Earnings Labs

Regeneron Pharmaceuticals, Inc. (REGN)

Q3 2016 Earnings Call· Fri, Nov 4, 2016

$734.06

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Transcript

Operator

Operator

Welcome to the Regeneron Pharmaceuticals Q3 2016 Earnings Conference Call. My name is Jason and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note, the conference is being recorded. I will now turn the call over to Dr. Michael Aberman. Dr. Aberman you may begin.

Michael Aberman

Management

Thank you very much and good morning and welcome to Regeneron Pharmaceuticals Third Quarter 2016 Conference Call. An archive of this webcast will be available on our website under Events and Presentations for 30 days. Joining me on the call today are: Dr. Leonard Schleifer, Founder, President and Chief Executive Officer; George Yancopoulos, Founding Scientist, President of Regeneron Laboratories and Chief Scientific Officer; Bob Terifay, Executive Vice President, Commercial; and Bob Landry, Chief Financial Officer. After our prepared remarks, we will open the call for Questions & answers. I would also like to remind you that remarks made on this call include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and businesses, sales and expense forecasts, financial forecasts, development programs, collaborations, finances, regulatory matters, coverage and reimbursement matters, intellectual property, litigation matters 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 such statements. 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-Q for the quarter ended September 30, 2016, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed on today’s call. Information regarding our use of non-GAAP financial measures and a reconciliation of these measures to GAAP are available in our financial results press release, which can be accessed on our website at www.regeneron.com. Once our call concludes, Bob Landry and the rest of 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

Management

Thanks, Michael, and a very good morning to everyone who has joined us on the call and webcast today. I would like to begin by giving you a high-level stance of our near-term and longer term priorities at Regeneron. EYLEA our flagship anti-VEGF continues to remain a key financial driver for Regeneron. We are pleased with the continued growth of EYLEA and are committed to maintaining our leadership position in the branded anti-VEGF market by pursuing both additional indications for EYLEA such as diabetic retinopathy, where we currently have a Phase III study ongoing. And we are also looking at ways in which we can improve upon the high efficacy bar set by EYLEA through combinations within antibody to Ang2 where we currently have two Phase II studies ongoing. While EYLEA remains very important to our business, we are equally focused on the ongoing launch of Praluent or PCSK9 antibody for long LDL cholesterol as well as advancing our pipeline. For Praluent, we believe that if outcomes data are positive it will drive greater use of this class. As mentioned in our release, we expect this second interim analysis by the end of this month. Moving on to Sarilumab our IL-6 receptor antibody for the treatment of rheumatoid arthritis, as you heard last week, we received a complete response letter from the FDA, this was due to certain manufacturing deficiencies, not specific to Sarilumab. They we observed during a routine inspection of a Sanofi fill and finish plant in France. Sanofi has provided comprehensive responses and is working closely with the FDA to address the deficiencies as expeditiously as possible. It is only been a week since we received the complete response letter and we are preparing to engage in meaningful discussions with the FDA, so it is too early…

George Yancopoulos

Management

Thank you Len and a very good morning to everyone who has joined us today. I would like to begin with Dupixent, our IL-4/13 blocker, which we believe is one of the most exciting late stage drug candidate in the industry. We are investigating Dupixent in a wide variety of allergic diseases. The most advance of which is uncontrolled moderate-to-severe atopic dermatitis. Just last month, we had the opportunity to present detailed results from SOLO-1 and SOLO-2 which were two identical Phase III studies that investigated Dupixent in the monotherapy setting at the annual EADV Conference. These data were also concurrently published in the New England Journal of Medicine. These were the first large pivotal studies where systemic investigational therapy demonstrated significant reduction in the signs and symptoms of atopic dermatitis with an average reduction in skin scores of about 70% accompanied by a marked reduction in the usually unrelenting itch associated with this disease and almost 40% of these patients achieving clearing or near-clearing of their skin lesions. Unlike other immune modulating therapies, there was no evidence of increase immunosuppressant and the most common adverse events in the two trials were injection side reaction in conjunctivitis. We were encouraged by the excitement with which these data were received by the physician community, as well as by patients and we believe that this speaks to the current unmet need and frustration with currently available therapies for this severely debilitating disease. As Len mentioned, our BLA for Dupixent for the treatment of adults with moderate-to-severe atopic dermatitis is currently under FDA review and has been given priority review status and an action date of March 29, 2017. While the SOLO studies were in the monotherapy setting, we have also reported positive one-year top line data from the CHRONOS Phase III study,…

