Welcome to the Regeneron Pharmaceuticals Q4 2016 Earnings Conference Call. My name is Nicole, and I’ll 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 that this conference is being recorded. I will now turn the call over to Dr. Michael Aberman. Dr. Aberman, you may begin.

Thank you, and good morning, everybody. I hope you are all staying safe if you are on the East Coast. Welcome to the Regeneron Pharmaceuticals fourth quarter and full year 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; Dr. George Yancopoulos, Founding Scientist, President 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 Q&A. 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, product candidate 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 year ended December 31, 2016, which was filed with the SEC later today. 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 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 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.

Thank you, Michael. Very good morning to everyone, and I echo Michael’s sentiment here on the East Coast. I hope you are all safe from the storm. 2016 was an important and eventful year for Regeneron and one where we achieved significant progress on the commercial, research and development fronts. We currently have eight late stage Phase III programs and a total of 16 product candidates in clinical development. Our science driven approach has remained unchanged. As we look at 2017, we remain confident that we are well-positioned to reap the benefits of our long-standing scientific endeavors. We expect to new major drug approvals in the United States this year. First, we are anticipating regulatory action in the United States at the end of March for dupilumab, or Dupixent, our breakthrough IL-4, IL-13 blocker for moderate to severe atopic dermatitis. We believe that, if approved, Dupixent will change the way doctors are able to treat their moderate to severe atopic dermatitis patients. Secondly, we expect regulatory action by the FDA for sarilumab, our IL-6 receptor antibody for the treatment of rheumatoid arthritis. We are happy to report that just last week sarilumab, now also known by its brand name Kevzara, was approved by Health Canada. Strong preclinical data as well as our positive findings from our studies in atopic dermatitis, asthma and nasal polyps indicate that IL-4 and IL-13 signaling is a key pathway driving many allergic conditions and diseases. You will hear further details from George about our dupilumab development program. We are keenly focused on ensuring that the anticipated Dupixent launch in the atopic dermatitis indication is a success by all metrics. I personally in addition to the teams at Regeneron and Sanofi have engaged in fruitful discussions with payers, and we remain optimistic that Dupixent, the breakthrough…

Thank you, Len, and a very good morning to everyone who was joined us today. I’d like to begin with Dupixent, our IL-4, IL-13 blocker. I share Len’s excitement about this molecule and its potential use, not only in moderate to severe atopic dermatitis, but also in various other allergic conditions. As Len mentioned, Dupixent is on track towards the end of March for an expected regulatory approval in the United States for moderate to severe atopic dermatitis in adults. You will hear more about our ongoing launch preparations from Bob Terifay. In the fourth order of 2016, the marketing authorization application for Dupixent in this indication was accepted for review by the European Medicines Agency or the EMA. Dupixent has received breakthrough designation in both the adult and pediatric atopic dermatitis application. In the latter, we expect to initiate a Phase III study in adolescent patients between ages of 12 and 17 in the first quarter and in the second quarter another Phase III study in younger patients between the ages of six and 11. Scientific evidence indicates that the IL-4/13 pathway is essential not just in atopic dermatitis but also in a wide spectrum of allergic diseases. With that hypothesis we're exploring the use of dupilumab in multiple allergic conditions. Let me begin with asthma, positive data from our previously reported first pivotal study of dupilumab in persistent uncontrolled asthma, which has also been published in the New England Journal of Medicine, demonstrated that in all patients, regardless of their allergic classification, treatment with dupilumab resulted in improvement in both lung function as measured in FEV1 and exacerbations. In the overall population patients treated with the 300 milligram every other week dose had a 15% improvement over placebo in the FEV1 measure and a 75 % reduction in…

