Protalix BioTherapeutics Reports Fiscal Year 2024 Financial and Business Results
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, March 17, 2025 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the fiscal year ended December 31, 2024, and provided a business and clinical update.
"2024 was a record year in revenues from selling goods for Protalix, as we experienced increases in all three of our revenue streams, Chiesi, Pfizer and Brazil," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are pleased with the promising results from our first-in-human study of our gout candidate, PRX-115, in adult volunteers with elevated uric acid levels, and hope to build on this momentum with the goal of initiating a phase II clinical trial in patients with gout during the second half of 2025. At the same time, we continued to evaluate additional pipeline candidates, including PRX-119, for potential further development. Now that our debt is fully repaid and we no longer have outstanding warrants, our balance sheet is stronger and we are well-positioned to continue executing on our strategy through 2025 and beyond."
Fiscal Year 2024 and Recent Business Highlights
Pipeline and Clinical Developments
In 2024, we successfully completed the First-in-Human (FIH) phase I clinical trial of PRX-115, our recombinant PEGylated uricase product candidate in development as a potential treatment for uncontrolled gout. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD; reduction of uric acid) following a single dose of PRX-115 in subjects with elevated uric acid levels.
The results of the FIH study demonstrate that PRX-115 has the potential to offer an effective uric acid-lowering treatment with an added benefit of a potentially wide dosing interval, which may enhance patient compliance and treatment flexibility. Further studies are needed to confirm the long-term safety and efficacy of PRX-115 in the gout patient population.
The results were presented in a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2024, being held November 14-19, 2024 at the Walter E. Washington Convention Center in Washington, D.C. A copy of the poster is available on the Protalix website here: https://protalix.com/sites/default/files/PRX-115_SAD_Poster_ACR_2024_4Nov2024.pdf.
In June 2024, we hosted an Investor Day highlighting current treatment landscapes and clinical results for Fabry disease and uncontrolled gout. The event featured presentations from key opinion leaders (KOLs) Aleš Linhart, D.Sc., FESC (Charles University, Prague) and Naomi Schlesinger, M.D. (University of Utah). Our leadership also provided insight into our strategy and future plans. The KOL presentation slides can be found in the Presentations section of the Protalix website: https://ir.protalix.com/news-events/presentations.
Pegunigalsidase alfa
In December 2024, we and our global development and commercial partner, Chiesi Global Rare Diseases, announced that the European Medicines Agency (EMA) validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen at a dose of 2 mg/kg administered every four weeks in adult patients with Fabry disease. The variation submission is supported by a revised Population-PK model and new exposure-response analyses, and by the clinical data on pegunigalsidase alfa 2 mg/kg every four weeks from our completed phase III BRIGHT clinical trial of pegunigalsidase alfa (PB-102-F50) and the ongoing extension study.
Corporate Developments
In September 2024, we repaid in full all of the outstanding principal and interest payable under our then outstanding 7.50% Senior Secured Convertible Promissory Notes due September 2024. The repayment of the convertible notes at maturity was financed entirely with available cash.
Since December 31, 2024, we issued 908,000 shares of our common stock in connection with the exercise of warrants issued in 2020 generating proceeds equal to approximately $2.1 million from such exercises. The warrants expired on March 11, 2025. Accordingly, no warrants remain outstanding.
Fiscal Year 2024 Financial Highlights
We recorded revenues from selling goods of $53.0 million for the year ended December 31, 2024, an increase of $12.6 million, or 31%, compared to revenues of $40.4 million for the year ended December 31, 2023. The increase resulted primarily from an increase of $11.8 million in sales to Chiesi, an increase of $0.6 million in sales to Brazil and an increase of $0.1 million in sales to Pfizer Inc., or Pfizer.
