Full Press Release Details
Kamada Reports Second Quarter and First Half
2022 Financial Results;
Significant Growth Driven by Multiple Catalysts
Expected in Second Half of 2022;
Reiterates 2022 Revenue and Profitability Guidance
Rehovot, Israel, and Hoboken, NJ - August
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 and six months ended June 30, 2022.
"We continue to be highly encouraged by
the performance of our business in 2022, and believe it is a testament to our ability to rapidly transition from our past dependency on
GLASSIA sales to Takeda to a diversified fully integrated commercial company and a global leader in the plasma-derived specialty
market," said Amir London, Kamada's Chief Executive Officer. "Our recently acquired portfolio of four FDA-approved IgGs,
consisting of CYTOGAM , HEPAGAM B , VARIZIG and WINRHO SDF, continues to gain traction in the U.S. and international
markets, and delivered strong sales and gross margins of more than 50% in the first half of the year. We are focused on growing the new
portfolio's revenues through on-going promotional activities in the U.S. and expect these marketing efforts to bear fruit commencing
in the second half of 2022. We also anticipate meaningful growth outside the U.S. from these products in the second half of the year,
which is expected to include approximately half of the total revenues anticipated from the recently announced $11.4
million international VARIZIG supply agreement."
"Based on our expectation of significant
revenue growth and enhanced profitability in the second half of the year, we are reiterating our full-year 2022 financial guidance, which
represents a 20% to 30% increase over 2021 revenue and more than 2.5x over 2021 adjusted EBITDA. Our outlook for a stronger second half
of the year is driven by multiple key factors, including anticipated continued growth of the new IgG portfolio, including sales boosted
by the new VARIZIG supply agreement, and the expected growth of KEDRAB sales to Kedrion supporting the product continued increased
in-market sales during 2022. In addition, total revenues in the second half of the year will include two full quarters of GLASSIA royalty
income, as compared to only four months in the first half of the year. Second half profitability will continue to be driven by the new
IgG products and KEDRAB sales, all of which generate more than 50% gross margins, and the GLASSIA royalty, which represents pure profit.
Moreover, the now concluded labor strike will have a substantially reduced impact on the second half of the year profitability as compared
to the first half," continued Mr. London.
"Lastly, we continue to forecast growth
at a double-digit rate in the foreseeable years beyond 2022 driven by our proprietary product catalysts, our plasma collection operations,
GLASSIA's royalties and the planned launch of 11 biosimilar products in Israel. In addition, we continue to advance our inhaled AAT pivotal
phase 3 trial with the opening of additional clinical sites and recruitment of patients to the study,"
concluded Mr. London.
Financial Highlights for the Three Months Ended
Financial Highlights for the Six Months Ended
Balance Sheet Highlights
As of June 30, 2022, the Company had cash, cash
equivalents, and short-term investments of $29.9 million, as compared to $18.6 million as of December 31, 2021. The increase was due to
positive operational cash flows. Kamada's working capital as of June 30, 2022, comprising of current assets (excluding cash and
cash equivalents, and short-term investments) net of current liabilities, totaled $39.0 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 adjusted EBITDA during 2022 at a rate of 12% to 15% of total revenues, representing more
than 2.5x of the adjusted EBITDA for the year ended December 31, 2021.
Recent Corporate Highlights
Kamada management will host an investment community
conference call on Wednesday, August 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: 13732049. The call will also be webcast live on the
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 through 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) expectation for significant revenues and profitability growth in the second half of the 2022 driven by multiple catalysis;
2) expectation to meet full-year 2022 revenue guidance , which would represent a 20% to 30% growth compared to fiscal year 2021, and expected
adjusted EBITDA margins to expect to generate fiscal year 2022 total revenues in the range of $125 million to $135 million, which would
represent more than 2.5x of the adjusted EBITDA for the year ended December 31, 2021; 3) statements regarding the performance of the Company's
business in 2022 being indicative of the company's transition from dependency on GLASSIA sales to Takeda, into a diversified fully
integrated commercial company and a global leader in the plasma-derived specialty market; 4) statements regarding recently acquired portfolio
continuing to gain traction in the U.S. and international markets; 5) expectation that ongoing promotional activities in the U.S. market
will bear fruit commencing in the second half of the year; 6) expectations that approximately half of the sales under the recently signed
$11.4 million agreement to supply VARIZIG will be generated in the second half of 2022; 7) expectations for significant revenue growth
in the second half of 2022 due to multiple key factors including expectation for continued growth of the new IgG portfolio including sales
driven by the new VARIZIG supply agreement, anticipated growth of our KEDRAB sales to Kedrion, GLASSIA royalty income will include
two full quarters in second half 2022; 8) expectation for enhanced profitability in the second half of the year driven by the new IgG