OraSure Technologies, Inc. Q1 FY2026 earnings call

Overall, advancing strategic transformation and executing with discipline. Leveraging manufacturing capabilities and capacity for gross margin expansion and cost structure streamlining. Elevating core growth by expanding and diversifying product portfolio and customer relationships. Two mid-year product launches planned: rapid molecular self-test for CT and G, and Coli-P at-home urine collection device. International diagnostics business strengthening relationships in Africa and expanding SickleScan reach. U.S. diagnostics business focusing on HIV testing programs. Sample management solutions seeing improvement in commercial customers but impact from NIH funding on academic and government markets. Innovation and product pipeline with two FDA clearance applications in review, expecting mid-year clearances and revenue ramp in H2.

Total revenue in the first quarter was $27.9 million. Diagnostic products generated $16.9 million of revenue in Q1, with a fairly even split between U.S. and international revenue, and diagnostics revenue grew 12% sequentially. Sample management solutions revenue in Q1 was $9.1 million, basically flat sequentially. International diagnostics business made progress on nearshoring with initial orders to one partner and anticipation of more in H2; U.S. diagnostics business public health customers stabilizing; sample management solutions commercial customers gradually improving but academic and government markets muted due to NIH grant funding slowdown.

Expect Q2 revenue of $27 million to $30 million including negligible COVID-19 testing revenue; Q2 gross margin similar to Q1; Q2 operating expense in high $20 million range; Q3 operating expense to decline to mid-$20 million range. R&D expense expected to taper down in Q2 and Q3. G&A expense expected to decline to normalized levels starting in Q3 after non-recurring items. Ended Q1 with zero debt and $177 million in cash and cash equivalents; deployed $5 million to repurchase shares in Q1.

This call may contain forward-looking statements where actual results could differ significantly. Factors affecting results discussed in OTI's SEC filings. OTI undertakes no obligation to update forward-looking statements.

Q: Hi, this is Brendan on for Patrick. I just want to start on the nearshoring initiative...

A: Thanks, Brendan. So as far as nearshoring, we're really excited about the opportunity...

Q: And then to touch on the margins...

A: Yeah, thanks. And, yeah, so what we said is Q2 will be similar to Q1...

Q: Hey, good afternoon, and thank you for your view on the outlet for the CT and G test...

A: Hi, Mac. You know, you're right in that, you know, when you have the product launch expectation...

Q: And maybe following up on the margin question...

A: Yeah, I'll tell you what we said in the past, and we'll be answering your question as I go through that...