OSUR
OraSure Technologies, Inc.2.4200
-0.0800-3.2%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
R&D taper, nearshoring details
Q&A reinforced prepared remarks on stabilizing demand and midyear launches but added color on lower 2026 R&D after CT/NG and Colli-Pee submissions, with some Q1 clinical trial carryover. Nearshoring in Africa emerged as an additive opportunity via local assembly partnerships, starting Q1. Sample Management showed underlying YoY growth ex-one customer, fueled by diversification; diagnostics poised for recovery as funding normalizes. Manufacturing shifts from Thailand and Canada contractors will lift margins with volume. Nearshoring beckons meaningfully. Management stayed cautious on FDA timelines. Investors watch launch ramps and international funding durability.
Key Stats
Market Cap
176.99MP/E (TTM)
-Basic EPS (TTM)
-0.81Dividend Yield
0%Recent Filings
10-K
FY2025 results
OraSure's FY2025 revenues plunged 38% to $115M, with diagnostics off 12% to $66M on weaker HIV funding in Africa/Asia while syphilis sales rose; sample solutions dropped 25% to $38M hit by a key customer bankruptcy, and COVID tests cratered 99% to $0.6M as demand vanished. Q4 momentum faltered amid InteliSwab exit and genomics volatility, though non-product R&D grants jumped to $6M. Gross margins slipped to 41.9% on poor mix and underabsorbed overhead; operating loss ballooned to $72M on higher R&D for CT/NG trials. Cash pile sits at $199M after $15M buybacks. Customer concentration threatens genomics sales.
8-K
Director Shulkin resigns cleanly
OraSure Technologies director David J. Shulkin, M.D., resigned effective March 2, 2026, after notifying the board on February 28; he also left the Compensation Committee. No disputes with the board, company, or management triggered the exit. The board thanked him for his service. Board loses healthcare expertise.
8-K
Q4 revenues $26.8M, down 29%
OraSure reported Q4 2025 net revenues of $26.8 million, down 29% from $37.4 million in Q4 2024, with core revenues at $26.7 million off 22% due to lower HIV tests and genomics customer weakness. Gross margin rose to 41.0%, yet operating loss widened to $20.1 million. Cash stands at $199 million; Q1 2026 revenues guided $26-29 million. FDA submissions for CT/NG self-test and Colli-Pee device advance growth pipeline.
8-K
FDA submissions for CT/NG self-test
OraSure Technologies submitted FDA applications on January 5, 2026, for clearance of its rapid molecular self-test for CT/NG—delivering results in 30 minutes via self-swab in a disposable OTC format—and its Colli-Pee at-home urine collection device for STIs. These moves target lab-dominated testing, eyeing a $1.5B addressable market. Progress fuels decentralization push. FDA approval remains uncertain.
8-K
Execs adopt stock buy plans
OraSure Technologies' CEO Carrie Eglinton Manner and CFO Kenneth McGrath adopted Rule 10b5-1 trading plans on December 1, 2025, each allowing up to $165,000 in common stock purchases over six months post-commencement. Trading starts after the mandatory cooling-off period, tied to the 10-K filing. Executives hold no control. Plans signal confidence amid the company's repurchase program.
IPO
Website
Employees
Sector
Industry
AVTR
Avantor, Inc.
11.20-0.08
BDX
Becton, Dickinson and Company
196.39-3.70
BMRA
Biomerica, Inc.
2.37-0.08
CODX
Co-Diagnostics, Inc.
0.25-0.02
DHR
Danaher Corporation
224.70-3.83
HOLX
Hologic, Inc.
75.02-0.17
OPK
Opko Health, Inc.
1.31-0.04
QDEL
QuidelOrtho Corporation
28.88-0.18
RPID
Rapid Micro Biosystems, Inc.
3.52+0.05
XRAY
DENTSPLY SIRONA Inc.
11.37-0.03