Robert Terifay

Management

Thank you George and good morning everyone. Third quarter U.S. EYLEA or Aflibercept net sales grew 16% year-over-year. Net U.S. EYLEA sales in the third quarter were $854 million and year-to-date sales were $2.5 billion. Net Ex-U.S. EYLEA sales in the third quarter were $471 million, which represents 27% year-over-year growth unadjusted for currency fluctuations. Net Ex-U.S. year-to-date sales were $1.4 billion. EYLEA is the market-leading product among FDA approved anti-digest agents for all of its approved indications in the United States. In the U.S., we are seeing increased competitor discounts and rebates. We are carefully accessing these actions. As I’m sure you are well aware there is a pending proposal from the centers for Medicare and Medicaid services regarding position reimbursement for physician administrated Medicare Part B or buy and bill drugs. We have worked hard on the policy and legislative front on this issue and will be prepared to respond on the commercial front as needed to make sure that patients continue to have full and complete access to EYLEA. Bringing now the Praluent or Alirocumab. As reported by Sanofi, net sales in the third quarter were $38 million with the U.S. accounting for $32 million of the total. Sales data and IMS total prescription data indicate that Praluent and Evolocumab market share are roughly 50-50 in the United States. As reported by IMS, U.S. total prescriptions for Praluent increased sequentially to 60% versus second quarter of 2016. The challenge for the PCSK9 inhibitor class continues to be the significant reimbursement hurdles for the physicians’ offices and patients, resulting in a low volume of prescriptions being dispensed. This is resulted in physicians’ offices reserving their initial prescription to eliminate pool of patients. We continue to focus our efforts in improving access and improving the prescription process through the…

Robert Landry

Management

Thanks Bob and good morning. Regeneron posted strong financial results in the third quarter of 2016 as well as entered into two new exciting collaborations. We are also lowering and tightening full-year 2016 guidance on non-GAAP unreimbursed R&D, non-GAAP SG&A, our effective tax rate and capital expenditures. Let me start with our top-line third quarter earnings. The third quarter 2016 non-GAAP net income was 365 million in non-GAAP net income per diluted share was $3.13. This represents an increase of 32% in both non-GAAP net income per diluted share as well as non-GAAP net income in the third quarter of 2016 compared to the third quarter of 2015. Regeneron’s third quarter 2016 non-GAAP net income primarily excludes non-cash share based compensation expense and the $25 million upfront payment made connection with our third quarter 2016 license in collaboration agreement with Adicet and includes the income tax effect of these non-GAAP reconciling items. Of all reconciliation of GAAP to non-GAAP earnings that is set forth in our earnings release. Total revenues in the third quarter of 2016 were $1.2 billion, which represents year-over-year growth of 7% over the third quarter of 2015. Net product sales were $857 million in the third quarter 2016 compared to $738 million in the third quarter of 2015. EYLEA U.S. net product sales were $854 million compared to $734 million in the third quarter of 2015 representing 16% year-over-year growth, sequential quarter-over-growth was approximately 3%. During the third quarter of 2016, EYLEA experienced a slight increase in U.S. distributor inventory levels as compared to the second quarter 2016, but continues to be within our normal one to two week targeted range. As mentioned in our press release issued this morning, we are tightening our full-year 2016 U.S. EYLEA net sales guidance to be year-over-year growth of…

Michael Aberman

Management

Thank you Bob. Before turning over to Q&A let me remind everyone to please keep your questions to a single question to allow for most number of people to have a turn. With that operator, can we please open up for Q&A.

