Earnings Labs

Regeneron Pharmaceuticals, Inc. (REGN)

Q4 2018 Earnings Call· Wed, Feb 6, 2019

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Transcript

Operator

Operator

Welcome to the Regeneron Pharmaceuticals Fourth Quarter 2018 Earnings Conference Call. My name is Paulette and I will be your operator for today’s call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. I will now turn the call over to Mark Hudson, Senior Manager, Investor Relations. You may begin.

Mark Hudson

Analyst

Thank you, Paulette. Good morning, and welcome to Regeneron Pharmaceuticals’ fourth quarter 2018 conference call. An archive of this webcast will be available on our website for 30 days under Events. Joining me on the call today are Dr. Leonard Schleifer, Founder, President and Chief Executive Officer; Dr. George Yancopoulos, Founding Scientist, President and Chief Scientific Officer; Marion McCourt, Senior Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer. After our prepared remarks, we'll open the call for Q&A. I would also like to remind you that remarks made on this call today 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 milestone, collaborations, finances, regulatory matters, intellectual property, pending litigation, 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, or SEC, including its Form 10-K for the quarter ended December 31, 2018, which we plan to file with the SEC tomorrow. Regeneron does not undertake any obligation to update publicly, any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that the GAAP and non-GAAP measures will be discussed in today’s call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Once our call concludes, Bob Landry, Jay Markowitz and the IR team will be available to answer further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer.

Leonard Schleifer

Analyst

Thank you, Mark, and good morning to everyone, who has joined us on today's call and webcast. 2018 marked Regeneron's 30th year anniversary and it was a remarkable year for the company. We are pleased with our pipeline progress, our commercial execution and our financial results. And we remain true to our founding mission of inventing important new medicines for patients in need. EYLEA, the market-leading anti-VEGF therapy approved across a range of retinal disease, continues to grow. 2018 U.S. net product sales were $4.08 billion, an increase of 10% year-over-year. And 2018 global EYLEA product sales totaled $6.7 billion, an increase of 14% year-over-year. We continue to invest in retinal diseases and are pursuing new indications new formulations and new molecular entities. We have a PDUFA date in May for diabetic retinopathy without diabetic macular edema, or DME, and our submission was based upon our Phase 3 PANORAMA trial, in which we were able to reduce vision-threatening complications of diabetes. In 2018, we made progress fulfilling Dupixent's pipeline in a product promise by showing efficacy in additional diseases and patient populations. The clinical data continue to support our scientific hypotheses that Dupixent targets the molecular drivers of allergic and atopic deceases. In its first approved indication adult atopic dermatitis, Dupixent is now annualizing above $1 billion in net product sales in the United States alone. George and Marion will provide more detail, but let me emphasize that we are still in the early stages of the Dupixent opportunity with hopefully many more launches in new diseases, geographies and age groups. Finally, despite the remarkable accomplishments in the nascent field of immuno-oncology most cancer patients still don't benefit from this approach. We believe that the comprehensive and differentiated strategy that George outlined for you at the JPMorgan Conference is already beginning to deliver on its potential: to bring the hope and promise of immuno-oncology to many more patients. In September 2018, Libtayo became the third FDA-approved PD-1 antibody and the first FDA-approved therapy for the treatment of advanced cutaneous squamous cell carcinoma. In December at the 2018 American Society of Hematology Annual Meeting or ASH, we presented new data for REGN1979 our wholly-owned CD20xCD3 bispecific, which we are advancing this year into potentially registrational studies. We simplified and amended our immuno-oncology discovery agreement with our collaborator Sanofi. In the new agreement, we will continue to collaborate on the Libtayo as well as our MUC16xCD3 and BCMAxCD3 bispecific antibody programs. For the rest of our immuno-oncology programs including our co-stimulatory bispecifics Regeneron retains exclusive rights. In summary, in 2018 we continue to build upon the foundation that we established over the last 30 years, which positions us for future continued success as an innovative biotechnology company. And as I said at JPMorgan after 30 years all of us at Regeneron feel that we are just getting started. With that, I will now turn the call over to George.

