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Allovir, Inc. (ALVR)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 was execution-focused: three Phase 3 posoleucel registrational trials continued enrolling; topline data for all three trials anticipated in 2H 2024, with commercial launch planning underway and a potential 2025 launch indicated .
  • Operating expense guidance was maintained at $150–$170 million for FY 2023 (excluding non-cash), and quarter-end cash, cash equivalents, and short‑term investments were $213.3 million, supporting runway through pivotal readouts .
  • Net loss was $44.3 million and GAAP EPS was -$0.39; year-over-year loss widened largely due to higher R&D tied to posoleucel development .
  • S&P Global consensus estimates were not available; third-party data indicates a slight EPS beat in Q3 2023 of $0.01, but we do not anchor on non-SPGI sources .

What Went Well and What Went Wrong

What Went Well

  • Continued momentum in three Phase 3 posoleucel trials with topline data for all three indications anticipated in 2H 2024; “We expect a catalyst rich next 12 months…” (CEO) .
  • Strengthened commercial readiness: global launch planning for posoleucel underway ahead of a potential 2025 launch .
  • Pipeline progress: ALVR106 completed enrollment in Part A of the Phase 1b/2a clinical trial; posoleucel Phase 2 BKV data presented at ESOT 2023 .

What Went Wrong

  • Net loss widened year-over-year to $44.3 million from $42.1 million; management attributed the increase primarily to higher posoleucel development costs .
  • Cash declined sequentially from $246.5 million in Q2 to $213.3 million in Q3 as operating investments continued .
  • No product revenue; operating profile remains R&D-intensive with total operating expenses of $46.961 million in Q3 .

Financial Results

Quarter-over-Quarter and Year-to-Date Snapshot

Metric (USD)Q1 2023Q2 2023Q3 2023
Research & Development ($MM)$30.718 $34.824 $34.156
General & Administrative ($MM)$12.513 $12.480 $12.805
Total Operating Expenses ($MM)$43.231 $47.304 $46.961
Interest Income ($MM)$1.325 $1.516 $1.522
Other Income (Loss), Net ($MM)$0.723 $0.521 $1.167
Net Loss ($MM)$(41.183) $(45.267) $(44.272)
Diluted EPS ($)$(0.44) $(0.48) $(0.39)
Weighted Avg Shares (MM)93.304 94.626 113.894
Cash & Short‑term Investments ($MM)$202.570 $246.536 $213.318
Total Assets ($MM)$244.044 $282.692 $248.312
Total Liabilities ($MM)$50.512 $53.579 $52.978
Stockholders’ Equity ($MM)$193.532 $229.113 $195.334

Year-over-Year (Q3 2023 vs Q3 2022)

Metric (USD)Q3 2022Q3 2023YoY Δ
Research & Development ($MM)$30.004 $34.156 +$4.152
General & Administrative ($MM)$12.946 $12.805 -$0.141
Total Operating Expenses ($MM)$42.950 $46.961 +$4.011
Net Loss ($MM)$(42.072) $(44.272) -$2.200
Diluted EPS ($)$(0.50) $(0.39) +$0.11

Estimates vs Actuals (EPS/Revenue)

  • S&P Global consensus estimates were not available for ALVR in Q3 2023; therefore, comparisons to Wall Street consensus are not provided.
  • Third-party indicates GAAP EPS of -$0.39 “beats by $0.01,” but this is not anchored to SPGI and should be treated cautiously .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Expenses (excl. non‑cash)FY 2023$150–$170MM $150–$170MM Maintained
Operating Expenses (excl. non‑cash)FY 2023 (as of Q2)$150–$170MM $150–$170MM Maintained

Notes: Management reiterated cash resources support operations through pivotal readouts for all three trials in 2H 2024 .

Earnings Call Themes & Trends

Transcript was not available in our document corpus; the company scheduled the call for Nov 2, 2023 at 8:00AM ET . The below reflects themes from Q1–Q3 earnings releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2023)Trend
R&D executionQ1: Three Phase 3 trials on track; Phase 2 BKV results positive . Q2: Continued enrollment; detailed Phase 2 BKV and prevention data .Continued enrollment across all three Phase 3 indications .Steady execution; scale maintained.
Regulatory/clinical milestonesQ1: Plan to report Phase 3 data in 2024 . Q2: Preparing to meet FDA for BKV Phase 3 design .Data from all three Phase 3 trials anticipated in 2H 2024 .Timeline reiterated; regulatory engagement ongoing.
Commercial preparationQ2: Hired CCO; building global commercial team for potential 2025 launch .Global launch planning in progress; potential 2025 launch .Increasing readiness.
BKV kidney transplant programQ1: Positive Phase 2 results summary . Q2: Final Phase 2 data presented; FDA alignment sought .Phase 2 BKV data presented at ESOT 2023; designing Phase 3 .Advancing into Phase 3 design.
ALVR106 (respiratory viruses)Q2: Completed Part A enrollment .Part A enrollment completed; data to be shared at future congress .Stable progress.
Cash runway/financingQ1: Cash $202.6MM; OpEx guide $150–$170MM . Q2: Raised ~$75MM; cash $246.5MM; runway into 2025 .Cash $213.3MM; runway through Phase 3 data readouts .Adequate runway; sequential cash draw.
Manufacturing/supply chainNo issues noted (Q1/Q2) .No issues noted .Stable.
Macro/tariffsNot discussed .Not discussed .N/A.

Management Commentary

  • “We expect a catalyst rich next 12 months with clinical and regulatory milestones and continued commercial preparations in advance of a potential 2025 launch.” — Diana Brainard, M.D., CEO .
  • “As of September 30, 2023, AlloVir had cash, cash equivalents, and short‑term investments of $213.3 million providing runway through all pivotal trial data readouts.” .
  • “The increase year-over-year [in R&D] was primarily attributable to an increase in costs related to the development of the company’s lead product candidate, posoleucel.” .

Q&A Highlights

  • Full transcript was not available in our dataset; call occurred Nov 2, 2023 at 8:00AM ET .
  • As such, detailed Q&A themes and any guidance clarifications from the call cannot be provided.

Estimates Context

  • S&P Global consensus estimates for ALVR were unavailable; estimate comparisons are therefore limited.
  • Third-party source indicates Q3 2023 GAAP EPS of -$0.39 “beats by $0.01”; treat as indicative but non-SPGI .
  • Revenue consensus was not cited by management or third-party sources in Q3 releases, consistent with the pre-commercial stage .

Key Takeaways for Investors

  • Near-term catalysts are clinical: three Phase 3 posoleucel topline readouts expected in 2H 2024, a primary driver of stock direction and partnership/financing optionality .
  • Operating discipline remains broadly consistent: FY 2023 OpEx guide maintained at $150–$170MM (ex non-cash); quarterly OpEx held ~mid‑$40MM .
  • Cash runway supports pivotal readouts; monitor quarterly burn and any business development to extend runway into commercialization .
  • R&D YOY increase reflects intensified posoleucel development; investors should track trial enrollment completion pace and regulatory interactions, particularly for BKV Phase 3 design .
  • Commercial buildout is underway (CCO hired in Q2, global launch planning in Q3); execution risk shifts from clinical to commercial readiness as data approaches .
  • With no product revenue and limited estimate visibility, shares are likely to be event‑driven; risk/reward hinges on pivotal outcomes and regulatory alignment .
  • If future access to S&P Global estimates becomes available, reframe expectations around EPS/OpEx versus consensus to identify potential beats/misses.