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ORASURE TECHNOLOGIES INC (OSUR)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 results were in the top half of guidance; total net revenues were $31.2M and diluted non-GAAP EPS was $(0.19), with gross margin at 42.1% GAAP and 43.2% non-GAAP .
  • The company modestly beat Wall Street consensus: revenue $31.24M vs $30.36M estimate and EPS $(0.19) vs $(0.204) estimate; estimate set sizes: 3 for revenue and 2 for EPS* [Values retrieved from S&P Global].
  • Management guided Q3 2025 total revenue to $27–$30M (COVID < $0.1M), with gross margin percentage expected “consistent with Q2”; core OpEx ~$20M plus ~$10M innovation spend (SHERLOC $7–$8M) .
  • Strategic progress included July launch of HEMAcollect PROTEIN (blood proteomics), renewal with GeneDx, and appointment of new CCO, positioning for 2026 growth .
  • Key catalysts: clarity on USAID/PEPFAR-related funding constraints for international HIV programs, timing of US Together Take Me Home orders, in-house manufacturing efficiencies ramping, and pipeline milestones (Colli-Pee FDA submission, CT/NG OTC molecular test) .

What Went Well and What Went Wrong

What Went Well

  • Diagnostics revenue grew 3% YoY to $19.2M; core revenue was $30.8M (down 5% YoY) despite public health funding uncertainty .
  • Execution on internal manufacturing transition ahead of plan; non-GAAP gross margin of 43.2% “better than expectations,” supported by lower scrap and manufacturing improvements .
  • Product and commercial momentum: HEMAcollect PROTEIN launched (stabilizes plasma proteins up to seven days), and GeneDx agreement renewed; new CCO brings 25+ years of leadership from BD, Danaher, Quest, Siemens .
  • Quote: “I am confident that OTI is well-positioned to deliver growth in 2026…our strong balance sheet provides the flexibility to invest…” .

What Went Wrong

  • Total net revenues fell 43% YoY to $31.2M, primarily on the collapse of COVID revenues; GAAP operating loss widened to $(18.0)M vs $(2.7)M prior year .
  • Sample Management Solutions declined 22% YoY to $9.9M on disruption at a large consumer genomics customer; molecular services and risk assessment exited/declined .
  • International HIV orders expected to slow in H2 as partners work through inventory amid USAID funding freezes; US Together Take Me Home timing reduced Q3 recognition (~$0.5M vs ~$2M in Q2) .

Financial Results

MetricQ2 2024Q1 2025Q2 2025Q2 2025 ConsensusQ2 2025 Actual
Net Revenues ($USD Millions)$54.335 $29.931 $31.242 $30.358*$31.242
Gross Margin (%) (GAAP)45.4% 41.1% 42.1% —42.1%
Gross Margin (%) (Non-GAAP)47.4% 41.7% 43.2% —43.2%
Operating Income (Loss) ($USD Millions, GAAP)$(2.740) $(17.750) $(18.026) —$(18.026)
Diluted GAAP EPS ($)$(0.01) $(0.21) $(0.26) —$(0.26)
Diluted Non-GAAP EPS ($)$0.08 $(0.18) $(0.19) $(0.204)*$(0.19)
Cash and Cash Equivalents ($USD Millions)—$247.6 $234.6 —$234.6

Note: Asterisks (*) indicate values retrieved from S&P Global.

Segment Revenues ($USD Thousands)

SegmentQ2 2024Q1 2025Q2 2025
Diagnostics$18,746 $17,689 $19,222
Sample Management Solutions$12,609 $9,110 $9,855
Risk Assessment Testing$2,308 $1,420 $446
COVID-19 Diagnostics$18,934 $457 $28
Molecular Services$810 $873 —
Non-product & Services$386 $934 $1,395
Total Net Revenues$54,335 $29,931 $31,242

KPIs

KPIQ2 2024Q1 2025Q2 2025
Non-GAAP Operating Income (Loss) ($USD Millions)$3.346 $(0.325) $(13.172)
Operating Cash Flow ($USD Millions)—$(19.733) H1: $(29.956)
Share Repurchases—Authorization $40M program $5M (1.8M shares) in Q2

