Executive Summary

Q3 revenue declined 32% YoY to $27.1M and fell 13% QoQ; non-GAAP EPS of $(0.13) beat S&P Global consensus of $(0.19), while revenue missed $29.1M consensus due to softer international HIV testing and a consumer genetics headwind in Sample Management .
Gross margin improved to 43.5% GAAP and 44.2% non-GAAP, modestly above internal expectations on lower scrap; operating loss widened on elevated R&D and innovation investment .
Q4 guidance: revenue $25–$28M with non-GAAP gross margin in the low-40% range; guidance brackets Q4 revenue consensus ($26.4M*) and implies continued mix headwinds (higher international) and seasonal SMS softness .
Balance sheet remains a key support (cash & equivalents $216M; no debt); OTI repurchased ~$5M of stock (~1.5M shares) in Q3 and signed a tuck-in BioMedomics deal to add SickleSCAN to the international diagnostics portfolio .

What Went Well and What Went Wrong

What Went Well
- Non-GAAP EPS beat consensus: $(0.13) vs $(0.19)* and non-GAAP gross margin improved to 44.2% (vs 43.3% LY), helped by lower scrap and operational efficiencies; GAAP gross margin 43.5% (vs 42.8% LY) .
- Strong liquidity and capital deployment: cash & equivalents $216M, no debt; repurchased ~$5M (~1.5M shares) in Q3 .
- Pipeline and commercial progress: Together TakeMeHome mail-order HIV self-test program renewed (expect ~$1.8M Q4 revenue); BioMedomics acquisition expands portfolio into sickle cell testing for under-served international markets .
What Went Wrong
- Revenue miss and YoY decline: $27.1M vs $29.1M* consensus; Diagnostics -34% YoY (international HIV destocking/funding) and SMS -20% YoY (consumer genomics) .
- Operating leverage pressure: GAAP operating loss $(16.1)M vs $(6.0)M LY as R&D and innovation spending rose; YTD operating cash flow $(40.0)M .
- Outlook tempered by mix/seasonality: Q4 gross margin guided to low-40% (below Q3) on higher international mix; SMS expected to decline sequentially with typical seasonality .

Financial Results

Overall performance vs prior year and sequentially

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Net Revenues ($M)	$39.915	$29.931	$31.242	$27.085
GAAP Diluted EPS	$(0.06)	$(0.21)	$(0.26)	$(0.19)
Non-GAAP Diluted EPS	$(0.01)	$(0.18)	$(0.19)	$(0.13)
GAAP Gross Margin %	42.8%	41.1%	42.1%	43.5%
Non-GAAP Gross Margin %	43.3%	41.7%	43.2%	44.2%

Segment and category revenue mix

Category ($M)	Q3 2024	Q2 2025	Q3 2025
Diagnostics	$22.023	$19.222	$14.499
Sample Management Solutions	$12.806	$9.855	$10.306
Other product & services	$0.748	$0.296	$0.442
COVID-19 Diagnostics	$2.155	$0.028	$0.089
Risk Assessment Testing	$1.911	$0.446	$—
Molecular Services	$0.009	$0.810	$—
Net product & services	$39.652	$53.949	$25.336
Non-product & services	$0.263	$0.386	$1.749
Total Net Revenues	$39.915	$54.335	$27.085

KPIs and cash

KPI	Q1 2025	Q2 2025	Q3 2025
Cash & Equivalents ($M)	$247.569	$234.578	$216.478
Operating Cash Flow ($M)	$(19.733) (YTD)	$(29.956) (YTD)	$(40.027) (YTD); Q3 ≈ $(10) (mgmt)
Share Repurchases ($M)	$0 (authorization announced)	$5.0	$5.0

Non-GAAP adjustments (select items): stock-based comp, change in fair value of contingent consideration, executive severance, amortization of acquisition intangibles, equity method losses; see reconciliation for full list .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue	Q3 2025	$27M–$30M (8/5/25)	Actual: $27.085M	In range (low end)
Total Revenue	Q4 2025	—	$25M–$28M; COVID-19 < $0.1M	New
Non-GAAP Gross Margin %	Q4 2025	—	Low 40% range	New
Operating Expenses	Q4 2025	—	Core OpEx ≈ $20M; Innovation ≈ $10M (incl. Sherlock $7–$8M)	New

