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SI

SCYNEXIS INC (SCYX)·Q3 2022 Earnings Summary

Executive Summary

  • SCYNEXIS reported Q3 2022 net product revenue of $1.557m (+23% q/q) and a net loss of $(29.6)m, or $(0.62) per share; loss reflected a non-cash $(6.5)m warrant liability fair value adjustment and higher SG&A tied to BREXAFEMME commercialization .
  • Management is refocusing resources toward hospital-based indications for ibrexafungerp, actively pursuing a U.S. commercialization partner for BREXAFEMME, and expects its cash runway to extend into Q2 2024 .
  • BREXAFEMME Q3 KPIs: 5,785 prescriptions, ~2,500 prescribers, and coverage expanded to 130m commercially insured lives (~70% of the universe); note press release cites +13% sequential script growth while the call referenced +30% .
  • Near-term catalysts: November 30, 2022 PDUFA date for recurrent VVC (management “on track” and confident), MARIO Phase 3 IC enrollment ongoing, and FURI/CARES nearing closure with data intended to support a 2024 hospital-setting NDA; these are likely stock reaction drivers .
  • Directionally, Q4 sales may be lower sequentially due to winding down in-person promotion; OpEx expected to trend toward pre-commercial levels (2019–2020) as the company prioritizes R&D and hospital programs .

What Went Well and What Went Wrong

What Went Well

  • Coverage and demand expanded: BREXAFEMME prescriptions reached 5,785 in Q3, ~2,500 prescribers (+11% q/q), and coverage rose to 130m lives (~70%) with a new national PBM, supporting access and potential market uptake .
  • Strategic focus sharpened: “SCYNEXIS is transforming the company by refocusing our resources to the clinical development of ibrexafungerp for severe hospital-based indications,” positioning for higher long-term returns in life-threatening infections .
  • Clear pipeline momentum: “We have already reached our target enrollment of 200 subjects in the FURI study… CAURES will follow a similar timeline… MARIO… anticipating completion by end of next year with data in early 2024”—creating a path to the first hospital approval late 2024 .

What Went Wrong

  • Profitability pressure: Q3 net loss increased to $(29.6)m vs $(0.6)m in Q3 2021, driven by higher SG&A, R&D, and a non-cash $(6.5)m warrant liability adjustment (vs +$18.8m in Q3 2021), showing earnings volatility from mark-to-market effects .
  • Promotional disruption: Management expects Q4 sales to be down versus Q3 due to ending the Amplity field promotion, implying near-term topline headwinds despite broader payer coverage .
  • Mixed script growth messaging: The press release cites +13% q/q prescriptions while the call remarked +30%—a discrepancy that can create investor confusion; anchor on the filed EX-99.1 (+13%) .

Financial Results

Revenue, EPS, and Net Results (USD)

MetricQ3 2021Q1 2022Q2 2022Q3 2022
Product Revenue, net ($mm)$0.516 $0.700 $1.300 $1.557
Net Loss ($mm)$(0.605) $(5.5) $(13.3) $(29.6)
EPS (basic)$(0.02) $(0.17) $(0.31) $(0.62)

Operating Expense Detail (USD)

MetricQ3 2021Q1 2022Q2 2022Q3 2022
Cost of Product Revenue ($mm)$0.145 $0.100 N/A$0.189
R&D Expense ($mm)$4.401 $5.7 $7.1 $6.430
SG&A Expense ($mm)$15.411 $14.6 $15.8 $16.739
Total Operating Expenses ($mm)$19.957 N/AN/A$23.358
Loss from Operations ($mm)$(19.441) N/AN/A$(21.801)

Other Income/Expense and Adjustments (USD)

MetricQ3 2021Q2 2022Q3 2022
Total Other Income (Expense) ($mm)$+18.786 $+8.4 $(7.783)
Warrant Liabilities FV Adjustment ($mm)$+18.8 $+9.7 $(6.497)
Derivative Liabilities FV Adjustment ($mm)$+1.400 $+0.2 $(0.042)

Balance Sheet and Liquidity

MetricDec 31, 2021Q1 2022Q2 2022Q3 2022
Cash & Equivalents ($mm)$104.5 $95.2 $118.7 $68.620
Short-term Investments ($mm)———$27.470
Total Cash + ST Investments ($mm)$104.5 $95.2 $118.7 $96.090
Cash Runway (Mgmt View)—Q1 2024 Q1 2024 Q2 2024

KPIs (Commercial Execution)

KPIQ1 2022Q2 2022Q3 2022
Total Prescriptions~4,000 5,141 5,785
Prescribing HCPs (unique)~1,800 ~2,200 ~2,500
Commercial Coverage (lives)93m (~55%) 109m (~60%) 130m (~70%)

