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Alector, Inc. (ALEC)·Q2 2024 Earnings Summary
Executive Summary
- Q2 2024 collaboration revenue was $15.1M, down 73% year over year due to prior-year non-cash AL101 contract modification and lower AL002 program revenue, partially offset by latozinemab revenue; net loss was $38.7M ($0.40/share) versus net income of $1.4M in Q2 2023 .
- 2024 guidance reiterated for collaboration revenue ($60–$70M) and G&A ($60–$70M); R&D tightened to $210–$220M (from $210–$230M previously) .
- Cash, cash equivalents and investments were $503.3M, with runway through 2026; pivotal catalysts remain on track: AL002 INVOKE-2 Phase 2 data in Q4 2024 and latozinemab INFRONT-3 Phase 3 readout late 2025/early 2026 .
- Management highlighted supportive FDA feedback that PGRN biomarker effects may serve as confirmatory evidence for latozinemab, and strong INVOKE-2 LTE participation (~95% of eligible participants), framing potential upside into year-end; S&P Global consensus estimates were unavailable for this review window .
What Went Well and What Went Wrong
What Went Well
- Strong cash runway with $503.3M in cash/investments, sufficient through 2026; management reiterated preparedness to fund key readouts and beyond .
- FDA engagement: in a recent Type B interaction, agency indicated plasma/CSF PGRN could serve as confirmatory evidence alongside clinical endpoints for latozinemab, supporting path to potential approval in FTD-GRN .
- INVOKE-2 fully enrolled with robust LTE participation (~95% of eligible participants) and biomarker-rich design; management expects comprehensive clinical and biomarker top-line readout in Q4 2024; quote: “we’re going to include…not only the typical top line primary clinical outcomes and safety, but…relevant biomarkers…with the press release” .
What Went Wrong
- Collaboration revenue fell to $15.1M in Q2 2024 from $56.2M in Q2 2023, driven by prior-year AL101 non-cash adjustment and AL002 timing effects; resulted in swing from $1.4M net income in Q2 2023 to $38.7M net loss in Q2 2024 .
- ARIA-like MRI findings in APOE4 homozygotes required protocol changes; while incidence and severity decreased with enhanced MRI surveillance and titration adjustments, the signal necessitated exclusion of APOE4 homozygotes and monitoring burden .
- Estimate benchmarking unavailable: S&P Global consensus for Q2 2024 revenue and EPS could not be retrieved in this session, limiting beat/miss quantification versus Street expectations (see Estimates Context) [GetEstimates error: Daily Request Limit Exceeded].
Financial Results
Income Statement and EPS (vs prior year and prior quarter; estimates unavailable)
Notes: Year-over-year revenue decline was mainly due to the 2023 AL101 non-cash adjustment and lower AL002 revenue, partially offset by latozinemab program revenue .
Balance Sheet and Liquidity
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- CEO framing upcoming catalysts: “we remain on track to report data from INVOKE-2…in the fourth quarter…we are encouraged that the recently reported patient baseline characteristics reflect a study population appropriate for the clinical evaluation of a TREM2 agonist” .
- On latozinemab regulatory path: “the FDA…would consider the effects of latozinemab on plasma and cerebrospinal fluid…progranulin…as confirmatory evidence…supplementing the potential clinical effects…pending BLA review” .
- On INVOKE-2 readout scope: “we’re going to include…not only the typical top line primary clinical outcomes and safety, but…relevant biomarkers…we intend to report out on all of those…with the press release” .
- CFO on funding: “Our cash runway extends through 2026…covering…AL002 INVOKE-2…Phase II data readout and…INFRONT-3 Phase III…with the runway coverage extending approximately a year beyond the INFRONT-3 readout” .
Q&A Highlights
- AL002 dataset composition and LTE: ~250 completers at 48 weeks; ~50% with 72 weeks; ~⅓ with 96 weeks; LTE remains blinded; APOE4 homozygotes discontinued due to ARIA-like MRI findings .
- Latozinemab biomarkers: FDA feedback supports GFAP, NFL, and volumetric MRI as confirmatory evidence with clinical endpoint; management sees potential for full approval but notes accelerated approval as a backup if clinical endpoint is equivocal .
- AbbVie option payment timing: concept study package to be shared in Q4; AbbVie has 90 days to opt-in, implying payment timing toward end of Q1/early Q2 thereafter; payment size $250M .
- INVOKE-2 analysis approach: proportional MMRM in a common-close design to leverage all data through 48–96 weeks; sensitivity analyses planned; tercile analyses by p-tau also prespecified .
- ARIA management: incidence likely increases with surveillance but severity reduced; LTE testing slower titration and lower starting dose to mitigate ARIA-like findings .
Estimates Context
- S&P Global consensus for Q2 2024 revenue and EPS was unavailable during this session due to data access limit. As a result, explicit beat/miss versus the Street cannot be quantified in this report. Values retrieved from S&P Global were not available at time of analysis.
- Given the YoY revenue drop and swing to loss, we expect Street models to focus on collaboration revenue cadence and the updated (tightened) R&D spend range, with potential estimate adjustments around full-year revenue recognition timing and OpEx mix .
Key Takeaways for Investors
- Revenue cadence remains lumpy; Q2’s 73% YoY decline reflects prior-year non-cash AL101 adjustment and program-specific revenue timing—focus shifts to H2 readouts rather than near-term top-line growth .
- Regulatory de-risking for latozinemab: FDA confirming biomarker role enhances probability of success; full approval remains goal, but accelerated pathway is a potential backup if clinical signals are directional but not definitive .
- AL002 is a differentiated microglial mechanism with add-on potential to anti-amyloids; broad biomarker package and analysis plan improve odds of an actionable dataset in Q4—stock likely to trade on magnitude/consistency across clinical and biomarker endpoints .
- AbbVie’s $250M opt-in is a material catalyst; timing suggests opt decision window ~90 days post-concept package—capital inflow would extend runway and validate program .
- Cash runway to 2026 provides strategic flexibility entering multiple data readouts and regulatory dialogues; balance sheet supports continued ABC platform development without near-term financing needs under base case .
- Watch ARIA-related safety narrative: management’s titration/surveillance mitigations and LTE learnings reduce perceived risk; absence of significant other safety signals is constructive .
- Near-term trading: shares likely to be event-driven into Q4; positioning around INVOKE-2 readout (clinical + biomarker scope) and AbbVie option signal may drive volatility and price discovery .
References: Q2 2024 8-K press release and exhibits ; Q2 2024 earnings call transcript –; Q1 2024 8-K –; Q4/FY 2023 8-K –; Q2 2024-related press releases in June .