KMDA Kamada Ltd.

6.96
-0.27  -4%
Previous Close 7.23
Open 7.11
52 Week Low 4.4
52 Week High 13.33
Market Cap $311,326,744
Shares 44,742,963
Float 28,895,797
Enterprise Value $225,357,411
Volume 159,314
Av. Daily Volume 186,473
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Upcoming Catalysts

Drug Stage Catalyst Date
Plasma-derived IgG product
COVID-19
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
Phase 1/2
Phase 2 trial completed.
Alpha-1 antitrypsin (AAT)
Graft Versus Host Disease (GvHD)
Phase 2/3
Phase 2/3
Phase 2 trial ongoing.
Inhaled formulation of AAT
AATD - Alpha-1 Antitrypsin deficiency
Phase 3
Phase 3
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 Three Products Are Expected to Be Launched, Subject to Israeli Ministry of Health Approval, Between 2022 and 2024
    • Potential Collective Maximum Sales of the Three Products in the Israeli Market is Estimated at $5-$7 Million Annually
    • These Sales Are in Addition to the Potential $20-$30 Million from the Recently Licensed Alvotech Biosimilar Portfolio

    REHOVOT, Israel, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced that the Company has entered into agreements with two undisclosed international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by the European Medicines Agency (EMA) and subsequently…

    • The Three Products Are Expected to Be Launched, Subject to Israeli Ministry of Health Approval, Between 2022 and 2024
    • Potential Collective Maximum Sales of the Three Products in the Israeli Market is Estimated at $5-$7 Million Annually
    • These Sales Are in Addition to the Potential $20-$30 Million from the Recently Licensed Alvotech Biosimilar Portfolio

    REHOVOT, Israel, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced that the Company has entered into agreements with two undisclosed international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by the European Medicines Agency (EMA) and subsequently by the Israeli Ministry of Health (IMOH), the three products are expected to be launched in Israel between 2022 and 2024. The two pharmaceutical companies will maintain development, manufacturing, and supply responsibilities for these three products.

    "These agreements expand our pipeline of biosimilar product candidates for distribution in Israel, which already includes six products previously licensed from Alvotech, and further position Kamada as a leader in the emerging biosimilar market in Israel," said Amir London, CEO of Kamada. "The Israeli market for the referenced innovative products to which these three biosimilar products are targeted was between approximately $20-$25 million in 2019, and we estimate the potential collective maximum sales generated by the distribution of these three products, achievable following regulatory approval and within several years of launch, to be in the range of $5-$7 million annually. These sales will be in addition to the $20-$30 million of potential maximum sales of the six Alvotech biosimilar products, which, subject to approval by the EMA and subsequently by the IMOH, are expected to be launched between 2022 and 2025. The distribution of this biosimilar portfolio is expected to further support the anticipated future revenue and profitability growth in our Distribution Products segment."

    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) approval by EMA and subsequently by IMOH of the three new biosimilar products; 2) Israeli launch of the three new biosimilar products between 2022 through 2024; 3) Kamada's position as a leader in the emerging biosimilar market in Israel; 4) Kamada's estimation that the potential maximum sales generated from the distribution of the three products, achievable after regulatory approval and within several years of launch, to be in the range of $5-$7 million annually; 5) approval by EMA and subsequently by IMOH of the six biosimilar products licensed from Alvotech; 6) Kamada's expectation to launch six biosimilar products licensed from Alvotech during 2022-2025; 7) Kamada's estimation that the potential maximum sales generated by the distribution of the six biosimilar products licensed from Alvotech, after regulatory approval and achievable within several years of launch, to be in the range of $20-$30 million annually; and 8) expectations that Kamada's Distribution segment will continue to grow in revenues and profitability in the coming years. 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, delays in the approval by the EMA and IMOH of the biosimilar products, additional competition in the biosimilar market in which Kamada operates, prevailing market conditions, corporate events associated with our partners, including the two undisclosed entities, 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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  1. REHOVOT, Israel, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), plasma-derived biopharmaceutical company, today announced that it has been selected as one of 10 winners of the Genesis Prize Foundation (GPF) Start-Up Nation Central (SNC) competition recognizing Israeli companies working to combat coronavirus and the damage of future pandemics. Based on its development of a plasma derived immunoglobulin (IgG) product as a potential therapy for coronavirus disease (COVID-19), Kamada was selected for its significant contributions towards fighting COVID-19 and advancing a promising technology that has the potential to provide significant benefits in the near future. The winners were announced in a virtual ceremony by Reuven…

