KMDA Kamada Ltd.

8.36
+0.34  (+4%)
Previous Close 8.02
Open 8.33
52 Week Low 4.4
52 Week High 13.33
Market Cap $372,220,389
Shares 44,523,970
Float 28,688,913
Enterprise Value $267,851,979
Volume 277,479
Av. Daily Volume 570,373
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Upcoming Catalysts

Drug Stage Catalyst Date
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
Phase 1/2
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Alpha-1 antitrypsin (AAT)
Graft Versus Host Disease (GvHD)
Phase 2/3
Phase 2/3
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Plasma-derived IgG product
COVID-19
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Inhaled formulation of AAT
AATD - Alpha-1 Antitrypsin deficiency
Phase 2
Phase 2
Phase 3 trial initiation announced December 16, 2019.
KamRAB
Prophylaxis of rabies disease
Approved
Approved
Approval announced August 25, 2017.
Alpha-1 Antitrypsin (AAT)
Pediatric patients newly diagnosed with type 1 diabetes
Phase 2
Phase 2
Phase 2 data released November 3, 2017. No significant treatment effect noted overall.

Latest News

    • The Phase 1/2 Open-Label, Single Arm, Multi-Center Clinical Trial is Testing Kamada's Hyperimmune IgG Product in Hospitalized, Non-Ventilated COVID-19 Patients with Pneumonia
    • Symptoms Improvement Observed in 11 of the 12 Patients within 24 to 48 Hours of Treatment; All 11 Patients Subsequently Discharged from Hospital within a Median of 4.5 Days from Treatment
    • IgG Product Demonstrated Favorable Safety Profile to Date
    • Top-Line Results Expected to be Available by January of 2021
    • U.S. FDA Response on Submitted Pre-IND Information Package Expected Next Month; U.S. Clinical Development Anticipated to Commence in Early 2021

    REHOVOT, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company…

    • The Phase 1/2 Open-Label, Single Arm, Multi-Center Clinical Trial is Testing Kamada's Hyperimmune IgG Product in Hospitalized, Non-Ventilated COVID-19 Patients with Pneumonia

    • Symptoms Improvement Observed in 11 of the 12 Patients within 24 to 48 Hours of Treatment; All 11 Patients Subsequently Discharged from Hospital within a Median of 4.5 Days from Treatment
    • IgG Product Demonstrated Favorable Safety Profile to Date
    • Top-Line Results Expected to be Available by January of 2021
    • U.S. FDA Response on Submitted Pre-IND Information Package Expected Next Month; U.S. Clinical Development Anticipated to Commence in Early 2021

    REHOVOT, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced the completion of enrollment and initial interim results from its ongoing Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel of the Company's anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19).

    The trial is designed to assess the safety, pharmacokinetics, and pharmacodynamics of Kamada's plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients (age 34-69) were enrolled in the trial and received the Company's product at a single dose of 4 grams IgG within five to 10 days of initial symptoms. Patient follow-up will occur for 84 days.

    To date, five of the 12 patients have completed 21-day post-treatment follow-up, two patients have completed 14-day post-treatment follow-up and the additional five patients have completed 7-day post-treatment follow-up. Symptoms improvement was observed in 11 of the 12 patients within 24 to 48 hours from treatment. All 11 patients were subsequently discharged from the hospital within a median hospital stay of 4.5 days from treatment.

    The medical condition of one patient, who completed the 14-day post-treatment follow-up, deteriorated and this individual is currently on mechanical ventilation. One patient had a serious adverse event four days after treatment, which was categorized by the investigator as unrelated to the Company's IgG product, that the patient received in the trial.

    "The safety profile of our IgG product and symptoms improvement preliminarily demonstrated by these results are favorable and we plan to continue characterizing the virus neutralization activity of the product in order to calibrate the treatment dose," said Dr. Naveh Tov, Kamada's VP Clinical Development and Medical Director.

    "We expect that these initial interim results, and the final trial results, to be available by January 2021, will support our clinical plan to advance our IgG product as a potential treatment for hospitalized COVID-19 patients," said Amir London, Kamada's Chief Executive Officer. "As a reminder, the FDA recently issued an Emergency Use Authorization for convalescent plasma as a potential treatment for COVID–19. Convalescent plasma plays an important role in the immediate and intermediate response to the disease. Plasma-derived IgG product, as developed by Kamada, is considered to have multiple advantages over convalescent plasma transfusion, such as standardized antibody levels, higher potency, extensive viral inactivation processing, the absence of a blood-type matching requirement, smaller infusion volumes, the ability to be produced in large quantities, an expected longer shelf life and preferred storage conditions," concluded Mr. London.

