Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Terence Flynn - Morgan Stanley - Analyst : Thanks, Ryan. You win the award for the longest disclosures. Well, Chris, I thought we'd start first with you. It's been about a year since you're announced as the company's CFO. Maybe just talk to us about your top three priorities here since assuming that position and what you're focused on the forward?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. Great. There is more on the strategy side. But I think Regeneron, at least in the large-cap universe, you're still one of the few companies that doesn't give revenue guidance on an annual basis. Just any thoughts on that now that you're in the CFO seat in terms of kind of the pros and cons? And would you make that change at some point in the future?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. Great. You alluded to this in your opening remarks, just on capital allocation and cash has been building on the balance sheet. And I know the preference has been internal investment, obviously, a lot on the pipeline on the R&D side. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 3:30PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference And also select business development more earlier stage and talking to Len and George. Historically, it's always platforms where maybe you guys don't have as big of a presence. And so I guess the big picture question first is just at some point, would you consider a dividend? And then how do you think about a starting point for any kind of payout ratio?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. In terms of the business development front, from a framework, anything that's shifting or changing in terms of some of those comments I made before in terms of how you're approaching that? And what are you seeing out there right now from kind of like a partnership appetite perspective?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Got it. And what's the opportunity set look like right now? I guess more on the partnership front, I mean, obviously, some of the mid-cap biotech companies, the financing window has been pretty tight. Does that create an opportunity for you guys to find more partnerships right now? Or is it more kind of need dependent? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 3:30PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Okay. Great. Maybe just moving on to some of the products now. Maybe just any update on progress with high-dose Eylea conversion in the US? I guess, as we step back, very attractive product profile, a space you guys know very well. So I guess is there a reason why you couldn't get over 90% conversion from low-dose as you think over the longer term?

Question: Terence Flynn - Morgan Stanley - Analyst : And largest players, is that when you think about both branded and unbranded, somewhere on volume when we think about largest player on a volume basis?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. And what -- how do you think about the -- maybe coverage dynamics? I mean that's one question we get in terms of like fail first on Avastin. I mean, is that likely to remain steady state here? Or are there any other changes as we think about 2025 that we need to consider? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 3:30PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : And maybe just remind us on the prefilled syringe. I know it's something else that helped accelerate the launch of low-dose Eylea. I know VABYSMO has one, they might already have it out in the market. You guys are working on it, but what's the time frame there?

Question: Terence Flynn - Morgan Stanley - Analyst : So is that more like an incremental step or cost? Or what's the hurdle to the filter needles? Is it more the perception of safety, which of those?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Okay. We'll stay tuned. The -- I guess the other question we get is around high-dose formulation such as an Eylea, how that will be treated under IRA. And so as you think about that dynamic, maybe any considerations to think about? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 3:30PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference Obviously, we had the first round. That was only for the Part D drugs. Part B is next up in a couple of years. But how do you see -- how does the company see this playing out? It's maybe one of the bigger picture questions we get oftentimes.

Question: Terence Flynn - Morgan Stanley - Analyst : So no even like bookends in terms of when we might hear something from them, if you have to take a guess?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. So Morgan Stanley Conference 2025.

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. And then what -- just again, to close the loop on that before you go to Dupixent, remind us of what is the earliest low-dose biosimilar could enter the US market right now.

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Great. Moving on to Dupixent, again, one of the other important growth drivers here of the company. I think the breadth of label has been a big part of the story here. And so maybe as we think about the indications, you could just kind of give us an overview of like relative size. I'm assuming atopic derm is still at the top because that was the first indication. But as you go through some of these other indications, maybe how do those stack up as we think about the opportunity set here?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. Maybe you can unpack a little bit of this. Atopic derm, a question we get is just there's obviously other competitors potentially coming here, lebrikizumab, the OX40, Rinvoq is -- has been relegated to second-line setting given the label. But just how do you think about maintaining that kind of first-line position given some of these other biologics that could be coming to the market in atopic derm?

Question: Terence Flynn - Morgan Stanley - Analyst : Does that become disruptive from a pricing standpoint at all? Or again, because you guys have the breadth of label, that really gives you an advantage in terms of that formulary positioning?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Got it. The other, obviously, interesting area that people are focused on is COPD. You alluded to this, Chris, you have a PDUFA date later this month. Maybe just talk to us high level about some of the commercial preparations and anything different about the ramp in this indication versus some of the other disease areas we've been watching, atopic derm, asthma and nasal polyps that make us more optimistic about a quicker ramp or we should have a more measured view of kind of that trajectory out of the gates in COPD?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. That contracting process, can you just remind us like is that a six-month process, approximately longer than that, shorter?

Question: Terence Flynn - Morgan Stanley - Analyst : Few months. Okay. Got it. Okay. Okay. Great. And then any -- the other one is a geographic basis, anything like US versus ex-US that's notable about COPD? Or nothing to call out? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 3:30PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. Great. The other question is just the margin profile of the Dupixent JV. So Chris, this is probably more one for you. There's obviously some incremental spend on the COPD launch that we're just talking about. Directionally, how should we think about that margin opportunity on the JV here with COPD coming online?

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Okay. Okay. Great. And then the last one on Dupixent for you, some of the pipeline is a question we get somewhat frequently is just IP and how to think about that. Obviously, we've seen the Eylea strategy and how that's played out. Maybe just any high-level commentary on how to think about Dupixent IP in the US?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Great. Maybe just in the last few minutes, shifting over to the pipeline. I think one of the near-term data sets is your LAG-3 in combination with LIBTAYO Phase 2 data for lung cancer. Again, maybe just high level of the design of those two trials? And then how much data we're actually going to get from this initial cut versus maybe another more mature cut down the road?

Question: Terence Flynn - Morgan Stanley - Analyst : And is that -- is this data going to be enough to make a Phase 3 go no go? Is that the trigger to expand into Phase 3? Or do you need to see that PFS, OS data to then pull the trigger on expanding into the Phase 3 portion? Or how does that work? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 3:30PM, REGN.OQ - Regeneron Pharmaceuticals Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Yes. Do you guys -- but are you more confident in that population? Or are you still confident in just the all-comer population?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Maybe just last minute, linvoseltamab. You have the CRL just next BCMA for multiple myeloma, for those that don't know. Maybe just next steps here post the CRL that we got in August?

Question: Terence Flynn - Morgan Stanley - Analyst : And then how long post that would the action be? Like would -- is there anything else procedurally you guys need to do as Regeneron or it's just getting that inspection clearance and then the FDA would act on your application?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. And does this impact at all like the -- any of the commercial plans or anything? Or is it just kind of pushed out a little bit, but anything like steps you're taking to kind of mitigate that delay?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. All right. Well, thank you so much, Chris, Ryan, really appreciate the time today.