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Bernstein Insights: Healthcare Leaders and Disruptors - 2nd Annual Healthcare Forum

Sep 24, 2025

William Pickering
Senior Analyst, Bernstein

Good morning, everyone. My name is Will Pickering. I cover U.S. biotech at Bernstein. Very pleased today to have Regeneron Pharmaceuticals with us. I'm joined by CFO Chris Fenimore and SVP and Head of Investor Relations Ryan Crowe. Thanks so much. Ryan, let me hand it over to you for some forward-looking statements.

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Thanks, Will, for having us at the Bernstein Conference. Always great to be here. Shana Tova to all who celebrate. I'll just read this forward-looking statement, then we'll get straight into your questions. I'd like to remind you today that remarks made may include forward-looking statements about Regeneron Pharmaceuticals. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in such statements. A description of material risks and uncertainties can be found in Regeneron Pharmaceuticals' SEC filings. Regeneron Pharmaceuticals does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. Will?

William Pickering
Senior Analyst, Bernstein

Excellent. For the discussion today, I thought that we could start with the commercial business and then spend some time on the pipeline as well. Maybe just to kick things off with EYLEA HD, it would be great to know, like, really what drove such strong performance of HD in the second quarter? You've had all these sort of headwinds that you've been working to get through over the course of the year and really hadn't fixed those yet by the second quarter. What drove that strong performance?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

Sure. Again, thanks, Will, for having us. It's a pleasure to be here. If you look at the product of EYLEA HD in terms of how it's performed, both the first quarter we saw growth. We saw about 5% sequential growth in demand. We saw in the second quarter about 16% sequential growth in demand. That's really attributable to solid execution by our commercial team in terms of getting the word out with both the physician community out there in the retinal space, as well as with patients and educating them about a product that they're very familiar with. If you look at EYLEA 2mg, it's a product that both physicians and patients know brings both great efficacy as well as safety. EYLEA HD obviously brings additional sort of dosing flexibility and durability for patients. It's in the markets where we can compete today.

If you look at AMD and DME and DR, you know we're able to effectively compete in that landscape. The teams have done a remarkable job of really getting the word out and driving that demand. With that being said, those headwinds still do exist. We are working diligently in terms of trying to get those resolved. They are important. We do believe once we have those sort of established and approved, we will see an inflection in terms of that demand. Every four-week dosing is very important to the retinal community. It's something where there's a certain subset of their patients that they treat may not be able to get out to seven weeks. They want to know that if they use the product, they're going to get reimbursed.

That's something that we clearly hear from the community that we are obviously working very hard to see that get approved. Prefilled syringe is also another area where we know that physician preference is to utilize a prefilled syringe. If you look at the EYLEA 2mg business, I think it's up like a 95%+ of utilization is in the prefilled syringe. Something, again, that's very important. RVO is a sizable opportunity in terms of it's probably 20% of the market out there. We feel that once we've got those three, you know, obviously buttoned up, that will just bode well for EYLEA HD going forward.

William Pickering
Senior Analyst, Bernstein

Excellent. In terms of the timing for that, I believe, is it October for the prefilled syringe and the next month for the others?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yes, that's correct, Will. There's a PDUFA in late October for a prefilled syringe and one in late November for the RVO and Q4 dosing sBLA. Maybe I'll take the opportunity to comment on Scholar Rock's update yesterday on their application, which is involved in Catalent and filling operations. They received a CRL. I think there was a bit of a misconception about what that actually means for our applications. In fact, nothing has changed. All the read-through that you can make on the FDA's decision to provide a CRL to Scholar Rock is that the Catalent facility, the remediation is not complete yet as of Monday. There was no indication that it was completed as of Monday. The outcome was not terribly surprising to us. There was some speculation about why we received a major amendment versus them receiving a CRL.

