Esperion Therapeutics' (ESPR) CEO Tim Mayleben on Q2 2014 Results - Earnings Call Transcript

Aug.12.14 | About: Esperion Therapeutics (ESPR)

Esperion Therapeutics, Inc. (NASDAQ:ESPR)

Q2 2014 Earnings Conference Call

August 12, 2014 04:30 PM ET

Executives

Mindy Lo – Investor Relations

Tim Mayleben – President and CEO

Roger Newton – Executive Chairman and Chief Scientific Officer

Marianne Andreach – VP, Strategic Marketing & Product Planning

Rick Bartam – Controller

Narendra Lalwani – EVP, Research and Development and COO

Analysts

Jason Butler – JMP Securities

Jonathan Eckard – Citi

Jeremiah Shepard – Credit Suisse

Operator

Good day, ladies and gentlemen and welcome to the Esperion Therapeutics Second Quarter 2014 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 follow at that time. (Operator Instructions). I would now like to introduce your host for today's conference Ms. Mindy Lo with Esperion. You may begin.

Mindy Lo

Thank you Andrew. Good day, everyone and welcome to the Esperion Therapeutics second quarter 2014 earnings call. I'm Mindy Lo from Esperion and with me today are Tim Mayleben, our President and CEO, Roger Newton, our Chief Scientific Officer, Marianne Andreach, our Vice President of Strategic Marketing & Product Planning and Rick Bartam, our Controller. We are also joined by the newest member of our team Narendra Lalwani, Esperion's, Executive Vice President, Research and Development and Chief Operating Officer, As a reminder, this conference call is being recorded. To access the playback of this webcast, please go to the Investor's Section of the Esperion website at esperion.com.

I would like to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements, due to the risks and uncertainties associated with the company's business.

These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, August 12, 2014. Esperion undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. We issued a press release earlier today detailing the content of today's call. A copy can be found at esperion.com within the investor's 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 question. Please be email me directly at mlowe@esperion.com and I will scheduled 15 minutes for you and the team.

Now I'd like to turn the call over to Esperion's President and CEO Tim Mayleben. Tim?

Tim Mayleben

Thank you Mindy. I hope you are all enjoying the summer and I'd like to welcome you all to our call and thank you for joining us today as we provide you an update on our second quarter of 2014. Before we get started, I wanted to provide a brief introduction of Dr. Narendra Lalwani, who as Mindy mentioned in Esperion's new Executive Vice President of Research and Development and Chief Operating Officer.

For those of you, who may not remember? Narendra worked with Roger, Marianne and others on the development of Lipitor at Warner-Lambert/Parke-Davis. He was part of the original Esperion, where he was Vice President of Drug Safety until its acquisition by Pfizer in 2004 and most recently was Chief Scientific Officer at Cerenis Therapeutic.

We are happy to have Narendra back with the Esperion team and we welcome his deep drug development experience and key insights as we advance the development of ETC-1002. As many of you know, we held our inaugural Analyst Day two weeks ago. A lot of material was covered during almost 3.5 hours of presentation by several of the world's leading experts in their fields.

Perhaps the session has been very well received and we heard from many of you, that you came away with new insights and answers to many of your questions. with that in mind and for those of you, that weren't able to attend or watch the webcast yet. I want to start today's call by providing just a few highlights from that event.

Next I'll provide a brief update on the 1002 development program and remind everyone of the key dates for our upcoming results and milestones. Rick will review highlights for the second quarter 2014 financial results and then, we will open the call for your questions. so let me start with highlights from our Analyst Day, Dr. James McKenney kicked off by reviewing the long history of LDL cholesterol as a biomarker.

He then provided really a history lesson in LDL cholesterol management reminding us that 1985 marked the inception of the NCEP or the National Cholesterol Education Program and also the Adult Treatment Panel I guidelines, which were the first ever LDL cholesterol guidelines.

