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Kamada Issues 2024 CEO Letter to Shareholders | ||
By: GlobeNewswire - 06 Mar 2024 | Back to overview list |
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REHOVOT, Israel, and HOBOKEN, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- 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 issued a Letter to Shareholders from Amir London, Chief Executive Officer. Dear Shareholders, Colleagues and Business Partners: The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field. During the year, we continued our major transformation to a diversified, fully integrated specialty plasma company with six U.S. Food and Drug Administration (FDA) approved proprietary products and strong commercial capabilities in the U.S. market, as well as a sales footprint in over 30 countries. Earlier today, we reported our full-year 2023 financial results, which met our annual guidance, with total revenues of $142.5 million and adjusted EBITDA of $24.1 million, representing margins of 17%. Our strong performance in 2023 represented an adjusted EBITDA increase of 35% as compared to 2022. Looking ahead, we expect the momentum from 2023 to extend throughout 2024, with profitability to be further increased as compared to last year. As such, we are introducing full-year 2024 revenue guidance of $156 million to $160 million, and adjusted EBITDA guidance of $27 million to $30 million, which would represent double digit top- and bottom-line growth. Our impressive results in 2023, and positive outlook for this year, are the outcome of our ability to leverage our growth drivers, including a significant increase in sales of our anti-rabies immunoglobulin product, KEDRAB®, and the promotion of CYTOGAM®. These significant catalysts are propelling our continued annual double-digit profitable growth with substantial upside potential and limited downside risk. KEDRAB, our anti-rabies immunoglobulin, was especially impactful in 2023 and following the recent amendment and extension of our distribution agreement with Kedrion, we expect this trend to continue in 2024 and beyond. Throughout last year, we experienced a significant increase in demand for the product in the United States, driven by Kedrion's extensive market coverage and robust commercial activity, as well as the FDA approval for a label expansion for the product, obtained in 2021, that has differentiated it as the first and only human rabies immunoglobulin available in the United States to be clinically studied in children. As a result of this significant growth, we generated approximately $32.8 million in revenues from sales of KEDRAB to Kedrion during 2023, which more than doubled our sales compared to 2022. Looking ahead, the extended agreement with Kedrion, which is our largest commercial agreement signed since Kamada’s inception, is a tremendous milestone for the company, guaranteeing approximately $180 million in revenues within the first four years of the eight-year term, which began this past January. We are confident that the continuation of our partnership with Kedrion maximizes the future growth and value potential of KEDRAB, while it also most effectively exploits our U.S. business by allowing us to focus our own internal sales efforts on the commercialization of our other specialized FDA-approved IgG products, primarily in transplant centers, as Kedrion continues to promote KEDRAB in numerous hospitals and medical centers across the United States. Our U.S. team, established in 2022, continues to achieve steady progress in promoting our portfolio to physicians and other healthcare practitioners through direct engagement and opportunities at medical meetings. Our activities promoting these important therapies, primarily CYTOGAM and VARIZIG, represent the first time in over a decade that these hyper-immune specialty products are being supported by field-based activity in the United States. Each of these products made important contributions to our financial results in 2023, and we expect further impact this year. CYTOGAM is the largest of the four products we are self-marketing. The product is indicated for the prophylaxis of cytomegalovirus disease associated with solid organs transplantation. This proprietary and unique therapy is the only FDA approved IgG product for its indication. During 2023, we received the FDA’s and Health Canada's approvals of our applications to manufacture CYTOGAM at our Israeli facility, following completing the technology transfer of the product manufacturing from its prior manufacturer, CSL Behring. While our CYTOGAM sales during 2023 were temporarily impacted by the shorted-dated inventory we initially purchased as part of the product acquisition in 2021, the technology transfer approvals and "fresh" product batches available since October 2023 ensure continuous long-term supply of the product to the U.S. and Canadian markets, without interruption. Importantly, during 2023 we established a CYTOGAM Scientific Advisory Board, consisting of eight U.S. based, world-renowned thought leaders in the solid organ transplantation field, which evaluates new opportunities and future research and development possibilities for this important product. The results of the first of those studies, conducted by Dr. Fernando Torres, Clinical Chief, Division of Pulmonary and Critical Care at University of Texas Southwestern Medical Center, were announced in October 2023 at IDWeek. In his summary, Dr. Torres concludes that the use of a proactive