Protalix Biotherapeutics' Earnings Call Highlights Shifting EU Dosing Timelines and PRX-115 Trial Delays

Date of Call: Mar 18, 2026

Financials Results

• Revenue: $51.8 million, a modest decrease compared to 2024

Guidance:

• Total revenue for 2026 expected to range from approximately $78 million to $83 million, including a $25 million regulatory milestone payment.
• Revenues from Chiesi projected at approximately $33 million to $35 million, representing growth of more than 50%.
• Revenues from Elelyso expected to be approximately $20 million to $23 million.

Business Commentary:

Revenue Growth and Milestone Payments:

• Protalix BioTherapeutics reported total revenues of $51.8 million for 2025, with a projected range of $78 million-$83 million for 2026, including a $25 million regulatory milestone payment from Chiesi.
• The growth is driven by the recent European Commission approval of a new dosing regimen for Elfabrio and increased sales to Pfizer due to manufacturing issues.

Fabry Disease Treatment and Market Positioning:

• The approval of the 2 mg/kg every 4 weeks dosing regimen for Elfabrio in the EU strengthens its competitive positioning and is expected to enhance long-term management for patients.
• This development is attributed to Chiesi's dedicated efforts and professional execution, along with the therapeutic's differentiated profile and strong commercial execution.

Pipeline Advancements and Clinical Trials:

• Protalix is advancing its pipeline with PRX-115, with the phase two trial (RELEASE study) now enrolling patients, anticipating top-line results in the second half of 2027.
• The momentum in the pipeline is due to the high unmet need in indications like uncontrolled gout, with PRX-115 potentially becoming a best-in-class therapy.

Financial Position and Strategic Flexibility:

• The company projects a cash balance of approximately $50 million by early April 2026, following the milestone payment, enabling comfortable execution of its strategy.
• This strong financial position is supported by a growing commercial foundation with partners and a focus on advancing clinical trials.

R&D Investment and Revenue Mix:

• Research and Development expenses increased by 51% year-over-year to $19.6 million, primarily due to spending on the PRX-115 RELEASE study.
• The revenue mix is expected to shift towards higher-margin contributions from Chiesi, solidifying the company's margin profile and positioning for future growth.

Sentiment Analysis:

Overall Tone: Positive

• Management stated: 'We enter 2026 with strong business flexibility... projected cash position of approximately $50 million... we are looking forward to a productive 2026.' and 'I’m happy to update you within about... two months on the outcomes of the first quarter of this year.'

Q&A:

• Question from Ram Selvaraju (H.C. Wainwright & Co.): Can you give insight into additional marketing and promotional initiatives Chiesi has planned for Elfabrio in the US, and how the recent European approval affects sales trajectory there? Also, any perspectives on timing for US approval?
  Response: Chiesi is conducting promotions, including patient ambassador programs, which are effective in increasing patient numbers. The European approval is a major competitive edge that will take time to implement across all EU countries due to regulatory logistics. It may accelerate US approval, but timing is too early to plan.

• Question from Ram Selvaraju (H.C. Wainwright & Co.): Regarding PRX-115 in gout, how might it be positioned, what competitive advantages are expected, and how could dosing frequency and safety translate commercially?
  Response: PRX-115 has a differentiated design with potential for less frequent dosing (once every 4, 6, or 8 weeks) and a favorable immunogenicity profile, which could make it best-in-class. The uncontrolled gout market is projected to be over $2 billion by the time of potential approval (2031-2032).

• Question from Ram Selvaraju (H.C. Wainwright & Co.): For PRX-119, which rare renal conditions are targeted, and do any of them involve pediatric populations that could make it eligible for a priority review voucher?
  Response: Specific indication and mechanism of action will be updated by end of Q2 2026 after additional experiments. It targets a high unmet need renal indication, but details on pediatric eligibility were not provided.

• Question from John Vandermosten (Zacks): What is the estimated timeline for rollout of Elfabrio 4-week dosing in the EU, and when will it be available to patients?
  Response: Availability will vary by country within the EU, with some markets getting it soon and others taking a few months. The effect is expected to start taking place in the second half of 2026, increasing in 2027.

• Question from John Vandermosten (Zacks): Is there a physician education effort planned to accompany the rollout of Elfabrio 4-week dosing in Europe?
  Response: Chiesi is professionally engaging with treating physicians and stakeholders across Europe to communicate the new regimen's approval.