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Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN)

Morgan Stanley Global Healthcare Conference Call

September 9, 2013 2:25 pm ET

Executives

Michael Aberman – Vice President of Strategy and Investor Relations

Analysts

David Friedman – Morgan Stanley & Co. LLC

David Friedman – Morgan Stanley & Co. LLC

All right, thanks everyone for joining us today, Dave Friedman, biotech analyst and joined on stage here by Michael Aberman VP of Strategy from Regeneron Pharmaceuticals, we’d love for this to be as interactive as possible. So please everyone feel free to raise your hand then we can make sure you get a microphone and get your question asked. So thanks so much for joining us. And maybe for those who aren’t familiar if you can just give a couple of minute overview of the Company and the sort of the key takeaways as people just think about Regeneron overall as an organization.

Michael Aberman

Sure. First of all thank you for inviting me. It’s always my pleasure to come back to this conference. As some of you may know I started my, early in my career at Morgan Stanley as a biotech analyst, so it has a special place in my heart. So thank you for having me.

I may make forward-looking statements. So through this if I do, please know that there are risks associated with those and you can look at our SEC filings for more details on the risks and uncertainties around those.

So Regeneron, it’s been a great few years for us. Our CEO liked to joke that we have been an overnight success after 25 overnights, because obviously the Company was started quite a while ago and is finally enjoying some of the success that the Company thought would come a lot earlier when you marry really strong science and stick to that conviction of strong science to deliver better medicines.

One thing the Company has done well from beginning is that science and it stuck through that and as a result now, really what’d be considered our first real transformative blockbuster product EYLEA, a drug for wet age-related macular degeneration as well as other types of blinding diseases, Wet AMD being the leading cause of blindness absolutely in the developed world, which we expect to do $1.3 billion to $1.35 billion in sales this year.

Really that’s transformed the Company in many ways, however it wasn’t the first product we got-to-market. We also have a drug for rare disease, ARCALYST for CAPS, which is a rare disease and it is less in terms of sales, but that was the first step we had towards building a really fully integrated company all the way from research through the commercialization, manufacturing, every step along the way and as many of you know, we’ve always invested in our technologies and our pipeline and that has been a core focus of the Company.

As a result, we are able to get some of really the industry best partnership deals. Probably the one that stands out the most for us is our collaboration with Sanofi for our antibody platform, although it’s for lot more than just that. That program allows us and gives us the resources – has given us the resources to have right behind our product that are in market.

Again, EYLEA for wet age-related macular degeneration and other blind diseases. ZALTRAP for cancer which is partnered with Sanofi globally and ARCALYST I just mentioned, the antibody platform right behind that has multiple more than 10, 12 antibodies in development, three of which are in late stage, two in Phase III, our PCSK9 antibody which I’m sure will talk about that target lowering blood cholesterol or the bad cholesterol. Sarilumab our program for rheumatoid arthritis that targets IL-6 receptor and Dupilumab which targets IL-4 and IL–13 pathway in allegoric disease which we are developing for asthma, atopic dermatitis and potentially other allegoric diseases.

So we are trying to do something that happens every once in a generation for the biopharmaceuticals industry which is to really become a company that can develop over and over multiple drugs that make a difference for patients and we’re hopefully well on the way to doing that. So with that long-winded, I’ll further of the questions.

David Friedman – Morgan Stanley & Co. LLC

And so maybe if you can just give sort of with one broad question which is EYLEA and PCSK9 and Sarilumab. I thought IL-6R drug and ZALTRAP those are likely or are in markets where you are not the only player with that mechanism and so in general the world are praising for spaces that have more than one drug is getting tricky that has mostly been on the pill side of things and we see it in diabetes and then we see it in inhalers.

Have you guys gotten a sense that those types of formulary pressures are coming for biologics and given that you have a couple of drugs where if that were to be true, you would have to think about that, how are you thinking about development programs and marketing programs that protect you from that and that can pullout that sort of differentiating aspects of the drug?

Michael Aberman

It’s a great question and absolutely is not just a pill issue. I think value in drugs is an important issue for everyone in this industry whether you are in the company, you’re a patient, you are physician, you are an investor and this is something that we grapple with and think about on a regular basis.

