KMDA Kamada Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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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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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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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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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Plasma-derived IgG product
COVID-19
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Phase 1/2
Phase 1/2
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Phase 1/2 trial to be initiated 3Q 2020.
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Inhaled formulation of AAT
AATD - Alpha-1 Antitrypsin deficiency
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Phase 2
Phase 2
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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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- Kamada Completed Manufacturing and Released the First Batch of its Plasma-Derived Immunoglobulin Product for Coronavirus Disease (COVID-19) and it is Available for Compassionate Use Treatment in Israel; Additional Production is On-Going
- Kamada Intends to Initiate a Phase 1/2 Clinical Study in Hospitalized COVID-19 Patients in Israel During the Third Quarter of 2020
- Kamada and its Partner Kedrion are Expanding the Clinical Development Program to the U.S. and Expect to Hold a Pre-IND Meeting with the FDA Early in the Third Quarter of 2020
- Kamada Intends to Manufacture Future Batches of the Product using U.S. COVID-19 Convalescent Plasma Collected by Kedrion
REHOVOT, Israel, June 17, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a plasma-derived biopharmaceutical company, today provided an update on its development of a plasma-derived immunoglobulin (IgG) product for Coronavirus Disease (COVID-19).
Kamada completed manufacturing of the first batch of its plasma-derived IgG product for COVID-19 utilizing the Company's approved proprietary IgG platform technology, and additional production is ongoing. The initial vials are available for compassionate use in Israel. In addition, Kamada's proposed clinical protocol for a Phase 1/2 clinical trial was submitted to the Israeli Ministry of Health, and the Company expects to initiate the study during the third quarter of this year.
In order to expand its clinical development program to the U.S., Kamada, with the support of Kedrion Biopharma, intends to conduct a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) early in the third quarter in order to obtain FDA's acceptance of the proposed clinical development program. Pursuant to the Company's global collaboration agreement with Kedrion for the development, manufacturing and distribution of the plasma-derived IgG product for COVID-19, Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to manufacture additional batches of the product. Kedrion is collecting the plasma, through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the United States.
"We are extremely pleased with the rapid and important progress achieved to date in advancing our plasma-derived IgG product for COVID-19," said Amir London, Kamada's Chief Executive Officer. "To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of COVID-19. This achievement validates our advanced IgG development and manufacturing capabilities and our ability to rapidly focus our efforts on providing potential solutions to emerging pandemic situations. We anticipate the initiation of a Phase 1/2 clinical trial in Israel during the third quarter and are concurrently expanding our development program to the U.S. with our partner, Kedrion. We believe that Kamada and Kedrion, two leaders in plasma-derived protein therapeutics, are uniquely positioned to make a positive impact in the treatment of COVID-19 patients."
About Kamada
Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KAMRAB®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KAMRAB is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to GLASSIA and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection. The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding 1) Kamada intending to initiate Phase 1/2 clinical trial in hospitalized COVID-19 patients in Israel during the third quarter of 2020; 2) Kamada and Kedrion working together to hold a pre-IND meeting with the FDA early in the third quarter of 2020; 3) that to the best of its knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of COVID-19; and 4) the belief that Kamada and Kedrion are uniquely positioned to make a positive impact in the treatment of 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, including its effect and duration, availability of sufficient raw materials required to continue manufacturing of the plasma-derived hyperimmune IgG product for COVID-19, competition from other products for the treatment of COVID-19 patients; 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, 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, ability to find doctors and medical facilities to collaborate on 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]kamada.comBob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected]
- Kamada Completed Manufacturing and Released the First Batch of its Plasma-Derived Immunoglobulin Product for Coronavirus Disease (COVID-19) and it is Available for Compassionate Use Treatment in Israel; Additional Production is On-Going
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- Total Revenues were $33.3 Million, an Increase of 24% Year-over-Year
- Net Income was $5.2 Million, an Increase of 6% Year-over-Year
- Company Reports Continued Progress of its Development Program of a Plasma-Derived Hyperimmune IgG Therapy for COVID-19; Product Availability for Clinical and Compassionate Use Treatment for COVID-19 patients in Israel is Expected by End of the Second Quarter of 2020
- Company's Manufacturing Plant Continues to Operate Without Significant Disruption During Ongoing Coronavirus (COVID-19) Outbreak
- Kamada Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million
REHOVOT, Israel, May 18, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA)), a plasma-derived biopharmaceutical company, today announced financial results for the three months ended March 31, 2020.
