The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Roanna Ruiz - Leerink Partners - Analyst
: Hi. Good morning, everyone. So a quick one for me, could you talk a bit more about the factors behind PYLARIFY's 3Q revenues? I appreciate that
there was a bit of a seasonality impact, and I was also curious if there were some changes or new strategic partnerships that might have come
online. And could you help us think about how this should flow into the rest of the year?
Question: Anthony Petrone - Mizuho Securities USA - Analyst
: Thanks, and congratulations on another good quarter here and the positive announcement from CMS. Maybe, Paul, just to clear up some of the
comments on the final rates for 2025. You said they're largely in line. I know there was some confusion out there between mean unit cost and ASP,
but Addendum B seems pretty clear that the reimbursement rate for PYLARIFY will remain steady in 2025. So just to parse out that in a little bit
more detail.
And then maybe just quickly, I'll sneak it in, just the implied 4Q guide is a little bit light. So just maybe talk through the bridge between the first
nine months and the 2024 guide by the step-down sequentially. Thanks again. Congratulations.
Question: Richard Newitter - Truist Securities - Analyst
: Hi. Thanks for taking the questions -- or a question. Just sticking on PYLARIFY, kind of a two-part single question, sorry. You said you maintain
confidence that you can see PYLARIFY sustaining as a $1 billion franchise in 2025. You used the word sustain, not grow, and you provided commentary
just now that it sounds like your assumption is that the pricing in the hospital patient Medicare setting is not going to be all that different than
what it's been.
Just help me reconcile why you use the words sustain instead of grow. And then do you have direct dialogue with CMS that gives you that level
of confidence to know that this is going to be unchanged pricing at a market level in 2025? Just what's your degree of confidence there, or is that
something that you're assuming, but it could change? Thank you.
Question: Matt Taylor - Jefferies - Analyst
: Hi. Thanks for taking the question. Just as a follow-up, I wanted to see if we could pin down on the final addendum there. The unit price is $650. Is
that the price that you understand you're going to get now?
And as far as the strategic contracting goes, obviously you gave up some price to lock up these partners longer term. Can you talk about your
ability to adjust pricing within those contracts if you are going to get this better price in the future?
Question: Larry Solow - CJS Securities - Analyst
: Great. Good morning. Just on this pricing issue, can you just maybe give us a little more color on how much of the price or the strategic partnerships
were implemented this quarter? Just like a rough idea, was there a significant material amount of them, or was there a lot more that still have not
rolled in yet? Or is this kind of a good basis to annualize what that impact was based on what happened this quarter?
And the second question is just on -- it sounds like you're a little bit hesitant to give guidance for next year, and I fully understand that. But do you
still expect PYLARIFY to grow on a multi-year basis, both volume and less impact from price to continue to grow it on a revenue basis? Thanks.
Question: Tara Bancroft - TD Cowen (Research) - Analyst
: Hi. Good morning, and thanks for taking the questions. So I'm going to deviate a little bit from the pricing questions, but I'm curious to hear more
on the Alzheimer's diagnostic pipeline. So can you tell us how these assets differentiate from what's currently available or the blood tests that are
coming down the external or the other pipeline? What's your thinking on that and on the market for these? And could we potentially hear a little
bit more about these in 2025?
Question: Yuan Zhi - B. Riley Securities, Inc. - Analyst
: Good morning. Thank you for taking our questions. Maybe asking the question differently, so for the CMS reimbursement rate update, we saw that
the MUC method will get a lower reimbursement rate for PYLARIFY. However, in this latest update, it actually went up. So how should we think
about this calculation? And what does it mean to 2026 if there is a change from this MUC method to ASP method? Thank you.
Question: Kemp Dolliver - Brookline Capital Markets - Analyst
: Great. Thank you. I'm going to ask about PNT2002, and this is going to be a hypothetical question. But if CMS wants you to go to wait for 100% of
events in the trial, are we looking at roughly a six-month timeframe, nine-month timeframe? What should we expect if you have to go that route?
Question: Justin Walsh - JonesTrading Institutional Services LLC - Analyst
: Hi. Thanks for taking the question. Sticking with PNT2002, I'm wondering if you can provide any commentary on the planned subset analysis
analyses. And related to this, what outcomes do you think would push Lantheus to stick with the POINT-Lilly agreement versus stepping away?
Question: Andy Hsieh - William Blair & Company, L.L.C. (Research) - Analyst
: Great. Thanks for taking our question. We're curious about the $1.5 billion, $2.5 billion TAM for the Alzheimer's market. Thanks for providing that
guidance. Maybe talk about kind of the number of scans dynamic that's baked into this assumption and what's currently kind of the average scans
per patient and how will that grow in your view into the next decade. And along with that, how will the dialogue with payers just to ensure them
that there's actually a benefit to patients as you kind of use these agents to track the disease progression on a longitudinal basis? Thank you.
Question: Ed Ridley-Day - Redburn Atlantic - Analyst
: Thank you very much. If we could follow up a little bit also on, if you could give any color, how we should be thinking about the royalties from
PYLCLARI now that that is launched and any early color that you have on that, that would be helpful.
And also, you highlighted, obviously, the approval of FLYCARDO. How would you be thinking about the ability to grow that business given also
the supply implications?
|