    The Phase 1/2 trial in Israel is being conducted as part of Kamada's global collaboration with Kedrion Biopharma, established in April 2020, for the development, manufacturing, and distribution of a plasma-derived IgG product as a potential treatment for COVID-19.  With Kedrion's support, Kamada submitted a pre-Investigational New Drug (IND) information package to the U.S. FDA, with its proposed U.S clinical development plan, FDA's response is expected next month.

    About Kamada

    Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited 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 is planning to 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. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel 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% 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) favorable top-line results of the ongoing Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel of the Company's hyperimmune IgG product as a potential treatment for COVID-19 based on the symptoms improvement within 24 to 48 hours of treatment and subsequent discharge from hospital within a median hospital stay of 4.5 days from treatment, both as seen in most patients; 2) belief that the Company's IgG product has demonstrated favorable safety profile to date; 3) expectation that results from the ongoing phase 1/2 open-label, single-arm, multi-center clinical trial in Israel would be available by January of 2021; 4) expectation of obtaining U.S. FDA response on submitted Pre-IND package next month; 5) plans to continue characterizing the virus neutralization activity of the IgG product to be used to calibrate the treatment dose; 6) expectation that the results of the ongoing phase 1/2 open-label, single-arm, multi-center clinical trial in Israel will support the clinical plan to advance the Company's IgG product as a potential treatment for hospitalized COVID-19 patients with pneumonia; and 7) statements that a plasma-derived IgG product, as developed by Kamada, has multiple advantages over convalescent plasma transfusion; . 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, including its effect and duration, availability of sufficient raw materials required to continue manufacturing of the plasma-derived hyperimmune IgG product for COVID-19, competition from other products for the treatment of COVID-19 patients; ability to conduct clinical trials in light of restrictions during COVID-19, ability to obtain regulatory approval for a clinical trials of the plasma-derived immunoglobulin IgG product for COVID-19, 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

    Primary Logo

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    • The Study of KEDRAB®(Rabies Immune Globulin [Human]) Conducted in Children was the First and Only Pediatric Study for any HRIG Available in U.S.
    • The Study Met its Primary Objective, Which Was to Confirm the Safety of KEDRAB in the Pediatric Population.
    • Study Results Have Been Submitted to the U.S. FDA for Review and Potential Update to the KEDRAB Prescribing Information.
    • KEDRAB was Launched in the U.S. in 2018 and it Generated In-Market Sales of $31 Million in 2019, Representing Approximately 20 Percent Share of the U.S. HRIG Market.

    REHOVOT, Israel and FORT LEE, N.J., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics…

    • The Study of KEDRAB® (Rabies Immune Globulin [Human]) Conducted in Children was the First and Only Pediatric Study for any HRIG Available in U.S.
    • The Study Met its Primary Objective, Which Was to Confirm the Safety of KEDRAB in the Pediatric Population.
    • Study Results Have Been Submitted to the U.S. FDA for Review and Potential Update to the KEDRAB Prescribing Information.
    • KEDRAB was Launched in the U.S. in 2018 and it Generated In-Market Sales of $31 Million in 2019, Representing Approximately 20 Percent Share of the U.S. HRIG Market.

    REHOVOT, Israel and FORT LEE, N.J., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, today announced results from a U.S. post-marketing pediatric trial of KEDRAB® (Rabies Immune Globulin [Human]). The study represents the first and only trial of a currently available human rabies immune globulin (HRIG) conducted in children in the U.S. to date. The results have been submitted to the U.S. Food and Drug Administration for review and inclusion as pediatric data in the KEDRAB full prescribing information. KEDRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) treatment of rabies infection, when given promptly after contact with a rabid or possibly rabid animal.

    The KEDRAB U.S. Pediatric Trial was conducted at two sites, one in Arkansas and another in Rhode Island. The study included 30 pediatric patients (ages 0-17 years old), each of whom received KEDRAB as part of PEP treatment following exposure or suspected exposure to an animal suspected or confirmed to be rabid, and safety follow-up was conducted for up to 84 days. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population. Secondary objectives included the evaluation of antibody levels and the efficacy of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine according to the PEP recommended guidelines.

    No serious adverse events were observed during the study. No incidence of rabies disease or deaths were recorded throughout the 84-day study period.

    "These key study results represent the first clinical trial data in the U.S. pediatric population for any HRIG currently available in the US," said Michal Stein, M.D., Vice President, Medical Director (Immunology) at Kamada. "According to the World Health Organization, 40 percent of people bitten by suspected rabid animals are children under 15 years of age. Despite the large proportion of pediatric cases, limited safety and efficacy data from clinical trials currently exist for this population. Meeting the primary study objective of KEDRAB in children further strengthens our ongoing confidence in the product. We continue to believe that sales of KEDRAB has the potential to continue growing in the U.S., capturing a significant share of the estimated annual $150 million U.S. HRIG market."