"As the ongoing COVID-19 global pandemic continues to create substantial complications in daily life and business operations, we are focused on the safety and well-being of our employees, who continue to find innovative solutions to support our patients and partners," said Amir London, Kamada's Chief Executive Officer. "These efforts contributed to our strong performance in the first quarter of the year. Total revenues were $33.3 million, an increase of 24 percent year-over-year. These results were driven by similar year-over year increase in sales of both our Proprietary and Distributed products. Based on our strong performance in the first quarter and our current outlook for the remainder of the year, we are reiterating our guidance of total revenues of between $132 million and $137 million for full-year 2020."
"To date, our manufacturing plant remains operational with no effect on business continuity, even amidst the emergency regulations enforced in Israel in recent months due to the COVID-19 pandemic. Moreover, based on the most recent interactions with our U.S. distribution partners regarding finished product inventory levels available for distribution in the U.S and our planned supply for the remainder of the year, we do not anticipate meaningful supply shortages in the foreseeable future in the U.S. market for GLASSIA® or KEDRAB®. In addition, based on currently available inventory levels and planned supply of our Distributed products in Israel, we do not anticipate significant supply shortages in the foreseeable future. Going forward, although certain COVID-19 pandemic-related dynamics may affect market demand and production conditions, we intend to maintain our current manufacturing and supply plans, and increased inventory levels of raw materials through our suppliers and service providers in order to appropriately manage any potential supply disruptions and secure continued manufacturing," continued Mr. London.
"As previously reported, during the first quarter, we were able to quickly focus our efforts on the development and manufacturing of a plasma-derived hyperimmune IgG product for COVID-19, which leverages our proprietary IgG platform technology, as a potential treatment for COVID-19 patients. We are pleased to report today that we have secured adequate quantities of COVID-19 convalescent plasma in Israel. This has enabled us to initiate manufacturing of the product, which is expected to be available by the end of the second quarter for compassionate use treatment in Israel, based on Israeli Ministry of Health (IMOH) regulations. Concurrently, we have ongoing discussions with the IMOH with regard to the potential initiation of related clinical trials. In addition, we were excited to recently announce our global collaboration with Kedrion Biopharma, which will allow us to more rapidly develop our plasma-derived hyperimmune IgG product for COVID-19 and broaden our international reach," concluded Mr. London.