George Yancopoulos

Analyst

Thank you, Leonard, and good morning to everyone. I'd like to begin with our efforts to continue to expand and optimize the benefits provided to patients by EYLEA. As a reminder, in September of 2018, the FDA accepted our supplemental BLA for diabetic retinopathy with an action date of May 13, 2019. This potential label expansion to include patients with diabetic retinopathy without DME coupled with our existing approval in DME puts EYLEA on the forefront of treating diabetic eye diseases. Let me emphasize data from our Phase 3 PANORAMA study in diabetic retinopathy. In addition to anatomic improvement, we have for the first time shown that EYLEA can reduce vision-threatening complications in people who have diabetic retinopathy. Contrary to the perception of some that diabetic retinopathy is a slowly evolving condition, our PANORAMA study demonstrated that patients with moderately severe or severe diabetic retinopathy may progress rapidly developing vision-threatening complications or new onset DME. With more than 40% of the overall patient population suffering from these events and more than 50% of the patients in the severe category certainly showing the high risk that these patients are under. In the overall patient population, EYLEA reduced these events by more than 75%. In patients with -- in any case more complete data on the 52-week Phase 3 PANORAMA study will be presented in Angiogenesis Meeting on Saturday and has been submitted to the FDA. It is remarkable that despite many attempts to improve upon the efficacy of VEGF blockade for retinal disease based on the data we have seen no other mechanism has proven more beneficial and no other drug can have that pivotal trials has shown superior visual acuity compared to EYLEA, but we aren't standing still. Our goal is to further advance the treatment of retinal diseases. Later…

Marion McCourt

Analyst

Thank you, George, and good morning, everyone. I'd like to start with EYLEA. For the fourth quarter U.S. EYLEA net product sales grew 11% year-over-year to $1.08 billion and for the full year 2018 U.S. EYLEA sales grew 10% to $4.08 billion. EYLEA sales growth resulted from an increase in demand and not from price. Based on U.S. net product sales EYLEA continues to be the market leader with 72% of the overall branded U.S. anti-VEGF market in the fourth quarter. We continue to see overall market growth in both wet AMD and DME driven by the aging population increase in diabetes prevalence and physician preference for EYLEA. Approximately 90% of patients across all peer segments can access EYLEA as their first line of therapy. Regeneron will continue to stay engaged with stakeholders in order to preserve physician choice and patient access to EYLEA and its significant clinical benefits. Building on our leadership position and wet AMD and diabetic eye disease, we see a major growth opportunity for EYLEA in diabetic retinopathy without DME. The PDUFA date for this new indication is May 13th. As a reminder of the estimated 3.5 million people in the U.S. with diabetic retinopathy without DME approximately one million individuals have moderately severe or severe disease and are at greatest risk for progression in loss of vision. We believe the PANORAMA results that George discussed support early intervention with EYLEA and may help evolve the clinical treatment paradigm. Pending approval of EYLEA in this indication comprehensive plans are in place to support disease education focused on the benefits of early treatment. We also remain on track to launch EYLEA prefilled syringe in 2019 pending regulatory approval. Turning now to Dupixent. Local net product sales in the fourth quarter were $319 million and in the U.S.…

