Thank you for holding for PTC's third quarter 2013 conference call. (Operator Instructions) At this time, I would like to turn the call over Jane Baj of PTC. Please begin.

Thank you, operator, and good morning, everyone. Thank you all for joining us for PTC's third quarter financial results conference call. With me here today are Dr. Stuart Peltz, Chief Executive Officer of PTC; Mr. Shane Kovacs, Chief Financial Officer; and Dr. Jay Barth, Senior Vice President of Clinical Development. Stuart will provide opening remarks and share some highlights of the quarter and recent events. Shane will then provide detailed financial results, and we will open up the call for questions. Earlier today, we issued a press release detailing PTC's third quarter 2013 financial results, which is available on our website at ptcbio.com. During today's call, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory timelines, the potential success of our product candidates and financial projections. Actual results may differ materially from those indicated by these statements. Any forward-looking statements represent our views as of today only. We may update these statements in the future with what we disclaim any obligation to do so. With that, let me pass the call over to Stu.

Thanks Jane, and good morning, everyone. Welcome to our third quarter financial results conference call. 2013 has been an important and successful year so far for PTC and we are very happy to report strong progress in the third quarter on multiple fronts, including clinical, regulatory and corporate. Our activities for the third quarter have been focused on advancing our clinical development programs and pipeline candidate. Let me start with an update on the progress of our most advanced product candidate, ataluren, which is specific to patients with genetic disorders, as a consequence of nonsense mutation, and will then update you on some of our earlier stage product candidates. Ataluren is a wholly-owned program, so it provides a great opportunity for value creation. We are developing ataluren for the treatment of nonsense mutation Duchenne muscular dystrophy or nmDMD and nonsense mutation cystic fibrosis or nmCF. Available treatments in the development today do not address the underlying cause of these diseases. Approximately 13% of patients have DMD, as a result of a nonsense mutation. And currently, we are testing ataluren in a confirmatory Phase 3 clinical trial for that indication. As in our previous study, the trial is a 48-week, multi-standard, randomized, double-blind, placebo-controlled trial, evaluating the efficacy and safety of ataluren. The primary objective of this trial is to confirm the effect of ataluren ambulation. The primary endpoint is the change in walking distance as measured by the six-minute walk test. The design of the clinical trial was informed by the results from our previous clinical studies, including the natural history of DMD. Multiple natural history studies have since confirmed our prior work and give us a high degree of confidence that our confirmatory study is both well-designed and well-powered to confirm the efficacy of ataluren. In our confirmatory trial,…

Thanks, Stu. I'm happy to report that PTC continues to be in a very strong financial position to execute upon our strategy and build a leading company focused on rare diseases. I'll just review the highlights, and then speak to our cash balance. The company reported a net loss of approximately $4.4 million for the quarter ended September 30, 2013, compared with a net loss of approximately $7.3 million for the third quarter of 2012. Total revenues for the quarter were approximately $16.3 million, comprised primarily of $15.5 million of collaboration revenue and $800,000 of grant revenue. That compares to total revenue in the third quarter of 2012 of approximately $7.2 million, which was comprised of $6 million in collaboration revenue and $1.2 million related to grants. Research and development expense for the third quarter was $13.9 million compared to $10.5 million in the third quarter of 2012. As you would expect, the increase resulted primarily from the ongoing expense as a confirmatory Phase 3 clinical trial of ataluren for the treatment of nmDMD as well as our open-label extension studies in nmDMD and nmCF. G&A expense for the third quarter was $6.7 million compared to $3.8 million in 2012. This increase was driven primarily by public company related expenses, pre-commercial activities and increased non-cash stock-based compensation expense. With the aggregate proceeds from our equity financings in the first half of this year as well as a $10 million milestone we received from Roche in the most recent quarter for the selection of a development candidate in our SMA collaboration, we ended the third quarter with over $157 million in cash versus approximately $166 million at the end of the second quarter of this year. During the quarter, we repaid all of our outstanding, $2.7 million debt balance. And based upon our current operating plans, we expect that our current capital will fund our operations through the end of 2015. We currently have 23.8 million shares issued in outstanding and another 1.1 million shares of unvested restricted stock. With that, let's open the call for questions. Operator?

(Operator Instructions) Our first question comes from Geoff Meacham with JPMorgan.

Just one on the EMA news, how should we think about the Scientific Advisory Group, the panel, was there any judgment of risk benefit for ataluren that went into the decision to advance it to the advisory group? Then I have one follow-up.

We're pleased that the CHMP is convening the SAG Meeting for the evaluation of ataluren and DMD. Obviously, that will allow a robust discussion between experts on the SAG, outside experts as well as patient efficacy groups. So that's a meeting that will happen, and we'd say then we'll have an opinion that will be given to the CHMP.

But there wasn't really any, like the EMA pretty much just passed decision on to the Scientific Advisory Group or did they make their own separate decision before they decided to take it to an advisory group?

The CHMP decided that they need more expert opinion before making the decision, so they determined that they need the expert advice on this matter as well as they hear the patient advise from the patient advocate. So they don't pass it on, they actually utilize that additional information to then go on and make a final decision.