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from Robyn Karnauskas from Citigroup.

Robyn Karnauskas

Analyst

Hi guys, thank you. I’ll stick to the one question. So if I heard you correctly, it sounded like the [Indiscernible] revenue was concluded - and it’s a 12-week study, so is it possible that we could - well in the first quarter and if so or when we get results remind us how you typically release them [Indiscernible] maybe some color and executions around that. Thank you.

Leonard Schleifer

Management

First. Since you are talking about timing, we really don’t give guidance on timing and as we have with our - we typically look at this and give the top-line press releases is our typical practice.

Robert Landry

Management

But more in general comment Robyn, we would say that and George might want to amplify and I think it’s a tough bar, and we are constantly looking to try and improve on that and so when we get the data we certainly will give you a top-line assessment.

Operator

Operator

Our next question comes from Terence Flynn from Goldman Sachs.

Terence Flynn

Analyst

Hi, thanks for taking the question. It’s just one of the two parts, first just maybe walk us through some of the key drivers of EYLEA growth that we should consider as we head into next year here. And then Bob maybe just last year at this time you highlighted 2016 was shaping up to be an important investment year. Any thoughts here as we head into 2017 produce the [Indiscernible] market. Thank you.

Leonard Schleifer

Management

So Flynn I’ll let Bob amplify if he likes, but the obvious potential growth drivers for EYLEA comes from demographics, aging population, more patients with diabetic eye disease, potentially would come from market share depending upon what continues to happen in the marketplace. This is potential for ups and downs there. And obviously an additional indications diabetic retinopathy those in the three places where we would be focusing and looking to drive growth off of a very large base obviously.

Robert Landry

Management

Terence hi, it’s Bob. Yes, I mean we go out with our SG&A guidance upcoming we are not in a position right now to talk to that, but again we have spent time on this call and you have heard us previously with regards to the spending we have around Dupixent. So with the March 29th PDUFA date coming, we need to ensure that we are ready with regards to our marketing and our sales team is everything to be able to hit the road very quickly on that. And again, we are still investing behind Praluent as we wait for the outcomes data in Sarilumab. As I mentioned on the call, I mean we are putting promotional dollars behind that in our marketing and spending and when the FDA list the regulatory approval on that then we will be in a position to ensure that the product is fully supported from a marketing and sales perspective.

Michael Aberman

Management

Next question.

Operator

Operator

Next we have Ying Huang from Bank of America Merrill Lynch.

Ying Huang

Analyst

Hi, good morning. Thanks for the question. I have a question on the ODYSSEY outcome study here. So we know the hurdle for overwhelming efficacy ratio of less than 0.02 with the p values less than 0.0001. Can you elaborate, do you need to see consistency in every composite of the prime end-point, the all four composite of prime end-point. And also can you tell us how much confidence you have in terms of being able to need that end-points by the end of this month? Thank you.

George Yancopoulos

Management

Yes, this is George. In some ways this decision is out of our hands and it’s very subjective in terms of there is independent monitoring board that without us is going to look at the data regardless of even if we hit the numbers that you stated in terms of our overwhelming efficacy. They have to make a decision about not only consistency and so forth that they are going to take into account whether there is rationale and it’s worthwhile, because maybe they want to look with in subgroup or another to get the complete data set. And so it’s very hard to predict something like that and as I said, is up to an independent data monitoring, its completely out of our hand and they could simply decide for example that they want to follow and get more [deaths] (Ph) in one particular subgroup even though the overall population was very clear. So the end result is I can’t really answer your question, because we just don’t know.

Michael Aberman

Management

Okay. Next question.

Operator

Operator

Next we have Chris Raymond from Raymond James. Mr. Raymond your line maybe muted.

