Executive Summary

Q3 2025 net product revenue was $13.1M, up 11% quarter-over-quarter and 41% year-over-year; net loss narrowed sharply to $10.5M (EPS -$0.06) from $60.7M (EPS -$0.51) in Q3 2024 .
Results were essentially in line with Wall Street: revenue modestly above consensus ($13.13M vs. $13.10M*) and EPS beat (-$0.06 vs. -$0.08*); EBITDA was better than consensus (-$10.9M vs. -$11.9M*) (all S&P Global).
Balance sheet strengthened: $85.0M cash at 9/30 and “over $100M” in October; subsequent $125.0M gross proceeds public offering announced Nov. 18 enhances funding for pivotal VYD2311 program launch .
Regulatory and clinical momentum: U.S. IND cleared and FDA alignment for the REVOLUTION pivotal program (DECLARATION and LIBERTY) with initiation around year-end 2025 and top-line data mid-2026, a key stock catalyst path .

What Went Well and What Went Wrong

What Went Well

Product growth and disciplined spending: “third quarter revenue growth, combined with controlled operating expenses” set up investment in VYD2311 and commercial build-out .
Regulatory clarity: “clear path forward for VYD2311 with recent IND clearance and U.S. FDA alignment,” preparing for pivotal studies and potential launch .
Improving capital position and execution: Raised ~$87M in and shortly after Q3, plus ATM in Oct.; CFO: “Invivyd is now well capitalized through anticipated pivotal data… potentially well beyond” .

What Went Wrong

SG&A increase y/y: SG&A rose to $15.0M from $13.0M due to personnel costs, partially offset by lower sales and marketing .
R&D variation vs. prior plans: While R&D fell to $8.0M y/y, company did not provide quantitative revenue guidance; reliance on future pivotal execution creates timing risk .
Profitability target slippage earlier in the year: Management previously targeted near-term profitability in 1H 2025 but did not meet it (context from Q2) .

Financial Results

Quarterly P&L and Cash (USD)

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Net Product Revenue ($USD Thousands)	$9,300	$11,304	$11,786	$13,129
Cost of Product Revenue ($USD Thousands)	$806	$834	$685	$1,088
R&D Expense ($USD Thousands)	$57,850	$10,641	$9,573	$8,046
SG&A Expense ($USD Thousands)	$12,955	$16,751	$16,588	$15,018
Loss from Operations ($USD Thousands)	$(62,311)	$(16,922)	$(15,060)	$(11,023)
Net Loss ($USD Thousands)	$(60,739)	$(16,289)	$(14,660)	$(10,470)
Diluted EPS ($USD)	$(0.51)	$(0.14)	$(0.12)	$(0.06)
Cash & Cash Equivalents (Period-End, $USD Thousands)	N/A	$48,078	$34,905	$84,967

Notes: Operating margin % would be negative and is calculable from loss from operations and revenue; values above provide the components with citations.

Consensus vs. Actual – Q3 2025

Metric	Q3 2025 Estimate	Q3 2025 Actual
Revenue ($USD)	$13,100,000*	$13,129,000
Primary EPS ($USD)	-$0.08*	-$0.06
EBITDA ($USD)	-$11,900,000*	-$10,874,000*

Values with asterisk (*) retrieved from S&P Global.

Segment/Product Revenue

Metric	Q1 2025	Q2 2025	Q3 2025
PEMGARDA Net Product Revenue ($USD Thousands)	$11,304	$11,786	$13,129

Commercial KPIs (Launch-to-Date through 9/30/2025)

KPI	Value
GPO Contracted Sites	15,000+
Available Sites for Infusion	1,200+
Accounts with PEMGARDA Infusion Experience	811
Reordering Accounts (%)	76%
Conferences/Exhibits Attended	125+

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VYD2311 pivotal program start	Around year-end 2025	Q2 2025: Rapid BLA pathway, compact 12-week primary endpoint, pending protocol review	IND cleared; REVOLUTION (DECLARATION, LIBERTY) to begin around year-end 2025	Maintained/clarified timeline
VYD2311 top-line data	Mid-2026	Not previously dated	Mid-2026 top-line anticipated	New timing specificity
PEMGARDA commercial strategy	Ongoing	Q1/Q2: Internalized sales force; expanding reach; guidelines inclusion	Continued growth among HCPs, expanded field presence; 76% reordering	Maintained, execution progressing
Financial guidance (revenue/EPS/margins)	2025	Q2: “Near-term profitability (1H 2025) was not met but remains possible”	No quantitative guidance provided in Q3 release/call	Withdrawn/omitted quantitative targets

