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Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN)

2011 Deutsche Bank BioFEST Conference Call

December 05, 2011 1:05 PM ET

Executives

Leonard S. Schleifer - President and Chief Executive Officer

Michael Aberman – Vice President, Investor Relations

Moderator

Thanks for joining us. So thank you all for joining in and listening. For those of you who are on the webcast, next we have Regeneron Pharmaceuticals with the CEO, Leonard Schleifer as well as Michael Aberman from Investor relations. For those of you who are in the audience, just raise your hand. We have mics, we can bring them over to you. For those of you who have figured out how to use the Internet, well there is a website and an app where we are sort of letting people ask questions completely anonymously. If you post it on the wall basically you can ask a question without me knowing who you are and there is also a poll question. We would like more people to poll sort of figuring out like why you own Regeneron and whether or not you think they are going to beat, miss or have consensus, probably (inaudible), whether you think they’ll beat, miss or come in line next year (inaudible) and also email me at (inaudible) with any anonymous questions.

And with that, Len, to start with you, Len, so you had some great data this morning that you released which created a lot of controversy for the day. Maybe talk a little bit about your point of view, maybe just summarize for those – the people in the room who don’t know the data and then maybe give your point of view of what are the key points of the data. What are people missing who are responding negatively?

Leonard Schleifer

Sure. But before we begin let me just give you our forward-looking statement quickly because remarks that are not historical in nature may be forward-looking about Regeneron and subject to a number of risks and uncertainties, our actual results may differ materially. Such remarks may include, but are not limited to those related to Regeneron and its products, development programs, finances, business including EYLEA, all of which involve a number of risks and uncertainties and a complete descriptions of all those risks and uncertainties can be found in our filings with the SEC including our 10-K for December 31st, 2010 and in our Form 10-Q for September 30th. And we don’t undertake any obligation to update any public forward-looking statements.

Now also since we have in the middle of launching a product, EYLEA, I want to point out that we’ll be discussing data for EYLEA, including some of the two year data you just asked me about and that - those data have not been reviewed by the FDA, they are not in our approved label. As a reminder, EYLEA is approved in the US for the treatment of wet age-related macular degeneration at a recommended dose of two milligrams administered by intravitreal injection every four weeks or monthly for the first 12 weeks or three months and followed by two milligrams, once every eight weeks or two months thereafter and I’d direct you to the full prescribing information which is available on regeneron.com for important safety information and risks associated with the use of EYLEA.

Okay. Now having gone through that, let’s talk a little bit about the data that we released this morning which is the two year data from our VIEW studies. Just to remind everybody, the VIEW studies were designed to test the hypothesis that every other month dosing of EYLEA, Regeneron’s anti-VEGF product for intravitreal administration, when after a loading dose and then given every other month, could be found to be non inferior in the clinical trial with the gold standard at the time which was Lucentis given a half a milligram every month. Those data, we released about a year ago and those were the basis of our priority review and ultimately approval by the FDA and the study reached its primary endpoint by demonstrating that a similar safety pattern as well as clinically equivalent efficacy with our drug given every other month compared to Lucentis given monthly.

When we designed the trial, we had to figure out well, we needed – we know we needed to follow these patients for longer, to see how they did over time, whether these effects were sustainable and the question is what to do with the patients in the second year? At the time, we didn’t know for sure although we had a high degree of confidence that our every other month would work, but we needed to come up with alternatives, including testing for example, some less frequent dosing such as PRN, because everybody wanted something that could - who was designed in the trial that could relieve the monthly burden. So sort of like a backup plan, if every other month didn’t work, then we’d go to PRN in the second year.

So the study, because of its design has many limitations. Some limitations are that all the primary and secondary endpoints were done at the end of year one, so everything at year two was technically an exploratory endpoint. Second of all, there was no comparison; there was no continuation of the every other month. Everybody switched to PRN. Now the PRN allowed for two things. One is you had to have very careful monthly monitoring. So all the patients were seen monthly and could be treated as frequently as monthly as opposed to what was in the case in the first year of the study where they only could be treated every other month. Being able to be treated every month was based on criteria such as – the standard criteria in these trials, if your vision was getting worse, if you had flu, if you were gaining thickness in your retina, etcetera.

