Protalix BioTherapeutics Reports Fiscal Year 2024 Financial and Business Results

PR Newswire

CARMIEL, Israel, March 17, 2025

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$(R)$ 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 $(FIH.UK)$ 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_202 
      4_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(R) 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 $(BLA.AU)$ 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, 2025

Time: 8:30 a.m. Eastern Daylight Time (EDT)

Toll Free: 1-877-423-9813

International: 1-201-689-8573

Israeli Toll Free: 1-809-406-247

Conference ID: 13752080

Call me$(TM)$: https://tinyurl.com/yey23rkc

The Call me(TM) feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.

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/events

Webcast Link: https://tinyurl.com/yjfybd5t

Conference 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(R) , 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 uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio(R) (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA) approval received for the product; the possible disruption of our operations due to the war declared by Israel's security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, new trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity or debt markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer and Chiesi; risks related to the amount and sufficiency of our cash and cash equivalents and short-term bank deposits; risks relating to changes to interim, top-line or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, an arm of the Brazilian Ministry of Health, with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Investor Contact

Mike Moyer, Managing Director

LifeSci Advisors

+1-617-308-4306

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