Biotech Values

[jbog]

ROBYN KARNAUSKAS, ANALYST, DEUTSCHE BANK: Great. Well, thank you very much for coming in so early in the morning. I do appreciate it. Got a very full day today. So we're going to try to keep everything on track so my name's Robin Karnauskas. I'm the DB analyst, the biotech analyst here. And to kick it off this morning we have Momenta Pharmaceuticals. We have Craig Wheeler and Rick Shea. Craig is the CEO and Rick is the CFO.
And they've had a very big year with approval of the first complex, complex -- I call it a biologic, but it's not really, a complex drug. And it's sort of really started a huge discussion along, among I thing pharma and biotech investors as far as whether or not biosimilars and what other drugs can come to market in 2011. So with that, I'm going to kick it off, and I guess I'm going to start off with -- go through first [capacitor] and then talk a little bit about your biosimilar program. So the number one question I get of course is when is Teva's generic Lovenox going to get approved, or what is my opinion is that?

CRAIG WHEELER, CEO, MOMENTA PHARMACEUTICALS, INC.: Hopefully a long way out.

ROBYN KARNAUSKAS: Right. So I was just wondering -- I know you guys can't say too much. You don't know what Teva's doing. But can you just explain your thoughts on their rationale for why they, you know, they claim that they were delayed by a month in filing, and still yet they have not been approved? What are your thoughts on that?

CRAIG WHEELER: Well, obviously I can't have any direct insight into what their interactions with the FDA are. That's really Teva's business, and we don't have good clarity into that. But it is interesting to kind of track what Teva has been saying over -- it's not just at -- since we got approved, but since before we've been approved. But most notably, when we were approved, and that -- you've referred to it as they came out and said well, we filed our immunogenicity a month after Momenta, so we must be a month behind them. Well, that month came and went, and now -- and then they said they hoped to be approved soon. And now they've said they will be disappointed if they're not approved by the end of the year.

So I think that's more investor relations and how they're talking. But you have to begin to piece apart, what are they really facing at the FDA? I mean, we've obviously faced a very torturous task; so have they. But they're making this point, that they're dealing with immunogenicity. And let's go back and review the facts on immunogenicity. Immunogenicity was asked, of all of the applicants in the pool in 2007 -- and were asked to determine the potential for immunogenicity of our product -- the same question was asked of everybody. We talked about it with our investors.
And they -- those of you who were in the stock, remember the challenge that we had with our stock when that was announced. But everybody got that same letter. We pursued that, where we actually filed a briefing book to the FDA thing, here's how we would approach analyzing immunogenicity, and that was filed in the spring of 2008, followed by a set of discussions with the FDA where we completed that analysis and actually submitted our response to those questions in September of 2008. So we actually submitted that, and we were basically clear of that. And we indicated to the street we were, sometime in 2009. Kinds of things that we actually dealt with in the last year of our application were really around our supply chain, reinspection of the Chinese heparin supplies, and not around immunogenicity.

That's what we were dealing with. And we were I think very transparent with the inspections that were going on and what was happening there. Now you could go back and say, they got the letter at the same time as us, so why are they still dealing with it? Well, that's only speculation, but I'll tell you at least how I do the math. There's three possible things. The first is, they're having trouble with assaying immunogenicity. Now, I agree that this is very complex, to do immunogenicity analysis of a drug like this.

But it is not rocket science, in the fact that it's well established; people have immunogenicity assays. And I actually give Teva a lot of credit. I would say, by this point in time, I doubt that they're having any problems with the assays to be able to check immunogenicity. So then you go back and say, well, what, if it's not the assays, what could be holding them up? Why are they so far behind on it? And I come back and I say, it's one of two things. The first is -- and you go back to the questions that were asked -- if there's innate immunogenicity in the product? Heparin is (inaudible) cytopenia for heparins.
And basically we had to show that we were not inducing immunogenicity that was different from Lovenox's. If they're having that problem, they have a problem with the product, if they're actually having variability vis--vis Lovenox. The second thing that we were asked is to look at potential contaminants -- you know, cellular contaminants, foreign DNA, foreign proteins that could come through in the purification process that also can be potentially immunogenic.
And if they're having that problem, then they have a supply chain problem. So immunogenicity is not, is not just what we're discussing -- immunogenicity. It really comes down to, where's the problem? Is it a product problem or is it a supply chain problem? And both of those are complex problems. They've even there a long while, so I can't, I can't foresee when they will resolve those. But it's much more than a discussion, I would say, if they're still working on immunogenicity.

