Protalix signals $100M+ Elfabrio royalties by 2030 as Phase II PRX-115 trial advances

Earnings Call Insights: Protalix BioTherapeutics (PLX) Q2 2025

MANAGEMENT VIEW

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Dror Bashan, President and CEO, reported a 50% increase in revenues from selling goods for the first half of 2025 compared to the same period last year, primarily driven by Elfabrio sales to Chiesi. He described Chiesi as an “ideally suited partner for the commercialization of Elfabrio for Fabry disease,” highlighting the estimated $2.3 billion market in 2025 and a forecast of $3.2 billion by 2030. Bashan emphasized, “we continue to anticipate Elfabrio royalties exceeding $100 million by 2030 based on the projected 15% to 20% market share of the estimated $3.2 billion Fabry total market.”

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Bashan indicated that the Phase II study for the gout candidate PRX-115 is targeted to start in the second half of 2025, with first patient enrollment anticipated in the fourth quarter. He noted, “the encouraging results from the study suggest a long-acting effect and the potential of widening the dose interval, which would enhance patients' compliance and treatment flexibility.”

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Bashan also announced CFO succession, stating, “Eyal is stepping down as our Chief Financial Officer after 6 years of dedicated service... Eyal is to be succeeded by Gilad Mamlok.”

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Eyal Rubin, outgoing CFO, stated, “We recorded revenues from selling goods of $15.4 million during the 3 months ended June 30, 2025, an increase of $2.1 million or 16% compared to revenues of $13.3 million for the 3 months ended June 30, 2024.” He called out an $8 million increase in sales to Chiesi and addressed a decrease in sales to Brazil and Pfizer. Rubin noted, “Cost of goods sold was $5.9 million... a decrease of $3.6 million or 38%.” He further highlighted a rise in R&D expenses “primarily from preparations for the planned Phase II clinical trial of PRX-115.” Rubin confirmed the company closed the quarter with $33.4 million in cash and equivalents and reported net income of approximately $164,000 for the quarter.

OUTLOOK

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Management reiterated the expectation that Elfabrio royalties will exceed $100 million by 2030, based on a projected 15% to 20% market share of the Fabry disease market.

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Bashan said the company is “focused on building on the momentum and continue to progress towards initiation of a Phase II study in the second half of 2025 and enrollment of the first patient in the fourth quarter” for PRX-115.

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On the EMA label variation for Elfabrio, Bashan stated, “This variation submission is still under review by the EMA.”

FINANCIAL RESULTS

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Protalix reported $15.4 million in revenues from selling goods for the quarter ended June 30, 2025. Cost of goods sold was $5.9 million. Revenues from license and R&D services were $0.2 million.

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Research and development expenses totaled approximately $6 million, up from $3 million in Q2 2024, reflecting increased investment in clinical development, especially for PRX-115.

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Selling, general and administrative expenses were $2.6 million, down from $3.5 million in the prior-year quarter.

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Net income for the quarter was approximately $164,000 or $0 per share basic and diluted, compared to a net loss of approximately $2.2 million or $0.03 per share in Q2 2024.

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Cash and cash equivalents plus short-term bank deposits were $33.4 million at quarter-end.

Q&A

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John D. Vandermosten, Zacks Small-Cap Research, asked about Chiesi’s PEGASO study for Elfabrio. Dror Bashan responded it is “part of their Phase IV program in order to enhance... the merits and strengths of the program.”

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Vandermosten asked about PRX-115 Phase II trial sites. Bashan replied, “We plan a couple of dozens of sites... most of the sites supposed to be in the U.S., I would say, between 20 to 30 sites overall. And a couple of sites will be outside the U.S.”

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Daniel Robert Smith, H.C. Wainwright, asked about Chiesi’s Fabry market share and expansion strategies. Bashan said, “We do not disclose number of patients and/or market share... Chiesi does well on the marketplace, actually better than we expect. We continue to see growth of patient acquisition and actually a significant growth.”

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Smith inquired about leveraging new CFO Gilad Mamlok’s business development experience. Bashan explained, “Protalix right now is not planning, as far as I know, any mergers and acquisitions. We are focusing on growing our pipeline right now.”

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A private investor asked about the remaining value of the Chiesi contract. Rubin stated, “the sales to Chiesi are going to exceed $100 million by 2030... we believe that Protalix can be entitled up to $0.5 billion in milestones, both commercial and regulatory... but again, it’s far out... it all depends on the market and the penetration.”

SENTIMENT ANALYSIS

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Analysts expressed interest in clinical strategy, market penetration, and the Chiesi partnership, with a generally positive and supportive tone, including well-wishes to the outgoing CFO and constructive questions on trial plans and revenue streams.

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Management maintained a confident and measured tone, emphasizing partnership stability, growth in revenue, and the potential of the pipeline. Bashan reiterated confidence in the partnership with Chiesi and future growth prospects.

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Compared to the previous quarter, the analyst tone remained positive and inquisitive, while management maintained a stable, forward-looking, and consistently confident outlook, especially regarding commercial partnerships and clinical advancement.

QUARTER-OVER-QUARTER COMPARISON

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There was a notable increase in revenues from selling goods compared to the previous quarter, with a shift in sales mix: Q1 was driven by Pfizer and Brazil, while Q2 growth was attributed to Chiesi.

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Research and development expenses doubled quarter-over-quarter, reflecting increased clinical trial preparation for PRX-115.

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Net income improved from a net loss in Q1 to a small net profit in Q2.

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Guidance language around Elfabrio royalties and market share was reiterated, with a continued focus on internal pipeline growth and no new M&A activity planned.

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Analyst focus continued to center on commercialization strategy, market share, and clinical development timelines for pipeline assets.

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Management’s confidence was consistent, with the added announcement of CFO succession planning.

RISKS AND CONCERNS

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Management reiterated the unpredictability of Chiesi’s ordering patterns in the early launch phase, cautioning that “there may be quarters with no bulk orders are made due to inventory destocking.”

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There is continued reliance on Chiesi’s commercialization efforts and market penetration for Elfabrio.

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Increased R&D expenses are expected as clinical trials for PRX-115 and other pipeline assets advance.

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Management noted ongoing evaluation of U.S. tax reform impacts on financial statements.

FINAL TAKEAWAY

Protalix BioTherapeutics reported strong revenue growth in Q2 2025, primarily driven by Chiesi’s commercialization of Elfabrio, and anticipates royalties from this partnership exceeding $100 million by 2030. The company continues to advance its pipeline with a Phase II trial for PRX-115 set to begin later this year, while maintaining a healthy cash position and completing a CFO transition. Management remains focused on internal growth and responsible pipeline development, signaling confidence in both its commercial partnership model and its strategic direction moving forward.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/plx/earnings/transcripts]

MORE ON PROTALIX BIOTHERAPEUTICS

* Protalix BioTherapeutics, Inc. (PLX) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4813722-protalix-biotherapeutics-inc-plx-q2-2025-earnings-call-transcript]
* Protalix BioTherapeutics appoints Gilad Mamlok as CFO [https://seekingalpha.com/news/4469170-protalix-biotherapeutics-appoints-gilad-mamlok-as-cfo]
* Seeking Alpha’s Quant Rating on Protalix BioTherapeutics [https://seekingalpha.com/symbol/PLX/ratings/quant-ratings]
* Historical earnings data for Protalix BioTherapeutics [https://seekingalpha.com/symbol/PLX/earnings]
* Financial information for Protalix BioTherapeutics [https://seekingalpha.com/symbol/PLX/income-statement]