So it certainly, if you look in our products, our EYLEA as an example, we took that into consideration when we priced EYLEA and while that Phase III program show that we could have clinically equivalent efficacy at less frequent dosing and the traditional markers told you for equal value you could price it on a per injection base at higher, we want to do something a little different, which was look, we have what we believe to be a better drug, but priced at a way that it’s also less expensive for injection. So it’s always on our mind and so we think pricing to value is going to be incredibly important. I think some of our other products we will have to think about that as well.

So I think pharmaceuticals still create tremendous amount of value for patients and I think are appropriately thought of it and reimbursed and EYLEA is an example in VEGF space in general, you are talking about taking patients who would be loosing vision without therapy and gaining vision and our company, I am a physician, our CEO, our Chief Scientific Officer, majority of our Board are physician scientists, National Academy of Science members, there is three Noble Laurels.

I say that in part to brag about the scientific expertise we have in situ, but also we worry about these same issues, our Chairman of our Board, Roy Vagelos has been very outspoken and he is someone who may have spoken about publicly the value pricing is important and something that we think is important. That doesn’t mean that pharmaceuticals and innovation shouldn’t be valued, it should it’s a question of pricing them appropriately.

David Friedman - Morgan Stanley & Co. LLC

So maybe if we jump right into EYLEA and you guys are fairly showed nice and rapid uptick, so can you just give a picture of where you are in the AMD space in terms of market share and what are some of the dynamics that you guys are seeing that have allowed you to grow in both the U.S. and in Europe with your partner?

Michael Aberman

Sure. So we’ve been on the market in U.S. for north around six quarters and we did see really adoption that surprised us well as the market in terms of its rapid adoption and in part we initially thought our main advantage is this less frequent dosing, which was in our label and that was the main goal of our development program to show that you can get clinically equivalent efficacies with less frequent dosing.

The anecdotes however once we came out with physicians we are using this in their heart to treat patients sort of the second line. However there is lot of patients that despite using the previous or the other branded or the off label Avastin and the other being Ranibizumab Lucentis by Roche and Genentech in U.S., south of the U.S. You could do well if you switch them to EYLEA and that gave us a really big boost in terms of the perception of EYLEA as a drug that has the ability not only to be given less frequently as per label but also it was used anecdotally better in those patients. So we saw quiet a bit of adoption.

Right now in the U.S., the markets is roughly split between the branded therapies and off label cancer drug Avastin that’s used in the eye and within the branded market we’re splitting that roughly 50-50. We think there is room to continue to grow in both markets obviously one of the concerns with the off label Avastin is that it’s produced by compounding pharmacies that have been under scrutiny as a result of really what is one of the biggest drug catastrophes that has happened in the U.S. in terms of 100’s of patients contaminated with a fungally contaminated injections into the spine that led to meningitis and dozens of deaths and there is legislation going through working it’s way through to try to regulate these compounding pharmacies.

Outside the U.S. we are just getting started. We are only a couple few quarters in. As many of you know, we roll out on a country-by-country basis in terms of reimbursement in Europe. We’ve improved in Japan, Australia, more than 20 plus countries but as that continues to roll out with our partner Bayer, where we have a 50–50 profit split on sales outside the U.S., they are doing a great job and we are looking forward. But if I can go any further, so we’ve got growth potential in the AMD market. We also have growth potential outside the U.S. where we intent obviously the launch is just getting underway.

I think the other big move for EYLEA is new indication. We have recently released data for diabetic macular edema and we will be presenting those data, September 27 in the U.S., at the Retina Society Meeting in Beverly Hills. I believe at the same we will presenting it in the European Retina Society Meeting, in Europe. And the top line data has come out and we’ve also shown efficacy at both the every month dosing and the every other month dosing with a safety profile. Again you have – that looks very good.

So from a competitive standpoint, again we’re looking to hopefully expand into the diabetic macro edema market. One of the big news that came from that is traditionally there has been requirement for two year efficacy endpoint by the FDA regulators, in Europe they have been one year, after extensive discussions with the FDA, we are going to be filing with a one year data in the U.S.

