#Israel #Protalix BioTherapeutics #Elfabrio #Carmiel #PRX-115

Protalix BioTherapeutics Reports Fiscal Year 2025 Results

Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical firm concentrating on innovative treatments for rare diseases, declared its financial outcomes and business advancements for the fiscal year ending December 31, 2025. The company emphasizes its pivotal developments, primarily the European Commission's approval of the 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio®, a medication for Fabry disease. This approval represents a considerable stride in reducing treatment obligations for patients, leading to a $25 million milestone payment from Chiesi Farmaceutici, thereby enhancing Protalix's financial position with an expected cash balance of around $50 million by April 2026.

Dror Bashan, President and CEO of Protalix, stated, “2025 was marked by substantial enhancements in commercial execution and strategic planning across our clinical and preclinical pipelines. The E4W dosing approval signifies our long-term commitment to providing innovative solutions for patients, effectively decreasing the treatment burden associated with Fabry disease.” This advancement not only maintains efficacy but also improves the quality of life for patients by reducing administration frequency.

Significant Developments and Financial Overview

In addition to the Elfabrio achievement, Protalix is advancing its other pipelines, notably PRX-115, aimed at tackling uncontrolled gout. The ongoing Phase 2 clinical trial, RELEASE, is currently enrolling participants, and initial results have shown promising tolerability along with efficient serum urate reduction. Protalix anticipates releasing top-line results by the second half of 2027, showcasing its potential to become a leading therapy in the gout treatment space. The design of PRX-115 focuses on addressing immunogenicity while enabling more flexible dosing schedules, potentially transforming patient compliance and treatment outcomes.

On the financial front, the company reported a revenue of approximately $51.8 million for FY2025, slightly down from $53 million in 2024. This decrease was primarily attributable to a decline in sales to Chiesi, offset partially by increased revenue from Pfizer, with heightened purchases of Elelyso due to manufacturing issues on Pfizer’s end. Revenue from license and R&D services showed a significant rise to $0.9 million, underlining the company's collaborative efforts and partnerships.

The company's research and development expenses reflected a robust increase, largely driven by preparations for the PRX-115 trial, totaling $19.6 million for the year. Protalix maintains a strong financial position with no outstanding debt, projecting a revenue range for FY2026 between $78 million and $83 million, which includes the aforementioned milestone payment.

Future Focus and Strategic Direction

As Protalix navigates through 2026, the company remains committed to developing rare renal disease therapies, particularly through its program PRX-119, alongside its collaboration with Secarna. Protalix's focus on these areas highlights its dedication to addressing significant unmet medical needs while aiming for profitable growth.

Bashan concluded, “Our ongoing dedication to driving growth and expanding opportunities enhances our ability to develop therapies that meaningfully improve patient lives. We are excited about our future direction, centered on innovative solutions that address the unique challenges faced by patients with rare diseases.”

Conference Call and Webcast

Following the financial report, the company is set to host a conference call to discuss its results in further detail. Interested participants can dial in or access the live webcast through Protalix's official website, anticipating an in-depth discussion on both financial outcomes and strategic initiatives moving forward.

In summary, Protalix BioTherapeutics is poised for a transformative year in 2026, backed by its robust pipeline and adaptive business strategy aimed at addressing pressing healthcare challenges in rare diseases.