Good day, ladies and gentlemen, and welcome to the PTC Therapeutics First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a remainder, this conference call may be recorded. And I introduce your host for today’s conference Jane Baj, please go ahead.

Thank you. Welcome to our conference call. Today, we will discuss PTC’s first quarter 2016 financial results and provide a corporate update. Before we start, let me remind you that today’s call will include forward-looking statements based on current expectations. These include statements about our future expectations regarding clinical developments, regulatory and commercialization timelines and potential outcomes including statements related to our ability to resolve matters set forth in the Refuse to File letter we received from the FDA in connection with our New Drug Application for the Translarna for the treatment of Duchenne muscular dystrophy and our ability to obtain and maintain marketing authorizations for Translarna, including in Europe, the potential success of our products and product candidates, addressable patient populations and financial projections. Actual results may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties including the timing and outcome of interactions PTC has with the FDA with respect to Translarna, including whether we are required to perform additional clinical and non-clinical studies at significant costs which if successful may enable FDA review of an NDA; whether the EMA determines that the risk benefit balance of Translarna supports continuation of our marketing authorization in the EEA, the outcome of pricing and reimbursement negotiations in those countries in which we are authorized to sell Translarna; and the price at which we are able to sell Translarna; and those risks discussed under heading Special Note Regarding Forward-Looking Statements and Risk Factors in our 2015 Form 10-K and our most recent Form 10-Q which will be available from the SEC or our website later toady. Such statements represent our judgment as of today and PTC undertakes no obligation to publicly update any forward-looking statements except as required by law. Information regarding our use of GAAP and non-GAAP financial measures and a reconciliation of GAAP to non-GAAP is available in today’s financial results press release. With that let me pass the call over to Stuart.

Thank you. Good afternoon. Thank you for joining us on the call. We’re happy to report on the progress we’ve made in the first quarter across our regulatory commercial and clinical front. Important first quarter updates include recent discussions with the regulatory authorities in both the United States and Europe, progress on our Translarna commercialization efforts, development in our clinical pipeline and financial results for the quarter. Let me start with the work we’re doing to make Translarna available to all patients globally who may benefit, including patients in the United States. We’ve begun a dialogue with the FDA to discuss and clarify the matters described in the recent Refuse to File letter. We anticipate that this process may require multiple interactions before we come to a conclusion. Given the sensitivity around these discussions as well as their iterative nature, we will refrain from any public comment, including responding to questions today as they might adversely affect the overall integrity of the process. We intend to provide an update once we have clarified our regulatory strategy in the United States. We believe that this approach is in the best interest of our patients and their families, our investor and the company. At the start of the year, we also submitted the ACT DMD Phase 3 results to the EMA in support of the marketing authorization for Translarna for the treatment of nonsense mutation DMD. And separately submitted the request for annual renewal of our conditional marketing authorization, which involves an assessment of Translarna benefit risk profile. As I’m sure you are aware, the process with the CHMP is also in iterative one. As part of this process, the CHMP has sent us questions related to these submissions. These are primarily focused on an assessment of efficacy in light of the…

Thanks, Stuart. We’re happy to report the strong start to the first quarter of 2016. With Translarna net product sales of $18.9 million, which represents a 49% quarter-over-quarter increase versus the $12.7 million we’ve reported in the fourth quarter of 2015. Contributing to this growth, as Stu mentioned, was a large order from Brazil. Brazil represents a significant market opportunity for us with a population nearly two-thirds the size of the United States. Our team has made significant progress working with local key opinion leaders to help identify DMD boys with the nonsense mutation. In Brazil, orders for certain pharmaceutical are fulfill in larger bulk orders on a semiannual basis. As a result, the timing of these orders is expected to have an impact on our quarterly reported revenues and may result in our second quarter net sales being lower than those for the first quarter that we’re reporting today. First quarter revenues were negatively impacted by a lower net sales price in Germany as a result of the mandatory discount and closed by the GKV prior to delisting. This lower price in Germany is expected to tail into our second quarter revenues during which period patient were transitioned to imported therapy. Overall, we continue to have confidence in our ability to achieve our prior revenue guidance of $65 million to $85 million in Translarna net product sales for 2016. This guidance assumes current exchange rate and the continued rollout on a country-by-country basis for Translarna outside of the U.S. As we progress throughout this year, we anticipate updating this guidance when and if appropriate. As a result of the Refuse to File letter that we received from the U.S. FDA, we announced a workforce reduction as part of the plan to optically manage expenses. This resulted in an approximate…

