Good day, ladies and gentlemen and welcome to the Esperion Therapeutics Second Quarter 2015 Conference Call and Webcast. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. I would now like to introduce you to your host for today's conference, Ms. Mindy Lowe with Esperion. You may begin.

Thank you Christine. Hello everyone and welcome to the Esperion Therapeutics ETC-1002 program update and second quarter 2015 financial results call. I am Mindy Lowe from Esperion and with me today are Tim Mayleben, our President and CEO; Mary McGowan, Chief Medical Officer; Marianne Andreach, Senior Vice President of Strategic Marketing and Product Planning and Rick Bartram, Vice President of Finance. As a reminder this conference call and webcast is being recorded. To access the playback, please go to Investors section of Esperion's website at esperion.com. We issued a press release earlier detailing the content of today’s call can be found at Esperion.com in the Investors section. We’ll begin with prepared comments from our team and then we’ll open the call for your questions. Following today’s call, the management team will be available for any follow-up questions. Please email me directly at mlowe@esperion.com if you’d like to speak with the team. We will use slides for our presentation today. These slides have been posted on our website and are available to those following along throughout today’s live webcast. Our comments today will be governed by our Safe Harbor statement which in summary filed through the course of our presentation and discussion today, we may make certain forward-looking statements and actual results may vary materially. Now I would like to turn the call over to Esperion's President and CEO, Tim Mayleben. Tim?

Thank you, Mindy. Good afternoon everyone. I would like to welcome you to our call and thank you for joining us today as we provide you with an update on the ETC-1002 development program and review our second quarter 2015 financial results. Also on today’s call, we will take some time to address a few topics you have been asking us about leading up to and following the Investor Day we held last Thursday morning. I want to emphasize just one thing before I begin. Our enthusiasm around the 1002 program and its potential to benefit patients is unwavering. If approved, we see a clear place for 1002 as a new oral LDL cholesterol lowering drug. Recall that cardiovascular disease is still the number one cause of death in the US and the cholesterol treatment market is very large and it continues to evolve. Despite the availability of a variety of therapeutic options, there remains a significant unmet medical need for the large number of patients who are still unable to reach targeted LDL levels. Based upon the results from our study today, we continue to see that 1002 is nicely differentiated from all the other current and potential future therapies. So, in addition to the quarterly 1002 program updates and financial results, let me highlight a couple of topics we will cover related to 1002. We’ve received several questions on the topic of the incremental LDL cholesterol lowering efficacy of 1002 on top of low versus moderate intensity statin and so I will discuss some additional insights from the Phase 2b 09 clinical study from a post hoc analysis of these results which as most of you know, which typically be disclosed in a peer reviewed publication or presentation. We will also walk you through our insights into the…

Thank you, Tim. As of June 30, 2015 Esperion had approximately $314 million in cash and investment securities and approximately $5 million in debt outstanding under our existing credit facility. We expect our current cash and investment securities to be sufficient to fund the Phase 3 development programs and our operations through the expected approval of 1002. R&D expense was $7.2 million during the second quarter of 2015, compared to $6.5 million for the second quarter of 2014. The increase was primarily related to R&D costs associated with the further advancement of 1002 and the completion of our Phase 2 development program. G&A expense was $5.3 million during the second quarter of 2015, compared to $2.7 million for the second quarter of 2014. The increase was primarily associated with increased, stock-based compensation expense, public company operating costs and our commercial strategy activities. Our net loss for the three months ended June 30, 2015 was $12.4 million or $0.55 per share, compared to $9.2 million or $0.60 per share in the prior year. We currently have 22.5 million shares of common stock outstanding with another 2.6 million to be issued upon the exercise of options and warrants. Looking forward, we estimate that cash used in operating expenses for the full year 2015 to be approximately $42 million. We also expect to incur approximately $12.5 million of non-cash expenses during the full year 2015, which primarily consists of stock-based compensation expense. We expect to end 2015 with approximately $290 million in cash and investment securities. As I mentioned earlier, we continue to expect our current cash and investment securities will be sufficient to fund 1002 through the completion of the Phase 3 program and our operations through the expected approval of 1002. With that, I will turn the call back over to Tim.