    REHOVOT, Israel, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), plasma-derived biopharmaceutical company, today announced that it has been selected as one of 10 winners of the Genesis Prize Foundation (GPF) Start-Up Nation Central (SNC) competition recognizing Israeli companies working to combat coronavirus and the damage of future pandemics. Based on its development of a plasma derived immunoglobulin (IgG) product as a potential therapy for coronavirus disease (COVID-19), Kamada was selected for its significant contributions towards fighting COVID-19 and advancing a promising technology that has the potential to provide significant benefits in the near future. The winners were announced in a virtual ceremony by Reuven Rivlin, President of Israel.

    The annual Genesis Prize, dubbed the "Jewish Nobel" by TIME Magazine, honors extraordinary individuals for their outstanding professional achievement, contribution to humanity, and commitment to Jewish values. Natan Sharansky, the human rights activist, was announced as the 7th Genesis Prize Laureate in December 2019 and directed his $1 million award to organizations fighting the COVID-19 pandemic. Part of Mr. Sharansky's award was used to fund the competition.

    SNC is an Israel-based non-profit organization that works to ensure the strength and vitality of the Israeli tech ecosystem and to enhance its positive global impact. SNC leverages its in-depth knowledge of the country's innovation sector to connect multinational corporations, governments, and NGOs to those people and technologies in Israel most relevant to their needs.

    "We are deeply honored to receive this prestigious award from the GPF and SNC and for being recognized for the development of our plasma-derived IgG product against COVID-19," said Amir London, Kamada's Chief Executive Officer. "As previously reported, we executed an agreement with the Israeli Ministry of Health ("IMOH") to supply our product for the treatment of COVID-19 patients in Israel, under which the initial supply is expected to generate approximately $3.4 million in revenues during the first quarter of 2021. Importantly, per recent discussions with the IMOH, the treatment utilizing our product will be provided as part of a multi-center clinical study led by the IMOH."

    About the Genesis Prize

    The mission of the Genesis Prize is to foster Jewish identity, inspire Jewish pride and strengthen the bond between Israel and the Diaspora. The Prize celebrates Jewish talent and achievement, honoring individuals for their accomplishments and commitment to Jewish values, inspiring Jews to connect to their heritage and to Israel.

    The vision of the Genesis Prize is a strong and vibrant Jewish people, aware of its roots while looking to the future; a Jewish community flourishing in diversity, yet united in appreciation of Jewish values and support for the Jewish State.

    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) GPF and SNC's recognition of Kamada's development of a plasma derived immunoglobulin (IgG) product as a potential therapy for COVID-19 that has the potential to provide significant benefits toward fighting COVID-19 in the near future; 2) Kamada's expectation of generating approximately $3.4 million in revenues during the first quarter of 2021 from the supply of its IgG product for the treatment of COVID-19 patients to the IMOH; and 3) plans by the IMOH to utilize Kamada's product as part of a multi-center clinical study in COVID-19 patients. 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 relating to the immunoglobulin (IgG) product, 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 for the immunoglobulin (IgG) product, disruption to the supply chain due to COVID-19 pandemic, ability to obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, unexpected results of clinical studies and on-going compassionate-use treatments, outcome of continued discussions with IMOH regarding the utilization of Kamada's immunoglobulin (IgG) product, 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

    View Full Article Hide Full Article
  2. REHOVOT, Israel, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ:NBI). The annual re-ranking of the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index (NBI) is a modified market-cap weighted index designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NBI is re-ranked each year and is calculated under a modified capitalization-weighted…

    REHOVOT, Israel, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (NASDAQ:NBI). The annual re-ranking of the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index (NBI) is a modified market-cap weighted index designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NBI is re-ranked each year and is calculated under a modified capitalization-weighted methodology. Additionally, the NBI forms the basis for a number of Exchange Traded Funds (ETFs), including the iShares NASDAQ Biotechnology ETF (NASDAQ:IBB). More information about the NBI, including eligibility criteria, can be found at https://indexes.nasdaqomx.com/Index/Overview/NBI.