Does that mean there was some sort of setback at Catalent? The answer to that is no. The decision on whether or not Catalent's response could be considered a major amendment is at the discretion of each division director at FDA. In EYLEA HD's case, it's the ophthalmology division. In the case of Scholar Rock, it's a different division. I'm not sure which. I don't think there's any read-through into the actual action that the FDA took with Scholar Rock. We still remain confident that these issues can be addressed in time for these upcoming EYLEA HD PDUFA dates. We look forward to getting these into the label and hopefully accelerating uptake thereafter.

William Pickering
Senior Analyst, Bernstein

Great. Great. Are there any outstanding items that you're working through on these filings apart from CMC issues?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

I would say we feel like we're in a pretty good spot with the FDA on the prefilled syringe, as well as on RVO and Q4 dosing. We believe what we've submitted is approvable in its current form, and we are just looking forward to getting Catalent squared away so that those approvals can come.

William Pickering
Senior Analyst, Bernstein

Excellent. Coming back to 2 milligrams, biosimilars are getting close to one year in the market. How should we think about the shape of that erosion curve and where we are on that curve?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

There is one biosimilar that's out there in the market today. We have seen some uptake out there in the marketplace. We would describe it as gradual at this point. With that being said, there are certain subsegments of the market, retinal practices that are financially sensitive, where we would say the uptake has been a little bit greater than in the broader marketplace. What we don't know going forward is there will be additional biosimilar entrants that will enter the marketplace. We have negotiated settlements with both Biocon and Sandoz. The entrants in terms of timing for those two are second half of 2026 and fourth quarter of 2026, respectively. We don't know what will happen in terms of what the uptake will look like once those two enter the marketplace.

If you look at similar analogs in the past, it would suggest that there would be additional pricing pressure and make it obviously a little more competitive. We have to wait and see in terms of what that looks like. We will tell you, rest assured, that our primary objective is to be out there getting the word out on EYLEA HD and doing all that we can to convert as many patients from 2mg over to EYLEA HD as rapidly as possible.

William Pickering
Senior Analyst, Bernstein

In terms of the demand decline, do you feel like the rate of that decline has sort of stabilized? Do you see that changing between now and when those other two come into the market?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

I think we've seen, obviously, as I said, there's been an uptake. I think the expectation is that we should continue to expect to see additional uptake going forward. It's hard to obviously quantify what that might look like.

William Pickering
Senior Analyst, Bernstein

Moving over to DUPIXENT, what would you say have been the primary drivers behind continued strength this year, and just any color on the relative size of those drivers?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

DUPIXENT is a remarkable drug. I mean, we've described it as literally a pipeline and a product. There's eight approved indications in the U.S. at this point. All indications are doing exceedingly well. I mean, if you look at the established indications, those indications that have been on the market for a while, whether it's asthma or AD or some of the others, we continue to drive growth there with our collaborators at Sanofi in a joint effort, really trying to get the word out in both patient and physician education, driving additional biologic penetration. We've got obviously new launches in COPD, CSU, and bullous pemphigoid, where the teams are out there actively getting the word out and really trying to continue, again, on education. As of right now, we're firing on all cylinders.

The brand continues to do well, and we expect it to continue to do well going forward.

William Pickering
Senior Analyst, Bernstein

Great. On COPD, could you talk about some of the things that you've done to invest in the launch? I think that many of us have seen the commercials, but any incremental investments in the field for us or just other comments on investments in the launch?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

I think for competitive reasons, we won't go into necessarily some of the investments that we made. Obviously, with the asthma indication, we've got a dedicated pulmonary team out there, both ourselves and our collaborators in Sanofi. That field force has been out there. They're very familiar with the pulmonologists. They've been communicating the merits of the product, obviously, for asthma, what it can do for their asthma patients. You obviously get some leverage when you're out talking to the same physicians, now being able to talk to them about what DUPIXENT can do for their COPD patients. The response thus far has been very, very positive. We've heard feedback from the physician community, but also anecdotal stories from patients that have seen a reduction in exacerbations, have seen their quality of life improve, have seen reductions in their reliance with oxygen, and things like that.

