Rehovot, Israel, and Hoboken, NJ – March 6, 2024 — 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 months and year ended December 31, 2023.
“We are extremely pleased with the strong financial and operational momentum we experienced through 2023, which allowed us to achieve our full-year guidance,” said Amir London, Kamada’s Chief Executive Officer. “Total revenues for 2023 were $142.5 million, representing record annual revenues and 10% year-over-year growth, and adjusted EBITDA was $24.1 million, up 35% year-over-year. We continue to effectively leverage our growth drivers, including a significant increase in sales of our anti-rabies immunoglobulin product, KEDRAB® and the promotion of CYTOGAM®.”
“The growing increase in KEDRAB sales is expected to continue through 2024 and beyond. We recently signed an amendment and extension of our distribution agreement with Kedrion. This strategic agreement represents our largest commercial pact since Kamada’s inception, and within the first four years of the eight-year term, which commenced in January 2024, Kedrion is required to purchase minimum quantities of KEDRAB with total revenues to Kamada of approximately $180 million,” continued Mr. London.
“Looking ahead, we anticipate continued momentum through 2024, with double-digit top- and bottom-line growth. Specifically, we are introducing full-year 2024 revenue guidance of $156 million to $160 million and adjusted EBITDA guidance of $27 million to $30 million. We maintain the financial strength and flexibility to accelerate the growth and profitability of our existing business beyond 2024 at double-digit rates and pursue compelling new business development opportunities, a process we are actively engaged in and that would further enhance our future growth,” added Mr. London.
“We continue patient enrollment in our ongoing pivotal Phase 3 InnovAATe clinical trial for the inhaled Alpha-1 Antitrypsin therapy for the treatment of AAT Deficiency. Importantly, the U.S. Food and Drug Administration (FDA) recently reconfirmed the overall design of the study, endorsed the independent Data and Safety Monitoring Board’s (DSMB) unblinded positive safety assessment, and accepted our plan to conduct an open-label extension study, expected to be initiated in mid-2024. The Agency also expressed willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the efficacy primary endpoint for registration, which may allow for the acceleration of the program. As a result, we plan to present a revised statistical analysis plan (SAP) and study protocol for the InnovAATe study and to seek the FDA’s feedback by mid-2024,” concluded Mr. London.
click here to review the full financial report.
Financial Highlights for the Year Ended December 31, 2023
Financial Highlights for the Three Months Ended December 31, 2023
Balance Sheet Highlights
As of December 31, 2023, the Company had cash and cash equivalents of $55.6 million, as compared to $34.3 million as of December 31, 2022.
Recent Corporate Highlights
Fiscal Year 2024 Guidance
Kamada expects to generate fiscal year 2024 total revenues in the range of $156 million to $160 million, and adjusted EBITDA in the range of $27 million to $30 million, representing double digit top- and bottom-line growth.
Conference Call
Kamada management will host an investment community conference call on Wednesday, March 6, 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: 13744277. The call will also be webcast live on the Internet at:
https://viavid.webcasts.com/starthere.jsp?ei=1655132&tp_key=6e560eef4a.
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 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.
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.
About Kamada
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: KEDRAB®, CYTOGAM®, VARIZIG®, WINRHO SDF®, 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 and in addition have eleven biosimilar products in its Israeli distribution portfolio, which, subject to European Medicines Agency (EMA) and 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), KAMRAB and KEDRAB. 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 regarding: 1) anticipation of continued momentum through 2024, with double-digit top- and bottom-line growth, 2) full-year 2024 revenue guidance of $156 million to $160 million and adjusted EBITDA guidance of $27 million to $30 million, 3) maintaining financial strength and flexibility to accelerate the growth and profitability of our existing business beyond 2024 at double-digit rates and pursue compelling new business development opportunities, a process actively engaged in and that would further enhance future growth, 4) continue to effectively leverage growth drivers, including a significant increase in sales of KEDRAB and the promotion of CYTOGAM, 5) increase in KEDRAB sales expected to continue through 2024 and beyond, 6) projected $180 million revenues from sale of KEDRAB to Kedrion during the first four years of the amended and extended distribution agreement, 7) plans to initiate an open-label extension study by mid-2024, 8) plans to present a revised SAP and study protocol for the InnovAATe study and seek the FDA’s feedback, by mid-2024, which may allow for the acceleration of the program, 9) plans to distribute a portfolio of eleven biosimilar products, expected to be launched subject to EMA and Israeli Ministry of Health approvals, 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 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 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, 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, unexpected results of clinical studies, 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 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 by law.
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
Britchie@LifeSciAdvisors.com