Thank you, Rick. For those of you listening, note that there are, as Mindy highlighted earlier, a few slides that we made on the – in connection with our call today, but for those of you who can’t access those, please don’t worry. First of all, they will be available to you later and second, my comments should be clear enough that you won’t have to have the slides in front of you to understand what we are saying. So as I noted earlier, we have conducted some additional analyzes of the data from our 2009 add-on to statin study. Of particular interest, we did a post hoc analysis of the LDL cholesterol lowering which compared low intensity statins with the moderate intensity statins that is the incremental LDL cholesterol lowering. What you’ll see in the slides is that, there was no statistically significant difference in the reductions between the two groups within the 180 mg dosing arm which is the dose that we are taking into our Phase 3 program and you’ll see further that it was 19% incremental LDL cholesterol lowering on the low-intensity statins and 25% incremental LDL cholesterol lowering on moderate intensity statins. While post hoc in nature, these data are very encouraging as we continue to plan for our Phase 3 using maximally tolerated statin therapy. Let me also highlight that the majority of patients in the 180 mg dosing arm received moderate intensity statin therapy as opposed to the low intensity statin therapies. Now with respect to safety and tolerability in the 09, I would like to remind you that we did not observed any increases in either CPK or liver function test. As you know, increases in CPK indicates potential damage to muscle cells and we didn’t see any of that. There were…

[Operator Instructions] Your first question comes from the line of Jason Butler from JMP Securities. Your line is open.

Hi, thanks for taking the questions and appreciate all of the additional information you’ve given this afternoon. First question, just focusing on the new data that you gave from the 09 study. Acknowledging the patient numbers are not large here, can you speak to whether you saw any differences between the different statins in this trial?

I don’t think we have that level of detail, Jason. I think, generally, the data that we reported is representative of what we saw across the different statins. But I – there is nothing that stands out if you will on the different statins.

Okay, great and then, I guess, pointing to the prior trial, the 007 trial, in that trial, I guess the way we thought about that was, you view it as a two of a ten as a low dose statin. In this analysis, you are including the two of the ten as a moderate dose? Can you just help us understand how you classified the statin doses into low and moderate intensity? And if you – for example, switch it over into the low intensity would there be any – I guess, what I am asking is again, if there are any sensitivity analyses here? If you move different statin doses around as the data still robust?

Yes, I’ll let Mary to comment

So what we decided to do for this analysis was utilize the AKACC guideline to inform us as to what we should refer to as low intensity statin therapy and moderate intensity statin therapy. And to the low intensity statin therapy, it will be a statin therapy that includes – atorvastatin 10, Pravastatin 10 and 20, Lovastatin 20, rosuvastatin 20 and 40 and Pitavastatin 1 mg. In our studies we had only four statins, atorvas simvas resouva and prava on moderate intensity statins, and I’ll just include those that we included moderate intensity statins are defined as atorvastatin 10 and 20, rosuvastatin 5 and 10, simvastatin 20 and 40, and pravastatin 40 and 80. So this is what we used because there – this is in the literature.

Okay, great. Again, just the last questioning, I guess, in clinical practice do you view Atorva 10 as low or moderate and then, if you looked Atorva 10 as low in this analysis would you have seen a difference?

There were so – but I will tell you that Atorva 10, I would consider it to be a moderate intensity statin and Atorva 10 really only had a muscle ache or a muscle on AE in the 10 mg group in a placebo, not.

But I think, Jason, you were asking about the efficacy?

Yes, please.

Yes, so the efficacy of Atorva 10 would fall into the moderate intensity because hat 30% to 50% or 30% to less than 50% on atorva 10 classically lowers LDL of 38%.