Bob Landry

Analyst

Thank you, Marion, and good morning to everyone on the call today. Regeneron delivered record financial results during the fourth quarter of 2018 and completed a year of strong financial performance. For the fourth quarter, non-GAAP diluted net income per share grew 31% to $6.84 on non-GAAP net income of $786 million. And for the full-year, non-GAAP diluted net income per share grew 40% to $22.84 on non-GAAP net income of $2.62 billion. Total revenues were $1.93 billion for the fourth quarter and $6.71 billion for the full year 2018 which represented 22% growth versus fourth quarter 2017 and 14% growth versus full year 2017. For the fourth quarter of 2018, revenue growth continue to be driven by global sales of EYLEA and a significant increase in Sanofi collaboration revenue due to lower losses from the commercialization of antibodies and the recording of a cumulative catch-up adjustment to revenue, principally due to the amendment of the immuno-oncology discovery and development agreement. For the fourth quarter of 2018, global net product sales of EYLEA were $1.8 billion, an increase of 12% year-over-year. For the full year, global EYLEA net product sales were $6.75 billion, an increase of 14% year-over-year. In our reported U.S. EYLEA results, distributor inventory experienced a slight increase in the fourth quarter of 2018 as compared to the third quarter of 2018, yet remained within our normal 1- to 2-week targeted range. Ex-U.S. EYLEA net product sales recorded by our collaborator Bayer were $724 million for the fourth quarter of 2018 representing a 14% reported and an 18% operational or constant-currency basis increase year-over-year. For the full year of 2018, Ex-U.S. EYLEA net product sales were $2.67 billion and grew 20% on a reported basis and 18% on an operational basis as compared to the full year of…

Mark Hudson

Analyst

Thank you, Bob. That concludes our prepared remarks. We'd now like to open up the call for Q&A.

Operator

Operator

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Ying Huang from Bank of America Merrill Lynch. Please go ahead.

Ying Huang

Analyst

Hi, good morning. Thanks for taking the question and congrats on the quarter. First question on EYLEA, obviously you're waiting for FDA approval in diabetic retinopathy. Can you tell us whether you do think that's going to be a significant growth driver for 2019? Or do you think we should EYLEA -- we should expect EYLEA to provide market growth rate? And then maybe you can comment on the net pricing trend in 2019 for EYLEA as well? Secondly, can you talk about Dupixent outlook? Do you believe the asthma indication will start to be a more important growth driver versus atopic dermatitis for 2019? Thank you.

Leonard Schleifer

Analyst

Okay. So thanks for the questions, Ying. On the issue of whether or not diabetic retinopathy is going to be a growth driver in 2019? I think it will be in the early stages of the launch that indication. It's going to think a lot of patient education because it's a paradigm shift. So we don't give guidance, but from a general point of view, I think is going to take some time to develop that market. Pricing trends, I'm not sure what you're getting at. Whether you're talking about external forces or not? But our price has been marked very modestly impacted to the negative side, based upon a slight discount that was provided across the board in 2018. And in terms of asthma, Marion?

Marion McCourt

Analyst

I am happy to comment on asthma. So I gave you some information today on what is very early in the launch and favorable indicators. As I look at your question on asthma growth opportunities for the future, we do see that as very important. It's not the only Dupixent growth driver asthma describe the atopic dermatitis growth opportunity in adults and with FDA approval potentially with the adolescents this year. But back to your question on asthma, what's most interesting in these early stages of launch is the response that we're hearing from both allergists and pulmonologists to the differentiating profile of Dupixent. Both in terms of its clinical efficacy, the established safety profile and then also there's very, very important factor of patients being able to self administer or at home administer, that coupled with the fact that for some of these physicians, they're treating patients that have co-morbidities such as when other Type II diseases occur with asthma. So again it's very early days, but we feel good about the early launch. And I look forward to giving updates in the future. I'll also remind, just in terms of size of patient population for asthma biologics, it's about a 1 million patients. But to-date only about 100,000 patients have been treated, eligible asthma patients with Biologics. So it is a market with tremendous opportunity.

Mark Hudson

Analyst

Operator next question?

Bob Landry

Analyst

I'd like to just add to Len's point in response to the contribution in diabetic retinopathy market opportunity. I don't want to address the market opportunity specifically, but very importantly about whether this should really be paradigm shifting and whether or not there should really be a new way of treating patients? And I think that looking at the data, physicians are going to have make their decisions. But there is a lot of very important outcomes from our study. Number one is already mentioned. That the rates of visions threatening complications in progression in people who have moderate and particularly severe non-proliferative diabetic retinopathy is I think much higher than most people thought. Once people progress, treatment at that point we know, is probably not going to be as good as prevention. And I think it's a very important question now asked in terms of physicians in the entire community, should we be working harder to prevent onsets of the diseases and loss of vision that you may never get back? And in this particular case, is a little bit of prevention really worthwhile for the so many patients who are in a such high risk? And I think that something that the community I'm sure is going to be debating strongly especially when all this data is comes out and it is digested and is discussed.

