SCYNEXIS, Inc.
SCYNEXIS, Inc. Q3 FY2021 earnings call
November 10, 2021 · fiscal period ended 2021-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2021-11-10
Management highlights
Marco Taglietti's Remarks: - Inaugural earnings call since FDA approval of BREXAFEMME in June. - Vision is to build a global antifungal franchise using ibrexafungerp. ### Christine Coyne's Commercial Updates: - Launched BREXAFEMME for vulvovaginal candidiasis; physician feedback is excellent. - As of October, there were 1,100 prescriptions for BREXAFEMME. - Coverage of BREXAFEMME has grown to over 30% of commercial live and is still growing. - Working on educating and activating patients in 2022. ### David Angulo's R&D Updates: - Finishing Phase 3 CANDLE study for recurrent VVC, expected top-line results Q2 2022 with potential FDA approval by end 2022. - Completed Phase 1 for liposomal intravenous formulation with better tolerability. - FURI and CARES programs progressing for invasive fungal infections. - Preclinical development shows ibrexafungerp in combination with liposomal amphotericin B may be synergistic for mucormycosis. ### Eric Francois' Financial Update: - Cash and cash equivalents totaled $100.1 million on September 3, 2021. - Expect to fund operating requirements into 2023 with existing cash, NOL sales, and BREXAFEMME sales.
Segment performance
In the third quarter of 2021, BREXAFEMME, the company's product, generated $516,000 in net sales. This was the first quarter reporting product sales, marking the start of commercialization for BREXAFEMME.
Guidance
- Anticipates second approval for ibrexafungerp in prevention of recurrent VVC by end of 2022. ### - Believes existing cash and cash equivalents, plus NOL sales and BREXAFEMME sales, will fund operations into 2023. ### - Plans to provide hospital program plans and timelines in a December 6 teleconference.
Risks
- Potential delays in clinical trial enrollments due to COVID-19 pandemic impact on hospital resources. ### - Regulatory uncertainties in obtaining approvals for new indications. ### - Dependence on successful commercial coverage and payer negotiations for BREXAFEMME.
Q&A highlights
Q: Provide updates on partnership with Hansoh Pharma in China and commercialization plans outside the U.S.?
A: Hansoh filed IND for vulvovaginal candidiasis in China. SCYNEXIS is in talks with potential partners outside the U.S. to commercialize ibrexafungerp globally.
Q: Role of patients as advocates for BREXAFEMME via word of mouth?
A: Patients are advocates, but early stage focuses on getting prescribers familiar with BREXAFEMME; marketing team to educate patients in 2022 to facilitate better interaction between patients and prescribers.
Q: Inventory numbers and Q4 pull through for BREXAFEMME?
A: At launch, stocked pharmacies to ensure availability; aim to keep about three weeks of inventory on hand, with reordering happening and coverage continuing to grow.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.06 | $-0.79 | +92.4% | — |
| Revenue | $516,000 | $893,529 | -42.3% | — |
Transcript
November 10, 2021Full transcript unavailable for redistribution
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