Thank you, George, and good morning, everyone. Fourth quarter U.S. EYLEA or aflibercept net sales grew 15% year-over-year. Net U.S. EYLEA sales in the fourth quarter were $858 million and full-year 2016 sales were $3.32 billion. Net ex-U.S. EYLEA sales in the fourth quarter were $496 million, which represents 20% growth year-over-year unadjusted for currency fluctuations. Net ex-U.S. EYLEA full-year 2016 sales were $1.87 billion. In 2016, global net sales of EYLEA exceeded $5 billion. EYLEA is the market leading product among FDA-approved anti-VEGF agents for all of its approved indications in the United States. EYLEA will continue to be a major revenue driver for Regeneron over the years to come. Our quarter-over-quarter EYLEA sales growth has slowed, reflecting normal market dynamics for a more mature product that has been on the market for over five years with no price increase since launch. We continue to focus our promotional efforts and the clinical efficacy and safety of EYLEA and our development efforts on potential new indications and new combinations. The next potential driver for EYLEA growth could be an indication for non-proliferative diabetic retinopathy which is currently in Phase III development. Our fixed combination program for EYLEA and nesvacumab, our angiopoietin 2 inhibitor is currently in Phase II clinical development. Turning now to Praluent, or alirocumab, as reported by Sanofi, net sales in the fourth quarter were $41 million worldwide, with the U.S. accounting for $33 million of the total. Full year net sales were $116 million with the U.S. accounting for $94 million. We are pleased that the Federal Court has suspended the injunction on Praluent sales, marketing and manufacturing. Therefore, we will continue our efforts to grow Praluent sales and alleviate reimbursement roadblocks. Remember, Praluent is the only PCSK9 inhibitor that offers a low-dose option. Most of our…

Thanks, Bob, and good morning to everyone. Overall, we delivered solid fourth quarter financial results. In the fourth quarter of 2016, we earned $3.04 per diluted share from non-GAAP net income of $343 million. For the full year 2016, we earned $11.32 per diluted share from non-GAAP net income of $1.32 billion. This represents a year-over-year increase in non-GAAP diluted EPS and net income of 36% and 37%, respectively, for the fourth quarter and a year-over-year increase in non-GAAP diluted EPS and net income of 39% and 40%, respectively, for the full-year 2016. Regeneron’s fourth quarter and full year 2016 non-GAAP net income primarily excludes non-cash share-based compensation expense and includes the income tax effect of non-GAAP reconciling items. A full reconciliation of GAAP to non-GAAP earnings is set forth in our earnings release. All of the financial guidance mentioned on this call today and in our fourth quarter 2016 earnings release issued earlier this morning assumes that Praluent will remain on the market throughout 2017. Total revenues in the fourth quarter of 2016 were $1.23 billion and $4.86 billion for the full year 2016, which represented year-over-year growth of 12% for the three months and 18% for the full year. Net product sales were $863 million in the fourth quarter of 2016 and $3.34 billion for the full year 2016 compared to $750 million in the fourth quarter of 2015 and $2.69 billion for the full year of 2015. EYLEA net product sales in the United States were $858 million in the fourth quarter of 2016 and $3.32 billion for the full year of 2016 compared to $746 million in the fourth order of 2015 and $2.68 billion for the full year of 2015, which represented an increase of 15% and 24%, respectively. During the fourth quarter of 2016,…

Thanks, Bob. Operator, we can now open the call for Q&A. But I’d like to remind everybody to please limit yourselves to a single question to allow time for others to ask their questions. Operator?

Thank you. We will now begin the question-and-answer session. [Operator Instructions] We are standing by for questions. And our first question comes from Terence Flynn from Goldman Sachs. Your line is open, Terence.

Hi. Thanks for taking the question. Maybe just on the Ang2 Phase II trials, if you can remind us there if those are blinded or open label and then what’s the rationale to wait for the 36-week data instead of reporting the 12-week primary endpoint data? Thanks.

Well, it’s a blinded trial. It’s a single injection either with EYLEA alone or in various combination arms, and we believe that the 36-week data is going to provide us the best opportunity to really evaluate the value of adding angiopoietin-2 to EYLEA. And that’s how we’ve designed the study.

I should add that primary endpoint is 36 weeks…

All right.

Next question.

And our next question comes from Geoffrey Porges from Leerink Partners. Your line is open.

Thank you very much. So, Len, you mentioned the weather in New York and I wanted to make sure that there wasn't any snow going on in this conference call, so I have to ask you about the guidance for EYLEA. So, you're really guiding to a significant slowdown in 2017, even compared to your growth trajectory in Q4, could you talk a little bit about the puts and takes in that guidance, particularly whether you're assuming any changes in reimbursement for Medicare Part B? And secondly, what is it that you're seeing in terms of the penetration, particularly in the DME that suggests that the product’s reaching maturity now? Thanks.