    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. 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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    • Third Quarter and First Nine Months of 2020 Revenues were $35.3 million and $101.7 million Respectively, a 7% Increase Compared to Both 2019 Periods; Company Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million
    • Net Income for Third Quarter and First Nine Months of 2020 was $6.8 million and $15.5 million, Respectively, Compared to $5.8 Million and $16.9 Million in 2019, Respectively
    • Continued to Advance Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) Through a $3.4 million Supply Agreement with the Israeli Ministry of Health and Positive Interim Results from an Ongoing Phase 1/2 Clinical Study
    • Exploring Strategic Business Development Initiatives
    • Third Quarter and First Nine Months of 2020 Revenues were $35.3 million and $101.7 million Respectively, a 7% Increase Compared to Both 2019 Periods; Company Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million
    • Net Income for Third Quarter and First Nine Months of 2020 was $6.8 million and $15.5 million, Respectively, Compared to $5.8 Million and $16.9 Million in 2019, Respectively
    • Continued to Advance Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) Through a $3.4 million Supply Agreement with the Israeli Ministry of Health and Positive Interim Results from an Ongoing Phase 1/2 Clinical Study
    • Exploring Strategic Business Development Initiatives Focused on Utilizing Kamada's Core Plasma-Derived Pharmaceuticals Development, Manufacturing and Commercialization Expertise by Leveraging Its Strong Financial Position

    REHOVOT, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today announced financial results for the three and nine months ended September 30, 2020.

    "We are pleased with our solid financial and operational results during the recently completed quarter and first nine months of 2020, achieved in the midst of the COVID-19 global pandemic," said Amir London, Kamada's Chief Executive Officer. "Total revenues increased seven percent for both the three and nine months ended September 30, 2020 as compared to the same periods in 2019. Based on our solid performance in the first nine months of the year, and our positive outlook for the fourth quarter, we are reiterating our full-year 2020 total revenue guidance of $132 million to $137 million."

    "We continue to achieve important progress in the development of our plasma derived immunoglobulin (IgG) product as a potential therapy for COVID-19 disease," continued Mr. London. "We executed an agreement with the Israeli Ministry of Health ("IMOH") to supply our product for the treatment of COVID-19 patients in Israel, under which the initial supply is expected to generate approximately $3.4 million in revenues during the first quarter of 2021. Importantly, per recent discussions with the IMOH, the treatment utilizing our product will be provided as part of a multi-center clinical study led by the IMOH. From a supply perspective, we are ramping up our COVID-19 IgG manufacturing capacity, and we intend to increase our supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets. In addition, we completed enrollment and announced positive initial interim results from our ongoing Phase 1/2 open-label COVID-19 clinical trial in Israel. Lastly, following recent response from the U.S. Food and Drug Administration ("FDA") to our previously submitted pre-Investigational New Drug (IND) information package, we, together with our partner, Kedrion Biopharma, are currently evaluating the suitable targeted patient population for our US clinical program and will submit an IND application upon conclusion of such evaluation and successful completion of additional required activities."

    "As we move into 2021 and in anticipation of the reduction in revenues due to the planned transition of GLASSIA manufacturing to Takeda, we are exploring strategic business development opportunities that will utilize and expend our core plasma-derived therapeutics development, manufacturing, and commercialization expertise. These opportunities will be funded by our strong cash position. We believe that our COVID-19 IgG program demonstrates Kamada's ability to quickly respond to emerging pandemic situations, and we plan to leverage these capabilities and our IgG platform technology as a strategic business line, with the ability to respond to other potentially similar future pandemic situations. These strategic opportunities are anticipated to be added to the expected organic commercial growth of our existing products portfolio, including KEDRAB, our distributed products in Israel, the anticipated future royalty payments from Takeda, and the contract manufacturing of an FDA approved and commercialized specialty IgG product." concluded Mr. London.

    Financial Highlights for the Three Months Ended September 30, 2020

    • Total revenues were $35.3 million in the third quarter of 2020, a 7% increase from the $33.1 million recorded in the third quarter of 2019.
    • Proprietary Products segment revenues in the third quarter of 2020 were $29.7 million, a 19% increase from the third quarter of 2019.
    • Distribution segment revenues were $5.6 million in the third quarter of 2020, a 31% decrease from the third quarter of 2019.
    • Gross profit was $14.8 million in the third quarter of 2020, compared to $12.9 million reported in the third quarter of 2019.
    • Proprietary Product segment gross margins in the third quarter were 46%, down one percentage point from the third quarter of 2019. For full-year 2020, Kamada continues to expect an annual decrease of three to five percentage points in Proprietary Product segment gross margins, primarily 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 third quarter of 2020, as compared to $7.2 million in the third quarter of 2019.
    • The Company continues to expect a 13%-15% increase in Research and Development expenses for full-year 2020 as compared to 2019.
    • Net income was $6.8 million, or $0.15 per share, in the third quarter of 2020, as compared to net income of $5.8 million, or $0.14 per share, in the third quarter of 2019.
    • Adjusted EBITDA, as detailed in the tables below, was $9.3 million in the third quarter of 2020, as compared to $7.2 million in the third quarter of 2019.
    • Cash used in operating activities was $2.4 million in the third quarter of 2020, as compared to cash provided by operating activities of $6.1 million in the third quarter of 2019.