In addition, we – to this PRN regimen, we put in what’s called a capped PRN, which is the minimum number of injections, in this study was three injections a month every three months and just by the time of the trial, that minimum would be three injections. So every group got at least three injections and by trial that was done by a protocol mandated because nobody really knew, there was some feeling that if you didn’t do that that PRN and you can see from other studies, the PRN may not be as good frankly as every other month. So when you look at all the data, now that you understand a little bit about the design, I think it’s safe to say that we are very glad that we set up an every other month regimen the first year and we won on that.

What can we learn from the second year data that we saw in this study? Well first of all, we saw that the visual acuity was sustained, both for the monthly Lucentis group out to the end of the second year, as well as the every other month EYLEA group. They both lost about seven or eight-tenths or nine-tenths of the latter. Some was like that; they lost about the same in fact, almost exactly the same over the course of the second year.

So it looked like we don’t know how they continued on monthly or every other month because there would have been some gain and so PRN certainly didn’t maintain 100%, but it maintained quite a bit of the visual effect and it was certainly sustainable over the second year.

Well then the question becomes, was there any difference in the number of injections that could be – that you needed to maintain the vision? And overall there was a half of an injection less in the EYLEA group than in the Lucentis group. People have asked, what is the p- value? Is it statistically significant etcetera? As I said, because these are exploratory studies, exploratory analysis, because all the primary and secondary endpoints of the trial occurred at the end of a year, you can’t use the words statistically significant, it wouldn’t be proper. But if you look at the p- values, the p- values were extremely small, and so what we call normal p- value was a very small number suggesting that probably those differences were real.

Now where were the differences coming from? It seemed that in the study, those people who needed a lot of injections, there were many more of them who needed a lot of injections in the Lucentis group than in the EYLEA group. For example, the number of patients who needed six or more injections, which would be like more than every other month, was only about 15% to 16% in the EYLEA group and about 26%, 27% in the Lucentis group. So those people who the doctors determined needed more, what I would call the high users if you will, they were almost twice as many of those in Lucentis than there were who needed that high use in EYLEA.

What about the average number of injections? Where did the difference come from? Well, it turns out that if you look at the patients and you will see all these at our upcoming conference, but just to give some flavor for this, if you divide the patients into two groups which is each group in half, those who needed less than the mean number of injections and median number of injections than those who needed more, what you found is that in both groups although slightly more in the EYLEA group had the minimum - about half the people had the minimum number of injections. That was pretty close to half in the EYLEA group, a little less than half in the Lucentis group.

And what did that mean? That meant that those patients would be uninformative for the question of was there a difference in how many injections you needed because some of those patients may have needed two injections, they may have needed one and half on average. Whatever it was, but you couldn’t tell that because they got a minimum number of injections per protocol. But, if you looked at the half and slightly more than half of patients in Lucentis who needed more than the minimum, it turns out that there was a full injection difference. That is an actual one more injection in half the patients was needed in Lucentis group than was needed in the EYLEA group to maintain the visual acuity. And one more injection is we think in that trial is the meaningful number of injections difference and it made sense that the more VEGF blockade demand was, so if you looked in the – not just the top half, you looked in the top quartile, it was almost one and a half injections.

So I think that what you see in this study when you step back is that a drug could be used and should be used as it’s labeled every other month following a loading dose and the data from this trial, once again not in a label and nothing that we can promote on or Genentech can make any comparative statements etcetera, but for the purposes of understanding the scientific data, we can look at this data and see a clear indication that our drug lasted longer as reflected in the fact it needed less injections and in those people who tended to need lots of injections, there were a few of them in the EYLEA group.

Question-and-Answer Session

Moderator

That was helpful. So help us understand why PRN , say for the capped trial because you only had a loading dose or then PRN versus here you have 12 months versus PRN. Is the difference or the better data that we have appear in Lucentis just because you’ve got a full month or 12 months of Lucentis?