    "We know the incidence of kids being exposed to animals that may transmit rabies is high in the U.S. and abroad," said Novinyo Amega, M.D., Head of U.S. Medical Affairs at Kedrion Biopharma. "However, little data exist that can help clinicians better understand the safety profiles of the various HRIG products currently available. Therefore, we are pleased to see that top-line results of this pediatric study support KEDRAB's safety profile. Importantly, we believe that meeting the primary objective of this study could further differentiate KEDRAB from other currently available HRIGs in the U.S."

    KEDRAB was launched in the U.S. in April 2018 and generated in-market sales of $31 million in 2019, representing approximately 20 percent of the U.S. HRIG market.

    About KEDRAB®

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

    Important Safety Information

    • Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB, because KEDRAB may interfere with the anamnestic response to the vaccine.
    • KEDRAB should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock.
    • Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity.
    • KEDRAB contains a small quantity of IgA. Patients who are deficient in IgA have the potential to develop IgA antibodies and may have anaphylactic reactions following administration of blood components containing IgA.
    • KEDRAB administration may interfere with the development of an immune response to live attenuated virus vaccines.
    • KEDRAB is derived from human plasma; therefore, the potential exists that KEDRAB administration may transmit infectious agents.
    • In clinical trials, the most common adverse reactions in subjects treated with KEDRAB were injection site pain, headache, muscle pain, and upper respiratory tract infection.
    • Please see KEDRAB Full Prescribing Information for complete prescribing details.

    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 Kamada

    Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel 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% of the outstanding ordinary shares.

    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 and Hungary 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 www.kedrion.com and www.kedrion.us.

    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 (i) the expectation that based on the results submitted to the U.S. Food and Drug Administration, it will approve the inclusion of pediatric data in the KEDRAB full prescribing information; (ii) the belief that sales of KEDRAB has the potential to continue growing in the U.S. by capturing a significant share of the estimated annual $150 million U.S. HRIG market, and (iii) the belief that meeting the primary objective of this study could further differentiate KEDRAB from other currently available HRIGs in the U.S.  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, if and when the U.S. FDA would include pediatric data in KEDRAB's label, 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:

    Forrest McCaleb

    Director Global Communications-US





    Sheila Burke

    Method Health Communications

    484-667-6330



     

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    • Lilach Asher Topilsky, a Director on the Company's Board and a Senior Partner at FIMI Opportunity Funds, Appointed Chairman
    • Current Chairman, Leon Recanati, Remains on the Board as a Director  
    • Ari Shamiss, MD, MPA, Veteran Hospital Senior Executive, Joins as New Director

    REHOVOT, Israel, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced changes to the composition of its Board of Directors. Lilach Asher Topilsky, a Director on the Company's Board and a Senior Partner at FIMI Opportunity Funds, the leading private equity investor in Israel and Kamada's largest shareholder, has been appointed Chairman of the Board. The current Chairman, Leon Recanati, will…

    • Lilach Asher Topilsky, a Director on the Company's Board and a Senior Partner at FIMI Opportunity Funds, Appointed Chairman
    • Current Chairman, Leon Recanati, Remains on the Board as a Director  
    • Ari Shamiss, MD, MPA, Veteran Hospital Senior Executive, Joins as New Director

    REHOVOT, Israel, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced changes to the composition of its Board of Directors. Lilach Asher Topilsky, a Director on the Company's Board and a Senior Partner at FIMI Opportunity Funds, the leading private equity investor in Israel and Kamada's largest shareholder, has been appointed Chairman of the Board. The current Chairman, Leon Recanati, will remain on the Board as a Director. In addition, Ari Shamiss MD, MPA, a veteran hospital senior executive, has joined as a new Director, to serve until the Company's next annual meeting of shareholders, at which he will stand for election by the shareholders. The Company's Board now consists of nine members. 

    "Since 2005 when I joined Kamada's Board and during my seven years as Chairman, after the passing of the co-founder and former Chairman Mr. Ralf Hahn, it has been my pleasure to work with my colleagues on the Board and the management team, led by our CEO, Amir London, to help lay the foundation for the Company's long-term success," said Mr. Recanati, an avid believer and investor in the Israeli Biotechnology and Medtech sector. "Kamada now has two U.S. FDA approved products, an attractive clinical pipeline and continues to achieve solid growth in sales and profitability. Moreover, the Company's industry-leading technology remains a significant competitive advantage, as recently demonstrated by our ability to become the first company globally to complete the manufacturing and release of a plasma-derived immunoglobulin product for the treatment of COVID-19, which is currently under clinical development in Israel. Following the significant investment in Kamada by FIMI earlier this year, I believe now is the right time for Lilach to assume the responsibility as Chairman of the Board. I look forward to continuing to serve the Company as a Director, and I wish Lilach much success in her new role."

    "I am honored to have been appointed as Kamada's Chairman of the Board," said Ms. Asher Topilsky. "Kamada has proven to be a leader in plasma-derived pharmaceutical products through its sustained innovation and cutting-edge technology. I am excited to continue working closely with the other Board members and the Company's management team to support its next phase of growth. I would like to thank Leon for his service as Chairman, and look forward to his continued significant contribution to the Board."

