STIFEL 2026 HEALTHCARE CONFERENCE - CELCUITY INC

Financial Performance:

• No specific Q1/Q2 revenue figures, net income, or cash flow metrics disclosed; focus remains on qualitative launch progress and market potential.
• Total addressable market (TAM) for Revertropic (Regetta) in the second-line breast cancer setting estimated at approximately $9 billion.
• Reimbursement status: >90% of patients covered by insurance policies due to successful prior pre-launch work securing NCCN Level 1 recommendations.
• Supply chain costs managed via a direct-to-infusion-center drop-ship model, bypassing specialty pharmacies to ensure just-in-time inventory.

Guidance and Future Outlook:

• Revertropic launch trajectory projected to peak in approximately 36 months (30–42 months range) based on analogs for first-time oncology drug launches.
• Second New Drug Application (SND-A) for PIK3CA-mutated breast cancer expected to receive a PDUFA decision by the end of Q2 (late June).
• Phase 3 trials in first-line breast cancer populations (two distinct subgroups) initiated; high probability of success expected given favorable preliminary data.
• Second manufacturing site (redundancy/capacity) expected online in mid-2027; European third manufacturer in process for EU supply.
• Prostate cancer Phase 2 study completion anticipated in 2027 to determine final dose (likely 240 mg) and population for registrational studies.

Business Segments and Product Lines:

• Revertropic (PIK3CA inhibitor): Launched for PIK3CA wild-type, second-line breast cancer; positive Phase 3 data reported.
• New Indications: Launching in second-line setting; evaluating first-line treatment for ~90,000 potential patients.
• Oncology Pipeline:
  • Breast Cancer: Positive Phase 3 data for PIK3CA wild-type (approved/launched); positive Phase 3 data for PIK3CA-mutated (SND-A submitted, PDUFA end of Q2).
  • Prostate Cancer: Metastatic castration-resistant (mCRPC) Phase 2 data encouraging; dose-dependent PSA reduction observed at higher doses (up to 300 mg).
• Regimen Strategy: Market preference observed for triplet regimens (RevTropic + Palbo + Endocrine) over doublets, supported by superior efficacy data (21.5 months PFS vs. 11.5 months for doublet in liver-metastasis-negative patients).

Market and Competitive Landscape:

• Market Share/Adoption: Successfully secured order approvals from ~80% of the 36 key strategic accounts (representing >1,000 treatment sites and 50% of breast cancer patients).
• Competitive Positioning: Positioned as the "first best" alternative to "second best" existing therapies (e.g., NHER2, chemotherapy).
• Competition: Stacks up favorably against Lilly's Abemaciclib/Ibrutinib and Roche's Guidestar/Everolimus in the ESR1 mutant subset (2x likelihood of progression-free survival vs. Abemaciclib/Ibrutinib doublet).
• Market Fragmentation: Second-line landscape is fragmented; Revertropic aims to capture patients currently on endocrine therapy, chemotherapy, or ADCs by offering a superior endocrine-based backbone.
• Testing Rates: ESR1 mutation detection remains ~40% in clinical trials; CEO dismisses speculation that real-world rates (with cfDNA testing) would significantly exceed this.

Risks and Challenges:

• Supply Chain: Unique direct drop-ship model limits data granularity; revenue tracking relies on vial counts and site orders rather than pharmacy claims data.
• Reimbursement Gatekeepers: Dependence on formulary inclusion and order set build-outs at large health systems; potential delays in insurance policy updates.
• Regulatory Uncertainty: FDA may delay priority review or limit label approval to the triplet only due to "complex review" status associated with the non-alpha allocated doublet analysis.
• Operational Friction: J-code availability (temporary code until April 1) may delay some site participation; infusion centers prefer just-in-time ordering, potentially limiting bulk stocking.
• Clinical Trial Complexity: Small sample sizes in doublet subgroups (1/3 size of triplet) introduce variance in interpreting efficacy differentials.

Management Commentary and Tone:

• Tone: Highly confident and optimistic; CEO describes the past 18 months as "transformative" and the launch as off to a "good start."
• Strategic Focus: Emphasis on securing "gates" (insurance, formulary, KOL engagement) prior to launch to ensure rapid uptake.
• Data Interpretation: Management strongly advocates for the triplet regimen, citing significant differentiation in PFS and OS trends over the doublet, despite statistical nuances.
• Market Vision: CEO projects Revertropic could become a multibillion-dollar drug with a high probability of reaching approval for first-line indications.

Analyst Questions and Answers:

• Launch Metrics: Management confirmed 80% of strategic accounts ordered, >90% reimbursement coverage, and strong KOL engagement.
• Order Patterns: No fixed stocking pattern; centers order based on immediate needs (1–3 vials), leveraging just-in-time logistics to avoid inventory holding.
• Utilization Data: Field force reports bulk of volume comes from progressive disease patients (not salvage switching), with a preference for second-line use and triplet regimens.
• Label Strategy: Management assumed regular review for SND-A due to complexity; manuscript supporting NCCN inclusion expected this quarter.
• Prostate Dosing: 240 mg identified as likely dose for future studies due to favorable safety profile (less stomatitis) compared to women and 180 mg in men.
• Market Size: Reiterates $9B TAM for second-line breast cancer, emphasizing the potential for a massive first-line opportunity (60,000 patients, 48-month PFS vs. 25-month historical standard).

Other Key Points:

• Supply Chain Redundancy: Current supplier covers demand through 2027; second supplier planned for 2028 capacity needs; European third manufacturer in development.
• Data Presentation: Meta-analysis at ESMO demonstrated Revertropic triplet offers 2x progression-free survival advantage over competitor doublets in ESR1 mutant patients.
• First-Line Potential: Preliminary 48-month median PFS in first-line patients vs. 25-month historical standard suggests profound clinical impact if trials succeed.
• Regulatory Nuance: FDA caution on approving the doublet indication due to lack of prespecified alpha; approval of the triplet is considered straightforward.
• KOL Strategy: Heavy reliance on peer-to-peer programs with regional/national KOLs to validate data and drive physician adoption.