EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2020-05-07
Management highlights
• Despite COVID-19, Savara had a strong start to 2020. • Continued discussions with FDA about IMPALA 2, aiming for a feasible study design with DLCO as primary endpoint. • Pipeline expanded with Apulmiq, a late-stage investigational inhaled ciprofloxacin for non-cystic fibrosis bronchiectasis. • Cystic fibrosis studies (AVAIL and ENCORE) stopped enrolling new patients due to COVID-19, but efforts to keep enrolled patients in studies ongoing. • Contributing to COVID-19 research by discussing supply of Molgradex for a placebo-controlled study in COVID-19 pneumonia. • Cash position as of March 31, 2020, was ~$105 million with ~$25 million debt; sufficient to fund operations into 2022. • R&D priorities include advancing Phase 3 programs and ensuring operational maturity.
Segment performance
No specific segment performance data with revenue contributions provided in the transcript.
Guidance
• Discussions with FDA for NCFB program to initiate trial are a priority in 2020 but no specific timeline given. • IMPALA 2 study design has differences from IMPALA, including primary endpoint change to DLCO, 48-week placebo-controlled treatment period. • Resources allocated with first priority to IMPALA 2 study, and Apulmiq program to be funded as prep work for ORBIT-5 progresses.
Risks
• COVID-19 impact on study enrollments and timelines for cystic fibrosis studies. • Uncertainties in finalizing study protocols for IMPALA 2 and NCFB programs, leading to potential delays.
Q&A highlights
Q: Do you have enough cash to get through the IMPALA 2 study?
A: Still several open factors impacting study size and timelines, including pandemic effects. Working to finalize protocol and arrangements by June for better estimates.
Q: Can you tell us specifically what you're talking about regarding operational maturity efforts?
A: Successful execution of Phase 3 studies requires robust internal processes and topnotch external vendors for high-quality study activities and robust study oversight; Savara is putting effort into implementing improvements to operations and strengthening resources for study success.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.27 | $-0.28 | +3.6% | — |
| Revenue | — | — | — | — |
Transcript
May 7, 2020Full transcript unavailable for redistribution
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