KMDA Kamada Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Plasma-derived IgG product
COVID-19
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
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Phase 1/2
Phase 1/2
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Phase 2 trial completed.
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Alpha-1 antitrypsin (AAT)
Graft Versus Host Disease (GvHD)
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Phase 2/3
Phase 2/3
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Phase 2 trial ongoing.
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Inhaled formulation of AAT
AATD - Alpha-1 Antitrypsin deficiency
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Phase 3
Phase 3
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Phase 3 trial initiation announced December 16, 2019.
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KamRAB
Prophylaxis of rabies disease
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Approved
Approved
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Approval announced August 25, 2017.
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Alpha-1 Antitrypsin (AAT)
Pediatric patients newly diagnosed with type 1 diabetes
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Phase 2
Phase 2
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Phase 2 data released November 3, 2017. No significant treatment effect noted overall.
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Latest News
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- 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
[email protected]Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected]
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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
[email protected]Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected] -
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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
[email protected]Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected] -
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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 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
[email protected]Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected]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 INCOMENine 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 FLOWSNine 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 FLOWSNine 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 EBITDANine 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 incomeNine 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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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
[email protected]Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected]