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: Akash Tewari - Jefferies - Analyst
: All right. Thank you very much. So look, I wanted to start off maybe with high-dose Eylea because I think that's where we get the most amount of
questions. And this is what I tell investors a lot. Everyone's like, oh, my god, the high-dose Eylea launch is disappointing.
And I point out to investors if you peg the launch of high-dose Eylea versus low-dose Eylea and Vabysmo it is still the best launch we've seen in
wet AMD in history thus far. It's -- maybe it's slower than maybe investor expectations, but it's certainly not a bad launch.
But I do think on the Q3 call, you did say like, hey, there are some areas where we can improve and here's some things whether it's the prefilled
syringe, whether it's getting monthly on the label, where we feel like we can really accelerate this.
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NOVEMBER 19, 2024 / 11:00AM, REGN.OQ - Regeneron Pharmaceuticals Inc at Jefferies London Healthcare
Conference
So can you kind of frame how the launch is going in context early on? And what are some landmarks going into 2025 and beyond, that could lead
to an inflection on that launch?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now when you look at low dose Eylea, there's kind of three buckets. There's the 12 to 16-week kind of treat extend patients. There's
the -- that's the third -- maybe the two months and then the thirds the people who are very short in vitro half-life and they're going to be on monthly
dosing.
Going if -- logically, you would have thought the patients who are on monthly dosing, they're going to be the first ones to raise their hand and try
to get on the high-dose Eylea product. Can you talk about not having monthly on your label for high-dose Eylea? Why is that maybe leading to
that actual -- the lowest hanging fruit, I feel like biologically not maybe switching as fast as expected.
And then number two, you're generating data to get monthly dosing on your label. Can you talk about when that data comes out and then the
possibility of an updated label as we get into 2026 or beyond?
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NOVEMBER 19, 2024 / 11:00AM, REGN.OQ - Regeneron Pharmaceuticals Inc at Jefferies London Healthcare
Conference
Question: Akash Tewari - Jefferies - Analyst
: Understood. And I was talking to Ryan about this post quarter, okay, you might get that monthly on the label, but it does seem like between that
or the prefilled syringe. The prefilled syringe is probably the more important opportunity from a commercial inflection. Talk to me about why the
prefilled syringe is important. And could we expect an inflection of uptake in the back half of next year as you get that online?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now I think the question we get a lot from investors is, okay, well, there's a potential for an Amgen biosimilar to enter the market now.
Regeneron is really going to have to work on the switch. And in the back of my mind, I'm like what could they do differently?
You guys are already trying to switch as many patients as possible onto your next-gen formulation. I mean, is that perception correct? Now that
you do likely anticipate a biosimilar to enter, what happens commercially the day after that news gets hit on the preliminary injunction that changes
your commercial strategy on high-dose Eylea or is it nothing changed. We are switching patients as fast as possible.
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NOVEMBER 19, 2024 / 11:00AM, REGN.OQ - Regeneron Pharmaceuticals Inc at Jefferies London Healthcare
Conference
Question: Akash Tewari - Jefferies - Analyst
: Understood. And just to put a finer point on that. To kind of what you're alluding to, any ophthalmologist should wait. I mean what happened with
Bayview, what's happened with some of the GA products.
The Amgen biosimilar does look like it's a bufferless formulation. I mean just to be clear, do you feel like that will have any difference in terms of
clinical profile or probably unlikely? It's more just these doctors are going to be conservative in terms of adopting anything.
Question: Akash Tewari - Jefferies - Analyst
: Understood. Yeah, I was -- this is a question that actually I've been starting to get more with investors on Avastin, and there's obviously been a
shortage of Avastin in kind of the space, and it's just impossible for me to kind of track the compounding market because you just don't know
what's getting used for oncology versus what's getting used in a compounding setting for wet AMD.
But has the supply disruption for Avastin somehow change either your patient mix or increase the opportunity for low dose Eylea to kind of take
share as kind of that first treatment that you're putting patients on?
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NOVEMBER 19, 2024 / 11:00AM, REGN.OQ - Regeneron Pharmaceuticals Inc at Jefferies London Healthcare
Conference
Question: Akash Tewari - Jefferies - Analyst
: Understood. Maybe stepping back and talking about Dupi in the COPD launch because I think there's a lot of interest there. I mean I think a lot of
people don't understand. That's the third biggest killer of Americans in the United States.
