Sign in
II

Invivyd, Inc. (IVVD)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 net product revenue of $13.8M for PEMGARDA rose 48% q/q (from $9.3M in Q3) as provider awareness and adoption improved; year-end cash was $69.3M, and management reiterated a target of near-term (by end of 1H 2025) profitability driven by revenue growth and sharply lower manufacturing costs .
  • Operating cost discipline accelerated into year-end: preliminary Q4 total operating costs and expenses were ~ $32M, down 55% vs Q3’s $71.6M, supporting the path to profitability by mid-2025 .
  • Regulatory: FDA declined Invivyd’s request to expand PEMGARDA’s EUA to treatment of mild-to-moderate COVID-19 in immunocompromised patients in Feb-2025; the company has asked the FDA to reconsider (dialogue pending) .
  • Pipeline: VYD2311 Phase 1/2 data showed favorable safety/PK and ~17x greater in vitro neutralization potency vs pemivibart across contemporary variants; commercial manufacturing was substantially completed, with minimal 2025 manufacturing expenses expected, improving operating leverage .

What Went Well and What Went Wrong

What Went Well

  • Strong sequential demand: Q4 PEMGARDA net product revenue grew 48% q/q to $13.8M (Q3: $9.3M), reflecting increased provider awareness and adoption .
  • Cost inflection: Preliminary Q4 total operating costs/expenses ~ $32M, down 55% vs Q3’s $71.6M, with minimal 2025 manufacturing expenses anticipated, reinforcing the 1H'25 profitability target .
  • Next-gen antibody traction: VYD2311 Phase 1/2 readout indicated positive safety/PK and ~17x potency vs pemivibart across tested variants; PK suggested long-acting potential and IM/SC feasibility .

What Went Wrong

  • Regulatory setback: FDA declined adding treatment of mild-to-moderate COVID-19 to PEMGARDA’s EUA in Feb-2025; Invivyd requested reconsideration, introducing near-term regulatory uncertainty .
  • 2024 guidance withdrawal: The company withdrew its $150–200M FY24 revenue outlook in late Q3 amid Fact Sheet-related headwinds, creating investor uncertainty into year-end (ultimately finishing 2024 with $25.4M product revenue) .
  • Limited disclosure of Q4 earnings details: The March press release emphasized quarterly revenue and full-year P&L, but did not provide Q4 EPS or margins; consensus estimates were unavailable at time of query, limiting beat/miss precision .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
PEMGARDA Net Product Revenue ($USD Millions)$2.3 $9.3 $13.8
Diluted EPS ($)$(0.40) $(0.51) N/A (not disclosed in Q4 PR)
Total Operating Costs & Expenses ($USD Millions)$51.5 $71.6 ~ $32.0 (prelim)

Notes:

  • Year-end cash/cash equivalents: $69.3M at 12/31/2024 .
  • FY 2024 PEMGARDA revenue: $25.4M .

Gross margin snapshot (where calculable):

  • Q2 2024: Revenue $2.264M; COGS $0.088M → Gross margin ~96.1% (calculated from ).
  • Q3 2024: Revenue $9.300M; COGS $0.806M → Gross margin ~91.4% (calculated from ).
  • FY 2024: Revenue $25.384M; COGS $1.618M → Gross margin ~93.6% (calculated from ).

Key KPIs and balance sheet

KPIQ2 2024Q3 2024Q4 2024
Cash & Cash Equivalents ($USD Millions)$147.9 $106.9 $69.3
Accounts Receivable ($USD Millions)$2.888 $8.154 $10.906
Inventory, net ($USD Millions)$5.333 $27.067 $25.907

Estimates vs Actuals (S&P Global)

MetricPeriodActualConsensusBeat/Miss
Revenue ($USD Millions)Q4 2024$13.8 Unavailable from S&P Global at time of queryN/A
EPS ($)Q4 2024N/AUnavailable from S&P Global at time of queryN/A

Consensus estimates were unavailable from S&P Global at time of query due to data access limits; therefore no beat/miss assessment is provided.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent/UpdatedChange
FY RevenueFY 2024$150–$200M net product revenue (Aug-14, 2024) Formal revenue guidance withdrawn (Oct-29, 2024) Withdrawn
Year-end CashFY 2024≥ $75M (Aug-14, 2024) ≥ $65M (Oct-29, 2024) Lowered
Profitability Timing1H 2025Target near-term profitability by end of 1H 2025 Reiterated (Feb-3 prelim; Mar-20 PR) Maintained
Manufacturing Expenses2025N/AMinimal manufacturing expenses expected in 2025 New disclosure
PEMGARDA EUA – Treatment2025Requested EUA amendment for treatment (2024) FDA declined Feb-2025; company requested reconsideration Setback; reconsideration requested

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript was not available in our document set; we reviewed the company’s Q2/Q3 earnings materials and a Feb-12, 2025 Oppenheimer conference transcript for thematic continuity.