He also reminded us that there has been a 60% reduction in gas from cardiovascular diseases over these past 30 years. really since the initiation of the NCEP, but even with all that progress cardiovascular disease is still the number one cause of death in the US today and LDL cholesterol is the number one modifiable Lipid risk marker, which is why we are focused with 1002 unlowering [ph] LDL cholesterol.

Finally, he reviewed and provided perspective on the1002 development program to-date which includes seven completed Phase 1 and Phase 2a clinical trials. Dr. Mark McGovern the podium and reviewed Esperion's three ongoing Phase 2 clinical trials of 1002 and importantly provided some context both as a physician and as a very successful Lipid drug developer for each of our ongoing clinical trials.

For the first time, he also summarized our initial thoughts on the Phase 3 programs for 1002 in statin intolerant patients. Next Dr. Jamie Underbird [ph] spoke about statin intolerance from a practicing physician's standpoint. He emphasized that statin intolerance is a real problem and his best estimate is that, 10% of patients who have taken a statin are statin intolerant.

This based on only and what he have seen in his own patients, but also his review of the medical literature. A video on statin intolerance featuring Dr. Paul Thompson, who you guys should probably remember from the AHA, 2013 is from Hartford Hospital, is an expert in statin intolerance and he was featured in this video, along with two patients from Dr. Thompson's practice, who are statin intolerant and for the first time, as we'd like to say, help put a face on statin intolerant.

I encourage you to watch the video, if you haven't had a chance to see it yet. After a short break, Dr. Greg Steinberg and Esperion's Steve Pinkosky, outline the novel first-in-class dual mechanisms of action of 1002. For the first time for analyst and investors, they revealed the more than 40-years history of ATP citrate lyase as a validated target for Atherosclerosis research and the more recent and intensive research in the AMP kinase at the validated target.

They also spoke about the relevant for this research to Atherosclerosis and LDL cholesterol and it's translation to our current results. And finally, Dr. Peter Libby, the world's leading expert on inflammation and cardiovascular disease, spoke about the importance of inflammation in Atherosclerosis and why lowering hsCRP, a key risk marker of inflammation, is so important to the management of cardiovascular disease risk.

Of note, only statin's and 1002 have been shown to consistently lower both hsCRP and LDL cholesterol. As I highlighted during the analyst event, interest in 1002 is continuing to build and we think there are number of reasons for that. first, 1002 is novel and its first-in-class and we are way ahead of anyone else in development.

As I mentioned, ACL and AMPK are well validated drug targets.1002 is an oral, once-daily, till NA bottle, which is the standard of care in all of the successful LDL lowering therapies where convenience of dosing and ease of administration has always been important in this area. The thing you have to remember about this disease is that, unlike diabetes for example patients with high LDL cholesterol or Atherosclerosis typically don't feel bad, if they don't take their medication, so convenience of dosing is important.

1002 is a small molecule, with low relative cost of goods and this is important in what we are seeing as an increasingly economically constrained payer environment. The Phase 1 and Phase 2a data for 1002 have been very promising. 1002 lowers LDL cholesterol by 27% to 40% and hsCRP by a similar amount.

The only drug, other than statin will consistently do both. 1002 has been very well tolerated especially notable in statin and tolerant patients. And 1002 is in a late-stage clinical development program unlike many therapeutic indications LDL cholesterol is a well validated biomarker and 1002 lower LDL cholesterol 27% to 40%, with LDL cholesterol lowering therapies, which you have to remember is that what you see from an efficacy standpoint in Phase 1 and Phase 2a is what you see in Phase 2b and Phase 3.

The past FDA approval with LDL cholesterol lowering is well-trodden plus 1002 low as hsCRP similar to statin and from a safety standpoint has demonstrated positive effects from blood pressure, another very well accepted biomarker for lowering cardiovascular disease risk.

Finally, as we heard of the analyst day. Statin intolerance is real and it's a huge and growing problem. So let me walk through some numbers for perspective. You heard me say, 70 million people in the US have high LDL cholesterol level or hypercholesterolemia. Approximately half of 35 million people need to take therapies to lower their LDL cholesterol levels and corresponding reduce the risk of cardiovascular disease.

