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Jun 30, 2020
Sage Q2 2020 Earnings Report
Sage reported financial results and business highlights, focusing on pipeline progress and clinical trial initiations.
Key Takeaways
Sage Therapeutics reported $1.1 million in net revenue from ZULRESSO sales for the second quarter of 2020. The company is advancing its pipeline with multiple clinical trials across its depression and neurology franchises. They are initiating a Phase 3 study in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS).
Initiated enrollment and dosing in Phase 3 SKYLARK and WATERFALL Studies with zuranolone 50 mg.
Initiated dosing in the 50 mg cohort of the open-label Phase 3 SHORELINE Study.
Initiated dosing in the Phase 2 KINETIC Study evaluating SAGE-324 in patients with essential tremor.
Zuranolone was generally well-tolerated and showed a similar safety profile as seen in earlier studies.
Forward Guidance
Sage anticipates a cash balance of at least $550 million at end of 2020, which the Company anticipates will support operations into 2022 based on current operating plans. The Company does not plan to provide revenue guidance for the balance of 2020.
Positive Outlook
- Initiate dosing in Phase 3 CORAL (MDD-305) Study evaluating a two-week course of zuranolone 50 mg, when co-initiated with an open-label anti-depressant, as an acute rapid response therapy in patients with MDD.
- Report topline data from Phase 3 SHORELINE (MDD-303 – 30 mg) Study.
- Initiate Phase 3 study in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS).
- Report topline data from Phase 2a study in patients with Parkinson’s disease cognitive dysfunction.
- Report topline data from Phase 2 placebo-controlled study in ET (4Q 2020/1Q 2021).
Challenges Ahead
- The Company expects the significant adverse impact of the pandemic on ZULRESSO revenues to continue.
- Concerns about exposure to the virus have also caused a significant reduction in the number of women with PPD seeking treatment with ZULRESSO and in physicians willing to prescribe it.
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