Full Press Release Details
Kamada Reports Strong First Quarter 2023 Financial
Revenue and Profitability Guidance
REHOVOT, Israel, and Hoboken, NJ - May
24, 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 three months ended March 31, 2023.
an excellent start to 2023, both financially and operationally," said Amir London, Kamada's Chief Executive Officer. "With
total revenues in the first quarter of $30.7 million, which represented year-over-year growth of 9%, and EBITDA of $3.8 million, an increase
of 16% year-over-year, we achieved the top- and bottom-line growth anticipated in our business to begin the year. Importantly, we continue
to effectively leverage multiple growth drivers, including KEDRAB sales in the U.S, the profitable
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."
quarter results are impressive, we are equally excited about our outlook for the remainder of the year," continued Mr. London. "As
such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26
million, which would represent profitability growth of over 30% as compared to 2022. Looking beyond 2023, based on multiple catalysts
from our existing business, we continue to anticipate annual double-digit growth rate in revenues and profitability in the foreseeable
were recently further significantly enhanced by the successful completion of multiple key achievements. The $60 million financing agreement
signed with FIMI will provide us with financial flexibility, allowing us to accelerate the growth of our existing business and pursue
compelling business development opportunities. Moreover, regarding our existing business, the FDA approval to manufacture CYTOGAM
at our facility in Israel, and the initiation of our commercial manufacturing, will positively impact our facility's utilization
and efficiency. In addition, we are encouraged by the most recent progress achieved in our ongoing pivotal Phase 3 InnovAATe clinical
trial for the inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). The study has enrolled
60 patients to date and the independent Data Safety Monitoring Board (DSMB) recently recommended study continuation without modification
for the fifth time since study initiation," concluded Mr. London.
Financial Highlights for the Three Months Ended March 31, 2023
Balance Sheet Highlights
As of March 31, 2023, Kamada had cash, cash equivalents,
and short-term investments of $27.1 million, as compared to $34.3 million on December 31, 2022. This figure does not include the expected
net proceeds from the recently announced $60 million financing, which is expected to close during the second half of 2023.
Recent 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 EBITDA during
2023 in the range of $22 million to $26 million, representing profitability growth of over 30% from the year ended December 31, 2022.
Kamada management will host an investment community
conference call on Wednesday, May 24, 2023, 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.), 1 809-406-247 (from
Israel) or 1-201-689-8263 (International) using conference ID 13738719. The call will also be webcast live on the Internet at: https://viavid.webcasts.com/starthere.jsp?ei=1614685&tp_key=87fb1414ee.
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 and is expected to beneficially own approximately 38% upon the closing of the Private Placement.
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) 2023 revenue guidance in the range of $138 Million to $146 Million; (2) 2023 EBITDA of $22 million to $26 million representing
profitability growth of over 30% from the year ended December 31, 2022; (3) commercial manufacturing of CYTOGAM in Israel shortly, which
will positively impact the facility's utilization and efficiency; (4) expected annual double-digit growth rate in revenues and profitability
in the foreseeable years ahead; (5) effectively leveraging multiple growth drivers, including KEDRAB sales in the U.S, 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; (6) receiving net proceeds from the recently announced $60 million financing; (7) closing of the recently announced
$60 million financing during the second half of 2023; (8) the financing providing the Company with financial flexibility, allowing the
Company to accelerate the growth of its existing business and pursue compelling business development opportunities; (9) the downsizing
is expected to result in an annualized reduction of approximately 6% in overall Israeli labor costs; and (10) optimism about AATD Phase
3 clinical trial progress. 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, success in receiving the necessary shareholder and regulatory approvals for the Private Placement, timing of Kamada's release
of its financial results for the second quarter of 2023, overall stock market conditions and specifically Kamada's stock price,
availability of sufficient raw materials required to maintain manufacturing plans, continued utilization of Kamada's Israeli manufacturing
site, continuation of inbound and outbound international delivery routes, continued demand for the IgG product portfolio, FDA and international
health authorities' approval process, financial conditions of the Company's customers, suppliers and services providers, Kamada's
ability to 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, Kamada's ability to manage operating expenses,
additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general
economic, industry or political conditions in the U.S., Israel or otherwise, and other risks detailed in Kamada's filings with the