Leonard Schleifer

Speculation, you can make a reasonable guess, that’s a reasonable hypothesis. What I am saying is, the PRN is doing so well with Lucentis because they had 12 solid injections before they went to PRN. That’s a possibility. Obviously we did equally well in this study and we had half as many injections overall. Remember we had every other month after the loading dose versus them in every month. The other possibilities is that there is differences from trial to trial, and remember every PRN therapy isn’t well, I think you are going to need less so come in when you think you need it or I think you need it, it’s very careful, arduous monitoring of the patients every month, making them come to the doc, they are getting sophisticated tests. So I think that you could imagine that those criteria could be applied differently from trial to trial and certainly I would imagine wouldn’t be as applied as rigorously out in the practice world as they would be in a trial world.

Moderator

Do you think that doctors will put that in context most PRN data with Lucentis’ outlook over time; it looks like the patient will go blind over time. Will they look at this stage and think any differently of Lucentis or?

Leonard Schleifer

I mean the big question is whether or not – I think you are asking the bigger context is will docs be shift – want to shift over to a regimen that’s not dependent upon a patient showing up every month and getting an assessment and somebody making a decision. And I think that’s what one thing that EYLEA offers, that’s the only drug that’s labeled that can be used less frequently than monthly and still have clinically equivalent efficacy outcome. Clinically equivalent efficacy outcome in a label used less than monthly, it’s the only product that has that. Might doctors get there another way with PRN? I don’t think they can get there without monthly monitoring, I’ll say that, although some people would try treating extent, how are they going to get there? Doctors are going to do what obliviously they think is best for patients, but we are offering them a very, clear cut alternative. It’s labeled, it’s approved, it’s simple, patients don’t have to – they’re not required to show up every month for the monitoring. So I think that is a differentiated product.

Moderator

Do you think though this data will change anyone’s mind on Lucentis less frequently?

Leonard Schleifer

It’s a funny thing. When the CAT data came out, if you talked to people who believed in Avastin, they thought this was the greatest data in the world and it showed that Avastin could be substituted for Lucentis. And if you talk to people who believed in Lucentis, they saw the data and they said what are you talking about? Lucentis was better than Avastin. Avastin didn’t even meet the criteria of non-inferiority when given PRN. So this is really a case where beauty may be in the eyes of the beholder, but I don’t think it’s going to – for sure it’s not going to be binary. This is not a binary outcome for anybody that is – someone is going to say I must do this. I must switch to regimens every other month or I have to continue with PRN. It’s not everybody is going to go that and I think that we would hope that practice would evolve over time to what’s a pretty convenient and straight-forward approach to treating patients.

Moderator

So a couple – several investor questions. One, what was the proportion of patients with absence of fluid in eyes, or tears in each arm.

Leonard Schleifer

Yeah. I don’t have those data for you today but we should have those in the – I can’t remember, hope – we’re presenting this sometime in the early part of next year and those data should be available then.

Moderator

Then this is sort of similar to what we are asking, but they’re asking about the real world significance of this data. This is sort of getting to where I - do you think a 0.5 injection difference will play a different role in the markets? I mean the key question here is when we go to the Retina meeting and we are in the audience …

Leonard Schleifer

How are the dots going to react?

Moderator

What are they going to say?

Leonard Schleifer

Well, think about it this way. If you think about our data, and you say well, 25% of people needed from these data in this study, and you can’t generalize, it hasn’t been approved by the FDA, but in this study, one and half, approximately 1.4 more injections Lucentis and the top half of the people need on average one injection. The problem is that when you start treating a new patient, you don’t know which patients they are. Are they going to be a high requirer or a low requirer? I would imagine – and I don’t know this, that docs who are really committed to the PRN approach would prefer to use a drug that appears to be able to deliver across the spectrum at least in this trial the data that we saw. I would prefer that, if it were up to me, and I don’t dictate practice obviously, but if it were up to us, people would follow the labels and rely on what’s been carefully vetted and carefully tested and reviewed by the FDA and in our case, once again it’s the only label that says you can use it less frequently than monthly and get clinically equivalent efficacy. I think we haven’t – I mean you guys are always a little bit maybe avant-garde. You’re always looking at – what’s the next thing…

Moderator

Crazy.