Note: Q3 call mentioned “almost 5,800” scripts and 30% growth; the EX-99.1 press release cites 5,785 scripts and +13% sequential growth .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BREXAFEMME Net SalesQ4 2022NoneDirectionally lower vs Q3 due to ending in-person promotion; impact partially offset by broader coverage Lowered (directional)
OpExQ4 2022 & 2023NoneRefocus on R&D; use 2019–2020 pre-commercial OpEx as reference range (no numeric guidance) Strategic shift (lower than commercial ramp)
Cash RunwayForwardInto Q1 2024 Extended into Q2 2024 Extended
Recurrent VVC PDUFA11/30/2022Accepted with date set “Weeks away,” management confident in positive outcome Maintained
Hospital Program (IC, salvage therapy)2023–2024On track; MARIO enrollment started FURI target enrollment reached; MARIO to complete by end-2023; NDA supportive package and first hospital approval anticipated late 2024 Maintained (milestones reaffirmed)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Product performance (BREXAFEMME)Q1: ~4,000 scripts, $0.7m, building prescriber base and DTC “Say No More” launch -. Q2: 5,141 scripts, $1.3m, prescribers ~2,200 .Q3: 5,785 scripts, prescribers ~2,500, coverage to 130m; management noted possible Q4 disruption .Improving sequentially; near-term promotional wind-down risk.
Regulatory (recurrent VVC)Q1: sNDA planned -. Q2: sNDA accepted; PDUFA 11/30/22 .“Weeks away”; confidence in approval .On track; imminent catalyst.
R&D execution (hospital programs)Q1: MARIO initiation; FURI/CARES progress; late-2024 hospital approval targeted . Q2: MARIO sites opened; SCYNERGIA slower enrollment; data in 2023 .FURI target met; CARES enrollment to complete by YE; MARIO global sites expanding; IV program to start Phase 2 in 2023 .Steady progress; timelines reaffirmed.
Commercial strategy (partnering)Not emphasized in Q1/Q2.Actively pursuing U.S. partner; winding down promotion while keeping BREXAFEMME available .Strategic pivot toward partnership.
External validation (WHO fungal list)Not discussed.WHO highlights deadly fungal pathogens addressed by ibrexafungerp; supports policy and funding narratives - .Positive narrative support.
PBM coverageQ1: 93m lives (~55%) . Q2: 109m (~60%) .130m (~70%) after major PBM deal .Strengthening access.
OpEx & cash runwayQ1/Q2: runway into Q1 2024 .Extended into Q2 2024; OpEx rebalanced to R&D focus .Improved liquidity outlook.

Management Commentary

  • “SCYNEXIS is transforming the company by refocusing our resources to the clinical development of ibrexafungerp for severe hospital-based indications, where higher long-term returns are expected” (CEO prepared remarks) .
  • “We stand ready… with a significantly derisked antifungal asset… with an anticipated first approval in the hospital setting by late 2024” (CMO) .
  • “BREXAFEMME net product revenues in the third quarter… increased approximately 23% to $1.6 million… R&D expenses… $6.4 million… SG&A… $16.7 million… Total other expense was $7.8 million… non-cash loss of $6.5 million on the fair value adjustment of our warrant liabilities” (CFO) .
  • “We are now weeks away from our November 30 PDUFA date for BREXAFEMME in recurrent VVC… and remain confident in the positive outcome” (CMO) .
  • “Our [hospital] franchise not only has the potential to generate $300 million to $400 million a year in net sale in the U.S. alone” (CEO) .

Q&A Highlights

  • Partnering timeline: Active discussions underway; recurrent VVC approval expected to enhance attractiveness; targeting partners with larger women’s health footprint and synergistic portfolios .
  • Hospital-setting strategy: Differentiation via novel class and broad spectrum activity; limited competition and high unmet need create opportunity for predominant place in treatment pathways .
  • Q4 sales and OpEx: Expect Q4 net sales down versus Q3 due to promotion cessation; OpEx to align with pre-commercial (2019–2020) levels under R&D-focused strategy .
  • WHO list implications: Supports policy momentum and potential for non-dilutive funding (e.g., BARDA), and favorable legislative conditions (PASTEUR/DISARM) .
  • MARIO study logistics: Target 70–80 global sites; trajectory and site activations on track to complete enrollment by end-2023 .
  • PDUFA process: No late-cycle meeting needed; label discussions ongoing; signs positive toward approval at the target date .
  • FURI/CARES data usage: Final data to be reviewed by an external committee; outcomes will be contrasted with external controls to support a salvage therapy indication in 2024 NDA -.
  • SCYNERGIA timing: Enrollment closure anticipated by end-2022; data in 1H 2023 .

Estimates Context

  • S&P Global consensus (EPS and revenue) for Q3 2022 was unavailable via our tool at this time; therefore, we cannot determine a beat/miss versus Street. We will anchor on reported results and sequential/YoY trends.
  • With payer coverage now ~70% and scripts improving sequentially, near-term estimate revisions may reflect the promotional wind-down in Q4 and the pivot toward partnering while preserving access .

Key Takeaways for Investors

  • Liquidity extended to Q2 2024 supports execution of hospital programs and the IV formulation while partnership discussions advance; reduces financing overhang near term .
  • Near-term event risk high: Recurrent VVC PDUFA on Nov 30, 2022 and potential out-licensing updates—both are key stock catalysts; management expresses confidence .
  • Commercial trend constructive but fragile: Scripts, prescribers, and coverage improved; expect Q4 sequential sales decline due to promotion wind-down—watch the cadence of refill and partner transition .
  • Pipeline is the medium-term thesis: FURI/CARES/MARIO converge for a 2024 hospital-setting NDA; SCYNERGIA readout in 1H 2023 can inform Aspergillus path .
  • Earnings volatility from non-cash FV adjustments (warrants/derivatives) will continue to affect quarterly GAAP results—focus on operational metrics and cash .
  • Differentiated MOA and broad-spectrum activity (including C. auris) align with WHO priorities; enhances policy narrative and non-dilutive funding optionality - .
  • Trading lens: Expect binary volatility into PDUFA; any partnering announcement could reset commercial strategy and SG&A trajectory. Medium-term value creation hinges on hospital approval and IV program advancement .