ROBYN KARNAUSKAS: Now, and is it fair from my perspective, when I think of a supply chain and I think of a two-year fix at least? Or is it, say if it's a product problem, that may take a shorter time to fix? But still, it's a significant problem. Therefore thinking about timelines, a lot of investors are thinking, you know, how do I think about timeline for a potential generic approval? They may be longer than what investors (inaudible - multiple speakers)?

CRAIG WHEELER: It certainly could be. It really depends on what the problem is. But for example, if you take a product problem and say that we're having problems with, in having a product that reliably does, has the same immunogenic profile, that points back to you have to have a manufacturing process that you understand and be able to control in the same way. That could be a short fix.
It's more likely to be, you're going to have really revamp how you do your controls and your process and how you actually understand your product. On a supply chain, where you're actually sourcing and you're actually getting contamination through, well, is that a, is that a purification issue? Is it a, is it a -- you're sourcing from the wrong suppliers? Those types of things also can be long or short to try to resolve. But they're all involved types of things if you have to actually go back and open it up that can impact everything from your inventory that you have available to launch to your ability to actually reliably supply the product, et cetera. So, and again, not knowing what their issues are, I can't predict that. But it could be a pretty broad range of things.

ROBYN KARNAUSKAS: Okay. And then just one last question on generic Lovenox. I know the street is very focused on this. But really, it's not really the -- there's a lot of other stuff going on in the company. They just sort of view it as sort of a, a big event and a reason why people are skeptical about owning the stock or not owning the stock. Can you just give us some sense of, of I mean -- obviously the launch has gone very, very well. I mean, so what do you see as far as pricing? I know that you came in at a discount, and the brand lowered their pricing. Are we seeing any changes in the marketplace for the generic launch? Are we seeing any changes for pricing? Because theoretically they -- the brand -- shouldn't have really lowered their price if you were only, had 30% market, ability to go to 30% of the market.

CRAIG WHEELER: Yes. Well, first let's talk about the launch. When we launched the product we said we were able to slide between a 35% and 40% share of the market.

ROBYN KARNAUSKAS: Yes.

CRAIG WHEELER: We have incrementally improved that since the launch. And I think you'll see that in some of the market data that you look at. But not significantly. So we've actually added some supply. And that's basically on the supply -- [chance] we have on the overall supply chain. In the marketplace, we're not talking about specific pricing that we're see -- you know, we're doing out there. But if you look at how pricing has behaved, it's actually been relatively stable since we launched it. Different classes -- this is typical in generic -- different classes will have different price points.

ROBYN KARNAUSKAS: Yes.

CRAIG WHEELER: But we're not seeing any -- I would, what I would call irrational pricing behavior. And I think that's, that is because I think that the competitors realize that there are supply issues that really allow them to make sure they can behave more rationally in the pricing arena.

ROBYN KARNAUSKAS: And the patents lawsuits now versus Teva.

CRAIG WHEELER: Yes.

ROBYN KARNAUSKAS: They have a new patent. So how do you see that playing out, impacting a potential Teva launch?

CRAIG WHEELER: Well, it's really up to the courts to decide how that plays out in impacting the launch. What we look at is, we've developed -- and I've said this over the years as we were trying to get this approved -- whenever we work on a program like this, because we're developing new technology to be able to characterize it and understand these drugs and be able to reverse engineer manufacture them, as we built these into manufacturing and into release, we actually build those -- IP around this. So think of it -- you know, and I always like to say, Lovenox is not a biologic; it's an A&D drug.

ROBYN KARNAUSKAS: Right.

CRAIG WHEELER: But this is actually similar to biologics, is that the controls that we put into manufacturing and releasing the product are very similar to what protects biologics. And so we understand how that works, and therefore understand what you have to do to be able to control that process and build that in to reverse engineer it. So we've always said we intended to try to defend that Of course, when we saw the FDA's Citizens' Petition Response, I was in one way thrilled, in one way very concerned.
I was thrilled that they actually took advantage of our technology and approved a drug. And, business the other side of it is that there are many things buried in that petition. There are clearly -- are things that we own patents to, and therefore want to protect. So when we looked at that and saw that they were expecting those around manufacturing controls and release standards, and that Teva was out there saying, we're now manufacturing inventory for launch, it created an opportunity for us to actually assert those patents.
And so that's this process. In that process, you know, as you would in anything where you've actually said, we're looking for damages; we're looking at the potential for an injunction, et cetera -- whether and how those things play out clearly depends on the court process, the discovery process, and all those types of things that will now kick off based upon the filing of the lawsuit.