Mark Hudson

Analyst

Operator, next question please?

Operator

Operator

Our next question comes from Chris Raymond from Piper Jaffray. Please go ahead.

Chris Raymond

Analyst

Hey. Thanks. Just a – maybe a couple of pipeline questions. So first just on the CD20 costimulatory bispecifics. IgG antibodies have had some challenges I guess in the solid tumor setting due to the physiologic and physical properties of these tumors. So your bispecifics maintain an IgG-like structure. I guess, can you maybe talk about some of the properties of these antibodies that may allow for better tumor penetration? And how you going to be maybe little bit more descriptive of that as we get into the clinic with these two? And then, also maybe on your C5 antibody 3918, I think in your press release you talked about initiating a Phase 2 trial in PNH. But Len, I think I've heard you say last month in San Francisco that enrolling a switching study from eculizumab might be a challenge. So maybe any color there as to the plan just targeted at new patients or some other strategy? And maybe if there is some other complement-mediated disease that may make sense as well. Thanks.

Leonard Schleifer

Analyst

So it's a highly competitive space. So we're not going to get too much into our thinking on C5. But as we get down the road, I think our strategy will emerge. I'm going to let George of course deal with the CD28 question.

George Yancopoulos

Analyst

Yeah I think there's a whole field of pseudoscience that somehow seems to think that the problem with getting responses in solid tumors have something to do with antibodies not having access. Actually, if one really looks carefully and objectively at all the data, if anything there is better access to the tumor immune blood vessels become actually more permeable and leaky in the levels of natural antibodies as well as administering antibodies is actually much higher in those settings. So that has nothing to do with our strategy or our approach. Our belief and I think the overwhelming science argues that the lack of response to has much more do with very specific immune recognition issues. And that's exactly what our co-stems do. They add another level of activation specifically targeted against tumor which will add to the immunotherapy benefits of either, for example checkpoint inhibitors such as PD-1 or the more conventional CD3 like bispecifics. So it's all about properly manipulating the immune environment to attack the tumor. And the problems have really nothing to do with antibody access and whether you're using a full-length antibody or something that's smaller. And certainly, all you have to due to understand that is look at the performance of our CD3 bispecific compared to for example smaller bites. And that I think – even cross study shows that the activities are really not at all limited by the size of the reagents. And that's about it.

Chris Raymond

Analyst

Okay. Thank you.

Mark Hudson

Analyst

In the interest of time, I just want to – as a reminder to ensure that we get to many people as possible. We could just limit the Q&A to one question at this time. Operator, can you please go to the next caller?

Operator

Operator

Our next question comes from Geoffrey Porges from SVB Leerink. Please go ahead.

Geoffrey Porges

Analyst

Thank you very much. And congratulations on both the results and not being mentioned in the safety union last night. I wonder if we could talk a little bit about the cadence through the year, Bob, your revenue and income statement is notoriously hard to model. And you did have quite a few one-time items -- non-recurring items in Q4. Could you give us a sense of how we should be thinking about collaboration revenue through the year? And whether we should expect it to be a step down in revenue in Q1 which is what we've heard about for many of your peers. Thanks very much. You also commented about the cadence or expenses through the year, just so we can try and get our models a little bit more in line with your outlook. Thanks.

Bob Landry

Analyst

Yeah. Geoff, as you know, I mean, we don't get into that much specifics with regards to the quarterly division on expenses and on revenue. I will say which may not be so evident. With regards to the fourth quarter for Sanofi 2018, right, I mean, we did call out the catch-up adjustment that we’re talking about as a result of amending the I/O discovery agreement. So I think that that's clear. But what I also think didn’t get caught during the year is that we did terminate the I/O – sorry, the antibody discovery agreement at the end of 2017. So for each of my quarters in 2018 as it pertains to Sanofi, I was going up against the 2017 run rate that included $130 million of the antibody discovery agreement that I will not have to go up against in 2019. So when people saw the fourth quarter, sure, the one-time catch-up adjustment was significant. But also, I didn't go up against the 2017 fourth quarter Sanofi antibody development because it had been exhausted by the third quarter of 2017. So, again, a lot of maturations with regards to that. I don't see anything special with regards to how we would break out expenses throughout the year. I mean, we don't have that much seasonal impact. I have been reading the comments that you've said amongst our peers. I do not express to have the kind of the same to same inkling that you've heard from them. And that's what -- that's been put out to the street on it.

