Minerva Neurosciences, Inc. Q3 FY2020 earnings call

• Approaching FDA meeting on November 10 regarding roluperidone, confident in its potential for schizophrenia patients, especially for unmet negative symptoms.
• Phase III trial top-line results in May showed 64-mg dose had early beneficial effect on negative symptoms and functional improvements; roluperidone was well-tolerated. Completed analysis of Phase III and other trials, including integrated analysis showing significant separation between roluperidone doses and placebo. 40-week open-label phase of Phase III trial on schedule to complete Q1 2021.
• Submitted briefing book to FDA for November 10 Type C meeting, awaiting feedback. R&D expenses decreased in 2020 due to completion of MIN-117 trial and Phase III double-blind portion of roluperidone. G&A expenses decreased due to lower noncash stock-based comp and commercial expenses. Collaborative revenue increased to $41.2 million in 9 months 2020 from co-development and license agreement with Janssen.

For the 3 months ended September 30, 2020, R&D expenses were $4.6 million, G&A expenses were $3.5 million, and net loss was $8.1 million. For the 9 months ended September 30, 2020, R&D expenses were $18.5 million, G&A expenses were $13.5 million, net income was $9.3 million, and collaborative revenue was $41.2 million (an increase from $0 in 2019 due to opting out of the Janssen co-development agreement).

• Cash, cash equivalents, and restricted cash as of September 30, 2020, were ~$32.6 million; existing cash expected to meet capital requirements into early 2022 based on current plan. Anticipating outcomes from November 10 FDA meeting and preparing for next steps, including potential NDA filing or additional trials. Open-label extension of Phase III trial to complete Q1 2021, data expected towards end of Q1 or start of Q2 2021.

• Forward-looking statements subject to risks and uncertainties detailed in SEC filings, including factors that may cause actual results to differ from forward-looking statements. Uncertainty around FDA feedback from the November 10 Type C meeting and its impact on next steps. Dependence on successful regulatory outcomes for roluperidone development.

Q: Had the FDA provided feedback on the Type C meeting material?

A: As of today, no feedback received, expecting it later this week or early next week.

Q: Used ATM facility in current quarter?

A: Sold ~$7M in Q3, haven't sold in Q4, $38M remaining on $50M ATM.

Q: Preparations for FDA meeting outcomes?

A: Anticipating different outcomes, working on next steps if additional study needed, extension study data expected Q1 2021.

Q: Data from open-label extension?

A: Last patient visit Q1 2021, data expected end of Q1/beginning of Q2 2021.

Q: Differences in PSP and Marder NSFS results?

A: Analyzed sub-scores, Marder NSFS split into experience and expression, PSP shows functional improvement, avolition sub-score significant.

Q: Timeframe for additional study if needed?

A: Ready to proceed as soon as FDA feedback received, study design and infrastructure ready.

Q: Opt back into seltorexant program?

A: No opt back, mid single-digit royalty on seltorexant sales.

Q: Quick start of additional study if required?

A: Ready-to-go, infrastructure and CRO in place.

Q: Item-by-item analysis of PANSS results?

A: Analyzed avolition-related items, significant effect, split Marder NSFS into experience and expression, showing drug activity.