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01/11 11:06
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Earnings call shows EPS and net loss near lower guidance, no share repurchase, and uncertainties in AL amyloidosis treatment. Q&A reveals lack of specifics on critical issues and unclear management responses, indicating potential risks. Although management is optimistic about birtamimab's market potential, the financial metrics and lack of guidance clarity suggest a negative sentiment. Given the small-cap nature of the company, this could lead to a stock price decline of -2% to -8%.
Reported EPS $-1.08 EPS, a decrease from expectations of $-1.02.
Net cash used in operating and investing activities $150.3 million, which is at the low end of guidance range of $148 million to $160 million.
Net loss $122.3 million, which is at the low end of guidance range of $120 million to $135 million.
Cash, cash equivalents, and restricted cash $472.2 million, in-line with guidance of $468 million.
Ordinary shares outstanding Approximately 53.8 million shares.
Estimated net cash used in operating and investing activities for 2025 Expected to be between $168 million and $175 million.
Estimated net loss for 2025 Estimated to be between $197 million and $205 million, which includes an estimated $41 million of non-cash share-based compensation expense.
Expected cash, cash equivalents, and restricted cash at end of 2025 Approximately $301 million, representing the midpoint of the range.
Birtamimab: Currently the only potential treatment for AL amyloidosis that has demonstrated an early survival benefit in a randomized clinical trial. Expected to submit a BLA to the FDA for potential U.S. launch by the second half of 2026.
PRX012: Anti-A-beta program designed for a single injection once-monthly subcutaneous treatment. Initial results expected mid-2025.
PRX123: Dual anti-A-beta and anti-tau vaccine with fast-track designation and IND cleared by the FDA.
PRX019: Received an $80 million payment from BMS for a global license agreement and initiated a Phase 1 clinical trial.
AL Amyloidosis Market: Approximately 16,000 diagnosed and treated AL amyloidosis patients in the U.S., with a significant unmet need for treatments addressing early mortality.
Global Market Opportunity for Birtamimab: Expected to be a multi-billion dollar global market opportunity at peak.
Cash Position: As of December 31, 2024, Prothena had $472.2 million in cash, cash equivalents, and restricted cash.
2025 Financial Guidance: Expected net cash used in operating and investing activities to be between $168 million and $175 million.
Partnerships: Four ongoing clinical partnerships with large pharmaceutical companies to advance potentially transformative medicines.
Commercial Strategy for Birtamimab: Plan to independently commercialize birtamimab in the U.S. and evaluate launch timing in European markets.
Earnings Miss: Prothena Corporation missed earnings expectations with a reported EPS of $-1.08, compared to expectations of $-1.02.
Regulatory Risks: The company is subject to regulatory risks associated with the FDA's approval process for its clinical programs, particularly the Phase 3 AFFIRM-AL trial for birtamimab, which has a defined statistical significance threshold.
Clinical Trial Risks: The success of Prothena's clinical programs, including birtamimab and its Alzheimer’s portfolio, is contingent on upcoming trial results, which may not meet expectations.
Market Competition: Prothena faces competitive pressures in the biotechnology sector, particularly in the treatment of AL amyloidosis and Alzheimer’s disease, where multiple therapies are being developed.
Financial Performance: The company reported a net loss of $122.3 million for 2024, which is at the low end of their guidance range, indicating ongoing financial challenges.
Cash Flow Risks: Prothena expects net cash used in operating and investing activities to increase in 2025, with an estimated net loss of $197 million to $205 million, raising concerns about cash flow sustainability.
Partnership Dependencies: Prothena's reliance on partnerships with large pharmaceutical companies for clinical programs introduces risks related to the performance and decisions of these partners.
Market Access Challenges: The company anticipates challenges in establishing market access and commercial capabilities for birtamimab, particularly in a specialized treatment landscape.
Birtamimab: Birtamimab is the only potential treatment for AL amyloidosis that has demonstrated an early survival benefit in a randomized clinical trial. The primary endpoint in the ongoing Phase 3 AFFIRM-AL trial is time to all-cause mortality, with top-line results expected in Q2 2025.
Alzheimer’s Disease Portfolio: Prothena's Alzheimer’s disease programs, PRX012 and PRX123, are designed to address unmet needs in early symptomatic and presymptomatic patients. Initial results from the Phase 1 ASCENT clinical trials for PRX012 are expected mid-2025.
Commercialization Strategy: Prothena plans to independently commercialize birtamimab in the U.S. by the second half of 2026, targeting a market of approximately 16,000 diagnosed AL amyloidosis patients.
Partnerships: Prothena has four ongoing clinical partnerships with large pharmaceutical companies to advance transformative medicines.
2025 Financial Guidance: Prothena expects net cash used in operating and investing activities to be between $168 million and $175 million for 2025, with an estimated net loss of $197 million to $205 million.
Cash Position: Prothena anticipates ending 2025 with approximately $301 million in cash, cash equivalents, and restricted cash.
Market Opportunity: Birtamimab is projected to be a multi-billion dollar global market opportunity at peak, with a focus on Mayo Stage IV AL amyloidosis patients.
Share Repurchase Program: None
Earnings call shows EPS and net loss near lower guidance, no share repurchase, and uncertainties in AL amyloidosis treatment. Q&A reveals lack of specifics on critical issues and unclear management responses, indicating potential risks. Although management is optimistic about birtamimab's market potential, the financial metrics and lack of guidance clarity suggest a negative sentiment. Given the small-cap nature of the company, this could lead to a stock price decline of -2% to -8%.
The earnings call highlights strong financial health with no debt, strategic partnerships, and significant cash reserves. Product development in Alzheimer's and Parkinson's disease is progressing well, with promising preclinical results and ongoing trials. The Q&A section did not reveal any major concerns, and the management's responses were clear. Although there are operational and supply chain risks, the company's strong financial position and strategic advancements suggest a positive outlook. Given the small-cap status, these positive factors are likely to result in a stock price increase of 2% to 8%.
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