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Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA)

Deutsche Bank BioFEST Conference Call

December 2, 2013 4:35 pm ET

Executives

Craig A. Wheeler – President and Chief Executive Officer

Analysts

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

All right, good afternoon. Thank you all for joining us today. Next we have Momenta Pharmaceuticals. And with us we have Craig Wheeler, the CEO of Momenta. My name is Robyn Karnauskas; I’m one of the biotech analysts here at Deutsche Bank. I was commenting to Craig ahead of the call, but there is so little that you can talk about until Copaxone is approved and we know what their – officially what their biosimilars are, but I feel bad that we keep asking him the same question, so I’ll try to come up with some different ones.

Craig A. Wheeler

I’ll try to answer it slightly differently, okay.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Just answer them slightly differently. So as a reminder Momenta, while they do have a generic Copaxone, they also have a global collaboration with Baxter to develop six biosimilar products. We don’t know what those products are, but I assume we will once they start to go into the clinic.

I guess we’ll first talk about generic Copaxone. That's what everyone asks about first. So how – I guess going back to Lovenox, remind me how soon post clarity at the appeals court of the Lovenox patent situation did the FDA approve on Enoxaparin, because they are prioritizing applications based on…

Craig A. Wheeler

Yes, well they are. I mean I should talk a bit about how they are prioritizing the applications. So the FDA in trying to work off the backlog that they have now 5000 products backlog in the opposite generic drug at this point in time, have worked with the industry to try to prioritize the applications that they are going to review first, as they are working off the new – under the new GDUFA guidelines. But we are in that category of products that they are working on first.

So they are looking at paragraph fours, paragraph threes that have not yet had products approved, age, drugs and drug shortages. So we are in no drugs approved in the paragraph four and the first product to file against an agent. So we are definitely in the priority review for them. That's a small subset of the 5000 with a couple of 100 products, and that's good news, I mean they are paying attention to the product and reviewing it.

In this situation, where they are working towards, they have stated that they are working towards for not just our product, but all products looking at when the patent expirations are. So they track internal to the agency Orange book patents, expiration of Orange book patent and try to prioritize agents ahead of that, so they can actually get products into the marketplace when they would hope to have them launched after patent expiration. So that’s all good news, they are prioritizing us into the category and we know they are prioritizing based upon patent dates.

Beyond that, it’s very hard to speculate. They’re not really thinking about where there are vis-à-vis appeals court, et cetera, there really – the appeals process was not an Orange book patent. It was on a – so that wasn’t really something that FDA was concerned about. So we’re kind of in that cycle now of these complete responses and hoping they can get them completed in an urgent enough manner that we can actually get approved by when patterns expire.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Got it, okay. How is the discussion around generic Copaxone changed over the years at the FDA?

Craig A. Wheeler

Well, I mean, the main thing that changed is, they have moved from a regime of trying to figure how they are going to review this complex application to getting through and understanding the application, so that they really understand what they are looking at and what we filed. When we first filed it, the FDA actually had gotten to hire people in Bioinformatics and computers to actually understand some of the analytics we have done, they had to bring in experts on polymers and now to a point they are really in the rhythm of understanding what there are. And that’s how dialogues changed, I mean when we started, it was really explaining what Copaxone was, I mean now they really execute on that.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. And then how do we think, I mean, the Lovenox generic – and Enoxaparin launch was spectacular by Sandoz. How do we think about a generic launch in the MS market, what are the different challenges that Sandoz will face?

Craig A. Wheeler

Well, it’s quite a different product, because it’s a chronic used product and it’s marketed into a very specialty group and unlike Lovenox. So, I would expect there is going to be a more tempered ramp; it’s not going to be all of a sudden you have 40% market share. I think the maximum sizes of the market in terms of penetration can be very similar to Lovenox, but patients are chronic use, they are going to have longer-term prescriptions here, so it’s going to take longer to change them over, there are some step that may need to be put in place [indiscernible] especially pharmacies and those types of things.

