Full Press Release Details
Kamada Affirms 2024 Financial Guidance and Announces
Expected Continued Double-Digit Profitable Growth for 2025
REHOVOT, Israel, and HOBOKEN, NJ - January
8, 2025 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a 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 that the Company expects to achieve
its 2024 financial guidance of $158 million - $162 million in revenues and $32 million - $35 million of adjusted EBITDA, with 2024 year-end
cash of $78 million (unaudited). The Company further announced that, based on its positive outlook for 2025, it is forecasting continued
double-digit profitable growth, with 2025 annual guidance of $178 million - $182 million in revenues and $38 million - $42 million of
adjusted EBITDA. The mid-point of the 2025 guidance represents an increase of 13% in revenues and 19% in adjusted EBITDA based on the
mid-point of the 2024 guidance.
"We enter 2025 from a position of significant
strength and are pleased with the progress made over the past year. We look forward to achieving our value generating objectives for 2025
driven by our four strategic growth pillars, comprising of organic commercial growth, the execution of business development and M&A
transactions, our plasma collection operations, and the further advancement of our pivotal Phase 3 Inhaled AAT program," said Amir
London, Kamada's Chief Executive Officer. "Based on our robust operational and financial performance, we are affirming that
2024 revenue and adjusted EBITDA will both be in line with our previously provided guidance, and we expect continued double-digit profitable
growth in 2025, driven by our diverse commercial portfolio marketed in over 30 countries."
"We continue to demonstrate our
ability to convert adjusted EBITDA into operational cash, providing critical resources to enable us to secure compelling new
business development and M&A transactions in 2025. These anticipated additions will enrich our portfolio of marketed products
and leverage synergies with our existing commercial operations. We also expect to expand our plasma collection operations, including
the opening of our third location in San Antonio, TX, by the end of the first quarter of 2025. Once at full collection capacity, we
anticipate that each of the Houston and San Antonio centers will contribute annual revenues of $8 million to $10 million in sales
of normal source plasma," added Mr. London.
"Moreover, we are pleased to report that
the U.S. FDA recently confirmed its agreement with our previously proposed relaxed two-sided Type 1 error rate control change from 5%
to 10% (p-value of 0.1) for the ongoing pivotal Phase 3 InnovAATe clinical trial for our inhaled Alpha-1 Antitrypsin therapy. Based on
the accepted change in the p-value, as well as additional expected revisions to the statistical analysis plan, we intend to reduce the
study sample size from 220 patients to approximately 180 patients, while maintaining the statistical power of the trial, and conduct an
interim futility analysis by the end of 2025," concluded Mr. London.
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 is 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, whereas adjusted EBITDA is the EBITDA plus non-cash share-based compensation expenses
and certain other costs.
For the projected 2025 and 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 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 , 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, 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. During recent years the Company
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 licensed plasma collection
center in Beaumont, Texas, which currently specializes in the collection of Anti-Rabies and Anti-D hyper-immune plasma used in the manufacturing
of the Company's relevant products and recently opened a new plasma collection center in Houston, Texas in which it collects normal
source plasma and intends to also collect specialty plasma. 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
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 to achieve the 2024 annual guidance, 2) projected annual 2025 guidance, 3)
expectation to achieve value generating objectives for 2025 driven by our four strategic growth pillars, 4) aiming to secure new
business development and M&A transactions during 2025, leverage overall financial strength and existing commercial
infrastructure to accelerate long-term growth, 5) expansion of plasma collection operations, including opening the third location in
San Antonio, TX, by the end of the first quarter of 2025, and anticipation that each the Houston and San Antonio centers will
contribute annual revenues of $8 million to $10 million from sales of normal source plasma, and 6) intention to reduce the pivotal
Phase 3 InnovAATe clinical study sample size to approximately 180 patients, while maintaining the statistical power of the trial,
and conduct an interim futility analysis by the end of 2025 based on the accepted change in the p-value, as well as additional
expected changes to the statistical analysis plan. 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 evolving nature of the conflicts in the Middle East and the impact of such
conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general
economic, industry and political conditions in Israel, the U.S. and globally, continuation of inbound and outbound international
delivery routes, continued demand for Kamada's products, financial conditions of the Company's customer, suppliers and
services providers, Kamada's ability to leverage new business opportunities and integrate the new product portfolio into its
current product portfolio, Kamada's ability to grow the revenues of its new product portfolio, and leverage and expand its
international distribution network, ability to reap the benefits of the acquisition of the plasma collection center, including the
ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products,
the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies,