Good morning and welcome to the Regeneron Pharmaceuticals' Third Quarter 2024 Earnings Conference Call. My name is Shannon and I will be your operator for today's call. At this time all participants are on a listen-only mode. Later we will conduct a question-and-answer session. Please note that this conference call is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President, Investor Relations. You may begin.

Thank you, Shannon. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our third quarter 2024 earnings conference call. An archive and transcript of this call will be available on the Regeneron investor relations website shortly after the call ends. Joining me on today's call are Dr. Leonard Schleifer, board Co-Chair, Co-Founder, President, and Chief Executive Officer; Dr. George Yancopoulos, Board Co-Chair Co-Founder, President and Chief Scientific Officer; Marion McCourt, Executive Vice President of Commercial; and Chris Fenimore, Senior Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for your questions. I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include but are not limited to those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30th, 2024, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be accessed on the Regeneron Investor Relations website. Once our call concludes, Chris and the IR team will be available to answer any further questions you may have. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len.

Thank you, Ryan, and thanks to everyone for joining today's call. Regeneron had a strong quarter, highlighted by 11% revenue growth and 8% non-GAAP earnings growth, along with continued investments and advances across our broad-pipeline. For my remarks today, I'd like to review some of our key performance drivers and then briefly discuss near-term pipeline opportunities. After my remarks, George will provide further updates on our pipeline. Marion will then review our commercial performance. And finally, Chris will detail our quarterly financial results. Third quarter, 2024 total revenues grew 11% to $3.72 billion, primarily driven by higher Sanofi collaboration revenues reflecting the continued strong performance of Dupixent, continued growth for Libtayo, and growth for combined EYLEA HD and EYLEA in the United States. Dupixent had another strong quarter with global revenues of 24% on a constant currency basis to $3.8 billion. With this latest quarterly result, global Dupixent revenues are annualizing at over $15 billion, with over 1 million patients currently on treatment around the world across seven approved indications in patients as young as six months. In September, the FDA and Chinese regulators both approved Dupixent for patients with uncontrolled COPD and an eosinophilic phenotype. These approvals, along with the approval in Europe in June, enabled Dupixent to address several hundred thousand patients that are currently uncontrolled on maximal inhaled triple therapy. As Marion will discuss, early launch indicators have been positive with strong physician interest and initial favorable US payer coverage decisions. As the only approved biologic for COPD, we anticipate these ongoing launches will represent a meaningful driver for depictions continued growth in 2025 and beyond. Net product sales for EYLEA HD and EYLEA combined were $1.54 billion, up 3% compared to the prior year. EYLEA HD generated $392 million in its fourth -- full quarter on…

Thanks, Leonard. I'll start with EYLEA HD and the data from the Photon extension study in diabetic macular edema, that were recently presented at the American Academy of Ophthalmology Annual Meeting. In addition to demonstrating that the vision gains and anatomic achievements or improvements with EYLEA HD over two years could be sustained over a third year of treatment at EYLEA HD, the results of the extension study provided the first data for patients who switched from EYLEA to EYLEA HD. For these switch patients who were dosed for 88 weeks with EYLEA every eight-weeks following five initial loading doses, retinal fluid re-accumulation was substantially slower after a single EYLEA HD injection at week 96, as compared to these patients' previous rate of fluid accumulation with our EYLEA 2 milligram. In addition, after one year of EYLEA HD treatment, 83% of these switch patients had a last assigned dosing interval of at least 12 weeks. Importantly, mean visual and anatomic achievement improvements achieved with EYLEA were sustained following the switch to longer dosing intervals with EYLEA HD. For Photon, patients assigned to EYLEA HD treatment groups at baseline, visual gains and anatomic improvements achieved in the first two years were all sustained in three years, but many of these patients were able to meaningfully extend the dosing interval. At the end of three years of treatment, nearly half were signed the final dosing interval of at least 20 weeks. In summary, EYLEA HD achieved consistently longer dosing intervals, as well as notably slower fluid re-accumulation as compared to EYLEA, a first for the category. When all other antiVEGF agents were compared to EYLEA and head-to-head studies, these agents did not demonstrate slow fluid re-accumulation. The safety profile of EYLEA HD has continued to be similar to EYLEA through three years…

Thank you, George. Our third quarter performance demonstrates Regeneron's ongoing leadership across therapeutic categories. We continue to advance the strength and diversity of our product portfolio. And as George described, our pipeline is advancing with several potential regulatory filings and approvals on the horizon, creating both near and longer-term opportunities. I'll begin with EYLEA HD and EYLEA. In the third quarter, combined US net sales were $1.54 billion, a 3% year-over-year increase. EYLEA HD and EYLEA net sales were favorably impacted by approximately $40 million, as a result of higher wholesaler inventory levels for EYLEA HD at the end of the third quarter partially offset by lower inventory levels for EYLEA. As a result, we expect fourth quarter EYLEA HD net sales to be negatively impacted as this increase in wholesaler inventory is absorbed. Together, EYLEA HD and EYLEA captured 44% of the total anti-VEGF category in the third quarter, demonstrating retina specialists experience and confidence in both brands. EYLEA HD net sales grew 29% sequentially in the quarter to $392 million, driven by ongoing adoption across treatment experienced and treatment-naive patients as treatment Experience grows, retina specialists reporting to EYLEA HD's durability, coupled with its efficacy and safety as important clinical differentiators. Recent late-breaking data presented at American Academy of Ophthalmology's annual meeting highlighted EYLEA HD's potential best-in-class profile. As George highlighted, diabetic macular edema patients who switched to EYLEA HD, consistently achieved longer dosing intervals and slower retinal fluid re-accumulation. While we anticipate the anti-VEGF category to continue to be highly competitive with both branded and biosimilar products in the marketplace, we plan to further strengthen the EYLEA HD product profile through the anticipated launch of our differentiated prefilled syringe by mid-2025 and a potential approval of the RVO indication, which is registration-enabling data are expected by the…

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis unless otherwise noted. Regeneron delivered strong financial performance in the third quarter with continued execution driving top and bottom-line growth. Total revenues increased 11% year-over-year to $3.7 billion, primarily driven by higher Sanofi collaboration revenue, continued growth for Libtayo and US growth of total EYLEA HD and EYLEA. Third quarter net income per share grew 8% from the prior year to $12.46 on net income of $1.5 billion. Third quarter revenues from our Sanofi collaboration were $1.3 billion inclusive of $1.1 billion related to our share of collaboration profits. Regeneron's share of profits grew 26% versus the prior year driven by volume growth for Dupixent and improving collaboration margins, with collaboration profitability reaching another all-time high in the third quarter. The Sanofi development balance was approximately $1.8 billion at the end of the third quarter, reflecting a reduction of approximately $200 million from the end of the second quarter and approximately $520 million from the end of 2023. Moving to Bayer. Third quarter ex-US net sales of EYLEA and EYLEA 8 mg were $932 million, up 9% on a constant currency basis versus the prior year. Total buyer collaboration revenue was $391 million, of which $368 million related to our share of net profits outside the US. We recorded $35 million of sales for Inmazeb, our antibody cocktail for Ebola in the third quarter related to deliveries to the US government under our existing agreement. We still expect 2024 Inmazeb sales to be in-line with 2023 sales of approximately $70 million. Other revenue in the third quarter was $114 million. We expect other revenue will increase sequentially in the fourth quarter of 2024, but on a full year basis, is expected to…

Thank you, Chris. This concludes our prepared remarks. We will now open the call for Q&A. [Operator Instructions]. Shannon, can we please go into our first question.

Thank you. [Operator Instructions] Our first question comes from the line of Chris Schott with JPMorgan. Your line is now open.

Hi. This is Taylor Hanley on for Chris Schott. We just had a question on EYLEA. So with Amgen launching their biosimilar, how are you thinking about EYLEA going forward? And what levels can you pull to potentially accelerate conversion to high-dose EYLEA? And how are you thinking about pricing for the franchise more broadly? Thank you.

So [may] (ph) -- may have some extra comments on that. But look, EYLEA is a fantastic product. We have delivered probably somewhere in the neighborhood of around 100 million or more injections with EYLEA. And so the performance and safety of the product, our transparency with safety issues that may arise over the past decade, I think has given physicians and their patients, a lot of comfort with EYLEA, and you see some stickiness of that product. Nonetheless, we think that EYLEA HD is a differentiated product, and we are continuing to work on using the standard approaches of education and informing the doctors about the potential use in patients, providing them with more data, as George referred to some of the long-term data is rather striking. We know that there is a biosimilar in the market for EYLEA, not for EYLEA HD, and we know it will be competitive, but we think we'll be able to compete well.

Okay, next question, please Shannon.

Our next question comes from the line of Evan Seigerman with BMO Capital Markets. Your line is now open.

Evan, we don’t hear you. Maybe we’ll come back to Evan. Shannon, why don’t we go to the next.

Our next question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.

Hi, guys. Good morning. Congrats on the quarterly results and all the progress. Can you reiterate your confidence in EYLEA HD quarter-over-quarter growth going into Q4 despite the negative impact due to wholesaler inventory? And are you seeing a tailwind with the overall franchise yet due to the removal of product from a major supplier of Avastin?

So let me take both of those, Tyler. First, as I described to you the performance in the quarter showed growth for EYLEA and EYLEA HD? And then more specifically to your comment related to EYLEA HD, we have very strong confidence in the product profile, the interest of the retina community, the quality of our safety, clinical data durability are all being seen. But I did want to call out that we did see an inventory matter take place in the quarter that I wanted to comment on. We're not going to give fourth quarter guidance. But specifically, I wanted to be an awareness related to the favorable impact of approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD. At the end of the third quarter, partially offset by wholesaler inventory levels that were lower -- a bit lower on EYLEA. So we wanted to share that information, but certainly we have every confidence in EYLEA HD performance, but that inventory obviously will be used in the fourth quarter of this year.

Looking forward, Tyler, to next year, I think Marion may mentioned that bringing our prefilled syringe to market around -- by the middle of the year, I think will be a nice catalyst for acceleration I think that we've taken a lot of pain to make sure that when we bring something to the market, it is going to withstand the test of millions and millions of injections our competition may have brought something forth that, for example needs a [filter needle] (ph) because they must be trying to filter something out, we presume. We are hoping to not have to have that issue and we are looking very carefully to make sure that we bring something that really will not result in inflammation. Remember that in this marketplace, products have been really killed if you have too much inflammation, which leads to potential for retinal vasculitis and even occlusive retinal vasculitis with loss of vision. So we are very sensitive to all that. I think doctors will be sensitive to that with any new launch despite biosimilars. They're going to probably want to look carefully and they know EYLEA and EYLEA is something I think they can trust in. So we will be methodical about how we do this, and we're in this for the long game.

Tyler, I also want to cover your question related to [Pine] (ph) and they are coming away from support of Avastin in the marketplace. So we're very well aware of that. And certainly, our teams are actively involved in retina offices supporting staff and working with them on any challenges that present I would share that at this point, there still is Avastin inventory from Pine in the market. I think it's anticipated to run out within a couple of weeks. So we haven't seen a material uptake in EYLEA HD or EYLEA related to that yet, but we're staying very close to that situation and support to our customers.

Thank you. Next question please Shannon.

Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.

Hi, there. Good morning. Thanks for taking my question. On the HD prefilled syringe, can you talk about the potential inflection in use that, that could catalyze next year, including how the differentiation of that prefilled string might resonate. And maybe also elaborate on some of the gating factors to development there, time line sounds like they've been pushed out a little bit. Thanks.

Yes. As I said, we anticipate bringing that to the market by the middle of next year. I believe already or almost immediately, Bayer will be bringing the same device to the market with EYLEA HD, outside of the United States. So we have a high degree of confidence. There are some additional requirements that you have to do inside the United States, which we are working through. And as I said, we think we'll have a differentiated product opportunity there. So you're right, Brian, it's possible that there could be an inflection when that comes to market because there is a preference for the prefilled syringe.

Okay. Thank you. Next question please.

Our next question comes from the line of Carter Gould with Barclays. Your line is open.

Yeah. Good morning. Thanks for taking the question. Maybe for Leonard and Chris, just now in the [wake] (ph) of sort of Amgen potentially being on the market has driven any sort of change in conservative conceptually how you're thinking about the pace of R&D investments going forward or your capital allocation priorities, you're potentially leaning into buybacks or further rolling out or delaying a potential dividend? Any color on that front would be helpful.

Well, we're -- they say imitation is the best form of flattery. So we're glad to be flattered by Amgen that they're spending their time imitating our products. We're spending our money trying to bring new products to market which where we think is what this industry really is built for. It's really not built -- biosimilars are fine, but we think the industry is best built and Regeneron is best built to bring innovative products to market. As I mentioned, we have over 40 products in clinical development, many of which are in Phase III. As George detailed, there are a lot of exciting programs in there with lots of data readouts. We're not going to gate spending based upon a biosimilar entry, we're going to spend what's appropriate based upon the opportunities that we see. We have a strong balance sheet. We have good earnings. We have the capability to make significant investments. And George has built, I think, the most prolific research and development organization in the industry. So it would be full hardy not to invest in that, and you'll probably see some investments to go up. The big question in this game always is, will these investments pay-off I think our past performance will not guarantee to anything in the future, the more than 10 or 12 products that George and [indiscernible] have bought market there's a good harbinger of things to come. And as I said, with more than 40 things in development, we couldn't be more excited about our future product profiles.

Thanks Len. Next question please Shannon.

Our next question comes from the line of Terence Flynn with Morgan Stanley. Your line is now open.

Great. Thanks for taking the question. I know you have some upcoming Factor XI readouts here before the end of the year. Maybe you could just tell us what you're looking for to make the decision about whether to advance those into a Phase III program and how you're considering them versus each other and also versus the standard-of-care. Thank you.

Yes. This is George. We're very excited about our Factor XI program because we think it's very different from anything else that's out there. we chose to take a different approach where we attack Factor XI in two different ways, what we call our A2 domain antibody or catalytic domain antibody. Our A2 domain antibody is not a complete blocker of Factor XI, it actually is more like a complete Factor XII blocker. It's expected to not have as profound effect on the coagulation pathways, but to have a much milder safety profile. In contrast, we believe that our catalytic domain antibody is the best-in-class blocker of Factor XI will come with the best ability to control coagulation among all agents that are attacking this pathway. But of course, it will also have presumably a higher safety load than our A2 domain antibody. So we think it's very exciting to have these two parallel but very distinguished approaches. We actually hope to be able to show that both of these substantially controlled thrombo formation in the clinical trials that we now have running. And we hope to then in the future, decide based on how well they each control and their expected safety profile, we expect the ability to consider multiple indications that we can evaluate each one for different potential indications for one versus the other. So these are sort of a pipeline in and of themselves able to attack, we believe, a variety of different coagulation settings, and each one of them can be used differentially and provide a different profile of efficacy versus safety as might be needed in the different clinical settings.

One second. I just wanted to add to that. What George has taught me over the years is that not all antibodies are created equal. And I would not -- not all blockers of the pathway are created equal. And we have in-house pharmacodynamic data, which suggests that the antibodies that Regeneron has created and selected, we really have a competitive advantage in how we do that outperform other Factor XI antibodies or small molecule competitors. Of course, with the small molecule competitors, it's hard to get to the high dose because you have off-target problems. And with the antibodies, people can't always get the best antibodies. We think we have the technology and these things are not all created equal. So the proof of the pudding, will be in the eating, when we get the data and see how that performed.

Okay, thank you. Next question please.

Our next question comes from the line of Chris Raymond with Piper Sandler. Your line is now open.

Thank you. Maybe just a follow-up on the last and supply issue with Pine and potentially others exiting the market. Maybe just stepping back, compounded Avastin has seen supply and quality issues before. Do you see this episode as different from prior disruptions? We had a KOL tell us that he believes this marks sort of the beginning of the end for Avastin. I'd love to hear your thoughts on that. And maybe as a follow-up, if Avastin is likely to play less of a role here, does this not provide more of an opening for a biosimilar option?

So Chris, let me take the impact and the situation with Pine and say that I think that probably what we're hearing is that because of the prior Avastin shortages last year around this time that the same thing occurred, offices and practices are getting used to how to deal with the situation. And obviously, the confidence in Avastin goes down in the supply. So certainly, it's important. And I see -- I think the evolution that you're hearing is because it's a situation that has been dealt with before. We certainly want physicians to have choice in prescribing the anti-VEGF category product brand that they think is best for their patients. And certainly, I think it is a competitive marketplace, but as we show in growth of our franchise, this quarter, we did last quarter as well, we certainly think that both EYLEA HD and EYLEA are both positioned very well in this competitive marketplace.

Thanks Marion. Shannon, next question please.

Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

Thank you. Good morning. Can you just elaborate on the drivers for the pricing pressure noted for EYLEA HD and whether these pressures are going to be ongoing on the Ford? And just in that context, maybe discuss kind of your outlook for overall growth of the branded anti-VEGF market in the context of the biosimilars. Thank you.

So as we reflect on anti-VEGF category pricing pressure, that is something, Salveen, that has an impact on all products in the category, branded products, biosimilar products as well, and it's not inconsistent with other competitive categories. What's really important to note though is what often prevails is the product that physicians most often want to prescribe, meaning what has been their experience, what is the safety profile of the product, what is the efficacy? And now in the case of bringing EYLEA HD to the marketplace, the durability. So we think those factors are very important and allow us to compete successfully in the anti-VEGF category. As to overall category growth, I would say that it is probably roughly in -- and this is overall, not just branded, it is roughly in the mid-single-digit range. And then come back again just to say a little bit more about the pricing pressure. Obviously, that's something that's been more apparent for EYLEA and probably the product now having been on the marketplace for over a decade is understandable. The differentiation for EYLEA HD is the clinical profile, the product that is giving physicians the opportunity not only for the confidence in clinical aspects, results and safety as they have with EYLEA, but also now this really demonstrated durability that we're seeing more and more of. And obviously, our clinical data is supporting in the longer term as well.

Thank you. Next move to the next question please Shannon.

Our next question comes from the line of Mohit Bansal with Wells Fargo. Your line is now open.

Great. Thank you very much for taking my question. I just want to understand how high does EYLEA uptake so far is tracking versus your own internal expectations, given that, I mean, it seems like about 25% conversion has happened yet at point. And at the same time, compared to -- this has been growing really rapidly. So just trying to understand what are the dynamics that we need to look at here and if there are any levers you can pull going forward to help increase uptake?

So Mohit, thanks for the question. Obviously, we don't give specific guidance on conversion or the size of the market, but we do talk about what we think the catalyst can be -- and I do feel that we have a bunch of catalysts next year, the potential approval and data for RVO, more importantly, perhaps the prefilled syringe by mid-year. So I think that next year, we could see a little bit of an acceleration. Obviously, we're working very hard. It's a great product. But there are -- these things don't happen overnight because people do love EYLEA. And it is more sticky than one might have anticipated but I think the progress is solid and we expect it to keep going.

Okay, let’s move to the next question please Shannon.

Our next question comes from the line of Trung Huynh with UBS.

Good morning. This in [indiscernible] on for Trung from UBS. And thanks for taking all the questions. So I want to switch gears to the obesity program and about the ongoing [Phase II trevogrumab] (ph) plus garetosmab and [GP1 study] (ph) seems like you recently increased the trial size from 620 plus to 1,000 with 3 new arms added. And now the study has a total of 13 investigational arm does seem like you want to very comprehensive to hear. Could you provide more granularity why the protocol changes here are necessary? And why would you like to further expand the trial. Thank you.

Can we have somebody to repeat that question because I really couldn't understand it at all -- Go ahead.

Definitely. Yes. Just the ongoing Phase II obesity study of trevogrumab] plus garetosmab,and with and without [indiscernible]. So you recently increased the trial size [indiscernible], previously I think it was 620 plus. You also added two new arms. So why do you think like those protocol changes are necessary. And why would you like to further expand the trial? Thank you.

Yes. I think what you're probably referring to is that we added additional dosing arms in our trial to expand different doses of the -- hopefully, muscle-enhancing treatments. And that's the major reason that the trial was enlarged. So that we would have broader information on different doses and their effects on muscle preservation.

Right. And just to remember, we didn't see any -- in the healthy volunteer study, we were able to do that because we didn't see any new safety signals. So I think it's just a matter of exploring additional doses.

Trying to find the right mix of antibodies with semaglutide to maximize the quality of the weight loss. Let’s move to the next question please.

Our next question comes from the line of Evan Seigerman with BMO Capital Markets. Your line is now open.

Hi, guys. Thanks for taking my question. Sorry about the earlier mishap. Just a follow-up on obesity. I know, George, you've spoken a lot about the really need for quality of weight loss, and I think that's very important. Maybe talk to the regulatory environment for muscle or preservation or muscle building assets. I know FDA has been kind of hesitant there. And they're really focused on weight loss, but maybe how you talk about -- how those will evolve in the coming years.

Yes. I guess what you're referring to is obviously we all know, and it's been widely noted and acknowledged that in the setting of the very rapid weight loss that can be caused by these GLP related agents, you get significant lean body and muscle loss up to 30%, 40% of the weight loss, especially because most of these patients actually go off these treatments and then often cycle, this can actually lead to cumulative loss of muscle over time, which can actually be quite catastrophic. We may be creating a secondary problem here over time as people cycle on and off these treatments. So our approaches are intended to maintain the muscle. That said, the agents because they're promoting muscle. Remember, muscle is the major non-essential spender of energy that is renowned for its ability to expand energy. We've seen in the animal models that it can also cause our approaches when you maintain muscle, you are increasing the metabolic rate. So you're actually expending more calories, so you actually can lose more weight while you're gaining the muscle or preserving the muscle because the muscle itself is eating up the calories or using up the calories. So the easiest regulatory path will be if our approach is, as has been seen in the preclinical studies actually result in more weight loss but a better composition of that weight loss. So that one won't even have to actually rely on a muscle regulatory end-point, just on the increased weight loss itself. Of course, one will then hopefully be able to describe, and this is all part of ongoing discussions with regulatory agencies that not only might you be seeing increased weight loss, but the body composition results will be better. So the simplest regulatory path will be just by…

Thanks George. Let’s move to the next question Shannon.

Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.

Yes. Thanks very much. So I have -- I'll just keep it to one question, please. Regarding next-gen product development. So clearly, Regeneron was extremely successful in creating EYLEA HD. Could you talk about your efforts to develop a next-gen Dupixent, including whether it would be a less frequently administered product? Thanks very much.

All we can say is that we are constantly working on both improving approaches for something where we already have important products such as in the Dupixent class, as well as coming up with entirely new and different products and approaches as well. And as you might imagine, we delivered with HD, I mean this is what we're trying to do all the time. We're trying to improve the current approaches but we're also trying to come up with an entirely different next-gen approach as well. That's what we do here at Regeneron.

Thanks, George. Time for two more questions, Shannon.

Our next question comes from William Pickering with Bernstein. Your line is now open.

Hi, thank you for taking my question. Do you think that the rate of biosimilar erosion for Lucentis is a good proxy for what we can expect for EYLEA. I think they saw about 25% of volume switch over in the first 12 months? And are there any important differences in the commercial dynamics to keep in mind? Thank you.

Just would say that it's very -- and way too early to comment. And I think that through the conversation today, we've gone through the factors that create such confidence in EYLEA, the demonstrated use of the product on a worldwide basis, but very early to try to make any comment about a product that hasn't been used in the real-world setting yet.

Well, I think it's also important. The situation is very different because at the same time, there are patients on EYLEA who might have a choice of going to a bio similar staying and EYLEA are actually moving to a differentiated product profile, which is EYLEA HD. So that's a very different sort of situation than you had with just the Lucentis erosion situation.

Great point.

Thank you. Shannon, let’s take our last question.

Our last question comes from the line of Cory Kasimov with Evercore ISI. Your line is now open.

Hi, good morning guys. Thanks for fitting me in. I wanted to follow up on Carter's question earlier about capital allocation priorities. I'm sure you're pretty frustrated by the market reaction to recent developments around EYLEA. I know you have nearly $3 billion left in your authorized share repo. But have you given any thoughts to an ASR? And what are your evolving views around a dividend given that you already have over $15 billion in net cash on hand? And obviously have another significant inflection in additional cash generation not too far down the road. Thank you.

So we have lots of discussions on this. We don't really have anything more to add than we've said publicly, which is perhaps the best opportune time to think about the dividend is when we have paid-off the development balance to Sanofi, which we anticipate should be somewhere around the end of 2026. But beyond that, how we repurchase stock, when, whether, et cetera, et cetera, is something that we really don't discuss until it's happening.

Okay. Thank you, Len, and thanks to everyone who dialed in for your interest in Regeneron. We apologize to those remaining in the Q&A queue that we did not have a chance to hear from. As always, the Investor Relations team here. Regeneron is available to answer any remaining questions you may have. Thank you once again. Happy Halloween, happy Diwali. Have a great day.

This concludes today's conference call. Thank you for your participation. You may now disconnect.