Those all bode well for the launch in COPD. If you look at top-tier pulmonologists, I think upwards of 70% of them have already prescribed to their patients. Our goal and objective is, as you said, you've alluded to the commercials, to educate the consumer, get them out there, get them talking to their physicians about their condition and whether or not something like DUPIXENT would be applicable for them. Then educating the physician community about what patients might be applicable for DUPIXENT for their COPD patients, educating them obviously about quantifying EEOs and helping them identify those patients that have type 2 applicability for COPD.

William Pickering
Senior Analyst, Bernstein

There has been some news recently about potential restrictions on DTC advertising from the administration. Have you had any communications with the administration on that? Do you have any comments on it from a policy lens?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

The only thing I think we can say is that there was a broad communication that came out from the administration to probably all manufacturers. We received that generalized communication. There was nothing specific to Regeneron Pharmaceuticals. It was just the standard letters that went out to all manufacturers. We obviously read the letter. I will assure you that in preparation of our materials, whether it's for those materials that go out to physicians, to consumers, or others, we have a very diligent process to ensure that everything that goes out there is fair and balanced and educates whatever target audience it is about both the risks and the benefits of whatever product that we're talking about.

William Pickering
Senior Analyst, Bernstein

Great. On DUPIXENT exclusivity, I realized the timing of that is 2031 at the earliest. It is obviously quite some time. You said to expect some INDs in the next, say, six to nine months. I was wondering, what is the strategic ambition here? Is it to develop something before that patent cliff that could eventually have a similarly large place in the market as DUPIXENT? Should we think of it as more of one of many pieces across your pipeline that could allow you to continue to grow through that LOE?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, I mean, as Chris said, DUPIXENT is a remarkable drug and is one of the top selling. It will end up likely being one of the top selling drugs ever. It's going to be very hard to replace that with a single magic next drug. Yes, we're working on some lifecycle opportunities for DUPIXENT. I don't think any will, any in and of themselves, will replace it. We're looking at longer-acting DUPIXENTs. We're looking at adjacent type 2 pathways that can address certain conditions that DUPIXENT currently treats that have longer dosing intervals. We're looking at other novel targets in the inflammatory cascade as well. There are many things that are coming. We still believe that they can be brought to the clinic, at least some of them, in the next few months.

Beyond that, obviously, the rest of the pipeline is very critical to delivering as well in hopes of bringing them to market by the end of this decade, including in hematology, in inflammation, in immunology, and oncology. I could go down the list, rare disease. We certainly are ambitious in replacing DUPIXENT, but probably not with a single opportunity, but rather a basket of opportunities.

William Pickering
Senior Analyst, Bernstein

Great. Maybe let's move over to that pipeline. Maybe starting with oncology, you've gotten several recent approvals for your bispecifics in the relapse refractory setting. Initial feedback on the Linezyth launch in the U.S. or either launch in Europe?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, it's still very early. We got approved for Linezyth, I believe, in July. We've only been on the market for a couple of months in the U.S., similar time frame in the EU. Associated with the label is a REMS program. You need to go through the discussions with payers. You need to go to the different institutions to get them REMS certified. You need to get them added to the pathways model that a lot of these institutions use to get into the treatment algorithm. Those are all the blocking and tackling of the launch, which is well underway. We've had a few patients dosed till those early days. We're optimistic. We think we've got a best-in-class product. When you look cross-trial in the late line settings, we look better than Janssen's BCMA by CD3 antibody. We look better than Pfizer's BCMA by CD3 antibody.

We look forward to competing with them in not only these fifth line plus patients, but in earlier lines. We can talk a bit about that development program perhaps later in our chat.