Okay, it’s helpful, thank you very much. And thanks for taking the questions.

Thank you, Jason.

Your next question comes from the line of Jessica Fye from JPMorgan. Your line is open.

Hey guys. Just, the questioning around the communication after your end-of-Phase two meeting, I just want to make sure I understand when we could expect an update. Are you not going to wait for the minutes to communicate to the street, i.e. could we hear an update in August, is that what you are saying?

No, I am sorry if I misspoke, Jess, I think, we’ve been saying consistently that we will wait for the meeting minutes to communicate the outcome of the end-of-Phase 2 meeting.

Okay, got it.

And we expect those within 45 days.

Okay, so, second half of September kind of?

Yes, I think that’s the right timeframe to think about.

Okay, and then, since we are going to get the Amgen label between now and then, is there anything that you are watching for in that label? I think that you ran sort of a broader clinical program? Are you expecting any differences between their indication and that for follow-on?

It’s a good question and I think official answer is, we’ll find out on the 27 with everybody else.

Okay, thank you.

Your next question comes from the line of John Accord from Barclays. Your line is open.

Hi, thanks for taking the question. I know there is so much focus on US right now, which obviously is legitimate. But when it comes to oral drugs like ETC, I guess when we look at Zetia, when it comes to the ex-US opportunity, what do you see as the relevant global opportunity ex US versus US? And is there a drug such as Zetia that could be used as a comp to see how such a drug is used in other parts of the world?

Thanks for the question, John. Marianne, can you respond?

Sure. Thanks for the question, John. As we think about what we can expect outside the US, I think as we’ve mentioned before, we are going to – we’ve imitated some dialogue in Europe and we’ve thought about that as Zetima is approved and used throughout Europe. It’s something that we are certainly paying attention to as you’ve suggested, because when you look at statins for example you are most to the merger – most if not all our generic sites at this point and are all reference priced. And as we look at Zetima it actually is a good come for us to start with. So, we’ll definitely be with you.

I guess, two things, one thing I notice is that Zetima’s last year, it was like 45% of the sales reps outside of the US. Is this – how does this if you are willing to say, how does this come into the thought process when you talk broadly with partners in the past? I mean are they – because everybody really just care about US first and rest later or does the profile of the drug outside the US. Is that critically important to the thought process as well?

So, John, this is Tim. So without standing in the shoes of potential partners, I would just say generally that the ex-US opportunity is viewed generally in this therapeutic area as being almost of equal value over the long-term as the US opportunity and I think that’, if you look at the revenue generated by LDL cholesterol lowering drugs, obviously oral, LDL cholesterol lowering drugs I think the revenue would generally support that as well, the revenue generated by the drugs will support that.

Do you feel that the PCSK9s over in Europe, how specially since they have a relatively broad label or broader than – here. Could that change the impact of small molecule drugs in Europe at least in the future?

It’s a very interesting question. Marianne, do you have any initial thoughts?

Yes, that is a great question, John and it’s something that we have thought about a bit. If you think about this we talk about in the US focusing here that we are going to now have a new class of large molecule injectibile biologics. We’ll think about Europe too, and entered which – the one thing we recognized about Europe relative to the US is there seems to be a higher degree of cost containment when it comes to the purchases utilization of pharmaceutical products. So, I think when you look at Europe, the number of prescriptions written for statin is about equal to that of the number of prescriptions written here in the US. So that shows us right away there is a large group of patients, renal patients aren’t necessarily all being treated to go so there is certainly opportunities for new therapies. How Europe and the individual countries are going to look at reimbursement and access relative to the large molecule injectible biologics remains to be seen. But it’s certainly is going to change, could change the phase of treatment in Europe and could potentially have benefits for an oral small molecule like ETC 1002 following them on to the market in Europe.