    Financial Highlights for the Nine months Ended September 30, 2020

    • Total revenues were $101.7 million in the first nine months of 2020, a 7% increase from the $95.1 million recorded in the first nine months of 2019.
    • Revenues from the Proprietary Products segment for the first nine months of 2020 were $77.6 million, a 7% increase from the $72.5 million reported in the first nine months of 2019.
    • Revenues from the Distribution segment were $24.1 million in the first nine months 2020, a 7% increase from the $22.6 million recorded in the first nine months of 2019.
    • Gross profit was $37.4 million in the first nine months 2020, compared to $37.6 million in the first nine months of 2019.
    • Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other Expenses, totaled $20.8 million in the first nine months 2020, as compared to $20.3 million in the first nine months of 2019.
    • Net income was $15.5 million, or $0.35 per share, in the first nine months of 2020, as compared to net income of $16.9 million, or $0.42 per share, in the first nine months of 2019.
    • Adjusted EBITDA, as detailed in the tables below, was $21.1 million in the first nine months of 2020, as compared to $21.7 million in the first nine months of 2019.
    • Cash provided by operating activities was $6.4 million in the first nine months of 2020, as compared to cash provided by operating activities of $18.9 million in the first nine months of 2019.

    Balance Sheet Highlights

    As of September 30, 2020, the Company had cash, cash equivalents, and short-term investments of $99.7 million, as compared to $73.9 million at December 31, 2019. This increase is mainly related to the sale of $25 million of equity to FIMI Opportunity Fund, the leading private equity investor in Israel.

    Recent Corporate Highlights

    • Appointed Yifat Philip, Esq. as Vice President Legal, General Counsel and Corporate Secretary.

    Conference Call

    Kamada management will host an investment community conference call on Wednesday, November 11, 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 877-407-0792 (from within the U.S.), 1-809-409-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13710863. 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. 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) total revenues to be in the range of $132 million to $137 million for fiscal 2020; 2) ability to ramp up Kamada's COVID-19 IgG manufacturing capacity and its plan to increase its supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets; 3) ability to advance the U.S. clinical development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for COVID-19; 4) ability to explore strategic business development opportunities that utilize and expend Kamada's core plasma-derived therapeutics development, manufacturing, and commercialization expertise; and 5) Kamada's belief that its COVID-19 IgG program demonstrates its ability to quickly respond to emerging pandemic situations, and its plan to leverage these capabilities and its IgG platform technology as a strategic line of business. 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 September 30,  As of

    December 31,
     
     2020  2019  2019 
     Unaudited  Audited 
       
     U.S Dollars in thousands 
    Assets  
    Current Assets           
    Cash and cash equivalents$52,487  $27,449  $42,662 
    Short-term investments 47,230   39,380   31,245 
    Trade receivables, net 28,643   23,999   23,210 
    Other accounts receivables 3,533   1,722   3,272 
    Inventories 42,618   34,031   43,173 
    Total Current Assets 174,511   126,581   143,562 
                
    Non-Current Assets           
    Property, plant and equipment, net 25,323   24,197   24,550 
    Right-of-use-assets 3,694   4,100   4,022 
    Other long term assets 1,081   178   352 
    Contract asset 1,438   -   - 
    Deferred taxes 298   1,445   1,311 
    Total Non-Current Assets 31,834   29,920   30,235 
    Total Assets$206,345  $156,501  $173,797 
    Liabilities           
    Current Liabilities           
    Current maturities of bank loans$322  $573  $489 
    Current maturities of lease liabilities 1,038   964   1,020 
    Trade payables 15,110   13,079   24,830 
    Other accounts payables 6,236   5,439   5,811 
    Deferred revenues 486   561   589 
    Total Current Liabilities 23,192   20,616   32,739 
                