Thanks, Geoff. No slow at all. Let me just address the question -- your question and generally about our guidance here. First of all, I remind you that this will be the last year that we do individual product guidance. I'm not a big fan of being in the forecasting business, we’re in the drug discovery, development and optimization business and forecasting is always somewhat tenuous. A lot of people have been concerned about how we get to the guidance and why is the range single digits which can be rather broad. You have to remember, we are a science-driven company and when you look at all of the errors in the estimates of things that can go into it such as market share, anything that could happen in government policy, negotiations, our ability to hold off any growth of Avastin, any market forces that require increase gross to net. When you put all of these puts and takes, if you will, it does become somewhat of a blizzard which obscures the landscape and it's very difficult to feel comfortable that we can make -- give you precision that you would like when there are too many estimates in there that when -- that you could -- when you put them all together, the precision is just not there. So it is the fifth year of this products. We've grown rather substantial and we do think there’s growth also to still be had with new indications, and also, obviously, growth outside United States with Bayer. But as the year goes on we'll see how this all plays out.

Next question.

And our next question comes from Ronny Gal from Bernstein. Your line is open.

Good morning. I’m going to ask one alternate in case you cannot answer the first one. So, the first one is, in case you have the opinion from the court about the preliminary injunction, can you just give us a bit of color about this particularly what was the appellate court's opinion about the likelihood of success on the merits. Now if you haven’t got the opinion yet, I would ask you about the Praluent trajectory and market share for 2017. Obviously, some of your clients will be a bit worried about the potential final outcome, should we expect you guys to begin to lose a little bit of share against Repatha in that market?

Let me deal with the opinion, the legal opinion, I think that’s what you are asking related to the injunction. By the way it was not a preliminary injunction, it was a permanent injunction, which is what you get at the end after a jury trial. A preliminary injunction is something you might get before a jury trial which was not sought in this case. We read the opinion which is available online I think you can probably find it linked to our press release, and what the court said is that as is typical in all cases when they are determining whether to upset, if you will or put a hold on an injunction that a lower court issued, that they consider four factors, and these factors, the first factor relates to the question of whether you've made a strong showing of a likeliness to win on the underlying appeal; and the second factor has to do with whether or not you will suffer irreparable harm if you don’t get this stay during the appeal. And third factor has to do with how this affects the other party and the fourth factor has to do with how it affects the public. From the way that we look at the actual opinion, the court said that the first two of the factors are the most critical and that is whether Regeneron and Sanofi have made a strong showing of a likelihood of success in the merits and whether or not we would be irreparably harmed. And they said, based on the submissions and the papers that they felt that we met that standard and we were entitled to an injunction to be stayed. So, I think that’s all we know at this point. Now, we are moving forward on a somewhat accelerated basis. The briefing -- our opening brief on the underlying appeal that the judges were talking about when they said whether we made a strong showing of our winning on the success, that’s what they are talking about. We're going to now go, try and win on the success on the merits. I hope that answers your question.

Next question?

Our next question comes from Mark Schoenebaum from Evercore. Your line is open.

Hey, guys. Thanks a lot for taking my question. Thanks to Michael, Manisha and Len for all your help while I was out helping out the team. I really appreciate it. And, Len, it’s great to hear your voice. I thought I’d ask a big-picture question. hopefully, I can get Len fired up here. President Trump was quoted -- it was his press secretary, I think, a couple days ago, when he mentioned that he was clearly in favor of the government directly negotiating drug prices with drug manufacturers. I’d love to hear your thoughts on this. Do you believe it? What does it mean for the sector if it were implemented? What do you think -- what kind of impact would it have on drug prices if indeed it were implemented? And, more broadly, what do you actually think is going to happen with all of this drug pricing stuff? Thanks a lot, Len.

You’re welcome, Mark. Nice to hear your voice as well. Look, I don’t have a particularly unique pipeline into what the president is thinking here. We take him at his word for what he said that he thinks that the U.S. is paying too much and is not negotiating. I think, as he gets deeper into the policies, I think, he is going to find that in fact that we do negotiate prices for Medicare drugs. We just do it with individual Medicare carriers rather than one negotiator. I think that my own perspective on this is that what’s going to happen here is a little bit more of a nuanced dialogue that says that the public is going to recognize and I think the president recognizes that this is a very, very hard business. Innovating and discovering new drugs that can really change people’s lives either how long they live or what the quality of their life is -- is something that’s extremely hard to do. On the other hand, it doesn’t do us any good to do all that if we can’t get these drugs to people who can actually afford them. Where I actually think that, there will be some consensus in Congress, which is this is going to take Congressional action, I believe, I think, there will be some consensus in trying to deal with how much of the payments individuals are making for drugs. The co-pays or coinsurances are really what I think most problematic for the people. And that I think that people are beginning to recognize that the skin in the game that the government wanted for a lot of this has gone a little too far making it hard for people, literally to get the drugs. And I think some relief there will be forthcoming. But at the end of the day, the attention probably will be and it's just my guess is, on somehow setting standards that breakthrough drugs ought to be rewarded and price increases that are not -- that are unrelated are uncoupled from innovation, will be pushed back on. Anyway, at the end of the day, we're going to have to figure out how to protect incentives through innovation. And in -- not matter what we think coming back now to Regeneron, I think Regeneron is extremely well-positioned because I think the winners and losers in our space will be those that are really viewed as the true innovators. If you can come up with a product like Dupixent hopefully which will be approved towards the end of this quarter where you can change people's lives, that is always going to get value for you. So maybe I'll just stop there and take the next question.