    Ms. Asher Topilsky has served as a Senior Partner at FIMI Opportunity Funds since December 2019.  Previously, she was the President and CEO of Israel Discount Bank (IDB), one of the leading banking groups in Israel. During her tenure at IDB, Ms. Asher Topilsky also served as the Chairman of Mercantile Bank and IDB New York BANKCORP and as a Director at IDB Bank New York. Prior to IDB, she held increasingly senior roles at Bank Hapoalim, including, in her last position, Deputy Chief Executive Officer and Head of the Retail Banking Division. Before joining Bank Hapoalim, Ms. Asher Topilsky was a consultant with The Boston Consulting Group in Chicago.  Currently, Ms. Asher Topilsky is the chairman of G1 Security (TASE), a director at Amiad Water Systems (AIM) and a member of the Tel Aviv University Executive Council.

    Commenting on Prof. Shamiss' appointment, the Chairman said, "I am happy to welcome Prof. Shamiss to Kamada's Board of Directors. His extensive experience as a senior executive at leading hospitals in Israel will be critical in strengthening our business, including our commercial products as well as clinical pipeline.  Prof. Shamiss is a highly-respected healthcare authority in Israel, and we look forward to his significant contributions to Kamada."

    Prof. Shamiss is the Founder, General Partner and Chairman of the Investment Committee at Assuta Life Sciences Ventures, a life sciences-focused venture capital entity.  Previously, he served as CEO of Assuta Medical Centers, the largest private hospital network in Israel, which includes eight hospitals and medical centers, with over $600 million in annual revenue. Prior to this, Prof. Shamiss was CEO of Sheba General Hospital, the largest hospital in Israel. He was also Vice Dean at Ben Gurion University School of Medicine and remains a Professor at the institution. Prof. Shamiss is a past Surgeon General of the Israel Air Force, Colonel (Retired). He currently serves on the boards of BATM Advanced Technologies and Therapix Biosciences.

    About Kamada

    Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel 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% 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 1) Mr. Recanati's statement that Kamada has an attractive clinical pipeline and continues to achieve solid growth in sales and profitability, and that Kamada's industry-leading technology remains a significant competitive advantage, and 2) The Chairman's statements that Dr. Shamiss' extensive experience will be critical in strengthening Kamada's business, including commercial products as well as clinical pipeline. 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, ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, 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 obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies and on-going compassionate-use treatments, 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

    Primary Logo

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    • Second Quarter Revenues were $33.1 million, Compared to $35.3 million in 2019, First Half 2020 Revenues were $66.4 million, up 7% from 2019 
    • Net Income for the Second Quarter and for the First Half of 2020 was $3.5 million and $8.7 million, Respectively, Compared to $6.1 million and $11.1 million in 2019 Respectively
    • Significant Progress Achieved in Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19)
    • Approximately $100 million of Available Net Cash as of June 30, 2020
    • Exploring Business Development Initiatives Targeted to Mitigate the Effect of the Planned Transition of GLASSIA® Manufacturing to Takeda During 2021
    • Company Reiterates Full-Year 2020 Total Revenue Guidance of $132
    • Second Quarter Revenues were $33.1 million, Compared to $35.3 million in 2019, First Half 2020 Revenues were $66.4 million, up 7% from 2019 

    • Net Income for the Second Quarter and for the First Half of 2020 was $3.5 million and $8.7 million, Respectively, Compared to $6.1 million and $11.1 million in 2019 Respectively
    • Significant Progress Achieved in Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19)
    • Approximately $100 million of Available Net Cash as of June 30, 2020
    • Exploring Business Development Initiatives Targeted to Mitigate the Effect of the Planned Transition of GLASSIA® Manufacturing to Takeda During 2021
    • Company Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million

    REHOVOT, Israel, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced financial results for the three and six months ended June 30, 2020.

    "Kamada presented solid financial and operational performance during the first six months of 2020," said Amir London, Kamada's Chief Executive Officer. "While the global COVID-19 pandemic persists, we generated total revenues of $66.4 million during the first half of the year, representing an increase of 7% year-over-year. Importantly, our manufacturing plant continues to be operational and we do not anticipate any meaningful changes in the foreseeable future due to COVID-19 pandemic. Based on our results in the first six months of 2020 and our current outlook for the remainder of the year, we are reiterating our guidance of total revenues of between $132 million and $137 million for full-year 2020."

    "We continue to expeditiously advance the development of our plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19)," continued Mr. London. "We have completed manufacturing of the initial batches of our product and earlier this week we announced first-patient-in our Phase 1/2 open label clinical trial in Israel. We are also working with the support of our partner, Kedrion Biopharma, toward obtaining FDA's acceptance of the proposed clinical development program and we expect to hold a pre-IND meeting with the FDA during this quarter."