Leonard Schleifer

.I don’t want to say crazy, you invited me to your conference and I appreciate that, but the truth of the matter is that I read a data that the basis of approval has to be digested, understood and applied. Let alone the data that hasn’t been approved but these data, I think the data in this study surely favored EYLEA as a lone reacting agent in this study.

Moderator

Another question. What proportion – I think you sort of answered this I just want to make sure we have the answer right. How many patients in the EYLEA and Lucentis arm needed protocol mandate minimum injections? Is it about 50%?

Leonard Schleifer

Right. It was very close to 50% for the EYLEA group and somewhat lower than that – I think it was in the neighborhood of about, not quite 20% on a percentage based basis, somewhere in the low 40s, got the minimum with Lucentis. So no matter how we looked at it, how many people got the minimum, how many people needed – if you are at the high end, how many injections you needed, what was the average number of injections across all the patients, cutting the patients in half, there basically seems to be a shift in the requirement for a greater requirement of treatment with Lucentis. When you spread it across an entire trial where about half the patients are uninformative because they are getting the minimum, you only see about a half an injection difference. When you look in the part of the trial where there is a potential to do better, there was a full injection. A full injection in a one year period is a meaningful amount in a clinical trial.

Moderator

That’s helpful. Well, let’s think about the less – the good data with less frequent dosing of EYLEA. Do you think that will influence the real world dosing frequency of EYLEA? You could have after a loading dose, six doses a year, I think we modeled five. What do you think the people – doctors are really going to do?

Leonard Schleifer

Once again, I don’t know the answer to that. I hope, I wish that they would follow the label. Obviously not everybody is going to do it exactly as it’s labeled, but the label offers a very straightforward answer.

You can get on average, the clinically equivalent results that you can get with monthly Lucentis. That’s a pretty powerful statement that the FDA has put in our label and I think you can try and do better by seeing the patients monthly, but I’m not sure what you’d actually accomplish rather than just using the drug the way I think it was recommended for use.

Moderator

Great. Okay, and more questions, a lot of questions from clients.

Leonard Schleifer

Okay.

Moderator

I’m going to wait for that one. That one is on PC SK9; we’ll save that for later.

Leonard Schleifer

Okay.

Moderator

Maybe you can talk a little bit about your initial feedback on the launch of EYLEA.

Leonard Schleifer

Right.

Moderator

What is the initial feedback on the price and what is the initial feedback on sort of your strategy?

Leonard Schleifer

Right. So let’s talk a little bit about the price. We believe that it was possible to deliver a price that was fair to payers…

Moderator

Can you hold on one moment?

Leonard Schleifer

Yes.

Moderator

I think we’re having a problem with the feed. Probably they are going to get me your…

Leonard Schleifer

There’s my…

Moderator

Switch mics.

Leonard Schleifer

I hope we didn’t lose all of that. How is that? Is that a little better?

Moderator

Whoever wrote this on the iPad...

Leonard Schleifer

How is that, better?

Moderator

All right, keep going.

Leonard Schleifer

So, you asked me about price and how the launch is going. So let me talk to you first about the price. I really believe that we tried to find the price that was fair to patients, fair to the healthcare payers and fair to our shareholders, and solving that equation, our normal approach – what I wanted to do is chop the country up into four quadrants and try a whole bunch of prices from very low to right where we were to a little higher to a lot higher to see how it would have worked and would have felt better about it. But you don’t get to do that. You get to price the product and we had to pick a price. The feedback we got was very positive. The key opinion leaders who we work with, they felt that we listened and we did listen to them and they had a big influence on us and the patients and payers and doctors influenced us to price this and so we listened, we did what they asked. We came in somewhat modestly below the per-injection cost of Lucentis.

