Eduardo Han

Eduardo asked for clarity on the specific clinical milestones for MDX-2001 and MDX-2004 in 2026. He also questioned the BioReference margin expansion and expense bridge, noting that the total expense guidance of $725 million-$750 million seemed high following the divestiture, and sought more color on the OpEx for the new BioReference.

Answer

Elias Zerhouni, Vice Chairman and President, OPKO Health, outlined MDX-2001's milestone as completion of the dose regimen and entry into Phase 1b. For MDX-2004, the goal is to complete Phase 1a within the year to determine the optimal dose. Adam Logal, SVP and CFO, OPKO Health, explained that while BioReference's overall expense base is expected to decline due to operating efficiencies, the expense expansion primarily stems from increased R&D investments, with other operating company expenses expected to remain stable or decrease.

Eduardo Han, on behalf of Yi Chen, followed up on the mix of growth for thrombectomy, asking about the revenue growth attributable to price increases versus volume. He also requested an update on the Ambition BTK clinical trial, including its timeline and the anticipated market impact of its findings.

Answer

CFO Steve Trowbridge confirmed that mechanical thrombectomy growth is a combination of price increases, new customer acquisition, and increased utilization, attributing this to the strong product portfolio. CEO James Clemmer emphasized the importance of the Ambition BTK trial for both Auryon and the atherectomy market, noting confidence in Auryon's role for below-the-knee calcifications. He reported good enrollment pace in both the RCT and registry segments of the trial, expecting it to be a significant part of the Auryon business going forward, though not an immediate conclusion.

Eduardo Han, representing Yi Chen from H.C. Wainwright & Co., questioned the drivers of mechanical thrombectomy revenue growth, specifically the mix between new customer penetration, increased utilization, and price increases. He also sought an update on the Ambition BTK clinical trial, its timeline, and the anticipated market impact of its findings.

Answer

CFO Steve Trowbridge confirmed that mechanical thrombectomy revenue growth is a combination of price increases, new customer acquisition, and higher utilization, attributing this to strong product adoption. CEO Jim Clemmer described the Ambition BTK study as crucial for Auryon and the atherectomy market, expressing confidence in positive outcomes based on existing data. He noted the study's comprehensive structure (RCT and registry) and satisfactory enrollment pace, indicating it will be a significant future component of the Auryon business.