So again EYLEA is almost a pipeline within a product we’ve got AMD in the U.S. geographic expansion, diabetic macular edema hopefully coming soon. We’ve got central retinal vein occlusion already approved in the U.S. and Europe, just more recently in Europe, and then branch retinal vein occlusion is another indication where we expect data later this year. So EYLEA has been a great success story thus far and we hope to continue that growth.

So as you think about these markets AMD, CRVO, DME, and then branch retinal vein occlusion, how do you sort of organize them in terms of size?

Michael Aberman

Well, clearly AMG has been the largest market where the branded therapies are selling globally on run rate 4 plus billion dollars and when you combine EYLEA and Lucentis globally and then when you look that there is still market being sold in Avastin. The retinal vein inclusion both branch and central retinal vein occlusion are smaller indications, but important for patients and for a company, so we don’t think only in terms of market size, we obviously – it is all important. Obviously, however diabetic macular edema is the next indication where we think it has the potential to be as large as the wet AMD market.

The reason being is a) diabetes is an epidemic and it is increasing the portion of patients with diabetic macular edema continues in those patients and these patients are younger than the AMD patients, represent more on their 50s than in their 70s et cetera with wet AMD 70s and 80s. So we think they are going to be on therapy for a long time.

David Friedman - Morgan Stanley & Co. LLC

Is there anything different about either your understanding of the data or the market dynamics that should suggest that your performance in AMD would be different, either better or worse in diabetic macular edema?

Michael Aberman

With the data relatively fresh, but there is no reason for us to think that we won’t do just as well in diabetic macular edema where again we were able to show that every other month dosing look just as good as it will be monthly or monthly. In this particular trial, the comparator was laser knife Lucentis because it’s worth an approved, but that is very favorable. In addition, there was some concern whether or not we will see any systemic toxicities or signal which we haven’t seen to-date with the one year data the full data will be shown shortly in a medical conference as I mentioned, but we think there continues to be a higher medical need in that population and we are looking forward to that as well.

David Friedman – Morgan Stanley & Co. LLC

And then just in term of the U.S. versus Europe, is there a difference in behavior around either I guess AMD or DME in terms of the frequency with which people are getting shocks or anything else around the dynamics of the patients that would make you think that you would do better or worse the same in Europe as you’ve done in the U.S.?

Michael Aberman

Well, we certainly are hoping that Bayer does just as well not better and so far so good in terms of how they’re doing. There are differences on a country-by-country basis, broadly speaking some countries Japan and Australia for example Avastin is not used off label there are some countries in Europe where it’s the same.

In addition, the labels are slightly different in Europe than in the U.S. and the practices are more centrally based in Europe. We believe that there is probably reasons on both sides of the coin, but one other reasons where we might do better is the potential of there is some under dosing in Europe due to label constrains. So that would mean having a more potent, [indiscernible] and they can last longer might lead to physicians feeling more comfortable. So there is reasons to believe we could do well. I’m sure there is reasons that Novartis hopefully won’t do as well, but so far so good.

David Friedman – Morgan Stanley & Co. LLC

Any questions? Okay, and then after these sort of four indications I guess that we’ve talked about are there others that are relevant at all for this drug or is this what you’ll be sort of working for a while?

Michael Aberman

So, in terms of the eye pain, there is another disease called Myopic CNV that’s more common in Asian countries and there is a trial there. So that’s something that we will be filing outside the U.S. as well, but the eye franchise is critically important to us, so we do look towards what else is happening in the marketplace towards competitors in our own pipeline.

I should mention everything we do thus far has all come from our own research laboratories, let’s not just say we won’t look externally and don’t look externally we do, but it’s just again as the measure not a scientific strength and we have two pipeline products that we hope to combine with. EYLEA 1 is targeting the PDGF and the two other angiogenesis pathways which we hope to be filed in 90s for one or both by year end, so getting in the clinic.

The anti-VEGF is an huge advance. We are not finished there. We think this like the innovation to continue to happen in the eye space, but in terms of the diseases that’s hit the main ones.

David Friedman – Morgan Stanley & Co. LLC

And in terms of those new drugs, when is a reasonable timeframe to see proof-of-concept in them?