Now we are the first to acknowledge because of our history in this therapeutic area, that most patients can take a statin, but with those numbers and up to 10% of patients not being able to tolerate statin at any dose and many others only able to tolerate statin's at a low to moderate dose, that don't get them to their LDL cholesterol lowering goal, this has affected 2 million to 7 million patients.

Statin intolerant patient and their physician, which is you heard me say are most typically lipidologist and specialized cardiologist any new alternative inexpensive oral therapies that can provide them statin like or 30% to 40% lowering of the LDL cholesterol and hsCRP levels, but without the side effects that they experience with statin.

We believe that 1002 can fill that need; we believe that 1002 can be that alternative and we believe that 1002 is the right drug and development for LDL cholesterol lowering at the right time for this statin intolerant patient population.

A patient population that it has high and met need and reserves more effective better tolerated oral therapies. So let me shift gears now and briefly update you on the 1002 development program. Our largest clinical trial, the 349 patient Phase 2b 008 statin intolerant study has completed last patient, last visits and our COO has begun the trial wrap of activities.

We are on target, to report top line results from this study in early October. Our second phase 2b clinical trial, though 132 patient 09 add on to statin study will complete screening and randomization of patients this quarter. now this is a few weeks behind, where we had hope to be and as a result, we are now projecting the 09 top line results will be available in Q1 of 2015 rather than the very end of Q4, 2014.

Finally, our third ongoing Phase 2 clinical trial, the 144 patient 014 study and patients with both hypercholesterolemia and hypertension was initiated earlier this quarter. enrollment has started out well and top line results are expected to be available in Q2, 2015.

Shifting gears once again to the non-clinical front. We told in May, that the long-term safety reports were complete and we can now tell you that they have been submitted to the FDA at the end of June. Finally, I'm pleased to report that we are on target to complete and submit reports from our 2-year carcinogenicity studies to the FDA in December of 2014.

These are important milestones in the continuing development of 1002 and all of them serve to continue to enhance the value of 1002 program. The bottom line is this; we grow ever more confident that 1002 could play an important role in cost effectively and conveniently providing LDL cholesterol lowering to patient with hypercholesterolemia and a history of statin intolerance. A patient population with a very high level of unmet medical need.

I will turn the call over to Rick for review of the financial highlights from the second quarter. Rick?

Rick Bartam

Thanks, Tim. As of June 30, 2014 Esperion had approximately $67 million in cash and investment securities and approximately $5 million in debt outstanding under our new credit facility. Our net loss for the six month ended June 30, 2014 was $17.1 million compared to $11.2 million in the prior year comparative period.

The change was primarily related to increases in R&D cost of the advancement of 1002 in the 08 and 09 studies and increases in public company operation costs. We currently have 15.4 million shares of common stock outstanding with another 1.8 million to be issued upon the exercise of options and more.

Lastly, I want to make a few final comments for those of you with financial projection models for our business. As we reported earlier today, EPS for the three months and six months ended was a loss of $0.60 and $1.11 per share respectively.

We expect our R&D cost for the remainder of the year to be approximately $18.5 million. We expect our G&A cost for the remainder of the year to be approximately $5 million. We also estimate our full year EPS will be a loss of approximately $2.60 per share. As we stated on our last earnings call, we continue to expect our current cash, cash equivalence and investment securities will be sufficient to fund our operations in early 2016.

With that, I'll turn the call back over to Tim.

Tim Mayleben

Before, we open the call to your questions. let me just highlight a few of key dates or reiterate a few of the key dates for the month ahead. In early October, 2014 we will report top line results from the Phase 2b 08 clinical trials in statin intolerant patients.