Financial Highlights for the Three Months Ended March 31, 2020
- Total revenues were $33.3 million in the first quarter of 2020, a 24% increase from the $26.8 million recorded in the first quarter of 2019
- Revenues from the Proprietary Products segment in the first quarter of 2020 were $25.3 million, a 24% increase from the $20.4 million reported in the first quarter of 2019
- Revenues from the Distribution segment were $8.0 million in the first quarter of 2020, a 24% increase from the $6.4 million recorded in the first quarter of 2019
- Gross profit was $11.5 million in the first quarter of 2020, a 2% increase from the $11.2 million reported in the first quarter of 2019; overall gross profitability differences are affected by changes in product sales mix between the quarters
- Operating expenses, including R&D, Sales & Marketing, G&A, and Other expenses, totaled $6.6 million in the first quarter of 2020, as compared to $6.0 million in the first quarter of 2019. This increase was primarily driven by increased R&D expenses specifically related to the initiation of the Company's pivotal Phase 3 InnovAATe clinical trial which is designed to evaluate the Company's proprietary inhaled Alpha-1 Antitrypsin therapy for treatment of Alpha-1 Antitrypsin Deficiency
- Net income was $5.2 million, or $0.12 per share, in the first quarter of 2020, as compared to net income of $4.9 million, or $0.12 per share, in the first quarter of 2019
- Adjusted EBITDA, as detailed in the tables below, was $6.3 million in the first quarter of 2020, as compared to $6.7 million in the first quarter of 2019
- Cash used in operating activities was $1.9 million in the first quarter of 2020, as compared to cash provided by operating activities of $6.1 million in the first quarter of 2019. This change in operating activity cash flow is specifically related to timing of payments to suppliers on account of inventories which are expected to be sold later this year
Balance Sheet Highlights
As of March 31, 2020, the Company had cash, cash equivalents, and short-term investments of $96.4 million, as compared to $73.9 million at December 31, 2019. This includes the net proceeds generated from the $25 million private placement transaction with the FIMI Opportunity Fund closed in February 2020.Recent Corporate Highlights
- Plasma-derived hyperimmune IgG product for COVID-19
° Announced a collaboration with Kedrion Biopharma for the development, manufacturing and distribution of a plasma-derived hyperimmune IgG product for COVID-19
° Initiated manufacturing of the product based on collected convalescent plasma in Israel; product is expected to be available for clinical and compassionate use treatment in Israel by the end of the second quarter- Inhaled AAT product
° Enrolment in the pivotal Phase 3 InnovAATe clinical trial, which continued through February 2020, was temporarily halted due to the impact of COVID-19 pandemic on healthcare systems. Patients already recruited to the study continued treatment as planned. The Company anticipates resuming enrollment into the study in the third quarter of 2020, pending appropriate conditions at clinical trial sites.
° InnovAATe clinical trial is designed to evaluate the Company's proprietary inhaled Alpha-1 Antitrypsin therapy for treatment of Alpha-1 Antitrypsin Deficiency
° Obtained U.S. Food and Drug Administration (FDA) acceptance for the protocol design of a 30 patient sub-study, designed to evaluate the effect of Kamada‘s Inhaled AAT on pharmacokinetics of IV-AAT and collect safety and immunogenicity data, including the effect of anti-drug antibodies (ADA) on AAT levels in plasma. Initiation of this sub-study has been delayed due to COVID-19 pandemic effectConference Call
Kamada management will host an investment community conference call on Monday, May 18, 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.), 1809 406 247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13699990. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.About Kamada
Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection. 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) the total revenues to be in the range of $132 million to $137 million for fiscal 2020; 2) not anticipating meaningful supply shortages in the foreseeable future in the U.S. market for GLASSIA® or KEDRAB®; 3) not anticipating significant supply shortages in the foreseeable future for Kamada's Distributed products in Israel; 4) anticipating maintaining current manufacturing and supply plans; 5) increasing inventory levels of raw materials through suppliers and service providers in order to appropriately manage any potential supply disruptions and secure continued manufacturing; 6) anticipating availability for clinical and compassionate-use treatment in Israel of a plasma-derived hyperimmune IgG product for COVID-19, form COVID-19 convalescent plasma, by the end of the second quarter of 2020; 7) anticipating that the global collaboration with Kedrion Biopharma will allow Kamada to speed up the development of the plasma-derived hyperimmune IgG product for COVID-19 and broaden the product's international reach; and 8) anticipating that Phase 3 InnovAATe clinical trial will resume enrollment in the third quarter of 2020. 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 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, continued demand for Kamada's products, including GLASSIA and KEDRAB, in the U.S. market and its distributed products in Israel, 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, ability to find doctors and medical facilities to collaborate on 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 Balance Sheets As of March 31, As of
December 31,2020 2019 2019 Unaudited Audited U.S Dollars in thousands Assets Current Assets Cash and cash equivalents $ 49,288 $ 22,037 $ 42,662 Short-term investments 47,124 33,800 31,245 Trade receivables, net 26,266 23,210 23,210 Other accounts receivables 1,736 3,442 3,272 Inventories 41,787 31,708 43,173 Total Current Assets 166,201 114,197 143,562 Non-Current Assets Property, plant and equipment, net 24,379 24,642 24,550 Right-of-use assets 3,800 4,187 4,022 Other long term assets 1,053 174 352 Deferred expenses 421 - - Deferred taxes 939 1,895 1,311 Total Non-Current Assets 30,592 30,898 30,235 Total Assets $ 196,793 $ 145,095 $ 173,797 Liabilities Current Liabilities Current maturities of bank loans $ 465 $ 470 $ 489 Current maturities of lease liabilities 928 961 1,020 Trade payables 18,440 15,255 24,830 Other accounts payables 4,875 4,424 5,811 Deferred revenues 649 461 589 Total Current Liabilities 25,357 21,571 32,739 Non-Current Liabilities Bank loans 138 591 257 Lease liabilities 3,663 4,036 3,981 Deferred revenues 569 605 232 Employee benefit liabilities, net 1,251 823 1,269 Total Non-Current Liabilities 5,621 6,055 5,739 Shareholder's Equity Ordinary shares 11,647 10,412 10,425 Additional paid in capital net 204,702 179,352 180,819 Capital reserve due to translation to presentation currency (3,490 ) (3,490 ) (3,490 ) Capital reserve from hedges 264 11 8 Capital reserve from financial assets measured at fair value through other comprehensive income - 118 145 Capital reserve from share-based payments 8,903 9,463 8,844 Capital reserve from employee benefits (356 ) 4 (359 ) Accumulated deficit (55,855 ) (78,401 ) (61,073 ) Total Shareholder's Equity 165,815 117,469 135,319 Total Liabilities And Shareholder's Equity $ 196,793 $ 145,095 $ 173,797 Consolidated Statements of Comprehensive Income Three months period ended Year ended March 31, December 31, 2020 2019 2019 Unaudited Audited U.S Dollars in thousands Revenues from proprietary products $ 25,317 $ 20,381 $ 97,696 Revenues from distribution 7,973 6,416 29,491 Total revenues 33,290 26,797 127,187 Cost of revenues from proprietary products 14,947 10,490 52,425 Cost of revenues from distribution 6,892 5,123 25,025 Total cost of revenues 21,839 15,613 77,450 Gross profit 11,451 11,184 49,737 Research and development expenses 3,347 2,766 13,059 Selling and marketing expenses 940 1,092 4,370 General and administrative expenses 2,312 2,094 9,194 Other expense 2 23 330 Operating income 4,850 5,209 22,784 Financial income 317 280 1,146 Income (expense) in respect of securities measured at fair value, net 102 (52 ) (5 ) Income (expense) in respect of currency exchange differences and derivatives instruments, net 432 (313 ) (651 ) Financial