Michael Aberman

Well, as you probably know there is potential proof-of-concept for the PDGF from a Phase 2 trial from a competitor. I’d say potential because in this disease we’ve seen in our own trials that variations in letters gained, three, four letters gain can have even within the same trial design. So for example, in our wet AMD trials, we had two trials, the VIEW 1 and the VIEW 2 trial and one of those trials are two milligrams every monthly arm, well statistically significantly better than we send monthly.

In the next trial, identically design is actually not as good, still met the non-inferiority endpoint, but the variation was about four letters and this other trial was relatively right sized for a Phase 2 trial that showed a four letter difference and that what’s given us our interest in moving forward, our own PDGF molecule, so we are looking forward to seeing whether that replicates in multiple trails.

In terms of ANG2 and the net PDGF, in terms of ANG2 we have a lot of preclinical data that suggest synergy with the VEGF blockade. We are very excited about that. We are developing that in combination with ZALTRAP our oncology drug for that blockade VEGF and that’s our in combination trial and we are looking to do again clinic for eye indication as I mentioned filing the IND's by year end.

David Friedman – Morgan Stanley & Co. LLC

Any last questions on EYLEA?

David Friedman – Morgan Stanley & Co. LLC

So maybe if we can move on to your PCSK9 program, if you can just give a quick overview of what you’ve shown to date that’s gotten you excited. You are running a large phase III program. When do we start to see some data?

Michael Aberman

Sure, so PCSK9 is a really important protein that helps regulate the LDL Receptor. The receptor on liver cell that’s critically important to regulating the level of the bad cholesterol in your body. And it was first learned when we looked at, when we say that collectively scientists look at patients who had mutations in their PCSK9 protein and if you didn’t have PCSK9 or less PCSK9 you actually had lower LDL or bad cholesterol and fewer cardiovascular events.

So there was a big race on to find drugs that can block the PCSK9. We were and are in the lead in terms of having an antibody that blocks PCSK9 and lowers LDL cholesterol. Amgen is either caught up with us or right around with us in terms of their program that’s also an antibody blocking PCSK9 and leaves others behind. Both ourselves and Amgen have shown that blocking PCSK9 can lower LDL on top of the statin, so if you’re already on the statin by as much as 60% to 70%.

So a real major reduction in LDL, there hasn’t been seen since then, but to do this in top of statins is very meaningful and just in terms of the market, there is over 10 million patients in the U.S. alone, who aren’t statins yet haven’t to – are unable to achieve their LDL goals, and there is a view that lower is better and we obviously share that view with our company.

We have in addition to scientist who discovered the role of LDL receptor, probably that just brought the first statin et cetera. So we have a lot of expertise and interest in this space, and so think this is a big breakthrough.

We have a large Phase 3 program underway as they mentioned over 22,000 patients, a big junk of that is in OUTCOMES trial, about 18,000 patients but this 4,000 patients plus in our main LDL lowering trials that we’re going to be using for our initial approval.

So looking to get our first data from that just later this year, the first trial will be a small piece of the puzzle, it’s 100 patient trial called the ODYSSEY MONO trial, unlike the majority of our trials which are on top of statins this is one of the trials that we have that’s going to look at whether or not monotherapy will work. In fact we know from our Phase 1 data as well as our competitors’ Phase 2 data in the setting where you have monotherapy, that monotherapy in PCSK9 can lower the LDL in the 40% to 50% range, so we’re looking forward to seeing the Phase 3 data there.

How our strategy, our protocol, the way we are testing the drug as with – it was called an up titration approach, we start with a 75 milligram dose every two weeks, and if you don’t reach pre-specify targets you go up to a higher 150 milligram dose, so I will also want to see in this particular patient population, we expect the majority will stay on that 75 milligram dose that we’re looking forward to seeing those data later this year. The overall package most of the lot of this data – and most of this data will be coming in 2014, we should expect to see similar data or data from our competitor. So 2014, we expect to hear a lot from PCSK9 program.

We hope to have our initial launch by end of 2015, global roll out in 2016. So again this is an area where unlike some of those that you mentioned, we’re really in the lead or neck and neck with the competitor with a novel mechanism that we think really can make a difference to patients, remember cardiovascular disease despite the availability of Statins remains the leading cause of morbidity and mortality in a developed world, so…

David Friedman – Morgan Stanley & Co. LLC

In terms of the outcome study, how important you guys view that as sort of driving uptake of the drug, but also potentially differentiating yours versus competitors?

