Akero Therapeutics, Inc. (AKRO)·Q3 2024 Earnings Summary

Executive Summary

• Clinical progress dominated Q3: first patient dosed in Phase 3 SYNCHRONY Outcomes (F4 cirrhotics), with all three Phase 3 trials actively enrolling; Week 96 SYMMETRY (F4) readout guided for February 2025, and Phase 3 SYNCHRONY Real-World and Histology primary endpoints expected in 2026 and H1 2027, respectively .
• Financial position remained strong: cash, cash equivalents and short- and long-term marketable securities were $787.1M at 9/30/24, supporting operations and Phase 3 programs into 2H 2027; operating expenses rose with Phase 3 ramp (R&D $72.2M; total OpEx $81.7M) .
• No product revenue; net loss widened sequentially as trial activity scaled: Q3 net loss was $(72.7)M and EPS $(1.05) vs Q2 $(56.0)M and $(0.81); YoY comparisons reflect higher clinical and manufacturing spend .
• Catalysts: near-term SYMMETRY Week 96 data in Feb-2025 (potential to influence Phase 3 design), continued Phase 3 enrollment, and 2026 Real-World readout; these, not quarterly financials, are the primary stock drivers for AKRO .

What Went Well and What Went Wrong

What Went Well

• First patient dosed in Phase 3 SYNCHRONY Outcomes, completing activation of all three pivotal studies; CEO emphasized progress toward delivering a differentiated MASH therapy if approved (“all three of our Phase 3 studies are actively enrolling”) .
• Program timelines reaffirmed: Real-World safety/tolerability readout in 2026 and Histology 52-week composite histology endpoint in H1 2027; SYMMETRY Week 96 results timing refined to February 2025 .
• Executive commentary underscored strong efficacy signal durability from HARMONY (F2/F3): 75% one-stage fibrosis improvement at 96 weeks for 50 mg EFX and unprecedented effect size; supports confidence in Phase 3 strategy and potential combinability with GLP-1s .

What Went Wrong

• Increased cash burn: R&D rose to $72.2M and total OpEx to $81.7M for Q3 as Phase 3 trials and manufacturing scaled, widening net loss vs prior quarter and year .
• No revenue contribution; quarterly results provide limited near-term financial catalysts, leaving the stock narrative reliant on clinical milestones and regulatory clarity rather than earnings beats/misses .
• SYMMETRY (F4) remains higher-risk; prior 36-week primary endpoint (fibrosis improvement) was not statistically significant, though NASH resolution and biomarker activity were encouraging—management reiterated cirrhotics are a tougher bar and outcomes will be required in the U.S. .

Financial Results

KPIs (Liquidity Trend):

Notes:

• AKRO reported no product revenue; statements present operating expenses and net loss typical of clinical-stage biotech .

Guidance Changes

Earnings Call Themes & Trends

Note: No official Q3 2024 earnings call transcript was available; management commentary is drawn from Q3 press release and a Sept-4 Morgan Stanley fireside chat transcript.

Management Commentary

• “The third quarter of 2024 marked an important milestone for EFX with the first patient dosed in the Phase 3 SYNCHRONY Outcomes study… moving us closer to delivering a differentiated treatment option, if approved, to patients living with MASH.” — Andrew Cheng, President & CEO .
• “Dosing the first patient in the SYNCHRONY Outcomes trial is an exciting milestone… potential to show that treatment with EFX can [delay or prevent liver failure] in different stages of disease progression.” — Kitty Yale, CDO .
• “At 96 weeks, 75% on the 50 mg dose demonstrated a one-stage improvement of fibrosis… a 51% effect size… unprecedented in NASH.” — Andrew Cheng at Morgan Stanley conference .
• “Adding efruxifermin to GLP-1s reduced liver fat an additional ~70% over 12 weeks… with tolerable safety.” — Andrew Cheng .
• “Cash gets us into the second half of 2027… through primary endpoints of the first two Phase III studies.” — Andrew Cheng .

Q&A Highlights

• Mechanism and differentiation: EFX’s Fc-FGF21 design acts both intrahepatic and extrahepatic, potentially differentiating from THR-β agonists like Rezdiffra; half-life supports weekly dosing .
• Market and combinations: Large NASH/MASH addressable population; GLP-1s likely earlier-stage utility with combo potential where monotherapy leaves many non-responders; EFX may augment efficacy .
• SYMMETRY (F4) context: 36-week fibrosis endpoint missed, but NASH resolution and biomarkers encouraged; 96-week readout (Feb-2025) may inform Phase 3 Outcomes design .
• Regulatory expectations: EU more receptive to histology endpoints in pre-cirrhotics; U.S. cirrhotic path requires clinical outcomes; Phase 3 designs reflect this .
• Funding and runway: Management reiterated runway through 2H 2027 and coverage for Phase 3 primary endpoints (Histology, Real-World) .

Estimates Context

• Attempts to retrieve S&P Global consensus EPS and revenue for Q3 2024 were unsuccessful due to SPGI daily request limits at time of analysis; therefore, comparisons to Wall Street estimates are unavailable. As a clinical-stage company, AKRO reported no product revenues and negative EPS driven by R&D and G&A spend this quarter .
• Implication: Near-term estimate revisions will likely hinge on Phase 3 enrollment cadence and Feb-2025 SYMMETRY readout rather than quarterly P&L variances .

Key Takeaways for Investors

• All three Phase 3 SYNCHRONY trials are active; first patient dosed in Outcomes (F4) strengthens the path toward outcomes-based approval in cirrhotics in the U.S. and histology-based accelerated approval in EU for pre-cirrhotics .
• Cash of $787.1M at Q3-end supports runways into 2H 2027 and primary endpoints for Histology and Real-World; expect continued sequential cash use as Phase 3 ramps .
• Feb-2025 SYMMETRY 96-week readout is the major near-term catalyst; positive durability in cirrhotics could de-risk the Phase 3 Outcomes program and influence design .
• Combination strategy with GLP-1s remains compelling given large non-responder segment; prior combo data and management commentary support potential synergistic efficacy with tolerable safety .
• Quarterly P&L (no revenue; higher OpEx) is less relevant to valuation than clinical milestones; focus trading around data readouts, enrollment updates, and regulatory interactions .
• Watch EU composite histology endpoint design (Histology) and 2026 Real-World outcomes for broader positioning and potential accelerated approval pathway signals .
• Risk: F4 cirrhotic population is intrinsically challenging; prior 36-week miss on fibrosis underscores need for longer dosing and outcomes endpoints—Phase 3 designs address this, but binary readout risk remains .