Earnings Labs

PTC Therapeutics, Inc. (PTCT)

Q2 2013 Earnings Call· Mon, Aug 12, 2013

$69.88

+0.95%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-2.98%

1 Week

+2.59%

1 Month

+32.08%

vs S&P

+32.18%

Transcript

Operator

Operator

Thank you for holding for PTC's Second Quarter 2013 Conference Call. At this time, all participants are in listen-only mode. Following the formal remarks, PTC management will open the lines for a question-and-answer period. Please be advised that this call is being taped at the company’s request and will be archived on the company’s website for two weeks from today. At this time, I would like to introduce Jane Baj from PTC.

Jane Baj

Management

Thank you, operator and good afternoon everyone. Thank you all for joining us for PTC’s first investor conference call. With me here today are Dr. Stuart Peltz, Chief Executive Officer of PTC and Mr. Shane Kovacs, Chief Financial Officer. Dr. Jay Barth, Senior Vice President of Clinical Development will be joining us for the QA session of the call. Earlier today, we issued a press release detailing PTC’s second quarter 2013 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, including those discussed in the final perspective for our initial public offering, which is on file with the SEC. Any forward-looking statements represent our views as of today only. We may update these statements in the future but we disclaim any obligation to do so. With that, let me pass the call over to Stuart.

Stuart Peltz

Management

Thank you, Jane and good afternoon everyone. On behalf of all my colleagues at PTC, I am delighted to welcome to our first investor call. It’s an exciting time for PTC. Since this is our first call, I wanted to give you a brief overview of PTC. We are focused on the discovery and development of orally bio-available therapeutic for patients living with serious and life threatening conditions. Our name PTC stands for post-transcriptional control, which are the processes that regulate the levels of protein production. As you know the absence or over production of specific proteins can lead to disease. At PTC we systematically target post-transcriptional control processes by combining our proprietary technology with extensive knowledge of this area of biology to bring an unexploited approach to drug discovery. While the therapeutic potential for our product candidates is broad, we are focused particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. One of our most advanced product candidates is ataluren which is specific to patients with genetic disorders as a consequence of a genetic mutation known as the nonsense mutation. Ataluren is in late-stage clinical development for the treatment of nonsense mutation Duchenne muscular dystrophy or nmDMD and nonsense mutation cystic fibrosis or nmCF. Available treatments today do not address the underlying cause of the disease. On the heels of two successful financing this year PTC is well positioned to continue advancing Ataluren in nonsense mutation DMD and CF as well as continuing to develop our pipeline. In March of this year we closed a $65 million private financing. In June we successfully completed a $144 million initial public offering. These two raises generated approximately $210 million in gross proceeds. We plan to invest the net proceeds in a number of key areas. Our primary…

Shane Kovacs

Management

Thanks, Stu. Since we issued a press release earlier outlining our second quarter 2013 financial results, I’ll just review the highlights and then speak to our cash balance and our financial guidance. The company had reported a net loss of approximately $15 million for the quarter ending June 30, 2013. That compares with net income of approximately $154 million for the second quarter of 2012. In 2012 we had recorded a gain of about a $160 million which was related to the exchange of convertible preferred stock in connection with the recapitalization. Total revenues for the second quarter were approximately $7 million comprised primarily of $6 million of collaboration revenue and 1 million of grant revenue. That compares to total revenue in the second quarter of 2012 of approximately $7.5 million which was comprised of $6 million in collaboration revenue and $1.5 million in dollars related to grants. Research and development expense in the second quarter was $14.7 million, a 23% increase over the $11.9 million of R&D spend in the second quarter of 2012 and as you would expect the increase resulted primarily from the initiation of the confirmatory Phase III clinical trial of ataluren for the treatment of nmDMD. G&A expense for the second quarter was $6.6 million which was a 108% increase was over 2012 and that was driven primarily by public company related expenses, pre-commercial activities and increase stock-based compensation. Of note in July of this year we repaid our outstanding balance of $2.6 million in venture debt. With the proceeds from our IPO financing we ended the second quarter with over a $165 million in cash and based upon our current operating plans we expect that this capital would be sufficient to fund our operations through 2015. With that let’s open up the call for questions. Operator?

Operator

Operator

(Operator Instructions). First question comes from Geoff Meacham from JPMorgan.

Geoff Meacham - JPMorgan

Analyst

Good evening guys and thanks for taking the question. Ataluren in DMD I am curious here how many of the sites in the ongoing Phase III were in your previous trials? I know it’s not a complicated endpoint, but want to get a sense of the experience with ataluren and then I have one follow-up.

Stuart Peltz

Management

Yeah so and so let me have Jay actually.

Jay Barth

Analyst

All of the -- hi Geoff, all of the sites that were previously participating in our Phase III study plan to participate in our Phase III study, we will also have additional sites.

