KOL Investor Event - SOL-GEL TECHNOLOGIES LTD

Explicit Guidance:

• Timeline to Approval & Launch: Top-line Phase 3 data expected "next month"; New Drug Application (NDA) submission targeted for April; Approval expected in Q2 (approx. 6 months post-NDA due to orphan/breakthrough designations); Commercial launch in the US scheduled for the "beginning of 2028."
• Revenue Targets: Projected peak sales penetration of 65% (approx. 4,000 patients) in the US alone; First revenue milestone is a "billion dollars" driven by the initial ~3,000–4,000 patient base.
• Pricing Strategy: US pricing anticipated to be comparable to high-value topicals, priced at "half of that" (referring to existing expensive topicals), with a high contribution margin supporting profitability with a relatively small patient base.
• Intellectual Property: Patent protection expected to remain effective until 2045 ("iron wall").

Business-Segment Outlook:

• Product Portfolio: SGT 610 (Patidigib) is the primary near-term asset; expansion into new indications is a core strategic pillar, including:
  • Geographic Expansion: Broadening from face to "whole body" application (neck, scalp, arms, legs).
  • Patient Cohorts: Phased introduction to pediatric patients (starting with those near normal height to monitor growth effects) and expansion to "high-frequency BCC" patients without Gorlin syndrome.
  • Adjunctive Uses: Investigating neoadjuvant therapy to downsize large BCCs prior to surgery (currently in early study); potential application for Odontogenic Keratocysts (OKCs) via impregnated gauze to reduce recurrence.
• Commercialization Model: Independent US commercial launch utilizing a lean team of ~20 FTEs/sales reps targeting ~200 centers of excellence; European and global expansion planned via licensing/partnerships to manage pricing complexities and avoid US price erosion.

Market and Competitive Outlook:

• Demand Trends: Anticipates a rapid uptake due to the unmet need for a safe, effective preventive treatment; physician education is simplified as hedgehog inhibitor efficacy is already established, with the new value proposition being safety/tolerability.
• Market Sizing: US TAM estimated at 600,000 eligible patients (after exclusions); global market is larger but deferred from financial modeling until pricing structures are resolved.
• Competitive Landscape: Differentiation via lack of systemic side effects (no hair loss, muscle cramps, taste changes) compared to oral hedgehog inhibitors (Vismodegib/Avodex); potential to displace oral agents for patients with moderate burdens.
• Adoption Velocity: Expected to be "very high, very fast" due to high patient desire and physician recognition of the drug's mechanism; projected to treat "every BCC" over time.

Macro / Industry Outlook:

• Regulatory Pathway: FDA engagement has been constructive; the study design (enriched population, 6+ BCCs) was developed to align with FDA recommendations for identifying sensitive patient populations.
• Reimbursement & Coding: Proactive application for a specific ICD-10 code for Gorlin syndrome (currently under a broader code) to facilitate market access and awareness.
• Global Pricing Constraints: International launches constrained by price controls; strategy involves ensuring international pricing does not negatively impact US pricing power.

Strategic Initiatives:

• Study Enhancements: Completed changes to Phase 3 to improve power: mandatory dermoscopy, central photography review board, reduced visit frequency (6 visits), and mandatory PTCH1 mutation screening.
• Awareness & Infrastructure: Launching awareness campaigns via social media and collaboration with the Gorlin Syndrome Alliance (GSA) to establish "regional centers of excellence" and integrate patient support (testing, education).
• Capacity: Preparing independent commercial infrastructure in the US; planning for future capacity to manage a larger patient base as indications expand.

Risks and Headwinds to Outlook:

• Clinical Execution: Placebo response variability in mild disease; reliance on post-hoc analyses for efficacy signals; need to maintain high adherence (projected 80%) over a chronic treatment course.
• Regulatory Uncertainty: FDA final approval date is contingent on NDA review; labeling restrictions may initially limit the patient population despite physician intent to treat early/low-burden patients.
• Commercial Risks: Potential price control issues in Europe limiting profitability; risk of patient drop-out if disease progression is perceived as "stable" or if adherence becomes difficult.
• Scientific Caveats: Current data excludes pediatric use (due to growth monitoring needs) and patients with SUFU mutations (potentially resistant); efficacy in non-Gorlin high-frequency BCCs requires further validation.

Management Tone on the Future:

• Confidence: High confidence in the drug's success, describing the data as "compelling" and the commercial potential as a "billion-dollar" product.
• Sentiment: Enthusiastic and urgent; management views the drug as "life-changing" and "revolutionary," emphasizing the "desperate need" in the patient community.
• Strategic Outlook: Believes the independent launch model is optimal due to the niche target audience and high contribution margins; expresses a long-term vision of "no more tumors, no more surgeries" as the drug's ultimate goal.

Miscellaneous:

• Key Metrics: 10% dropout rate in the study (vs. higher historical rates); 102 patients completed the trial (vs. 58 minimum required for 90% power).
• Patient Burden: Current standard of care involves ~25 days lost per year to treatments; goal is to reduce surgical burden by 30% (clinically meaningful) to 50% (post-hoc data).