Minerva Neurosciences(NERV) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2023, the net loss was approximately $7 million, or a net loss per share of $1.31, compared to a net loss of approximately $9.8 million, or a net loss per share of $1.83 for Q1 2022, indicating an improvement in financial performance [24] - General and administrative expenses decreased to $2.7 million in Q1 2023 from $3 million in Q1 2022, primarily due to lower non-cash stock compensation [23] - Research and development expenses decreased to $2.7 million in Q1 2023 from $5 million in Q1 2022, attributed to lower non-cash stock compensation costs and reduced consultant fees related to the NDA [43] Business Line Data and Key Metrics Changes - The company is focused on the roluperidone program, which is the first drug seeking to improve negative symptoms in schizophrenia patients, with the NDA filed and under review by the FDA [12][16] - The Phase 2b study met its primary endpoint and most secondary endpoints, while the Phase 3 study achieved a nominal P-value of 0.044 for the primary endpoint at the 64-milligram dose [34] Market Data and Key Metrics Changes - The company reported cash and cash equivalents of approximately $36.1 million as of March 31, 2023, slightly down from $36.2 million as of December 31, 2022 [56] - The FDA confirmed that there are no approved drugs in the U.S. specifically targeting negative symptoms of schizophrenia, highlighting a significant market opportunity for roluperidone [16][29] Company Strategy and Development Direction - The company intends to position roluperidone as a monotherapy specifically targeting negative symptoms in schizophrenia, addressing an underserved patient population [30][32] - The company is considering potential partnerships for the marketing of roluperidone, indicating a strategic approach to launch and distribution [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing dialogue with the FDA and the potential for approval of roluperidone following the review process [49][73] - The company highlighted the critical need for effective treatments for negative symptoms of schizophrenia, emphasizing the potential impact of roluperidone on patient care [40][76] Other Important Information - The company received a refund of $3.1 million from the FDA for the NDA filing fee, which is a fee waiver for small businesses submitting their first human drug application [56] - Non-cash interest expense increased to $2 million in Q1 2023 from $1.8 million in Q1 2022, primarily due to an increase in the carrying value of the liability related to future royalties [58] Q&A Session Summary Question: What drove the FDA to grant the appeal in favor of the company? - Management indicated that the formal dispute resolution request and the detailed briefing provided to the FDA were key factors in the positive outcome [46][48] Question: What is the company's strategy for the potential launch of roluperidone in 2024? - The company is considering partnerships for marketing and is evaluating its needs for launching the product [51][52] Question: Were all issues identified by the FDA resolved prior to the NDA filing? - Management confirmed that they addressed all issues raised by the FDA during their meetings, which contributed to the filing of the NDA [69]