Full Press Release Details
Kamada Reports Fiscal Year and Fourth Quarter
2021 Financial Results;
Provides Revenue and Profitability Guidance
with Significant Growth Expected in 2022
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 announced financial results for the 12 and three months ended December 31, 2021.
"2021 was a transformational year for Kamada
in our path toward becoming a global leader in the plasma-derived specialty hyperimmune market. With the recent acquisition of the portfolio
of four FDA-approved commercial products, that generated annual global revenue in 2021 of approximately $41.9 million with over 50% gross
margins of which approximately $5.4 million of revenue was recognized by the Company, 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 and 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," said Amir London, Kamada's Chief Executive Officer.
"Our business performed as expected during
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 of the 2021 EBITDA. This strong guidance
reflects the benefits stemmed from our new undertaken strategic direction and our expectation of rapid return to revenue and profitability
growth in 2022. We further expect continued growth at a double-digit rate in the foreseeable years ahead."
"I am happy to report that over the past
few months we have made significant progress with all our key growth catalysts, and we are implementing the needed steps to realize our
significant growth potential. The integration of the newly acquired immunoglobulins portfolio is well underway in the U.S., as well as
in the international markets. We are progressing with our plans for the opening of new plasma collection centers in the U.S. We have expanded
our portfolio of Biosimilar product candidates to be distributed in the Israeli market, increasing our expected peak potential annual
biosimilar sales, within several years of launch, to over $40 million. In addition, we are expanding our inhaled AAT pivotal Phase 3 trial
with up to six additional clinical sites to be opened by mid-2022. Further, commencing in the second quarter of 2022, we are expecting
to begin receiving GLASSIA royalty payments from Takeda, improving our profitability and cash position," concluded Mr. London.
Fiscal Year 2022 Guidance
Kamada currently expects to generate fiscal year
2022 total revenues in a range of $125 million to $135 million which would represent a 20% to 30% growth compared to fiscal year 2021.
The Company also anticipates generating EBITDA, during 2022, at a rate of 12% to 15% of total revenues, representing more than 2.5x of
the EBITDA for the year ended December 31, 2021.
Financial Highlights for the Year Ended December
Financial Highlights for the Three Months Ended
Balance Sheet Highlights
As of December 31, 2021, the Company had cash,
cash equivalents, and short-term investments of $18.6 million, as compared to $109.3 million on December 31, 2020. The primary use of
cash during 2021 was the acquisition of four FDA-approved plasma-derived hyperimmune commercial products. Kamada's working capital
as of December 31, 2021, comprising of current assets (excluding cash and cash equivalents, and short-term investments) net of current
liabilities, totaled $57.4 million, representing an increase of $13.7 million compared to December 31, 2020.
The Company secured a $40 million credit facility
from Bank Hapoalim, Israel's leading commercial bank. The credit facility is comprised of a $20 million 5-year term loan and a $20
million short-term revolving credit facility. As of December 31, 2021, the Company drew-down the entire long-term loan and did not utilize
the short-term revolving credit facility.
Kamada management will host an investment community
conference call on Tuesday, March 15, 2022, at 8:30am Eastern Time to present the Company's 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: 13727620. The call will also be webcast live
Non-IFRS financial measures
We present EBITDA and adjusted EBITDA because
we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a
means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to
investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational
decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company's core
ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance
and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical
tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS
financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash,
non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation
of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA
and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating
performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of
EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are
defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense
in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and
derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain
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) expected continued growth at a double-digit rate in the foreseeable years ahead, 4) expectation
of rapid return to revenue and profitability growth in 2022, 5) plans for the opening of new plasma collection centers in the U.S., 6)
expectation of peak potential annual biosimilar sales to over $40 million for the 11 Biosimilar product candidates to be distributed in
the Israel market, 7) expansion of inhaled AAT pivotal Phase 3 trial with up to six additional clinical sites to be opened by mid-2022,
8) receipt of GLASSIA royalty payments from Takeda during the second quarter of 2022, 9) optimism about strategic business development
opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise, and 10)
the belief that those opportunities are may be significant steps toward accomplishing our strategic goal of becoming a fully integrated
specialty plasma company. 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, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international