ROBYN KARNAUSKAS: And so when we were talking right after the CP was released, in response to CP, you mentioned process controls. I remember this sticking out in my mind as something. And then I was in marketing in Europe, and a lot of people were like, who else has process -- the ability to put process controls in place when they are developing or reverse engineering a biologic? And what are your views on your ability to do that, the importance of that? Do the brands have process controls in place right now when they're making their drugs?

CRAIG WHEELER: Yes, well, in any process you have process controls in place. But let's first start talking about how we do it in the brand, and in the brand in a complex product where, you know -- and this is where in biologics you always hear, it's a black box and the process is the product -- if you've heard those words -- the way the brand industry -- and I ran a brand industry business as well before I came here, and we also are in the brand business here; there's no drugs launched yet, but -- because you couldn't tell everything that was in it, what you did is you actually put a lot of controls around your process to run your process exactly the same way every time.
And those controls, because "the product was a process," allowed you to make sure you had the same product coming out. So process controls are always there. The difference is, when you're trying to reverse engineer a product, you know, we have to go much deeper in understanding it. And then we actually have to build our own controls in to make sure that we are manufacturing that product within the band width of the [iminator]. But we can't have all the nuances and details of understanding of the processes, because many of those are trade secrets.
So we actually have to go back and reverse engineer. Once we reverse engineer, to make sure that we run our process consistently, we have to take those analytics that we use to understand it and apply them to control that process, to be able to make sure that we don't run a reaction too far, to be able to make sure that our feed stocks are the right feed stocks, to be able to make sure that when we actually bring things forward to the product that we've actually made sure we manufactured the right criteria in the drug. So everybody has process analytics. The process analytics necessary to reverse engineer or make a complex product like this are actually I think a level of -- well, at a level of insight above what you would normally do to put a drug in place because of what we're trying to do.

ROBYN KARNAUSKAS: Okay. I have a question for Rick, so he doesn't feel left out. So number one, how does it feel to have cash on your balance sheet? And number two, the recent financing -- can you just give some color around the use of cash?

RICK SHEA, SVP, CFO, MOMENTA PHARMACEUTICALS, INC.: Well, we took a view of cash -- yes, it's nice to have cash in biotech in general. And we're taking a longer view of what our cash requirements are. You know, we look around at the biotech landscape, and what we want to do is we want to be assured that we can push our programs forward beyond generic Lovenox. So we still need to get generic Copaxone to market. We want to push forward follow on biologics, that's a key area for us. And hopefully we'll be getting M402 into the clinics sometime next year.
All of these will pay cash. And we just want to make sure we have that runway to continue to move those programs forward adequately. And as Craig said, we don't have any particular insight or transparency into Teva's discussions with the FDA. Though certainly from a finance point of view I have to take the conservative position with respect to when that might happen. Even though operationally we're pedal for the metal and trying to maximize the commercial success of our generic Lovenox product.

ROBYN KARNAUSKAS: So and -- then quickly moving to Copaxone, and then we'll get back to what you were talking about with biosimilars. So -- and this is probably for a lot of Teva investors listening on the call -- so for generic Copaxone, we think about generic Copaxone -- and Craig and I spent some time talking a little bit about the manufacturing -- if you're accepted at the FDA -- and I know some people have not been accepted at the FDA for their filing for generic Copaxone -- what does that tell you about your application versus another application?

CRAIG WHEELER: Well, I think it's worth going back and looking at the process when we actually filed Copaxone. You know, we filed the drug, and it took us -- sorry -- six months to actually have the FDA accept that drug. So we filed it in December of 2007. 2008 in July is when we found out that we actually were accepted. That's a long time for somebody to take to accept a generic application. So in retrospect, we found out that what was happening is there were discussions at the FDA. There were discussions between the New Drugs Division and the Generic Division to say, is this is a generic?
Can we characterize this as a generic or should we take it through the J pathway? So the nice thing about it is, they made that decision explicitly before they took this drug into the J pathway. Now that's different if you remember when Enoxaparin, we had that debate all the way through [Enox]. Are they going to push it to B2 or are they going to keep it as a 505j? So they made a cross-divisional decision that this is a 505j application. So we think that's very positive for us. And then that was obviously on the strength of the application that they were able to make that decision.