Christopher Raymond

Analyst

Oh, sorry. Can you hear me now? Yes, thanks. So on Sarilumab, so just putting me the manufacturing delay for the drug aside, there has been some news in the biologic space information recently Amgen sort of talking about running out of it’s sort of pricing runway. And we have actually seen from some of our own work, pretty strong evidence that other sort of newer biologics have been gaining traction for some time. I wonder if you could maybe described at a high level your views maybe of the changing landscape with respect to access in PBM market power. And how you think Sarilumab once it is ultimately approved is positioned, not just necessarily from a clinical standpoint, but how you think for commercial landscape is changing in ways that may or may not favor the drug. Thanks.

Leonard Schleifer

Management

Sure, this is Len. At the risk of unveiling a little bit of our strategy here, but not too much of it because obviously we have to get to market. It is a tough environment and the people who are paying the bills have seen what I would consider in some cases almost outrageous increases at least on the WAC price of the wholesale acquisition drugs, rheumatoid arthritis where people taking double-digit increases, sometimes twice a year. To me that suggests some sort of tone deafness in this environment. We think that we have to compete on two in two way, we have to compete with a very good drug, which we think Sarilumab will be. Of course, we have to get over this filling glitch and get to market as quickly as we can. But we think that the class is doing very well, there is some date out there from the first engine of the class where monotherapy against the leading NITNF, the and IL-6 receptor class performed better. And there are some people who simply don’t like to take Methotrexate, we have data of our own, which probably won’t be enough for us filing similar types of results with outperforming in monotherapy. But giving a solid entry with good properties is not going to be enough here and we have to compete with an offering that payers will find attractive. I think Regeneron is willing to break some of the mold here and now I’m getting some hints from my colleagues that I have probably said enough. So I will leave it at that.

Robert Landry

Management

Its Bob. I think it’s important though also to keep in mind that the market has been characterized by a significant amount of TNF cycling and the reality is after a patient receives one TNF inhibitor, if they move a second, we see a diminishing efficacy overtime. We have an obligation from a sales and marketing perspective when we get approved to stop the TNF cycling and IL-6 inhibition plays a central role in RA. It plays a role in not only the symptoms but in terms of the progression of joint damage. And we have to educate physicians on that. So we are anxious to have the product get approved and get that message out there.

Michael Aberman

Management

Okay, thanks for the question. Next question.

Operator

Operator

Next we have Geoffrey Porges from Leerink Partners.

Geoffrey Porges

Analyst

Thanks very much for the question. Perhaps a question on the manufacturing issue. It’s been weeks since the Sanofi conference call so I presume you both had a lot more information. Could you confirm whether the auto field finish facility was included in the original BOI and whether its straightforward to switch the fill finish [Indiscernible] to that alternative facility. And then secondly, could you just tell us whether the inventory of Praluent, Sarulimab and Dupilimab, which presumably have already pre-launched is embargoed or is it likely to be usable and can you be selling Praluent from that inventory already? Thanks.

Leonard Schleifer

Management

Yes, Jeff. As usual, you ask some of the best and most penetrating questions. And as usual we will give you or we would love to give you an answer, but we really not in a position to discuss the details of discussions that aren’t going with the FDA, how they are going to be resolved, the strategy redundancy, what is in filing, what isn’t and so on and so forth. We can summarize by saying that Sanofi is working very hard and they believe they can quickly remedy the deficiencies that were not related to Sarilumab per say, but rather some general GMP deficiencies, which there frankly and well on their way to remedy of course we have to work with the agency and they have to be satisfied. In terms of products that are already manufactured there. I think you should think the FDA sort of takes a risk based approach here, they have sort of maybe frozen in place those things that are actually being - assuming that they don’t think a plant is way out of whack. And nothing can be shipped and still they continued to fill an used product from that facility for approved products. It’s a new product such as Sarilumab, which gets sort of shout off obviously and unfortunately. We are working with them on Sarilumab and we are also working with a different group on Dupixent, which is a breakthrough product, which has a whole different set of approaches to it. So it’s complicated, you can imagine there is tremendous amount of work, a week seems like a long time maybe in your world, but in the world of regulatory interactions and manufacturing remedies and so on, it’s still relatively short time.

