Lantheus Holdings, Inc. (NASDAQ:LNTH) Q2 2023 Earnings Call Transcript

And I think by any means measurable, and you would call this a blockbuster launch. And I say that — I’m proud to say that, but I’m much more proud about, why that happened? That happened, because the level of innovation that was represented by PSMA imaging, was correlated and matched by our commercial execution, the excellence with which we brought this product to physicians and to the market. So I think that is really going to be much more the basis of how physicians choose going forward. What products to use when scanning their patients? When it is relevant to necessary, they do refer back to packet inserts to make sure that they’re own practices kind of in line with that. We bought particular attention to it today, only because we’ve been offered significant for back about the attempt to make a claim about F 18 agents in general being alike, and we wanted to clarify where the products are different.

And as I said, most distinctively, they’re different in that they’re both their unique new chemical entities that both follow different paths to approval based on the construct of the isotope and the ligand that attached to it.

Paul Blanchfield: And I would just add, I do think these matters in the marketplace. I think clinical and commercial differentiation is important. We saw that with our early commercial competitor, where they were approved about six months after us. And if you look at the relative share position, those clinical and commercial differentiators do play out. We welcome, as we expected additional competition with another F 18 agent, but as a fourth-to-market agent, where PYLARIFY has a significant market leadership where over 200,000 patients have been scanned, where this has been used in over 1,000 imaging centers that we’ve shared. We think we have a market-leading position with sustainable clinical and commercial advantages that will enable us to remain the market leader for many years to come.

Operator: Thank you. And we have a follow-up question from Richard Newitter from Truist Securities. Richard, your line is open.

Richard Newitter: Hi. Thanks for taking my follow-up. I also have two quick ones here. Mary Anne, you had mentioned something about a slight change to your guidance, I think, either philosophy with this updated guide, can you just refresh us on what that meant with a narrower band? And then just the second question is on, the SPLASH trial. You’re going to have Novartis PSMA 4 trial probably read out before or around the same time. Investors are naturally going to ask or try to compare between those trials. So Paul or anything you can say about differences between those trials that you’d highlight as people try to compare them. Is that fair? And what do you think would be a reasonable way to compare the PFS primary endpoint? Thanks.

Mary Anne Heino: Welcome. So I’ll take on your first question, Rich, with kind of what I was trying to convey. I think we have been — again, we have been through a pandemic and then through a launch, we have not — we have had our guidance more reflects a wider range just because of the uncertainty of what was going on in the market when it points during the launch. You just — you know your products going well, you just don’t know exactly where it’s going. We feel now, and this is what you’re seeing in our guidance is somewhat of a tightening of the range or confidence in having better line of sight to what our products do. And it’s at both ends and DEFINITY, we’re now confident that patient volume is coming back into that market.

So the market now represents again the opportunity that it had before the pandemic, and so we have better line of sight in forecasting there. But we also built as a company based on what has been our long-standing pattern of feeding and raising on guidance that it was also fair to our analyst community to try to give a tighter view as to where we think we’re heading.

Bob Marshall : Yes, and probably add here. Yes, Rich, and I don’t want you to take the impression that this is new. I actually made those kinds of comments that we were taking that kind of a shift in the new just as Mary Anne has outlined over the last couple of quarters. So we’re kind of continuing the trend here of what we had kind of came into the 2023 fiscal year with that kind of a view as we had continued to gain knowledge with a couple of years of experience under our belt, we can see things like holiday schedules and so forth that start to outlined a clearer pattern for us to be able to give, we think, intelligent and guidance ranges.

Mary Anne Heino : And to your second question, Rich, about the SPLASH, you are so right that people will be incredibly eager to compare not only the trial design, but the trial results when you talk about PSMAfore and then SPLASH. And you’re also correct our market intelligence would also suggest that the PSMAfore data will read out at ESMO, which will precede what we believe what is — what will be the release and the availability of the SPLASH data. I won’t use this time here to try to compare actual trial designs. What I will say that is important is that both PSMAfore and SPLASH are in the same patient population, which is the pre-chemo population. And the — any comparison to-date has been between the SPLASH dosimetry data, the lead-in data and the VISION trial data, which really are a different patient population.