But the demand pressure for generic in the MS space is very, very strong. So what we are seeing out there and when we talk to payors or pharmacy benefit managers, is a strong, strong desire to see this products in the market as soon as possible, because they have no generics anywhere in the MS space. So they have no ability to manage costs in the MS marketplace. And so they look at this as something where there is a huge opportunity for us. I think that will encourage more rapid turnover.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Do you think that payors will immediately put in – step at it where you basically are making a point try one drug or put in rules to make a point try the cheap Copaxone over Interferon or at least…

Craig A. Wheeler

Well, I mean I think what they will probably do is just watch the market a little bit first to see how the AB rating does in terms of substitution, but if they are not getting substitution that way, and then I think they would be pretty quick to pull the trigger on it, because if you think about like for example, PBM, the way they get paid is how they can reduce cost of pharmacy for their customers, they have a benefit manager and so it’s not the pharmacy, it’s a benefit manager piece of it. And so they’ll use the tools they have, so they can actually up their compensations. So they’ll play to that strength of being able to edit or drive – also negotiate with the brand of course, but they’ll try to do whatever they can to drive shifts.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Do you think they will shifts in front of interferon, like they’ll make a doctor choose the cheap Copaxone if they were…

Craig A. Wheeler

Well, that’s a really good question, I think the…

Robyn Karnauskas – Deutsche Bank Securities, Inc.

You are doing asset before.

Craig A. Wheeler

No we’ve asset that way before, oh good. I actually think that there is a chance that the Copaxone market can be expanded by the launch of a generic here, because there are no generics, this will be the only generic in the marketplace for all MS and because Copaxone is used as a first-line product, and it will be – all the products, the orals as well as the injectables of all price up to the $50,000 to $60,000 a year level for patients. There is a first chance that they had to begin to manage that.

and so you could see encouragement’s on formularies to try apply people to Copaxone first, since it’s already a successful first-line agent before they try any of the newer agents. I’m not sure that’s going to be prevalent, but I would not be surprised to see some people trying to do that which actually would increase the usage versus some of the other products like the interferon that are out there.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

I mean versus Tecfidera might be more challenging since the date it’s differentiated.

Craig A. Wheeler

It should be more challenging versus Tecfidera, yes.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. But typically, step at it’s – I mean it’s about what’s that is rate, those occur – do you think that will occur very quickly, if they don’t have…

Craig A. Wheeler

If they don’t see the substitution at AB, because that step out is required on the formularies…

Robyn Karnauskas – Deutsche Bank Securities, Inc.

But even if you have an AB rating, like cant you still put them in front of interferon as well?

Craig A. Wheeler

They may, they may. Yes.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay but that would happen pretty quickly I assume.

Craig A. Wheeler

I think so.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. Do you think this is a new product or a switch product like the generic Copaxone?

Craig A. Wheeler

I think it’s certainly going to be fastest in the new prescriptions. But I think once use gets going, it will be also a switch product just because of the economics of it.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Because I know it’s not a biosimilar, but I was at a biosimilar conference, they were saying that they may be able to put – step at it and place some – to make new patients try the drug first, but existing patients, they may have less power over. Is that true for Copaxone?

Craig A. Wheeler

Well, it’s questionable it’s going to come through step edits or it’s going to come from differentiated co-pays, right. So remember many of these patients out there are paying thousands of dollars a year out of their own pocket for the drugs, which is very a big hardship, even with Teva’s prescription assistant. And so if you start putting those economic pressures on something, which is an AB rated equivalent product, you may see a lot of pressures from the doctors and the patients especially as well.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

And how quickly can Sandoz launch, given that that you need a sales force, you don’t know when this whole thing is going to happen?

Craig A. Wheeler

So we can’t disclose specific market preparations, but sufficed to say we will be ready to launch, our goal is to ready to launch when we are finished.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. So like waiting around basically.

Craig A. Wheeler

Well, yes.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay, all right.

Craig A. Wheeler

I go deeper, I’m starting to review.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay, any other questions Copaxone? I thought we would switch to biosimilars, so I did this on a conference recently on biosimilars and there was a lot of – I thought it was interesting, there was emphasis by the payers on manufacturing credibility versus price points, saying that they would prioritize only, but one or two brands or biosimilar brands on a formulary and pick them and they put Pfizer and Amgen at the top, Sandoz wasn’t mentioned or Momenta wasn’t mentioned. I guess what are your thoughts on that as far as I guess Samsung and Biogen wasn’t mentioned as far as top of the list?

