Prothena Corporation plc
Prothena Corporation plc Q4 FY2022 earnings call
February 24, 2023 · fiscal period ended 2022-12
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2023-02-24
Management highlights
• Prothena is a late-stage clinical biotechnology company with a robust pipeline including four wholly-owned programs and five partner programs. • In 2022, advanced PRX012 and PRX005 into clinic, expect Phase 1 data from both; completed IND enabling studies for PRX123; prasinezumab evaluated by Roche in Phase 2b PADOVA and open-label extension of Phase 2 PASADENA; birtamimab in confirmatory Phase 3 AFFIRM-AL study; NNC6019 in Phase 2 study by Novo Nordisk. • Ended 2022 with $713M cash position, including $40M from Novo Nordisk milestone. • Highlighted breakthroughs in Alzheimer's disease, including lecanemab's approval and PRX012's potential as best-in-class subcutaneous treatment.
Segment performance
No detailed breakdown of product segments by revenue contribution in absolute terms provided in the transcript.
Guidance
• 2023 net cash used in operating and investing activities expected to be between $213M and $229M, ending with ~$512M cash. • Milestones in 2023: PRX012 multiple ascending dose study to report top line data by end 2023; Phase 1 multiple ascending dose study for PRX005 to report top line data by end 2023; submit IND for PRX123 by end 2023. • Milestones in 2024: Roche reports top line data from Phase 2b PADOVA study for prasinezumab; AFFIRM-AL study reports top line data for birtamimab; Novo Nordisk reports top line Phase 2 data for NNC6019.
Risks
• Forward-looking statements subject to risks, uncertainties, and other factors that could cause actual results to differ materially from forward-looking statements. For discussion, see press release and SEC filings.
Q&A highlights
Q: Michael Yee at Jefferies asked about PRX012's Phase 1 MAD study, what to look for after six months and contextualizing PET data.
A: Gene Kinney, Tran Nguyen, and Hideki Garren responded discussing safety, pharmacokinetics, pharmacodynamics, and PET as a tool, with focus on active data and dose bracketing.
Q: Neena Bitritto-Garg at Citi asked about number of patients for PRX012 data and PET metrics.
A: Gene Kinney, Tran Nguyen, and Hideki Garren replied discussing Phase 1 study primary endpoint safety, pharmacokinetics, pharmacodynamics, and PET parameters.
Q: Charles Duncan at Cantor Fitzgerald asked about where PRX012 single dose data will be presented and subq target product profile.
A: Gene Kinney and Wagner Zago responded discussing announcement of data submission and acceptance, and key characteristics of PRX012 for subq administration.
Q: Jay Olson at Oppenheimer asked about reimbursement landscape for Alzheimer's therapeutics.
A: Gene Kinney and Tran Nguyen responded discussing CMS's announcement, potential for Part D reimbursement, and accelerated approval pathway.
Q: Brian Abrahams at RBC Capital Markets asked about future dosing paradigm for Alzheimer's beta amyloid antibodies and its impact on PRX012.
A: Gene Kinney and Wagner Zago responded discussing chronic treatment likely needed for Abeta targeting, and how different mechanisms affect dosing paradigms.
Q: Jason Butler at JMP Securities asked about PRX005's MAD results and biomarkers.
A: Gene Kinney, Hideki Garren, and Wagner Zago responded discussing MTBR region targeting, safety, tolerability, and CSF target engagement data expected by end 2023.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
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Transcript
February 24, 2023Full transcript unavailable for redistribution
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