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SI

SCYNEXIS INC (SCYX)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 marked steady commercial progress for BREXAFEMME: net product revenue was $0.7M, with ~4,000 prescriptions and expanding payer coverage to 93M commercially insured lives (55%) .
  • The cash runway was extended into Q1 2024 following the April offering ($45M gross; ~$42M net), supporting both commercial execution and late-stage R&D across rVVC and hospital indications .
  • Management reiterated near-term catalysts: sNDA submission for rVVC in Q2 2022 with anticipated approval by year-end, initiation of the MARIO Phase 3 IC study with first patient by end of Q2 2022, and scale-up of the IV formulation .
  • On the call, CEO outlined a long-term vision: combined indications could create a franchise with potential U.S. net sales of $700–$800M annually, highlighting strategic ambition and confidence in execution .

What Went Well and What Went Wrong

What Went Well

  • Prescription and coverage momentum: ~4,000 Q1 prescriptions and coverage expanding to 93M commercially insured lives (55%), with 1,800 unique HCPs and 55% repeat writers; management emphasized messaging is resonating and direct-to-patient campaigns launching (“Say No More”) .
  • R&D execution: Positive interim analyses in FURI/CARES showing 83.2% clinical response across 131 severe fungal infection cases; CANDLE Phase 3 showed statistically significant prevention of rVVC with plans for sNDA in Q2 and anticipated approval by year-end .
  • Strengthened liquidity: $95.2M cash at quarter-end plus ~$42M net proceeds from April offering extends runway into Q1 2024, enabling continued commercial scaling and hospital programs .

What Went Wrong

  • Commercial momentum impacted by environmental factors (e.g., Omicron) resulting in slowed growth trends over winter; strategy pivoted to intensify focus on high-prescribing HCPs and patient activation to re-accelerate .
  • SCYNERGIA Phase 2 enrollment lagged prior expectations due to COVID-era hospital constraints; management expects activity to improve through 2022 with decisions guided by data later in the year .
  • No explicit revenue/EPS guidance and limited visibility on consensus comparisons; while net selling price is expected to improve, Wall Street consensus from S&P Global for Q1 2022 was not available at time of analysis .

Financial Results

MetricQ3 2021Q4 2021Q1 2022
Net Product Revenue ($USD Millions)$0.5 $0.6 $0.7
Cost of Product Revenue ($USD Millions)$0.1 $0.2 $0.1
R&D Expense ($USD Millions)$4.4 $7.7 $5.7
SG&A Expense ($USD Millions)$15.4 $15.0 $14.6
Total Other Income/(Expense) ($USD Millions)$18.8 ($6.9) $9.6
Net Loss ($USD Millions)($0.6) ($29.2) ($5.5)
Basic EPS ($USD)($0.02) ($1.05) ($0.17)
Cash & Equivalents ($USD Millions, period-end)$100.1 $104.5 $95.2

KPIs (Commercial Metrics and Adoption)

KPIQ4 2021Q1 2022
BREXAFEMME Prescriptions (IQVIA)~3,700 ~4,000
Unique HCP Prescribers>1,600 >1,800
% Repeat Writers40% 55%
Commercial Insurance Coverage (Lives; % of Commercial)81M (48%) 93M (55%)

Monthly Prescription Trend (Q1 2022)

MonthPrescriptions
January 20221,070
February 20221,328
March 20221,579

Notes:

  • Prior-year comparison: Q1 2021 net loss was $4.7M and $0.18 basic loss per share, reflecting early pre-launch phase; Q1 2022 loss was $5.5M and $0.17 loss per share .
  • No segment breakdown applicable (single-product launch); margins were not disclosed in filings and call.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-level liquidityInto Q2 2023 Into Q1 2024 (after April offering) Raised runway
rVVC sNDA TimingLabel ExpansionsNDA Q2 2022; approval late 2022 sNDA Q2 2022; approval by year-end Maintained
MARIO (IC Step-Down)Clinical programEnrollment to begin Q2 2022 Initiated; first patient by end of Q2 2022 On track
IV FormulationDevelopmentPhase 1 complete; moving to next stage Scaling up manufacturing for additional IV trials Advancing
Net Selling PriceCommercialNot statedExpect net selling price to improve over 2022 New commentary
Hospital Indication ApprovalRegulatoryNot specifiedOral step-down IC approval targeted by end of 2024 New long-term target

