Orasure International diagnostics revenue projected to decline ~ 20% for full year 2025

 

RISKS

International diagnostics revenue is projected to decline approximately 20% for full year 2025 compared to 2024, with management explicitly noting this is due to lower HIV test orders as partners work through inventory and respond to changes in funding.

Management indicated an environment with elevated levels of uncertainty related to funding for public health programs and research, as well as the government shutdown in the US, signaling an ongoing external demand headwind.

The consumer genetics customer headwind persists, with revenue from this segment is expected to remain lower in Q4 2025 due to continued disruptions in ordering patterns.

Operating loss reached $16.1 million in Q3 2025, while operating cash flow was negative $10 million in Q3 2025, reflecting continued near-term pressure on profitability and cash generation from investments in R&D and innovation.

TAKEAWAYS

Total Revenue -- $27.1 million total revenue for Q3 2025, with core revenue at $27 million; this excludes COVID-19 products and exited businesses.

Diagnostics Revenue -- Diagnostics revenue was $14.5 million, driven by both international and US segments.

Sample Management Revenue -- $10.3 million for Sample Management Solution revenue in Q3 2025, with core customer base (excluding the consumer genetics customer) showing year-over-year growth.

GAAP Gross Margin -- 43.5% gross margin for Q3 2025, slightly above expectations due to lower scrap expenses and operational efficiencies.

Non-GAAP Gross Margin -- 44.2% non-GAAP gross margin, achieving a modest gain above internal forecasts.

GAAP Operating Expenses -- Operating expenses were $27.9 million in Q3 2025, including $2.8 million in noncash stock compensation in Q3 2025 and $376,000 from acquisition-related contingent consideration adjustment in Q3 2025.

GAAP Operating Loss -- Operating loss was $16.1 million for Q3 2025, and Non-GAAP Operating Loss -- Non-GAAP operating loss was $12.7 million.

Total Cash and Cash Equivalents -- Ended the quarter at $216 million with zero debt.

Operating Cash Flow -- Negative $10 million operating cash flow, aligned with expectations given ongoing platform investments.

Share Repurchase -- $5 million was used to buy back approximately 1.5 million shares.

Q4 Revenue Guidance -- Forecasted Q4 2025 revenue at $25 million to $28 million, with less than $100,000 expected from COVID-19 products.

Q4 Gross Margin Guidance -- Low 40% range gross margin for Q4 2025, expected to be lower than Q3 due to seasonality and increased international mix.

Q4 Operating Expense Guidance -- Core expenses around $20 million for Q4 2025; innovation investment of $10 million (including $7 million-$8 million for SHERLOC development).

International Diagnostics Annual Outlook -- Revenue now expected in the low to mid $30 million range for full year 2025, "representing a decline of approximately 20%" per management compared to 2024, as national health programs adapt to funding environment changes.

US Diagnostics Annual Outlook -- Revenue projected in the low to mid $30 million range for full year 2025, corresponding to a low single-digit percentage decline.

Sample Management Full-Year Outlook -- Revenue expected in the high $30 million range for full year 2025, approximately flat compared to 2024, excluding the impact of the decline in orders from the consumer genetics customer.

BioMedomics Acquisition -- Definitive agreement signed for $4 million upfront plus potential contingent payments, targeting sickle cell diagnostics for underserved international markets.

BioMedomics Revenue Contribution -- Currently near $1 million in annual revenue, with potential to reach several million over several years and expected to be cash flow breakeven as integration leverages existing infrastructure.

Together Take Me Home Program -- Renewed for a fourth year, with management expecting to recognize approximately $1.8 million in revenue in Q4 2025 and similar quarterly run-rate in 2026.

Product Pipeline Progress -- Mid-year launch of HemaCollect protein product for RUO markets; ColliPea clinical trial data FDA submission targeted for late 2025 or early 2026; SHERLOC platform’s first CTNG assay progressing toward an FDA submission in the same timeframe.

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