expense (77 ) (71 ) (293 ) Income before tax on income 5,624 5,053 22,981 Taxes on income 406 130 730 Net Income $ 5,218 $ 4,923 $ 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 ) 108 143 Gain on cash flow hedges 241 74 92 Net amounts transferred to the statement of profit or loss for cash flow hedges 34 (2 ) (23 ) Items that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain (loss) from defined benefit plan - - (388 ) Tax effect 27 (28 ) (11 ) Total comprehensive income $ 5,332 $ 5,075 $ 22,064 Earnings per share attributable to equity holders of the Company: Basic income per share $ 0.12 $ 0.12 $ 0.55 Diluted income per share $ 0.12 $ 0.12 $ 0.55 Consolidated Statements of Cash Flows Three months period Ended Year Ended March 31, December 31, 2020 2019 2019 Unaudited Audited U.S Dollars in thousands Net income $ 5,218 $ 4,923 $ 22,251 Adjustments to reconcile net income to net cash provided by operating activities: Adjustments to the profit or loss items: Depreciation and impairment 1,192 1,127 4,519 Financial expenses (income), net (774 ) 156 (197 ) Cost of share-based payment 258 315 1,163 Taxes on income 406 130 730 Loss (gain) from sale of property and equipment - (6 ) (2 ) Change in employee benefit liabilities, net (18 ) 36 94 1,064 1,758 6,307 Changes in asset and liability items: Decrease (increase) in trade receivables, net (3,016 ) 4,727 5,117 Decrease (increase) in other accounts receivables 1,513 131 (214 ) Decrease (increase) in inventories 1,386 (2,392 ) (13,857 ) Decrease (increase) in deferred expenses (421 ) (246 ) 399 Increase (decrease) in trade payables (7,216 ) (2,368 ) 6,259 Increase (decrease) in other accounts payables (1,180 ) (510 ) 863 Increase (decrease) in deferred revenues 397 (63 ) (283 ) (8,537 ) (721 ) (1,716 ) Cash received (paid) during the year for: Interest paid (55 ) (63 ) (243 ) Interest received 451 172 1,106 Taxes paid (61 ) (8 ) (134 ) 335 101 729 Net cash provided by (used in) operating activities $ (1,920 ) $ 6,061 $ 27,571 Consolidated Statements of Cash Flows Three months period Ended Year Ended March 31, December 31, 2020 2019 2019 Unaudited Audited U.S Dollars in thousands Cash Flows from Investing Activities Investment in short term investments, net $ (15,646 ) $ (1,058 ) $ 1,727 Purchase of property and equipment and intangible assets (896 ) (304 ) (2,300 ) Proceeds from sale of property and equipment - 6 9 Net cash used in investing activities (16,542 ) (1,356 ) (564 ) Cash Flows from Financing Activities Proceeds from exercise of share base payments 5 3 16 Repayment of lease liabilities (278 ) (263 ) (1,070 ) Repayment of long-term loans (123 ) (115 ) (476 ) Proceeds from issuance of ordinary shares, net 24,894 - - Net cash provided by (used in) financing activities 24,498 (375 ) (1,530 ) Exchange differences on balances of cash and cash equivalent 590 (386 ) (908 ) Increase in cash and cash equivalents 6,626 3,944 24,569 Cash and cash equivalents at the beginning of the year 42,662 18,093 18,093 Cash and cash equivalents at the end of the year $ 49,288 $ 22,037 $ 42,662 Significant non-cash transactions Purchase of property and equipment through capital lease $ 58 $ 4,431 $ 5,035 Purchase of property and equipment $ 579 $ 235 $ 992 Adjusted EBITDA Three months period Ended Year ended March 31, December 31, 2020 2019 2019 U.S. Dollars in thousands Net income (loss) $ 5,218 $ 4,923 $ 22,251 Taxes on income 406 130 730 Financial income, net (774 ) 156 (197 ) Depreciation and amortization expense 1,192 1,127 4,519 Cost of share - based payments 258 315 1,163 Adjusted EBITDA $ 6,300 $ 6,651 $ 28,466 Adjusted Net Income Three months period Ended Year ended March 31, December 31, 2020 2019 2019 U.S. Dollars in thousands Net income (loss) $ 5,218 $ 4,923 $ 22,251 Cost of share - based payments 258 315 1,163 Adjusted net income $ 5,476 $ 5,238 $ 23,414 - Total Revenues were $33.3 Million, an Increase of 24% Year-over-Year
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REHOVOT, Israel, May 11, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced that it will release financial results for the first quarter ended March 31, 2020, prior to the open of the U.S. financial markets on Monday, May 18, 2020.