Craig A. Wheeler

So, I’m curious.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

What do you think it will take to educate people or do you think that payors will understand that having Momenta behind it...

Craig A. Wheeler

So I can tell you we have had to spend a fair amount of time out there talking with payors as well, we find that there is a strong interest in the characterization technology, there is a strong noticing with the highest quality products are in the marketplace. I think if you go to – I don’t say uninformed, but a group of people that are not necessarily thinking about biosimilars and the companies that are competing there, they will probably go to the companies like Amgen they know that make biologics, but I don’t think that’s the way P&T committees – formularies are going to make their decision.

They are going to look at the packages that are presented P&T committees usually require presentation, the quality of the products, not certainly the quality of the brands. And I think for us Baxter is a tremendously strong brand in this marketplace and knows these formularies quite well, as you know. So I don’t really take much at this point in time from how people are beginning to prioritize impressions because it is so early days in biosimilars.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

And you are speaking to sort of higher standard to structural characterization and you’ve talked about maybe that may reduce the clinical work required for approval, but how do you think it will be reflected in FDA approval or in a label?

Craig A. Wheeler

Well, so I think our approach – let me just correct you now, our approach is more than just structural characterization. I mean we think we bring competitive advantages in a number of places, but mostly around the quality of the molecule, right. And that characterization allows us to understand the structures and the brands with internet knowledge. It allows us to look at cell lines that we’re developing and choose a cell line that has the ability, genetic ability to make the attributes we want in the brand and then it allows us to prove in great detail that we’ve made the same thing and reduced physical uncertainties.

So the package is more than just characterization package, its really a set of tools that allow us to reverse engineer and develop a product that actually should be very, very close if not identical to the innovators and then it give us a characterization power on the bioside as well as the physical side to reduce the uncertainties that the regulators are seeing. So we hope through that it will give us the opportunity to both reduce clinical trials and hopefully achieve interchangeability on a faster path than other competitors.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

If you don’t get interchangeability though, you maybe left with two competitors, one with a massive package, maybe you have a smaller package, but maybe the data look similar on paper. So is there any other way – how else will your characterization would be reflected in the label, at that point will there be an advantage of…

Craig A. Wheeler

If we’re not an interchangeable product then it would probably not be reflected in the label.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

So one of the things at this conference I attended, they were talking about four interchangeabilities that will probably require multiple switching back and forth between the brands once or twice. And that there is some incentive, but incentive isn’t enough for a lot of people to do those studies, could you remind us what the incentive is for it?

Craig A. Wheeler

Well I mean certainly if you listen to the owners of the brand products, they’re suggesting that you would need to do multiple, multiple switches in every indication that ever got approved. I mean if you listen to what the FDA is saying, they are interested in understanding the potential for immunogenic activity if there are switches. But they haven’t started saying use of multiple switches; in fact they haven’t even said it has to be trialed. Right they’re looking for ways of looking at information that we’ve stated these lines have different immunogenic profiles. Right. So we would hope that we could actually use if not in the trial through looking at ex vivo data from human subjects or other models that we’re going to be able to tell and reduce the risk on that.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. All right so M293, we don’t know...

Craig A. Wheeler

923.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

923, sorry. We don’t really know on what this is theoretically. How important is it to be a first to market by biosimilar? Will it just be theoretically about generic – I’m bringing it up because Amgen has one and there is going to be multiple ones, how important is it and how – what advantage do you have if you are first-to-market and…

Craig A. Wheeler

So we think it’s important to be first-to-market because of how we think the market is going to evolve here. So I personally believe that this market will evolve relatively rapidly in the U.S. Its going to be a slow, slow adoption that you’ve seen in many of the countries in the Europe, because of the payor pressure and the controls that we have a here with shift share that they don’t have in Europe. And even in Europe where they do have those at the government level, you have seen pretty rapid shifts and launches of programs like equal in England and Germany.

