Full Press Release Details
Kamada Reports Continued Profitable Growth with
Strong Third Quarter and Nine Month 2024 Financial Results; Raises Full-Year Profitability Guidance
REHOVOT, Israel, and HOBOKEN, NJ - November
13, 2024 -- 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 financial results for three months
and nine months ended September 30, 2024.
strong operational and financial momentum continued in the third quarter as we again generated solid results," said Amir London,
Kamada's Chief Executive Officer. "While we benefit from the strength of our entire portfolio, we continue to improve the
overall sales mix through increased sales of our two most profitable growth drivers KEDRAB and CYTOGAM .
Total revenues for the first nine months of 2024 were $121.9 million, which represents year-over-year growth of 15%, and adjusted EBITDA
was $25.4 million, up 43% year-over-year, representing a 21% margin of revenues. Based on our continued profitable growth and positive
outlook for the remainder of 2024, we are increasing our annual adjusted EBITDA guidance to $32 million to $35 million, a 12% increase
of the midpoint from our previous guidance and reiterating our full-year 2024 revenue guidance of between $158 million to $162 million."
"Importantly, we consistently demonstrate
our ability to convert our reported adjusted EBITDA to operational cash flow, as we generated $37.2 million of cash from operating activities
during the first nine months of the year. As of the end of the quarter, we had $72.0 million of available cash. We remain focused on identifying
compelling new business development opportunities and leveraging our overall financial strength to further support our continued double-digit,
longer-term growth," added Mr. London.
"We also continue to advance multiple additional
existing long-term growth drivers. To this end, during the third quarter, we announced the expansion of our plasma collection operations
with the opening of a new plasma collection center in Houston, TX. This new center is expected to support an estimated total collection
capacity of approximately 50,000 liters annually. The center is expected to be one of the largest sites for specialty plasma collection
in the U.S. and will also collect normal source plasma to be sold to third parties. Additionally, patient enrollment continues in the
ongoing pivotal Phase 3 InnovAATe clinical trial for our inhaled Alpha-1 Antitrypsin therapy. The independent Data and Safety Monitoring
Board (DSMB) recommended study continuation without modifications at its recently conducted semi-annual meeting. We remain engaged in
active discussions with the U.S. FDA on our previously filed IND amendment consisting of a revised Statistical Analysis Plan (SAP) and
study protocol, which, if approved, may allow for the acceleration of the program," concluded Mr. London.
Financial Highlights for the Three Months Ended
Highlights for the Nine Months Ended September 30, 2024
Balance Sheet Highlights
As of September 30, 2024, the Company had cash,
cash equivalents, and short-term investments of $72.0 million, as compared to $55.6 million on December 31, 2023.
Recent Corporate Highlights
the expansion of the Company's plasma collection operations with the opening of a new plasma collection center in Houston, TX.
The new 12,000 square foot center is operated by Kamada's wholly owned subsidiary, Kamada Plasma, and is planned to support over
50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually. The new center will collect normal
source plasma and specialty plasma, such as Anti-Rabies and Anti-D, and is anticipated to be one of the largest sites for specialty plasma
collection in the U.S. The new center also supports the Company's strategy to become a leading global vertically integrated supplier
of specialty plasma-derived products. Kamada expects to open its third plasma collection center in San Antonio, TX, during the first
half of 2025, and expects each collection center to contribute annual revenues of $8 million to $10 million in sales of normal source
plasma at its full capacity.
Fiscal Year 2024 Guidance
Kamada is increasing its adjusted EBITDA guidance
from a range of $28 million to $32 million to a range of $32 million to $35 million, a 12% increase of the midpoint from the previous
guidance, and continues to expect to generate fiscal year 2024 total revenues in the range of $158 million to $162 million, representing
double digit top- and bottom-line growth year-over-year.
Kamada management will host an investment community
conference call on November 13, 2024, 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 1-877-407-0792 (from within the U.S.) or 1-809-406-247
(from Israel) or 1-201-689-8263 (International) using conference ID 13749715. The call will also be webcast live on the Internet at https://viavid.webcasts.com/starthere.jsp?ei=1694075&tp_key=3a2494a103
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 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 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