William Pickering
Senior Analyst, Bernstein

Yeah, that was where I was going to go next. I mean, you've talked about some ambitious plans in earlier lines that would be differentiated versus competitors. Could you say a little bit more about that and also the timelines for that?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Sure. Yeah, we have very broad ambitions for linvoseltamab or Linezyth in earlier lines of myeloma, as well as in precursor conditions. Before the end of this year, we intend to launch a study in second line plus that will combine Linezyth with carfilzomib. This would be built on the data that we presented at ASCO earlier this year, where we showed a 90% plus a 90% response rate and a 76% complete response rate in third line plus patients. You would expect that to improve as you go a little bit earlier into the second line setting. As far as I know, we're the only company pursuing a combination with carfilzomib. That's really key to our strategy, a limited combination or monotherapies instead of trying to just layer on top of very complex three, four, and five drug treatment regimens that are currently the standard of care today.

Second line plus is going to be combined with carfilzomib. We're going to look at newly diagnosed multiple myeloma in transplant-eligible patients, as well as transplant-ineligible patients. Those are studies that will launch probably by end of year and early 2026. In smoldering myeloma, we discussed some data on our most recent earnings call that really is compelling relative to Darzalex monotherapy, which was recently approved in Europe with an 8.8% complete response rate versus the 19 patients that we've been able to observe. All of them responded. Of those that have been on treatment over a year, five of six reached MRD negativity. We're very excited about it in these precursor conditions that could potentially forestall or prevent progression to myeloma.

Last point is in light chain amyloidosis, which is even before smoldering, where we've seen patients reach normal levels of the biomarker for it within six weeks in patients that have been on other drugs, whereas Darzalex in a four-drug regimen, including Darzalex, really was not that competitive. It took much longer for it to reach in newly diagnosed patients. We've got a differentiated antibody. We look forward to getting this broad development program underway. Certainly, there will be more to come on that as we move forward.

William Pickering
Senior Analyst, Bernstein

Excellent. In the near term, you've got a LAG-3 readout in melanoma that there's a lot of interest in. How would you frame what a win looks like for that trial?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, we're very excited about pembrolizumab and Libtayo combined in advanced melanoma. We're running a study in first line advanced melanoma that is using pembrolizumab as the comparator arm. We're looking at a high dose of pembrolizumab and a low dose of pembrolizumab and comparing both. That's mainly to satisfy the FDA's Project Optimus dose-finding requirements in oncology studies. We'll see what we get with the lower dose. We think we've got a pretty good differentiated combination because of what we saw in the early first in human studies across three independent cohorts. We saw response rates in the low 60% to high 50%. We saw median PFS when pooled of 24 months and complete response rates around 25% in about 100 patients. That would be very differentiated relative to PD-1 monotherapies, as well as cross-trial to approved immunotherapy combinations, including the approved LAG-3 combination that's out there.

I think for us, success is obviously you need to beat pembrolizumab. That's sort of table stakes here. I think there will be immediate cross-trial comparisons made to Opdualag, where they, in their FDA label, have a 10-month median PFS and a response rate of approximately, I think it's 43%. If we're able to replicate or even approach replicating what we were able to generate in the first in human studies, I think we'd be very well positioned to become the new standard of care in advanced melanoma. While we're talking about it, I might as well throw in the rest of the upcoming readouts there. We're going to have lung cancer data likely in the early part of 2026. This is a great unknown for us. We know that the tumor is a bit less immunogenic than melanoma is.

We're looking forward to seeing what an early cut of PFS and OS could look like in patients all comers, as well as in a high-expressing study as well.

William Pickering
Senior Analyst, Bernstein

You've also got a head-to-head study with pembrolizumab and Libtayo against Opdualag in melanoma. Could you talk about the timeline for that trial and also just the degree to which you think that that's a gating factor for a successful launch?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, I think it'll be interesting to watch. This is a study that we are. That objective response rate is the primary endpoint. Of course, we'll have progression-free survival and overall survival as key secondaries. They may not be mature when we read out the ORR data, which I think we expected. The completion date on clinicaltrials.gov is in the first half of 2027. We still have a little bit of time before that data will mature. I don't know that it's key to the launch. I think it really comes down to how successful are we in that pembrolizumab-controlled study. You'll be able to compare the baseline characteristics and compare the results. The head-to-head could certainly seal the deal for pembrolizumab and Libtayo to become the new standard of care.

