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Akero Therapeutics, Inc. (AKRO)·Q4 2024 Earnings Summary

Executive Summary

  • Reported Q4 2024 and FY 2024 results with total operating expenses of $78.0M and net loss of $70.0M; cash, cash equivalents and short-term marketable securities were $743.1M as of December 31, 2024 .
  • Bold clinical catalyst: reported an unprecedented, statistically significant reversal of compensated cirrhosis (F4) at Week 96 in the Phase 2b SYMMETRY study for patients treated with 50mg EFX, including 39% reversal in completers vs 15% placebo and 29% ITT vs ~12% placebo; noninvasive fibrosis and liver injury measures also improved .
  • Strengthened balance sheet via a $402.5M upsized public offering closed on January 30, 2025; management now guides cash runway into 2028, extending prior guidance .
  • Phase 3 SYNCHRONY program progressing: Real-World double-blind enrollment completed in January 2025; increased screening for Outcomes following January SYMMETRY readout; Histology 52-week results remain on track for H1 2027, Real-World topline on track for H1 2026 .
  • Wall Street consensus (S&P Global) for Q4 2024 revenue/EPS was unavailable due to data access limits; cannot assess beats/misses relative to estimates.*

What Went Well and What Went Wrong

What Went Well

  • Bold efficacy signal in compensated cirrhosis (F4): 39% reversal with 50mg EFX at Week 96 among completers vs 15% placebo; ITT 29% vs ~12% placebo; in non‑GLP‑1 baseline subgroup, 45% reversal vs 17% placebo, supporting effect attribution to EFX .
  • Management tone confident: “These exciting results… show EFX’s potential to improve outcomes… for those with compensated cirrhosis” – Andrew Cheng, M.D., Ph.D., CEO .
  • Execution in Phase 3: Real‑World double‑blind enrollment completed; Outcomes seeing increased screening post‑readout; Histology and Real‑World timelines reaffirmed .

What Went Wrong

  • Operating expenses elevated: Q4 2024 total OpEx $78.0M vs $61.9M in Q4 2023; driver was higher R&D tied to Phase 2b SYMMETRY and Phase 3 SYNCHRONY studies, plus personnel costs; net loss $70.0M vs $55.2M prior year quarter .
  • Interest expense modestly higher year over year in Q4 ($1.2M vs $0.9M), adding to net loss despite higher interest income ($9.2M vs $7.6M) .
  • No product revenue disclosed; the P&L reflects R&D‑heavy burn typical of clinical‑stage companies, necessitating continued access to capital (offering closed Jan 30, 2025) .

Financial Results

Metric (USD)Q2 2024Q3 2024Q4 2024
Total Operating Expenses ($ Thousands)$65,741 $81,703 $78,025
Net Loss ($ Thousands)$(55,987) $(72,705) $(70,024)
Net Loss per Share (Basic & Diluted, $)$(0.81) $(1.05) $(0.99)
Interest and Other Income, net ($ Thousands)$10,985 $10,244 $9,201
Interest Expense ($ Thousands)$(1,231) $(1,246) $(1,200)
Cash, Cash Equivalents & ST Marketable Securities ($ Thousands, period end)$760,194 (6/30/24) $717,247 (9/30/24) $743,078 (12/31/24)

KPIs (Clinical, Q4 2024 focus):

KPIQ4 2024
SYMMETRY Week 96 ≥1-stage fibrosis improvement without worsening of MASH (Completers, 50mg EFX vs Placebo)39% vs 15%
SYMMETRY Week 96 ITT ≥1-stage fibrosis improvement without worsening of MASH (50mg EFX vs Placebo)29% vs ~12%
Non‑GLP‑1 baseline subgroup reversal (Completers, 50mg EFX vs Placebo)45% vs 17%
Liver stiffness relative change (FibroScan, LS mean)−24% (50mg) vs −8% placebo
Mean liver stiffness absolute reduction (kPa)−7.3 kPa (50mg) vs −5.0 kPa placebo
ELF score change (LS mean)−0.53 (50mg) vs +0.22 placebo

Segment breakdown: Not applicable; company has no disclosed commercial segments; financials presented as consolidated R&D and G&A .