Geoff Meacham - JPMorgan

Analyst

Got you. And then you know I know you are perhaps a year away in CF from starting a pivotal there. How are you guys thinking about expanding the opportunities, is there an appetite for doing Phase II combo with either one of Vertex’s correctors or is there a strategy for growing beyond the homozygous nonsense mutation population? Thanks.

Jay Barth

Analyst

Yeah, sure. Obviously we are moving forward to look at ataluren in the nonsense mutation cystic fibrosis patients, but clearly the (inaudible) has showed some activity with being able to open up the chloride channel in other types of mutations as well as in wild type gene. So it’s something certainly that we’re interested in evaluating and I think we will think about ways to evaluate them and that’s what we are doing right now.

Geoff Meacham - JPMorgan

Analyst

Yes but would you start a trial before like a Phase II before with that strategy or would go full-on to Phase III and then do a [Phase II] (ph) following?

Stuart Peltz

Management

Well I think we are just looking at evaluating this right now perhaps even pre-clinically and then deciding what to do after that.

Geoff Meacham - JPMorgan

Analyst

Okay, thanks guys.

Stuart Peltz

Management

Thanks, Jeff thanks for your call. Thanks for the question.

Operator

Operator

Thank you. (Operator Instructions). Our next question comes from Jason Kantor from Credit Suisse. Jason Kantor – Credit Suisse: Hi, thanks for the update. Couple of questions. I guess on the plans to file for cystic fibrosis for conditional approval in Europe. Is that in anyway tied to what happens with the DMD filing. Are you waiting to get the recommendation or not, is there any read through from one filing to the other?

Stuart Peltz

Management

Hi, Jason thanks for the question. Yeah we are working now towards the MAA filing and that probably has a good chance of being done prior to that although we’ll evaluate that as time moves on. We’ll probably put it in before the end of the year though. Jason Kantor – Credit Suisse: But I mean if the European authorities reject the DMD filing I mean do you think that this stands separately on the merits as well and you would pursue that, there is no linkage there in your mind?

Stuart Peltz

Management

No, we think that we’re going to be having, we’re working hard on this right now and we’ll evaluate it as it comes in but we’re working hard now to get that in. Jason Kantor – Credit Suisse: Got it. And then in terms of the SMA program that you spoke about I guess what would the next milestone that would trigger a payment. How big might that payment be and could you just speak a little bit to what makes this program particularly differentiated?

Jay Barth

Analyst

Sure we are pretty excited about the SMA program. It’s an orally bio-available molecule that can pass obviously the blood-brain barrier and has shown really incredible changes in the preclinical, as a -- a severe form of the SMA model. So we were happy to with Roche in the SMA Foundation to pick a development candidate that triggered the $10 million milestone. So the next step of that is obviously to move it through the development phase. So that’s where we are now working with our partner. Beyond that we can’t disclose all that much more beyond where we are right now. Jason Kantor – Credit Suisse: And then if I can ask one more question. There has obviously been a lot of discussion about the FDA’s willingness to potentially look at accelerated approval paths for DMD trials and I am just wondering is there any way to potentially get Ataluren approved even if the 6-minute walk comes in with some sort of mix result. Is there any kind of end point that you are looking at you’ve been discussing with FDA or is that pretty much the only path available to you?

Stuart Peltz

Management

Well we are obviously doing the 6-minute walk test and the time function test, quality of life as well that we’re measuring as well. We think we are pretty well positioned in terms of the 6-minute walk since as you know we were the first to really do a Phase IIb study and where we pioneered really trying to understand the natural history, even though we weren't optimal in terms of inclusion criteria because we didn’t know. I think we now understand this quite well and I think we really positioned the trial to have the best chances of success. But we are pretty confident of this upcoming trial. Jason Kantor – Credit Suisse: Thank you.

Operator

Operator

Our next question comes from Gregory Wade from Wedbush.

Gregory Wade- Wedbush Securities

Analyst

Hi, good afternoon. Thanks for taking my questions. Well Stu, I have a quick question on the SMA program, how long do you think it’s going to take to get this candidate into the clinic and then can you share with us a potential clinical path to registration statement or registration filing? Thanks.

Stuart Peltz

Management

Sure, so we are working with the Roche and the SMA Foundation on the next steps and they are really putting a lot of resources in to this. This program right now is actually getting a high senior attention at Roche. So that we are confident they are going to move it as ratably as possible. But that's about all that we can disclose about this at this time.

Gregory Wade- Wedbush Securities

Analyst

Okay, thank you.

Operator

Operator

Thank you. I am showing no further questions in queue. I would like to hand the conference back over to management for any closing remarks.

Stuart Peltz

Management

Okay, well thank you operator. As you know I founded the company really with the vision of bringing these medicines to patients with a range of debilitating and fatal diseases, particularly rare disorders and we are very proud of what we and our partners have accomplished so far. We really know that everyday counts for patients living with DMD and CF and so we really look forward to bringing these small molecules to these patients who are declining and their families and their physicians. So thank you again for joining us to our first call and we look forward to speaking with you all soon. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes our program for today. You may all disconnect and have a wonderful day.