Full Press Release Details
Kamada Issues 2022 CEO Letter to Shareholders
REHOVOT, Israel - March 15, 2022
-- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived
therapeutics, today issued the Letter to Shareholders from Amir London, Chief Executive Officer.
Dear Shareholders, Colleagues and Business Partners:
The recently completed 2021 year was a transformational
period for Kamada in our path toward becoming a global leader in the plasma-derived specialty market. Following the completion of the
planned manufacturing transition of Glassia to Takeda, our recent acquisition of four FDA-approved commercial immunoglobulins and
the establishment of Kamada Plasma, our U.S. based plasma collection company, we are embarking on a new and exciting chapter in the Company's
evolution. We are building on the strong foundation established over the years, entering 2022 as a "New Kamada" - a fully-integrated
specialty plasma company with six FDA-approved products and strong commercial capabilities in the U.S. market, as well as a global commercial
footprint in over 30 countries.
Our business performed as expected in 2021 and
we look ahead to 2022 for which our revenue guidance is between $125 million to $135 million, representing a 20% to 30% growth compared
to 2021, with expected EBITDA margins of 12% to 15%, which would represent more than 2.5x the 2021 EBITDA. This strong guidance reflects
the benefits stemmed from our new undertaken strategic direction, and the resume of revenue and profitability growth in 2022. Importantly,
we further expect continued growth at a double-digit rate in the coming few years.
The acquisition completed in November 2021, following
a thorough search for the ideal assets for Kamada, was a critical strategic and synergistic step for the Company. The acquired products
generated revenues exceeding $40 million in 2021, with over 50% gross margins, and we anticipate significantly growing the new portfolio's
revenues through proactive promotional activities in the U.S, where our newly established subsidiary, Kamada Inc., is responsible for
the commercialization and direct sales of the products. We also intend to leverage our existing strong international distribution network
to grow product revenue in new territories, primarily in Asia, Latin America and the Middle East. I am pleased to report that these promotional
and sales activities have already commenced.
Of the four acquired products, the largest is
Cytogam , indicated for the prophylaxis of cytomegalovirus disease associated with solid organs transplantation. This proprietary
and unique product is the only FDA-approved IgG product for its indication. The transition of Cytogam manufacturing to our facility is
already well underway, and we expect to receive FDA approval for its production at our Israeli facility by early 2023. Moreover, based
on the Cytogam manufacturing transfer, expected growth of KedRAB , our FDA-approved anti-Rabies hyperimmune product, and planned manufacturing
transition of the other acquired products over the next few years, we anticipate improving the gross margins of our proprietary products
by effectively utilizing our plant capacity.
Another major strategic step taken is the acquisition
of a plasma collection facility in Texas, in early 2021, which primarily specializes in the collection of hyper-immune plasma used for
Anti-D immunoglobulin, a product manufactured by Kamada and distributed in international markets. This acquisition represented Kamada's
entry into the U.S. plasma collection market and supported our strategic goal of becoming a fully integrated specialty plasma company.
We are already actively engaged in the expansion of the hyperimmune plasma collection capacity at this center and are simultaneously advancing
our plan to open additional centers in the U.S. to further enhance our supply of specialty and regular plasma.
KedRAB, marketed in the U.S by Kedrion, continues
to gain market share in the $150 million U.S. market. During 2021 the FDA approved a label expansion for the product which differentiates
KedRAB as the first and only human rabies immunoglobulin (HRIG) available in the U.S. to be clinically studied in children and confirming
the safety and effectiveness of its use in pediatric population. We anticipate sales of the product to grow significantly during the next
During 2021, as planned, Takeda completed the
transition of Glassia manufacturing to their own facility, and we fulfilled our supply commitments. Going forward, we expect to begin
receiving royalty payments from Takeda, commencing during the second quarter of 2022, in the range of $10-$20 million per year from 2022
to 2040, adding to our profitability and cash position. In addition, we continue to grow sales of the product in international markets
through our local partners.
Turning to our promising clinical development
pipeline, we are excited about the potential of our innovative Inhaled AAT product for the treatment of AAT Deficiency, a technology which
has shown to be highly effective in delivering AAT directly into a patient's lungs. A substantial opportunity exists for inhaled
AAT to be a revolutionary product in a market that is already over $1 billion in annual sales in the U.S. and EU. We are currently conducting
the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 study. While enrollment in the study was
slowed during recent two years due to the COVID-19 pandemic, we are currently expanding the study with up to six additional clinical sites
planned to be opened shortly, thereby expediting enrollment. Importantly, this is a unified study, as the trial's data are expected
to qualify for regulatory submissions with both the FDA and EMA.
In our distribution segment, which is an additional
important growth catalyst for Kamada, we leverage our expertise and strong presence in the Israeli market to register, market and distribute
more than 20 products that are developed and manufactured by our international partners. Since 2018, we significantly grown our pipeline
of distributed products and in 2022 we anticipate launching an array of new products across multiple medical specialties. An area of key
strategic focus in our distribution business is the planned distribution of a portfolio of 11 biosimilar products, expected to be launched
upon receipt of Israeli regulatory approval, between the years 2022 and 2028, with an overall annual anticipated peak sales, within several
years of launch, of more than $40 million. Included in this portfolio are 8 products through a distribution agreement with Alvotech, a
global leader in the development and manufacturing of biosimilar drug candidates.
In closing, 2021 was
a year of great importance for Kamada, as we successfully executed on multiple critical strategic transactions, ensuring a rapid financial
turnaround of the Company, with significant revenue growth anticipated in the years ahead.
As we enter 2022, the
initial benefits of the decisive actions we have taken are already evident. Kamada is uniquely positioned for growth as a global leader
in the specialty plasma industry, with multiple robust value-creating catalysts.
On behalf of the entire
Kamada team, we look forward to continuing to help clinicians and patients with the important lifesaving products that we develop, manufacture
and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value.
Chief Executive Officer
Kamada Ltd. (the "Company") is a vertically
integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, with a diverse portfolio of marketed products,
a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable
growth from our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical
market. The Company's commercial products portfolio includes its developed and FDA approved products GLASSIA and KEDRAB
as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM , HEPAGAM B , VARIZIG and WINRHO SDF.
The Company has additional four plasma-derived products which are registered in markets outside the U.S. The Company distributes its commercial
products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S.,
Canada, Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of
development pipeline products including an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting
the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise
and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties
and have recently added eleven biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals,
are expected to be launched in Israel between the years 2022 and 2028. 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) 2022 revenue guidance in the range of $125 million to $135 million, a 20% to 30% growth compared to 2021, 2) 2022 EBITDA,
as a rate of total revenues, of 12% to 15%, 3) The strong guidance reflects the benefits stemmed from our new undertaken strategic direction,
and the resume of revenue and profitability growth in 2022, 4) expected continued growth at a double-digit rate in the foreseeable years
ahead, 5) anticipation to significantly growing the new portfolio's revenues through proactive promotional activities in the U.S,
where our newly established subsidiary, Kamada Inc., is responsible for the commercialization and direct sales of the products, 6) expectation
to receive FDA approval for Cytogam production at our Israeli facility by early 2023, 7) anticipation that sales of KedRab will grow significantly
during the next few years, 8) expectation to begin receiving royalty payments from Takeda, commencing during the second quarter of 2022,
in the range of $10-$20 million per year from 2022 to 2040, adding to our profitability and cash position, 9) expectation to expand InnovAATe
clinical study with up to six additional clinical sites planned to be opened shortly, thereby expediting enrollment, 10) planned distribution