[Management View]
OraSure Technologies views 2025 as a transition year, with a focus on strategic transformation and positioning for growth in 2026. The company is expanding its product portfolio and customer relationships, accelerating growth through investments in R&D, acquisitions, and partnerships. The acquisition of BioMedomics aims to enhance the diagnostic portfolio with sickle cell testing for underserved markets.

[Outlook]
For Q4 2025, OraSure forecasts revenue between $25 million and $28 million, with gross margins expected in the low 40% range due to seasonality and increased international revenue. The company anticipates a return to growth in 2026, driven by innovation investments and expanded commercial capabilities.

[Financial Performance]
Total revenue for Q3 2025 was $27.1 million, with diagnostics revenue at $14.5 million and sample management revenue at $10.3 million. GAAP gross margin was 43.5%, slightly above expectations. Operating loss reached $16.1 million, with negative operating cash flow of $10 million, reflecting ongoing investments in innovation.

[Q&A Highlights]
Question 1: Could you discuss the BioMedomics acquisition and what attracted you to that asset?
Answer: The acquisition aligns with OraSure's international portfolio, focusing on rapid diagnostic testing for underserved markets. Sickle cell testing addresses a significant need in regions like Africa and Latin America. The deal structure includes a small upfront payment with contingent considerations, offering a strong return on investment. BioMedomics is expected to be cash flow breakeven, leveraging OraSure's existing capabilities.

Question 2: Can you highlight some of the factors affecting gross margins and any lingering costs from insourcing?
Answer: Gross margins exceeded expectations due to lower scrap expenses, driven by operational efficiencies. OpEx was in line with expectations, with innovation investments focused on SHERLOC CTNG clinical trial submission. Q4 margins are expected to be slightly lower due to seasonality and increased international revenue mix.

[Sentiment Analysis]
Analysts and management maintained a constructive tone, focusing on strategic growth initiatives and operational efficiencies. The sentiment was optimistic regarding future growth prospects and the impact of recent acquisitions.

[Quarterly Comparison]
| Metric | Q3 2025 | Q2 2025 | YoY Change |
|----------------------------|---------|---------|------------|
| Total Revenue | $27.1M | $27.0M | Mixed |
| Diagnostics Revenue | $14.5M | $14.0M | Positive |
| Sample Management Revenue | $10.3M | $10.0M | Positive |
| GAAP Gross Margin | 43.5% | 42.0% | Positive |
| Operating Loss | $16.1M | $15.0M | Negative |

[Risks and Concerns]
International diagnostics revenue is projected to decline by approximately 20% for 2025 due to lower HIV test orders and funding changes. The consumer genetics segment faces ongoing disruptions, impacting revenue. Elevated uncertainty related to public health funding and the US government shutdown poses external demand challenges.

[Final Takeaway]
OraSure Technologies is navigating a transition year with strategic acquisitions and innovation investments aimed at driving future growth. Despite current headwinds in international diagnostics and consumer genetics, the company remains committed to expanding its product portfolio and leveraging its commercial strengths. The acquisition of BioMedomics and continued innovation within platforms like SHERLOC and ColliPea are expected to position OraSure for a return to growth in 2026, supported by a strong cash position and strategic focus on decentralizing diagnostics and increasing self-collection adoption.