Esperion Therapeutics Inc (ESPR) 2015 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Esperion Therapeutics First Quarter 2015 Conference Call. (Operator Instructions) I would now like to introduce your host for today's conference, Ms. Marianne Andreach with Esperion. You may begin.

Thank you, Carmen. Hello, everyone, and welcome to the Esperion Therapeutics ETC-1002 Program Update and First Quarter 2015 Financial Results Call. I am Marianne Andreach from Esperion, and with me today are Tim Mayleben, our president and CEO, and Rick Bartram, Vice President of Finance. As a reminder, this conference call is being recorded. To access the playback, please go to the Investors section of Esperion's 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 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, May 7, 2015. 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 detailing the content of today's call. A copy can be found at esperion.com within the Investor section.

We will begin with prepared comments from the team and then we will open the call for your questions. Following today's call, the team will be available for any follow-up questions. Please email me directly at mandreach@esperion.com, if you would like to speak with us. Now, I would like to turn the call over to Esperion's President and CEO, Tim Mayleben. Tim?

Thank you, Marianne. 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 first quarter 2015 financial results. I will start by highlighting the accomplishments from our transformational first quarter; Marianne will touch on commercialization strategy; and then Rick will provide you with a summary of our first quarter 2015 financial results. I will wrap up with an overview of our most important upcoming milestones, and then we will open the call to your questions.

So, I would like to begin by highlighting the accomplishments of the Esperion team and our progress with 1002 during the first part of 2015. We have had what can only be described as a transformational start to the year, which has set us on a clear path towards completing development of 1002, and initiating our Phase 3 studies later this year.

The year started with the submission of our response to the FDA for the PPAR partial clinical hold. In only three weeks following that submission the FDA removed the hold, allowing Esperion to conduct long-term clinical trials. In mid-March, at the American College of Cardiology meeting at San Diego, Dr. Paul Thompson presented the full results from the Phase 2b 008 clinical study in statin tolerant and statin intolerant patients, which, among other things, showed that 1002 plus ezetimibe lowered LDL cholesterol by almost 50% and was both safe and well tolerated. For context, 50% LDL cholesterol lowering is what the most recent ACC/AHA guidelines recommend as a target for LDL cholesterol lowering. It is also what a patient would expect to achieve on 80 milligrams, or the highest dose of Lipitor, and the same level of LDL cholesterol lowering a patient could expect to achieve with an injectable PCSK9 monotherapy. But as we have highlighted, the single pill fixed dose combination of 1002 plus ezetimibe will be available in a much more convenient oral dose form with all the benefits of a pill versus an injectable therapy, in particular, for those patients who cannot tolerate a statin.

Later in March, we announced top line results from the Phase 2b 009 add-on to statin clinical study, which showed, among other things, that 1002, when added to low and moderate doses of the four most popular statins provided incremental LDL cholesterol lowering of up to 24%, or total estimated LDL cholesterol lowering of more than 60%. Again, for context, this level of LDL cholesterol lowering is greater than even the highest doses provided by statins today. Importantly, 1002 was safe and well tolerated by patients already taking statins.

Closing out March, we completed a very successful follow-on offering raising $200 million, and we are now funded through the expected NDA approval of 1002. As I noted at the start of the call, the events of the first quarter were transformational, as they have set a clear path forward for us to begin the Phase 3 development program, jumpstart our commercialization strategy planning, and ultimately file an NDA.

Now, I would like to lay out the next steps for Esperion in 1002. First, you may have noted back in March that our discussion of the use of proceeds from the follow-on offering re-referenced that we would begin spending on developing our precommercial launch strategies for 1002. Consistent with that, you may have seen the announcement Myrtle Potter & Company issued earlier today announcing that Esperion had retained their services to develop the commercialization strategies for 1002 monotherapy and 1002 fixed dose combination products. This is an exciting development for Esperion and represents the next logical step in our work to maximize the value of 1002, and by extension, Esperion. At this stage of our development, we believe it is absolutely necessary for us to develop a world-class commercial strategy for 1002, and this is essential if we are to fully understand and maximize the clinical and commercial potential of this new therapy. I would now like to turn the call over to Marianne to provide some additional color on our commercial plans for 1002. Marianne?

Thank you, Tim. The data from our Phase 1, Phase 2 and Phase 2b clinical studies have demonstrated a superb efficacy, safety and tolerability profile for ETC-1002. We have evaluated 1002 as monotherapy; we have evaluated 1002 in combination with ezetimibe; and we have evaluated 1002 as an add-on to statins. To quote one of our KOLs, we have an innovative oral therapy in ETC-1002 that is patient-friendly, physician-friendly, and payer-friendly. From experience, we know that it is never too early to begin to plan for a successful commercial launch, especially for a product like 1002. The healthcare environment around us continues to evolve, and we are thinking now about what the LDL cholesterol-lowering market may look like around the time that 1002 should receive FDA clearance. Our preparations are beginning now with Myrtle and our team.

