Full Press Release Details
Kamada Reports Strong Fiscal Year and Fourth
Quarter 2022 Financial Results, and Provides 2023 Guidance Representing Significant Profitability Growth
REHOVOT, Israel, and Hoboken, NJ - March
15, 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 12 and three months ended December 31, 2022.
our rapid strategic transformation to a diversified, fully integrated specialty plasma company is evidenced by our impressive full-year
2022 financial results," said Amir London, Kamada's Chief Executive Officer. "We met our 2022 revenue and profitability
guidance, with total revenues of $129.3 million, which represented 25% growth compared to 2021, and EBITDA of $17.8 million, a 3x increase
over 2021. Moreover, we generated operating cash flow of $28.6 million during 2022, supporting the increase in our cash position to $34.3
million as of December 31, 2022. These impressive results were driven by our ability to leverage multiple growth drivers, including the
portfolio of four FDA approved IgGs acquired in late 2021, the sales of which increased 24% year over year in 2022, KEDRAB sales in the
U.S., GLASSIA royalties from Takeda, the sales of our other Proprietary products in the international markets, and our thriving Israeli
distribution business," continued Mr. London.
expect the momentum from 2022 to extend throughout 2023, with profitability to be further enhanced. As such, we are introducing full-year
2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million. Mid-point expected EBITDA represents
approximately 35% growth year over year. Moreover, our multiple catalysts are anticipated to drive annual double-digit growth in the foreseeable
years ahead, with significant upside potential and limited downside risk," concluded Mr. London.
Financial Highlights for the Year Ended December
Financial Highlights for the Three Months Ended
Balance Sheet Highlights
As of December 31, 2022, the Company had cash,
cash equivalents, and short-term investments of $34.3 million, as compared to $18.6 million on December 31, 2021. The increase in Kamada's
cash position was driven by continued positive operational cash flows, which is indicative of the significant momentum in the Company's
commercial operations.
Recent Corporate Highlights
Fiscal Year 2023 Guidance
Kamada currently expects to generate fiscal year
2023 total revenues in the range of $138 million to $146 million and EBITDA in the range of $22 million to $26 million; mid-point expected
EBITDA represents approximately 35% growth year-over-year.
Kamada management will host an investment
community conference call and webcast with slides on Wednesday, March 15, at 8:30 AM 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). The live webcast will be available on the Internet
Non-IFRS financial measures
We present EBITDA and adjusted EBITDA, which is
defined as net income, plus (i) tax expense, (ii) financial income (expense), net, (iii) depreciation and amortization; and (iv) non-cash
share-based compensation expenses, 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 other costs.
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
and during recent years 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
registered 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
Fund, the leading private equity investor 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) 2023 revenue guidance in the range of $138 million to $146 million, 2) 2023 EBITDA guidance in the range of $22 million
to $26 million, 3) expected mid-point EBITDA representing approximately 35% growth year over year, 4) expectations that significant multiple
catalysts are driving Kamada's annual double-digit growth in the foreseeable years ahead, with significant upside potential and
limited downside risks, 5) intention to meet with the FDA and European Medicines Agency during the first half of 2023 to discuss study
progress and potential opportunities to shorten the regulatory pathway, and 6) expectation of launching eleven biosimilar products in
the Israel market through 2028. 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 continued evolvement of the COVID-19 pandemic, its scope, effect and duration, availability of sufficient raw materials required
to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international
delivery routes, impact of the workforce downsizing plan, continued demand for Kamada's products, financial conditions of the Company's customer, 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 this new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the recent
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, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes,
regulatory delays, the impacts of the failure of Silicon Valley Bank and recent turmoil in the banking industry, 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 U.S. Securities and Exchange Commission (the "SEC") including those discussed in its most recent Annual Report
on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC's
website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes
no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required