William Pickering
Senior Analyst, Bernstein

Excellent. Moving over to complement, you had some MG data recently that, I know it's a crowded space, but at least from my standpoint, looked very, very compelling. You probably had a bit more time to talk to some docs since then. What are you hearing about how this might fit into the treatment paradigm?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, just to refresh, we read this data out last week of August. We generated the best data. We generated two positive data sets, actually, the combination of our C5 antibody and the C5 siRNA, as well as the siRNA monotherapy. The siRNA monotherapy, despite having less robust C5 blockade, actually generated the better reduction in MGADL, the primary endpoint for the study. That's kind of a best-case scenario for us because this siRNA monotherapy, cemdisiran, can be dosed every three months. Quarterly dosing, we think, is a meaningful advantage over today's C5 inhibitors that are approved in generalized myasthenia gravis. There's a once-daily subcutaneous injection, zilucoplan. There's an every four-week infusion, Soliris, and an every eight-week infusion with Ultomiris. Clearly, a dosing interval advantage, as well as an efficacy advantage when you compare cross-trial. Our data stacks up pretty well in the C5 category.

If you look beyond that in the FCRNs, we also compare pretty well on an efficacy and safety standpoint. I think our view is this is going to be a pretty big player in the MG space. Beyond that, we have a real franchise opportunity in C5 with PNH, where we're evaluating that combo I mentioned and should have data in early 2027. Even beyond that, in geographic atrophy, we're looking at, again, the monotherapy, as well as the combination, and could have data there in 2027. We're moving forward pretty quickly in C5. We think we've got great tools to use to try and treat these complement-mediated diseases.

William Pickering
Senior Analyst, Bernstein

In geographic atrophy, you said timing was, what did I hear?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

2027, I believe we'll have some initial data.

William Pickering
Senior Analyst, Bernstein

Great. Great. On Factor XI, this is another part of your pipeline that's getting a bit more focused now. You've started a few trials this year on the back of the Phase 2 from last year. Maybe if you could just give an overview of that program.

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yes, we are very excited about Factor XI and the potential to really expand how anticoagulants are used today. They are already used quite widely, especially in indications like stroke prevention, as well as in anticoagulating conditions, such as following orthopedic surgery and other settings like that. We think that the main reason this category has been somewhat limited is the bleeding risk. We think that Factor XI will address that, and you'll get maybe as good efficacy, perhaps slightly better, but you'll have markedly lower risk of bleeding, which we think will be market expanding. We've launched our initial phase three study in VTE following knee replacement surgery, and it's going to look at both of our antibodies, our catalytic domain antibody, REGN7508, and our A2 targeting antibody, REGN9933.

The reason we have two is we think they're going to have distinct profiles that can address perhaps different populations, with REGN7508 addressing patients that need to maximize antithrombotic activity. We know from preclinical assays that the time to clot is significantly longer with REGN7508 versus other antibodies in the category, as well as the small molecules. Whereas REGN9933, which, as I mentioned, targets a different domain on Factor XI, could have significant safety advantages while still having competitive antithrombotic activity. We can kind of pick and choose which antibody is right for a certain population. We're really just getting started. We began a phase two in a stroke prevention setting that's primarily to assess safety. Once we get some of that initial data, we'll be moving into phase three studies.

There are other indications that we haven't discussed yet, but will once we're ready to launch them, which should be within the next few months. Another one or two this year and then a few more in early 2026 is the plan.

William Pickering
Senior Analyst, Bernstein

Is the level of R&D dollars that you would want to put against Factor XI contingent on the data from Milvexian that we'll see next year?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

I don't think we would ever peg our investment to someone else's drug. We also believe that, like I said, we have very different pharmacodynamic properties than the small molecules. We'll see what we get with olorepatide. I'd be probably more interested in what the safety looks like than what the efficacy looks like. I wouldn't want to make a decision on one of our programs based on someone else's drug.