    Non-Current Liabilities           
    Bank loans 48   461   257 
    Lease liabilities 3,589   4,052   3,981 
    Deferred revenues 1,525   347   232 
    Employee benefit liabilities, net 1,262   884   1,269 
    Total Non-Current Liabilities 6,424   5,744   5,739 
                
    Shareholder's Equity           
    Ordinary shares 11,703   10,420   10,425 
    Additional paid in capital 209,650   179,589   180,819 
    Capital reserve due to translation to presentation currency (3,490)  (3,490)  (3,490)
    Capital reserve from hedges 234   18   8 
    Capital reserve from financial assets measured at fair value through other comprehensive income -   137   145 
    Capital reserve from share-based payments 4,550   9,898   8,844 
    Capital reserve from employee benefits (356)  4   (359)
    Accumulated deficit (45,562)  (66,435)  (61,073)
    Total Shareholder's Equity 176,729   130,141   135,319 
    Total Liabilities and Shareholder's Equity$206,345  $156,501  $173,797 







    CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME

     Nine months period ended  Three months period ended  Year ended 
     September 30,  September 30,  December 31, 
     2020  2019  2020  2019  2019 
             
     Unaudited  Unaudited  Audited 
       
     U.S Dollars In thousands 
                   
    Revenues from proprietary products$77,633  $72,521  $29,691  $24,859  $97,696 
    Revenues from distribution 24,071   22,595   5,634   8,207   29,491 
                        
    Total revenues 101,704   95,116   35,325   33,066   127,187 
                        
    Cost of revenues from proprietary products 43,817   38,412   15,936   13,234   52,425 
    Cost of revenues from distribution 20,500   19,056   4,568   6,968   25,025 
                        
    Total cost of revenues 64,317   57,468   20,504   20,202   77,450 
                        
    Gross profit 37,387   37,648   14,821   12,864   49,737 
                        
    Research and development expenses 10,335   9,730   3,365   3,477   13,059 
    Selling and marketing expenses 3,297   3,441   1,179   1,161   4,370 
    General and administrative expenses 7,133   6,851   2,514   2,230   9,194 
    Other expenses 34   327   -   299   330 
    Operating income 16,588   17,299   7,763   5,697   22,784 
                        
    Financial income 865   887   250   328   1,146 
    Income (expense) in respect of securities measured at fair value, net 102   (3)  -   55   (5)
    Income (expenses) in respect of currency exchange differences and derivatives instruments, net (696)  (503)  (761)  25   (651)
    Financial expenses (204)  (217)  (69)  (68)  (293)
    Income before tax on income 16,655   17,463   7,183   6,037   22,981 
    Taxes on income 1,144   574   348   214   730 
                        
    Net Income$15,511  $16,889  $6,835  $5,823  $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)  132   -   (66)  143 
    Gain (loss) on cash flow hedges 516   99   75   28   92 
    Net amounts transferred to the statement of profit or loss for cash flow hedges (273)  (20)  (266)  (18)  (23)
    Items that will not be reclassified to profit or loss in subsequent periods:                   
    Remeasurement gain (loss) from defined benefit plan -       -   -   (388)
    Tax effect 29   (33)  14   16   (11)
    Total comprehensive income$15,595  $17,067  $6,658  $5,783  $22,064 
                        
    Earnings per share attributable to equity holders of the Company:                   
    Basic net earnings per share$0.35  $0.42  $0.15  $0.14  $0.55 
    Diluted net earnings per share$0.35  $0.42  $0.15  $0.14  $0.55 







    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

     Nine months period Ended  Three months period Ended  Year Ended 
     September 30,  September 30,  December 31, 
     2020  2019  2020  2019  2019 
          
     Unaudited  Audited 
       
     U.S Dollars In thousands 
    Cash Flows from Operating Activities              
    Net income$15,511  $16,889  $6,835  $5,823  $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 3,632   3,379   1,252   1,128   4,519 
    Financial expenses (income), net (67)  (164)  580   (340)  (197)
    Cost of share-based payment 853   987   265   353   1,163 
    Taxes on income 1,144   574   348   214   730 
    Gain from sale of property and equipment (7)  (2)  (1)  -   (2)
    Change in employee benefit liabilities, net (7)  97   (5)  66   94 
      5,548   4,871   2,439   1,421   6,307 
    Changes in asset and liability items:                   
                        