Of course if you look on a label basis we’re substantially less expensive because you’re talking about not having to do monitoring every month and you’re talking about not having to do injection fees every month and you’re not talking about monthly injections. So we’re less expensive on a per injection basis. We’re less expensive on a use basis comparing label to label. But some people would say well, are you – you’re less good. Is that why you’re less expensive? That’s the old paradigm I think in pharma. Don’t ever come in a little bit lower because people will say that you’re not as good. We don’t believe that. We actually believe that you can come in a little bit lower and still have a product that offers advantages to patients. So of course the proof of the pudding in all this is how the launch going. So I desperately want to…

Moderator

Would you like to go at the first week of sales?

Leonard Schleifer

I desperately want to pay out first six stage of sales volume but nobody around the company thought that was a good idea. But we’ve only had a few selling days obviously, but we’re very pleased on how the launch is going. We’re very pleased on the reception. We’re pleased on the ordering etcetera, but once – we can’t get into anything quantitative until we have some real world experience over a longer time. But I’m very pleased.

Moderator

And has there been any changes with competitive pricing or how has the competition responded to your price point?

Leonard Schleifer

We haven’t heard anything on that front yet.

Moderator

Are you seeing uptake in - initial uptake in any – or any physicians where they get volume based discounts on Lucentis where they are getting more discounts on Lucentis than maybe some…?

Leonard Schleifer

Right, I don’t have that kind of segmentation from seven days of selling, but I can tell you that we don’t see that approach. That approach was not particularly well received. Maybe it meets the legalities and I assume that it does, but the approach of giving volume-based discounts was not well received by this – the retinal community and we wanted to be responsive to that. You can lose goodwill pretty quickly and it takes a lot to earn it. We’d like to earn that and stick with it.

Moderator

Okay. One of the things everyone’s focused on for Regeneron is consensus numbers. And you guys gratefully put out updated consensus number of $100 million for next year roughly. When you think about the market, current sales of Lucentis is about $1.4 billion, $1.5 billion. What percentage of those are really AMD?

Leonard Schleifer

I think the vast majority of those sales are AMD. I don’t have a specific number for you, but certainly the vast majority of AMD and I want to point out by the way, we didn’t put out consensus numbers.

Moderator

Right, compiled.

Leonard Schleifer

They were compiled. You guys asked for it. We don’t stand behind them, they are not our estimates. We’re not going to – don’t interpret that as any guidance from us. Good, better and different.

Moderator

So when you think about what $100 million means, that may be less than 10% of the market. If you looked at Lucentis during the launch, they got to $300 million. What is realistic in this day and age for launches and how much market share?

Leonard Schleifer

Right. So I don’t want to get into quantitative and you can – some people have made the point that if you assume - if every single patient were to go on a branded therapy, it’s a $5 billion market in the United States and maybe somewhat significantly higher than that globally, but obviously that isn’t the case. There’s only $2 billion, but if you just sort of market share points obviously, then each market share point is somewhere in the neighborhood of $50 million in revenues. We’re going to see how we go, but I do want to point out that – just to be a little bit critical of you and your friends on – not you personally but Wall Street that is the notion, I’ve heard this so many times, Len, forget about it, your launch isn’t going to go well. No launches go well. It’s like the industries can - never sold anything and we’re going to show at the launch.

I don’t really pay that much attention to this, but I do want to point out one thing. We are not – we don’t have the burden of launching a product where we have to teach the doctors that we have something that’s worthwhile for their patients. We don’t have to explain to them that the pricing is fair. We’re going to a market where the anti-VEGF may be one of the most important drugs in the entire pharmaceutical industry. And by the way it’s important not only for eye, but it’s obviously important for cancer. And before I forget I just want to mention that – and we may or not get to it – our ZALTRAP which is our cancer product has been filed. We’ve gotten very solid second line colorectal data. We’ve seen the top line data of our first line study which was a small underpowered study, but we were able to see – we saw what we expected in terms of the same kinds of side effects when you combine with FOLFOX6, there’s no statistical differences in the outcome in the small study.

