OPKO Health, Inc. Q3 FY2025 earnings call

• BioReference: Completed sale of oncology division, now focused on core clinical testing in NY/NJ, 4Kscore test volume up >20% in Q3. Employee headcount reduced by 25% since January, aiming for profitability and growth.
• Therapeutics: Entered collaboration with Regeneron, advancing EBV vaccine trial with Merck. Immuno-oncology programs like MDX2001 and MDX2004 in clinical trials. OPK-88006 and oral GLP-2 tablet in pre-IND stage. International operations continuing growth despite foreign currency pressures.

Diagnostics

• Q3 2025 revenue was $95.2 million, including $19.5 million from the recently sold oncology assets. Continuing business revenue grew, with 4Kscore volumes up over 20%. Total costs and expenses were $115.2 million, down from $184.2 million in 2024. Diagnostic operating income improved to $81.6 million. Annualized cost savings expected to be over $25 million, aiming for breakeven operating results in Q4 2025.

Pharmaceutical

• Revenue was $56.4 million, up 8% from 2024's $52.4 million. Product revenue was $37.7 million, partially offset by increased revenue from Rayaldee ($7.5 million in Q3 2025, a 29% increase from 2024). IP transfer revenue rose to $18.7 million. Pharmaceutical operating loss was $24.2 million, a 25% improvement from the prior year.

• Q4 2025 revenue expected $135M-$140M, costs $175M-$180M.
• 2026 guidance: BioReference profitable with low single-digit revenue growth, pharmaceutical businesses mid-single-digit growth, NGENLA profit share ~$32M-$35M, $100M+ R&D investment, up to 6 Phase I programs enrolling in 2026.

Q: Congrats on the progress. I had one for MDX2001. Wondering if you could say how many patients you've dosed at the fifth dose level? And will you proceed to dose level 6 with the program? And is there anything more you can share on the safety profile and potentially whether you're seeing any efficacy signals at this point as well?

A: Gary Nabel: Sure. We've 5 patients at the current dose level. Any responses with this small number of patients are anecdotal. Time to look at efficacy would be when going to expansion cohorts in Phase Ib. We'll share news as soon as available.

Q: Maurice Raycroft: Got it. Yes. It’s okay. Phillip Frost: Total numbers are close to 30 or so, but yes, 5 in this cohort, as Elias mentioned. Maurice Raycroft: Okay. And you will go to dose level 6 as well? Phillip Frost: We would expect.

Q: Maurice Raycroft: Okay. Okay. That's helpful. And I had a quick question on the 4Kscore. For that label expansion and the 20% growth that you mentioned, is the growth directly related to the expansion? And how should we think about the importance of this product as a contributor going forward?

A: Elias Zerhouni: Yes, the growth is based on the former label. The label change expands the market to primary care doctors. The 4Kscore franchise is national, and we're just beginning to tap into the expanded market.

Q: Yi Chen: My first question is, could you give us some more color on the Regeneron collaboration, whether the program is exclusively focused on oncology or it could be some candidates in other therapeutic sectors? And also, can you comment on how many total programs are currently ongoing?

A: Elias Zerhouni: There's nothing exclusive on oncology or immunology. We've agreed to work on 4 programs covering metabolism, oncology, and immunology. Gary Nabel: We're excited to work with Regeneron in areas like metabolism, immunology, and selected oncology opportunities. There are 4 targets to start with, but the agreement can be expanded.

Q: Kevin DeGeeter: Maybe 2 for me. The first one is on MDX2001. Can you walk us through your current thinking on how you're thinking looking at patient selection for the Phase Ib expansion cohorts? Are there specific tumor types that makes sense based on how you think about the profile of this molecule?

A: Gary Nabel: Criteria include tumor types with high levels of CMet and Trop2, and those more immunogenic. High on the list are non-small cell lung cancer, renal cell carcinoma, and PD-1 failure in melanoma. We'll explore harder targets after establishing efficacy in initial cohorts.

Q: Yale Jen: Just a few here. The first one is in terms of the EBV virus vaccine data, first Phase I data, do you anticipate to report that data in near term? Or you think that Merck may not report that data just to go ahead for the Phase II?

A: Gary Nabel: We're in close contact with Merck. Merck is responsible for trials, but we expect them to report data as per NIH guidelines when complete. The decision on Phase II start is yet to be determined but will be shared when known.

Q: Michael Petusky: Adam, I just want to clarify something real quick. The $4.2 million in severance, that's in addition to the $25.2 million of expenses -- costs and expenses associated with the assets that are being sold. Is that correct?

A: Adam Logal: That's right.

Q: Michael Petusky: Okay. Great. And then I guess one of the earlier callers sort of alluded to increased granularity. I'm going to actually give it a shot and ask for it now. Would you guys be willing to share sort of year-to-date revs through 9 months of 4Kscore or third quarter revenue associated with the test?

A: Adam Logal: We haven't separately disclosed it yet, but we'll start to provide more clarity there.

Q: Michael Petusky: Okay. Could I ask in terms of the -- and I really super appreciate the '26 high-level guide. In terms of the low single-digit growth that you guys expect in the lab business, what are you assuming around volume growth and pricing? I mean, I don't know, is pricing sort of a neutral, a bad guy? Can you just sort of talk about what you expect in terms of volume growth and pricing for '26?

A: Adam Logal: We would expect volume growth to be in the low single-digit numbers. We're assuming stable pricing, with potential upside from 4Kscore reimbursement discussions.

Q: Michael Petusky: Okay. And then just last one and sticking with the ‘26 high-level guide. The Pfizer profit share guide that you gave, to me, feels a little lighter than I would have guessed. Can you just talk about what's going on there in terms of conversion to weekly and just any other sort of data points you can share around that relationship and that effort to get that business going?

A: Adam Logal: The market is converting slower than expected. Pfizer is competing well globally, but market conversion has been slower than initial models. We expect the market to pick up, but for now, the profit share guide is ~$32M-$35M as per current trends.

Q: Michael Petusky: Great. It really does. Let me just sneak one last one in. Just around -- and this should be a quick answer, I think. 4Kscore, I think you said the test volumes were up 20% in the quarter. Would revenue be up approximately 20%? Or would that be lagging that 20% figure?

A: Adam Logal: It's similar, both the same.