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HilleVax, Inc. (HLVX)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 reflected increased operating spend tied to pipeline expansion (HIL-216 license) and continued HIL-214 development; net loss widened to $46.8M and EPS was -$0.97 versus -$0.71 in Q1 2023 .
  • Cash, cash equivalents and marketable securities were $272.7M at March 31, 2024, down from $303.5M at year-end, providing at least 12 months of liquidity under current plans .
  • Management reiterated the key catalyst: topline NEST-IN1 Phase 2b infant data “mid-2024,” with Phase 3 plans to follow if positive; posture remained confident on HIL-214’s leadership in norovirus vaccines .
  • No formal financial guidance was provided; operational guidance (timing of NEST-IN1 readout) was maintained versus prior quarter .

What Went Well and What Went Wrong

  • What Went Well

    • Clear catalyst: “We are excited to remain on track to report top-line data from our ongoing NEST-IN1 clinical trial in infants by mid-2024,” positioning HIL-214 for rapid progression to Phase 3 if positive .
    • Strategic portfolio build: closed an exclusive license for HIL-216 (hexavalent norovirus VLP covering ~90% of infections globally), adding a second candidate with strong genotype coverage .
    • Liquidity: $272.7M cash, cash equivalents and marketable securities supports operations and clinical supply readiness; ATM raised ~$14.9M in Q1 to bolster flexibility .

  • What Went Wrong

    • Loss widened: total operating expenses rose to $49.8M (including $15.3M in in-process R&D from HIL-216 upfront), increasing net loss to $46.8M (from $26.9M YoY) .
    • R&D intensity: core R&D expense rose YoY to $26.0M despite a $2.6M decrease in clinical development costs for HIL-214; headcount and stock comp drove the increase .
    • Cash burn: net cash used in operating activities was $33.0M in Q1, reflecting pipeline investments and working capital changes .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.0 $0.0 $0.0
Research & Development ($USD Millions)$27.3 $33.3 $26.0
In-Process R&D ($USD Millions)$0.0 $0.0 $15.3
General & Administrative ($USD Millions)$6.6 $7.0 $8.5
Total Operating Expenses ($USD Millions)$33.9 $40.3 $49.8
Other Income ($USD Millions)$2.1 $3.3 $3.0
Net Loss ($USD Millions)$(31.8) $(37.0) $(46.8)
Net Loss per Share (Basic & Diluted, $)$(0.81) $(0.78) $(0.97)
Weighted Avg Shares (Basic & Diluted)39,039,553 47,557,423 48,460,185
Balance Sheet MetricQ3 2023Q4 2023Q1 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$324.4 $303.5 $272.7
Total Assets ($USD Millions)$367.0 $344.4 $314.2
Total Liabilities ($USD Millions)$68.3 $78.9 $75.3
Total Stockholders’ Equity ($USD Millions)$298.6 $265.5 $238.9
KPIsQ1 2024
Net Cash Used in Operating Activities ($USD Millions)$(33.0)
ATM Issuance Proceeds ($USD Millions)$14.9
Long-term Debt (Principal incl. PIK, $USD Millions)$25.8

Notes: Company has not generated product revenue; operates as a single segment .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
NEST-IN1 topline safety & efficacy data timingMid-2024Mid-2024 Mid-2024 Maintained
Phase 3 progression plans (infants/older adults) contingent on NEST-IN1Post-readoutPlanned if positive Planned if positive Maintained
Financial guidance (revenue/margins/OpEx)2024Not provided Not provided Maintained

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was available in our document catalog; themes below reflect press releases and SEC filings.

TopicPrevious Mentions (Q3 2023, Q4 2023)Current Period (Q1 2024)Trend
Clinical timing (NEST-IN1)“Remain on track” mid-2024 topline; enrollment completed >3,000 infants Mid-2024 timing reiterated, catalyst emphasized Stable/on track
Manufacturing readinessProgress on manufacturing activities for HIL-214 for subsequent registrational trials Phase 3 readiness implied upon positive NEST-IN1 Building capability
Portfolio expansion (HIL-216)Not highlighted in Q3 PR; noted later in filings Exclusive license executed; $15.0M upfront expensed as IPR&D Expansion/second asset
Liquidity and financingIPO (2022), underwritten offering (Sep-2023), term loan capacity $272.7M cash; ATM raised $14.9M; term loan outstanding $25.8M Adequate runway
Regulatory/ACIP strategyACIP precedent for infant/adult programs referenced (rotavirus/RSV) Intend to pursue ACIP recommendations following Phase 3 Consistent strategy

Management Commentary

  • “We are excited to remain on track to report top-line data from our ongoing NEST-IN1 clinical trial in infants by mid-2024. With positive results from NEST-IN1, we expect HIL-214 to rapidly progress into Phase 3 clinical trials in both infants and older adults...” — Rob Hershberg, MD, PhD, Chairman and CEO .
  • On portfolio: “HIL-216 includes VLPs for six of the most common norovirus genotypes... Selected genotypes cover approximately 90% of norovirus infections worldwide.” — Corporate materials on Kangh license .
  • Financial posture: as of March 31, cash, cash equivalents and marketable securities totaled $272.7M .

Q&A Highlights

  • No Q1 2024 earnings call transcript found; therefore no formal Q&A themes or clarifications to report from an analyst session (no transcript available in our catalog).

Estimates Context

  • S&P Global consensus estimates were unavailable at the time of retrieval due to access limits; as such, comparisons to SPGI consensus cannot be provided.
  • Third-party reporting indicates EPS of -$0.97 missed an external consensus of -$0.84; revenue was not reported (company has no product revenue) .
Estimate Comparison (Non-SPGI)Q1 2024
EPS Actual (GAAP, $)$(0.97)
EPS External Consensus (InvestorPlace/TradeSmith, $)$(0.84)
Difference (Actual – External Consensus, $)-$0.13 (miss)

Key Takeaways for Investors

  • Mid-2024 NEST-IN1 topline is the defining near-term catalyst; management’s reiterated timing and Phase 3 intent, if positive, supports upside optionality and narrative strength around first-to-market norovirus vaccination .
  • Q1 OpEx spike was driven by the $15.0M HIL-216 upfront (IPR&D), expanding the portfolio's breadth; expect future spend to track development milestones across HIL-214 and HIL-216 .
  • Liquidity of $272.7M provides ≥12 months runway to cover NEST-IN1 readout, tech transfer, and Phase 3 supply readiness; incremental flexibility from ATM and term loan, with covenants to monitor .
  • Earnings profile remains GAAP-only with no product revenue; focus analytical lens on cash burn, R&D productivity, and clinical risk-adjusted value creation rather than conventional margin metrics .
  • If SPGI consensus confirms an EPS miss similar to external sources, sell-side models may need to incorporate higher non-recurring IPR&D and updated OpEx pacing; price action will hinge on NEST-IN1 efficacy and safety outcomes .
  • Watch financing cadence (ATM usage, term loan tranches contingent on clinical milestones) and manufacturing scale-up milestones as leading indicators of Phase 3 readiness .
  • The narrative is an execution story: de-risked adult PoC, infant efficacy pending; portfolio expansion (HIL-216) adds optionality but increases near-term spend and clinical complexity .