Margins: Not applicable due to absence of product revenue; the company reports operating expenses and net loss .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SYNCHRONY Outcomes (F4) – Enrollment dynamics & histology endpoint timingOngoingFirst patients dosed in Q3 2024; 96-week histology endpoint for Cohort 1; outcomes endpoint across cohorts Increased screening post‑January SYMMETRY readout; 96‑week histology endpoint re‑affirmed; outcomes endpoint across cohorts Enrollment momentum increased
SYNCHRONY Histology (F2‑F3) – 52‑week primary histology resultsH1 202752‑week results expected first half of 2027 52‑week results remain on track first half of 2027 Maintained
SYNCHRONY Real‑World (F1‑F4) – topline safety/tolerabilityH1 2026Results expected in 2026 Preliminary topline results on track first half of 2026 Refined timing (H1 2026)
Cash runwayMulti‑yearSufficient to fund plan into H2 2027 Sufficient to fund current operating plan into 2028 Extended
Capital positionImmediateN/AClosed upsized offering; gross proceeds ~$402.5M on Jan 30, 2025 Strengthened capital base

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D execution & Phase 3 progressInitiated Phase 3 SYNCHRONY Outcomes; active Histology and Real‑World; LyoJect 3S device for self‑administration across studies First patients dosed in Outcomes; all Phase 3 actively enrolling Real‑World double‑blind enrollment completed; increased screening in Outcomes Accelerating execution
Clinical data readoutsHARMONY 96‑week analyses presented at EASL; deepening responses over time Week 96 SYMMETRY results expected Feb 2025 Unprecedented Week 96 SYMMETRY reversal of cirrhosis; additional noninvasive improvements Strong data momentum
Capital & runwayCash $760.2M (6/30/24) Cash $787.1M (9/30/24) Cash $743.1M (12/31/24); $402.5M offering closed; runway into 2028 Strengthened balance sheet
Timelines & milestonesHistology 52‑week H1 2027; Real‑World 2026 Histology H1 2027; Real‑World 2026 Histology H1 2027 maintained; Real‑World H1 2026 specified Timelines reaffirmed/refined
Safety/tolerabilityHARMONY: generally well tolerated through 96 weeks N/ASYMMETRY: generally well tolerated; no deaths on EFX; common AEs GI Grade 1–2 Consistent tolerability profile

Management Commentary

  • “The preliminary topline results… showed an unprecedented, statistically significant reversal of compensated cirrhosis due to MASH in patients treated with 50mg EFX for 96 weeks.” – Andrew Cheng, M.D., Ph.D., President and CEO .
  • “We remain committed to advancing EFX as a potential therapeutic breakthrough for individuals living with advanced MASH and look forward to building upon this momentum as we progress our Phase 3 SYNCHRONY program.” – Andrew Cheng, M.D., Ph.D. .
  • External PI perspective: “Now we have reason to be optimistic about the future potential of EFX… as a much‑needed treatment for cirrhosis, if approved.” – Mazen Nourredin, M.D., Houston Methodist Hospital (SYMMETRY PI) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in the document set; the company did host an investor webcast on January 27, 2025 to discuss SYMMETRY Week 96 results .
  • Guidance clarifications in written materials: timelines reaffirmed for Histology (H1 2027) and Real‑World (H1 2026); Outcomes enrollment momentum noted post‑readout .

Estimates Context

  • Wall Street consensus estimates via S&P Global for Q4 2024 revenue and EPS were unavailable due to access limits, so we cannot provide a beat/miss assessment.*
  • Given elevated R&D linked to Phase 3 activities and January efficacy readout, Street models may reassess R&D run‑rate and cash runway assumptions; no explicit non‑GAAP financial guidance was provided in company materials .

Key Takeaways for Investors

  • Bold efficacy in F4 compensated cirrhosis: 39% reversal (completers) and 29% (ITT) for 50mg EFX vs placebo, with corroborating noninvasive improvements – a clear differentiation catalyst in MASH cirrhosis .
  • Execution strength: Real‑World double‑blind enrollment completed; Outcomes screening increasing; Histology and Real‑World timelines intact, maintaining line‑of‑sight to pivotal Phase 3 milestones .
  • Capital secured: $402.5M offering closed; runway extended into 2028, reducing near‑term financing risk amid Phase 3 spend .
  • R&D burn remains material: Q4 OpEx $78.0M and net loss $70.0M; higher spend driven by Phase 2b/3 programs and personnel, aligning with development cadence .
  • Trading lens: Near‑term narrative likely anchored by SYMMETRY durability and Outcomes enrollment cadence; conference presence and publications add credibility to the clinical thesis .
  • Risk management: No product revenue disclosed; reliance on capital markets persists until approval; regulatory timelines (Histology H1 2027, Real‑World H1 2026) frame key de‑risking events .
  • Watch for data flow: Additional analyses/publications, Phase 3 operational updates, and Real‑World safety/tolerability readout in H1 2026 are the next catalysts .

*Estimates unavailable: Values that would normally be retrieved from S&P Global were not accessible at this time.