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Mar 31, 2022
Scynexis Q1 2022 Earnings Report
SCYNEXIS reported financial results for Q1 2022, highlighting BREXAFEMME's commercial progress and ibrexafungerp's clinical advancements.
Key Takeaways
SCYNEXIS reported Q1 2022 financial results with BREXAFEMME generating $0.7 million in net product revenue. The company's cash balance was $95.2 million as of March 31, 2022, and with a recent public offering, SCYNEXIS expects to fund operations into Q1 2024. Clinical updates included positive results from the FURI and CARES trials and the Phase 3 CANDLE study.
BREXAFEMME achieved almost 4,000 prescriptions with net revenues of $0.7 million in Q1 2022.
Commercial insurance plans covered BREXAFEMME for 93 million, or 55% of commercially insured lives as of May 2022.
SCYNEXIS initiated MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC).
Positive results were reported from new interim analyses of the FURI and CARES trials, with 83.2% of combined patients demonstrating a clinical response to oral ibrexafungerp.
Scynexis
Scynexis
Forward Guidance
SCYNEXIS anticipates continued growth and advancement in building a broad antifungal franchise for ibrexafungerp across multiple indications. The company plans to enlarge the prescriber base, expand payer coverage, and grow BREXAFEMME revenues. SCYNEXIS also plans to file a supplemental New Drug Application (sNDA) in recurrent vulvovaginal candidiasis (rVVC) and receive approval for this label expansion by the end of 2022.
Positive Outlook
- Expanding payer coverage for BREXAFEMME.
- Growing BREXAFEMME revenues.
- Plan to file a supplemental New Drug Application (sNDA) in recurrent vulvovaginal candidiasis (rVVC).
- Receiving approval for rVVC label expansion by the end of 2022.
- Advancement of IV formulation
Challenges Ahead
- BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects.
- Risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications.
- Unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission.
- SCYNEXIS’ need for additional capital resources.
- SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products.