Kamada management will host an investment community conference call on Monday, May 18, 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: 13699990. 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. 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. 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] -
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- Kamada is Responsible for Product Development, Manufacturing, Clinical Development, and Regulatory Submissions, as well as Distribution in Territories not under Kedrion's Responsibility
- Kedrion is Responsible for the Collection and Supply of Plasma from Convalescent COVID-19 Patients, Support of Clinical Development and Distribution in the U.S., Europe, Australia, and S. Korea
REHOVOT, Israel and CASTELVECCHIO PASCOLI, Italy, April 27, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two prominent bio-pharmaceutical companies specialized in plasma-derived protein therapeutics, today announced a global collaboration for the development, manufacturing and distribution of a human plasma-derived Anti-SARS-CoV-2 (COVID-19) polyclonal immunoglobulin (IgG) product as a potential treatment for coronavirus patients. The announcement follows separate previous reports by each of the two entities in connection with initiation of development programs for such product. The plasma-derived Anti-SARS-CoV-2 IgG product will be developed and manufactured utilizing Kamada's proprietary IgG platform technology.
Pursuant to the agreed terms, Kedrion will provide plasma, collected at its KEDPLASMA centers, from donors who have recovered from the virus and, upon receipt of regulatory approvals, will be responsible for commercialization of the product in the U.S., Europe, Australia, and South Korea. Kamada is responsible for product development, manufacturing, clinical development, with Kedrion's support, and regulatory submissions. Kamada will also assume distribution responsibility in all territories outside of those Kedrion is responsible for. Marketing rights for the product in China will be shared by the parties.
The initial primary focus of the collaboration will be to provide the product as treatment to patients in Italy, Israel and the U.S. through various clinical programs, while subsequently expanding development and commercialization efforts to additional markets.
"In light of the current global coronavirus outbreak, Kedrion and Kamada have quickly focused their efforts on developing and manufacturing a potentially safe and effective treatment," said Paolo Marcucci, Chief Executive Officer of Kedrion. "We are excited to collaborate once again with Kamada, our partner for KEDRAB® [Rabies Immune Globulin (Human)]. Based on our collective expertise in plasma-derived protein therapeutics, we believe Kedrion and Kamada are uniquely positioned to develop, manufacture and supply, in a relatively short period of time, an Anti-SARS-CoV-2 IgG treatment. We believe we have an important opportunity to make a significant impact for patients in need during this pandemic."
"As previously reported, we initiated the development of an Anti-SARS-CoV-2 polyclonal immunoglobulin and intend to begin clinical manufacturing of the product shortly. I believe that the collaboration with Kedrion, a global leader in plasma collection and plasma-derived therapeutics, will allow us to speed up the development of the product and strengthen our international reach," said Amir London, Kamada's Chief Executive Officer. "Our successful collaboration with Kedrion around our joint KEDRAB program is indicative of the unique capabilities of both companies, and we look forward to another successful partnership leveraging our strong working relationship and the core strengths of both companies."
This global collaboration expands the existing relationship between Kamada and Kedrion beyond KEDRAB, a plasma-derived FDA-approved human rabies immune globulin that was launched in the U.S. market in April 2018, based on a separate strategic supply and distribution agreement between the two companies.
There can be no assurance that the planned development and manufacturing of an Anti-SARS-CoV-2 product will receive regulatory approval, be available in a timely manner and/or result in a safe, effective and approvable therapy for COVID-19.
