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8I

89bio, Inc. (ETNB)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was execution-focused: management reiterated Phase 3 timelines in MASH (ENLIGHTEN-Fibrosis 1H 2027; ENLIGHTEN-Cirrhosis 2028) and SHTG (ENTRUST 1Q 2026) while absorbing a one-time $42.4M manufacturing facility payment; net loss widened accordingly .
  • EPS missed Wall Street consensus due to elevated R&D tied to Phase 3 programs and the non-recurring payment: Actual EPS was -$0.71 vs consensus -$0.48 to -$0.49*; R&D rose to $103.9M from $44.9M YoY .
  • Cash and equivalents of $561.2M support continued Phase 3 execution and commercial-scale readiness; remaining facility obligation is a $13.5M milestone payable in 2026 .
  • Stock reaction catalyst: the EPS miss driven by a one-time CMC payment and higher Phase 3 spend contrasts with strong liquidity and unchanged trial timelines, setting expectations heading into ENTRUST topline in 1Q 2026 .

What Went Well and What Went Wrong

What Went Well

  • Phase 3 programs on track: ENTRUST topline (SHTG) expected 1Q 2026; ENLIGHTEN-Fibrosis 1H 2027; ENLIGHTEN-Cirrhosis 2028; reiterated alignment with FDA/EMA for accelerated approval based on histology cohorts .
  • Manufacturing readiness: commercial-scale production facility construction remains on schedule to support BLA; flexible global manufacturing footprint highlighted earlier in the year .
  • CEO confidence on differentiation: “pegozafermin is poised to potentially deliver best-in-class relative risk ratio on histology endpoints, a favorable safety and tolerability profile, and a convenient dosing approach” .

What Went Wrong

  • EPS miss vs consensus: Actual -$0.71 vs consensus around -$0.49 to -$0.48*, driven by a one-time $42.4M facility payment and higher Phase 3 R&D .
  • Operating spending intensity: R&D rose to $103.9M (from $44.9M YoY) and G&A to $11.9M (from $8.6M YoY), widening net loss to $111.5M from $48.0M YoY .
  • Long-dated MASH timelines: major catalysts (MASH histology) do not occur until 2027–2028, extending the path to potential full approval despite accelerated-approval strategy .

Financial Results

Headline P&L and Cash (USD)

MetricQ2 2024Q1 2025Q2 2025
Net Loss ($USD Millions)$48.0 $71.3 $111.5
Diluted EPS ($USD)-$0.48 -$0.49 -$0.71
R&D Expense ($USD Millions)$44.9 $64.4 $103.9
G&A Expense ($USD Millions)$8.6 $11.5 $11.9
Total Operating Expenses ($USD Millions)$53.4 $75.9 $115.8
Cash & Equivalents ($USD Millions)—$638.8 $561.2

Notes: “—” denotes not disclosed for Q2 2024 in the press materials above. All figures per company’s condensed statements and press releases.

Balance Sheet Snapshot (USD)

MetricDec 31, 2024Jun 30, 2025
Cash & Equivalents ($USD Millions)$439.955 $561.164
Total Assets ($USD Millions)$478.685 $603.485
Total Stockholders’ Equity ($USD Millions)$400.789 $521.733

Consensus vs Actual (Current Quarter)

MetricQ2 2025 ConsensusQ2 2025 Actual
Primary EPS Consensus Mean ($USD)-$0.48 to -$0.49*-$0.71
Primary EPS – # of Estimates7.0*—
Revenue Consensus Mean ($USD)$0.00*N/A (not disclosed in press materials)
Revenue – # of Estimates5.0*—

Values marked with an asterisk (*) retrieved from S&P Global.