Michael Aberman

Management

Next question.

Operator

Operator

Next we have Ronny Gal from Bernstein.

Ronny Gal

Analyst

Thank you for taking my question. So just very quickly following on Jeff. Just looking at generic industry here when it comes to facilities the cycles improving facilities and getting product approved is actually quite long and what gives you conviction that in this case, it will be a relatively short one. And then if I could sneak a second one, 340B there has been some discussion form for that program. If you kind of give us an update about this program and how it impacts EYLEA sales?

Leonard Schleifer

Management

We are going to give you only one question. And so the first question has to do with how do we know how quickly this is going to be remedied. Well we don’t know how quickly it’s going to be remedied for sure, obviously. We know how quickly, which is in a relatively short period of time that Sanofi feels as if they can get the plant in full GMP compliance. In fact, they have already broadened all sorts of efforts and resources, they have already submitted a detail plan, they have already submitted the first or second progress reports against that plan. And so, we feel that the strategy is the right one, and the approach is the right one. Obviously, we will just have to work with the agency and see how quickly they can feel comfortable that the plan is ready to go. Next question.

Operator

Operator

Next we have a Alethia Young from Credit Suisse.

Alethia Young

Analyst

Hi, guys. Thanks for taking my question. Just one on the pediatric population, I know you quantified a little bit more about the adults with the 300,000 a-day. Can you kind of frame that in similar likely nature or similar nature as to the pediatric population please.

Leonard Schleifer

Management

Bob do you want to comment at all on this.

Robert Terifay

Management

Yes, I don’t think we are prepared to sort of go into the numbers in the pediatric population especially things were just embarked on our Phase III program now.

Michael Aberman

Management

Okay. Next question.

Operator

Operator

Next we have an [Indiscernible] RBC Capital Markets.

Unidentified Analyst

Analyst

Hey, thanks for the question. Maybe for Bob, On EYLEA pricing issue are aside - is EYLEA growth tampering a bit. We had thought that DME would be as big as A&D. What are the individual market dynamics, perhaps if you can give any color on that?

Robert Landry

Management

So, we have done very, very well with EYLEA in DME that has been the driver of growth over the last couple of years. Primarily driven by the impressive protocol p results, which indicated that EYLEA was superior Lucentis and that Fasinumab on its primary end-point. The challenge with continuing growth in DME is that there are number of patients that never make it to the retinal specialist office. They go to an ophthalmologist who do laser therapy, laser is a revenue driver in the ophthalmologist office and they don’t make it to the retinal physician’s office where they could get access to anti-VEGF therapy. This has been a focus for us, we are educating, we are trying to educate patients that if they do have DME, they ought to get themselves to an retinal specialist, but this is chipping away at a habit among the ophthalmologist and its going to take some time. But we continue to see that the DME market does offer substantial growth opportunities for us in the future and as Len mentioned earlier if and when we get to diabetic retinopathy indication that would be a further driver.

Michael Aberman

Management

Thanks. Next question.

Operator

Operator

Our next question comes from John Scotti from Evercore ISI.

John Scotti

Analyst

Hi, good morning thanks for taking my question. On EYLEA, I think you previously mentioned that you are seeing a bit of an increase in gross to net and I was just wondering if you are still seeing that steady increase in gross to net and potential smaller erosion in that price. And if so, what is the magnitude of that and whether or not you see this trend is stabilizing or continuing into 2017.

Leonard Schleifer

Management

Yes. I don’t think there has been much sequential change at all in the gross to net, it’s been flat sequentially in the last two quarters.

Michael Aberman

Management

Next question.

Operator

Operator

Next we have Cory Kasimov from JP Morgan.

