Protalix Biotherapeutics Third Quarter 2026 Financial and Business Results Conference Call - PROTALIX BIOTHERAPEUTICS INC

Explicit Guidance:

• No specific numerical financial guidance provided for FY2026 full-year or FY2027 revenue, earnings, margins, or cash flow; CEO confirmed "no guidance" currently but intends to reiterate FY2027 guidance following the publication of FY2026 annual results.
• 2026 Outlook: CEO stated an expectation for "a good 2026 overall" and "a good 2020" (transcript error for 2026), driven by continued progress in revenue and financial position.
• FY2027 Guidance Timeline: Management confirmed intent to provide FY2027 guidance once FY2026 annual results are published.
• PRX-115 Clinical Timeline: Expected top-line results from the Phase II "REDIS" study in the second half of 2027 (implied by "second half of next year" relative to the Q3 2026 call date).
• PRX-119 Decision: Management expects to decide on entering clinical trials for the PRX-119 program in the current quarter (Q4 2026).

Business-Segment Outlook:

• El Fabrio (Fabry Disease):
  • Revenue growth expected to continue driven by increased sales to Kiersey (Chiesi) and the impact of the new 4-week dosing regimen approved in March 2026.
  • 4-Week Dosing Adoption: Anticipated to capture a "significant portion" of the patient population in Europe; expected to drive accelerated patient enrollment and geographic expansion, though no specific penetration percentage is forecasted.
  • Sales Trajectory: Management does not view current Q3 2026 revenue levels as a plateau; a "positive momentum" is expected to continue, effectively setting a new baseline.
• PRX-115 (Uncontrolled Gout):
  • Targeted as a "blockbuster Eureka's market opportunity" and potential "best-in-class" therapy due to reduced immunogenicity and prolonged half-life.
  • Dosing Strategy: Phase II study will test fixed doses at intervals including 6, 13, 16, 18, and 24 weeks; if successful, a dosing frequency of "once every six weeks" is envisioned as a commercial alternative.
  • Commercial Foundation: Reliance on the "Alfabra" (El Fabrio) business to fund the advancement of the PRX-115 pipeline.
• Rare Renal Diseases Pipeline: Building a pipeline focused on rare renal diseases, leveraging the commercial business and balance sheet to "limit downside risk while preserving significant upside potential."
• PRX-119: Decision on clinical initiation to be made in Q4 2026; currently delayed.

Market and Competitive Outlook:

• Global Fabry Market: Projected to reach approximately $3.2 billion by 2031; Protallax believes its partnership with Kiersey positions the company to capture a "significant portion" of this growth.
• Competitive Positioning: PRX-115 aims to displace existing uricase drugs by offering superior convenience (less frequent dosing) and stable plasma levels measurable up to 85 days.
• Margin Sustainability: Q3 2026 gross margins (driven by higher El Fabrio sales to Kiersey) are expected to serve as a new baseline; El Fabrio specifically has a higher gross margin than El Aliso.
• Backlog/Pipeline: TheREDIS study is "actively enrolling" with plans to finalize enrollment by the next quarter (Q4 2026).

Macro / Industry Outlook:

• FX/Tariffs: No specific macroeconomic outlook provided; however, financial income net included exchange restructuring impacts, and GILTI taxes were a notable expense driver.
• Regulatory: Approval for the 4-week dosing regimen for El Fabrio was received in March 2026; the company is eligible for and intends to file for grants under the L&D law.
• Interest Rates: Financial income saw an increase due to "higher interest income," reflecting a cash-rich environment ($48.5M cash/deposits).

Strategic Initiatives:

• Partnership Leverage: Continuing to execute the partnership with Kiersey (Chiesi) to expand global reach, specifically in Europe, for El Fabrio.
• Capital Allocation: Maintaining a balance sheet with no debt or warrants ($48.5M cash) to support pipeline advancement without financial constraint.
• Clinical Advancement: Advancing the Phase II REDIS study for PRX-115 and evaluating the PRX-119 asset for clinical entry.

Risks and Headwinds to Outlook:

• Clinical Failure: Outcome of Phase II REDIS study (efficacy, safety, immunogenicity) is binary; failure to meet active arm outcomes would negate the "best-in-class" positioning.
• Manufacturing Issues: Previous revenue fluctuations were partially caused by manufacturing issues with Pfizer; while improved, supply chain consistency remains a factor.
• Unintended Guidance Implications: Management explicitly avoided providing new numerical guidance, citing the risk of "unknown and unknown risks and uncertainties."
• Grant Dependency: The R&D expense reduction included a $1M grant; continued eligibility for such grants under the L&D law is not guaranteed.

Management Tone on the Future:

• Confidence Level: Highly confident in the "foundation" business (El Fabrio) and the "significant upside" of the PRX-115 pipeline.
• Language: Used descriptors such as "position of strength," "continued progress," "encouraging" Phase I data, and "positive momentum."
• Hedges: Strictly avoided numerical projections for 2027, deferring all specific financial targets to the annual report and FY2027 guidance release.

Miscellaneous:

• Financial Health: Ended Q3 2026 with $48.5 million in cash and deposits, up from $40.7 million in Q2 2026.
• Next Events: Full year 2026 and future 2027 outlook to be discussed in mid-March 2027.