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3 2025)	Trend
Regulatory path for VYD2311	Q2: FDA alignment on compact Phase 2/3, single trial supporting BLA; head-to-head safety vs. vaccine planned	IND cleared; REVOLUTION program structure clarified; initiation around year-end; top-line mid-2026	Advancing from alignment to execution
Commercial footprint (PEMGARDA)	Q1: Internalized sales force; guideline additions; HCP engagement ramp	15,000+ GPO sites; 1,200+ infusion sites; 76% reordering; continued QoQ revenue growth	Scaling and deepening
Safety/tolerability narrative vs. vaccines	Q2: Planned head-to-head safety evaluation	Call emphasized safety advantage of mAbs; plan to demonstrate tolerability vs. mRNA vaccines in LIBERTY	Reinforced differentiation
Capital plan and runway	Q2: $30M SVB facility; targeting profitability	~$87M raised in/after Q3; Oct ATM $29.8M; post-Q3 $125M offering pricing	Strengthened liquidity
Pipeline expansion (RSV, measles)	Q2: RSV candidate update Q3; measles update Q4	Discovery efforts continue; differentiation focus; update “before end of year”	Ongoing discovery momentum

Management Commentary

“With a strengthened balance sheet and a clear path forward for VYD2311 with recent IND clearance and U.S. Food and Drug Administration (FDA) alignment, Invivyd is well-poised to provide Americans with antibody protection as an alternative to COVID vaccination.” – Marc Elia, Chairman .
“Our past discipline and learnings from our commercial organization will enable us to further invest in VYD2311… and related commercial build-out to prepare for launch, if approved.” – Bill Duke, CFO .
“We believe Invivyd can, in one single study, provide more information on the extent, durability, and quantitative predictability of protection from COVID than we have had from COVID vaccines over the past five years.” – Marc Elia .

Q&A Highlights

Sunset of PEMGARDA post VYD2311 approval? Management: “No… we would have no plans to actively sunset it” .
LIBERTY study coordination (CBER/CDER): Expect dialogue between centers given concomitant vaccine and mAb administration; goal is useful labeling for HCPs and vulnerable populations .
Commercial expansion beyond infusion centers: Building scalable foundation, increasing digital assets and field presence to reach broader audiences ahead of IM delivery for VYD2311 .
RSV/measles timelines and differentiation: Programs in discovery; differentiation via resistance profile, potency, half-life; updates expected before year-end .

Estimates Context

Q3 2025 revenue modestly above consensus ($13.13M actual vs. $13.10M*), EPS beat (-$0.06 vs. -$0.08*) and EBITDA better than expected (-$10.9M vs. -$11.9M*). Near in-line top-line and improved operating performance likely reflect commercial traction and disciplined opex .
With pivotal initiation near-term and strengthened balance sheet, 2026 estimates may embed program risk; upside revisions could follow successful enrollment progress and clearer timelines.
Values with asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

In-line top-line with EPS/EBITDA beats underscores commercial momentum and cost control; trajectory improving into respiratory season .
Regulatory de-risking: IND clearance and FDA alignment for VYD2311 sets a visible path to mid-2026 top-line; program initiation around year-end is a major catalyst .
Liquidity fortified: $85.0M cash at Q3 end, >$100M in October, and $125.0M gross from Nov. offering provide runway through pivotal data and commercial build-out .
Strategic choice narrative vs. vaccines resonates; LIBERTY head-to-head safety could be a key market education lever pre-launch .
Maintain focus on execution risks: enrollment pace, regulatory coordination (CBER/CDER), manufacturing scale-up for IM mAb .
Near-term trading: watch for trial initiations, additional commercial KPIs, and variant susceptibility updates; funding events have reduced financing overhang .
Medium-term thesis: If DECLARATION shows robust efficacy and LIBERTY confirms safety advantages, mAb prophylaxis could unlock a large market, supporting multiple expansion and revenue inflection.

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Citations: Earnings press release and 8-K ; Earnings call transcript ; Prior quarters Q2 and Q1 8-Ks ; Financing press releases . Values with asterisk (*) retrieved from S&P Global.

Invivyd, Inc. (IVVD)·Q3 2025 Earnings Summary