Full Press Release Details
Kamada Issues 2023 CEO Letter to Shareholders
Rehovot, Israel, and Hoboken, NJ - March
15, 2023 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed
products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today issued a Letter to Shareholders
from Amir London, Chief Executive Officer.
Dear Shareholders, Colleagues and Business Partners:
The recently completed 2022 year was a transformational
period for Kamada as we embarked on a new and exciting chapter in the Company's evolution. Most importantly, we have now completed
our rapid transition from our historical dependence on GLASSIA sales to Takeda to a diversified, fully integrated specialty plasma
company with six U.S. Food and Drug Administration (FDA) approved proprietary products and strong commercial capabilities in the U.S.
market, as well as a global sales footprint in over 30 countries.
Earlier today, we reported our full-year 2022
financial results, which met our annual guidance, with total revenues of $129.3 million and EBITDA of $17.8 million, representing margins
of 14%. Our strong performance in 2022 represented year-over-year revenue growth of 25%, and a 3x increase in EBITDA.
Moreover, we generated a record operating cash
flow of $28.6 million during 2022, supporting the increase in our cash position to $34.3 million as of December 31, 2022.
Looking ahead, we expect the momentum from 2022
to extend throughout 2023, with profitability to be further increased as compared to the past year. As such, we are introducing full-year
2023 revenue guidance of $138 million to $146 million and EBITDA of $22 million to $26 million; the mid-point expected EBITDA represents
approximately 35% growth year-over-year.
Our impressive results in 2022, and positive outlook
for this year, are the consequence of our ability to leverage multiple growth drivers, including the portfolio of four FDA approved IgGs,
acquired in late 2021, KEDRAB sales in the U.S., GLASSIA royalties from Takeda, other Proprietary products sales in the international
markets, and our thriving Israeli distribution business.
These significant catalysts are driving our
annual double-digit growth, with significant upside potential and limited downside risk.
The November 2021 acquisition of the four FDA
approved IgGs, consisting of CYTOGAM , HEPAGAMB , VARIZIG and WINRHO SDF, following a thorough search for the ideal assets
for Kamada, was a critical strategic and synergistic advancement for the Company. Full-year 2022 revenues of the acquired portfolio increased
by 24% as compared to full-year 2021. This portfolio is generating over 50% gross margins. I am pleased to report that we anticipate continued
growth in the portfolio's revenues in 2023 and beyond.
During 2022, as part of the establishment of our
direct presence in the U.S. market, we deployed a team of U.S.-based experienced sales and medical affairs professionals who have rapidly
established our operations in this key market. The U.S. sales team is making good progress in promoting our portfolio of specialty plasma-derived
IgG products to physicians and other healthcare practitioners through direct engagement and opportunities at medical conventions. The
Medical Affairs team is working to educate physicians, while addressing their scientific and clinical inquiries, including participating
in major medical conferences in the U.S. We are also leveraging our existing strong international distribution network to grow product
revenue in new territories, primarily in Asia, Latin America and the Middle East. Our achievements with these key products in 2022 included
winning a new $11.4 million procurement agreement for VARIZIG from an international organization operating principally in Latin America
and securing a $22 million extension of a Canadian supply tender.
CYTOGAM is the largest of the four acquired products.
The product is indicated for the prophylaxis of cytomegalovirus disease associated with solid organs transplantation. This proprietary
and unique therapy is the only FDA approved IgG product for its indication. We recently submitted an application to the FDA to manufacture
CYTOGAM at our plant in Israel, and we expect to receive regulatory approval to do so by mid-2023. The anticipated FDA approval will mark
the successful conclusion of the technology transfer process for the product from its previous manufacturer, CSL Behring. The ability
to manufacture the product at our facility will positively impact our plant utilization and efficiency.
KEDRAB, marketed in the U.S. by Kedrion, continued
to gain market share during 2022 in the U.S., a market which is estimated to be $150 million annually. With Kamada's support, Kedrion's
commercial team successfully leveraged the FDA approval obtained in 2021 for a label expansion for the product that helped differentiate
it as the first and only human rabies immunoglobulin (HRIG) available in the U.S. to be clinically studied in children. We anticipate
that sales of the product will continue to grow significantly over the next few years.
During 2022, as planned, we began receiving royalties
from Takeda based on sales of GLASSIA. We expect royalties in the range of $10 million to $20 million per year through 2040, which will
support our profitability and cash position. In addition, we continue to grow sales of GLASSIA in international markets through our local
Another major strategic step we are taking is
the advancement of our plasma collection business through our wholly owned subsidiary, Kamada Plasma, based in Texas. Last year, we expanded
the hyperimmune plasma collection capacity at our first center and are currently advancing our plan to open additional centers in the
U.S. to further enhance our supply of specialty and regular plasma.
We are also very excited about our innovative
investigational Inhaled AAT product candidate 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 transformational 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. During 2022, we began to accelerate trial recruitment with seven
clinical sites now open and enrolling patients. In November 2022, the independent Data Safety Monitoring Board (DSMB) recommended that
the study continue without modification for the fourth time since study initiation. Moreover, based on encouraging safety observed to
date, the study inclusion criteria were revised to also include patients with severe airflow limitation. During 2023, we intend to continue
expediting trial recruitment, as well as meet with the FDA and the European Medicines Agency to discuss study progress and potential opportunities
to shorten the regulatory pathways.
In our distribution segment, we are leveraging
our expertise and strong presence in the Israeli market to register, market and distribute more than 25 products that are developed and
manufactured by our international partners. In recent years, we have significantly grown our pipeline of distributed products and, in
2023, we anticipate continuing to launch new therapies across multiple medical specialties. An area of key strategic focus in this business
is the planned distribution of a portfolio of 11 biosimilar products, expected to be launched upon receipt of Israeli regulatory approval,
through 2028, with 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 drugs.
In closing, 2022 was a year of significant progress
for Kamada during which we executed on a rapid financial turnaround of the Company by leveraging multiple robust value-creating catalysts,
and we are well-positioned for further substantial revenue and profitability growth in 2023 and the years beyond with substantial upside
potential and limited downside risk as a global leader in the specialty plasma industry. Importantly, looking past 2023, based on our
multiple catalysts, we continue to project annual double-digit growth in revenues and profits in the foreseeable years ahead.
On behalf of the entire Kamada team, we look forward
to continuing to support patients and clinicians 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 commercial
stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in
the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative
development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable
growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical
fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM ,
KEDRAB , WINRHO SDF , VARIZIG , HEPAGAM B and GLASSIA , as well as KAMRAB , KAMRHO (D) and two types of
equine-based anti-snake venom (ASV) products. 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, Argentina, Brazil, India,
Australia and other countries in Latin America, Europe, Middle East, and Asia. The Company leverages its expertise and presence in the
Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers
and during recent years added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines
Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA
registered plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the
manufacture of KAMRHO (D). In addition to the Company's commercial operation, it invests in research and development of new product
candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is