Thank you. [Operator Instructions] Our first question comes from Christopher Marai of Oppenheimer. Your line is open.

Good afternoon. Thanks for taking the question and congrats on the quarter. I was just wondering if you could further elaborate on sales in Germany. I was wondering are those sales via the importation pathway in newly identified patients or are those old patients who had previously received drug and now have been converted. And then could you perhaps comment, I guess this is for Mark, on patient finding efforts in Germany now that you’re using that importation pathway. And I have a follow-up, thanks.

So, Hi, Chris, this is Mark, thanks for the question. So I think the first priority for patients in Germany is that those that are an existing treatment get successfully transferred onto the foreign importation process. So we’re very pleased to see that that is already happening and it’s very fast. If you think about the fact that we delisted on the 1 of April already numerous patients have already shifted on to foreign importations. So that’s the first priority and this will happen – we expect in the coming month or so. Beyond that, as new patients get identified, they will then be able to also access Translarna through this process.

But just to be clear, Chris, it’s Shane speaking. For the first quarter sales none of those sales in the first quarter reporting today reflect the real importation into Germany.

Right. They were all discounted price for delisting.

Got it. And then, how far along are you with respect to converting those Q1 delisted patients into importation pathway patients. Is there a percentage you could give roughly?

Thank you very much for asking, but I think you’ll appreciate that we’ve really don’t go down to patient type of level detail. But you may recall that we were suggesting it could take a couple of months to undertake this process, and we’re really pleased that in less than a month we’ve already seen numerous patients already switched on to this. And I guess more importantly you’ve seen that today we’ve reiterated our revenue guidance of $65 million to $85 million this year.

Got it. And then just with respect to the ongoing NICE discussions, I mean it sounds like they were delayed slightly. Could you just confirm what we've learned which is that the additional time required with NICE is not about our price to pay, but it's rather about other aspects such as like five-year follow-up and other high requirements that they had a few? Thanks.

So you’ll recall that we got a positive recommendation for funding from NICE back in April. And you're right, they’ve recently just extended the periods for public consultation followed by about eight weeks before – by which they’ve agreed to publish to that point the final guidance. So within this period that NHS England and PTC are just working to finalize the elements of the managed access agreement. And this is a high priority for both parties. We've had multiple productive discussions and we have a draft agreement and we're just looking forward to finalizing that as soon as possible, there are many different elements in a managed access agreement.

Okay. And just to be clear, it's not regarding a price to pay, correct?

This is about finalizing the draft agreement. And I said there are a multiple different points that were opened that needed just be closed. It’s a general point that this whole agreement has many different chapters, it just needs to be finalized, I's dotted and the T's crossed.

Understood. Thanks so much.

Thank you. Our next question comes from Geoff Meacham of Barclays. Your line is open.

Hey, guys. This is Evan Seigerman on for Geoff. Thanks for taking my questions. So the first one is have is about the current Phase 3 in CF. I know you had mentioned something about this before, but how much of a role does this have and EMA’s decision regarding conditional approval. Now from the commentary it appears that you will most likely need this, but could you give us some understanding of why EMA would potentially, conditionally approve without this data.

So, let me just remind you that we – obviously we – with CF is actually a variation on the conditional approval, so it’s actually a full approval it’s variations. So if this mission is really based on the full approval from our previous Phase 3 trial. So it’s really just based on recent interactions with the regulator, the recent interactions with the regulator, that really basically that we submitted the basis of that, and that we're testing whether it's sufficient enough to demonstrate benefit for patients. So I think what we're doing is that they're linked and so in a sense that CF variation really is depended on the market authorization for DMD. So that's really the connection between the two of them.