ROBYN KARNAUSKAS: Okay. And next step. So if you are required to do a clinical study, even in healthy volunteers, what are you going to communicate to the street? Or what -- what exactly would come out of FDA discussions that you would feel is necessary to convey to the street, and what things would you not tell us regarding the generic Copaxone?

CRAIG WHEELER: Well, that's hard to say, a priori, because you don't know what the FDA is going to tell you. But I think if we're in a situation where we have to do a significant trial, we would absolutely have to come and tell the street. I guess the way we're doing this is, we're judging our communications all the time just like we did with Lovenox. And I think we did -- you know, you guys are the judge of that -- but I think we did a pretty good job of determining when to come to the street on Lovenox.
When we came out with immunogenicity we came out with Chinese inspections, et cetera. So the things that actually take it out of kind of the normal course are things which we came to the street and talked about. And I would expect we would use that same logic here, if it's materially different from the expectations of the pathway, I think we would come out and talk about it.

ROBYN KARNAUSKAS: And then, lastly, the number one question I get in Copaxone -- and I've asked you this before -- so most people believe that you need to have a test like with Lovenox to actually prove bioequivalent.

CRAIG WHEELER: Yes.

ROBYN KARNAUSKAS: If you were required to come up with a test for Copaxone, would you be able to do so? Is that something that you thought of when you were coming, going in front of the FDA?

CRAIG WHEELER: Well, we thought about that a lot. And I think it's clear from the CP that Teva put in earlier this week that they've thought about it a lot as well. And so there's -- Teva, Tea actually put in their third citizens' petition on Copaxone this week. And it puts some new twists in, but it's more of the same. But the premise has been, if you look at Enoxaparin, you know, 10A and 2A, if you look at Copaxone, well, we don't have those surrogate markers for Copaxone.

And if you look at their recent petition, you look at Peptamen's petition that was put in, there are a lot of markers that can tell biologically what's happening with this drug. Those are new markers, blood markers, et cetera, antibodies. And so people always go back and say, well, both 10A and 2A tell you what the efficacy of Lovenox is. And I want to say, patently that is not true. Right? 10A and 2A activities tell you the activity of the molecule. They do not directly correlate to efficacy. If you look at an Enoxaparin molecule, you know, it has [night] activity; it has [ancuticity] activity.

There are many factors that influence the coagulation. And you actually -- it's been shown -- you can actually have similar 10A and 2A ratios and have different coagulation parameters. So you're looking for an indication of similar biologic activity that's not sufficient, right, it's not sufficient. You also have to be able to show that you can actually have identity characterization, which is what Enoxaparin shows, which is what we show in [Copaxone]. But we believe it is eminently doable.
And I think, in fact, if you look at the latest citizen's petition, where before everybody said you can't measure this stuff, and that was exactly a quote -- you can't measure this stuff, can't understand it -- and the latest, you have Teva putting in eight ways of doing it, commenting on all these other things, saying, yes, you can measure it. And in fact, they go as far as saying, and look, if we make something different, it shows different measurements than this; but that doesn't matter, you can't use these anyway. You have to do full pivotal, two pivotal efficacy trials; you can't use MRI end points.
And so, I find it a curious argument for a company that is actually working to try to get Enoxaparin approved, to try to say that it's so different, when many of the same principles actually hold for approval of Copaxone. I think it is fair to say these are not going to be the same criteria as Enoxaparin. It's a very different drug. Those criteria are going to be different. But they're very doable.

ROBYN KARNAUSKAS: And regarding that -- so if you're required to do clinical trials, number one, would you be willing to do them? And number two, do you think there are going to be multiple entrants? If you're the only entrant, it's still a good revenue opportunity for you.

CRAIG WHEELER: Well, so, clinical trials is a pretty broad category. So I can't answer definitively.

ROBYN KARNAUSKAS: Beyond healthy volunteer study.

CRAIG WHEELER: So, but what are you talking about here? You're talking about switching studies? Are you talking about efficacy studies?

ROBYN KARNAUSKAS: I have no idea.

CRAIG WHEELER: That's the point, that's the point, right? So, so if, if clinical trials were going to be required here, through the J pathway, I believe they would be trials that would have to have the analytic and characterization package in combination with whatever data you generated, whether it be from human studies or animal studies, in combination, that would allow that approval.