William Pickering
Senior Analyst, Bernstein

On obesity, you recently shared the full 26-week data for the myostatin and activin trial. We've seen a lot of data across the space from those programs, including from Lilly. What would you say are the overall learnings from how these muscle-sparing agents could fit into the obesity landscape?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

It's a great question. I think for us, we were interested in seeing whether or not these muscle preservation assets could reduce the amount of lean mass that's lost while patients are on a GLP-1 or a GLP-1/GIP. We know that that number is somewhere around 20% to 40% of your total weight is lost in lean mass. We saw it exactly replicate that number. I think it was 33% of your weight was lost in lean mass on the semaglutide control arm in our study. When we combined semaglutide with trivagramab or myostatin blocking antibody, we saw about half of that lean mass be preserved. We lost similar amounts of weight, but the composition of that weight loss was much more fat versus less and less lean mass.

When we layered on garetosmab to the semaglutide-trivagramab combination, we saw an even greater preservation of lean mass, something around 80%, 85% of lean mass was preserved. Nearly all of your weight loss was in the form of fat. That one did carry with it some safety side effect issues that we need to consider if we're going to move it forward or not. I think we are most interested in looking at combining weight loss assets with trivagramab. We have another study underway that'll look at what the weight loss curve is over a longer time period, over a year, as opposed to six months. We're interested in what that looks like, and we'll make some decisions there. We also have some work that we're doing preclinically on next-gen assets that may be more effective than what we are currently looking at.

William Pickering
Senior Analyst, Bernstein

You also recently licensed the GLP-1. Could you talk about how you would fit that into your program?

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, and maybe the whole philosophy for us on obesity is not so much about the weight loss, but the quality of the weight. It's not just weight loss. It's really about fat loss. We don't think that Hanso's GLP-1/GIP that we license, which is known as olorepatide, is going to be really any different than what's already out there between semaglutide and tirzepatide. We do believe we have the assets to help improve the quality of weight loss. We'll be looking at that, as well as in combination with other agents in our pipeline and our portfolio that can address obesity comorbidities. Of course, there's many of those. We haven't divulged exactly what we're going to be doing there. We do have several that we think would look attractive. Overall, we are going to pursue monotherapies with olorepatide in generalized obesity, as well as in type 2 diabetes.

We hope to get started in our phase three program next year, subject to regulatory feedback. Once we get underway there, I think we'll begin in earnest evaluating what some of the combinations that we have in mind look like for those certain patients that we can address.

William Pickering
Senior Analyst, Bernstein

Great. Great. Chris, I think I've given you enough of a break. I'll come back to you now.

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

I appreciate that, Will.

William Pickering
Senior Analyst, Bernstein

Maybe if you could start with just sort of laying out the overall capital allocation framework for Regeneron Pharmaceuticals. I've got a few specific follow-ups.

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

Sure. So you know we've been very consistent in terms of how we describe our capital allocation priorities. First and foremost, it's in internal R&D. I think you've heard from Ryan about sort of the breadth and depth of the pipeline. We'll continue to invest as appropriate in that pipeline. Beyond that, we also look at external opportunities. A lot of questions we get from the investment community is about M&A. It's not the primary focus of our external investment. We also have a very active business development group that looks to license technologies and do collaborations. I think you've seen us do deals with Alnylam Pharmaceuticals. You've seen us do deals with Intellia Therapeutics, where we think there are opportunities to complement our core sort of antibody expertise with other modalities where it makes sense to target particular disease areas. Beyond that, we return capital to shareholders.

We've had a share repurchase program that we implemented. I believe it was in 2019. If you look at the level of repurchases, we've stepped those up in recent history. The first and second quarter, on average, we repurchased about $1.1 billion of our shares to $2.2 billion through the first half of this year. We also implemented a dividend program this year. That's been in effect for all of 2024. It's, in terms of yield, fairly modest. The intent of that was to basically open up the shareholder base to those interested in Regeneron Pharmaceuticals that had a dividend mandate. This gives them the opportunity to, if they believe in the Regeneron Pharmaceuticals story, to give them an opportunity to make those investments. Those are what we call the pillars of our capital allocation sort of strategy.

