SCYNEXIS, Inc. Q1 FY2022 earnings call

• BREXAFEMME launch: Launched in September 2021, BREXAFEMME had nearly 4,000 prescriptions and $700,000 in net revenues in the first quarter of 2022. Prescriber base grew about 10% in the first quarter of 2022, with repeat prescribers contributing 56% of volumes in the first quarter of 2022 compared to 20% in the fourth quarter of 2021. - R&D progress: Expect to file the supplemental NDA for the recurrent VVC indication this quarter with an approval by the end of this year. Positive results from the new interim analysis of the FURI and CARES trials were reported. The MARIO study is initiated and expects the first patient to be enrolled soon, with results expected in 2024 and potential approval for hospital indications by the end of 2024. - Commercial efforts: Launched the 'Say No More' campaign, which was first rolled out with HCPs in April and will be amplified to patients starting this month. Commercial coverage continued to expand, with more than $93 million commercially insured lives covered by the end of the first quarter of 2022, representing 55% of the commercial universe. - Cash situation: Closed the first quarter of 2022 with more than $95 million in cash, and the $45 million public offering in April 2022 strengthened the cash position, enabling advancement of the antifungal franchise goal.

In the first quarter of 2022, BREXAFEMME, SCYNEXIS's first commercial product, achieved nearly 4,000 prescriptions and net revenues of $700,000. Cost of product revenue was $100,000 for the first quarter. R&D expense decreased to $5.7 million from $6.9 million compared to the prior - year quarter. SG&A expense increased to $14.6 million from $6.7 million compared to the first quarter of 2021. As of March 31, 2022, SCYNEXIS had cash and cash equivalents of $95.2 million, and received $45 million in gross proceeds from a common stock offering in April 2022. BREXAFEMME contributed $700,000 to net revenues, representing a specific financial performance for this product segment.

• Expect to file the supplemental NDA for the recurrent VVC indication this quarter with an approval by the end of 2022. - The MARIO study is expected to report results in 2024 with the potential approval for hospital indications by the end of 2024. - Continue to accelerate sales efforts for BREXAFEMME, including broadening the prescriber base and launching patient - focused campaigns to drive prescription growth.

• Facing environmental challenges such as the war in Ukraine, the ongoing pandemic (uncertain if it is over), inflation, and higher interest rates. These challenges can impact the company's operations and growth plans.

Q: How do you view the response rates of the FURI and CARES studies compared to other novel fungals? And how many patients are projected to be involved in NDA filing?

A: David Angulo said that the response rates in the salvage therapy setting are very satisfactory. More than 60% of patients have complete or partial responses. Regarding the number of patients projected for NDA filing, the estimated enrollment for the studies is around 200 subjects in one study and about 30 subjects in the CARES study, and they are on target to complete enrollment within the disclosed time.

Q: For BREXAFEMME, what is the update on the percentage of scripts going to women with rVVC? Has it changed since the last quarter?

A: Christine Coyne said that from a commercial standpoint, they stay on - label and track scripts of VVC, not specifically rVVC scripts.

Q: How will the recent approval of Mycovia's drug impact the uptake of BREXAFEMME? What is the relationship with Amplity? Are there any distribution or market access challenges hindering the uptake of BREXAFEMME?

A: Marco Taglietti said they are happy to see innovation in the VVC field. BREXAFEMME has unique advantages and is expected to remain a major innovation. Regarding Amplity, it is a contract commercial organization partnership. Christine Coyne said there were no trouble with distribution and no obstruction seen in script adjudication, with good commercial coverage and copay support program in place