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Minerva Neurosciences(NERV) - 2021 Q4 - Annual Report
2022-03-01 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36517 Minerva Neurosciences, Inc. (Exact name of Registrant as specified in its Charter) Delaware 26-0784194 (State or other jurisdic ...
Minerva Neurosciences(NERV) - 2021 Q3 - Earnings Call Transcript
2021-11-08 19:11
Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2021 Results Earnings Conference Call November 8, 2021 8:30 AM ET Company Participants Geoff Race - President Remy Luthringer - Chief Executive Officer Frederick Ahlholm - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies Thomas Shrader - BTIG Jason Butler - JMP Securities Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva Neurosciences Third Quarter 2021 Call. At this time, all participants are in a listen-only mode. There ...
Minerva Neurosciences(NERV) - 2021 Q3 - Quarterly Report
2021-11-08 12:00
[PART I — Financial Information](index=4&type=section&id=PART%20I%20%E2%80%94%20Financial%20Information) [Financial Statements](index=4&type=page&id=Item%201.%20Financial%20Statements) Minerva Neurosciences reported a net loss for the nine months ended September 30, 2021, primarily due to absent collaborative revenue, while its balance sheet strengthened from a **$60 million** royalty sale [Condensed Consolidated Balance Sheets](index=4&type=page&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2021, total assets increased to **$97.6 million** driven by higher cash, while total liabilities grew substantially to **$69.5 million** due to a **$64.6 million** royalty sale liability, leading to a decrease in stockholders' equity | Balance Sheet Highlights | Sep 30, 2021 (USD) | Dec 31, 2020 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $65,588,119 | $25,356,952 | | Total current assets | $67,438,570 | $27,440,216 | | Total assets | $97,559,049 | $57,626,209 | | **Liabilities & Equity** | | | | Total current liabilities | $3,082,760 | $3,160,252 | | Liability related to the sale of future royalties | $64,594,985 | $— | | Total liabilities | $69,481,101 | $4,963,608 | | Total stockholders' equity | $28,077,948 | $52,662,601 | [Condensed Consolidated Statements of Operations](index=5&type=page&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the nine months ended September 30, 2021, the company reported a net loss of **$28.6 million**, a significant shift from **$9.3 million** net income in 2020, primarily due to the absence of **$41.2 million** collaborative revenue and new non-cash interest expense | Statement of Operations (Nine Months Ended Sep 30) | 2021 (USD) | 2020 (USD) | | :--- | :--- | :--- | | Collaborative revenue | $— | $41,175,600 | | Research and development | $13,292,488 | $18,488,108 | | General and administrative | $10,695,944 | $13,541,253 | | Non-cash interest expense for the sale of future royalties | $4,594,985 | $— | | **Net (loss) income** | **($28,599,303)** | **$9,265,598** | | **Net (loss) income per share, basic** | **($0.67)** | **$0.23** | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=page&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased from **$52.7 million** to **$28.1 million** as of September 30, 2021, primarily due to the **$28.6 million** net loss, partially offset by stock-based compensation - The accumulated deficit increased from **$(284.8) million** at the start of 2021 to **$(313.4) million** by the end of Q3 2021, reflecting the net loss incurred during the period[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=page&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2021, net cash used in operating activities was **$19.8 million**, while **$60 million** from the sale of future royalties led to a **$40.2 million** net increase in cash, bringing the total to **$65.7 million** | Cash Flow (Nine Months Ended Sep 30) | 2021 (USD) | 2020 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($19,768,833) | ($26,663,142) | | Net cash provided by investing activities | $— | $24,528,294 | | Net cash provided by financing activities | $60,000,000 | $13,238,058 | | **Net increase in cash, cash equivalents and restricted cash** | **$40,231,167** | **$11,103,210** | - The primary source of cash in 2021 was the **$60 million** received from the sale of future royalties, whereas in 2020, financing was sourced from public stock offerings (**$12.6 million**) and stock option exercises (**$1.1 million**)[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=page&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on the company's operations, liquidity, and significant events, including the **$60 million** sale of seltorexant royalty rights, which is treated as debt, and management's belief that existing cash of **$65.7 million** is sufficient for at least the next 12 months - The company is a clinical-stage biopharmaceutical firm focused on CNS diseases with lead candidates roluperidone and MIN-301[23](index=23&type=chunk) - Management believes existing cash of **$65.7 million** is sufficient for at least the next 12 months, but acknowledges the need to raise additional capital for later-stage clinical development[26](index=26&type=chunk)[27](index=27&type=chunk) - In January 2021, the company sold its royalty interest in seltorexant to Royalty Pharma for an upfront payment of **$60 million** and up to **$95 million** in potential milestones, accounted for as debt, resulting in a liability of **$64.6 million** as of September 30, 2021[77](index=77&type=chunk)[80](index=80&type=chunk) - A stock option exchange program was completed in August 2021, where options to purchase **7.6 million** shares were exchanged for **3.8 million** performance-based restricted stock units (PRSUs)[85](index=85&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=page&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the roluperidone NDA timeline despite FDA feedback, noting decreased R&D and G&A expenses, a shift to net loss due to absent collaborative revenue, and bolstered liquidity from a **$60 million** Royalty Pharma payment [Clinical and Regulatory Update](index=20&type=page&id=Clinical%20and%20Regulatory%20Update) The 40-week open-label extension of the Phase 3 trial for roluperidone showed continued improvement in negative symptoms and was well-tolerated, and a pivotal bioequivalence study met its objectives, despite the FDA denying a pre-NDA meeting - The FDA denied a pre-NDA meeting for roluperidone, recommending a Type C guidance meeting instead, but the company still plans to submit an NDA in the first half of 2022[105](index=105&type=chunk) - Results from the 40-week open-label extension of the Phase 3 trial showed mean improvements in negative symptoms and functional scores, with a relapse rate of **11.7%** over one year[107](index=107&type=chunk)[108](index=108&type=chunk)[111](index=111&type=chunk) - A pivotal bioequivalence study successfully demonstrated comparability between the clinical trial formulations of roluperidone and the planned commercial formulation[114](index=114&type=chunk) [Results of Operations](index=22&type=page&id=Results%20of%20Operations) For the nine months ended September 30, 2021, R&D expenses decreased by **$5.2 million** and G&A expenses fell by **$2.8 million**, while the absence of **$41.2 million** in collaborative revenue and a new **$4.6 million** non-cash interest expense significantly impacted net results | Expense Comparison (Nine Months Ended Sep 30) | 2021 (in millions USD) | 2020 (in millions USD) | Change (in millions USD) | | :--- | :--- | :--- | :--- | | Research and Development | $13.3M | $18.5M | ($5.2M) | | General and Administrative | $10.7M | $13.5M | ($2.8M) | - The decrease in collaborative revenue by **$41.2 million** was the primary reason for the shift from net income in 2020 to a net loss in 2021[130](index=130&type=chunk) - A new non-cash interest expense of **$4.6 million** was recorded in the first nine months of 2021 due to the sale of the seltorexant royalty interest[136](index=136&type=chunk) [Liquidity and Capital Resources](index=24&type=page&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2021, the company had **$65.7 million** in cash, significantly bolstered by a **$60 million** upfront payment from Royalty Pharma, which management believes is sufficient for at least the next 12 months, though additional capital will be needed for future development - The company had cash, cash equivalents, and restricted cash of approximately **$65.7 million** at September 30, 2021[137](index=137&type=chunk) - In January 2021, the company received a **$60 million** upfront payment from Royalty Pharma for its royalty interest in seltorexant[137](index=137&type=chunk)[141](index=141&type=chunk) - Management believes existing cash is sufficient to fund operations for at least the next 12 months[137](index=137&type=chunk)[144](index=144&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=27&type=page&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable to the company for the reporting period - The company has indicated that there are no applicable quantitative and qualitative disclosures about market risk to report[159](index=159&type=chunk) [Controls and Procedures](index=27&type=page&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting during the third quarter - Management concluded that disclosure controls and procedures were effective as of September 30, 2021[161](index=161&type=chunk) - No material changes to internal control over financial reporting occurred during the most recent fiscal quarter[162](index=162&type=chunk) [PART II — Other Information](index=28&type=section&id=PART%20II%20%E2%80%94%20Other%20Information) [Legal Proceedings](index=28&type=page&id=Item%201.