Mark Hudson

Analyst

Operator, next question?

Operator

Operator

Our next question comes from Terence Flynn from Goldman Sachs. Please go ahead.

Terence Flynn

Analyst

Hi. Thanks for taking the question. The first one is I was just wondering now the common period is closed, would be great to hear your latest thoughts on the Part B demonstration project. If you think the final version will include a provision for EU reference pricing? And if you can't answer that, would love to hear about insight on the Libtayo launch. Maybe just talk a little bit about more about the kind of breadth of prescribing? How many of your target accounts are already prescribing or connect over the course of the year? Thanks.

Leonard Schleifer

Analyst

So I'll let Marion cover them in on Libtayo and we'll give you your two questions since you guys are so convicted on your opinions about us. We'll anticipate something has got to give regarding the international reference pricing situation, because the public, the administration, myself personally and a lot of people in the industry I think feel and Americans in general feel it's a bit unfair for America to produce all the drugs to its research and development ecosystem and finance it to its financial marketplace and then pay for it for its consumers. And then have a very well-healed European companies get those drugs at a much lower price. The trouble is figuring out a system that can really balance that. And as I've said before when you have a biotechnology companies who have given away the European rights, there is no way to connect those to pricing. You can open it up while you want, but you have different people making pricing decisions. So I think the administration does get that. To the extent that this will force people to give them as I said before courage we'll see. Our sense is a little bit of opposition to the way that has been proposed on the hill, but we have to see how it all come washes out. Marion on the Libtayo?

Marion McCourt

Analyst

So happy to comment on the Libtayo launch. First and foremost, incredibly important because Libtayo is the first product with the approval that I mentioned earlier this morning on four CSCC patients with metastatic and advanced disease where previously they didn't have a treatment therapy. So we've had great interest. To your question on the targets of our activities. We've certainly seen uptake in appropriate way albeit early in the launch from some of the most prestigious academic centers. And we see that on a geographic basis across the country. Similarly we're also seeing uptake, secondarily in more community, large hospital settings that has sophisticated oncology, and also in some instances move surgeons in their practice. I'd also comment that as we look very carefully at the launch, I reported today on 15 million ex-factory sales, I mentioned that it is demand driven. This is not a product with a lot of inventory building and what we are seeing is that each month we're showing progress in terms of demand for a Libtayo. So early days we're pleased. The payor and access coverage as I mentioned went quickly and was very well managed by our team, so we feel very good about the launch of Libtayo. We're working very hard on it.

Leonard Schleifer

Analyst

Everybody has their own metrics turns for how launch is going. But the one that I use is when oncologist calls us up and tell us that he had a gentleman who had had a continue squamous cell carcinoma and exhausted all possible treatments including multiple rounds of surgery, maximum radiation therapy, other types of targeted and chemotherapy. And was in the midst of discussion and headed for hospice because the tumor had invaded from the skin deep into his jaw and then to the base of his skull. He wasn't able to eat let alone smile. Heading for hospice to the days after the drug was approved this oncologist had heard about drug and a podcast convinced the patient to try it. And six weeks later, the patient was home for the holidays with a big smile on his face. Those are the source of the anecdote that tell us that this launch is making a difference and will go pretty well. Next question?

Mark Hudson

Analyst

Operator next question please?

Operator

Operator

Our next question comes from Carter Gould from UBS. Please go ahead.