You have the functional lung benefit, and you have a prescribing base, which is already educated in how to use and understand type 2 inflammation.
I think we always get ahead of ourselves, but why wouldn't this launch -- just why wouldn't this launch be meaningfully better than what you saw
in asthma with Dupixent? Any early thoughts there?
Question: Akash Tewari - Jefferies - Analyst
: Understood. And then maybe what you've seen in Europe and what you expect in the US? I mean you don't have a cutoff for 300 eosinophils, right?
It's just basically -- because rarely do patients have sustained elevated eosinophils, you have a broader just elevated label.
Question: Akash Tewari - Jefferies - Analyst
: Understood. And I mean, I think the question becomes from a payer perspective and really where this market gets adopted, I feel like over time,
it's going to just basically be generally too high. Maybe 150 will be the cutoff that actually gets used in clinical practice.
And then number two, you're not even waiting for patients to be on triple therapy. They might be on double therapy and you're like, look, if they
need a clinical benefit, we're going to get them on something that's disease-modifying like Dupixent. What are the kind of access restrictions you've
seen so far with COPD? And how do you think that may evolve over time?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Maybe switching to atopic dermatitis. And this is obviously a major label for Dupixent. Lilly is entering, you have the OX-40s and Lilly's
talked about, hey, we're going to not do the same mistake we did with Taltz where maybe we didn't discount out of the gate aggressively enough.
But Dupixent is clearly standard of care there.
It's great payer access. How do you anticipate commercially handling the entry of a legitimate competitor like Lilly with the IL-13, which does also
have comparable data. Do you expect to see any change in the market share or your uptake in atopic derm growth going into next year and beyond?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now I remember meeting with [Lennon George] at the event at JPMorgan. I felt like there was increased confidence on the IP for
Dupixent, where I think a lot of investors are like, okay, it probably goes off early 2030s. And your team was like, no, we see this going into the
mid-2030s or potentially beyond. Can you talk to us about your confidence on the IP portfolio for Dupixent? What should investors be modeling
as a base case and why?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now I mean, I know maybe I wasn't thrilled with the OX-40 data that maybe has initially come out. But I think a legitimate point, some
people say is like Sanofi has done a better job than Regeneron thus far, elucidating what a life after Dupixent looks like.
And I think that's -- right now, it's probably true, right? You haven't really had next-gen INI targets that you've announced yet, but I'm sure your
team is working on it. Talk to me about what's the internal Regeneron plan for life after Dupixent? And can we think about new product candidates
being announced and trials starting to occur in 2025. What's the strategy there?
Question: Akash Tewari - Jefferies - Analyst
: Okay. Understood. Now maybe thinking about capital allocation. I mean you're approaching $20 billion cash on hand. And everyone is like,
Regeneron doesn't like buying stuff. They have inventor syndrome. But you're at a different place in terms of your -- where you are as a company.
You have a lot of flexibility with your balance sheet.
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NOVEMBER 19, 2024 / 11:00AM, REGN.OQ - Regeneron Pharmaceuticals Inc at Jefferies London Healthcare
Conference
So talk to me about your appetite of share buybacks, dividends, things that can maybe open yourself up to a new shareholder base versus going
out and doing a larger transaction, a $5 billion, $15 billion deal, where you feel like you can diversify away from Dupixent, Eylea.
I think you guys would probably agree right now the valuation is probably not even fully reflecting your base case on Dupi and Eylea. So where
does BD fit in versus some of these other levers you can pull?
Question: Akash Tewari - Jefferies - Analyst
: Understood. And look, maybe just on obesity. I feel like I would say the interest on your program and my stance in general for obesity, it's gone
down, it's not gone up over the last year. And I think part of that point is why would you want to stay on a myostatin forever? You use it in a short
period of time when you're buys in a catabolic state, you're eating away at your body as you're in a chloric deficit.
But then get off the myostatin and stay on the GLP-1. And I feel like when I talk to your team, it's the opposite. I want you to stay on the myostatin
and get off the GLP-1. Why is that the right paradigm? And then number two, what do you feel like investors are maybe misunderstanding about
your myostatin program right now?
Question: Akash Tewari - Jefferies - Analyst
: Understood. I know we're out of time. Thank you so much. Really appreciate it.
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