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025, Q2 2025)	Current Period (Q3 2025)	Trend
Funding/Macro	Persistently high uncertainty in public health funding; mix pressure on GM	Elevated uncertainty continued; slower HIV orders internationally as partners work through inventory	Unchanged/pressure persists
International HIV	Noted strength in 2024; anticipated slower H2 orders (Q2 call/PR)	Diagnostics -34% YoY; softness aligned with prior commentary	Deteriorated YoY as expected
SMS/Consumer Genomics	Declines tied to one large customer; sequential improvement possible (Q2)	SMS +QoQ in Q3; guide sequential decline in Q4 on seasonality	Stabilizing ex-large customer; seasonal
Pipeline: Sherlock CT/NG	Clinical progress; late 2025/early 2026 FDA submission target	On track; investment priority in Q4 ($7–$8M)	Execution ongoing
Pipeline: Colli-Pee	RUO traction; plan FDA submission late 2025/early 2026	Advancing; discussions with platform providers (STIs/HPV)	Advancing
Proteomics (HEMAcollect)	RUO launch July; early feedback positive	Customer interest; 2026 momentum expected	Building
Capital Allocation	$40M buyback authorization (Q1); $5M Q2 buyback	$5M Q3 buyback; tuck-in M&A (BioMedomics)	Active
M&A	—	BioMedomics: $4M upfront, milestone-based earnout; near breakeven cash flow	Portfolio expansion

Management Commentary

“In Q3 we delivered $27.1 million of revenue… we remain confident in our opportunities to return to growth in 2026, driven by diversification in our customer base and contributions from planned launches of new products in both rapid diagnostics and sample management solutions.” — Carrie Eglinton Manner, CEO .
“Non-GAAP gross margin was 44.2%, which was slightly better than our expectations due to lower scrap expenses.” — Ken McGrath, CFO .
“We ended Q3 with zero debt and total cash and cash equivalents of $216 million… We deployed $5 million during the third quarter to repurchase approximately 1.5 million shares.” — Ken McGrath, CFO .
“We signed a definitive agreement to acquire BioMedomics… we can significantly expand the reach and adoption of SickleSCAN by leveraging our international sales channels and relationships with national health programs.” — Carrie Eglinton Manner .

Q&A Highlights

BioMedomics acquisition: Management framed it as a low-risk tuck-in leveraging existing channels in Africa/LatAm; $4M upfront plus contingent milestones; expected cash flow breakeven with attractive ROI as revenues scale .
Gross margin puts/takes: Q3 upside from lower scrap and operational efficiencies; Q4 margin guided slightly lower on seasonality and higher mix of international revenue .
Spending priorities: Core business near breakeven; incremental spend concentrated in innovation (Sherlock CT/NG clinical and other internal programs) .

Estimates Context

Q3 2025 vs S&P Global consensus: Revenue $27.085M vs $29.128M* (miss), Primary EPS (non-GAAP proxy) $(0.13) vs $(0.19)* (beat) .
Q4 2025 setup: Guide $25–$28M vs revenue consensus $26.443M*; Primary EPS consensus $(0.205)*; mix/seasonality imply slight margin downtick to low-40% .
Full-year context: FY25 consensus revenue $114.701M* and Primary EPS $(0.865)*; YTD revenue $88.258M through Q3 .

Values marked with * were retrieved from S&P Global consensus (GetEstimates).

Actual vs Consensus Table (S&P Global)

Metric	Q3 2025 Actual	Q3 2025 Consensus*	Δ
Revenue ($M)	$27.085	$29.128*	$(2.043)
Primary EPS	$(0.13)	$(0.19)*	+$0.06

Forward	Q4 2025 Guide	Q4 2025 Consensus*
Revenue ($M)	$25–$28	$26.444*
Primary EPS	—	$(0.205)*

Key Takeaways for Investors

Mixed print: Revenue miss but EPS beat as gross margin execution offset volume/mix headwinds; focus near-term on order patterns in international HIV and seasonality in SMS .
Guidance brackets Street: Q4 revenue $25–$28M envelopes consensus and points to continued mix pressure on margins (low-40% guided) .
Cash-rich with active capital deployment: $216M cash, no debt; ongoing buybacks and selective tuck-in M&A (BioMedomics) provide optionality while funding innovation .
2026 growth narrative intact: Sherlock CT/NG OTC molecular self-test and Colli-Pee FDA submissions targeted for late 2025/early 2026; proteomics RUO traction could add incremental growth levers .
Watch funding dynamics: Continued uncertainty in U.S. public health budgets and international HIV program funding is the primary risk to near-term revenue stabilization .
Estimate revisions: Expect modest downward revenue revisions for Q3 actual miss and cautious Q4 mix, partly offset by EPS resilience from GM execution; FY25 consensus already embeds losses* .
Trading setup: Shares likely to trade on evidence of order normalization (HIV/SMS) and regulatory milestones pacing (Sherlock/Colli-Pee); balance sheet limits downside, catalysts skew to 2026 .

ORASURE TECHNOLOGIES INC (OSUR)·Q3 2025 Earnings Summary