I was fortunate enough to have had the experience of working with Myrtle at Bristol-Myers Squibb earlier in my career as Pravachol, Glucophage and Plavix all began to realize their true potential as blockbuster cardiovascular and metabolic therapies. The relationship with Myrtle and her team jumpstarts Esperion commercialization journey and is an important first step for us. We will begin to more fully understand our customers, patients, physicians and payers, and develop positioning and branding for 1002. I would now like to turn the call over to Rick, who will review our financial highlights from the first quarter of 2015. Rick?

Thank you, Marianne. As of March 31, 2015, Esperion had approximately $323 million in cash and investment securities, and approximately $5 million in debt outstanding under our existing credit facility. Our cash and investments securities balance increased from year-end primarily as a result of the follow-on offering completed in March, where we received net proceeds of over $190 million. We continue to expect our current cash and investments securities will be sufficient to fund a Phase 3 development program for 1002, and our operations through the expected approval of 1002.

R&D expense was $7.4 million during the first quarter of 2015, compared to $5.4 million for the first quarter of 2014. The increase was primarily related to R&D costs associated with the advancement of 1002 in our completed 009 study and our ongoing 014 study.

G&A expense was $4 million during the first quarter of 2015 compared to $2.5 million for the first quarter of 2014. The increase was primarily associated with increased public company operating costs, stock-based compensation expense, and the initiation of our commercial strategy activities. Our net loss for the three months ended March 31, 2015 was at $11.5 million, or $0.56 per share compared to $7.9 million, or $0.51 per share in the prior year. We currently have 22.5 million shares of common stock outstanding with another 2.5 [million] to be issued upon the exercise of options and warrants.

Looking forward, we estimate cashed used in operating expenses for the full year 2015 to be approximately $42 million. We also expect to incur approximately $10 million of noncash 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 operation through the expected approval of 1002. With that, I will turn the call back over to Tim.

Thank you, Rick. Before we open the call to your questions, I would like to spend just a minute talking about the passion of our team, and provide you with some insight into why we do what we do here at Esperion. You have heard me talk about the tremendous success and deep experience that our team has in discovering and developing LDL cholesterol-lowering drugs. What I haven't shared, though, is what drives our team and why we are so passionate about developing new therapies to treat patients with cardiovascular disease. I think this is especially timely, since this Saturday, May 9, marks the 15th year that Esperion has supported the American Heart Association's annual Heart Walk. Esperion has long been a supporter of AHA and our team personally donates thousands of dollars each year. Fittingly, this year's AHA theme is Why? Why walk in the annual Heart Walk? Why donate to cardiovascular research? Why devote all of our time and efforts to developing 1002 to treat patients with high LDL hospital and at risk for cardiovascular disease?

Speaking personally, my why is my father. Sadly, he died from a heart attack almost 35 years ago, at a very young age. He was only 48. Speaking more broadly, virtually all of us at Esperion, and I would venture most of you listening today on this call have been impacted by cardiovascular disease either in our own families or those of a friend. And the problem is that despite all of the advances with new therapies over the past 30 years, cardiovascular disease is still the number one cause of death in the US. While my risk of dying from cardiovascular disease today is 60% less than it was more than 30 years ago, when my own father died, we believe that the risk of dying from cardiovascular disease is still far too high. I believe, as does the entire team at Esperion, that we can help reduce that risk by doing what we do best -- focusing the expertise, the experience and the prior successes of our team will result in our developing new therapies to help lower cardiovascular disease risk.

Our desire is that the molecule that Roger and the team discovered at the original Esperion, ETC-1002, and that our team here at the new Esperion is developing, will one day make a difference in the lives of millions of patients at risk from cardiovascular disease. We have shown that 1002 can significantly and consistently lower LDL cholesterol, the number one modifiable lipid risk factor. As monotherapy, we have shown between 30% and 40% LDL cholesterol lowering. Last October we showed that 1002 in combination with ezetimibe lowered LDL cholesterol almost 50%, and just recently, in March, we showed that 1002 in combination with statins reduced LDL cholesterol well over 60%. 1002 has also shown that even on top of a statin it consistently lowers hsCRP by 30% to 40%. That kind of new therapy can't help but make a difference in the lives of patients, and that is our why.