ROBYN KARNAUSKAS: Okay.

CRAIG WHEELER: And so I think it's still a very viable pathway, if we were asked to do this kind of thing. Because you actually have to have the characterization. You have to know that you're making a product that's the same.

ROBYN KARNAUSKAS: Are there any questions from the audience regarding these two products, before you go to biosimilars? Okay, so then on the biosimilar pathway. So Sandoz and Teva are both now starting a lot of biologic clinical trials in Europe. And there's a big focus in Europe on biologics, generic biologics or biosimilars -- however you want to call them. So what are your thoughts on your biosimilar program? And how are you thinking about the next steps? Whether it's partnership; are you ready for that? And what are you looking for in a partner for a biosimilar?

CRAIG WHEELER: There's a lot of things in that question you just asked.

ROBYN KARNAUSKAS: I know. I tend to do that.

CRAIG WHEELER: Yes. Let's start off -- so what are we seeing right now in the leaders that are -- actually have the drugs they can bring into the FDA? Those are primarily the European companies. Because they have been developing products in Europe. They have products on the market in Europe. They've been doing clinical trials in Europe. And so what I very much expect to see is those companies will actually bring, and already starting to do that, those patient population databases, those clinical trials through the FDA. Talk to the FDA about what we're going to actually need for approval here.

May or may not hold. What they have in Europe may be applicable here. I suspect that they're actually going to need more trials, because many of those products actually have slightly different -- slight difference in the comparators, for example, in Europe. And they may have different requirements in terms of the data that the FDA wants to see. None of them that I've seen so far are even trying to say that they are a bioequivalent -- they're the same drug. All right, so they're not, not going to characterization and saying we're the same. In fact, many of them are acknowledging there are differences, and they're trying to, through clinical trials, say that we're going to be able to be, you know, classed biosimilar with some differences, and those differences matter or not through the clinical trials and launch them.
And most of them are not using the path. Most of them are using the BLA pathway at this point in time, and have said they're going to use the BLA pathway. But I expect that will happen for some time. I expect that many of the other companies that are starting to enter and are starting to look at, are really looking for, how can we actually pry open this new pathway that we have and take advantage of it through, you know, clinical trial work, characterization and the FDA review process, to be able to get expedited review and substitutability? That's the direction that we're taking. We want to take advantage of our analytics. We believe that our analytics, our cell line engineering, our clonal selection and our process capabilities allow us to actually get to true generic biologics -- meaning, they are actually going to be able to be controlled within the variation of the innovator.
And there's a lot of questions about what, which innovator are you shooting for because of product drift? But we think we can actually do that. And our labs have actually shown very, very promising results. Again, we're trying to take away that black box and (inaudible) from first principle to be able to do that. So that's our goal in terms of trying to actually differentiate ourselves from the construct of the business to be able to get products in there. We have products in our pipeline that we can certainly take forward, you know, given -- certainly if we have a continued good revenue stream from Lovenox, on our own.
Our preference is to actually have a broader partnership, so we can actually have, as opposed to rifle shots, we can have a broad front, a frontal approach with a number of products and try and take them forward. That requires the right philosophy in a partner. But that's the kind of partnership that we'd like to get. And I think there's a lot that's going to be worked out here. We've had that discussion with a couple folks at the beginning of this meeting, in the next year, in rulemaking in the FDA, about how they're going to implement this.

But the federal law pathway leaves quite wide discretion at the FDA to be able to take advantage of the kind of information that we're providing, understand characterization, but you know, what clinical trials are required or not and whether they grant substitutability. But now the process is, how does that law get translated into action at the FDA? And the lobbying is just as intense at the FDA as it was around the legislation. And so you're going to see all of that play out over the next year, 18 months, as the FDA does that. But that's the shot we're taking. We're going after -- you know, try to make, take advantage of the new pathway, and trying to get to, to substitutability.

ROBYN KARNAUSKAS: And before we get to what you want in a partner potentially, do you think that the awareness of investors is going to increase in 2011 regarding biosimilars in the US are actually going to come to market? I ask this because a lot of people say, Robyn, in the EU they haven't been successful. So why in the world would the FDA that's so risk adverse bring a biosimilar to market?