William Pickering
Senior Analyst, Bernstein

Great. How do you think about the right pace of R&D investments when your top line is under a bit of pressure from EYLEA? Is there a certain rate of earnings growth that is sort of a constraint on those investments, or is it purely just an NPV-based decision?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

Yeah, I will say we don't manage the business based on short-term, quarterly earnings targets. It's really about driving long-term shareholder value. We have a very robust process where the Senior Management Team is obviously very involved in determining which programs we're going to move forward, which ones we're going to fund, and then even within programs, which studies we're going to fund. We're very careful about gating spend. We look to obviously see opportunities where we can get proof of concept or get an early stage or an early look at efficacy through interims and things like that before we commit significantly to broader later stage programs. We look at other qualitative things that drive where we make the R&D investment.

As I said, the core pillar to our capital allocation strategy is to really invest in the internal capabilities of our R&D team, where we think that's the best opportunity to drive long-term shareholder value.

William Pickering
Senior Analyst, Bernstein

On the external innovation side, you touched on this a bit. If I could just go a little bit further on it, is there any shift in your openness to more sizable opportunities, just given the maturity of the company and the size of the balance sheet?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

I wouldn't say there's a shift. I think when people describe our M&A approach historically, it's described as being sort of bolt-on opportunities or fairly modest in size. That's just the result of those transactions where we thought it made sense for us to obviously consummate them. With that being said, we're constantly looking at various opportunities out there. The challenges with later stage opportunities, it's very, very competitive. We are very sort of focused on what value can we drive with some of those opportunities and where can we compete. We're also obviously price sensitive. We've looked at a lot of things. We have the balance sheet that offers us a tremendous amount of flexibility that if the right thing came along that we thought made sense, we would obviously be in a position to execute on that. We just haven't found the right thing right now. We're actively out there looking.

William Pickering
Senior Analyst, Bernstein

Great. Thank you so much. Just one last question would be, what would you say are the most exciting reasons to own Regeneron now and into 2026?

Chris Fenimore
EVP, Finance & CFO, Regeneron Pharmaceuticals

It's clearly the pipeline. I think if you look at the pipeline today, and I'd be curious to get Ryan's perspective, the breadth and depth of the pipeline we think is unprecedented in terms of what the opportunity is out there. We've got a team that is proven that if you look at what Regeneron Pharmaceuticals has done historically in terms of bringing both EYLEA and DUPIXENT to the marketplace, two unicorns in terms of what they've done, not only for shareholders of Regeneron Pharmaceuticals, but also for patients and the physician community, we are very confident that we're going to be able to, with the pipeline we have, to sort of drive additional opportunities both for patients as well as shareholders.

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Yeah, and my old boss, Bob Landry, used to use the iceberg analogy. I might as well too. Of our pipeline that I would agree with Chris is the most exciting part and the reason to own Regeneron. What's available to the outside world is a small fraction of what we're working on and what we're excited about. I've mentioned preclinical opportunities in the INI space. I happen to also be very excited about some preclinical opportunities that should be moving in demand in ophthalmology over the next couple of months. Some novel targets that'll treat some other diseases that are highly unmet. Additionally, in rare disease, we're working on various different projects there. We just read out some positive data for garetosmab in a terrible disease, FOP, that can hopefully help a lot of patients there.

We also have our otoferlin program for hearing loss, a genetic hearing loss that we're looking forward to hopefully bringing to patients very soon. There's a ton going on. We're very excited about all the opportunities we have, both in the clinic as well as what's to come. Genetics continue to be our compass. We believe that'll help us unlock disease and help a lot of patients.

William Pickering
Senior Analyst, Bernstein

Excellent. Thank you both so much for joining us.

Ryan Crowe
SVP - IR & Strategic Analysis, Regeneron Pharmaceuticals

Thanks.

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