Carter Gould

Analyst

Good morning. Congrats on the quarter. Question I guess for George or Len. On the bispecific -- on your CD20xCD3, just wanted to kind of get your latest thoughts on those think and specifically if you've nail down the go forward business with those pivotal studies, we recognize you're probably not going to give answers on this call, but just if you've nail those down internally and/or you're still waiting on some of the higher-dose data? Thank you.

Leonard Schleifer

Analyst

Well, I think as we've indicated and as we've shown in our presentations in follicular lymphoma, the results are so impressive. We certainly think we're in the right dose range. And with the DLBCL, we are now getting the sort of activities that are starting to approach, one might be seeing, with CAR-T-type therapies and so forth. So we certainly think we're in the right sort of dose range. And as we said, we anticipate being able to start pivotal studies in both of those settings this year.

Mark Hudson

Analyst

Operator, next question?

Operator

Operator

Our next question comes from Geoff Meacham from Barclays. Please go ahead.

Geoff Meacham

Analyst

Good morning, guys. Thanks a lot for the question. I appreciate it. Bigger picture question. So Libtayo opens up a new therapy area for you guys. But I want to ask about the broader I/O strategy. If rational combos are the main basis, how much of an emphasis does Regeneron place on novel MOAs are targeted, versus evaluating targets, let's say, pharma or others have explored? I'm just trying get a sense for differentiation in the oncology strategy. Thanks.

George Yancopoulos

Analyst

Well, I think that it's a mix of course. But as you can see from our whole new class of bispecifics the CD28s, we I think are leading a whole new approach that will allow for an entirely new group of combination opportunities. And particularly as we tried to explain, the opportunity to now activate immune responses and activate the ability of checkpoint inhibitors like the PD-1s to actually help in cancers that historically have not been viewed as immune responsive, which is, as you know, the vast majority of them. So we believe and I think a lot of other people now believe that we have one of the most innovative and leading-edge approaches to combination opportunities and that certainly having Libtayo as our foundation, approach is only going to help these novel approaches trying to extend the benefit to many more patients in need.

Leonard Schleifer

Analyst

And I would add to that Geoff the -- having the multiple approaches such as an approved PD-1 CD20xCD3, the costims that George mentioned and all the others, even some that others may have, under one umbrella one program I think is very powerful and efficient way to be able to move forward.

Mark Hudson

Analyst

Operator, next question?

Operator

Operator

Our next question comes from Cory Kasimov from JPMorgan. Please go ahead.

Cory Kasimov

Analyst

Hey. Good morning, guys. Thanks for taking the question. I wanted to ask you about Dupixent and on the asthma side of things. Curious how you're thinking about kind of future biologic penetration in both the moderate and severe asthma patients kind of sub-populations with the entrance of Dupi and other biologics. I mean, today, it's obviously been pretty modest for other biologics, even in the severe setting. So I'm curious how you see that changing over time. Thanks.

Marion McCourt

Analyst

So our label, Cory, as you know, includes both moderate and severe patients. It's not unusual that early in a launch we'll probably tend to get some of the type of patients. As I mentioned, we skew a little bit more towards biologic-naive patients, then switches of -- at this point, that have heard discussions of both and see evidence and the data of both. But on – I think we'll have to give it a little time, so I can give you a more robust answer on patient types and uptake of the launch. But certainly, we think the product profile that I've reviewed. In summary, the efficacy, the safety, the ease-of-use and the interest of the two major prescribing audiences of allergists and pulmonologists suggest that we have an important indication and a significant opportunity ahead.

Leonard Schleifer

Analyst

I think as Marion had mentioned maybe in her prepared remarks, but if not, just to reemphasize, a lot of factors of the allergists had a great experience with DUPI in atopic dermatitis and they might make up the fraction of prescribers. Not necessarily because they are treating patients with comorbid conditions although they can and that's in the label and they very well might. But the fact that they've had experience in another highly allergic disease has been so positive I think that that's having a nice halo effect for us, particularly amongst the allergists.

