Invivyd, Inc. (IVVD)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue was $11.3M, down sequentially from Q4 2024 ($13.8M) as Invivyd internalized its sales force in Jan–Feb; management cites early Q2 re-acceleration with record commercial days/weeks and continues to target near-term break-even in 1H 2025 .
• Results missed S&P Global consensus: revenue $11.3M vs $34.5M estimate and EPS -$0.14 vs -$0.03 estimate, driven by the planned field transition and seasonality; operating discipline continued with operating expenses down 15% QoQ (Q1 $27.4M vs Q4 $32.3M) . Consensus figures marked with asterisks—see Estimates Context (Values retrieved from S&P Global).*
• Cash and cash equivalents were $48.1M at March 31, 2025; the company also secured up to $30M in non-dilutive term loan capacity in April to extend runway and support growth .
• Strategically, Invivyd highlights durable variant coverage for PEMGARDA, a modest price increase in March, progress in expanding guidelines access (e.g., NCCN for B‑cell lymphomas), and a pipeline pivot to higher-potency COVID mAb VYD2311 (Phase 1 readout later in Q2 2025) plus early RSV and measles discovery efforts—potential catalysts alongside renewed FDA engagement under new leadership .

What Went Well and What Went Wrong

What Went Well

• Early Q2 momentum: after the Q1 field-force transition, management reported “biggest ever commercial day and week” and a return to growth in Q2 to date, supporting the 1H 2025 profitability target .
• Operating discipline: operating expenses fell to $27.4M in Q1 (from $32.3M in Q4), with minimal near-term manufacturing spend expected; gross margin was high given low COGS ($0.834M) on $11.3M revenue .
• Strategic positioning: PEMGARDA continues to show in vitro activity against prevalent variants (LP.8.1, XEC) and was added to NCCN B‑cell lymphoma guidelines; management took a modest price increase in March and sees improving institutional adoption .

Quotes:

• “We remain targeting near-term breakeven with continued revenue growth and operating expense management.” (Marc Elia)
• “We’re seeing strong revenues thus far in Q2, including…our biggest ever commercial day and…week.” (Tim Lee)
• “End[ed] Q1 2025 with approximately $48 million in cash…[and] potential to access up to $30 million in non-dilutive funding.” (Bill Duke)

What Went Wrong

• Missed Street expectations: revenue and EPS missed S&P Global consensus as the in-house sales ramp caused a Q1 revenue dip vs Q4; management attributes this to the January–February transition period . Consensus figures marked with asterisks—see Estimates Context (Values retrieved from S&P Global).*
• Regulatory setback for treatment EUA: FDA declined expansion of PEMGARDA’s EUA to include treatment in certain immunocompromised patients (Feb 2025), creating near-term uncertainty for the treatment opportunity until VYD2311 progresses or FDA engagement changes .
• Commercial headwinds lingering from 2024: HCP skepticism following last year’s inaccurate third-party virology references in the Fact Sheet (since corrected) required re-education, slowing broad adoption until updated data and guideline support took hold .

Financial Results

Summary P&L and Operating Metrics

Notes: Gross margin % computed from revenue and cost of product revenue in cited cells.

Actuals vs S&P Global Consensus (Q1 2025)

Values with asterisks (*) are from S&P Global; Values retrieved from S&P Global.

Balance Sheet and Liquidity

KPIs and Commercial Indicators:

• Q2-to-date momentum: “return to growth” with record commercial days/weeks post field transition .
• Guideline footprint expanding (IDSA and NCCN B‑cell lymphomas) supporting broader institutional adoption .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategy and profitability: “We remain targeting near-term breakeven with continued revenue growth and operating expense management.” (Marc Elia, Chair)
• Q2 trajectory: “We’re seeing strong revenues thus far in Q2, including…our biggest ever commercial day and biggest ever commercial week.” (Tim Lee, CCO)
• Expense discipline and liquidity: “Operating expenses [were] $27.4 million in Q1 2025…anticipate [they] will continue to decrease in the second quarter…[and] potential to access up to $30 million in non-dilutive funding.” (Bill Duke, CFO)
• Regulatory posture: “We intend to continue engagement with FDA, both on pemivibart…and on our new molecule, VYD2311…We appreciate the FDA’s alignment with our desire for greater public transparency.” (Marc Elia)

Q&A Highlights

• FDA/EUA path and endpoints: Management prefers to move beyond EUA to BLA via an accelerated approval-type paradigm leveraging sVNA titers as validated surrogates and unique contemporary efficacy data from CANOPY; discussions with the newly seated FDA are a priority .
• Q1 sales headwinds and Q2 outlook: The in-house sales build and training created a temporary Q1 disruption; breadth/depth and unique accounts increased through April; infusion access >880 sites; early Q2 metrics are supportive of continued momentum .
• Discovery prioritization: New measles discovery is additive (not a pivot) and within budgeted discovery spend; potential national-level interest could support future development .

Estimates Context

• S&P Global consensus for Q1 2025: revenue $34.45M (3 estimates) and EPS -$0.03 (3 estimates); actual revenue $11.304M and EPS -$0.14—both misses. The miss reflects the January–February sales force internalization and seasonality, with re-acceleration in Q2 to date noted by management . Values retrieved from S&P Global.*
• Implications: Near-term Street revenue/EPS models likely need to reflect the Q1 dip and a stepped Q2 recovery, while incorporating lower opex run-rate and minimal near-term manufacturing spend .

Key Takeaways for Investors

• The Q1 miss versus consensus was largely executional (planned sales force transition) rather than demand-driven; leading indicators and Q2-to-date updates point to resumed growth into summer COVID seasonality .
• Expense control is working; with Q1 operating expenses down 15% QoQ and minimal manufacturing expected in 2025, the 1H 2025 profitability target remains intact, supported by a $30M term loan facility for optionality .
• Strategic positioning strengthened via guidelines (IDSA, NCCN), ongoing variant coverage, and a modest price increase—supporting improved payer and institutional adoption .
• Regulatory risk shifts from PEMGARDA treatment to VYD2311: FDA’s decline for treatment EUA resets timing for treatment revenue, but VYD2311’s potency/PK profile and multi-route flexibility offer a clearer regulatory and commercial path; Phase 1 readout later in Q2 is a key catalyst .
• Trading setup: Near-term catalysts include VYD2311 Phase 1 data, Q2 revenue inflection evidence, and FDA engagement updates; focus on sequential growth, operating expense trajectory, and guideline-driven adoption to gauge break-even timeline .

Appendix: Quantitative Detail

Additional Financial Comparisons

Selected Commercial/Clinical Items

• Safety: Since PEMGARDA EUA (Mar 2024), no documented anaphylaxis across thousands of post-authorization doses; safety remains consistent with the Fact Sheet .
• Variant coverage: In vitro neutralization sustained vs LP.8.1 and XEC, variants comprising >75% of U.S. circulation per CDC at time of release .
• CANOPY efficacy (context): Prior disclosures highlighted substantial relative risk reduction vs placebo across multiple variant waves; management continues to lean on immunobridging and contemporary exploratory efficacy to support regulatory strategy .

Values with asterisks (*) in the Estimates section are from S&P Global; Values retrieved from S&P Global.