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2021)Previous Mentions (Q4 2021)Current Period (Q1 2022)Trend
Payer Coverage>30% of commercial lives 81M lives (48%) 93M lives (55%) Improving
Marketing/Go-to-MarketEarly launch momentum Continued build-out “Say No More” HCP+patient campaign, digital/social, satellite media tour Intensifying
rVVC Label ExpansionTop-line expected early Q2 2022 Positive CANDLE results; sNDA in Q2 sNDA Q2; approval by year-end On track
MARIO (IC Step-Down)Regulatory path discussed (LPAD potential) Study design (220 patients), global enrollment Q2 Initiated; first patient by end Q2 Progressing
IV FormulationPhase 1 successful Moving forward Scaling manufacturing for more IV trials Advancing
FURI/CARES OutcomesInterim analyses positive FURI interim: 62.1% response; 24.3% stable disease Combined 83.2% clinical response across 131 cases Positive
CompetitionNot highlightedNot highlightedMycovia’s approval acknowledged; SCYX positions BREXAFEMME as unique fungicidal option with broad labeling ambitions Emerging focus
Macro EnvironmentNot highlightedNot highlightedCEO cited war/inflation/higher rates context; emphasized fortified cash New headwind narrative

Management Commentary

  • “Our first commercial product, BREXAFEMME… achieved nearly 4,000 prescriptions and reached net revenues of $700,000 in the first quarter of 2022” .
  • “All these indications, when taken together, will create a franchise with the potential to generate $700 million to $800 million a year in net sales in the U.S. alone” .
  • “Having secured the cash to fund our corporate activities into the first quarter of 2024 puts us in a strong position” .
  • “Yeast infection, Say No More… our new rallying cry” .
  • On rVVC: “We are now on track for submission of a supplemental NDA by end of this quarter with an anticipated approval by end of this year” .
  • On hospital programs: “We have initiated the MARIO study… we anticipate first subject enroll this quarter” .

Q&A Highlights

  • Salvage therapy efficacy: Management emphasized strong response rates in difficult-to-treat populations; more than 60% complete/partial response and ~80% clinical benefit in FURI/CARES, supporting NDA strategy for invasive candidiasis salvage and step-down .
  • Commercial execution: Strategy refined to increase frequency among high-prescribing OB-GYNs; launch messaging to HCPs and patients sharpened for memorability (empowerment-focused) to accelerate adoption .
  • Competitive landscape: Acknowledged Mycovia’s approval; SCYX highlighted fungicidal profile, potential dual labeling (VVC treatment + rVVC prevention), and broader patient applicability as differentiators .
  • SCYNERGIA enrollment: Slower-than-expected during COVID; activity improving, with decisions on next steps guided by data later in the year .
  • MARIO operational details: ~70–80 global sites planned; sites opening in waves across regions; initial centers already open .
  • Mucormycosis: Encouraging preclinical synergy data with amphotericin B; FURI protocol now open for mucor patients, enabling enrollment .

Estimates Context

  • Wall Street consensus estimates from S&P Global (EPS and Revenue for Q1 2022) were not available at the time of analysis. As such, no beat/miss assessment versus consensus can be provided. Comparisons focus on sequential and year-over-year actuals disclosed by the company .

Key Takeaways for Investors

  • Commercial traction is building: Q1 net revenue $0.7M, ~4,000 scripts, 1,800 prescribers, and repeat writers rising to 55%; payer coverage broadened to 93M lives (55%), improving access .
  • Label expansion in sight: CANDLE Phase 3 was positive; sNDA submission targeted in Q2 2022 with anticipated approval by year-end—dual labeling (treatment + prevention) could materially improve adoption and durability .
  • Hospital program catalysts: MARIO (IC step-down) initiated with first patient by end Q2; complementary FURI/CARES salvage datasets continue to show strong clinical benefit—together underpin a path to a hospital indication by end 2024 .
  • Liquidity and execution runway: $95.2M cash at 3/31/22 plus ~$42M net offering proceeds extend runway into Q1 2024, supporting commercial scaling and pivotal R&D .
  • Pricing tailwind: Management expects net selling price to improve through 2022, offering leverage to net revenue as coverage and repeat writers expand .
  • Franchise potential: Management articulated a long-term net sales potential of $700–$800M in the U.S. across indications, underscoring breadth of opportunity if clinical and regulatory milestones are achieved .
  • Near-term trading catalysts: sNDA filing and approval timing, MARIO enrollment milestones, and evidence of accelerating prescriptions under the “Say No More” campaign can drive sentiment and stock reaction; watch monthly Rx trends and payer coverage updates for confirmation .

Citations:

  • Q1 2022 8-K press release and exhibit
  • Q1 2022 earnings call transcript
  • Q4 2021 8-K press release
  • Q3 2021 8-K press release