So let’s assume we’re going to use those tools. Being in the first wave allows you to get on the contracts to be able to get in substation – and substation on the formulary level even if you are not interchangeable. If you are interchangeable on that first wave and the others aren’t that’s a big advantage. Right because as you can have lower cost, you can get AB rating, you can get easier substitutability with the brand, you can reduce the uncertainty that many of the biosimilars are going to have between how they look versus the brand really.

However, if you are late to the party, if you or an interchangeable product that’s say three years late, or you are even different you’re a biosimilar product that’s three years late late, it’s not going to be – you are not going to capture that high economic rents there and the early days of marketplace is going to be hard.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. Remind me – so what is the minimum development criteria, you talked a lot about that?

Craig A. Wheeler

So for us in our Baxter deal we have for each of our product after our first product, we have three different milestones. And the first one is minimum development criteria. And we haven’t given the specifics of it, but that’s basically when the products has been developed to a point where we have got the cell line, we’ve scaled that to a point where we’ve mixed products and we can say that product is close enough to the original, that it’s really something we want take forward into the full development scale.

So once we’ve reached that scale that’s when Baxter makes a choice of opting in and pay for milestone. And they have to choose or not. I’m – so we have our first milestone of products, but think of it its a few million dollars for us not a lot to develop with MDC and once they’ve opted in on that first payment then we enter the really expensive phase which is kind of a process development, scale up phase of development. The next two milestones come pretty much simultaneously; one is IND and the other is having the validated supply chain scaled up to be able to supply the clinics, they both come at the same time, and one is a scale up milestone and one is entering the clinic milestone.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. And at what point will we learn about what these products are, I assume, when they go in clinical trials…

Craig A. Wheeler

So our goal in our discussions with Baxter is to reveal these programs when we go into the clinic. We have to make a joint decision with them. They have p12 [ph] right we have to disclose names on these products. They for, good reason, are thinking about when do they want to reveal to competitors, how do they want to think about potential legal – seeing up legal actions those types of things where that’s they will be keeping at little close to their best. Our logic is okay, so if we’re going to wait when we go into the clinic we might as well disclose it, it appears we’re going to be recruiting patients and so that gives a good chance to talk about it which is why I say next year for 923 we will be able to talk about it.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. What about for the other two products…

Craig A. Wheeler

Well, I think it’s going to – we’re going to have to wait and see how the competitive landscape shapes up. And certainly when they get to the clinic, but if we feel with our partner Baxter that it looks like there is really not much of a disadvantage from disclosing it now, we would do it, because obviously for Momenta it’s a benefit for us to disclose the name, you guys can begin to think about what’s in the pipeline.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. Is it possible for us to know all three of those next year?

Craig A. Wheeler

It’s certainly possible.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Possibility, is it likely?

Craig A. Wheeler

It’s probably not likely.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

What about by the end of 2015?

Craig A. Wheeler

Yes, more likely.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. Orphan antibody biosimilars pros and cons of going – developing biosimilars in orphan – in an orphan space?

Craig A. Wheeler

Well, we are thinking hard about where we go as a company beyond the Baxter relationship, right. And so we have six products with them, everything else is in our space. When you think about where we’ll be once Baxter – we put six Baxter programs, so we will have development engine which basically will be able to put in the new products every six to nine months, right so that’s a pretty high throughput, so we can put through. So we would like to use that.

And so we are starting to think through what categories of products we might look at. I think orphan products are not terribly different from the other products expect that tend to be smaller and the question is what’s the competition going to be like in space. So if you are in a pace with fewer competitors also pretty nice products to go after and so we are going to have make those judgments based upon, where we are at the time when we can pick up products outside of the Baxter partnership.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Is orphan more sticky though and will insurance companies or payor would be less likely to put in co-pay benefits for the patient?

Craig A. Wheeler

I don’t think so, because I think those are among the highest priced products as any products in the pharmaceutical industry. So and it certainly deserved the explicit that they have, but once the patents are gone then I don’t why they would be anymore sticky than the generic product.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

On the Baxter agreement, when Baxter was choosing the products that wants to – was there a restriction or like a restriction or an interest in certain products over certain threshold, like at this conference that we are talk anything about 2 billion is like high…

Craig A. Wheeler

So obviously bigger products are more interesting to a larger company like Baxter, but they are much more sophisticated in their choosing of the products, they think about therapeutic area, they think about IP, they think about competitive landscape and they think with us on the technical side of things, where do we have a competitive advantage scientifically to be able to go after these products. So there is a pretty complex algorithm, they think therapeutically where they want to be and choose products probably more preferentially where they want to be therapeutically, but I think its more than just thresholds, but they are going to choose a lot of products, I think is fair assumption.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

For an authorized biosimilar, you mentioned on the last call that you did on – that you don’t see it likely for Teva, but what about others, I mean do you think anyone might be – do you think authorized biosimilars will exist at some point?