Finally, let's turn our attention to key upcoming milestones for Esperion in 1002. First, I am very pleased to report that earlier this week we submitted our request to FDA for our end-of-Phase 2 meeting. With that, we anticipate that the meeting will occur in the first half of the third quarter of 2015. And the within 30 to 45 days of that meeting, of the end-of-phase 2 meeting we will host a conference call and webcast to report and discuss the results of that meeting with you. Also in the third quarter we will announce top line results from the Phase 2 014 study in patients with both hypercholesterolemia and hypertension. And when I say the third quarter, I mean July, so, early in the third quarter.

On July 30, we will host our second annual investor day, which will be held again this year in New York City. Details and save-the-date communications on this event will follow later in the quarter. Later this year, we will publish on our deepening scientific and mechanistic understanding of 1002, in particular, the focus on the inhibition of ATP citrate lyase, which lowers LDL cholesterol like a statin but without the potential for muscle-related side effects. And, finally, by year-end we expect to initiate our Phase 3 program for 1002, including our Phase 3 two-year long-term safety study.

I want to take just one minute to highlight that there is one other notable event, and this is not Esperion-related, but related to the broader LDL cholesterol-lowering space that will occur next month. It was recently confirmed by FDA that the Metabolism Division Advisory Committee will meet on June 9 and 10 to consider and discuss applications for new injectable LDL cholesterol-lowering therapies. We believe this is important to our therapeutic category, because this will be the first opportunity since the improvement results were released in November of last year for FDA to publicly comment on the LDL cholesterol-lowering hypothesis. Also of note, we expect to hear one of the first public discussions by FDA on statin intolerance. So, the next few months should prove to be even more interesting and impactful for 1002 and Esperion than even the last several months have been that we just completed. We will now open the call to you questions. Carmen, please poll for questions.

Thank you. (Operator Instructions) Our first question comes from Michael Yee from RBC Capital Markets.

Hi. Good afternoon. This is actually Judy Liu on for Michael Yee from RBC Capital Markets. So, I've got two questions, if you don't mind. First is the 014 study that you mentioned, the one for hypertension. Is there any reason to believe that the drug would have more pronounced (inaudible) in patients with higher blood pressure and, if so, what would be the mechanism for that? Why would you see any effect either way? And then I'll have a second question, please. Thank you.

Okay, Marianne, would you take that question?

Sure. Thanks, Tim. Yes, in the 014 study, just as a reminder, it's primarily designed to look at LDL cholesterol lowering in patients who have both hypercholesterolemia as well as hypertension. We designed this study because when we did a retrospective post hoc analysis of our Phase 2a program, we discovered that in patients with elevated blood pressure, that is, with systolic blood pressures of greater than 120 millimeters of mercury, there was a small but significant decrease in blood pressure. So, we wanted to test that prospectively. We are looking on the changes in blood pressure that might or might not be observed as more of a safety endpoint. Because there have been other products that have been reviewed through the metabolism division at FDA that have had problems with elevated blood pressure, the most recent of which was torcetrapib, the very first CETP inhibitor. And previous to that, obesity drugs, such as sibutramine, also had elevations of systolic blood pressure. So, the first thing, really, is to look at this from a safety perspective. And when we think about what 1002 can do, what we see is having a neutral or slightly positive effect is exactly what we would like to expect to have as findings from that study. Mechanistically, what could be explaining the effect of 1002 on blood pressure if it's real? At this point, we still don't know. We've done some initial work, and if there were greater changes or significant changes that we saw in this study, we would obviously look into that further.

Great, thank you so much. And so for the second question would be on PCSK9 inhibitor. So, if they either get a broad or narrow label, meaning that if they get approved (inaudible) based on limited (inaudible) intolerant patients, how would you interpret that possibility of a potential narrow label? Would that change your thinking on how you would use ETC-1002? Thank you.

Yes, thanks for the question. So, we anticipate that -- I know there has been a lot of discussion about this, but we do anticipate that those therapies will be granted, the very similar label to all other LDL cholesterol-lowering therapies that have been approved. And just to remind everybody on the call, there have been 15, 1-5, 15 LDL cholesterol-lowering therapies approved by this division over the last 28 years, so this is a well-trodden path. The labels for almost all of those -- well, for all of them are very similar, so we don't expect much deviation from the prior labels that have been granted. And, again, just to remind everybody, those labels have been granted, they have been approved based on demonstration by each therapy of at least 15% LDL cholesterol lowering together with a reasonable safety and tolerability profile. Carmen, could you go to the next question?

Our next question comes from the line of Jason Butler from JMP Securities.

Just wanted to comment on one of your last points. You mentioned the upcoming FDA advisory committee for the PCSK9 inhibitors. Can you talk a little bit more about what you're looking for that will give you comfort there, or any items that would concern you or change your current plans?

