Protalix plans Phase 2 for PRX-115 in H2 2025, projects higher royalty revenues by 2030

 

Management View

• CEO Dror Bashan highlighted the company's record revenue performance for 2024, driven by increased sales to key partners and the completion of all cohorts in the first-in-human Phase 1 trial of PRX-115, a recombinant PEGylated uricase candidate for uncontrolled gout. The Phase 2 trial for PRX-115 is planned for the second half of 2025, with ongoing dialogues with regulatory authorities.
• Protalix's partner, Chiesi Global Rare Diseases, submitted a variation application to the EMA for a less frequent dosing regimen of Pegunigalsidase alfa for Fabry disease. The company anticipates continued growth in royalty revenues from Chiesi, projecting revenues north of $100 million by 2030.
• CFO Eyal Rubin reported total revenues from selling goods reached $53 million for 2024, driven by a significant increase in sales to Chiesi. Revenues from license and R&D services decreased due to the completion of the Fabry clinical program and related regulatory processes.

Outlook

• Management confirmed that the Phase 2 clinical trial for PRX-115 is expected to commence in the second half of 2025, with a projected cost exceeding $20 million for third-party expenses. Results are anticipated approximately two years after the trial begins.
• Protalix is focusing on advancing its early-stage pipeline, particularly in renal rare diseases, leveraging its ProCellEx platform and pegylation expertise.

Financial Results

• The company reported a 31% increase in revenues from selling goods to $53 million for 2024, primarily due to higher sales to Chiesi and modest increases in sales to Brazil and Pfizer. Revenues from license and R&D services dropped to $0.4 million, reflecting the completion of regulatory milestones.
• Cost of goods sold increased by 6% to $24.3 million, aligning with the rise in sales. Research and development expenses fell by 24% to $13 million, attributed to the completion of the Fabry clinical program. Selling, general, and administrative expenses decreased by 19% to $12.2 million.
• Protalix reported net income of $2.9 million for 2024, compared to $8.3 million in 2023. Cash, cash equivalents, and short-term deposits totaled $34.8 million as of December 31, 2024.

Q&A

• Ram Selvaraju, H.C. Wainwright: Asked about revenue guidance based on royalties from Elfabrio. CEO Dror Bashan responded that while Chiesi's weekly patient additions indicate strong performance, Protalix cannot disclose specific revenue figures due to Chiesi's private company status. He reiterated the projection of over $100 million in revenues by 2030 from Chiesi.
• John Vandermosten, Zacks SCR: Inquired about the mechanism of PRX-115 and its impact on urate crystals. CEO Bashan explained that PRX-115 employs a pegylated uricase enzyme to effectively lower uric acid levels over extended periods, with further studies required to confirm its impact on refractory gout.

Sentiment Analysis

• Analysts expressed optimism regarding the company's progress, particularly with PRX-115 and its potential in the gout market. However, there were concerns about lack of revenue guidance and specifics on Elfabrio performance.
• Management conveyed confidence in their strategic direction, emphasizing the robustness of their balance sheet and the promising prospects for their pipeline. During Q&A, they occasionally exhibited defensiveness when pressed for specific financial or operational details, particularly regarding Chiesi's performance.

Quarter-over-Quarter Comparison

• Revenues from selling goods increased from Q3 to Q4, indicating strong demand. However, revenues from license and R&D services remained minimal, consistent with the prior quarter's report on the completion of Fabry-related regulatory milestones.
• Management's tone remained consistent, with continued emphasis on pipeline development and strategic partnerships. Analysts' focus shifted slightly toward understanding PRX-115’s market potential and Protalix's financial outlook.

Risks and Concerns

• Management acknowledged the reliance on Chiesi for Elfabrio commercialization and royalties, with uncertainties around patient uptake trends and inventory sales dynamics.
• Development timelines for PRX-115 and PRX-119 were highlighted as critical, with potential delays or high costs impacting future performance.
• Analysts raised concerns over the competitive landscape for refractory gout and Protalix’s ability to secure partnerships for late-stage pipeline assets.

Final Takeaway

Protalix BioTherapeutics reported strong financial performance for 2024, supported by expanding partnerships and pipeline advancements. The launch of a Phase 2 trial for PRX-115 in 2025 and projected growth in Elfabrio royalties signal long-term growth potential. However, reliance on key partners and competitive pressures in targeted markets remain critical areas to watch.

Read the full Earnings Call Transcript

https://www.msn.com/en-us/money/companies/protalix-plans-phase-2-for-prx-115-in-h2-2025-projects-higher-royalty-revenues-by-2030/ar-AA1B5spj?ocid=finance-verthp-feeds