George Yancopoulos

Analyst

And just like EYLEA has an opportunity really paradigm shifting in terms of having the opportunity to really change the practice of how you treat high risk diabetic retinopathy patient. I think Dupixent in asthma in particular, but in all of its settings has a real opportunity paradigm shifting, because I think there's increasing appreciation that all of these so-called allergic or atopic disease are really systemic conditions where the body's immune system has gone awry and gone in the wrong direction. And the data is starting to build up that Dupixent is really addressing this systemic probation of the immune system. And as we accumulate more and more data more and more clinical studies and more and more indications this may become increasingly clear and increase the opportunity. This is really a paradigm shifting where you can really change the course of an immune system and how it's gone wrong: by correcting and correcting it in all of its manifestations, not just in one tissue and one organ which is how historically medical community treats diseases. So I think in the long term, Dupixent really has an opportunity a very paradigm shifting in this space as well.

Mark Hudson

Analyst

Operator, next question please?

Operator

Operator

Our next question comes from Adnan Butt from Guggenheim Securities. Please go ahead.

Adnan Butt

Analyst

Thanks for the question. Maybe one detail. At this stage, are you able to break out that Dupixent asthma and atopic dermatitis and then the NBRx number Marion that you gave out, is that only for atopic dermatitis? Or is that a combined asthma number?

Marion McCourt

Analyst

So the numbers that I gave you in NBRx those were combined numbers. And of course, you know the timing of the asthma launch for obviously covering the last couple of months of the year. I don't have specifics for you at this time of NBRx broken out by indication. But as we move further into the launch window and have additional experience, we will probably be able to get some additional insights on what the splits are starting to look like.

Mark Hudson

Analyst

Operator, we'll take one more question.

Operator

Operator

And our last question comes from Robyn Karnauskas from Citi. Please go ahead.

Robyn Karnauskas

Analyst

Hi. Thanks for taking my question. I really appreciate it. So moving to see big picture on the Dupixent, it sounds like people are pretty comfortable there. Can you -- and I get a lot of questions actually of food allergies because its becoming a bigger deal globally and in the United States. What are these trials going to look like? And how do you -- how does this market tend to evolve, because this could be something that could have maybe a quicker uptake versus say asthma. Can you just give us some sense about market that's going to be the next place that you go after EYLEA?

Marion McCourt

Analyst

Well, I don't know about the market opportunity. For us, it always starts with the science. And I think that if you look at the science and is relating to what I was just talking about before and how all these allergic conditions seem to reflect the systemic probation of the immune system. And interleukin-4 and interleukin-13 seems to be the central drivers of the immune deviations that's leading to this incredible uptake in allergic disease in general and food allergies in particular. And based on our pre-clinical studies and actually a lot of other science as well, these two interleukins could be the central drivers in the whole process. And we believe that there is a possibility that we could be making fundamental difference in the many patients who are suffering from food allergies. And we of course are midst of important study collaborators at immune to explore this. We think that the data from our grass allergy study will also very relevant because desensitization approaches whether they are for food allergies or for aero allergens in some ways depend on the same sort of mechanisms. And we believe Dupixent is right centrally key in those and we'll see what the data shows, because we have these ongoing studies and depending on the data, and if it seems to hold true to the science, it could be important opportunity for so many patients who are suffering for these problems.

Leonard Schleifer

Analyst

So obviously from our point of view, from the market opportunity we always like to focus on the most severe patients, which is why George mentioned go after or perhaps peanut allergy first or maybe later you go after people who are children who have highly food allergies, having difficulty driving, we certainly are all aware of anecdotes of people on Dupixent who tell us they were allergic to this and they've been taking it for their atopic dermatitis and now they're not. Obviously, that could be wishful thinking, but it's a sort of thing that we want to study. But I do agree you are correct. In the severe up polyallergic – poly-food allergic individual the uptake there could be quite strong. So that's going to become an increasing focus as we get through these initial trials that George referred to grass and peanut, but plenty more to come.

Mark Hudson

Analyst

Great. Operator, this concludes today's call. Thank you everyone for joining. Again, Bob Landry, Jay Markowitz, and the IR team is here to answer any further questions. Thank you.

Operator

Operator

Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating. And you may now disconnect.