SCYNEXIS INC (SCYX)·Q2 2022 Earnings Summary

Executive Summary

• Q2 2022 showed accelerating commercial traction: BREXAFEMME net product revenue rose to $1.30M, up 86% QoQ, with 5,141 prescriptions (+29% QoQ), and coverage expanded to 109M commercially insured lives (60%) .
• The FDA accepted the sNDA for prevention of recurrent VVC with Priority Review; PDUFA action date set for November 30, 2022—key near-term catalyst .
• Cash and cash equivalents were $118.7M, extending runway into Q1 2024; SG&A expected to remain flat while reallocations optimize ROI on DTC and sales initiatives .
• Hospital programs progressed: MARIO (invasive candidiasis) enrollment initiated; VANQUISH (post‑fluconazole VVC failures) commenced, with readouts targeted in 2024 .

What Went Well and What Went Wrong

What Went Well

• Commercial momentum: prescriptions grew 29% QoQ to 5,141; net product revenue nearly doubled to $1.30M; prescribers grew to >2,200 (+25% QoQ). “We enjoyed significant quarter-over-quarter growth of 29%… prescriptions… representing a solid 29% growth over the first quarter” .
• Market access: coverage expanded to 109M lives (60% of commercial), strengthening payer acceptance—“Payers continue to see the value of BREXAFEMME” .
• Regulatory catalyst: sNDA accepted for prevention of recurrent VVC with Priority Review; PDUFA 11/30/22—“FDA… assigned the… PDUFA target decision date… November 30, 2022” .

What Went Wrong

• Operating loss widened QoQ: net loss increased to $13.3M (from $5.5M in Q1), driven by higher R&D ($7.1M) and SG&A ($15.8M). “Net loss for Q2 2022 was $13.3 million… R&D… $7.1 million… SG&A… $15.8 million” .
• Reliance on non‑cash gains: total other income fell to $8.4M vs $9.6M in Q1 and $15.0M in Q2’21, reflecting lower fair value adjustments—a headwind to reported EPS variability .
• In R&D, Synergia (aspergillosis) enrollment slower than planned; company cautioned patient numbers may be smaller than anticipated—completion/analysis targeted by year‑end 2022 .

Financial Results

KPIs

Notes:

• Q2 QoQ revenue growth +86% and Rx growth +29% reflect improved execution and DTC initiatives (Oprah podcast/Hulu/YouTube) .
• Other income variability stems mainly from non‑cash fair value adjustments to warrant/derivative liabilities .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We… achieved… approval of the first new class of antifungals in over 20 years… and continue to progress toward expanding… labelling” — Dr. Marco Taglietti, CEO .
• “BREXAFEMME… increased its net product revenues from $700,000… to $1.3 million… Cash and cash equivalents… totaled $118.7 million… runway into the first quarter of 2024” — Larry Hoffman, Interim CFO .
• “If this second indication is approved, BREXAFEMME will be the first and only product approved… for both the treatment of VVC and the prevention of recurrent VVC” — Dr. David Angulo, CMO .
• “We will keep SG&A flat and… reallocate resources… to maximize… returns” — Dr. Marco Taglietti, CEO .
• “All these indications… would create a franchise with… $700–$800 million a year in net sales in the U.S. alone” — Dr. Marco Taglietti, CEO .

Q&A Highlights

• RVVC market opportunity and coverage: management expects broader label to re‑engage physicians with new data; coverage targeted ~65% by 2023 (already ~60%) .
• Copays and access: wide range of out‑of‑pocket ($5–$600) depending on plan; majority $30–$50; copay cards reduce to ~$30; prior auth/step‑edits manageable; SG&A expected flat as copay support sunsets with coverage .
• Liposomal IV formulation: Phase 1 completed with target exposure; planning FDA discussion for efficient Phase 2/3 path; rapid start anticipated post‑agreement .
• VANQUISH timeline: ~18 months enrollment; readout targeted 1H 2024 .
• Competitive dynamics: Mycovia label viewed as restrictive; SCYX anticipates broader RVVC label without similar limitations .

Estimates Context

• Wall Street consensus (S&P Global) for Q2 2022 revenue and EPS was not retrievable at this time due to data access limits; comparisons to consensus cannot be provided at this time. Values would be retrieved from S&P Global if available.*
• Implications: With 29% QoQ Rx growth and net product revenue reaching $1.30M, near‑term sales ramp assumptions may be reassessed by analysts as payer coverage and DTC activation scale .

Key Takeaways for Investors

• Near-term catalyst: RVVC label expansion decision (11/30/22 PDUFA) could materially expand addressable use and prescriber confidence, supporting continued Rx and revenue growth .
• Execution momentum: Prescriptions, prescriber base, and coverage all improved QoQ; DTC programs and focused field execution are driving adoption .
• Operating discipline: Management intends to keep SG&A flat while reallocating spend to highest-return channels, mitigating opex growth amid revenue build .
• Hospital pathway: MARIO, FURI, CARES data flow into 2024 may enable first hospital approval, anchoring broader franchise expansion .
• Competitive positioning: Potentially broader RVVC label vs a competitor’s restrictive profile positions BREXAFEMME favorably in prevention and treatment narratives .
• Balance sheet: $118.7M cash and Q1 2024 runway support commercial scaling and pipeline milestones without immediate financing needs .
• Trading setup: Stock likely reactive to regulatory and R&D milestones (PDUFA, VANQUISH/MARIO progress); watch for payer wins and DTC ROI translating to script acceleration .

Footnote: *S&P Global consensus data unavailable at time of analysis; values would be retrieved from S&P Global when accessible.