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Annexon, Inc. (ANNX)·Q1 2025 Earnings Summary
Executive Summary
- Q1 2025 in line operationally with tightening timelines; EPS missed on higher R&D as programs advanced. GAAP net loss was $54.4M (–$0.37 EPS) vs –$25.2M (–$0.21) YoY as R&D rose to $48.2M on late‑stage spend in GBS (tanruprubart), GA (ANX007) and ANX1502 .
- Cash, cash equivalents and short‑term investments were $263.7M, funding runway into 2H 2026, consistent with prior disclosures; cash and ST investments decreased from $312.0M at 12/31/24 as expected with program ramp .
- Clinical/regulatory catalysts tightened: FDA meeting for tanruprubart scheduled Q2 2025 ahead of planned BLA; FORWARD open‑label access study to initiate in Q2 2025; ANX007 ARCHER II enrollment now targeted complete in Q3 2025 (tightened from 2H 2025), topline in 2H 2026; ANX1502 POC completion mid‑2025 .
- Estimates context: Revenue remained pre‑commercial; EPS missed S&P Global consensus by ~$0.08 (actual –$0.37 vs –$0.2873*). Revenue was in line with $0.0M* consensus . Values retrieved from S&P Global.
What Went Well and What Went Wrong
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What Went Well
- Regulatory path and timelines clarified/accelerated: tanruprubart FDA meeting scheduled in Q2 2025; ANX007 ARCHER II enrollment expected to complete by Q3 2025 (tightened from 2H 2025) .
- Positive external validation: RWE and pivotal analyses presented by IGOS and at PNS showed rapid strength gains by Week 1 and greater likelihood of better health states vs IVIg/PE; pivotal Phase 3 analyses reinforced early and durable effects .
- Strong strategic tone: “With continued strong strategic execution and runway into the second half of 2026, we are well‑positioned to drive immense near to mid‑term value” — Douglas Love, CEO .
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What Went Wrong
- EPS miss vs Street on higher R&D investment; GAAP R&D rose to $48.2M (vs $21.0M YoY) reflecting program advancement; net loss widened to $54.4M (–$0.37) from $25.2M (–$0.21) YoY .
- Cash draw as expected: cash+ST investments fell to $263.7M from $312.0M at 12/31/24 with ongoing late‑stage execution, though runway to 2H 2026 maintained .
- No commercial revenue and no non‑GAAP/adjusted P&L provided; investor focus remains on execution risk/timing of regulatory outcomes rather than financial leverage .
Financial Results
Notes: Revenue not presented in the company’s statements of operations; development‑stage with no reported product revenue .
KPIs (Execution)
- Tanruprubart: FDA meeting Q2 2025; FORWARD access study initiation Q2 2025 .
- ANX007: ARCHER II enrollment completion Q3 2025; topline 2H 2026 .
- ANX1502: POC completion in CAD mid‑2025 .
Guidance Changes
Earnings Call Themes & Trends
Note: A Q1 2025 earnings call transcript could not be located in our document repository after targeted searches of “earnings-call-transcript” around May 12, 2025; analysis below reflects Q3–Q1 press releases and related updates .
Management Commentary
- “Our innovative C1 platform has yielded multiple wholly owned late‑stage programs that have been shown to stop harmful neuroinflammation and lead to positive outcomes for patients across an array of diseases.” — Douglas Love, President & CEO .
- “ANX007 is poised to be the first vision‑preserving treatment for dry AMD with GA globally … we are on an accelerated pace to complete enrollment of the ongoing Phase 3 ARCHER II trial in the third quarter and deliver pivotal topline data in the second half of 2026.” — Douglas Love .
- “With continued strong strategic execution and runway into the second half of 2026, we are well‑positioned to drive immense near to mid‑term value” — Douglas Love .
Q&A Highlights
- The Q1 2025 earnings call transcript was not available in our source set despite multiple targeted searches around the May 12, 2025 results date; therefore, Q&A themes and clarifications are unavailable from a transcript [Search attempts and absence noted; see documents list and searches: no earnings-call-transcript returned for the window] .
- Clarifications gleaned from releases: R&D spend elevation reflects prioritized advancement in GBS, GA and ANX1502; cash runway into 2H 2026 maintained . RWE data and pivotal analyses provided supportive external validation for tanruprubart’s clinical profile .
Estimates Context
- Q1 2025: GAAP EPS –$0.37 vs –$0.2873 consensus* → bold miss on higher R&D; revenue in line with $0.0M consensus* . Values retrieved from S&P Global.
- Trailing quarters: Q4 2024 EPS –$0.33 vs –$0.2933* (miss); Q3 2024 EPS –$0.25 vs –$0.2699* (beat) . Values retrieved from S&P Global.
Values retrieved from S&P Global.
Implications: Street models likely lift R&D and operating loss trajectory near‑term given accelerated execution timelines; no change to revenue given pre‑commercial stage.
Key Takeaways for Investors
- EPS miss is a function of accelerated late‑stage execution (higher R&D); the operational update is arguably positive with more precise/earlier timelines (tanruprubart FDA meeting Q2, ANX007 enrollment Q3) .
- Regulatory and real‑world data momentum de‑risks the GBS program narrative into the pre‑BLA meeting and BLA filing; watch for any FDA feedback on the totality of evidence including RWE .
- ANX007 remains a large optionality driver; enrollment completion in Q3 2025 is a meaningful interim catalyst ahead of pivotal 2H 2026 data .
- Cash runway into 2H 2026 is intact; expect continued quarterly burn consistent with late‑stage programs; financing risk moderated near‑term but extends into regulatory decision windows .
- Near‑term trading setup hinges on: (1) outcomes/tones from the Q2 FDA meeting, (2) start of FORWARD access study, and (3) continued enrollment pace updates; any positive regulatory signals could be stock‑moving .
- No non‑GAAP metrics provided; focus on GAAP OpEx trajectory and milestone timing as primary model drivers .
- Risk factors: regulatory review outcomes, comparative positioning vs IVIg/PE in practice, and timing discipline across multiple concurrent programs .
Sources: Q1 2025 press release and 8‑K, prior quarter releases, and program updates . EPS and revenue consensus from S&P Global (asterisked).