Full Press Release Details
Kamada Provides Update on 2021 GLASSIA
REHOVOT, Israel - October 7, 2020
-- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced that, following recent
discussions with Takeda, it expects to receive approximately $25 million in revenues from the supply of GLASSIA to Takeda
As previously indicated, the agreement
with Takeda provided a supply range for 2021 pursuant to which Kamada's revenues from sales of GLASSIA to Takeda were projected
to be between $25 million to $50 million. The 2021 supply range was included in the agreement to provide flexibility for Takeda
to address any potential changes in the expected timeline for its completion of the planned transition of GLASSIA manufacturing
"Based on our recent discussions
with Takeda, the planned transition of GLASSIA manufacturing to their plant is advancing as expected," said Amir London,
Kamada's Chief Executive Officer. "As such, Takeda anticipates that its 2021 GLASSIA demand from Kamada will not exceed
the minimum commitment under the supply agreement which is expected to generate $25 million of revenue for Kamada. The Company
is prepared to make the necessary adjustments to our plant costs during 2021 to align with our manufacturing plan and future needs."
"We continue to intensively explore
business development opportunities that would over time mitigate the effects of the planned transition of GLASSIA manufacturing
to Takeda in 2021," added Mr. London. "These opportunities, funded by our strong cash position, along with organic
commercial growth of our existing products portfolio, our distributed products in Israel, the expected future royalty payments
from Takeda, the contract manufacturing of an FDA approved and commercialized specialty IgG product as well as the continued advancement
in the development of our COVID- 19 IgG product candidate which is advancing in the clinic are expected to contribute to our future
growth," concluded Mr. London.
Based on the agreement with Takeda, upon
the initiation of sales of GLASSIA manufactured by Takeda, Kamada will receive royalty payments at a rate of 12% on net sales through
August 2025 and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually for each of the years from 2022 to
2040. Although the transition of the agreement to its royalties phase will result in a reduction of Kamada's revenue from
Takeda, based on current GLASSIA sales in the U.S. and forecasted future growth, Kamada projects receiving royalties from Takeda
in the range of $10 million to $20 million per year from 2022 to 2040.
Kamada Ltd. ("the Company")
is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product
portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction
and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well
as other plasma-derived immune globulins. The Company's flagship product is GLASSIA , the first liquid, ready-to-use,
intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership
with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading
product is KamRab , a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA
approved and is being marketed in the U.S. under the brand name KEDRAB through a strategic partnership with Kedrion S.p.A.
In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered
by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India
and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation
of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications,
such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived
immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and
presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are
manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead
shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking
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) Expectation that various business development opportunities, funded by its strong cash position,
along with organic commercial growth of its existing products portfolio, its distributed products in Israel, the expected future
royalty payments from Takeda, together with the contract manufacturing of an FDA approved and commercialized specialty IgG product
and its investigational COVID- 19 IgG product will over time contribute to Kamada's future growth; 2) Kamada projecting to
receive royalties from Takeda in the range of $10 million to $20 million per year for 2022 to 2040; and 3) Kamada reiterating its
total revenues guidance of between $132 million and $137 million for full-year 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
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,
potential negative effects relating to Kamada's manufacturing plant associated with reduced manufacturing for Takeda; 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, 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.
Chief Financial Officer
LifeSci Advisors, LLC