In December, 2014 we will submit the 2-year carcinogenicity reports to the FDA. In Q1, 2015 we will report top line result from the Phase 2b 09 add on to statin clinical trials. And in Q2, 2015 we will report top line results from the Phase 014 clinical trial and patients with hypercholesterolemia and hypertension.

As you can tell from our comments today, Esperion will continue to report very meaningful data from the 1002 development program each quarter over the next year. We will now open the call to your questions. Andrew, if you will please pull for questions.

Questions-and-Answer Session

Operator

Certainly. Ladies and gentlemen. (Operator Instructions) and I'm showing, our first question or comment comes from the line of Mr. Jason Butler with JMP Securities. Your line is now open, sir.

Jason Butler – JMP Securities

Congrats in the progress this quarter. just first question on enrollment in the 009 study. Anything, anymore color there that you can give in terms of, you had any challenges specifically enrolling patients or is it simply that your estimates were just a low on the aggressive for the enrollment period?

Tim Mayleben

This it Tim, Jason. Thanks for your question, I'll start out and then Narendra if you want to add anything, please do. The bottom line is that, in any of these trials, we make estimates in terms of the number of patients and screen failure rates and number of centers; we need to accomplish our goal over a certain time frame in enrollment goal over certain timeframe and in our case.

I think in the 09 study, we started out with perhaps too few centers. We started out, I think with about 30, 25, 30 centers. We've subsequently bumped that up to about 40 centers and have experienced much better enrollment by the increased number of centers, but I think again, our estimates perhaps were a little bit more aggressive and again it's not a huge delay, but because of the original timing of the 09 results, I think we have pretty consistently said by the end of the fourth quarter, 2014.

Any slippage in the time frame was going to push the results into the early part of the first quarter of 2015 and that's exactly, what we are seeing. So we've seen much better enrollment like I said, we got off to a little bit of slow start by not having enough centers and estimating a screen failure rate that was a little bit on the lower side compared to what we actually experience and so that's the result and that's, that maybe more detailed than you were looking for, but that's the bottom line.

Jason Butler – JMP Securities

It's helpful, thanks a lot, Tim and then just on the study on hypertensive patients. Can you just give us a little bit more color on the rationale for that study and the data that you have so far, that supports why you think, 1002 can be useful in that patient population?

Tim Mayleben

Sure, thanks again for that question Jason. As we have been saying, we are not; we are definitely not developing a hypertensive drug. So, maybe just to start out with that, definitive statement on to take folks back to the Phase 2a clinical program, we did a safety analysis of what pressure in the Phase 1 and Phase 2a results, when we look at the Phase 2a results a retrospective analysis, we notice that not only were we not worsening the blood pressure in these patients, but in patients that had higher levels of blood pressure, not necessarily hypertensive but had greater than normal levels of blood pressure.

We were actually reducing systolic blood pressure in a statistically significant manner. So as is common when you see a retrospective analysis and you're doing good drug development. We turn that into a prospective hypothesis and that's the hypothesis that we are testing in 014 study to look specifically at patients that not only have hypertension but also hypercholesterolemia as you may recall Dr. Mark McGovern had reminded us that the overlap for those two conditions is something on the order of about 45% to 50%.

So they're co-morbid conditions in many patients. So we look at blood pressure as a safety measure of safety. It's also of course the one of the most well validated and well accepted biomarkers for cardiovascular disease risk that as if you lower the blood pressure, it is well accepted among thought leaders and FDA that you're also lowering cardiovascular disease risk and so we think in the case of 1002, if we can show as we did retrospectively.

If we can prospectively that ETC-1002 lowers blood pressure in this co-morbid population that is an exclamation point, if you will on the safety that we've seen so far in the 1002 development program.

Jason Butler – JMP Securities

Great. Thanks a lot for the color, there Tim.

Operator

And the next question or comment from the line of Jonathan Eckard with Citi.

Jonathan Eckard – Citi

Hello?

Operator

One moment please. And your line is now open, Mr. Eckard.

Jonathan Eckard – Citi

Hello, guys. Can you hear me?