Okay. And switching to DMD, could you remind us what the criteria would be for EMA to pull the drug? And are there any precedents for where to pull a drug from conditional approval where there is no safety signal.

Yes. So let me just remind you as I said in the prepared remarks there’s three – there are three ways in which we can get this drug which is full approval, condition approval or pull the drug. And obviously we're working hard to ensure that we get one of the two there. There are small number of cases of conditional approval and each one is different. So there's not a lot of data points to draw any conclusions from them. There's not very many of that happen. And our focus is really with the CHMP to make sure we discuss with them the efficacy of Translarna and belief that we have that the results support the benefit risk for the patients.

Okay. And then one more follow-up regarding your negotiation with UK NICE and NHS, is this delay at all related to the decision from EMA regarding conditional approval – becoming full approval or being pulled from the market? Are they waiting on that to make a final decision?

No, I think they are two independent agencies working on, have different roles and functions. So they're independent as a consequence of that.

Okay. So, there's no potential – there's no connection whatsoever between the two of them in your view?

No, one is about pricing and reimbursement and one is about approval.

Okay.

And maybe just build on that.

Yes.

Bear in mind that we’re now commercialized in many, many countries where, again, these are being completely dissociated processes. So, we’ve already shown you that we have the drug, reimbursed and available in numerous countries.

Okay, great. Thank you so much for taking my questions.

Thank you.

Thank you. Our next question comes from Anupam Rama of JPMorgan. Your line is open.

Hi, this is Yuko [ph] on the call for Anupam Rama this evening. Thanks for taking my questions. Could you provide some progress on commercial uptake of Translarna in globally such as number of patients and countries that now have access to Translarna?

So just to remind you we have established a commercial – global commercial footprint that covers 46 countries. And we reported previously 23 – 24 countries where we’re already reimbursed and patients are getting access. So the drivers of growth remain that not only do we continue to expand the number of countries where access is possible, but in countries where reimbursements already available. We continue to have patients have access and expand the number of patients. And all of that really adds up to say that where we reiterating our guidance of $65 million to $85 million for this year.

Okay, great, thank you.

Thank you our next question comes from Heather Behanna of Wedbush Securities. Your line is open.

Okay, thanks and congrats on the quarter. Just a couple of questions. One is just, when will we start seeing cost of goods for Translarna?

Hi, Heather, it’s Shane.

Hey.

So, once we’ve had discussions with our auditors about capitalizing inventory, and it’s – I think once we confirm approval with the EMA and ultimately our path forward in the U.S. that we would begin – that we would have certainty with respect to our operating expenses going to produce Translarna products for commercial sale. At that point, we would begin capitalizing those expenses as inventory and then expensing in accordance with sales as cost of goods. But up until now we had been expensing those production costs in the operating expenses.

Got it. That’s helpful. And then I’m just switching gears for a second. On the SMA program, if you could just give us any color on how you’ve been monitoring patients for the potential for any ocular toxicities for the new compound and sort of how that will play into your decision process once you get data in SMA patients.

Yes, so let me just remind you on the – we’ve showed in RG7916 is moving forward in healthy volatility – it has move forward in healthy volunteers. That was picked I should remind as we were going on in having a robust discovery program where we still had RG78100. And that was that moves forward because it was more of potent efficacious. And it show that to be the case in a Phase 1 trial, and that had a – we believe that RG7916 has the potential to have a wider safety window as compared to RG7800. And so, once – as I said in the prepared remarks, we’re going to move forward in SMA patients and once we have the SMN protein data in SMN mRNA level patient of RG7916 will be able to compare the activity in both compounds and prepare the best path forward. Along with that we’ll be looking at obviously we’ll be watching for monitoring for any eye issues. And that will then also be having undertaken longer term taxes in these study to explore the safety of tolerability of the compound at higher exposure in that longer duration of treatment that – then it’s being investigated in the both in the healthy volunteers and subsequent SMA patients. And so once that all through, we look forward to sharing those results with you once they’re final.

