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AP

Amylyx Pharmaceuticals, Inc. (AMLX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 showed disciplined expense control and maintained cash runway while pipeline execution remained the core narrative: net loss improved to $41.4M ($0.46/sh) vs $72.7M ($1.07/sh) a year ago on sharply lower operating expenses, and cash/marketable securities ended at $180.8M with runway “through the end of 2026.”
  • Clinical timelines reiterated: Phase 3 LUCIDITY (avexitide for PBH) enrollment completion expected in 2025, topline in 1H26; commercial launch targeted for 2027 if approved. Company emphasized launch readiness work and KOL momentum.
  • Regulatory and pipeline updates supported sentiment: FDA granted Fast Track to AMX0114 (ALS) in June; ORION PSP readout was guided for Q3 (post‑quarter, the program was discontinued on Aug 27 after not meeting endpoints).
  • Results vs estimates: EPS slightly below consensus by ~$0.01 (actual -$0.46 vs cons -$0.45*); revenue effectively zero as expected (consensus $0*). Management reiterated cash runway and key 2H25/2026 catalysts as stock drivers (LUCIDITY progress, AMX0114 early cohort data, and PSP clarity).

What Went Well and What Went Wrong

  • What Went Well

    • Expense discipline and improved loss profile: total operating expenses fell to $42.9M (vs $75.3M YoY), driving net loss improvement to $41.4M ($0.46/sh). CFO: “Total operating expenses for the quarter were $42.9 million, down 43% from the same period in 2024.”
    • Clinical execution and clarity: Company reiterated 2025 completion of LUCIDITY enrollment and 1H26 topline; CMO highlighted strong Phase 2b signal at the selected 90 mg QD dose (64% LS mean reduction in composite Level 2/3 events; p=0.0031) and 24‑hour PK/PD coverage.
    • Regulatory momentum: FDA Fast Track designation for AMX0114 in ALS, enabling more frequent FDA interactions and potential Priority Review.

  • What Went Wrong

    • No product revenue; ongoing reset post RELYVRIO/ALBRIOZA discontinuation: Q2 product revenue was $0 (vs -$1.0M in Q2’24 from returns/adjustments).
    • R&D stepped up sequentially on avexitide/PSP costs (to $27.2M vs $22.1M in Q1), though SG&A trended lower YoY (to $15.6M vs $21.6M).
    • Post‑quarter negative datapoint: ORION PSP Phase 2b showed no differences vs placebo at Week 24; program discontinued—narrowing multi‑asset optionality and increasing reliance on LUCIDITY for value inflection.

Financial Results

Income statement summary (USD thousands; exact figures; periods ordered oldest → newest)

MetricQ2 2024Q4 2024Q1 2025Q2 2025
Product revenue, net ($000s)(1,023) (665) — —
Research & development ($000s)23,347 22,892 22,119 27,217
Selling, general & admin ($000s)21,647 17,097 15,684 15,640
Total operating expenses ($000s)75,263 39,989 37,803 42,857
Other income, net ($000s)3,586 2,473 1,896 1,414
Net (loss) income ($000s)(72,700) (37,546) (35,907) (41,443)
Diluted EPS ($)(1.07) (0.55) (0.42) (0.46)
Weighted avg. shares (basic/diluted)68,024,929 68,593,499 85,697,108 89,138,568

Cash and liquidity (USD thousands)

MetricQ4 2024Q1 2025Q2 2025
Cash, cash equivalents & marketable securities ($000s)176,501 204,068 180,826
Cash runway guidanceThrough end of 2026 Through end of 2026 Through end of 2026

Results vs Estimates (Q2 2025)

MetricConsensus*Actual
EPS (Primary)-0.45*-0.46
Revenue ($M)0.0*0.0

Segment/KPIs: No reportable segments; management focused KPIs include LUCIDITY enrollment progress and cash runway through 2026.

Note: “—” indicates zero reported revenue in the period.

Guidance Changes

MetricPeriodPrevious Guidance (Q1 2025)Current Guidance (Q2 2025)Change
LUCIDITY (avexitide) enrollment completion20252025 completion expected 2025 completion expected Maintained
LUCIDITY topline1H 20261H 2026 anticipated 1H 2026 anticipated Maintained
Potential avexitide launch (if approved)20272027 anticipated 2027 anticipated Maintained
ORION PSP unblinded Phase 2b analysisQ3 2025Q3 2025 expected Q3 2025 expected Maintained
AMX0114 (ALS) early cohort data20252025 expected 2025 expected Maintained
Cash runwayThrough 2026Through end of 2026 Through end of 2026 Maintained

Subsequent event: On Aug 27, 2025, Amylyx discontinued the ORION PSP program after not meeting Week 24 endpoints in Phase 2b.