Cory Kasimov

Analyst

Hey, good morning guys, thanks for taking my question. So, what is the PEDUFA date for a monthly Praluent and early next year. Can you just talk a little bit about the importance of extended dosing in this study? I mean clearly this is a payer constraint market today, but what might monthly dosing mean a little bit down the road? And how do think about even maybe longer term dosing options potentially entering this market from competition at some point in the future. Thanks.

Leonard Schleifer

Management

Yes, I’m not convinced that the driver of this market is whether or not you have something every other weak or every month or what have you. I do believe that people will be driven by the LDL lowering by the outcomes data that would we hope we will support the LDL hypothesis, will continue to support it. And largely driven by payers, they have already demonstrated that they will not pay for convenience, if you look at the hepatitis C class, they put a much less convenient regimen up against a much more expensive regimen. So I don’t think convenience per say is going to drive the market. On the other hand, we like to come up with offerings that are as convenient as possible for patients.

Robert Landry

Management

So just add to that. So far the patients that have received Praluent on a every two week basis have been happy with the dosing frequent, whereas convenience is not a big issue, but as Len pointed out, we would like to offer another dosing form for those patients who do want monthly convenience. But this is not an issue in the marketplace at the current time.

Michael Aberman

Management

Next question.

Operator

Operator

Next we have Jim Birchenough from Wells Fargo.

James Birchenough

Analyst

Yes, hi guys, just a question on the co-formulated Ang2 EYLEA product. And referencing data for the PDGF program. Is there anything in the co-formulation of the two drugs that limits the efficacy of each individual component whether it’s viscosity and ability to inject the full dose of the amount of protein you are giving to the back of the eye. I’m just trying to see if there is learning’s from the PDGF program that might inform how we just think about the co-formulation part of this for the Ang2 product? Thanks.

George Yancopoulos

Management

Yes, we have no reason to think that there is any issues what so ever with that or that would have contributed all to the results and that the results we believe simply reflects the biology or the lack of biology for the PDGF pathway.

Michael Aberman

Management

Next question.

Operator

Operator

Next we have [Indiscernible] from SunTrust.

Unidentified Analyst

Analyst

Hi, guys. Thank you for taking my question. Question on Praluent. Could you comment on the value-base contract, I mean we know Amgen mentioned that they are entering into value-based contract for their PCSK9. Is that happening with you, how do you see that impacting the dynamics going forward?

Leonard Schleifer

Management

Well one thing I should mention is many plans do not have the ability at the present times to enter into these types of arrangements. So it’s going to be a rarity that a plan is able to implement value-based price contracting. However, for those that can do it, we are working with those plans to establish a value-based contract more appropriate.

Michael Aberman

Management

Great. Next question.

Operator

Operator

Next we have [Indiscernible] from Jefferies.

Unidentified Analyst

Analyst

Yes, thanks, guys for taking my questions. How do you think payers will define moderate-to-severe for atopic dermatitis patients, because we hear like many darns don’t typically follow easier score out at scales, but I just had a look at by surface area to determine severity of disease?

Leonard Schleifer

Management

I think it varies by geography in Europe, [EZ 75] (Ph) or PASI 75 is the driver of definition of disease in psoriasis. And we anticipate that EZ 75 will be something we have to educate physicians on and they are already preparing themselves for that. In the United States, you are correct, EZ scores are not relevant to the physicians and IG8 scores are not specific enough. So we are working right now on plans with payers on how to better define the disease. George?