%20Legal%20Proceedings) A consolidated securities class action lawsuit against the company regarding roluperidone development was voluntarily dismissed and the case officially closed in July 2021 - A securities class action lawsuit alleging misleading statements about the drug candidate roluperidone was voluntarily dismissed, and the case was closed by the court on July 9, 2021[165](index=165&type=chunk) [Risk Factors](index=28&type=page&id=Item%201A.%20Risk%20Factors) The company highlights key risks including a history of significant losses with an accumulated deficit of **$313.4 million**, the need for additional capital, potential stockholder dilution, and ongoing COVID-19 pandemic impacts - The company has a history of significant losses, with an accumulated deficit of **$313.4 million** as of September 30, 2021, and expects to incur further losses[167](index=167&type=chunk)[168](index=168&type=chunk) - Additional capital is required to finance operations, and there is no guarantee that it will be available on acceptable terms, with failure to secure funding potentially forcing the company to delay or discontinue development programs[169](index=169&type=chunk)[170](index=170&type=chunk) - The COVID-19 pandemic poses ongoing risks to the business, including potential delays in clinical trials, disruptions to operations, and negative impacts on financial markets and the ability to raise capital[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=page&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the reporting period - The company reported no unregistered sales of equity securities[175](index=175&type=chunk) [Exhibits](index=31&type=page&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and required CEO and CFO certifications - The report includes standard corporate governance documents and required CEO/CFO certifications as exhibits[181](index=181&type=chunk)
Minerva Neurosciences(NERV) - 2021 Q2 - Earnings Call Transcript
2021-08-02 16:19
Minerva Neurosciences, Inc. (NASDAQ:NERV) Q2 2021 Results Conference Call August 2, 2021 8:30 AM ET Company Participants William Boni - Vice President, Investor Relations & Corporate Communications Remy Luthringer - Executive Chairman & Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Andrew Tsai - Jefferies Myles Minter - William Blair Jason Butler - JMP Securities Douglas Tsao - H.C. Wainwright Operator Welcome to ...
Minerva Neurosciences(NERV) - 2021 Q2 - Quarterly Report
2021-08-02 11:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File No. 001-36517 Washington, D.C. 20549 Minerva Neurosciences, Inc. FORM 10-Q (Exact Name of Registrant as Specified in its Charter) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Indicate by check mark whether the registrant (1) has ...
Minerva Neurosciences(NERV) - 2021 Q1 - Earnings Call Transcript
2021-05-12 20:40
Minerva Neurosciences, Inc. (NASDAQ:NERV) Q1 2021 Earnings Conference Call May 12, 2021 8:30 AM ET Company Participants William Boni - Vice President, Investor Relations & Corporate Communications Remy Luthringer - Executive Chairman & Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Jason Butler - JMP Securities Tom Shrader - BTIG Jay Olson - Oppenheimer Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Op ...
Minerva Neurosciences(NERV) - 2021 Q1 - Quarterly Report
2021-05-12 11:00
Commission File No. 001-36517 Minerva Neurosciences, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdiction of I ...
Minerva Neurosciences(NERV) - 2020 Q4 - Earnings Call Transcript
2021-03-08 17:35
Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2020 Earnings Conference Call March 8, 2021 8:30 AM ET Company Participants William Boni - VP, IR and Corporate Communications Remy Luthringer - Executive Chairman and Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Jason Butler - JMP Jeet Mukherjee - Jefferies Joel Beatty - Citi Myles Minter - William Blair Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva ...
Minerva Neurosciences(NERV) - 2020 Q4 - Annual Report
2021-03-08 11:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36517 Minerva Neurosciences, Inc. (Exact name of Registrant as specified in its Charter) Delaware 26-0784194 (State or other jurisdic ...
Minerva Neurosciences(NERV) - 2020 Q3 - Earnings Call Transcript
2020-11-02 17:06
Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2020 Results Earnings Conference Call November 2, 2020 8:30 AM ET Company Participants William Boni - VP, IR & Corporate Communications Remy Luthringer - Executive Chairman and Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Joel Beatty - Citi Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Jeet Mukherjee - Jefferies Operator Welcome to the Minerva Neuroscie ...