And if I could make a comment, this is Mary McGowan, John, in my clinical practice and in the practice of my years and I work in cholesterol metabolism, it is very frequent for patients to request an oral agent above an injectible. It is very, very hard to convince patients to initiate an injectible agent when there are oral agents they haven’t yet tried.

Thanks. Tim, if somebody hits themselves with a – 8-K, or just in case, we got to any more of those. No, okay. I’ll get back in queue.

Thank you.

Your next question comes from the line of Michael Yee from RBC Capital Markets. Your line is open.

Hi guys, thanks. A couple questions. In your analysis that you show there in slide 3, is there any thought as to the dose response that you see with the low intensity statin versus why the difference in dose response versus the modern’s intensity statin. Just trying to understand those numbers?

Right and…

What that might be?

Yes, so, Mike, I think you know, it’s very tempting both to us and probably to you as well to what I’ll say is to read too much into these results. First, as we highlighted at the post hoc analysis I think, one of the concerns that we had heard expressed and again, I think this analysis nicely deflects that concern was that we would see a diminution in the – either the incremental LDL cholesterol lowering ETC 1002 as you dosed higher with statins and I think what this analysis does is, it show that that is not happening and again, if you read – again if you are tempted to read too much in it, you could even say that mainly there is a signal to the opposite and that’s why I say, we are trying to be very balanced because first of all, it’s a post hoc analysis, it’s not pre-specified and as I think Mary highlighted earlier, the numbers overall are small but it’s as we said it’s encouraging. It’s encouraging.

Yes, the point is that there is not a difference in totality.

Yes, that’s right. I think that’s right.

If the – in the upcoming announcement post you are on the Phase 2 meeting is there any chance that the FDA asks you to run some form of a Phase 2 3 study with maximally tolerated or high intense statins, what do you think the chances are?

It’s a very good question and we don’t know. We don’t think so and the reason – the reason we – again, we don’t know for sure, but the reason that we feel comfortable as I said in our prepared comments is, as we’ve gone from low-dose – low intensity statins to moderate intensity statins, we continue to see the efficacy and we don’t see any change in any of these safety or tolerability aspects and I think that’s one of the reasons that we had seen something we might – we and others might be concerned about us going to the high intensity statins, but given this very attractive safety and tolerability profile that we’ve seen, we don’t think so,. We think it’s the next natural progression is to study these patients and of course they will be monitored in our Phase 3 program. So, but we’ll see, we’ll certainly report back on that if that’s the case.

Okay, last question is regulatory in the US if Amgen gets the same label as generally with in terms of secondary prevention, will that change your view on your ability at primary and secondary, given that, say had a very balanced population of that and then in Europe same question, but more positive is that, following along on the other question, do you believe that there a broad label there, just basically regulatory bar can you see here – I mean, they even call it statin – so two different size of the Atlantic? How do you see?

So, you may have heard me say last week, we want to banish both broad and narrow from our –often and instead, really focus on the patient population. So, I think to your question about the PCSK9 label, keep in mind that I think the – and we’ve done some further analysis of this, but I think the estimates that we’ve seen are that that is 8 to 10 represents 8 million to 10 million patients in the US and even if we – again just to put this in perspective, even if we think about just an oral LDL cholesterol lowering therapy, that represents roughly a $16 billion to $20 billion market opportunity. So…

I am good with it. I just want to understand if that would change your thinking, because clearly they ran a broader population of mixed patients and they dealt maybe it’s going to be a class label – I just understand, I agree to be population is one of the things that change would be.

Yes, I think, we will learn, I know, and I am not trying to be evasive although it’s I think you are going to – you may think that, but I think, we are so close to being informed by our End-of-Phase 2 meeting that I don’t want to speculate when I know we are going to have this information in a matter of weeks. And, that is both our End-of-Phase 2 meeting as well as the Amgen label as you said.

Okay, and then on the Europe side, sorry that was it, just the Europe side, is the hurdle lower because of the label they gave there including statin tolerance. Do you see that is opposite?