Michael Aberman

I think there is probably more similarities than they are differences. And the end of the day, the both antibodies that block an important protein there is difference presentations or different dosing, there’s slightly different trial designed and approaches. In terms of the OUTCOMES trial, we think it’s very important to show outcomes. We don’t think it’s necessary for approval, most of our members of our scientific advisory committees and our board and will have you feel very strongly as well as the FDA that LDL is a valid circuit. So LDL predicts outcome and that remains the case.

So there is a very large number of physicians who subscribe to this dogma that lowering LDL is better and that will translate the outcomes, and our first initial approval will come, certainly five will come on LDL. However it’s important to have the outcomes sometimes there after in fact, as you said before the FDA has required that our OUTCOMES trial substantially underway, it’s a reflection of wanting to further validate that circuit once again. So there certainly will be some physicians who want to wait for the OUTCOMES trial and we’ll say, look I want to see the outcomes before I prescribe. So it’s important, it’s underway and it’s part of the program.

Unidentified Analyst

[indiscernible]

Michael Aberman

The question was around safety concerns, in any other sort of issues or concerns that the drug is being moving along?

Yeah, that’s a great question. I mean it’s very nice to have a drug in Phase 3 where you can have some degree of high level of confidence and efficacy based on what you’ve seen in Phase 1 and 2 program particularly with multiple companies going after the same target. Obviously Phase 3, part of that is doing larger patients for longer time looking for safety. We haven’t seen a signal that gives us any pause or any big concern.

There was recently some open label extension data from a competitor which further gives us comfort, although full data weren’t presented and will be presented later and that was the Phase 2 open label extension. But between us and our competitors there have been lots and thousands of patients that have already been treated. Nothing has really popped out, antibodies have the benefit of being very selective, but like you said that’s, lots of way to receive Phase 3, but so far as good.

Unidentified Analyst

[indiscernible]

Michael Aberman

And I am not sure what you’re referring to yes, but a PPT test, in terms of – yeah, so this drug doesn’t – is asking whether is there any immunologic effect of blocking PCSK9. It’s an antibody. So this particular antibody should not have any untoward effect on down regulating the immune system, because it’s the PCSK9 that it targets, doesn’t have a major impact on immunology, so there shouldn’t be an issue, again Phase 3 testing it will clear.

Unidentified Analyst

And in terms of the addressable market you sort of mentioned 10 million plus patients on statins but not a goal. What are the reasons that people are not getting to goal and is this a scenario where the presence of sort of a second line drug pushes people to do better on their first line and is that 10 release, six and a solid six or 12?

Michael Aberman

It’s a great question. I mean, to what extend have those 10 million patients are some of them not at goal or what the portion are from non-compliance versus other reasons, and is this going to force people. I think there is no question that stands our tremendous plan, they are generic, in expensive and we are not looking to displace them, but there are – what percent are non-compliant, I don’t have a precise number nor do I think anyone does, but I think there is clearly unmet need. There is also 1.5 million patients who don’t tolerate that. To some extent, they maybe some portion that are relatively intolerant, maybe you can take 20 or 40 of the [indiscernible]. It’s doesn’t get you there, when you get to 80, you get the muscle weaknesses that are associated with higher doses. So it’s impossible to know.

The other question we often get is, well, is it injectable? Who is going to want to take an injectable for a asymptomatic disease. Look, not everyone is going to want to do this, but if you have a family history and then a high risk and you had a heart attack and you on your Statins and your not at goal, you’re really motivated. It’s hard to predict exactly what percent are going to get there, but we know there is a high unmet medical need because those patients aren’t getting to goal.

We know that we can offer tremendous advance in terms of the amount of cholesterol lower we can get. I think some, and we’re going to do it in very patient friendly manner, easy to use self injectable auto injector, every two weeks. We’ve also recently started the trial for those patients who might prefer every weeks, we are going to do that presentation as well. So we do think this is going to be a sizable market opportunity.

Unidentified Analyst

[indiscernible]

Michael Aberman

So he was asking whether or not Amgen’s product is also injectable and we want to say relative merits. Again, I think there will be some similarities than difference, it’s also injectable. They focus a lot other program on every four weeks, and we believe that look to be the higher volume of injection, and in every two weeks we focus more in every two weeks, easy to use volume injecting but they probably have a different view on that, you have to ask them.