KPIs and Operating Items

KPIQ2 2024Q1 2025Q2 2025
Interest Income & Other, net ($USD Millions)$6.47 $6.04 $6.21
Weighted-Average Diluted Shares (Millions)99.83 146.37 157.88
One-time Facility Payment ($USD Millions)——$42.4

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ENTRUST topline (SHTG)1Q 20261Q 2026 (post-FDA update to unblind at Week 52) 1Q 2026 Maintained
ENTRUST unblinding approachStudy completionUpdated in Q4 2024 to unblind at Week 52 (primary endpoint still at Week 26, analyzed after Week 52) No change in Q1/Q2 2025 Maintained
ENLIGHTEN-Fibrosis histology readout1H 20271H 2027 1H 2027 Maintained
ENLIGHTEN-Cirrhosis histology readout20282028 2028 Maintained
Manufacturing/CMC readinessBLA prepFlexible global manufacturing strategy implemented; follow-on equity financing completed Facility on schedule; remaining $13.5M milestone due in 2026 Maintained; clarified payment timing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Regulatory alignment (FDA/EMA)Alignment obtained for accelerated approval based on histology cohorts; trials continue for outcomes toward full approval Reiterated FDA/EMA alignment; histology cohorts intended to support accelerated approval Stable, reaffirmed
R&D execution & trial enrollmentENLIGHTEN trials initiated; ENTRUST enrollment completed (369 pts) ENLIGHTEN trials continue enrolling; timelines intact Consistent execution
Manufacturing/CMC & scale-upFlexible global manufacturing strategy; optionality across geographies Commercial facility on schedule; one-time $42.4M payment; final $13.5M milestone in 2026 Advancing toward commercial readiness
Macro/tariffs risk commentaryGeneral macro risks noted Explicit mention of tariffs and potential additional tariffs in forward-looking risk factors Heightened macro watch
Financing & liquidityCash $440.0M YE 2024; follow-on offerings in 4Q’24 and 1Q’25 (gross $143.7M and $287.5M) Cash $561.2M at 6/30/25 Strengthened liquidity

Management Commentary

  • “As we enter the second half of 2025, we remain diligently focused on execution across our three global Phase 3 trials for pegozafermin in MASH and SHTG…pegozafermin is poised to potentially deliver best-in-class relative risk ratio on histology endpoints, a favorable safety and tolerability profile, and a convenient dosing approach…” — Rohan Palekar, CEO .
  • “To support our development and commercial readiness efforts, we have implemented a flexible, global manufacturing strategy with optionality for our manufacturing footprint across geographies, including the United States for the drug product.” .

Q&A Highlights

  • A Q2 2025 conference call was scheduled for August 7, 2025 at 4:00 PM ET; however, a full earnings call transcript could not be located via our document tools. “Press Release (8-K)” and “Quarterly Report (10-Q)” resources are available via MarketBeat’s aggregator (Press Release) and (resources list).
  • Given no transcript available in our repository, themes are inferred from the 8-K/press release: reaffirmation of timelines, accelerated-approval strategy, and manufacturing readiness .

Estimates Context

  • EPS missed Wall Street consensus: Actual -$0.71 vs consensus around -$0.48 to -$0.49*, reflecting higher R&D tied to Phase 3 and a one-time $42.4M facility payment .
  • Revenue remains immaterial for the clinical-stage portfolio; consensus revenue was $0.00* and no product revenue was disclosed in the company’s press materials .
  • Forward estimate implications: Near-term consensus may need to reflect the one-time CMC cash outflow already recognized and continued Phase 3 cost intensity; timelines remain unchanged (no adjustments to catalyst dating) .

Values marked with an asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term setup is defined by ENTRUST topline (SHTG) in 1Q 2026; timelines were reaffirmed, reducing calendar risk into 2026 .
  • The Q2 EPS miss was principally due to a non-recurring $42.4M facility payment; expect normalization of R&D cadence excluding such one-time CMC items .
  • Liquidity remains strong ($561.2M cash/equivalents), supporting trial execution and commercial readiness activities through key milestones .
  • Regulatory strategy remains consistent: accelerated-approval filings for MASH cohorts based on histology, with outcomes continuation for potential full approval; this underpins medium-term value creation into 2027–2028 .
  • Manufacturing readiness is advancing (facility on schedule), mitigating CMC/regulatory risk ahead of potential BLA submission pending positive Phase 3 data .
  • Watch macro/tariffs risk disclosures as a potential exogenous headline driver; otherwise, core narrative is clinical progress, CMC readiness, and balance sheet strength .
  • Trading lens: EPS miss headline is offset by clean reaffirmation of timelines and cash strength; focus shifts to any 10-Q disclosures and subsequent conference commentary to refine OpEx trajectory and cash burn expectations .

References: Q2 2025 8-K and press release ; Q1 2025 8-K and press release ; Q4 2024 8-K ; MarketBeat resources and earnings call schedule .