Next question?

Our next question comes from Ying Huang from Bank of America Merrill Lynch. Your line is open.

Hi. Good morning. Thanks for taking my question. I have a question on EYLEA, should we assume that your market share in 2017 in AMD and DME will be relatively stable. That’s how you come to the single digit guidance and then related to that, Novartis has a Phase III for RTH258 that’s comparing a Q3 month regimen to the Q2 month for EYLEA. I was wondering if you guys have any thought about that? Thank you.

Yeah. I'm not going to get into the granular basis of how we came up with our assumptions, Ying, because as I said, you start to add them up and you wind up with lots of errors. So, it isn’t like one thing drove it versus another. So, we'll keep you posted on a retrospective basis, how our market share is doing, but predicting that it's just -- it's very difficult. George can address the Novartis trial.

Right. And we want to remind you that their study is really just intended to show that some percentage of their patients can get by with every three months dosing. And we've already shown data that shows that a substantial number of our patients can also get by with three months dosing. I think that neither they nor I are advocating three months dosing for every patient. It's just that they're trying to produce data akin to ours which actually shows that a substantial number of patients can indeed get by with every three-month dosing.

Yes, and I will just say that, look, this is a hard business and when you load of the eye with a lot of drugs, which is what they're doing, they are going to have to show that they don’t get inflammation, they are going to have to show that you don’t get hypertension systemically which was seen in some of the earlier trials and you just don't know, so we will have to wait and see and we will look at their data, but as George said, I'm not sure that the way that they have set up the trials will accomplish anything more than we’ve already have data for, so we will see.

And I think one brings up an important point, I mean, they're trying to do it by putting in many, many more molecules of their agent as compared to EYLEA, and to get a rather similar efficacy bar and with that, as Len pointed out, comes additional risks that they are going to have to show that they are not actually causing.

Okay. Next question?

Our next question comes from Chris Raymond from Raymond James. Your line is open, Chris.

Hey, thanks for taking the questions. So still a question for the sarilumab, so assuming you guys get a timely US approval here, some of the survey work has shown real traction for a Kevzara especially in its subque format with -- it looks like real impact on embryo and HUMIRA, so at least my view sarilumab has pretty significant differentiation versus ACTEMRA, and you have got this positive head-to-head trial versus HUMIRA, it’s more convenient administration etcetera. So, Len, as you even mentioned on this call, you've been a pretty outspoken critic of pharma pricing and the TNF market has been one of more glaring examples of aggressive pricing practices and I know, Len, you don’t want to talk about specific pricing strategies but you guys really struck I think a great note with the pricing decision on EYLEA, would you say that the inflammatory biologics market allows a similar setup here for you to really make a statement or is that market different from the one that EYLEA launched into?

Chris in a word, yes, we think that the constant price increases and the magnitude of them are a reflection of several things, one somewhat tone deafness on the people taking these huge increases and somewhat of complexities of the system about how all of these rebates work, and I think some of this is being unwound. So, we do have sort of a three-part strategy if we get Kepzara to market, which we expect we will. One is to provide it as a reasonable alternative to anti-TNF therapy either in first-line or after failures. The second is to try and position it if we can as the preferred IL-6 agent based on the profile of the product. We’ll have to see how doctors respond to that. And by the way, there is this growing market for monotherapy, which I think as you mentioned we do have attractive data in. So, monotherapy -- that is without methotrexate, which is not the most well-liked drug, to be frank -- is a growing part of the market. And the third part of our strategy is the one that you just referred to, which is that there is an opportunity to come up with more responsible pricing. That’s all that I should say at this point.

Next question?

Our next question comes from Robyn Karnauskas from Citigroup. Your line is open.

Hi, guys. Thank you for taking my question. So, I just want to ask another pricing question. Can you talk a little bit about if you’ve seen any pricing pushback in the U.S. and Europe? And you did mention on pricing for -- I can never pronounce it. You talked about formulary -- they will be positioned positively. Maybe talk about how you think about the lessons from pricing PCSK9 and where you might be getting your confidence in the positioning on the formulary for [indiscernible].

