Minerva Neurosciences(US:NERV)2021-05-12 11:00Revenue and Financial Performance - The company reported no revenue from product candidates as none have been approved for commercialization[113]. - Collaborative revenue recognized in 2020 was approximately $41.2 million, previously included under deferred revenue[114]. - The company has not generated any revenue from product sales to date, only collaborative revenue from opting out of the license agreement with Janssen and a one-time sale of royalty interests for $60 million[132]. Expenses - Research and development expenses decreased to $3.3 million for Q1 2021 from $8.1 million in Q1 2020, a reduction of approximately 59%[122]. - General and administrative expenses remained stable at $4.2 million for both Q1 2021 and Q1 2020[123]. - The company anticipates an increase in expenses related to ongoing development activities, particularly for research and clinical trials[132]. Cash and Financing - Cash, cash equivalents, and restricted cash totaled approximately $80.2 million as of March 31, 2021[127]. - Net cash used in operating activities for Q1 2021 was approximately $5.2 million, primarily due to a net loss of $8.8 million[136]. - Net cash provided by financing activities in Q1 2021 was $60 million, resulting from the sale of future royalties[139]. - The company recorded an upfront payment of $60 million from the sale of future royalties as a liability to be amortized to interest expense over the life of the arrangement[142]. - The company expects its cash, cash equivalents, and restricted cash to be sufficient to meet cash commitments for at least the next 12 months[133]. - Net cash provided by investing activities was zero in Q1 2021, compared to $17.0 million in Q1 2020 due to the maturity and redemption of marketable securities[138]. Clinical Trials and Product Development - The Phase 3 trial of roluperidone did not meet its primary or key secondary endpoints in the intent-to-treat population[110]. - The mean improvement in negative symptoms for the 64 mg dose of roluperidone was 7.5 points during the 40-week open-label extension[105]. - The overall relapse rate during the open-label extension was 11.7%[107]. - The company expects to incur significant commercialization expenses for product sales, marketing, manufacturing, and distribution, contingent upon obtaining regulatory approval for its product candidates[133]. Financial Position - The company had an accumulated deficit of approximately $293.6 million as of March 31, 2021[127]. - The company has no off-balance sheet arrangements as defined under SEC rules[140]. - The company treats the sale of future royalties as a debt financing due to significant continuing involvement in facilitating the transfer of royalties[142].