About Kedrion Biopharma
Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as anti-hepatitis B, anti-tetanus and RhoGAM for prophylaxis against Rh sensitization and subsequent hemolytic disease of the fetus and newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in the United States and Hungary to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States. Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,500 employees and a commercial presence in approximately 100 countries worldwide. Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at www.kedrion.com and www.kedrion.us.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® ("GLASSIA"), the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection. 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 by Mr. Marcucci that Kedrion and Kamada are uniquely positioned to develop, manufacture and supply, in a short period of time, an Anti-SARS-CoV-2 IgG treatment, and that the parties have an important opportunity to make a significant impact for patients in need during this pandemic. Additional forward-looking statements including statements by Mr. London about initiation of clinical manufacturing of the product, the belief that the collaboration with Kedrion, a global leader in plasma collection and plasma-derived therapeutics, will allow to speed up the development of the product and strengthen its international reach and the potential for a successful partnership. Forward-looking statements are based on Kedrion's and 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, effectiveness of Anti-SARS-CoV-2 IgG to treat coronavirus, ability of Kamada to receive regulatory clearance to manufacture and sell Anti-SARS-CoV-2 IgG and the timelines of receiving such regulatory clearance, availability of plasma derived from coronavirus convalescent donors, anticipation that such plasma would include antibodies to the novel coronavirus, availability of hyper-immune plasma in light of potential shortages due to the coronavirus outbreak, commercial success of the Anti-SARS-CoV-2 IgG in the market, additional competition from alternative coronavirus treatment, regulatory delays, prevailing market conditions in general and specifically due to the effects of the COVID19 outbreak, corporate events associated with Kedrion, Kamada and their respective partners in relation to Anti-SARS-CoV-2 IgG 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, Kedrion 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:
Kamada:
Chaime Orlev, Chief Financial Officer
[email protected]
Bob Yedid; LifeSci Advisors, LLC
646-597-6989
[email protected]Kedrion Biopharma:
Gioacchino De Giorgi, Head of Business Development
[email protected]
Investor Relations
[email protected] - Kamada is Responsible for Product Development, Manufacturing, Clinical Development, and Regulatory Submissions, as well as Distribution in Territories not under Kedrion's Responsibility
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- Kamada Plans to Utilize its Hyper-Immunoglobulin (IgG) Platform Technology to Develop an Anti-Corona (COVID-19) Immunoglobulin as a Potential Therapy for Severely Ill Coronavirus Patients
- Kamada is Leveraging its Successful Launch of KEDRAB® (Rabies Immunoglobulin [Human]) in the U.S. which Reached an Approximately 20% Market Share in 2019, to Expand its International Sales of the Product, Securing a Supply Tender in Canada and to The Pan American Health Organization (PAHO)
- Kamada Received Notice of Allowance for a U.S. Patent Covering its Anti-Zika IgG Product Candidate for Treatment of Zika Virus Infection
REHOVOT, Israel, March 11, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a commercial-stage plasma-derived biopharmaceutical company, today provided an update on progress related to its proprietary hyper-immunoglobulin (IgGs) product portfolio and platform technology.
Anti-Corona (COVID-19) Immunoglobulin
Kamada plans to initiate the development of an Anti-Corona (COVID-19) polyclonal immunoglobulin using its proprietary plasma derived IgG platform technology as a potential treatment for severely ill coronavirus patients.The plasma-derived Anti-Corona (COVID-19) IgG product is expected to be produced from plasma derived from donors recovered from the virus, which is anticipated to include antibodies to the novel Corona virus (COVID-19). Kamada emphasizes that the development plan and manufacturing of the product are highly dependent on the availability of hyper-immune plasma and on the regulatory path to be defined with the health authorities.
There can be no assurance that the planned development and manufacturing activities will be successful in a timely manner and will result in a safe, effective and approvable therapy.
"The current global crisis resulting from the coronavirus outbreak calls for urgent highly-focused efforts to accelerate the development and manufacturing of potential treatments, especially for life threatening situations," said Amir London, Chief Executive Officer of Kamada. "Kamada intends to utilize its proven hyper-immune IgG development experience and proprietary technology platform to initiate the development of an Anti-Corona (COVID-19) IgG product. We are working with the Israeli regulatory authorities and local medical institutions to advance our program," concluded Mr. London.
KAMRAB®/KEDRAB®
Kamada's Anti-Rabies IgG product was launched in the U.S. in 2018 and is marketed by Kedrion S.p.A ("Kedrion") under the brand name KEDRAB. Kamada's revenues from sales of KEDRAB to Kedrion in 2019 were $16.4 million, an increase of approximately 39% over the $11.8 million generated in 2018. U.S. sales of KEDRAB by Kedrion in 2019 totaled $31.4 million, an increase of approximately 103% over the $15.5 million recorded in 2018. Moreover, KEDRAB's market share in the U.S. increased from approximately 10% in 2018 to approximately 20% in 2019."We are very pleased with the significant growth of KEDRAB sales in the U.S in 2019, and we anticipate continued growth in 2020 and beyond," said Mr. London.