Craig A. Wheeler

I think authorized biosimilars are more likely to exist when pricing starts to get more generic like, I think the pricing of the early products is at least where most people are strategically trying to get is going to be within a range of getting share, we’re not being too far below the brands. So there it doesn’t make sense to launch another competitors, if the prices start to collapse like in a generic market price then I think you will see people thinking about authorized generics to be able capture some of that while keeping a high priced brand.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay.

Craig A. Wheeler

They don’t think early on.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Are there any question in the audience?

Question-and-Answer Session

Unidentified Analyst

[Question Inaudible]

Craig A. Wheeler

Yes, so you know the – I mean it’s always a question we get and I do know the folks at Mylan well, but here is the calculus I do right, they are probably a year and half after us. So that should give us an advantage of getting through the process first. And they maybe able to catch-up some, because we are kind of blazed in the trial right, so that’s number one.

Number two, they license the product from Natco. Natco is a company in India who had been marketing a product in India for quite some time. I believe Teva had already analyzed Natco’s Indian product and so it was different. So they had some work to do to get that product into shape for the U.S.

Third point is that at least historically Mylan has not been known as a heavy chemistry analytic company, I mean the capabilities that our company has built around. So they didn’t start with core capabilities that we have used like for five years at the FDA. So all of that when I added up, it should give us the advantage in terms of being first approved, and potential of getting a reasonable amount of exclusivity before they are able to get their product approved. So that’s how I do the calculus, and I think they just have a higher amount to climb, because of their starting point than where we are starting from.

Unidentified Analyst

[Question Inaudible].

Craig A. Wheeler

So anybody can file any physician’s petition they want, but I would agree with you, it’s pretty hard to launch a set of petition against a product where you don’t you know what the product is, so something I could think about.

Unidentified Analyst

[Question Inaudible].

Robyn Karnauskas – Deutsche Bank Securities, Inc.

How much better do you think COGS are with biosimilars versus the brand?

Craig A. Wheeler

How much better? That’s a big question. It depends – some of our strategy is to try to use the original cell lines that the innovators used or close to them, so we can get closer to the structures, but those cell lines are older cell lines, and so we are – for us and unlikely they have dramatically higher yields than the innovators compound happen, so I don’t think our COGS are going to be much better structured wise than their COGS.

There are companies out there that are trying to make biosimilars with a newer cell lines and higher yields and the cell lines you here people talking about five grams per liter. Those cell lines will produce a lower cost product, because of their higher yield, they are much more difficult to make the same product with, because what happens with anything you try to boost the yield of protein is you try to – you are pushing out the product much more quickly and therefore it tends to actually change the glycosylation structures on the molecules, because they can’t – the cell doesn’t have enough time to fully construct the glycans on them, so it’s one harder one to actually figure the same.

So they would probably have a COGS example, they may have a harder time saying, using the path where they are saying that they are equivalent. The other thing to keep in mind is that these drugs are injectable drugs, and so a very high and particularly for some of these antibodies that you don’t have to use a high volume, these drugs – COGS are highly driven by the cost of the syringe, the cost of the filling the sterile package and all that stuff and so you could have quite a range of yields at the drug substance stage, but the drug product costs is still dominating, so you can still be competitive.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. So just a big picture, does that really come down to the payers. It’s really all the biosimilar uptick will really just come down to payers on what day?

Craig A. Wheeler

I think it comes down to payers and I think it’s also going to come down to the physician patient community. So I will give you an example, just an anecdotal example right. If you talk about oncology, in today’s oncology market, most of the oncology products are dealt with under the medical benefit, they are not yet dealt with under the pharmacy benefit. So they are in the capitation, and hospitals are finding it very difficult to offer some of these expensive therapies through their – in their capitation program through their clinics, in fact we were talking with an institution here in Boston who is pulling back products from their remote – their satellite clinics, because they were losing money on prescribing them.

