Full Press Release Details
Kamada Reports Significant Increase in Sales
and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance
Rehovot, Israel, and Hoboken, NJ - November
13, 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 nine months ended September 30, 2023.
"We are highly encouraged with our strong
financial and operational momentum during the first nine months of the year," said Amir London, Kamada's Chief Executive Officer.
"With total revenues of $106.1 million, which represent year-over-year growth of 26%, and adjusted EBITDA of $17.7 million, an increase
of 67% as compared to the first nine months of 2022, we achieved the top- and bottom-line growth anticipated in our business in the first
nine months of the year. We continue to effectively leverage our multiple growth drivers, including a significant increase in sales of
our anti-rabies immunoglobulin product, KEDRAB as well as the portfolio of the four FDA-approved immunoglobulins (CYTOGAM , HEPAGAMB ,
VARIZIG and WINRHO SDF), and our Israeli distribution business."
"We expect the momentum from the first nine
months of the year to extend through the fourth quarter of 2023, with annual 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
"During the recent period we reported multiple
achievements with CYTOGAM. Specifically, following recent FDA approval of the technology transfer process, CYTOGAM manufactured at our
Israeli facility is now available for commercial sale in U.S., and new clinical data highlighting five-year real-world survival benefits
of high risk CMV mismatch lung transplant patients receiving CYTOGAM were presented at IDWeek 2023. In addition, we continue to advance
our pivotal phase 3 InnovAATe trial for Inhaled AAT and we recently received positive feedback from the independent Data and Safety Monitoring
Board (DSMB) which recommended study continuation without modification for the sixth time since study initiation, based on encouraging
safety data observed in the study to date," added Mr. London.
"Our future prospects were also recently
further buoyed by the recent closing of our $60 million private placement with FIMI Opportunity Funds. This strategic investment provides
us with financial flexibility to pursue compelling business development opportunities, a process that we are currently engaged in,"
concluded Mr. London.
Financial Highlights for the Three Months Ended
Financial Highlights for the Nine Months Ended
Balance Sheet Highlights
As of September 30, 2023, the Company had cash,
cash equivalents, and short-term investments of $52.6 million, as compared to $34.3 million as of December 31, 2022. This includes the
net proceeds of $58.2 million received from the $60 million financing closed during the third quarter. In addition, during the third quarter
the Company made a $17.4 million pay-down in full the outstanding balance of a bank loan. The Company is currently debt free.
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
Kamada management will host an investment community
conference call on Monday, November 13, 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: 13741701. The call will also be webcast live on the Internet at:
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
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) continued ability to leverage growth drivers, 2) continuing the momentum of the first three quarters of 2023 in the last
quarter and ability to enhance profitability, 3) reiteration of fiscal year 2023 guidance, 4) exploration of future business development
prospects in the wake of the recent private placement proceeds, and 5) positive feedback relating to inhaled ATT clinical trial. 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 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 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 in new locations, unexpected results of clinical studies, Kamada's ability to manage operating expenses,