CRAIG WHEELER: Well, so I mean, again, in the EU, it's not that they haven't been successful in getting them approved, it's just then the difficulty of actually getting market penetration. Why have they had difficulty getting market penetration? Because none of them have substitutability, right. And so I look at a world out there where people are talking. I mean, how many people have announced an EPO program? So what are we going to have, seven sales forces [D50, telling] different EPOs in the marketplace?
I can't, I can't see that future. And I think, I think it's going to be an expensive future which is going to still be price competitive. And it's going to be a very difficult market for people to compete in. But I think ultimately you are going to have to get to businesses that have a cost structure that can actually afford to compete in this marketplace and still make a margin. And you're going to have to get substitutability. I think substitutability will happen from a regulatory pathway.

Whether it happens immediately or takes longer -- I suspect it will take a little longer -- I think it will happen before that on the formulary and therapeutic substitution where people are just going to say, we're just going to substitute them, going to force substitution on this. And I think as you get more and more experience with it -- and you're seeing that in Europe. Some of the countries in Europe are actually, just I the last year, are starting to get real penetration. You will start to get those kind of behaviors. So I do see the FDA willing to do this. I actually think though the FDA probably will set a higher characterization and maybe clinical hurdle for some of those programs.

ROBYN KARNAUSKAS: Would we hear about these clinical requirements next year, or is this a 2012 event?

CRAIG WHEELER: Well, you'll certainly hear about it from the competitors who are doing the BLA pathway.

ROBYN KARNAUSKAS: But I mean the new, the new FDA pathway?

CRAIG WHEELER: I don't know if you'll hear it or not. I don't know.

ROBYN KARNAUSKAS: And then, I guess we're running out of time. So probably last thing. So when are you looking forward to partner, and are you -- you say that's the only option? Do you have other options as far as like who you can partner with? Certainly on, on -- Biogen was here yesterday talking about biosimilars. And what are your, what are your thoughts on companies that have the manufacturing capacity to actually manufacture biosimilars?

CRAIG WHEELER: Well, you know, so what are we looking for in a partner? We're looking for a partner who can philosophically be aligned with the strategy that we're trying to pursue, and that brings capabilities we don't have. So first and foremost, we want people that want to play the same game that we're trying to change the regulatory environment, we're trying to build new technologies and bring them there in the pathway, and we're trying to drive that through to develop substitutable products.
Which we believe crates a lot of advantage pre-substitutability, probably a higher probability of success better cell line. Hopefully fewer fundable [travel] requirements, potentially marketing advantages. But also allows us to certainly get towards that holy grail of substitutability earlier than other strategies would get you there. That's number one, is we want to have somebody to align with us. Secondly, we want to have somebody that actually can work with us in a way that actually enhances what we do. So scale up in biologic manufacturing capability.
The commercial capabilities in the marketplace, like we got (inaudible) relationship. So those are the things that we're looking for. You asked a question, is Sandoz the only partner? I actually think that the waterfront is wide open for us. We have no limitations contractually who we can partner for in biologics. The Sandoz partnership has been very successful for us. But they actually are using much more of a European strategy, in developing their programs in Europe and bringing in CDS, which is a different strategy than I just articulated here.

But there are many, many companies that are either in, trying to develop strategies, or declare that they're going to enter this marketplace, including the biotech companies, including pharma companies, including other generic companies. So we're in the process now of trying to sort all that out. You know, there were two things that we needed before we could even find a partnership. One is, we needed a pathway, which we have. The other, quite frankly, is we needed to show we could get a product approved so that the FDA would take these analytics and consider them. Enoxaparin certainly showed that. So we have a lot of interesting discussions, and I think we're really trying to choose what the right course is for our company at this point.

ROBYN KARNAUSKAS: Does the biosimilar model -- is that actually a good biotech model? Do you think there's going to be one player, one biologic, and will it be profitable for a company that goes into the biosimilar business?

CRAIG WHEELER: I think it's going to be very hard unless you actually put all of the pieces of the business together. I think if you try to play it from a manufacturing structure that some of these companies have, a development structure that some have, commercial structure that some have, it's going to be a high-cost business. And I don't think there's only going to be one player. Because you've already seen many declaring on each of the products that they're trying to come in. So I don't think it's going to be a player on the biosimilar. I think on substitutability you may have many fewer companies that get there. And the risk about the similar, biosimilar market is, that's a fine place to compete until somebody gets a substitutable product. And then those -- that market is in big trouble.

ROBYN KARNAUSKAS: Okay.

CRAIG WHEELER: Okay?

ROBYN KARNAUSKAS: Thank you very much. I appreciate it.

CRAIG WHEELER: Thank you.
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