    "We are intensively exploring business development opportunities to mitigate the effects of the planned transition of GLASSIA® manufacturing to Takeda during 2021. I am optimistic that these opportunities, funded by our strong cash position, along with our organic commercial growth, our investigational COVID-19 IgG product, the expected future royalty payments from Takeda together with the contract manufacturing of an FDA approved and commercialized specialty IgG product will contribute to our future growth," concluded Mr. London.

    Financial Highlights for the Three Months Ended June 30, 2020

    • Total revenues were $33.1 million in the second quarter of 2020, a 6% decrease from the $35.3 million recorded in the second quarter of 2019

      -  Proprietary Products segment revenues in the second quarter of 2020 were $22.6 million, a 17% decrease from the second quarter of 2019. The decrease this quarter is due to expediting shipments in the first quarter in anticipation of global transportation instability in the wake of COVID-19. Overall six months revenues from the Proprietary Products segment are up 1%.

      -  Distribution segment revenues were $10.5 million in the second quarter of 2020, a 31% increase from the second quarter of 2019
    • Gross profit was $11.1 million in the second quarter of 2020, compared to $13.6 million reported in the second quarter of 2019

      -  Proprietary Product segment gross margins in the second quarter were 43%, down three percentage points from the second quarter of 2019, in line with previous guidance expecting three to five percentage points' annual decrease which is attributable to a change in sales product mix and reduced plant utilization.
    • Operating expenses, including Research and Development, Sales and Marketing, General and Administrative, and Other expenses, totaled $7.1 million in the second quarter of 2020, as compared to $7.2 million in the second quarter of 2019

      -  2020 Research and Development expenses guidance was for an expected 20-25% annual increase. Given COVID-19-related delays, we currently expect a 15-17% increase for full year 2020 as compared to 2019.
    • Net income was $3.5 million, or $0.08 per share, in the second quarter of 2020, as compared to net income of $6.1 million, or $0.15 per share, in the second quarter of 2019
    • Adjusted EBITDA, as detailed in the tables below, was $5.5 million in the second quarter of 2020, as compared to $7.8 million in the second quarter of 2019
    • Cash provided by operating activities was $10.7 million in the second quarter of 2020, as compared to cash provided by operating activities of $6.8 million in the second quarter of 2019 

    Financial Highlights for the Six Months Ended June 30, 2020

    • Total revenues were $66.4 million in the first six months of 2020, a 7% increase from the $62.1 million recorded in the first six months of 2019

      -  Revenues from the Proprietary Products segment for the first six months of 2020 were $47.9 million, a 1% increase from the $47.7 million reported in the first six months of 2019

      -  Revenues from the Distribution segment were $18.4 million in the first six months 2020, a 28% increase from the $14.4 million recorded in the first six months of 2019
    • Gross profit was $22.6 million in the first six months 2020, a 9% decrease from the $24.8 million reported in the first six months 2019, primarily due to changes in the product mix
    • Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other expenses, totaled $13.7 million in the first six months 2020, as compared to $13.2 million in the first six months 2019
    • Net income was $8.7 million, or $0.20 per share, in the first six months of 2020, as compared to net income of $11.1 million, or $0.27 per share, in the first six months of 2019
    • Adjusted EBITDA, as detailed in the tables below, was $11.8 million in the first six months of 2020, as compared to $14.5 million in the first six months of 2019
    • Cash provided by operating activities was $8.7 million in the first six months of 2020, as compared to cash provided by operating activities of $12.8 million in the first six months of 2019 

    Balance Sheet Highlights

    As of June 30, 2020, the Company had cash, cash equivalents, and short-term investments of $104.7 million, as compared to $73.9 million at December 31, 2019. 

    Conference Call

    Kamada management will host an investment community conference call on Wednesday, August 12, 2020, 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 855-327-6837 (from within the U.S.), 1-809-458-327 (from Israel), or 631-891-4304 (International) and entering the conference identification number: 10010379. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.

    About Kamada

    Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel 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% 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) Total revenues to be in the range of $132 million to $137 million for fiscal 2020; 2) not anticipating meaningful changes in operations in the foreseeable future due to COVID-19 pandemic; 3) actions taken to mitigate the effect of the planned transition of GLASSIA manufacturing to Takeda during 2021; 4) optimism that business development opportunities, funded by our strong cash position, along with our organic commercial growth, our investigational COVID-19 IgG product, the expected future royalty payments from Takeda together with the contract manufacturing of an FDA approved and commercialized specialty IgG product will contribute to our future growth; 5) developments relating FDA's acceptance of the proposed clinical development program and clearance of Kamada's IND relating to its plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) following the pre-Investigational New Drug (IND) meeting with the FDA expected to take place in the third quarter of 2020; 6) guidance of an expected annual three to five percentage points decrease in the Proprietary Product segment gross margin which is attributable to a change in sales product mix and reduced plant utilization; and 7) previously expected increase of 20-25% in Research and Development expenses for 2020 in comparison to 2019 will not materialize mainly related to COVID-19 related delays in research projects and current expectation of an approximately 15-17% increase in Research and Development expenses in full year 2020 as compared to 2019. 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, ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, 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 obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies and on-going compassionate-use treatments, 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 CONDENSED BALANCE SHEETS