I’ll ask Marianne to come in if you don’t mind Marianne?

Yes, no problem, Tim. Mike, it was – it’s interesting to see the difference. I think that, as we continue moving forward, the idea that we already know that has a specific indication in the Europe, specifically in France towards statin intolerance. So we knew that from a regulatory perspective, there could be a difference in how they look at program. So, as we move forward in our planning with respect to Europe and where we intend to seek scientific advice, I think that will truly help guide us in what we are thinking about but seeing what’s already happened to-date with the PCSK9,. So certainly really helpful to us as we think about what the European opportunity might really look like.

Okay, thank you guys.

Thank you, Mike.

[Operator Instructions] Your next question comes from the line of Andrew Peters. Your line is open.

Hey guys, thanks for taking my questions and I thank you again for all the clarity on the call. Just wanted to touch on something that you mentioned last week at the Analyst Day the potential for running a concurrent Phase 2 study is – that could read out next year along with the Phase 3 program. I was hoping for a little bit more detail on today’s call, so, can you outline your thoughts on additional kind of clinical work beyond discussed the Phase 3 plan right now and potential timing around this?

Yes, thanks, Andrew. So, yes, I think we had talked about the fact that we have interest in what I’ll say is, further expanding the profile of ETC 1002 by looking for example, I’ll just give you one example is, looking at ETC 1002 in a defined Phase 2 study on what we refer to as triplet therapy, triplet oral therapy looking at 1002 plus a statin and plus Ezetimibe. And really the goal there for example would be to characterize the total LDL cholesterol lowering of the three oral drugs combined. And of course continuing to evaluate the safety and tolerability profile. So, that’s just one for example, I think, we are very much in the evaluation and discussion phases of that and I think as you guys know, we try to be as transparent with you all as possible. But our immediate focus, as our maniacal focus as you’ve heard us say, is really on the End-of-Phase 2 meeting and successfully executing on the launch of the Phase 3 program. So, I think on our call in November, we will have more details, Andrew for you and others about, not only the details about those studies, but also as you requested the timing of those studies as well.

Great, thanks and a quick question on the accelerate cardiovascular outcomes trial, you’ve kind of gave your initial thoughts on the potential size of one at the Analyst Day, just wanted to see if – how your financial guidance could potentially change if FDA suggested a larger outcomes study would be needed in terms of guidance for sufficient through an NDA? Thanks.

Sure, so, maybe I’ll just take the opportunity, Andrew with your question about the CD outcomes trial. Just to remind folks that what we suggested is, our initial estimate is that we would include about 12,500 patients in our cardiovascular outcome study and that we are thinking about the initiation of that in late 2016 or the first half of 2017. I think some folks have raised the question of whether that the size of that cardiovascular outcomes trial is adequate or not especially in the context of other CD outcomes trials that are currently being run by other LDL cholesterol lowering drugs ranging from 18,000 to perhaps 30,000 patients in the case of one of the CETP inhibitors. But, I would just point everybody for context to one of the CETP inhibitor outcomes trial that is ongoing, and call the accelerate trial and just highlight that that study includes its – trials it includes about 12,000 patients. It has a very good definition of an endpoint as well in that study and of course that study has been deemed adequate by the regulators and I think, the – what is a imitation in the sincerest form of flattery, we have looked at that study and we think that it is a very efficient and appropriate study to consider for ETC 1002 as well. We have not, Andrew, looked at what the financial impact would be of a larger study, simply because we’ve got this very relevant, very appropriate comparator in the accelerate study.

Great, thanks.

Your next question comes from the line of Chad Messer from Needham & Company. Your line is open.

Great. I wanted to thank you guys for giving the best data-driven and so you got off to the question of statin interaction on those post hoc kind of analyses aren’t perfect, but as one of the people who was asking questions about that’s probably about all you could have done and just thanks for being so responsive on that.

Sure, thank you.

