Momenta Pharmaceuticals, Inc. (MNTA)

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Momenta Pharmaceuticals, Inc. (MNTA)

38th Annual dbAccess Health Care Conference

May 29, 2013 10:40 am ET

Executives

Craig Wheeler - President & Chief Executive Officer

Analysts

Robyn Karnauskas - Deutsche Bank Securities

Presentation

Operator

Robyn Karnauskas - Deutsche Bank Securities

Great. Thank you all for joining us this afternoon or this morning, sorry afternoon. My name is Robyn Karnauskas, with Deutsche Bank Biotechnology Analyst. With us next we have Craig Wheeler, the Chief Executive Officer of Momenta.

For those of you who are listening to the webcast, I’d been taking questions by email and happy to read those anonymously and my email address is robyn.karnauskas@db.com. And for those of you who in the audience, be feel free to use to (inaudible) which instructions were given with your registration packet. You can ask questions anonymously or make comments throughout the presentation.

And so thank you very much Craig, I appreciate it. Maybe, I thought that we can start off a little bit in a usual, a lot of investors are still very focused right now and copaxone and very focused on some of the legal cases that are on going but I thought firstly, we can start with your biosimilar program?

Craig Wheeler

Sure, I happy to.

Robyn Karnauskas - Deutsche Bank Securities

Okay. So, and you attend a lot of biosimilar meetings and you interact with the lot of different players, you know what is the real dialogue, I think investors are just trying to figure out where everyone is going to fit in and how all these players are going to fit in but what, what do you, what kind of discussions do you hear when you attend some of this big biosimilar meetings?

Craig Wheeler

Well, I think there is still a lot same in biosimilars and you probably going at most of the companies they are competing here. I mean we are still, one we were trying to define the competitive set, we’re trying to figure out exactly what the regulatory pathway is going to work. So most of the dialogue I hear is, one trying to understand how the U.S. pathway is going to look for the European pathway. How we are going to compete, is it going to be on science or is it going to be on clinical trials and data and what the FDA hopefully going to do in implementing this pathway, questions like how long is it going to take to get to interchangeability. Are we going to see the first programs being reduced files or not?

And I think that’s probably largely with the same dialogue that’s going on in the investors mind because we are at a stage in this industry where its really co-last to some degree, who is partner with who, you know, where the deep pockets are and you know what’s happening in terms of investments. But the opportunity that’s very clear what that opportunity is, how to get their and how its going to be split up on that backend of it. It is still got to play out.

You know for us many of the signs are positive, if you listen to the FDA, which is primarily the gating factor for us in terms of getting to the marketplace because we feel we can potentially create a competitive advantage to the regulatory process. But, its untried and untested and so there is a lot that’s need to be answered for both the company’s and for the investors.

Robyn Karnauskas - Deutsche Bank Securities

So are the companies when they attend these meetings trying to figure out, what current season you had, what we need to do to get that interchangeability, is there that kind of…

Craig Wheeler

Well, of course, I’m trying to figure out what each other is doing.

Robyn Karnauskas - Deutsche Bank Securities

All right. That was almost

Craig Wheeler

But, I think you find there is that competitive dynamic that is setting up, but there is also cooperation because in some senses we are facing, I don’t want to call it foe, but a common challenge right now in the regulatory process. And that’s because the FDA has never really truly approved these before. You can look at some drugs like (inaudible) and others that have been approved. But there is a B2 and the 351(k) pathways pretty untested. It’s going into a place that it was kind of a hybrid between the new drugs division which is kind of got the primary authority in the generics which is going to be providing some other resources with the new offices OPQ. And for this all of these changes where you can rely on the words of the companies or the FDA, but it’s really the proof is in the pudding and how well you can execute, how the FDA is going to implement.

And so we are all trying to figure out the same thing and that’s kind of an alliance it’s formed between the companies as how do we have that dialog with the FDA and understand plus their competitors so.

Robyn Karnauskas - Deutsche Bank Securities

So where, how we understand your strength and specifically, how do companies develop drugs when there is no regulatory framework?

Craig Wheeler

There is actually multiple strategies that are appearing, if you begin to look at the industry. There are companies who have placed the trial in Europe, their primary interest and they can take advantage and leverage the investments they have made in Europe and bring them into the U.S. And so their dialog is mostly we have trialed to give our competitor, you accept these trials, can do fewer trials European trials and try to bring them in.

Read the rest of this transcript for free on seekingalpha.com