      As of June 30,  As of December 31, 
      2020  2019  2019 
      Unaudited  Audited 
           
      U.S Dollars in thousands 
    Assets         
    Current Assets            
    Cash and cash equivalents $57,399  $23,835  $42,662 
    Short-term investments  47,272   38,122   31,245 
    Trade receivables, net  19,823   25,497   23,210 
    Other accounts receivables  2,980   3,292   3,272 
    Inventories  47,646   35,501   43,173 
    Total Current Assets  175,120   126,247   143,562 
                 
    Non-Current Assets            
    Property, plant and equipment, net  24,574   24,478   24,550 
    Right-of-use-assets  3,796   3,946   4,022 
    Other long term assets  1,058   174   352 
    Contract asset  911   -   - 
    Deferred taxes  632   1,644   1,311 
    Total Non-Current Assets  30,971   30,242   30,235 
    Total Assets $206,091  $156,489  $173,797 
    Liabilities            
    Current Liabilities            
    Current maturities of bank loans $431  $480  $489 
    Current maturities of lease liabilities  990   960   1,020 
    Trade payables  22,760   19,879   24,830 
    Other accounts payables  5,497   4,876   5,811 
    Deferred revenues  589   461   589 
    Total Current Liabilities  30,267   26,656   32,739 
                 
    Non-Current Liabilities            
    Bank loans  63   482   257 
    Lease liabilities  3,704   3,988   3,981 
    Deferred revenues  1,025   542   232 
    Employee benefit liabilities, net  1,267   818   1,269 
    Total Non-Current Liabilities  6,059   5,830   5,739 
                 
    Shareholder's Equity            
    Ordinary shares  11,662   10,418   10,425 
    Additional paid in capital  207,731   179,471   180,819 
    Capital reserve due to translation to presentation currency  (3,490)  (3,490)  (3,490)
    Capital reserve from hedges  411   8   8 
    Capital reserve from financial assets measured at fair value through other comprehensive income  -   187   145 
    Capital reserve from share-based payments  6,204   9,663   8,844 
    Capital reserve from employee benefits  (356)  4   (359)
    Accumulated deficit  (52,397)  (72,258)  (61,073)
    Total Shareholder's Equity  169,765   124,003   135,319 
    Total Liabilities and Shareholder's Equity $206,091  $156,489  $173,797 





    CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME

      Six months period ended  Three months period ended  Year ended 
      June 30,  June 30,  December 31, 
      2020  2019  2020  2019  2019 
                    
      Unaudited  Unaudited  Audited 
              
      U.S Dollars In thousands 
                         
    Revenues from proprietary products $47,942  $47,662  $22,625  $27,281  $97,696 
    Revenues from distribution  18,437   14,388   10,464   7,972   29,491 
                         
    Total revenues  66,379   62,050   33,089   35,253   127,187 
                         
    Cost of revenues from proprietary products  27,881   25,178   12,934   14,688   52,425 
    Cost of revenues from distribution  15,932   12,088   9,040   6,965   25,025 
                         
    Total cost of revenues  43,813   37,266   21,974   21,653   77,450 
                         
    Gross profit  22,566   24,784   11,115   13,600   49,737 
                         
    Research and development expenses  6,970   6,253   3,623   3,487   13,059 
    Selling and marketing expenses  2,118   2,280   1,178   1,188   4,370 
    General and administrative expenses  4,619   4,621   2,307   2,527   9,194 
    Other expenses  34   28   32   5   330 
    Operating income  8,825   11,602   3,975   6,393   22,784 
                         
    Financial income  615   559   298   274   1,146 
    Income (expense) in respect of securities measured at fair value, net *  102   (58)  -   (7)  (5)
    Income (expenses) in respect of currency exchange differences and derivatives instruments, net  65   (528)  (367)  (215)  (651)
    Financial expenses  (135)  (149)  (58)  (72)  (293)
    Income before tax on income  9,472   11,426   3,848   6,373   22,981 
    Taxes on income  796   360   390   230   730 
                         
    Net Income $8,676  $11,066  $3,458  $6,143  $22,251 
                         
    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)  198   -   90   143 
    Gain (loss) on cash flow hedges  441   71   200   (3)  92 
    Net amounts transferred to the statement of profit or loss for cash flow hedges  (7)  (2)  (41)  -   (23)
    Items that will not be reclassified to profit or loss in subsequent periods:                    
    Remeasurement gain (loss) from defined benefit plan  -   -   -   -   (388)
    Tax effect  15   (49)  (12)  (21)  (11)
    Total comprehensive income $8,937  $11,284  $3,605  $6,209  $22,064 
                         
