Full Press Release Details
Kamada Reports First Quarter 2022 Financial Results;
Reiterates Revenue and Profitability Guidance with
Significant Growth Expected in 2022
REHOVOT, Israel - May 17, 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 three months ended March 31, 2022.
"Our business is off to a strong start in
2022 as we continue to execute on our corporate strategy advancing towards our core objective of becoming a global leader in the plasma-derived
specialty market," said Amir London, Kamada's Chief Executive Officer. "We generated total revenues of $28.1 million
in the first quarter, representing strong 13% growth year over year. This is the first full quarter commercializing the portfolio of the
four FDA-approved commercial immunoglobulins acquired late last year. Sales and profitability levels generated by these products are in
line with our plans and expectations. We continue to expand our U.S. commercial-focused infrastructure, execute on key sales and marketing
initiatives to further penetrate the U.S. market with our extended product line, and expect that these four products will generate meaningful
year-over-year growth. We continue to expand sales of these products in additional new countries, primarily in the Middle East."
"Sales in the first quarter included $1.4
million of royalty income on GLASSIA sales by Takeda during March 2022, meeting our expected monthly rate and in line with our annual
projection. In addition, we are encouraged by KEDRAB U.S. in-market sales by Kedrion during the first quarter, which have grown in
comparison to the pre-COVID pandemic sales levels, a trend that we believe will continue. In the first quarter of 2022, we generated overall
gross profit and gross margins of $11.3 million and 40%, respectively, representing a strong 27% increase compared to the first quarter
of 2021. This increase was mainly driven by the four new immunoglobulins portfolio, which recorded over 50% of gross profitability. Moreover,
we generated $5.5 million of operating cash flows, that supported the increase of our cash position to a total of $22.0 million,"
continued Mr. London.
Based on our strong start to the year, we are
reiterating our full-year 2022 revenue guidance of between $125 million to $135 million, with expected EBITDA margins of 12% to 15%. This
guidance represents a 20% to 30% increase over 2021 revenue and more than 2.5x over 2021 EBITDA. Moreover, we continue to project revenue
growth at a double-digit rate in the foreseeable years ahead. Our positive long-term view is supported by the expected continued growth
in the proprietary product sales, and several additional key emerging catalysts in our business. The initiation of activities to open
new plasma collection centers in the U.S. will, over time, support continued revenue growth and strengthen our supply chain. The planned
launch of a portfolio of 11 biosimilar products in our Israeli distribution segment from 2022 to 2028 is expected to generate more than
$40 million in annual peak sales, achievable within several years of launch. Finally, our promising pipeline continues to advance, as
our inhaled AAT pivotal Phase 3 trial expands to additional six EU sites by mid-year,"
concluded Mr. London.
Financial Highlights
for the Three Months Ended March 31, 2022
Balance Sheet Highlights
As of March 31, 2022, the Company had cash, cash
equivalents, and short-term investments of $22.0 million, as compared to $18.6 million on December 31, 2021. The increase was due to positive
operational cash flows. Kamada's working capital as of March 31, 2022, comprising of current assets (excluding cash and cash equivalents,
and short-term investments) net of current liabilities, totaled $52.0 million.
Fiscal Year 2022 Guidance
Kamada continues to expect to generate fiscal year
2022 total revenues in the 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. While the ongoing labor strike impacting our production facility in Israel is expected to
temper our second quarter financial results, which we do not expect to be as strong as the first quarter, based on the diversification
of our commercial operations which includes multiple revenue generating sources including the recently acquired portfolio of four FDA-approved
commercial products, manufactured by an external contract manufacturer, the Israeli Distribution business which operates independent of
the production facility, the royalty income on GLASSIA sales by Takeda, as well as current sufficient inventory levels of finished products,
our positive outlook for the fiscal year remains unchanged.
Kamada management will host an investment community
conference call on Tuesday, May 17, 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 1-877-407-0792 (from within the U.S.), 1 809-406-247 (from Israel), or 1-201-689-8263
(International) and entering the conference identification number: 13729770. The call will also be webcast live on the Internet at: https://viavid.webcasts.com/starthere.jsp?ei=1547283&tp_key=3051633ddd
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 11 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 eleven(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) the four FDA-approved commercial immunoglobulins to generate meaningful year-over-year growth and expanding sales of these products
in additional new countries, mainly in the Middle East, 9) KEDRAB U.S. in-market sales by Kedrion during the first quarter, grown in comparison
to the pre-COVID pandemic sales levels, and our believe this trend will continue, 10) optimism about strategic business development opportunities
that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise, and 11) the belief that
those opportunities are may be significant steps toward accomplishing our strategic goal of becoming a fully integrated specialty plasma