In addition, Kamada's Anti-Rabies IgG product, under the brand name KAMRAB, obtained marketing authorization in Canada in November 2018. Kamada and Valneva Canada Inc. engaged in a marketing and distribution agreement for KAMRAB in Canada, and pursuant to a recently awarded supply tender, expect to begin selling the product in Canada during 2020. Moreover, Kamada was recently approved to supply KAMRAB through the 2019-2021 tender from the Pan American Health Organization (PAHO), the specialized international health agency for the Americas. KAMRAB sales through PAHO began in 2019, and are expected to continue in 2020 and 2021.
Anti-Zika IgG
On February 24, 2020, Kamada received a Notice of Allowance from the U.S. Patent and Trademark Office for patent application No. 16/118,847, titled "Therapy and Prophylaxis of Infectious Disease Caused by Zika Virus," covering therapy of Zika virus infection. The new patent, valid through 2037, covers a method of treatment comprising of polyclonal human immunoglobulins (IgG, antibodies) against the Zika virus. Kamada's pre-clinical data demonstrated a significant improvement in mortality and morbidity of Zika-infected mice receiving Kamada's Anti-Zika IgG product, as well as a significant reduction in viral load. The pre-clinical work was supported by the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID), and was recently presented at the 3rd International Conference of Zika Virus and Aedes Related Infections, which took place in February 13-16, 2020, in Washington, D.C.Zika is spread primarily through the bite of an infected Aedes mosquito. Zika can be passed from a pregnant woman to her fetus, which may cause birth defects, including severe brain damage, such as microcephaly. Zika infection during pregnancy is also associated with miscarriage, stillbirth, and other birth defects.
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® ("GLASSIA"), the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection. 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. For the year ended December 31, 2019 the Company's total revenues were $127.2 million, adjusted EBITDA was $28.5 million and net income was $22.2 million. As of December 31, 2019, the Company had cash, cash equivalents, and short-term investments of $73.9 million, and during February 2020 secured a $25 million private placement with the FIMI Opportunity Fund.Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding 1) the plan to develop an Anti-Corona (COVID-19) polyclonal immunoglobulin using Kamada's proprietary plasma derived IgG platform technology as a potential treatment of severely ill Coronavirus patients; 2) the expectation to manufacture the Anti-Corona (COVID-19) IgG from plasma derived from donors recovered from the virus, which is anticipated to include antibodies to the novel Corona virus (COVID-19); 3) the projection that the development plan and manufacturing of the Anti-Corona (COVID-19) IgG are highly dependent on the availability of hyper-immune plasma and on the regulatory path to be defined with the health authorities; 4) Kamada's anticipation that KEDRAB sales in the U.S will continue to grow during 2020 and beyond; 5) Kamada's expectation to commence KAMRAB sales in Canada during 2020; 6) Kamada's expectation to continue sales of KAMRAB to PAHO in the years 2020 and 2021; and 7) positive indications about Anti-Zika IgG regarding improvement in mortality, morbidity and viral load. 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, effectiveness of Anti-COVID-19 IgG to treat coronavirus, ability of Kamada to receive regulatory clearance to manufacture and sale Anti-COVID-19 IgG and the timelines of receiving such regulatory clearance, availability of plasma derived from coronavirus convalescent donors, anticipation that such plasma would include antibodies to the novel coronavirus, availability of hyper-immune plasma in light of potential shortages due to the coronavirus outbreak, commercial success of KEDRAB in the U.S. market and KAMRAB in non-U.S. markets such as Canada and PAHO, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions in general and specifically due to the effects of the COVID19 outbreak, corporate events associated with our partners 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] - Kamada Plans to Utilize its Hyper-Immunoglobulin (IgG) Platform Technology to Develop an Anti-Corona (COVID-19) Immunoglobulin as a Potential Therapy for Severely Ill Coronavirus Patients