Tim Mayleben

Hi, Jon. Yes.

Jonathan Eckard – Citi

So thanks for the introduction. Tim, I don't want to distract from your programs by talking about other programs such as the PCSK9s, but I would like to know when we have details from the IMPROVE-IT trial and when we have details from some of these PCSK9 trials, what are the things that you guys are most looking for to, not with regards to competitive landscape, but with regards to regulatory kind of reception broader landscape [ph] type of things, what are some of the findings bigger picture findings you're hoping to learn from both IMPROVE-IT and some of the PCSK9 data?

Tim Mayleben

And that is a great question, Marianne; can I ask you take initial crack at that question?

Marianne Andreach

Sure, Tim. Thanks. Hi, Jon. How are you doing?

Jonathan Eckard – Citi

I'm doing well, thanks.

Marianne Andreach

We are paying a lot of attention to IMPROVE-IT as well as the PCSK9 trial that will be reporting out between now and the end of the year. As you probably thought, today it was announced that the IMPROVE-IT results are going to be presented at the American Heart Association as well as a study from Sanofi, Regeneron on their PCSK9 in patients with statin intolerance.

So we look at those studies with as you would suspect a high degree of interest. IMPROVE-IT is a study that's out there to test the hypothesis of the addition of ezetimibe to Statin. So we are able to align more about what we might possibly see when you put those two therapies together and whether or not the additional LDL cholesterol lowering provided by ezetimibe actually would translate into clinical outcome reduction.

No one knows that happens we will see that and learn that from the results of the study. From the PCSK9 prospective especially thinking about the study that Sanofi, Regeneron is presenting. Is clear from the title of the talk, that's going to give at AHA that the design of this is different from other statin intolerant studies that we have seen before and that they happened after control arm of statin in the study.

So it will be interesting to see, not just the efficacy in that study, but the safety perspective and thinking about then what that's going to mean going forward for companies getting indication specifically to reduce elevated LDL cholesterol's in patients with hypercholesterolemia, who have the history of statin intolerance.

Jonathan Eckard – Citi

That's great.

Tim Mayleben

One other thing, Jon I just wanted to mention that build on, what Marianne was saying, I think one of the things that we always try to remind folks, we think that 1002 is well differentiated from for example the PCSK9s that are in development because we keep saying to it's an oral therapy and the tradition of all of the successful LDL cholesterol lowering therapies in the history of the world, that's one point of emphasis.

I think secondly that, we lower both LDL cholesterol and hsCRP and then finally, that in a payer constraint, what we are seeing is an increasingly economically payer constraint environment that relatively lower cost, small molecules we think will always have a place in the treatment armamentarium for physicians and then from a regulatory standpoint, we always folks on the team have been around long enough to remember that, the LDL hypothesis that lowering LDL cholesterol leads to lowering the cardiovascular disease risk is not just the been the statin's but there have been other therapeutic alternatives that have provided that same lower LDL cholesterol.

We also get a reduction in cardiovascular disease risk and so we like to remind folks that we are, in statin tolerant patients by definition not catch thing the same hypothesis that IMPROVE-IT is, which on top of statin or the some of the other recent trials, whether it's AIM-HIGH or HPS2-THRIVE. All of which were testing a different hypothesis than the one that we are testing in, statin intolerant patients which is, primary LDL lowering and a patient population that has a very high level of unmet medical need is demonstrated by the very high baseline LDL levels, you have seen not only in our trial, but in the trials the other statin intolerant trials that have been in this therapeutic area.

So we try to differentiate that the hypothesis that we are testing is different than perhaps what the PCSK9 sponsors are doing or any of the recent trials have done, which is always been testing this hypothesis of incremental LDL cholesterol lowering on top of statin, that's clearly not our focus with statin intolerance.

Jonathan Eckard – Citi

Perfect and then one question, is that some of the other again the PCSK9s and the design of their statin intolerance trials. It seems like, in a definition of statin intolerance, they have been doing a little bit of back pedaling with regards, what they initially did versus the FDA's definition of statin intolerance.