But we’re enthusiastic about moving forward in second line colorectal. We’re looking forward to getting the data from our prostate study which should be coming up in the first part of next year and we really would like to advance in anti-VEGF therapy and cancer because in the eye, anti-VEGF therapy is damn good. There’s no doubt about it and this is the Holy Grail. As a physician, if you can take a patient who can’t read and you can make them read, that’s giving sight to the blind. That’s a great space to be in but and I want to come back to that. Of course the cancer outcomes are not so great. You talk about does it really matter another month or two of living? Well, yes, it matters, it matters a lot to a lot of people. But on the other hand wouldn’t it be great if we can do a lot better than that and we’ve got some ideas that with our partner sanofi where we think that if we can combine our drug with some of our other anti-angiogenic agents, whether it be ANG2 or Dll4, we might be able to push the efficacy bosses, the anti-VEGF therapy or anti anti-angiogenic therapy in cancer can do more akin to what in cancer patients as it maybe surely does for eye patients.

Now, coming back to the eye patients, I’d have to say that we’re not trying to create a market here. The market exists. We’re not trying to justify even the price because we’ve come in lower based on the total number of injections you need and even on the price per injection. So what we have to do is we have to go out and sell our label. We have to convince docs that there’s – that yes, great spaces - there’s a multibillion dollar space here. We’re offering an important alternative and here is an alternative. Look at the label, look at the comparative studies in our label and you decide with your patients, have the conversation with your patients. Would you rather use Lucentis the way it’s used on the label, monthly, or would you rather use something that you don’t have to come in about every other month? And imagine if you’re a patient or you’re taking your elderly parent in, for sure I think that there will be people. For sure there are people who will find that an important differentiating factor. Are we going to get 100% of the market? I don’t think so. Will we get our fair share? I believe so.

Moderator

Okay. I guess those of you who are listening to the webcast and didn’t hear what Leonard said earlier, about half the patients needed probably around one more injection with Lucentis versus EYLEA.

Leonard Schleifer

So just to rephrase that very quickly if it wasn’t – didn’t come through in the webcast. Let me say it again. If you look at the study there was a minimum effect, so about half the patients on EYLEA, just a hair under 50% and just a little bit over 40% on Lucentis, required the minimum number of injections. But if you divided the patients into the median for each group, what you found is that those patients in the lower number of injections, you couldn’t do any better because you had a minimum number of injections. But those patients in the top half, you actually did a full injection better. One full injection better and if you looked at the more demanding ones, it was 1.4 injections better. So it’s clear that this data and this study indicate that Lucentis required more treatment, more intense treatment than EYLEA did, and so that was good. We didn’t design the study to exactly test all this. Once again if you didn’t hear it it’s not in the label and we suggest and recommend that you follow the label if you’re out there listening because we really believe that we have a well differentiated label that can make a difference.

Moderator

So going to that point of there are some patients who need a lot of injections. The Retina meeting last year there was a lot of talk about some people getting Lucentis twice a month even. What is the percentage of patients in the real world who really are not responding to on label Lucentis very well, need a lot more injections?

Leonard Schleifer

Right. Well, on label Lucentis – that’s…

Moderator

I know. Those are two questions there. On label with…

Leonard Schleifer

Yes, so two questions, on label Lucentis, most people do – the vast majority of people seem to do quite well and we can get clinically equivalent efficacy with every other month injection compared to on label. Now, off label use, which I’m not a believer in and I’m not a promoter of, certainly not in our product and nor Genentech’s products, I would say that in our trial those people who needed more than – needed six or more injections which would be basically more than every other month, was a full quarter of the patients on Lucentis, 26% or 27% and only about 16%, so, nearly half as many on EYLEA needed more than that six month injection. So I think what that says is, (inaudible) it kind of says we’ve got the study right in the first year and we did – our scientists did a really good job of picking what is the right interval and it seems to be every other month after loading dose as is in our label.

