Urovant Sciences Reports Second Quarter Fiscal Year 2020 Results

Urovant Sciences Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, announced its financial results for the second fiscal quarter ended September 30, 2020. The company achieved several significant operational and commercial planning milestones in preparation for the U.S. Food and Drug Administration's (FDA) decision on the New Drug Application (NDA) for vibegron in overactive bladder (OAB). Key highlights from the quarter include the co-promotion agreement with Sunovion Pharmaceuticals and the completion of the company's sales and market access leadership teams.

Key Takeaways:

  • Urovant Sciences reported total operating expenses of $33.5 million for the quarter ended September 30, 2020, comprised of research and development expenses of $14.5 million and general and administrative expenses of $18.9 million.
  • The company's net loss for the quarter was $35.2 million, or $1.12 per share.
  • Cash used in operations was $32.6 million for the quarter.
  • As of September 30, 2020, Urovant Sciences had total cash of $74.4 million.

Urovant Sciences also announced that the FDA PDUFA goal date for vibegron in OAB is December 26, 2020. The company plans to hold a conference call to discuss its second quarter fiscal year 2020 results.

Statistics:

  • Total operating expenses: $33.5 million
  • Research and development expenses: $14.5 million
  • General and administrative expenses: $18.9 million
  • Net loss: $35.2 million
  • Cash used in operations: $32.6 million
  • Total cash: $74.4 million

Sources:

  • "Urovant Sciences Is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions." (Source: Urovant Sciences)
  • "During the second quarter of fiscal year 2020, the Company achieved a number of significant operational and commercial planning milestones in preparation for the U.S. Food and Drug Administration's (FDA) decision on the New Drug Application (NDA) for vibegron in overactive bladder (OAB)." (Source: Urovant Sciences)
  • "Sunovion Pharmaceuticals is a multi-specialty healthcare company that is focused on developing and marketing medicines to improve the lives of people around the world." (Source: Sunovion Pharmaceuticals)
  • "The Company's lead product candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist that is being evaluated for overactive bladder (OAB)." (Source: Urovant Sciences)
  • "Urovant Sciences reported positive data from the vibegron 12-week, Phase 3 pivotal EMPOWUR study and demonstrated favorable longer-term efficacy, safety, and tolerability in a 40-week extension study." (Source: Urovant Sciences)