Annexon, Inc. (ANNX)·Q3 2025 Earnings Summary

Executive Summary

• Annexon reported Q3 2025 with rising R&D investment and a widened net loss as programs advanced; EPS of -$0.37 missed consensus by ~$0.03, while revenue remained at $0 given the pre-commercial profile . EPS consensus: -$0.343; Revenue consensus: $0.0.*
• Strategic timelines largely intact: EU MAA for tanruprubart (GBS) narrowed to January 2026 and ARCHER II (vonaprument in GA) topline remains targeted for 2H 2026; ANX1502 POC timeline slipped to 2026 from a year-end 2025 update .
• Liquidity extended: Cash and investments were $188.7M as of 9/30/25; company extended operating runway into late Q1 2027 (from Q4 2026 previously), and subsequently priced a $75M offering on Nov. 12-13, 2025 to bolster the balance sheet .
• Near-term stock catalysts: clarity on FDA BLA path for tanruprubart, EU MAA submission in Jan 2026, and continued EMA PDC engagement and Phase 3 execution in GA; the offering introduces dilution but supports runway through key milestones .

What Went Well and What Went Wrong

• What Went Well

  • Regulatory momentum: “Our registrational Guillain-Barré Syndrome program is on track for EU MAA submission in January 2026… Dialogue with the FDA is also ongoing regarding the generalizability package supporting the U.S. BLA submission.” – CEO Douglas Love .
  • GA program execution: ARCHER II completed enrollment early with 659 patients, exceeding targets; remains on track for topline in 2H 2026 and benefits from EMA PDC pilot support .
  • Runway strengthened: Runway extended into late Q1 2027 from Q4 2026 previously; post-quarter, a $75M offering further supports funding through milestones .

• What Went Wrong

  • Earnings miss and higher burn: EPS of -$0.37 missed consensus; net loss expanded YoY driven by Phase 3 spend and GBS filing prep . EPS consensus -$0.343.*
  • ANX1502 timing push: Company now anticipates POC study completion in 2026 vs. a year-end 2025 update previously, reflecting a delay in that program’s data timing .
  • FDA clarity outstanding: While EU MAA timing is specific (Jan 2026), U.S. BLA timing remains dependent on ongoing “generalizability” discussions with the FDA, leaving a key U.S. catalyst date unpinned .

Financial Results

Notes: All $ values are USD. Annexon reported no product revenue; financials emphasize operating expenses and cash runway .

Versus Estimates

Values marked with * are retrieved from S&P Global. Annexon did not report product revenue; results are consistent with a pre-commercial stage .

KPIs and Operating Metrics

Guidance Changes

Earnings Call Themes & Trends

Note: An official Q3 2025 earnings call transcript was not available in our corpus as of this report. Themes below reflect consistent disclosures across Q1, Q2, and Q3 press materials.

Management Commentary

• “Our registrational Guillain-Barré Syndrome program is on track for EU MAA submission in January 2026… Dialogue with the FDA is also ongoing regarding the generalizability package supporting the U.S. Biologics License Application (BLA) submission.” – Douglas Love, President & CEO .
• “Our registrational Phase 3 trial for vonaprument in GA is on track to deliver topline data in the second half of 2026. The study is designed to confirm the significant vision preservation observed in our Phase 2 trial…” – Douglas Love .
• “We’ve observed targeted drug levels in fasted CAD patients [ANX1502], and we continue to dose to deepen our understanding… anticipating study completion in 2026.” – Douglas Love .

Q&A Highlights

• Not available: The company did not post an earnings call transcript in our corpus for Q3 2025 as of this report date. As such, Q&A themes and any clarifications versus prepared remarks are unavailable.

Estimates Context

• Q3 2025 EPS came in at -$0.37 vs. S&P Global consensus of -$0.343, a ~$0.03 miss; revenue remained at $0, in line with the $0.0 consensus as the company is pre-commercial.* Actual EPS from reported financials .
• With R&D ramping for pivotal programs and regulatory packages, Street models may need to incorporate higher near-term OpEx and the extended runway into late Q1 2027, with program timelines largely unchanged except for the ANX1502 POC shift .

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

• EU MAA for tanruprubart is set for January 2026; timely acceptance/validation could be an early 2026 catalyst, while any FDA clarity on the “generalizability” package would materially de-risk the U.S. path .
• GA program remains on track (ARCHER II topline 2H 2026) with EMA PDC support, reinforcing a potentially differentiated “vision preservation” narrative; continued regulatory engagements are positives for sentiment .
• Burn stepped up with pivotal execution; expect OpEx to remain elevated through filings and Phase 3 readout, pressuring EPS near term; Q3 EPS missed by ~$0.03 vs consensus.* Actual EPS -$0.37 from filings .
• Liquidity improved: runway extended into late Q1 2027 and further strengthened by a $75M offering priced in November; dilution is a trade-off for funding milestones .
• ANX1502 POC push into 2026 tempers nearer-term optionality; monitor upcoming PK/PD and hemolysis marker read-throughs for broader autoimmune potential .
• Stock setup: near-term moves likely tied to U.S. BLA visibility and BD updates for tanruprubart, plus any interim regulatory feedback; medium-term thesis hinges on execution toward EU MAA and ARCHER II’s vision-preservation endpoint in GA .

References:

• Q3 2025 Press Release and Financials
• Q3 2025 8-K and Exhibit 99.1
• Q2 2025 Press Release and Financials
• Q1 2025 Press Release and Financials
• EMA PDC selection and ARCHER II enrollment completion
• Equity offering announcements (subsequent event)

S&P Global estimates:

• Q3 2025 EPS and revenue consensus, and # of estimates (EPS est. -$0.343; revenue est. $0.0; EPS # est. 4; revenue # est. 7).*