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Dec 31, 2024
Annexon Q4 2024 Earnings Report
Annexon reported a net loss of $48.6 million and an EPS of -$0.33 for Q4 2024, with total operating expenses at $52.479 million.
Key Takeaways
Annexon, Inc. reported a net loss of $48.6 million for the fourth quarter of 2024, with a diluted EPS of -$0.33. The company's total operating expenses reached $52.479 million, driven by increased research and development activities. Despite the loss, Annexon highlighted significant progress in its clinical programs, including ANX005 for GBS and ANX007 for dry AMD, and maintained a strong cash position with an anticipated runway into the second half of 2026.
Robust Phase 3 data and real-world evidence support ANX005 as a potential first targeted therapy for GBS, with a pre-BLA meeting targeted for 1H 2025.
A groundbreaking global registration path has been established for ANX007 as a potential first vision-preserving treatment for dry AMD with GA in Europe and the U.S., with topline Phase 3 ARCHER II data expected in H2 2026.
The first-in-kind oral C1s inhibitor ANX1502 is undergoing a POC trial with dosing in three patients with Cold Agglutinin Disease, and an expanded dataset is expected mid-2025.
Annexon maintains a strong balance sheet with approximately $312 million in cash, cash equivalents, and short-term investments as of December 31, 2024, providing an anticipated runway into the second half of 2026.
Annexon
Annexon
Forward Guidance
Annexon anticipates significant progress in its clinical programs and expects its current cash and investments to fund operations into the second half of 2026.
Positive Outlook
- Pre-BLA meeting for ANX005 targeted for 1H 2025, ahead of planned BLA submission.
- Groundbreaking global registration path established for ANX007 in Europe and U.S. for dry AMD with GA.
- Topline Phase 3 ARCHER II data for ANX007 expected in H2 2026.
- Expanded ANX1502 dataset to include up to seven patients expected mid-2025.
- Cash, cash equivalents, and short-term investments are expected to be sufficient to fund planned operating expenses into the second half of 2026.
Challenges Ahead
- Final results from the Phase 3 ARCHER II trial are subject to change.
- The company's history of net operating losses may continue.
- Ability to obtain necessary capital to fund clinical programs is a risk.
- Early stages of clinical development for some product candidates pose inherent risks.
- Public health crises could impact clinical programs and business operations.