Yeah. So, a good question, Robyn, and thanks. The PCSK9 story will be a case study, and there are lots of views on this. And the complexities in the context that they were launched following the Hep C struggles that the payers and manufactures had makes that somewhat of a unique story combined with the fact that you had a market of pennies a day fabulous statins which really could serve a lot of the market obviously. In our drug, Dupixent, this is a whole different story. First of all, we have outcomes data now. The outcomes data are the endpoints. People’s skin and their itch is really a big deal are getting dramatically better. And I think that -- so when you’re starting with that, that’s very important. You're also going into a field which the FDA has said it's a breakthrough, we think it's a breakthrough, I think my discussions with the payers, their people think it's a breakthrough. And most importantly, the patients and their doctors believe this is a breakthrough. So, that’s a whole different kettle of fish than when you're dealing with a drug, for example, a cholesterol-lowering drug where people are not even sure they want to have their cholesterol lowered, or if it was any good to have their cholesterol lowered. We believe it was, of course, but there was this pushback. Here with this drug, people want this drug, people need this drug, I think that the data are remarkable consistent across all of our trials, it really is a breakthrough. So, we have had very productive conversations meeting with payers who I think have been receptive to trying to not make is always so adversarial. And look, we have a role, they have a role and we can spend a lot of time pointing fingers at each other, like a lot of people do, and farmers running around saying, well, the middleman has taking too much of it and the middleman is saying that the prices are too high and their patients are wondering what is hell is really going on, or we can try and work together and come up with a breakthrough product that has responsible pricing and good solid formulary access without significant barriers to the right patients getting the drug. I am an optimist and I base that optimism not just based on my genetic makeup, but on the fact that I've actually had conversations with the most senior leaders of the most important payers and I have felt that we've gotten a very good reception to our approach. So, I'm really looking forward to telling you the details when we launch and to getting this product to patients.

Next question?

Our next question comes from Adnan Butt from RBC Capital Markets. Your line is open.

Thanks, Adnan.

Hi. Thanks. Maybe for George, based on -- for nesvacumab, based on either Phase I or biology, you mentioned the bar is high versus EYLEA, but is the bar different than the bar you would have expected for PDGF?

Well, I think that the preclinical data was just very weak for the PDGF class. We had been working on that for 20 years and largely went into that program as a defense as try to -- just in case somehow the anomalous early clinical data were proven to be true. Ang2, the data -- the preclinical data is much stronger, but as you said, EYLEA poses such a high bar for efficacy that it’s a challenge for anything to improve it, especially EYLEA does such a good job on things like retinal edema, which is one of the major causes of reversible vision loss. So, we're anxious to see, testing the hypothesis in patients, we think it’s worth going forward and testing it. We hope for patients’ sake that it is going to make an improvement, but like anything else, I mean it’s a high bar and it’s going to be hard to actually beat it.

Great. Next question?

Your next question comes from Yatin Suneja from SunTrust. Your line is open.

Good morning, guys, Thank you for taking my question. Question is on Praluent, could you guys comment maybe on how the ODYSSEY OUTCOME trial might differentiate Praluent versus Repatha? And then, George, you mentioned, you expect increased uptick after positive data in appropriate patient, could you maybe expand on that, how do you view or how do you define that appropriate patient population? Thank you.

Right. So, it’s a little bit early to answer the question on how we are going to differentiate. We know that the trials are slightly designed differently in different patient populations but we haven’t seen any data yet whatsoever, all we have heard is topline data so we have to wait until we actually get our data and analyze carefully the data that’s been presented. George, you can comment.

And just to remind you, your patient population was a higher risk population post-acute coronary syndrome type population. So, you might expect that these patients might have both a higher risk which is one reason why our study had less numbers of overall patients than the Repatha study, but also that you might have a different degree of benefit in these patients and that it might be represented in different components that comprised of various events of interest.

In terms of appropriate questions -- appropriate patients, I think that was actually Bob Terifay, who had mentioned that, I think what he is saying is that, we want people to be have the maximally tolerated statins before they go on to choose Praluent to further lower their LDL, assuming that they have the appropriate cardiovascular -- atherosclerotic cardiovascular disease. In terms of getting more patients through the system, I think this will be driven both by doctors. There are obviously some doctors who have been waiting for outcomes and, therefore, and only using, let’s say, in their most severe patients with severe hypercholesterolemia. But now I think that that may change. So, you might get more drive and more prescriptions coming through. I also believe that with OUTCOMES data the payers are not insensitive to the change in the science, and they will evaluate this and think about the various barriers that are in place. And I believe they may lessen some of those barriers to make it somewhat easier to get these prescriptions to go through.