George Yancopoulos

Management

Yes, we suggest like you know that obviously in our studies on average the patients that we study had more than 50% of their body surface. At baseline covered by this disease and a quarter of the patients had 85% or more of their body covered with this disease. This just shows how severely these patients are and it’s not just that their skin is covered with this rash, but this is a weepy, itchy, horrific rash that they just can’t escape. And remarkably enough as we said despite the heavy burden of disease at baseline almost 40% of these patients achieved a clear or almost clear status. Really in this business do you have a privilege to be involved in a story like this that can make such a difference in patients’ life. We have been lucky here at Regeneron that we have done this a couple of times already but we think that Dupixent is really a once-in-a-lifetime story where you can really impact such an important disease, so dramatically having an average 70% improvement among all patients. And the thing that’s also so stunning to us about Dupilumab is that it looks like it might have the promise to do likewise in a host of related allergic diseases. Including the overall asthma population where they are again and in most uncontrolled severe population once again the results are very impressive from our first pivotal study and we think the same maybe the case in a host of other allergic setting. So the short answer to your question is, unfortunately there is a lot of patients who have more than 50% of their body surface covered. Those patients are certainly by any category considered severe patients. As Bob already told you, many of them have exhausted all other options and we just hope that all the other ancillary things don’t keep these important patients from getting access to this important life-changing drug.

Leonard Schleifer

Management

Yes, I understand before I turn to what George has said, which is that in contrast to Praluent. We knew with Praluent of course that we could lower cholesterol rather dramatically, but to most patients unless they are highly involved in the detail of their care, which some are, but many to them that isn’t the end all, be all something that they wakeup everyday wondering how to get their cholesterol down. Of course they have had a heart attack and everybody in the family does, then they do pay attention to that. But then there was the push back, well you don’t really know do you that it improves outcomes and we’re just going on a hypothesis. Even though there is a great deal of data to certainly support that hypothesis. So it’s not a disease that people are clamoring to get treated and it’s not outcomes that are readily in hand. Contrast that with Praluent where these patients are desperate for treatment, truly desperate for treatment and we are not talking about the topical treatments that are available such as steroids that might become available when you are dealing with small areas relatively to modest disease. We are talking about the kind of patients George referred to, which are really quite significant. And these patients can see the outcome themselves, they can tell that they are doing better and we see it in our studies, we see it in our questionnaires, we see it in whether or not there is sweeping because they can scratch themselves so badly. I heard a story the other day which practically was a group of us who practically brought us all to tears, where a little boy who was visiting his grandparents and so cuddling and sleeping on the same bed. With very bad atopic dermatitis said to his grandparents, can you each hold one of my hands when I sleep so I don’t scratch myself so badly. I mean think about that, this is a disease that people really are looking for treatment. And if we can get this drug approved, first for adults and hopefully down the road for children, we can really provide something that they can tangibly feel. We are passive about making sure that we remove all the barriers out there and we expect to work with patients, with doctors, with payers, with organizations to make sure that people are aware of this treatment and can get access to it. Next question.

Michael Aberman

Management

Yes I think, we have time for one last question.

Operator

Operator

Our final question comes from Phil Nadeau from Cowen & Company.

Phil Nadeau

Analyst

Good morning. Thanks for fitting me in. Just one question on some of your prepared remarks. You mentioned that your competition for EYLEA is beginning to increase the discounts that they are offering. I want to understand the dynamics there a bit more, is there a cycle for when discounts are negotiated and there are any signs that you are seeing this is something that’s demanded by payers or is it just something that the competition is taking upon themselves to do?

George Yancopoulos

Management

Yes, remember this is a Part B drug and there really not the same kind of environment we have a timing and a cycle with patients. For the most part there is some small amount of that that goes on. But for the most part the discounts and rebates that have been offered have been sort of directly backed to the physician’s office et cetera, et cetera. We continually revaluate that situation, we looking what are impacts, we are very sensitive to doctors being have to make a choice of what to give the patients, what they might think the best drug would be because of a rebate situation or something like that. We think most retinal physicians don’t do that, but we certainly understand that we will then as the markets shifts we are prepared to react if necessary.

Leonard Schleifer

Management

Great. Thank you all for joining the call today. As we mentioned before, the IR team and Bob, the Chief Financial Officer will be available to answer any questions that didn’t make it on the call. That ends the call for today.

Operator

Operator

Thank you ladies and gentlemen. This concludes today’s conference. Thank you for participating. You may now disconnect.