Minerva Neurosciences(NERV) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the fourth quarter of 2022, the net loss was $6.7 million, or a loss per share of $1.26, compared to a net loss of $21.3 million, or a loss per share of $3.99, in the fourth quarter of 2021, indicating a significant improvement [8] - For the year ended December 31, 2022, the net loss was $32.1 million, or a loss per share of $6.01, compared to a net loss of $49.9 million, or a loss per share of $9.35, for the year ended December 31, 2021, showing a reduction in losses [8] - Cash, cash equivalents, and restricted cash as of December 31, 2022, were approximately $36.2 million, down from $60.9 million as of December 31, 2021 [36] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for the year ended December 31, 2022, were $14.6 million, down from $32 million in 2021, primarily due to an impairment charge [7] - General and administrative (G&A) expenses for the fourth quarter of 2022 were $1.9 million, compared to $2.6 million in the fourth quarter of 2021, reflecting a decrease of $0.7 million [38] Market Data and Key Metrics Changes - The company is focused on the development of roluperidone for the treatment of negative symptoms in schizophrenia, with ongoing discussions with the FDA regarding the NDA submission [5][34] Company Strategy and Development Direction - The company aims to develop roluperidone as a transformative treatment for patients with negative symptoms of schizophrenia, emphasizing the importance of demonstrating its efficacy through monotherapy [5][46] - The company is committed to addressing FDA concerns regarding the applicability of Phase 2b data to the U.S. population and the identification of patients who do not require antipsychotics [12][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming FDA concerns and highlighted the importance of ongoing dialogue with the agency [18][52] - The company anticipates that its existing cash and cash equivalents will be sufficient to meet capital requirements for at least the next 12 months [15] Other Important Information - The company received a refund of $3.1 million for its NDA filing fee from the FDA, which is a fee waiver for small businesses submitting their first human drug application [36] Q&A Session Summary Question: What are the latest outstanding issues with the FDA following the recent Type A meeting? - Management reiterated that the FDA's main concerns are related to the applicability of Phase 2b study results and the need for reassurance regarding patient identification and stability [17][40] Question: Has the FDA requested additional studies? - Management clarified that the FDA has not requested an additional study but is seeking more data to support the existing NDA [22][28] Question: What is the timeline for resolution or outcome regarding the NDA? - Management indicated that the dialogue with the FDA is ongoing, and while they hope for a resolution soon, specific timing cannot be confirmed [42] Question: How does the departure of Dr. Dunn affect the NDA process? - Management expressed confidence that the new personnel at the FDA will also be open to innovation and understand the importance of functional improvement in patients [43][69]