And there is one important thing though. Whenever we talk about differentiation from Repatha we need to keep in mind that we are differentiated. This is the only molecule that has a low dose option. There are a large number of patients receiving that low dose option and a large number of physicians who prefer to start with that dose. That is how we conducted the ODYSSEY OUTCOMES study.

Yes. Thank you.

Okay, Michael. Next question?

And our next question comes from Alethia Young from Credit Suisse. Your line is open.

Hey, guys. Thanks for taking my question. It seems like the FDA has been kind of tough around manufacturing and stuff. So, I know you’ve sort of addressed some things with the [indiscernible]. But maybe can you talk about how the breakthrough designation has helped with the Dupixent, and like kind of what are the remaining steps and how confident you feel about being on time for this approval?

Yeah. I think the FDA has been and should be tough about manufacturing. We rely on our system -- both self-regulated, responsible manufacturers regulating their production and quality; as well as third-party regulators, the FDA -- to ensure the quality of our drugs. We have no problem with that at all. And I think that sanofi doesn’t either, and they’ve worked hard now to improve and get that plant in an acceptable format. We still have to go through the routine pre-approval inspections -- routine in the sense it’s not a routine inspection; it’s routine in the sense that you have to have it before a drug is approved. But we’ve been through those before as they have, and we’re optimistic and we have worked very hard to get ready for that and expect that we should be able to get through that. If we do, we would expect an approval by the end of the year -- the end of the quarter. Sorry. And in terms of the breakthrough status, actually, that’s been very, very, very helpful. I think it’s a terrific program that Congress devised, because it gets the focus of the people, it gets the staffing on the project to move things along, it gets you more access, it gets your questions answered, etcetera, etcetera. So, I do think that is a good program and my perspective on it is, they don't give that out so easily, they have high standards, and when you get it they do work well with you. So, no gripes from me. I'm not one of those people, when things don't go well, I just blame the FDA, it's just the opposite. I want a test FDA, because I want a high bar, and want a balanced and fair playing field, but I want a high bar so that we're just not in the, if you will, as I said the other day, in the infomercial business and anything you can say is fine and doesn't matter whether the product actually works or not.

Next question. We have time for one more question. For those of you who don't get a question today, I want to apologize. We are in the office and we made an entry, so please give us a call and we'll try to get you on in the next earnings call. So, this will be the last question.

Our final question comes from Cory Kasimov from JPMorgan. Your line is open.

Hi. Good morning, guys. Thanks for taking my question and squeezing me in. so, relatively speaking, how do you view the market opportunity for EYLEA in non-proliferative diabetic retinopathy compared to the products currently approved indications, assuming of course you have positive Phase III data for that patient population? Thanks.

Yeah. Once again, I'm glad you asked the question on the way you did. On a relative basis, the number of patients is substantially higher who have proliferative diabetic retinopathy as compared to those that have proliferative diabetic retinopathy with diabetic macular edema. And so, you open up a much larger group of patients who potentially could benefit from the drug. Of course, this is, sort of, almost treating people who have yet to realize you’re treating people who have eye disease, lots of eye disease, but it hasn't affected their vision yet. And so, you have to convince them that to get an injection in the eye to protect their vision. I think that's somewhat of an impediment, but because -- if you have strong data, the numbers there are much, much larger. Anyway, so I think it's a big opportunity on a relative basis. Let me just close by saying that, for us, we get it. We know how important EYLEA is, but we -- and so we're going to defend and try to extend that. We also get how important it is to make our late stage pipeline a big commercial success. And we have worked very, very hard to get ready for what we think could be a game changing -- and people like to use game changing, breakthrough, all that stuff. But the truth of the matter is, those kinds of products don't come along that often. Where George and his team are able to give us a weapon to address, really almost put your finger on the control system for allergic diseases and do that in a way where you don’t have the immune system dysfunction that you do when you do that, let’s say, for Type I immunologic disorders such as the anti-TNF,…

Well, that concludes our call for today. We appreciate everyone calling in. Again, a couple of people have emailed me, we will call you back. If you want to hear from us, please give us an email or drop us a line, we are in the office. Operator, that concludes our call.

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