    Decrease (increase) in trade receivables, net (5,540)  4,408   (8,956)  1,806   5,117 
    Decrease (increase) in other accounts receivables 972   1,204   231   955   (214)
    Decrease (increase) in inventories 555   (4,715)  5,028   1,470   (13,857)
    Decrease (increase) in Contract asset and deferred expenses (2,464)  333   (1,553)  605   399 
    Increase (decrease) in trade payables (10,488)  (4,585)  (7,769)  (6,512)  6,259 
    Increase in other accounts payables 426   379   740   432   863 
    Increase (decrease) in deferred revenues 1,190   (221)  397   (95)  (283)
      (15,349)  (3,197)  (11,882)  (1,339)  (1,716)
    Cash received (paid) during the period for:                   
                        
    Interest paid (158)  (182)  (51)  (58)  (243)
    Interest received 891   554   290   254   1,106 
    Taxes paid (87)  (25)  (13)  (9)  (134)
      646   347   226   187   729 
                        
    Net cash provided by (used in) operating activities$6,356  $18,910  $(2,382) $6,092  $27,571 







    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

     Nine months period Ended  Three months period Ended  Year Ended 
     September 30,  September 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) $(6,160) $-  $(1,032) $1,727 
    Purchase of property and equipment and intangible assets (3,372)  (1,488)  (1,471)  (731)  (2,300)
    Proceeds from sale of property and equipment 7   9   1   -   9 
    Net cash used in investing activities (19,011)  (7,639)  (1,470)  (1,763)  (564)
                        
    Cash Flows from Financing Activities                   
                        
    Proceeds from exercise of share base payments 61   12   41   3   16 
    Repayment of lease liabilities (815)  (794)  (275)  (265)  (1,070)
    Repayment of long-term loans (373)  (353)  (127)  (121)  (476)
    Proceeds from issuance of ordinary shares, net 24,894   -   -   -   - 
                        
    Net cash provided by (used in) financing activities 23,767   (1,135)  (361)  (383)  (1,530)
                        
    Exchange differences on balances of cash and cash equivalent (1,287)  (780)  (699)  (332)  (908)
                        
    Increase (decrease) in cash and cash equivalents 9,825   9,356   (4,912)  3,614   24,569 
                        
    Cash and cash equivalents at the beginning of the period 42,662   18,093   57,399   23,835   18,093 
                        
    Cash and cash equivalents at the end of the period$52,487  $27,449  $52,487  $27,449  $42,662 
                        
    Significant non-cash transactions                   
    Right-of-use asset recognized with corresponding lease liability$539  $4,984  $194  $436  $5,035 
    Purchase of property and equipment$973  $264  $973  $264  $992 







    Adjusted EBITDA

     Nine months period ended  Three months period ended  Year ended 
     September 30,  September 30,  December 31, 
     2020  2019  2020  2019  2019 
       
     In thousands 
    Net income$15,511  $16,889  $6,835  $5,823  $22,251 
    Taxes on income 1,144   574   348   214   730 
    Financial expense (income), net (67)  (164)  580   (340)  (197)
    Depreciation and amortization expense 3,632   3,379   1,252   1,128   4,519 
    Non-cash share-based compensation expenses 853   987   265   353   1,163 
    Adjusted EBITDA$21,073  $21,665  $9,280  $7,178  $28,466 







    Adjusted net income

     Nine months period ended  Three months period ended  Year ended 
     September 30,  September 30,  December 31, 
     2020  2019  2020  2019  2019 
       
     In thousands 
    Net income$15,511  $16,889  $6,835  $5,823  $22,251 
    Share-based compensation charges 853   987   265   353   1,163 
    Adjusted net income$16,364  $17,876  $7,100  $6,176  $23,414 

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  3. REHOVOT, Israel, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), plasma-derived biopharmaceutical company, today announced that it will release financial results for the third quarter ended September 30, 2020, prior to the open of the U.S. financial markets on Wednesday, November 11, 2020.

    Kamada management will host an investment community conference call on Wednesday, November 11, 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: 13710863. The call will also be…

    REHOVOT, Israel, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), plasma-derived biopharmaceutical company, today announced that it will release financial results for the third quarter ended September 30, 2020, prior to the open of the U.S. financial markets on Wednesday, November 11, 2020.

    Kamada management will host an investment community conference call on Wednesday, November 11, 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: 13710863. 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 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.

    CONTACTS:

    Chaime Orlev

    Chief Financial Officer

    Bob Yedid

    LifeSci Advisors, LLC

    646-597-6989

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