And last question, I know that Roche is leading the program, but what are the gating factors to get the SMA kind of into the clinic. Are you guys thinking about maybe proof-of-concept endpoints in the Phase 1 that speed up the clinical development path?

I don't think anything is really gating, they are just finishing up the process to complete the early phase of safety toxicology, and that anticipate the move, the drug into the clinic by next year.

Our next question comes from Chris Marai with Wedbush Securities.

I was wondering if you could help me on two points, number one, where are you at with respect to enrollment in your Phase 3 trial for ataluren, specifically in the U.S. and EU side? And if you don't have an update yet, when will we hear an update? And then a follow-up to that would be I know on your Analyst Day, you had discussed next indications for ataluren and it appear to me that some of those indications that we discussed could have rapid routes to registration. And then I was wondering, when are we going to hear about the next indication and where do you see those going in terms of clinical trial.

So in terms of the Duchenne muscular dystrophy confirmatory trial, that's a global study with 53 sites. And as we have talked to everybody, we've said that we anticipate full enrollment by mid-2014. We're on track for that now. So I think it's moving forward quite nicely, and thus far we have no indications that we will meet that deadline that we've said. So I think it's going quite well. And you're right, at the R&D day I think we showed you -- what we did is on R&D Day is showed that there are number of model from where ataluren demonstrated efficacy in these both disease, animal and cell-based disease model. And that's very helpful to try and help decide what are certain indications. And what we've done is we have a committee here within the company that's prioritizing these indications, looking at what the indications are, the series of unmet medical need of them, what's the clinical path, and so on and so forth. So we're working through that so that we hope to be able to prioritize a set of indications that we opened, at least pick one or two to move forward in the next year or so.

And we're going to hear an update on that in 2014 at some time point of the expectation?

I think our expectation is that we should be able to decide that. So we hope that at some point we'll be able to discuss some of the indications that we're thinking about.

Our next question comes from Debjit Chattopadhyay with Emerging Growth Equities.

The couple of questions, if I may. Just getting a thought on the potential label for nmDMD, I mean do you think there is a possibility that the FDA could limit it to patient subgroups, which are being specifically enrolled in a Phase 3 trial?

So as you know, Duchenne muscular dystrophy affects kids from all ages and that there is certainly an early phase, a stabilization phase and the decline phase, where they then become non-ambulatory. Clearly, and obviously we had spend a significant time figuring out outcome measures and we used ambulation and demonstrated that the 6-minute walk test was a good endpoint and we're using that to demonstrate ataluren's activity in Duchenne muscular dystrophy. Clearly it's mechanism-based, so we fully expect that demonstration of efficacy, and this would indicate that it will be good for all phases of this disease. We do, however, have agreement with the Europeans that we have to study the pediatric population, so we will be doing that. We also have patients that are in extension studies that are non-ambulatory, and we're studying those patients as well. So I think what we're trying to do is be able to gather all that information and then it will be up to the regulatory authorities and within our discussions to determine the breadth of the label.

I mean would you be concerned that the FDA is basically asking a competitor to look at other endpoints along with 6-minute walk distance for their trial, and you have a 6-minute walk distance endpoint. I mean would that be some kind of gating factor for them?

Well, I think we've obviously spent a lot of time talking to regulatory authorities, both the EU as well as the FDA. And I would say that FDA has been very consistent with everything that we've actually discussed and that is that clearly that at the present time dystrophin is not reliable biomarker and that the 6-minute walk test is a acceptable outcome measure. So I don't think it would be appropriately a powered study, I think that there are no issues in using the 6-minute walk test as the primary outcome measure.

And one more question. And as for nmCF, given that the Class 1 mutations are the most aggressive phenotype, I mean what kind of benefit do you think would be really clinically relevant? I mean do you really have to go up to 5% change in FEV1? And a follow-up to that would be, are you going to use an absolute change or a relative change, so that it's kind of consistent with [ph] galenical.

So we're targeting, we're empowering us at least for a 5% difference between benefits from placebo to ataluren treated. Clearly, these are most severe form of the patients, and so that altering the course of the diseases is a great benefit to these patient, whether you stabilize them, we think is actually quite important. I think what we've done is used both relative and absolutely, basically report both of those. So I think the premier endpoint we've used in the past is relative, but we've also reported the absolute as well.

And I'm currently showing no further questions. I will now turn the call back over to Stuart Peltz for further remarks.

Well, thank you, operator. As you know, I founded PTC 15 years ago, based on technology platform that targets post-transcriptional control mechanisms, our mission is to leverage this technology platform to discover and develop differentiated new product candidates, aimed at improving the lives of patients suffering from these debilitating rare disorders. We are focused on bringing these patient candidates to the market to address the unmet needs of these patients. Thank you for your questions and with that we'll end the call.

Well, thank you, operator. As you know, I founded PTC 15 years ago, based on technology platform that targets post-transcriptional control mechanisms, our mission is to leverage this technology platform to discover and develop differentiated new product candidates, aimed at improving the lives of patients suffering from these debilitating rare disorders. We are focused on bringing these patient candidates to the market to address the unmet needs of these patients. Thank you for your questions and with that we'll end the call.

Thank you, ladies and gentlemen. That does conclude today's conference. You may all disconnect and have a wonderful day.