TopicQ2 2024 (Prior-2)Q3 2024 (Prior-1)Q4 2024 (Current)Trend
Commercial tractionPEMGARDA launch; $2.3M revenue; infrastructure build; payer coverage; infusion network scaling Q3 revenue $9.3M; Fact Sheet headwinds addressed; growth resuming Q4 revenue $13.8M (+48% q/q); in-house sales force transition Improving sequential growth
Cost disciplineOpex efficiency initiatives underway Opex elevated from VYD2311 manufacturing Q4 opex ~ $32M (−55% vs Q3); minimal 2025 mfg expenses Strong cost reset
Regulatory interactionsTreatment EUA amendment submitted Fact Sheet confusion then update; withdrew revenue guidance FDA declined treatment EUA expansion; reconsideration requested Mixed; near-term uncertainty
Variant coverage/virologyContinued in vitro activity vs emerging variants; immunobridging framework NEJM letter on immunobridging; continued neutralization (KP.3.1.1, etc.) PEMGARDA neutralization vs LP.8.1, KP.3.1.1, XEC; data submitted to FDA Reinforced messaging
Pipeline (VYD2311)FIH dosing starting late Aug; IM/SC focus Preliminary data expected late Q4 Phase 1/2 positive safety/PK; ~17x potency; IM/SC potential; mfg substantially complete Positive momentum
ProfitabilityTarget 1H’25 Reaffirm near-term profitability Reiterated; conference: exit 1H’25 profitable on prevention-only EUA Maintained confidence

Management Commentary

  • “We are pleased with the significant PEMGARDA revenue growth of 48% in the fourth quarter, reflecting increased provider awareness and adoption… working to achieve near-term profitability.” — Bill Duke, CFO .
  • “With our impressive fourth quarter growth as our catalyst, we began 2025 with a newly transitioned, in-house sales force.” — Tim Lee, CCO .
  • “We believe that we can get there by the end of the first half of this year… turn the corner to profitability… on the backs of the current EUA for prevention only.” — William (Bill) Duke, CFO (Oppenheimer Conference) .
  • “In February 2025, the FDA declined [PEMGARDA] treatment… Invivyd has submitted a response requesting that the FDA reconsider…” — Company press release .
  • “VYD2311… shows an average 17-fold greater neutralization potency than pemivibart… serum concentrations remain high with half-life not yet reached…” — Company press releases .

Q&A Highlights

  • Profitability timing: CFO reiterated month-by-month profitability by June 2025 based on prevention-only EUA, aided by reduced opex .
  • Positioning vs vaccines and small molecules: Management emphasized step-change protection and long-acting profile for mAbs vs vaccine waning and Paxlovid DDIs/rebound; targeting broader populations over time with convenient IM/SC dosing .
  • VYD2311 routes of administration: Program includes IV, IM, and SC cohorts to enable convenient prophylaxis and potential at-home use .
  • Variant coverage: Company confident in PEMGARDA activity vs XEC and related lineages with data submitted/ongoing, citing structural considerations around binding sites .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable at time of query due to access limits, so we cannot provide a beat/miss assessment. Actual Q4 revenue was $13.8M; EPS was not disclosed in the Q4 press release .

Key Takeaways for Investors

  • Sequential acceleration continued: Q4 revenue +48% q/q; cost base reset (~$32M Q4 opex) supports management’s reiterated 1H’25 profitability target, a key stock catalyst as investors look for self-funding operations .
  • Regulatory overhang persists: FDA declined treatment EUA expansion; Invivyd requested reconsideration. A positive outcome would expand TAM and strengthen the profitability profile; continued dialogue is a near-term swing factor .
  • Operating leverage inflecting: Minimal 2025 manufacturing expenses and in-house sales infrastructure should improve gross-to-net and opex trajectory as PEMGARDA adoption broadens .
  • Pipeline optionality: VYD2311’s ~17x potency and favorable PK (IM/SC potential) could enable lower dose, more scalable prophylaxis/treatment profiles—material upside if regulatory pathway aligns with immunobridging precedents .
  • Balance sheet runway: YE cash of $69.3M plus receivables provides cushion as the company targets profitability by mid-2025; watch working capital dynamics (A/R and inventory) as sales scale .
  • Narrative drivers: Provider education, payer access, and variant coverage updates are central to sustaining revenue momentum; continued real-world evidence and neutralization updates can reinforce physician confidence .

Appendix: Source Coverage and Availability

  • Q4 2024 8-K press release and full financial schedules (Ex. 99.1) were read in full .
  • Preliminary Q4 2024 press releases (Feb-3) were read in full .
  • Prior quarters’ 8-Ks for Q3 and Q2 2024 were read in full for trend analysis .
  • A Q4 2024 earnings call transcript was not found in the available documents; we reviewed the Feb-12, 2025 Oppenheimer conference transcript for contemporaneous Q&A and management tone -.