Protalix BioTherapeutics Reports First Quarter 2025 Financial and Business Results

PR Newswire

CARMIEL, Israel, May 9, 2025

Company to host conference call and webcast today at 8:30 a.m. EDT

CARMIEL, Israel, May 9, 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 quarter ended March 31, 2025, and provided a business and clinical update.

"We had another solid quarter, with an increase in revenues from selling goods compared to the prior year quarter," said Dror Bashan, Protalix's President and Chief Executive Officer. "Given the promising results obtained in 2024 from our first-in-human study of our gout candidate, PRX-115, we are focused on building on the momentum and working toward initiating a phase II clinical trial in patients with gout later this year. At the same time, we continued to evaluate additional pipeline candidates for potential further development, including PRX-119 as well as various early-stage clinical assets."

First Quarter 2025 and Recent Business and Clinical Highlights

Pipeline Developments

PRX-115

   -- 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. We are in the advance stages of preparations for the phase II 
      clinical trial we expect to commence during the second half of 2025. 
 
          -- The preliminary 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. 
 

Pegunigalsidase alfa

   -- In March 2025, our global development and commercial partner, Chiesi 
      Global Rare Diseases, announced multiple presentations on pegunigalsidase 
      alfa and Fabry Disease at the 21st Annual WORLDSymposium$(TM)$ Research 
      Meeting. The Poster presentations are available in the publications 
      section of Protalix's website. 

First Quarter 2025 Financial Highlights

   -- We recorded revenues from selling goods of $10.0 million during the three 
      months ended March 31, 2025, an increase of $6.3 million, or 170%, 
      compared to revenues of $3.7 million for the three months ended March 31, 
      2024. The increase resulted primarily from an increase of $5.9 million in 
      sales to Pfizer Inc. and an increase of $0.4 million in sales to 
      Fundação Oswaldo Cruz, or Fiocruz (Brazil). 
 
   -- We recorded revenues from license and R&D services of $0.1 million for 
      the three months ended March 31, 2025 and the three months ended March 
      31, 2024. Revenues from license and R&D services are comprised primarily 
      of revenues we recognized in connection with our license and supply 
      agreements with Chiesi. We expect to generate minimal revenues from 
      license and R&D services other than potential regulatory milestone 
      payments. 
 
   -- Cost of goods sold was $8.2 million for the three months ended March 31, 
      2025, an increase of $5.6 million, or 215%, from cost of goods sold of 
      $2.6 million for the three months ended March 31, 2024. The increase in 
      cost of goods sold resulted primarily from an increase in sales to Pfizer 
      and Fiocruz (Brazil). 
 
   -- For the three months ended March 31, 2025, our total research and 
      development expenses were approximately $3.5 million comprised of 
      approximately $1.8 million of salary and related expenses, approximately 
      $0.8 million in subcontractor-related expenses, approximately $0.2 
      million of materials-related expenses and approximately $0.7 million of 
      other expenses. For the three months ended March 31, 2024, our total 
      research and development expenses were approximately $2.9 million 
      comprised of approximately $1.5 million of salary and related expenses, 
      approximately $0.5 million of subcontractor-related expenses, 
      approximately $0.2 million of materials-related expenses and 
      approximately $0.7 million of other expenses. Total increase in research 
      and developments expenses for the three months ended March 31, 2025 was 
      $0.6 million, or 21%, compared to the three months ended March 31, 2024. 
      The increase in research and development expenses resulted primarily from 
      the advance in our clinical pipeline. 
 
   -- Selling, general and administrative expenses were $2.6 million for the 
      three months ended March 31, 2025, a decrease of $0.5 million, or 16%, 
      compared to $3.1 million for the three months ended March 31, 2024. The 
      decrease resulted primarily from a decrease of $0.4 million in salary and 
      related expenses and a decrease of $0.1 million in selling expenses. 
 
   -- Financial income, net was $0.4 million for the three months ended March 
      31, 2025, compared to financial income, net of $0.1 million for the three 
      months ended March 31, 2024. The difference resulted primarily from lower 
      notes interest expenses due to the September 2024 repayment in full of 
      all the outstanding principal and interest payable under our then 
      outstanding 7.50% Senior Secured Convertible Promissory Notes, partially 
      offset by lower interest income on bank deposits and higher exchange rate 
      costs. 
 
   -- For the three months ended each of March 31, 2025 and March 31, 2024, we 
      recorded a tax benefit of approximately $(0.1) million. The tax benefit 
      resulted primarily from deferred taxes on income mainly derived from 
      GILTI income mainly in respect of Section 174 of the U.S. Tax Cuts and 
      Jobs Act of 2017, 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 
      $34.7 million at March 31, 2025. 
 
   -- Net loss for the quarter ended March 31, 2025 was approximately $3.6 
      million, or $0.05 per share, basic and diluted, compared to $4.6 million, 
      or $0.06 per share, basic and diluted, for the same period in 2024. 

Conference Call and Webcast Information

We will host a conference call today, May 9, 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: Friday, May 9, 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: 13753682

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/3nn9jh5v

Conference ID: 13753682

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.

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