Minerva Neurosciences(US:NERV)2020-08-03 17:03Financial Data and Key Metrics Changes - As of June 30, 2020, the company reported cash, cash equivalents, restricted cash, and marketable securities of approximately $35.3 million, which is expected to meet capital requirements into early 2022 [11] - Research and development (R&D) expenses decreased to $5.8 million in Q2 2020 from $8.3 million in Q2 2019, and for the first six months of 2020, R&D expenses were $13.8 million compared to $19.9 million in the same period of 2019 [12][13] - General and administrative (G&A) expenses increased to $5.9 million in Q2 2020 from $4.6 million in Q2 2019, with six-month G&A expenses rising to $10.1 million from $9.3 million year-over-year [14] - The company reported a net income of $29.5 million for Q2 2020, compared to a net loss of $12.5 million in Q2 2019, and a net income of $17.4 million for the first six months of 2020 compared to a net loss of $28.3 million in the same period of 2019 [14] Business Line Data and Key Metrics Changes - The company opted out of the co-development agreement with Janssen for seltorexant, resulting in the recognition of $41.2 million in collaborative revenue during Q2 2020, which included a $30 million payment made by Janssen in 2017 [15] Company Strategy and Development Direction - The company remains focused on the development of roluperidone, which aims to be the first drug approved to treat negative symptoms in schizophrenia, addressing a significant unmet medical need [5][10] - The decision to opt out of the seltorexant program allows the company to retain full financial interest in future revenues while aligning resources towards the approval of roluperidone [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of roluperidone based on Phase 3 trial data, highlighting its innovative mechanism of action and safety profile [10] - The company plans to request a meeting with the FDA to discuss the data package and the path forward for roluperidone's development [8][22] Other Important Information - The Phase 3 trial of roluperidone included over 500 patients and showed statistically significant improvements in negative symptoms and functional outcomes, particularly with the 64 mg dose [7][8] - The company is preparing for a potential additional Phase 3 study based on FDA feedback, which may involve a simpler design with one dose and no extension [31][36] Q&A Session Summary Question: Why did the company opt out of the seltorexant program? - The decision was based on a return on investment analysis, determining that opting out would provide a better return for shareholders compared to the investment required for the Phase 3 program [19] Question: When will the company share additional details of the Phase 3 publication for roluperidone? - The company plans to submit a request for an FDA meeting soon, and the most important metrics for investors will be related to functional improvements and the impact of avolition [20][22] Question: What are the plans for an additional Phase 3 study for roluperidone? - If an additional study is needed, it would likely involve one dose without an extension, focusing on the best primary endpoint for measuring negative symptoms [31][36] Question: How does the company view the potential for development in the broader insomnia market for seltorexant? - The company believes that insomnia is already covered in the trials run by Janssen for major depressive disorder, as insomnia is a significant driver of depression [38] Question: What are the company's partnering priorities for roluperidone? - The company remains open to discussions with pharmaceutical companies and will provide updates post-FDA meeting [42]