    Earnings per share attributable to equity holders of the Company:                    
    Basic net earnings per share $0.20  $0.27  $0.08  $0.15  $0.55 
    Diluted net earnings per share $0.20  $0.27  $0.08  $0.15  $0.55 





    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

      Six months period Ended  Three months period Ended  Year Ended 
      June, 30  June, 30  December 31, 
      2020  2019  2020  2019  2019 
                    
      Unaudited  Audited 
           
      U.S Dollars In thousands 
    Cash Flows from Operating Activities                    
    Net income $8,676  $11,066  $3,458  $6,143  $22,251 
                         
    Adjustments to reconcile net income to net cash provided by (used in) operating activities:                    
                         
    Adjustments to the profit or loss items:                    
                         
    Depreciation and impairment  2,380   2,251   1,188   1,124   4,519 
    Financial expenses (income), net  (647)  176   127   20   (197)
    Cost of share-based payment  588   634   330   319   1,163 
    Taxes on income  796   360   390   230   730 
    Loss (gain) from sale of property and equipment  (6)  (2)  (6)  4   (2)
    Change in employee benefit liabilities, net  (2)  31   16   (5)  94 
       3,109   3,450   2,045   1,692   6,307 
    Changes in asset and liability items:                    
                         
    Decrease (increase) in trade receivables, net  3,416   2,602   6,432   (2,125)  5,117 
    Decrease (increase) in other accounts receivables  741   249   (772)  118   (214)
    Increase in inventories  (4,473)  (6,185)  (5,859)  (3,793)  (13,857)
    Decrease (increase) in Contract asset and deferred expenses  (911)  (272)  (490)  (26)  399 
    Increase (decrease) in trade payables  (2,719)  1,927   4,497   4,295   6,259 
    Increase (decrease) in other accounts payables  (314)  (53)  866   457   863 
    Decrease in deferred revenues  793   (126)  396   (63)  (283)
       (3,467)  (1,858)  5,070   (1,137)  (1,716)
    Cash received (paid) during the period for:                    
                         
    Interest paid  (107)  (124)  (52)  (61)  (243)
    Interest received  601   300   150   128   1,106 
    Taxes paid  (74)  (16)  (13)  (8)  (134)
       420   160   85   59   729 
                         
    Net cash provided by operating activities $8,738  $12,818  $10,658  $6,757  $27,571 





    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

      Six months period Ended  Three months period Ended  Year Ended 
      June, 30  June, 30  December 31, 
      2020  2019  2020  2019  2019 
                    
      Unaudited  Audited 
           
      U.S Dollars In thousands 
    Cash Flows from Investing Activities               
                         
    Proceeds of investment in short term investments, net $(15,646) $(5,128) $-  $(4,070) $1,727 
    Purchase of property and equipment and intangible assets  (1,901)  (757)  (1,005)  (453)  (2,300)
    Proceeds from sale of property and equipment  6   9   6   3   9 
    Net cash used in investing activities  (17,541)  (5,876)  (999)  (4,520)  (564)
                         
    Cash Flows from Financing Activities                    
                         
    Proceeds from exercise of share base payments  20   9   15   6   16 
    Repayment of lease liabilities  (540)  (529)  (262)  (266)  (1,070)
    Repayment of long-term loans  (246)  (232)  (123)  (117)  (476)
    Proceeds from issuance of ordinary shares, net  24,894   -   -   -   - 
                         
    Net cash provided by (used in) financing activities  24,128   (752)  (370)  (377)  (1,530)
                         
    Exchange differences on balances of cash and cash equivalent  (588)  (448)  (1,178)  (62)  (908)
                         
    Increase in cash and cash equivalents  14,737   5,742   8,111   1,798   24,569 
                         
    Cash and cash equivalents at the beginning of the period  42,662   18,093   49,288   22,037   18,093 
                         
    Cash and cash equivalents at the end of the period $57,399  $23,835  $57,399  $23,835  $42,662 
                         
    Significant non-cash transactions                    
    Right-of-use asset recognized with corresponding lease liability $345  $4,548  $287  $117  $5,035 
    Purchase of property and equipment $722  $385  $722  $385  $992 







    Adjusted EBITDA               
      Six months period ended  Three months period ended  Year ended 
      June 30,  June 30,  December 31, 
      2020  2019  2020  2019  2019 
                    
       In thousands 
    Net income $8,676  $11,066  $3,458  $6,143  $22,251 
    Taxes on income  796   360   390   230   730 
    Financial expense (income), net  (647)  176   127   20   (197)
    Depreciation and amortization expense  2,380   2,251   1,188   1,124   4,519 
    Non-cash share-based compensation expenses  588   634   330   319   1,163 
    Adjusted EBITDA $11,793  $14,487  $5,493  $7,836  $28,466 