Non-GAAP adjustments included stock compensation, executive severance, inventory reserves, change in fair value of contingent consideration, and exclusion of losses from equity method investee .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenues ($USD Millions)Q2 2025$28.5–$32.5 Actual $31.2 Delivered within range
Total Revenues ($USD Millions)Q3 2025N/A$27–$30 (COVID < $0.1) Initiated
Gross Margin (%)Q3 2025N/A“Consistent with Q2” Maintained vs Q2
Core Operating Expenses ($USD Millions)Q3 2025N/A~ $20 + ~$10 innovation (SHERLOC $7–$8) Initiated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
International HIV funding (USAID/PEPFAR)Waiver allowed operations, but disruptions; ~80% of int’l diagnostics donor-funded ~$1M headwind sized; stability in multilateral funding; steady/flat Slower pace of orders H2 as partners bleed inventory; timing impacts Worsening in near term
Together Take Me Home (US HIV self-test)Not highlighted~$4M FY25 expected; $1.5M in Q1; program scheduled to end 9/30 Q3 recognition ~$0.5M vs $2M in Q2; potential continuation but funding uncertain Near-term decline
Manufacturing/internalizationPlan to insource, automation (reel-to-reel), packaging; path to ~50% adj GM Transition substantially complete by end of Q2; margin expansion H2 Transition substantially complete; Q2 margins above expectations; efficiencies ramp into 2026 Improving structurally
Consumer genomics customerNot highlighted in Q4No volume expected in Q2; disruption concentrated in single large customer SMS down 22% YoY; no significant H2 revenue expected; ordering may resume in 2026 Headwind persists
Pipeline: CT/NG OTC molecular test (Sherlock)Acquisition; CT/NG in trials; submit by end 2025 $7–$8M quarterly investment; submission by end 2025 Clinical trial progression; 2025 submission target reaffirmed On track
Colli-Pee (urine)2025 FDA submission target Support Color Health NY approval using Colli-Pee; submission goal retained Strong progress; discussions with platform providers; multibillion TAM Advancing
Proteomics (HEMAcollect PROTEIN)Not in Q4Planned launch in 2025 July launch; strong early engagement; 7-day stabilization; broad tech compatibility Positive momentum

Management Commentary

  • “Core revenue of $30,800,000 was above the midpoint of our guidance range. Diagnostics grew 3% year over year…Sample Management...decline attributable to a large customer in the consumer genetics segment” .
  • “We substantially completed the transition from external contract manufacturing…to our internal capabilities in Pennsylvania” .
  • “I am confident that OTI is well-positioned to deliver growth in 2026…our strong balance sheet provides the flexibility to invest” .
  • “We launched our HEMAcollect PROTEIN…stabilizing proteins for up to seven days at room temperature…compatible with mass spec, immunoassays, and high-throughput affinity platforms” .
  • “In Q3, we expect core operating expenses of approximately $20,000,000 plus $10,000,000 of investments in innovation, including $7,000,000 to $8,000,000 related to SHERLOC” .

Q&A Highlights

  • Revenue guide drivers: international HIV timing headwinds (USAID funding freeze) and TTTH program order timing; expect slower pace in Q3 as partners bleed inventory .
  • Margin outlook: Q3 gross margin % “consistent with Q2”; efficiency benefits depend on volume; internal manufacturing transition completed ahead of schedule .
  • Proteomics traction: “enthusiastic customer engagement” for HEMAcollect PROTEIN; RUO launch into oncology, neurology, cardiometabolic use cases; momentum building into 2026 .
  • Diagnostics timing: Q2 benefited from TTTH orders; Q3 expected slowdown with program timing; international orders lumpy with inventory drawdowns .
  • Segment color: HCV expected stable QoQ; HIV slower internationally in Q3 as funding dynamics and inventory levels normalize .

Estimates Context

  • Q2 2025 vs Street: Revenue $31.24M vs $30.36M consensus; EPS $(0.19) vs $(0.204) consensus; estimate counts: revenue (3), EPS (2)* [Values retrieved from S&P Global].
  • Implication: Modest beat on both revenue and EPS; given thin coverage, estimate revisions likely hinge on visibility into international HIV funding and TTTH timing .

Key Takeaways for Investors

  • Core business resilience: Diagnostics +3% YoY and core revenue at the upper half of guidance despite public health funding uncertainty .
  • Near-term headwinds: International HIV orders and US TTTH timing will constrain Q3 revenue ($27–$30M guide) and keep results choppy .
  • Structural margin story: Internal manufacturing, packaging and reagent insourcing support margin stability in Q3 and expansion through 2026 with volume leverage .
  • Pipeline catalysts: Colli-Pee FDA submission (2025), SHERLOC CT/NG OTC submission (2025), plus HEMAcollect PROTEIN launch driving new use cases—watch regulatory milestones and early adoption .
  • SMS exposure normalized: Large consumer genomics customer disruption persists through 2025; renewal wins (GeneDx) and expansion into clinical settings help diversify .
  • Capital deployment: Ongoing $40M buyback authorization and $5M repurchased in Q2 underscore balance sheet strength; potential inorganic opportunities to accelerate near-term revenue .
  • Trading setup: Stock likely sensitive to updates on USAID/PEPFAR funding, TTTH program continuation, and evidence of margin traction from insourcing—monitor Q3 execution against guide and pipeline newsflow .

Sources

  • Q2 2025 press release and 8-K:
  • Q2 2025 earnings call transcript:
  • Q1 2025 press release and call:
  • Q4 2024 press release and call:
  • Product/commercial releases: HEMAcollect PROTEIN ; CCO appointment ; GeneDx renewal .

Note: Asterisks (*) indicate values retrieved from S&P Global.