111

   
   
   

   Adjusted Net Income
   		Three months period Ended								Year ended
   		March 31,								December 31,
   		2021				2020				2020
   		U.S. Dollars in thousands
   Net income (loss)		$	2,687			$	5,218			$	17,140
   Cost of share - based payments			215				257				977
   Adjusted net income		$	2,902			$	5,475			$	18,117

    
   
   

   
   
   

   

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4. 05 May 2021 Kamada to Announce First Quarter Ended March 31, 2021 Financial Results and Host Conference Call on May 12, 2021

   REHOVOT, Israel, May 05, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced that it will release financial results for the first quarter ended March 31, 2021, prior to the open of the U.S. financial markets on Wednesday, May 12, 2021.
   

   Kamada management will host an investment community conference call on Wednesday, May 12, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), or 201-689-8263 (International) and entering the conference identification number: 13719388. The call will also be webcast live on the Internet on the…

   REHOVOT, Israel, May 05, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced that it will release financial results for the first quarter ended March 31, 2021, prior to the open of the U.S. financial markets on Wednesday, May 12, 2021.
   
   

   Kamada management will host an investment community conference call on Wednesday, May 12, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), or 201-689-8263 (International) and entering the conference identification number: 13719388. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.

   The call will also be archived for 90 days on the Company's website at www.kamada.com.

   About Kamada

   Kamada Ltd. (the "Company") is a global specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable growth from its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company's two leading commercial products are GLASSIA® and KEDRRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited ("Takeda") and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) and an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added nine biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel between the years 2022 and 2025. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.

   CONTACTS:
   
   Chaime Orlev
   
   Chief Financial Officer
   
   

   Bob Yedid
   
   LifeSci Advisors, LLC
   
   646-597-6989
   
   

   
   
   

   

   View Full Article Hide Full Article
5. 07 April 2021 Kamada Announces Amendment to GLASSIA® License Agreement with Takeda

   • Following the Completion of the Transition of GLASSIA Manufacturing, Kamada will Transfer the Product's US Biologics License Application (BLA) to Takeda; Expected to Occur by End of 2021
   • Kamada to Receive from Takeda a Payment of $2 Million for the BLA Transfer
   • Final Sales-Based Milestone Payment of $5 Million Due to Kamada under the License Agreement was Accelerated
   • No Other Material Changes to the GLASSIA License Agreement Between Kamada and Takeda
   • Kamada Continues to Distribute GLASSIA Outside of Takeda's Territories and Invests in the Alpha-1 Antitrypsin Deficiency Field Through Continued Development of the Inhaled AAT Product, Currently in a Phase III Clinical Study

   REHOVOT, Israel, April 07, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ…

   • Following the Completion of the Transition of GLASSIA Manufacturing, Kamada will Transfer the Product's US Biologics License Application (BLA) to Takeda; Expected to Occur by End of 2021
   • Kamada to Receive from Takeda a Payment of $2 Million for the BLA Transfer
   • Final Sales-Based Milestone Payment of $5 Million Due to Kamada under the License Agreement was Accelerated
   • No Other Material Changes to the GLASSIA License Agreement Between Kamada and Takeda
   • Kamada Continues to Distribute GLASSIA Outside of Takeda's Territories and Invests in the Alpha-1 Antitrypsin Deficiency Field Through Continued Development of the Inhaled AAT Product, Currently in a Phase III Clinical Study

   REHOVOT, Israel, April 07, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced an amendment to the GLASSIA® [Alpha₁-Proteinase Inhibitor (Human)] license agreement with Takeda. Pursuant to the amendment, upon completion of the transition of GLASSIA manufacturing to Takeda, expected by the end of 2021, Kamada will transfer to Takeda the GLASSIA U.S. Biologics License Application (BLA). In consideration for the BLA transfer, Kamada will receive a $2 million payment from Takeda. In addition, the payment by Takeda of the final sales-based milestone of $5 million due to Kamada under the license agreement was accelerated and the Company anticipates it will be able to recognize this milestone during 2021. The parties have agreed to continue to share product related information and data following the BLA transfer. There are no other material changes to the existing GLASSIA license agreement.  

   "Based on the planned transition of GLASSIA manufacturing to Takeda later this year, and its continued distribution of the product in the U.S., the transfer of the BLA to Takeda is a prudent next step," said Amir London, Kamada's Chief Executive Officer. "Kamada, as the product's innovator, continues the registration and distribution of GLASSIA in countries, outside of the named territories of the U.S., Canada, Australia and New Zealand retained by Takeda, and invests in the Alpha-1 Antitrypsin Deficiency field through continued development of our proprietary Inhaled AAT product for which we are currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 study."

   GLASSIA was developed by Kamada, and the product's BLA was approved by the U.S. Food and Drug Administration in 2010 as the first liquid, ready-to-use, intravenous plasma-derived augmentation therapy to treat Alpha-1 Antitrypsin deficiency.

   As previously reported, Kamada expects to receive approximately $25 million in product revenues from the supply of GLASSIA to Takeda in 2021, and based on the agreement with Takeda, upon the initiation of sales of GLASSIA manufactured by Takeda, Kamada will receive royalty payments at a rate of 12% of 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. Although the transition of the agreement to its royalties phase will result in a reduction of Kamada's revenue from Takeda, based on current GLASSIA sales in the U.S. and forecasted future growth, Kamada anticipates receiving royalties from Takeda in the range of $10 million to $20 million per year from 2022 to 2040.

   About Kamada
   
   Kamada Ltd. (the "Company") is a global specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable growth from its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company's two leading commercial products are GLASSIA® and KEDRRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited ("Takeda") and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) and an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added nine biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel between the years 2022 and 2025. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.

   Cautionary Note Regarding Forward-Looking Statements
   
   This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: (1) the transfer of the BLA to Takeda to occur by the end of 2021; (2) Kamada's anticipation to be able to recognize the $5 million sales milestone during 2021; (3) the parties' agreement to share product related information and data following the BLA transfer; (4) statements regarding Kamada's continued registration and distribution of GLASSIA outside Takeda's territories, and investment in the Alpha-1 Antitrypsin Deficiency field through development of the Inhaled AAT product, currently in a Phase III clinical study; (5) Kamada's expectation of approximately $25 million in product revenues from the supply of GLASSIA to Takeda in 2021; and (6) Kamada's expectation of receiving royalties from Takeda in the range of $10 million to $20 million per year from 2022 to 2040. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, market demand for GLASSIA which affects royalties derived from GLASSIA by Kamada, delay or denial in the U.S. FDA approval process for Inhaled AAT products; Kamada's ability to conduct clinical trials in light of restrictions during the COVID-19 pandemic, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

   CONTACTS:
   
   Chaime Orlev
   
   Chief Financial Officer
   
   

   Bob Yedid
   
   LifeSci Advisors, LLC
   
   646-597-6989
   
   

   
   
   

   

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