    Adjusted net income               
      Six months period ended  Three months period ended  Year ended 
      June 30,  June 30,  December 31, 
      2020  2019  2020  2019  2019 
                    
       In thousands 
    Net income $8,676  $11,066  $3,458  $6,143  $22,251 
    Share-based compensation charges  588   634   330   319   1,163 
    Adjusted net income $9,264  $11,700  $3,788  $6,462  $23,414 

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    • Study Participants are Hospitalized, Non-ventilated COVID-19 Patients with Pneumonia 
    • Encouraging Neutralization Activity Observed with Virus Neutralization Assay
    • Pre-IND Meeting with U.S. FDA to be Conducted in Current Quarter, with U.S. Clinical Development Expected to Commence in Early 2021
    • Kamada Intends to Further Explore its IgG Product as a Potential Preventive Therapy for COVID-19 Disease in Healthy Subjects at Risk in a Separate Clinical Study

    REHOVOT, Israel, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced that the first patient has been recruited to the Phase 1/2 clinical trial of its anti-SARS-CoV-2 plasma-derived immunoglobulin (IgG) product as a potential…

    • Study Participants are Hospitalized, Non-ventilated COVID-19 Patients with Pneumonia 

    • Encouraging Neutralization Activity Observed with Virus Neutralization Assay
    • Pre-IND Meeting with U.S. FDA to be Conducted in Current Quarter, with U.S. Clinical Development Expected to Commence in Early 2021
    • Kamada Intends to Further Explore its IgG Product as a Potential Preventive Therapy for COVID-19 Disease in Healthy Subjects at Risk in a Separate Clinical Study

    REHOVOT, Israel, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced that the first patient has been recruited to the Phase 1/2 clinical trial of its anti-SARS-CoV-2 plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) in Israel.

    This Phase 1/2 open-label, single-arm multi-center study was approved by the Ministry of Health in Israel.  The trial will assess the safety, pharmacokinetics, and pharmacodynamics of the Company's plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients will be enrolled and receive Kamada's product at a single dose of 4g within 10 days of initial symptoms. Patients will be followed for 84 days. In parallel, Kamada intends to further explore the potential of its IgG product to prevent COVID-19 disease in healthy subjects at risk in a separate study.

    Kamada's plasma-derived IgG product has been evaluated for SARS-CoV-2 neutralization activity. Preliminary results are encouraging and suggest potential high neutralization titer.

    "Following our announcement in June regarding the availability of our COVID-19 IgG product for compassionate use treatment in Israel, we are happy to report further advancement of our program with the initiation of this important clinical trial," said Amir London, Kamada's Chief Executive Officer. "We are encouraged by the results of the product neutralization activity and we believe our product has the potential to be an effective treatment for hospitalized, non-ventilated COVID-19 patients with pneumonia, and look forward to the results from this trial."

    This milestone is part of the global collaboration agreement established in April 2020 between Kamada and its partner Kedrion Biopharma for the development, manufacturing and distribution of a plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19).

    In order to expand its COVID-19 clinical development program to the U.S., Kamada, with the support of Kedrion, intends to conduct a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) during the current quarter in order to obtain FDA's acceptance of the proposed clinical development program. Pursuant to the collaboration between the two companies, Kedrion is responsible for the collection of COVID-19 convalescent plasma from U.S. recovered patients. Kedrion is collecting the plasma through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the United States. If FDA clearance of the IND is received, Kamada and Kedrion intend to initiate their clinical program in the U.S. in early 2021.

    About Kamada

    Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel 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% 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) Kamada's intent to further explore the ability of its IgG product potential to prevent COVID-19 disease in healthy subjects at risk in a separate study; 2) optimism that preliminary results of Kamada's plasma-derived IgG product neutralization activity for SARS-CoV-2 are encouraging and suggest potential high neutralization titer; 3) the belief that Kamada's plasma-derived IgG product has the potential to be an effective treatment for hospitalized, non-ventilated COVID-19 patients with pneumonia; 4) intention of Kamada, with Kedrion, to conduct a pre-Investigational New Drug (IND) meeting with the FDA during the current quarter in order to obtain FDA's acceptance of the proposed clinical development program; and 5) if the FDA clearance of the IND is received, Kamada and Kedrion plan to initiate their clinical program in the U.S. in early 2021. 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, including its effect and duration, availability of sufficient raw materials required to continue manufacturing of the plasma-derived hyperimmune IgG product for COVID-19, competition from other products for the treatment of COVID-19 patients; ability to conduct a clinical trial in light of restrictions during COVID-19, ability to obtain regulatory approval for a clinical trial of the plasma-derived immunoglobulin IgG product for COVID-19, 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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