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01/11 08:23
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call highlights significant financial risks with an 80% revenue decline and increased R&D expenses, leading to a substantial net loss. Clinical trial failures and regulatory uncertainties amplify the negative outlook. The Q&A reveals management's evasiveness on trial specifics, further eroding confidence. Lack of shareholder return initiatives and competitive market pressures exacerbate concerns. Without positive catalysts or strategic plans, the stock is likely to experience a strong negative reaction.
Cash and Cash Equivalents $52.9 million as of December 31, 2024.
Total Revenue (Q4 2024) $15 million, a decrease of $58.5 million (80%) compared to $73.5 million in Q4 2023, primarily due to a decrease in collaboration revenue from agreements with GSK and Pfizer.
Total Revenue (Full Year 2024) $48 million, a decrease of $55.8 million (54%) compared to $103.8 million in 2023, primarily due to a decrease in collaboration revenue from agreements with GSK and Pfizer.
R&D Expenses (Q4 2024) $28.8 million, an increase of $12.2 million (73%) compared to $16.6 million in Q4 2023, primarily due to increased clinical trial activity related to the Phase 3 PIVOT-PO trial for tebipenem HBr.
R&D Expenses (Full Year 2024) $97 million, an increase of $45.6 million (89%) compared to $51.4 million in 2023, primarily due to increased clinical trial activity related to the Phase 3 PIVOT-PO trial for tebipenem HBr.
G&A Expenses (Q4 2024) $7.1 million, an increase of $0.7 million (11%) compared to $6.4 million in Q4 2023, primarily due to increased consulting and professional fees.
G&A Expenses (Full Year 2024) $23.7 million, a decrease of $1.9 million (7%) compared to $25.6 million in 2023, primarily due to decreases in personnel-related costs.
Net Loss (Q4 2024) $20.7 million, compared to a net income of $51.2 million in Q4 2023.
Net Loss (Full Year 2024) $68.4 million, compared to a net income of $22.8 million in 2023.
Diluted Net Loss per Share (Q4 2024) $0.38, compared to net income per share of $0.96 in Q4 2023.
Diluted Net Loss per Share (Full Year 2024) $1.27, compared to net income per share of $0.43 in 2023.
Tebipenem HBr: In a Phase 3 trial, tebipenem HBr is being developed as the first broad-spectrum oral carbapenem for treating complicated urinary tract infections (cUTIs). An interim analysis is expected in Q2 2025.
SPR720: SPR720, a gyrase B inhibitor for nontuberculous mycobacterial pulmonary disease, did not meet its primary endpoint in a Phase IIa trial, with potential safety concerns noted.
Market Positioning for Tebipenem HBr: Tebipenem HBr aims to address the unmet need for oral treatment options in complicated UTIs, potentially reducing hospitalization length.
Financial Position: As of December 31, 2024, Spero had cash and cash equivalents of $52.9 million, expected to fund operations into Q2 2026.
R&D Expenses: R&D expenses increased to $28.8 million in Q4 2024, primarily due to the Phase 3 trial for tebipenem HBr.
Discontinuation of SPR206: Spero has decided to discontinue the development of SPR206, an IV-administered next-gen polymyxin antibiotic.
Clinical Trial Risks: The Phase IIa trial for SPR720 did not meet its primary endpoint, showing insufficient separation from placebo and potential dose-limiting safety signals, including reversible grade 3 hepatotoxicity in the high-dose cohort.
Regulatory Risks: The success of tebipenem HBr is contingent on the completion of the Phase 3 trial and subsequent regulatory approval, which carries inherent uncertainties.
Financial Risks: A significant decrease in total revenue from $73.5 million in Q4 2023 to $15 million in Q4 2024, primarily due to reduced collaboration revenue from agreements with GSK and Pfizer.
Operational Risks: Increased R&D expenses from $16.6 million in Q4 2023 to $28.8 million in Q4 2024, indicating higher costs associated with clinical trial activities, which may impact financial stability.
Market Risks: The potential for competitive pressures in the biopharmaceutical market, particularly for treatments addressing multidrug-resistant infections, could affect market share and pricing.
Tebipenem HBr Phase 3 Trial: Spero's top priority is the continued advancement of the tebipenem program, with a prespecified interim analysis expected to be completed in Q2 2025.
SPR720 Development: The development of SPR720 has been paused following an interim analysis that did not meet primary endpoints, with further assessment of the full data set planned.
Discontinuation of SPR206: Spero has decided to discontinue the development of SPR206, an IV-administered next-gen polymyxin antibiotic.
Collaboration with GSK: If tebipenem HBr is approved, Spero could qualify for about $400 million in contingent milestones from GSK.
Cash Position: As of December 31, 2024, Spero had cash and cash equivalents of $52.9 million, expected to fund operations into Q2 2026.
Revenue Expectations: Total revenue for Q4 2024 was $15 million, down from $73.5 million in Q4 2023, with total revenue for 2024 at $48 million compared to $103.8 million in 2023.
R&D Expenses: R&D expenses for Q4 2024 were $28.8 million, up from $16.6 million in Q4 2023, primarily due to increased clinical trial activity.
Net Loss: Spero reported a net loss of $20.7 million for Q4 2024 and $68.4 million for the full year.
Shareholder Return Plan: Spero Therapeutics has not announced any share buyback program or dividend program during the call.
The earnings call highlights significant financial risks with an 80% revenue decline and increased R&D expenses, leading to a substantial net loss. Clinical trial failures and regulatory uncertainties amplify the negative outlook. The Q&A reveals management's evasiveness on trial specifics, further eroding confidence. Lack of shareholder return initiatives and competitive market pressures exacerbate concerns. Without positive catalysts or strategic plans, the stock is likely to experience a strong negative reaction.
The earnings call reveals significant financial challenges, with a drastic revenue decline and increased losses. The clinical trial for SPR720 failed to meet its primary endpoint, posing risks. The lack of a shareholder return plan and increased R&D expenses further dampen sentiment. The Q&A section highlights management's uncertainty and lack of clear guidance, exacerbating concerns. Overall, the combination of financial struggles, clinical setbacks, and unclear strategic direction suggests a strong negative sentiment, likely leading to a significant stock price decline.
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