Full Press Release Details
Kamada Reports Strong Second Quarter and First
Half 2023 Financial Results;
Reiterates 2023 Revenue and Profitability Guidance
Rehovot, Israel, and Hoboken, NJ - August
16, 2023 -- 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 and six months ended June 30, 2023.
"Our strong start to 2023 continued in the
second quarter, both financially and operationally," said Amir London, Kamada's Chief
Executive Officer. "With total revenues for the first six months of the year of $68.2 million, which represented year-over-year
growth of 32%, and adjusted EBITDA of $9.9 million, representing 24% growth year-over-year, we
achieved the top- and bottom-line growth anticipated in our business during the first six months of the year. We continue to effectively
leverage our multiple growth drivers, including a significant increase of KEDRAB sales to Kedrion
for further distribution in the U.S., as well as the portfolio of the four FDA-approved Immunoglobulins
(CYTOGAM , HEPAGAMB , VARIZIG and WINRHO SDF), and our Israeli distribution
"Importantly, we expect the momentum
in our business to continue through the second half of the year, with full-year profitability to be further meaningfully enhanced as
compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and adjusted
EBITDA of $22 million to $26 million; the mid-point of the range would represent profitability growth of approximately 35% over
2022," continued Mr. London.
"We continue to advance our pivotal phase
3 InnovAATe trial for Inhaled AAT and recently received positive scientific advice from the European Medicines Agency (EMA) that reconfirmed
the overall design of the on-going study and acknowledged the statistically and clinically meaningful improvement in lung function (FEV1)
demonstrated in our previous Phase 2/3 European study, which served as the basis for the design and the selection of the primary endpoint
of our current pivotal Phase 3 study. Discussion with the FDA regarding study progress will be completed by the end of 2023," added
"We are actively engaged in seeking shareholders'
approval, later this month, for the $60 million share purchase agreement previously signed with FIMI.
This strategic investment will provide us with financial flexibility to pursue compelling business development opportunities, a
process that we have initiated, and will be further ramped up upon receipt of shareholder approval and closing of the transaction. Additionally,
the recent extension through March 2026 of our U.S
distribution agreement with Kedrion for KEDRAB assures that this important product will remain a key growth catalyst for Kamada.
We remain in active discussions with Kedrion to potentially further expand the scope of the collaboration,"
concluded Mr. London.
Financial Highlights for the Three Months Ended
Financial Highlights for the Six Months Ended
Balance Sheet Highlights
As of June 30, 2023, the Company had cash, cash
equivalents, and short-term investments of $21.8 million, as compared to $34.3 million as of December 31, 2022. This
figure does not include the expected net proceeds from the recently announced $60 million financing, which is expected to close, subject
to shareholders' vote, during the third quarter of 2023.
Corporate Highlights
Fiscal Year 2023 Guidance
Kamada continues to expect to generate
fiscal year 2023 total revenues in the range of $138 million to $146 million. The Company also continues to anticipate generating
adjusted EBITDA during 2023 in the range of $22 million to $26 million, the mid-point of the range would represent profitability
growth of approximately 35% over 2022.
Kamada management will host an investment community
conference call on Wednesday, August 16, 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: 13740401. 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 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: CYTOGAM ,
KEDRAB , 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, 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 hyper-immune plasma used
in the manufacture of KAMRHO (D). 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 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 that the momentum in our business to continue through the second half of the
year, with profitability to be further meaningfully enhanced as compared to last year; (2) 2023 revenue guidance in the range of
$138 Million to $146 Million; (3) 2023 adjusted EBITDA to be in the range of $22 million to $26 million, with the mid-point of the
range representing profitability growth of approximately 35% over 2022; (4) Discussion with the FDA regarding study progress to be
completed by the end of 2023; (5) Potential expansion of the scope of the collaboration between Kamada and Kedrion; (6) effectively
leveraging multiple growth drivers, including significant increase of KEDRAB sales to Kedrion, the portfolio of four FDA approved
IgGs acquired in late 2021, the sales of our other Proprietary products in the international markets, and our Israeli distribution
business; (7) shareholder approval and expected closing of the recently announced $60 million