Certainly we think we are going to be competitive and it’s also an important because we think this is a market where we welcome to having a competitor. We think there is room for more than one player so we definitely belief that it’s going to education for physicians and patients whether the market is 50:50, 60:40, 70:30, 30:70 time will tell, but I would say in either of those cases, I think both – we’ll both be aware. So we also are partner with Sanofi. Sanofi has had one of the cardiovascular franchise with Plavix [ph]. They sell more injectables than anybody with Lantus. A lot of the patients that we’re going after unfortunate loss on diabetes definitely put them in high risk cardiovascular disease.

So we think we have a great partner, a great drug candidate, a great presentation and we welcome the competition. We think it means more patients will be getting PCSK9 inhibitor and getting better cholesterols.

Unidentified Analyst

I’m sorry. How is the drug going to be priced because one of the issues with the compliance is affordability?

Michael Aberman

So the question on pricing again like I said before, we think it’s important to price on a value basis. It’s too early for us to talk about pricing in specifics. But we are aware of those concerns. We certainly are not looking to displace generic statins which have an important role and they can be $0.01 today. We are certainly not going to be able to price at $0.01 today, the development program for each of these programs are in the billion dollar range. Especially, when you think of OUTCOMES and so, but we think there will be a price that we think we’ll able to get the value for that payers as well as patients and physicians will look at and say that’s fair pricing and value. It all depend on outcome of the data and et cetera.

David Friedman – Morgan Stanley & Co. LLC

Michael, I’m just curious, let me push to the other direction. Victoza costs $4,500 a year and has yet has not demonstrated outcome benefit on cardiovascular events, if this thing really reduces cardiovascular events by perhaps 50% in a select population wouldn’t the price north of $4,500 a year would be justifiable?

Michael Aberman

I’m still not going to specifics on pricing. But we’ll have an internal debate and it’s a good point. The reality is we think that this is going to have a meaningful difference. We are doing an OUTCOMES trial and patients who had a recent coronary syndrome and acute coronary syndrome are not able to get to their goal on statins.

This is a group that’s high unmet medical needs and our goal is to lower their LDL cholesterol by 50% to 70%. The data show historically that you lower that level, you are going to get a significant reduction outcomes. That’s going to be meaningful and so again that goes to the value pricing.

So we want to price this on the appropriate level, so that people can look at this and say, look they have had a big advance, this is priced fairly. That doesn’t mean inexpensive and it doesn’t mean super expensive, it means fair.

David Friedman – Morgan Stanley & Co. LLC

Any last, there is one question in the back.

Unidentified Analyst

Yeah, I guess the same topic, but just go back and look at performance attribution for EYLEA, you talk about value pricing, but doesn’t know is the lot of the uptick in the share was because the anecdotal, there is a certain select patients that did better in. When you go back and look now and then sort of analyze why you got the share you outperformed what you thought and what most people thought. How much have to do with the value pricing versus the anecdotal? So when you think about future pricing decisions, did you leave some on the table here because maybe just, have you guys looked at this at all or anything like that?

Michael Aberman

Yeah, I mean it’s a good question about pricing. Again the question is, can the pharmaceutical industry afford to leave some on the table for giving good value pricing, and we are not a single product company. We were looking to innovate and do well by doing good, we are not opportunistic [ph] we’re shareholders, but it’s hard to know. We think we have priced it right and we hope we continue to do that and that generate goodwill from patients and physicians, and payers. At the same time, we don’t want to underprice and not price the value that we are providing to patients. It’s hard to go back and know what exactly could we have priced it higher and done just as well.

Unfortunately the retrospect go doesn’t work that well, we are going to try to do this well going forward and do well by our investors by continuing to innovate bringing novel Medicare drugs to the market and pricing them in a way that we get a good return at the same time fair justice to the payers et cetera.

So I think…

Michael Aberman

I think we got it. Thanks very much…

David Friedman – Morgan Stanley & Co. LLC

Thank you every body for this great time.

Michael Aberman

…for the time and thanks everyone for coming.

Question-and-Answer Session

[No Q&A session for this event]

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