Moderator

Do you think it may be 10% of the patients that are not responding ideally to (inaudible) or doctors having trouble, is the vision (inaudible)?

Leonard Schleifer

I don’t know the answer to that. I can only tell you from our study there were 25% of patients, 27% of patients who were requiring more then, more than every other month therapy.

Moderator

Okay. Do you have any - does anyone have any questions in the audience on EYLEA before I turn quickly to the antibody business? To turn to the antibody business, the part of the business that people are not very focused on and there’s debate about like how much value you can assign now. When do you think people are going to get the antibody business? And the issue really comes from a lack of news flows. I get your PC SK9, that’s still in Phase 2, you’re a long way away from Pjhase3.

Leonard Schleifer

I’ve seen Phase 2 assets recently valued pretty highly in our industry.

Moderator

That’s true.

Leonard Schleifer

And so – but let’s talk a little bit about PC SK9 and why we’re excited about it and then let’s talk about the relationship overall with sanofi. Maybe I’ll start with the latter. Remember we have a very broad based relationship with sanofi and what that involves is about $160 million a year in discovery funding as well as funding for the development of our antibody pipeline to those molecules that they opt into. What’s important about that? Well if you’re a new company and all you had was EYLEA, you’d have to spend an awful lot of money to build the pipeline, an awful lot of money, and you’d eat up all your profits pretty damn quickly if you were doing anything close to what we’re doing, except we don’t eat up our profits because we’ve got this partnership with sanofi that leverages us and provides us all these resources. It allows us to keep just a little under 50% of the profit split with sanofi.

So that’s one thing that I think people – you say maybe people get it or they don’t get it. I think they will get it when they start to see how much we can continue to spend on the pipeline on one hand, but not have to eat up all the profits which we’ve worked so hard to deliver we hope to our shareholders with EYLEA for example. Now, what’s in that pipeline? Let’s talk about there’s a lot of things in there. I mentioned ANG2, potentially anti-ANG2, anti-Dll4 and there’s anti-IL-4 receptor. There’s a number of molecules in there, but let’s talk about PC SK9 because PC SK9 may be viewed as the most exciting one. But mind you, these things change and that’s the beauty of having a half a dozen or so of these things and constantly adding more that are percolating through.

PC SK9 is probably one of the hottest targets in biotech. There are a lot of big companies that are going after it. There’s Amgen for sure has got announced program, there’s Pfizer and there’s probably others. Best we can tell, sanofi and Regeneron appear to be in the lead. We’ve already announced that got a little bit lost in our – while people were waiting for EYLEA to be approved, nobody paid as much attention I think as they should have to the fact that our PC SK9 phase two data were rather – I thought were rather exciting. We had two studies, one was in heterozygous patients, with heterozygous familial hypercholesterolemia and the other was in patients who were already on a dose of statin and they could be changed to a higher dose of statin or a higher dose plus our drug and the bottom line of all this, when you add it all up, on top of high dose statins, you can still get with an injection, an infrequent injection of our product, you can still get another 65% lowering approximately of LDL, the bad cholesterol.

No other product class I’m aware of can come close to that. Certainly there’s any – none of these products can deliver and in fact, even if you go from 10 to 80 of LIPITOR you get another 17% or 20% or something of that nature. We’re talking about a 65% lowering. That’s a very meaningful, large amount of lowering and it means that we can start to get people towards a goal that they have never been able to get to with current treatments available. That’s very exciting. Obviously that’s why we’re at it, that’s why the competition is at it. It’s a big space. There’s probably 10 million people in the United States or thereabouts who can’t get to their goal with currently available therapy. So I would encourage people to look at this a little bit more carefully.

Moderator

I think we’re actually out of time.

Leonard Schleifer

Well, we can’t be out of time. We’ve got six more programs that we…

Moderator

I know. I know. I don’t think (inaudible).

Leonard Schleifer

If you invite us back next year we can continue this conversation. Thank you very much.

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Source: Regeneron Pharmaceuticals' CEO Presents at the 2011 Deutsche Bank BioFEST - Conference Call Transcript
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