STIFEL 2026 HEALTHCARE CONFERENCE - PROTALIX BIOTHERAPEUTICS INC

Explicit Guidance:

• FY2026 total revenue guidance of $78 million to $83 million, expected to be met or exceeded.
• FY2026 revenue from Chiesi partnership specifically projected at $33 million to $35 million, representing a 50% year-over-year increase.
• Q4 2024 revenue recognition anticipated to be $22 million to $25 million.
• Current cash and deposits position of $48.5 million, sufficient to finance Phase II enrollment and operations.
• FY2027 revenue guidance to be announced later, with management expressing confidence in continued growth.

Business-Segment Outlook:

• Elelysys (Gaucher Disease): Brazilian operations expected to grow slowly but significantly; market share with partner Chiesi in Brazil anticipated to reach 15% to 25% within the next 1–2 years.
• Elfabri (Fabry Disease): Continued growth in EU and US markets driven by the Q1 2024 "once-in-four-weeks" approval; management anticipates years of continued growth and enhanced market penetration in new markets.
• PRX115 (Gout Program): Targeting a specific uncontrolled gout population of ~180,000 patients in the US (out of 11 million total); current Phase II enrollment at two-thirds, with final enrollment targeted for Q1 2025.
• Rare Renal Programs: Pipeline expansion expected to yield 4–6 programs between discovery and Phase I within two years; no license-ready Phase II assets targeted due to limited commercial infrastructure.
• Chiesi Relationship: Strong collaboration with Chiesi, a profitable private entity, driving royalty and milestone income; potential regulatory and commercial milestones anticipated in the future.

Market and Competitive Outlook:

• Gout Market: Current approved therapy (Cristexa by Amgen) estimated at $1.6 billion; management projects the uncontrolled gout market to reach $2+ billion by 2031 if PRX115 succeeds.
• Differentiation Strategy: PRX115 aims to improve upon current standard of care (Cristexa's bi-weekly dosing) via potential infusion frequencies of once every 4, 6, or 8 weeks, potentially reducing patient visits from ~20-22 times/year to significantly fewer.
• Competitive Landscape: Competitors noted include Fabrazyme, Replagal, and BioMarin's GalaFold technology; PRX115 aims to differentiate through reduced dosing frequency and improved safety/immunogenicity profile.
• Brazil Market: New approval of both every-2-week and every-4-week regimens simultaneously expected to boost market adoption.

Macro / Industry Outlook:

• Regulatory Environment: Successful "once-in-four-weeks" approvals in the EU (March 2024) and US serve as key regulatory milestones; management expects continued approvals in new markets (e.g., Brazil) to support global expansion.
• Economic Context: Management views the current financial position as "much more solid" than prior periods, citing successful Q1-Q3 execution and strong cash reserves, enabling strategic planning for the next few years.

Strategic Initiatives:

• PRX115 Development: Completion of Phase II enrollment by Q1 2025 followed by a 6-month study protocol; top-line data readout expected one year from today (approx. Q1 2026).
• Phase III Planning: Intent to initiate a single pivotal Phase III study with the FDA following successful Phase II readout.
• Commercialization Strategy: By 2031, PRX115 commercialization may be executed internally (self-commercialized) to maximize upside, or via third-party partnerships/licensing (like Chiesi); market research with potential third parties is ongoing.
• Pipeline Expansion: Continued investment in the "Rare Renal" basket; focus on moving 4–6 programs from discovery to Phase I within 24 months.
• Platform Utilization: Leverage unique plant-expressed protein platform for new indications; potential for future collaboration or licensing deals.

Risks and Headwinds to Outlook:

• Revenue Fluctuation: Chiesi revenue recognition is not a 1:1 correlation with partner sales due to inventory management dynamics (batch ordering); quarterly fluctuations possible.
• Clinical Success: PRX115 Phase II success is not guaranteed; failure to hit endpoints in the 4 active arms would significantly impact the "major upside" thesis.
• Immunogenicity/Safety: Uncertainty remains regarding multiple-dose safety and immunogenicity profiles; a single anaphylactic event in Phase I (unrelated to enzyme) highlights the need for robust safety data in Phase II.
• Market Adoption: Success depends on demonstrating superior immunogenicity and safety profiles compared to existing therapies to gain physician/patient preference.
• Infrastructure: Lack of existing commercial infrastructure limits ability to license ready-to-Phase II assets.

Management Tone on the Future:

• Confidence Level: High confidence in 2026 execution and "professional joy" regarding current financial results; described as a "much more solid position."
• Optimism: Expresses strong optimism regarding the PRX115 program ("potential big upside," "home run") and the continued growth of the Chiesi partnership.
• Hedges: Notes that "we cannot foresee the future" regarding commercialization specifics (internal vs. external) and acknowledges that specific dosing arms (4, 6, or 8 weeks) depend on Phase II results.
• Stability: Emphasizes the stability and profitability of partner Chiesi and the success of the Elfabri launch as foundational to the business outlook.

Miscellaneous:

• Technology: Proprietary platform allows expression of complex human proteins via plants in suspension; unique competitive advantage cited.
• Financials: Achieved accumulated revenue of $75.6 million in recent periods; positioned to exceed guidance based on final batch releases.
• Key Catalysts: Q1 2025 Phase II enrollment completion and the subsequent readout are identified as the primary near-term catalysts.