Great, so just a quick follow-up. Were you able in the healthy volunteers to see that what you saw preclinically as far as efficacy is being recapitulated that the results are – that the pricing levels were higher than what you saw for RG7800?

So I think what we're able to disclose really right now is that we completed the Phase 1 – the single dose Phase 1 study, and we're able to show that the SMN – growth SMN mRNA, we are showing very NICE splicing. As we said it had – it was efficacious, so we're excited about that. And obviously we're moving that forward and then we'll be able to compare 7916 to 7800 once that data is complete.

Okay, thanks.

Thank you. Our next question comes from Alethia Young of Credit Suisse. Your line is open.

Hey. Hi, this is Ellie Merle [ph] on for Alethia, thanks for taking the question. My first question is just, if you can just characterize a little bit how large the order was from Brazil? And then what the gross rate of sales would have been without their partner from the Brazil?

Hey, thanks for the question, Eli. As you may expect we don't break out any specific country revenue numbers. However, these large orders from Brazil are expected to have an impact on our quarterly reported revenues. And as a result I think as we disclosed during the quarter it may result in our second quarter net sales being lower than those that we're reporting today.

Okay, that's helpful. And then just in terms of your guidance, I was just curious kind of what pricing assumption you have baked in there. If you could just comment a little bit on that.

Yes, I think as we talked about in prior calls now, we're in our second year of launch and as we were mature with this commercial expansion we have moved away – we have moved towards getting revenue guidance which integrates many factors including price, exchange rate, patient numbers, compliance, and average weights of patients. So really there's a number of factors that go into that overall guidance that we've given.

Okay, thanks.

Thank you. Our next question comes from Gena Wang of Jefferies. Your line is open.

Thank you for taking my questions. So I know you mentioned that you won’t give the specific numbers – patient’s numbers from each country. But just wondering could you provide total number of patients currently on drug. I know last time you provided was 206. Now wonder if this number has increased since last time.

So thank you for the question. We did mention in the previous call that we're moving away from providing specific patient numbers, but to move towards revenue guidance was our first time, so that's where we are today. But clearly the growth that you have seen quarter-on-quarter is driven primarily by patient growth. That’s the main driver. And I mentioned that’s partly due to new geography and partly to increase penetration of countries where we're already present. And Brazil is being a tremendous collaboration between PTC and the Ministry of Health, where there's a common goal really to look after the need of patients with very high unmet need at this nature.

Thank you. And maybe just one follow-up question regarding cystic fibrosis label extension. Could you remind us where – at which stage of in a process are you at right now?

So, yes, we're with the cystic fibrosis. As you may recall we have an ongoing cystic fibrosis trial that will be – the results will come out in early 2017. We also filed a variation and we're in the middle of that now. We anticipate that that will be completed mid-year this year – mid-year of this year. And so we're in the midst of that process now.

Sorry, maybe I did not make it clear, just wondering have you submit – which stage are you at, have you submit response to EMA or which stage are you at? Just wanted to have a little bit more clarity.

Yes. So the process is one and where – with the process one and where you have questions that they’re asking you respond to those questions, we've had – we've done that, we’re anticipating that as there might be another round of question. So we’re middle of those process, we’re waiting for response on that. And then – so that’s where we’re right now. We anticipate that process then would conclude mid-year some time.

Okay, thank you.

Thank you. I'm not showing any further questions in queue at this time. I’d like to turn the call back over to management for any further remarks.

Yes. Well, thank you, thank you for joining the call today. All of us in the rare disease community are we are working hard to develop treatments for patients who are without options today. When you're trying to get a new drug to the market in an uncharted therapeutic area, it's not surprising to encounter development and regulatory challenges. The way you should see this is to persevere. We continue to make progress and we’ll remain firmly committed to bring Translarna to the patients globally. Thank you for joining us today.

Ladies and gentlemen, thank you participating in today’s conference. This concludes today’s program. You may all disconnect. Everyone have a great day.