This article first appeared on GuruFocus .
Release Date: March 18, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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The European Commission approved a new dosing regimen for EFrio, enhancing treatment options for Fabry disease patients in the EU.
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Protalix BioTherapeutics Inc ( PLX ) received a EUR25 million milestone payment following the EU approval, boosting their financial position.
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Projected cash balance of approximately $50 million by early April 2026, providing strong financial flexibility.
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Expected revenue growth of over 50% in 2026, driven by increased patient numbers and milestone payments.
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Advancement of PRX 115 in the pipeline, with phase 2 trials underway, indicating strong momentum in R&D.
Negative Points
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Net loss of $6.6 million recorded for 2025, compared to a net income of $2.9 million in 2024, reflecting increased R&D investments.
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R&D expenses increased by 51% year over year, indicating higher costs associated with advancing the clinical pipeline.
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Cost of goods sold increased to $27 million, driven by higher sales volume and manufacturing issues at Pfizer.
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Revenue from licensed and R&D services remains minimal, indicating limited diversification in revenue streams.
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Uncertainty around the timing of US approval for the new dosing regimen, which could impact future sales growth.
Q & A Highlights
Q: Can you provide insight into additional marketing and promotional initiatives for Elfario in the U.S. and the impact of the recent approval of the less frequent dosing regimen in Europe? Also, any updates on the potential approval of this regimen in the U.S.? A: (Unidentified_4) In terms of marketing, there are various promotions, including symposiums and patient promotions in the U.S. The 1 to 4 weeks regimen approval in Europe is significant, reducing patient burden and offering a competitive edge. Approval in the U.S. is expected to be accelerated by the European approval, but it's too early to confirm the timing.
Q: How might PRX 115 be positioned in the gout market if approved, and what are its competitive advantages? A: (Unidentified_3) PRX 115 is designed with multiple dosing options, potentially offering significant differentiation in dosing frequency and safety. The gout market is expected to grow, and if PRX 115 proves to be a differentiated asset, it could capture a significant market share.
Q: Could you elaborate on the target conditions for PRX 119 and the commercial opportunities they might provide? A: (Unidentified_3) We are targeting high unmet need renal indications with PRX 119. Specific details will be shared by the end of Q2 after additional experiments. The mechanism of action is crucial, and we believe it could be very beneficial for patients.
Q: What is the estimated timeline for the rollout of the 4-week dosing regimen for Elfario in Europe, and will there be a physician education effort? A: (Unidentified_3) The rollout will vary by country in Europe, with some markets seeing availability soon and others taking a few months. A physician education effort is in place to ensure all relevant stakeholders are informed.
Q: What are the financial expectations for 2026, and how does the revenue mix look? A: (Unidentified_4) Total revenue for 2026 is expected to range from $78 million to $83 million, including a $25 million milestone from KSI. Revenues from KSI are projected to grow by more than 50%, and the revenue mix is expected to shift towards high-margin contributions from KSI.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