We recorded revenues from license and R&D services of $0.4 million for the year ended December 31, 2024, a decrease of $24.7 million, or 98%, compared to revenues of $25.1 million for the year ended December 31, 2023. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Company's license and supply agreements with Chiesi Farmaceutici S.p.A., or Chiesi. The revenues from license and R&D services for the year ended December 31, 2023 included the $20.0 million regulatory milestone payment from Chiesi in connection with the approval by the U.S. Food and Drug Administration (FDA) of Elfabrio® granted during that period. The remaining decrease resulted from the completion of our revenue-generating research and development obligations with respect to Elfabrio and, as Elfabrio was approved in the United States and the European Union in May 2023, from the completion of the regulatory processes related to the review of the Biologics License Application (BLA) and the Marketing Authorization Application (MAA) for Elfabrio by the FDA and EMA, respectively. As a result of the completion of the Fabry clinical program in 2023, we expect to generate minimal revenues from license and R&D services other than potential regulatory and commercial milestone payments.
Cost of goods sold was $24.3 million for the year ended December 31, 2024, an increase of $1.3 million, or 6%, compared to cost of goods sold of $23.0 million for the year ended December 31, 2023. The increase in cost of goods sold was primarily the result of the increase in sales to Chiesi. In addition, during the year ended December 31, 2023 a portion of the costs for certain drug substance sold were recognized as research and development expenses, not cost of goods sold, as such drug substance was produced as part of our research and development activities.
For the year ended December 31, 2024, our total research and development expenses were approximately $13.0 million comprised of approximately $7.1 million of salary and related expenses, approximately $2.4 million in subcontractor-related expenses, approximately $0.9 million of materials-related expenses and approximately $2.6 million of other expenses. For the year ended December 31, 2023, our total research and development expenses were approximately $17.1 million comprised of approximately $7.8 million of salary and related expenses, approximately $6.3 million in subcontractor-related expenses, approximately $0.6 million of materials-related expenses and approximately $2.4 million of other expenses. Total decrease in research and developments expenses was $4.1 million, or 24%, for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease in research and development expenses resulted primarily from the completion of our Fabry clinical program and the regulatory processes related to the BLA and MAA review of Elfabrio by the applicable regulatory agencies.
Selling, general and administrative expenses were $12.2 million for the year ended December 31, 2024, a decrease of $2.8 million, or 19%, from $15.0 million for the year ended December 31, 2023. The decrease resulted primarily from a decrease of $1.8 million in professional fees and of $1.0 million in salaries and related expenses.
Financial income, net was $0.2 million for the year ended December 31, 2024, compared to financial expenses, net of $1.9 million for the year ended December 31, 2023. The difference resulted primarily from a decrease of approximately $1.4 million in lower interest and related expenses due to the conversion of notes in 2023 and the September 2024 repayment in full of all the outstanding principal and interest payable under the remaining notes, as well as an increase in interest income, net of $0.7 million.
For the year ended December 31, 2024, we recorded income taxes of approximately $1.2 million, an increase of $0.9 million, or 300%, compared to income taxes of $0.3 million for the year ended December 31, 2023. The income taxes resulted primarily from the provision for current taxes on income mainly derived from GILTI income mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act, or the TCJA. Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States rather than deducting such costs in the current year.
Cash, cash equivalents and short-term bank deposits were approximately $34.8 million at December 31, 2024.
Net income for the year ended December 31, 2024 was approximately $2.9 million, or $0.04 per share, basic and diluted, compared to $8.3 million or $0.12 per share, basic, and $0.09 per share, diluted, for the same period in 2023.
Conference Call and Webcast Information
We will host a conference call today, March 17, 2025, at 8:30 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: Monday, March 17, 2025Time: 8:30 a.m. Eastern Daylight Time (EDT)Toll Free: 1-877-423-9813International: 1-201-689-8573Israeli Toll Free: 1-809-406-247Conference ID: 13752080Call me™: https://tinyurl.com/yey23rkc
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Webcast Details:
The conference will be webcast live from the Protalix website and will be available via the following links:
Company Link: https://ir.protalix.com/news-events/eventsWebcast Link: https://tinyurl.com/yjfybd5tConference ID: 13752080
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023.
Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long acting DNase I for the treatment of NETs-related diseases; and others.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and ...
