OPKO Health, Inc. (NASDAQ:OPK) Q4 2022 Earnings Call Transcript

Elias Zerhouni: Just as an add-on, Gary, if you allow me, the EBV vaccine is the most advanced in our portfolio and is likely to enter the clinic by the end of the year, beginning of next year as well. It’s one of those molecules — I mean programs that are pretty much going through the last stages of IND approval.

Operator: The next question comes from Edward Tenthoff with Piper Sandler.

Edward Tenthoff: Great. Thank you very much for the update and really looking forward to the R&D Day next month. I guess my question has to do just with respect to overseas and really how in NGENLA is doing? Are you seeing competition at this point from SKYTROFA? And how much of a delay do you think in terms of ultimate competition in the U.S. is the head start that SKYTROFA has gotten? How much of a setback do you think that might be for the ultimate market share here in the U.S.

Adam Logal: It’s Adam. I’ll start off, and I’m sure others will weigh in. So outside of the U.S. right now, at least in the Japanese markets or Japanese region, we don’t expect long-acting growth hormones to enter that market for a few years. In Europe, there is a head start that Pfizer has had on SKYTROFA as well. I think they’ve — SKYTROFA won’t be launched until the second half of this year in the European market. So there is a good deal of progress that Pfizer has been able to make in that market. As far as the U.S. delay is going, there’s — it’s a big market. Payer landscapes are challenging for all new entrants into the market, which is — which may have impacted SKYTROFA’s launch. So we think Pfizer is well positioned once they do have approval to launch in the U.S. So we expect it to be a competitive market. Today, it’s fragmented with 7 players in the daily market. So having 2 or 3 competitors should put us in a good spot.

Elias Zerhouni: Just one more thing, if I could, Adam. In addition to the upside or setbacks, as you asked, — there is an element that is important. And that is if and when, hopefully, we get approval for the FDA. Our R&D expenses in somatrogon will decrease significantly because we’re keeping sites open with extensions as long as we haven’t finalized the approval of that. So that will also help in the balance sheet, if you will, of the program. that I don’t think is taken into account and maybe Adam can give you the numbers eventually.

Operator: The next question comes from Yale Jen with Laidlaw & Company.

Yale Jen: My first question is in terms of NGENLA selling in Europe, and you will start to have a profit sharing later this year. Do we anticipate either Pfizer or you guys provide some sales figures over those territories to provide more colors.

Adam Logal: So Pfizer — I don’t know what their plans are to split out NGENLA’s revenue numbers. So we wouldn’t provide those when it becomes material to the overall financials of OPKO, we would potentially break out the profit share or royalty income that we’re receiving from it.

Yale Jen: And maybe a follow-up question on this point is that I think in the press release, you mentioned that there’s all priority markets to be launched this year. Could we give a little bit more color in terms of what to the priority markets in this statement?

Adam Logal: It’s the major pharmaceutical markets, is the way I would define it.

Yale Jen: Okay. And maybe the last question here is in terms of the diagnostics sector — groups. Could we get some sense of in terms of the headcount from the height of the COVID days to recently as well as — how does that compare to the pre-COVID days.