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 and Q1’25)Current Period (Q2’25)Trend
Avexitide Phase 3 LUCIDITY timelineInitiation and recruitment plans; 2025 completion and 1H26 topline reiterated. Timeline reaffirmed; site enthusiasm; 24‑hr PK/PD and 64% composite event reduction at 90 mg from Phase 2b highlighted; launch readiness underway. Consistent, growing confidence
PBH market sizing and accessEarly market education; focus on adult endocrinology; commercial groundwork building. KOL analyses suggest ~160k “medically important” PBH; targeted endo‑led launch; low concern about daily injection compliance; payer step edits on off‑label agents seen as unlikely. Visibility improving
AMX0114 (ALS)Phase 1 planning/activation; U.S. sites to open; 2025 early cohort data targeted. FDA Fast Track granted; early cohort data expected in 2025; biomarker (NfL) focus. Positive regulatory momentum
AMX0035 PSP (ORION)High bar set; Q3 2025 unblinded 2b analysis to drive go/no‑go. Maintained bar (≥20% slowing on PSPRS deemed meaningful); post‑quarter, program discontinued. Negative post‑quarter outcome
Diagnosis/Guidelines for PBHOngoing awareness building; code work and claims analyses underway. Standardized diagnosis seen as straightforward once suspected; work toward ICD‑10 code continues; awareness rising (boards/textbooks). Awareness increasing

Management Commentary

  • “We ended the second quarter with a cash position of $180,800,000… We expect our cash runway to last through 2026.” — CFO Jim Frates
  • “We expect to complete recruitment by year end [for LUCIDITY]… and anticipate a commercial launch… in 2027 [if approved].” — Co‑CEO remarks
  • “Avexitide 90 mg once daily… led to a 64% least‑squares mean reduction (p=0.0031) vs baseline in the composite rate of Level 2 and Level 3 hypoglycemic events… with more than half… experiencing no events.” — CMO Dr. Camille Bedrosian
  • “We have set a high bar for AMX0035 [in PSP]… a clear slowing of disease progression of at least twenty percent on the PSP rating scale… could signal meaningful clinical activity.” — CMO

Q&A Highlights

  • Market size and uptake: Management cited external KOL modeling of ~160k “medically important” PBH patients and ~30k “critical” PBH; initial targeting likely through adult endocrinologists with sizable existing patient pools.
  • Trial conduct and diet control: LUCIDITY includes structured run‑in and ongoing reinforcement of medical nutrition therapy; diet adherence monitored via site interactions and questionnaires.
  • Payer dynamics: Step edits to off‑label agents (diazoxide, octreotide) are not anticipated given limited evidence and poor tolerability/efficacy perceptions.
  • PSP go/no‑go criteria: ≥20% slowing on PSPRS plus totality of biomarkers and safety would drive advancement; ultimately, post‑quarter data did not support continuation.
  • Compliance with daily injections: Near‑100% compliance in prior avexitide studies; patient feedback indicates low burden vs frequent finger sticks and severe hypoglycemia risk.

Estimates Context

  • EPS: Q2 actual -$0.46 vs consensus -$0.45* (slight miss).
  • Revenue: Q2 actual $0.0 vs consensus $0.0* (in line).
  • Estimate base: 7 EPS estimates and 8 revenue estimates in the quarter.
    • EPS (# of est): 7*
    • Revenue (# of est): 8*

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Pipeline execution remains the core equity driver: LUCIDITY enrollment remains on track for 2025 completion, with 1H26 topline the key de‑risking event; investor focus should be on enrollment cadence updates and any interim operational disclosures.
  • Clinical risk concentration has increased post‑quarter with the discontinuation of PSP; avexitide readout and AMX0114 early cohort data (2025) are next major catalysts.
  • Expense discipline is tangible (YoY opex -43%), reducing burn while preserving runway through 2026; watch for opex mix as LUCIDITY scales.
  • PBH market formation looks favorable: rising awareness, clear KOL support, and payer outlook that is not biased toward step edits on poorly supported off‑label agents.
  • Clinical rationale for avexitide strong: consistent Phase 2 signals at 90 mg QD and 24‑hour PK/PD support endpoint selection for Phase 3.
  • Commercial groundwork is underway for a targeted endo‑led launch; near‑term updates on site activation/enrollment and disease education could inform launch pacing assumptions.
  • Risk/Reward: With no current revenue, thesis hinges on clinical/regulatory execution and financing runway; maintain vigilance on trial timelines, regulatory interactions (Fast Track in ALS helpful), and cash‑burn trajectory.

Citations:

  • Q2’25 press release and financials:
  • Q2’25 earnings call transcript:
  • 8‑K including Exhibit 99.1:
  • Q1’25 press release:
  • Q4’24 press release:
  • Fast Track PR (AMX0114):
  • ORION discontinuation (post‑quarter):