I was wondering, could you outline a little bit of the nuances of your trial design statin intolerance because you guys have both statin tolerant and intolerant patients. Could you maybe articulate some of the potential benefits of including both those populations and how the findings from this trial could provide you a little bit more insight and maybe somehow, how the other statin intolerant trials have been designed?

Tim Mayleben

Sure. It's a very interesting question and I appreciate you bringing that out, Jon. So again just to take folks back, so in our 08 study as Jon mentioned, we are including both statin tolerant and statin intolerant patients in the same study as far as we can tell from viewing the literature, this is never been done before that is looking at both statin intolerant and statin intolerant and I just want to highlight that the definition of statin intolerants that we are using is the one that is been promulgated by FDA and has been provided not only to us but our understanding is to others that are developing therapies in this space as well and that is failure on two or more statin's.

One at the lowest approved dose, secondary to muscle pain and muscle weakness. With that muscle pain and muscle weakness, dissipating with the cessation of therapy. So that's the FDA's definition of statin intolerance.

So coming back to the 08 study, we are looking at patients that need that definition 50% of the patients in the trial meet that definition. The other 50% of the patients are just hypercholesterolemic with no evidence of statin intolerance and the value of that is, for the first time to see the same trial, whether patients who are statin intolerant respond the same or different to our therapy or our therapy or the active control which is ezetimibe or the combination of the two.

So we will get some insight into the difference between those two patient population or if there are any differences, Jon and again because the study has never been done before, the hypothesis is never been tested. We don't know, the world doesn't know, we are going to find out and the world is going to find out.

I think, the other benefit of the trial design is in our case at the Phase 2b study, it's specifically looking at the 120 mg dose and 180 mg dose of Etc-1002 and then looking at those same doses in combination with ezetimibe. So in the case of the trial, we will get some insight into the doses that we should use in our phase 3 program and which is again a dose range finding experience that we're going through in the Phase 2b program.

So we'll get insight into dosing levels for the Phase 3 program.

Jonathan Eckard – Citi

All very helpful. Thank you so much.

Operator

And our next question or comment comes from the line of Brian Klein with Stifel. Your line is now open, sir.

Unidentified Analyst

Hi, this Colin Mackie [ph] in for Brian Klein. Thanks for taking the question. So I have question for you all about the safety data, the long-term chronic toxicology data and the carcinogenicity data. I'm just wondering, if will be able to see it before you submit it to the FDA and then to follow-up with that, I know that you said at your Analyst Day that one of the key objectives for your Phase 3 program will be coming up with a safety database.

So wondering if you are using the results to kind of start that process, inform that process and how you might structure the database and in general, what your thoughts are there going into Phase 3?

Tim Mayleben

Sure, Colin I'll take the last question first and then Narendra, I'll ask you to respond to the first question, after I finish on the last one. so just to remind folks, at the end of our Phase 3 program our human safety database was approximately 317 patients on drug for periods up to 12 weeks and up to 240 mgs.

We said by the end of our Phase 2b program, we will have approximately 750 patients to 800 patients who will have then on drug and we will have more than tripled the exposure. So by that is the patients who have drug exposure.

So by the end of our Phase 2b program and the end of Phase 2 meeting, we will be bringing a quite a substantial human safety database to our end of Phase 2 meeting as I said, 750 patients to 800 patients on drug for periods as long as 12 weeks. In fact, most of the patients will have been on 12 weeks of therapy and then we will continue to build on that safety database in our Phase 3 program.

I think Dr. McGovern at the Analyst Day as you had referenced had given some indication of what the Phase 3 program would look like and we're not being real specific about numbers at this stage probably simply because that will all come clear as a result of our end to phase 2 meeting with FDA, but we're experienced lipid regulating drug developers that's what we have on the team.

