Full Press Release Details
Kamada Reports Strong Fiscal Year and Fourth
Quarter 2023 Financial Results, and Provides Full-Year 2024 Guidance Representing Double-Digit Growth in Revenue and Profitability
Rehovot, Israel, and Hoboken, NJ - March
6, 2024 -- 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 announced financial results
for the three months and year ended December 31, 2023.
"We are extremely pleased with the strong
financial and operational momentum we experienced through 2023, which allowed us to achieve our full-year guidance," said Amir London,
Kamada's Chief Executive Officer. "Total revenues for 2023 were $142.5 million, representing record annual revenues and 10%
year-over-year growth, and adjusted EBITDA was $24.1 million, up 35% year-over-year. We continue to effectively leverage our growth drivers,
including a significant increase in sales of our anti-rabies immunoglobulin product, KEDRAB and the promotion of CYTOGAM ."
"The growing increase in KEDRAB sales is
expected to continue through 2024 and beyond. We recently signed an amendment and extension of our distribution agreement with Kedrion.
This strategic agreement represents our largest commercial pact since Kamada's inception, and within the first four years of the eight-year
term, which commenced in January 2024, Kedrion is required to purchase minimum quantities of KEDRAB with total revenues to Kamada of approximately
$180 million," continued Mr. London.
"Looking ahead, we anticipate continued
momentum through 2024, with double-digit top- and bottom-line growth. Specifically, we are introducing full-year 2024 revenue guidance
of $156 million to $160 million and adjusted EBITDA guidance of $27 million to $30 million. We maintain the financial strength and flexibility
to accelerate the growth and profitability of our existing business beyond 2024 at double-digit rates and pursue compelling new business
development opportunities, a process we are actively engaged in and that would further enhance our future growth," added Mr. London.
"We continue patient enrollment in our ongoing
pivotal Phase 3 InnovAATe clinical trial for the inhaled Alpha-1 Antitrypsin therapy for the treatment of AAT Deficiency. Importantly,
the U.S. Food and Drug Administration (FDA) recently reconfirmed the overall design of the study, endorsed the independent Data and Safety
Monitoring Board's (DSMB) unblinded positive safety assessment, and accepted our plan to conduct an open-label extension study,
expected to be initiated in mid-2024. The Agency also expressed willingness to potentially accept a P<0.1 alpha level in evaluating
InnovAATe for meeting the efficacy primary endpoint for registration, which may allow for the acceleration of the program. As a result,
we plan to present a revised statistical analysis plan (SAP) and study protocol for the InnovAATe study and to seek the FDA's feedback
by mid-2024," concluded Mr. London.
Financial Highlights for the Year Ended December
Financial Highlights for the Three Months Ended
Balance Sheet Highlights
As of December 31, 2023, the Company had cash
and cash equivalents of $55.6 million, as compared to $34.3 million as of December 31, 2022.
Corporate Highlights
Fiscal Year 2024 Guidance
Kamada expects to generate fiscal year 2024 total
revenues in the range of $156 million to $160 million, and adjusted EBITDA in the range of $27 million to $30 million, representing double
digit top- and bottom-line growth.
Kamada management will host an investment community
conference call on Wednesday, March 6, 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: 13744277. The call will also be webcast live on the Internet at:
Non-IFRS financial measures
We present EBITDA and adjusted EBITDA because
we use these non-IFRS financial measures 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 these non-IFRS financial measures 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
For the projected 2024 adjusted EBITDA information
presented herein, the Company is unable to provide a reconciliation of this forward measure to the most comparable IFRS financial measure
because the information for these measures is dependent on future events, many of which are outside of the Company's control.
Additionally, estimating such forward-looking measures and providing a meaningful reconciliation consistent with the Company's accounting
policies for future periods is meaningfully difficult and requires a level of precision that is unavailable for these future periods and
cannot be accomplished without unreasonable effort. Forward-looking non-IFRS measures are estimated in a manner consistent with
the relevant definitions and assumptions noted in the Company's adjusted EBITDA for historical periods.
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: KEDRAB ,
CYTOGAM , VARIZIG , WINRHO SDF , 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, the 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 in
addition have eleven biosimilar products in its Israeli distribution portfolio, which, subject to European Medicines Agency (EMA) and
Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection
center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D),
KAMRAB and KEDRAB. 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 continuing
to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds,
the leading private equity firm in Israel, is the Company's controlling shareholder, beneficially owning approximately 38% of the
outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking Statements
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) anticipation of continued momentum through 2024, with double-digit
top- and bottom-line growth, 2) full-year 2024 revenue guidance of $156 million to $160 million and adjusted EBITDA guidance of $27 million
to $30 million, 3) maintaining financial strength and flexibility to accelerate the growth and profitability of our existing business
beyond 2024 at double-digit rates and pursue compelling new business development opportunities, a process actively engaged in and that
would further enhance future growth, 4) continue to effectively leverage growth drivers, including a significant increase in sales of
KEDRAB and the promotion of CYTOGAM, 5) increase in KEDRAB sales expected to continue through 2024 and beyond, 6) projected $180 million
revenues from sale of KEDRAB to Kedrion during the first four years of the amended and extended distribution agreement, 7) plans
to initiate an open-label extension study by mid-2024, 8) plans to present a
revised SAP and study protocol for the InnovAATe study and seek the FDA's feedback, by mid-2024, which may allow for the acceleration