We are very comfortable with our market-leading position as the number one PSMA pet indigene aged. We are very pleased with the overall growth of the market that is now annualizing and our estimates of approximately $1.2 billion — and that’s versus the TAM that we shared back in January and noted there could be upside of $1.6 billion. So we still are very pleased with the uptake of Polarify, the uptake of the overall market. and where we’re going to go going forward.
Mary Anne Heino: And Rich, this is Mary. I’m just going to add what I say, if each time on these calls, I would like everyone to appreciate and something that we’re thrilled there. But we are still in a launch here — this is a brand-new market, a brand-new category, and we continue to be incredibly confident in what we see as a potential growth. As Paul mentioned, we’re already dollarizing at $1.2 billion. We see literally a TAM of $1.6 billion, and we see upside on that based on, again, evolving physician intent to use these products in their management, their diagnosis and management of prostate cancer
Operator: All right. Thank you. One moment for your next question. And for your next question, it comes from the line of Matt Taylor from Jeffries. Matt, your line is now open.
Matt Taylor : Hi. Thank you for taking the question. Good morning.
Mary Anne Heino: Good morning, Matt.
Matt Taylor : Good morning. So I wanted to see if you could comment a little bit further on some of the reimbursement developments that you talked about with CMS asking for public commentary and the Find Act is kind of running in parallel — maybe you could discuss some of the potential outcomes that you see there. Could you help us understand the timing of when some of these things had happened and maybe which of those you view as most likely?
Paul Blanchfield: Thanks for the question, Matt. So I think we were obviously pleased as we mentioned in our prepared remarks that CMS released their proposed OPPS rules for the calendar year 2024 in the middle of July, in those proposed rules for the first time since 2008 or 15 years, they included proposed rules, five of them, that it would adjust the reimbursement for innovative radiopharmaceutical diagnostics and two of which would dramatically change the current transitional pass-through payment status effectively as they proposed potentially beginning next year. And so we’re naturally very pleased that CMS has heard the need for continued patient access to these innovative radiopharmaceutical diagnostics and we are working with stakeholders as well as members across the industry to submit comments and to help CMS understand the importance of specifically a number of their proposed rules, which could go into effect in calendar year 2024.
Generally speaking, CMS finalizes its rules for the upcoming year in the early December, late November time frame, after which — before which they receive comments. And so we’re obviously working with them and our industry partners to ensure that they understand the importance and are optimistic that those could go into effect in next year. That said, we’ve always said we have a multi-pronged approach. And so we are also supporting the FIND Act, both in the House and in the Senate. The FIND Act was reintroduced in the house on February 27. It has 34 co-sponsors, including bipartisan support as the co-sponsors. It was also referenced in a recent House Energy and Commerce Committee meeting on July 18, where there were several members made comments about the importance of supporting the FIND Act.
And then it was introduced in the Senate on May 9 and also has a bipartisan sponsorship. And so we’re naturally hopeful that the FIND Act will be included in a legislative hearing this fall and being passed in due course. But as we said, we have a multi-pronged strategy, both through CMS and through the FIND Act as well as other commercial strategies to minimize the potential impact on pass-through and most importantly, ensure that prostate cancer patients continue to have access to innovative radiopharmaceuticals diagnostics, including clarify the market-leading agent
Operator: Thank you. As to your next question, it comes from the line of Anthony Petrone from Mizuho Americas. Anthony, your line is now open.
Anthony Petrone: Thanks, and good morning, everyone. Congrats on the strong quarter here. Maybe just high level on looking at the PSMA prostate cancer testing landscape and just in terms of share as we go forward here, we do have the third competitor in the US market. Maybe just thoughts on how share is going to trend now with three options in the marketplace? And then one quick follow-up will be on Europe. Just a recap on how we should be thinking about the rollout of PolariPy in Europe? There’s fewer pet facilities, but yet there’s a higher incidence of prostate cancer, so how should we be thinking about the rollout in Europe? And I have one quick follow-up.