As we look forward to the End-of-Phase 2 meeting and I know this team has been in front of the FDA quite a few times and has experienced with this kind of thing. How confident are you that we’ll get a pretty clear answer, not asking to speculate on what the answer is, but just, this is in a SPA negotiation or anything, it’s just an End-of-Phase 2 meeting. A clear answer on what the CDOT requirements are? Do you think it will be pretty black and white or is there chance that there would still be some grey zone?

Chad, it’s a very good question and I think, I’ll just highlight something on I said earlier which is that, there this summer has, I think if it has revealed nothing else, it has revealed that we are in what appears to be an evolving landscape. I think as we highlighted, the initial advisory committee meetings and then the recent label for another LDL cholesterol lowering drug proved to be somewhat surprising. Again, although as I said, the overall market opportunity has not changed, but it certainly appears that there has been some evolution and we – having said that, we feel very confident in – on our team’s ability to navigate that, especially as I highlighted earlier with Ashley joining our team and having some very recent and relevant experience leading a similar effort. So, more to follow when we report on the End-of-Phase 2 meeting results. But, I hope those comments were at least a little helpful.

Yes, thanks, it’s – that is helpful. Obviously, hoping we have the answers that investors want and not necessarily something grey, but life is what it is and we’ll have what we have when we have it. Thank you.

Yes, I think, just one other comment, Chad, which is that, I think sometimes the worst thing is the uncertainty and again having the End-of-Phase 2 meeting and being in a position to communicate those results is a great thing. So, we are definitely looking forward to the meeting and even more so looking forward to communicating the results.

Great, thank you.

Your next question comes from the line of Vamil Divan from Credit Suisse. Your line is open.

Hi guys, this is Lee Guo calling in for Vamil. I guess, our questions, most of our questions has actually been asked and one follow-up question is really regarding the comments between the interaction between ETC 10-02 in statins. I know you guys classified a 70% as a weak interaction. Is that something that the FDA has issued a guidance on or is that more of your view on the actual interaction?

Yes, that’s a good question, Lee, and I think the answer is that, it is – it’s a relative term not a great term because, weak versus strong, et cetera. There is some limitations to its use. That’s why we’ve generally referred folks to the percentage levels or the multiple levels. So as I said earlier, we are seeing a 0.7 increase versus a 4 to 5 times increase with other drugs on the labels or even as high as 30 times. We refer to those as 400%, 500% versus the 70%. So it’s, you are right, it is an imprecise term, but it was a – it is a relative term, relative to the other interactions that you see on the labels and that’s really all we were trying to do is to provide some context and, yes.

That’s great. Just a follow-up on that question. I know, you provided us a great level of information today. I just wanted a question about whether the interaction between low intensity versus moderate intensity statins change as you get to higher levels, is it the same 70% or do you see any change in terms of that interaction?

Great, so, in a drug, drug interaction study, you don’t – that’s not one of the outcomes that you can derive. So, we believe it will be the same and again it’s even our belief is based on tremendous experience, not only obviously in developing LDL cholesterol lowering drugs like Lipitor which our teams did. But, which many of our teams did, but also, obviously the involvement in the development of ETC 1002.

Okay, perfect. Thank you. I appreciated it.

You are welcome.

We will now conclude the Q&A portion of the call. As mentioned earlier, please email Mindy at mlowe@esperion.com if you have any questions from today’s discussion. Now I would like to turn the call back over to Tim Mayleben for closing remarks.

I want to thank you for joining our call today and for your continued interest in 1002 and your support of Esperion. I also want to extend my thanks to each Esperion colleague, we wouldn’t be here without their hard work and their passion to bring 1002 through development and approval. As you’ve heard we say before, we are truly blessed by all of their efforts. We look forward to continuing to update you on our progress throughout the rest of this very exciting year. Thank you.

This concludes today's conference call for Esperion Therapeutics. You may now disconnect.