We certainly understand what the requirements are, we certainly understand what the history is and so I think we have a good feeling for what that is and as we get closer to our end of Phase 2 meeting, we should have better estimates for you. With that, let me turn it over to Narendra to comment on the non-clinical.

Narendra Lalwani

Yes, thanks. Tim, As Tim mentioned earlier, we are submitting chronic drugs safety study data to FDA in June and we are going to resubmit in on the carcinogenicity study data in December, 2014. We are not expecting to have any discussions before end of Phase 2 meeting with FDA. So understand the program was continuous planned.

Operator

All right and next question or comment comes from the line of Mr. Jason Kantor with Credit Suisse. Your line is now open, sir.

Jeremiah Shepard – Credit Suisse

Yes, this is Jeremiah. Can you hear me?

Tim Mayleben

Yes, hi. Jeremiah.

Jeremiah Shepard – Credit Suisse

Yes, this is Jeremiah filling in for Jason. Thanks for taking our questions. regarding the meeting with the FDA in the Phase 2 meeting with FDA, what events do you need to completely in order to schedule that, is that just is studies 014, the last getting event until you final data handed, to do so.

Tim Mayleben

Thanks for the question, Jeremiah. Narendra, do you want to take that one as well?

Narendra Lalwani

Yes, right now we are planning end of Phase 2 meeting towards the end of second quarter, 2015. For this particular meeting, the main focus is going to be on what kind of Phase 3 clinical plans they want to have for approval. In order to achieve that, we have completed several Phase 2a and Phase 2b studies. Finally the 08 and 09 data will be included in this and we will definitely bring human safety database up to 014 study also in this meeting.

Along with that, we will definitely do such on the non-clinical studies that have been completed to-date to support development of this program. We are confident that with this package together, we will make progress to move the program into Phase 3.

Jeremiah Shepard – Credit Suisse

Follow-up to that, whenever the FDA is considering looking at clinical hold, do they traditionally communicate that at the meeting or just something that follow sometime after the meeting?

Narendra Lalwani

At this time, I don't think we can make – we cannot expect how they're going to communicate, but we are planning to have the issues address by that meeting.

Jeremiah Shepard – Credit Suisse

And this is last question, regarding studies 008. In regards to the combo arms with 1002 was Zetia, I know that they're relatively small patient numbers. Is there a certain threshold that would beat your interest in make you just pursue that type of regiment further?

Tim Mayleben

Jeremiah, this is Tim. I would say, there are two, not just two there are multiple factors that we will consider as we explore that potential for combination. First, I think you want to recognize that this initial look is very exploratory as you noted the numbers are quite small, 20 patients to 30 patients in each of those arms.

So a total of 50 patients to 60 patients of combination therapy. So we'll be looking at those numbers, but again we view them as exploratory, I think the other thing we are keeping our eye on of course is the acceptance exogenously of Zetia or the continued acceptance of Zetia.

It is as you and all of us know, it has become the standard of care for statin intolerant patients and some part because there are as we have seen saying they are just not very good options to statin's available in the market today. so we will keep an eye on the market. We will certainly keep an eye on how the dialog around Zetia when the IMPROVE-IT results come out and then the results from this exploratory arm as well.

So more to follow on that, but we are definitely looking for additional, we're very data driven on these kinds of things. So will be looking for additional data on multiple fronts to help inform that decisions.

Jeremiah Shepard – Credit Suisse

Thank you for taking the questions.

Operator

I'm showing no further questions or comments at this time and with that, we will now conclude the Q&A portion of the call. As mentioned earlier, please email Mindy Lo at mlowe@esperion.com. Schedule a follow-up call with management if there are any questions from today's discussion. Now I'd like to turn the call back over to President and CEO, Mr. Tim Mayleben for closing remarks.

Tim Mayleben

Thank you, Andrew. I want to thank everybody for joining the call today for your continued interest in 1002 and Esperion. As we have been saying, the next several months are going to be very eventful and we look forward to continuing to update you on our progress. Thank you again.

Operator

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

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