So in that kind of environment you create a strong incentive from a patient benefit and from a physician profit and a hospital profit to use these products, just like on the pharmacy side, when you are dealing with the patients and they have a high co-pays they should have incentives as well. So I think pharmacies have more tools at their advantage to ship large volumes, but I think you will see pressures particularly once these products start getting used and people get comfortable with them, coming from patients with high co-pays and physicians – their physicians as well as from medical plans that are trying to manage capitation.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay interesting. I guess lastly 402 also results second half of next year, maybe you can remind us of a studies design anything on top of Abraxane and gemcitabine versus gemcitabine and Abraxane alone. What data would result in a go forward decision like how much of the delta do you think is…

Craig A. Wheeler

Well, so right now we are in dose escalations, right. So now we are looking to see if we have a safe dose that gets enough drugs on target. So, we may see some light signals, but I don’t anticipate getting signals out of Phase I oncology trials, right. So, having done many of those [indiscernible] by Phase I data that I think it’s a good thing to actually pick a dose, but beyond that I wouldn’t, so we maybe able to get some directional data, but I would say already we’re at a dose level we’re feeling pretty good about the molecule.

All right we’re at dose level now where we are several fold higher against targets than up in itself would be which is the design of the product, and there is indications that we can continue to escalate the dose. So we are already in place where we feel pretty good and if we can continued escalate that does, we are getting higher and higher concentration on target in an area where there is already circumstantial that happens with low – its going to be for the targets to benefits. So, I would say we’re feeling pretty good that we will be able to get to dose that we are comfortable taking forward next year based on that.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

And are you comfortable funding that program?

Craig A. Wheeler

Yes. Absolutely I mean I think the for oncology components today I think you need to get to the proof of concept to get value for them and so we are going to certainly be funding that Phase II or part B of Phase I, II trial and who knows if we are successful with Copaxone biosimilars that might be a great product for us to take forward and commercial results we are about to see.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Excellent. Any other questions, I guess, I’ll ask one last one on Copaxone. How do you feel about giving guidance, say if the drug would be approved, what are your thought on guidance?

Craig A. Wheeler

On guidance in terms of means revenues?

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Yes. So, say it’s approved today.

Craig A. Wheeler

After what happen with the not so current…

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Yes, after what happened with the not current, how are you feeling about helping us to understand?

Craig A. Wheeler

So here is – I don’t feel terribly comfortable giving specific guidance, but let me give you framework for how I’m thinking about it.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay.

Craig A. Wheeler

So, assume we’re going to get approved, we’re going to be – its going to be Teva or us, or Teva, us and Mylan, I’m hoping its Teva and us that has a good reason to think about that. So the people out there Sandoz, Teva and Mylan are all very sophisticated generic competitors, that’s very different than the Enox play, power play, so if we get out there you are going to see Teva is going have to feature [ph] if they don’t, they are going to know that the competitors are going to drop price on them.

And just on the same side of it, you are going see companies like Mylan and Sandoz trying to calculate not to be too greedy, because otherwise they will force Teva down. So I think there is a much greater chance that you’ll see a more traditional two or three player markets here, which means you’ll see as if there is a single player 20% to 25% discount from the brand and if there is a multiplayer – two player markets plus the brand 30% to 35% maybe a little bit more discount from the brand.

I think unlikely Teva is going to launch authorized generic here, because particularly they have the three times per week and so you’ll see that market eventually evolve to a place where you’re seeing the market equivalent maybe 40/30, 30 or 60/40 or something like that eventually overtime, so if you put those numbers and assume those discounts you can come to a pretty good idea where it could get to. So that’s how we are thinking about the market today, it’s going to be a slow ramp-up than Enoxaparin.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. Got it.

Craig A. Wheeler

Good.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

All right. Thank you very much.

Craig A. Wheeler

Thank you.

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Source: Momenta Pharmaceuticals' CEO Presents at Deutsche Bank BioFEST Conference (Transcript)
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