multimodality CMV prophylaxis consisting of antivirals and immune augmentation with CMV immunoglobulin may improve outcomes among high-risk CMV mismatch lung transplant recipients. We have already been notified that two additional studies related to the benefits of CYTOGAM, conducted by other leading U.S. transplantation key opinion leaders (KOLs), have been accepted for presentation at transplantation-related medical meetings during 2024. We expect these medical and clinical initiatives to continue supporting the increase in usage of CYTOGAM in the coming years. In addition to KEDRAB growth and our U.S. promotional activities, we are leveraging our strong international distribution network to expand revenues of our IgG portfolio in other territories, primarily in Canada, Asia, Latin America and the Middle East, as well as with the Pan American Health Organization. We are also very excited about our innovative investigational Inhaled AAT product candidate for the treatment of AAT Deficiency, a technology that has been shown to be highly effective in delivering AAT directly into a patient’s lungs. A substantial opportunity exists for Inhaled AAT to be a transformational product in a market that is already over $1 billion in annual sales in the U.S. and EU. We are currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 study. During 2023, we continued recruiting patients into the study and made significant progress in our regulatory discussions, meeting both the FDA and the European Medicines Agency (EMA), presenting study progress and safety data and discussing potential opportunities to accelerate the program. Both agencies reconfirmed the design of the ongoing study and endorsed the positive safety data demonstrated to date. The EMA acknowledged the statistically and clinically meaningful improvement in lung function, measured by FEV1, demonstrated in our previous Phase 2/3 European study. As a reminder, the results from the prior study served as the basis for the design and the selection of the primary endpoint for our current pivotal Phase 3 study. During our discussions with the FDA, the agency expressed its willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the study’s 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 and study protocol for the InnovAATe study, and subsequently seek FDA's feedback by mid-2024. In parallel to our clinical and regulatory progress, we also continue to have active discussions related to potential partnering for this promising late-stage product candidate. During 2023, we continued to receive royalties from Takeda based on sales of GLASSIA in the United States. We expect royalties in the range of $10 million to $20 million per year through 2040, which will further support our profitability and cash position. In addition, we continue to grow sales of GLASSIA in other international markets through our local partners. Another major strategic step we are taking is the advancement of our plasma collection business through our wholly owned subsidiary, Kamada Plasma, based in Texas. During 2023, we expanded the hyperimmune plasma collection capacity at our first center and are currently advancing our plan to open additional centers in the U.S. to further increase our supply of specialty and regular plasma, enhancing our vertical integration and profitability. Our second center will be opened in Houston, Texas, during the second half of 2024. In our distribution segment, we are leveraging our expertise and strong presence in the Israeli market to register, market and distribute more than 25 products that are developed and manufactured by our international partners. In recent years, we have significantly grown our pipeline of distributed products and in 2024 we anticipate continuing to launch new therapies across multiple medical specialties. An area of key strategic focus in this business is the planned distribution of a portfolio of eleven biosimilar products, expected to be launched, subject to EMA and Israeli Ministry of Health approvals, through 2028, with overall annual anticipated peak sales, within several years of launch, to be in the range of approximately $30 million to $34 million annually. Included in this portfolio are eight products through a distribution agreement with Alvotech, a global leader in the development and manufacturing of biosimilar drugs. In closing, 2023 was another year of significant progress for Kamada during which we executed our plan by leveraging multiple robust value-creating catalysts, and we are well-positioned for further revenue and profitability growth in 2024, and the years beyond, with substantial upside potential and limited downside risk as a global leader in the specialty plasma industry. Importantly, we ended 2023 with over $55 million in cash and continue to have the financial flexibility to both accelerate the growth of our existing business and pursue compelling business development opportunities, a process we are actively engaged in. On behalf of the entire Kamada team, we look forward to continuing to support patients and clinicians with the important lifesaving products that we develop, manufacture, and commercialize. We thank all of our investors for their support and remain committed to creating long-term shareholder value. Sincerely, Amir London About Kamada Non-IFRS financial measures 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. Cautionary Note Regarding Forward-Looking Statements CONTACTS: Brian Ritchie |
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