Sure, Jason, thanks for the question. This is Tim. So, we are -- we like to say that we will have a front row seat. We hope to have a front row seat at the upcoming meetings, which is to say we'll be paying very close attention. I think what we expect to see there is some, I think as we highlighted on our prepared comments, we do expect to see a good discussion about not only in the briefing documents, but also in the formal meeting, a discussion about the LDL cholesterol-lowering hypothesis. And so we will be paying very close attention to that discussion. Again, I think just to remind everybody, our position on that has been, again, given all of our experience in this space, that the LDL cholesterol-lowering hypothesis, which is that if you lower LDL cholesterol, you do get a cardiovascular disease risk reduction. And, of course, IMPROVE-IT was the first study to show that that's possible on top of statins and with a mechanism different from statins on top of a statin. So, that will be, I think, very impactful for the space.

And, secondly, I think as we highlighted, the comments around statin intolerance, there has not been much, if any, public discussion by FDA about statin intolerance, so we will be tuned in to the discussion there as well. There are multiple -- to your question about what might impact our further development plans. I would love to be able to touch base with you guys later this year, after that meeting, rather than speculate what the outcome might be or might not be. But I think once we have all had a chance to listen to those meetings, then we will be much better prepared to talk about what, if any, the results from that AdCom meeting will have on our development plans.

That's fair. Thanks, Tim. Another question. On those limiting partial clinical holds, have you had any more interactions with FDA on this point? Have you heard any feedback from FDA on this (inaudible)?

Yes, Jason, that's a good question and it's one that we do get frequently. We are in active discussion with FDA on that partial clinical hold, and maybe just for reference, I'll just take everybody back. So, we submitted a response to FDA at the beginning of the year, not only on the PPAR partial clinical hold, which, of course, got released within three weeks because that impacted, or that had the potential to impact our development plans. The 240 milligram partial clinical hold response did not apparently warrant the same level of attention from FDA. Because, as you've heard from us and I think now obviously with the response from FDA as well, that that does not have the potential to impact our development plans and so is on a much different timeline, a much slower timeline for addressing it in resolution. And the reason for that is because we have told FDA and the world that we are not planning to dose above 180 milligrams per day. So, we are in active discussions, though, with FDA, but there is no timeline, no official timeline for their response as there was with the PPAR partial clinical hold.

What we have said about that is that we do expect to wrap up our discussions with FDA during the second quarter, and no later than the time of our end-of-phase 2 meeting with FDA so that we can have that finalized and addressed. Then what we would like to see, obviously, is that 240 milligram partial clinical hold removed, since while it doesn't affect our development plans, it does affect people's perceptions, we have heard. It does affect people's perceptions about the program, and so we want to clarify that for everybody.

Okay, great. Thanks for taking the questions and congrats on all the progress.

And our next question comes from the line of Andrew Peters from UBS.

I guess the first question I have is, is it possible that during kind of the Phase 3, as part of the Phase 3 plan, could you look at a possible triple combination of 1002 to a statin and ezetimibe, or would you need to run more of a Phase 2 kind of dosing study around that?

Andrew, thanks for that question. It is very close to our top of mind. And, of course, coming out of the 009 results, where we saw that ETC-1002 could provide that 24% incremental LDL cholesterol lowering on top of a statin, but as importantly was very safe and well tolerated in combination with statins. That has definitely got us thinking about the potential for a triplet therapy that would involve ETC-1002, and then, of course, generic ezetimibe and a generic statin. In particular, a low-dose statin because of the very nice safety and tolerability profile associated with low-dose statins. So, I think my initial comment would be stay tuned.

As you may recall, when we first got the 008 results and we were talking about a potential fixed dose combination for ezetimibe and 1002, it took us a few months to evaluate things like the pharmaceutics, the IP, and then also conduct a little bit of market research, initial market research around the desirability of having that triplet combination. In particular, what we thought about related to that triplet combination is to provide an oral therapy in a single pill perhaps that would provide the LDL cholesterol lowering of a statin plus an injectable PCSK9 in an all-oral form. So, we will test that in our market research and see -- have that help guide our thinking on further development of that triplet combination. But it is definitely intriguing. Marianne, anything that you would add there?

Just one comment on that, Tim. Andrew, as we think about how our Phase 3 program is going to unroll out there, there will be studies where the standard of care will be utilized in patients, and there is the possibility that patients could come into one of our Phase 3 studies already taking a statin and ezetimibe. So, we are not designing a trial specifically, as Tim had said, because we need to do some more work to understand this better, but we are not discounting the opportunity that may arise within Phase 3, where patients are receiving standard of care and ETC-1002 on top of that.

Okay, great. And then just a question on kind of the commercial strategy, or the evaluation of a commercial strategy. How much of this will really depend on regulatory feedback and discussions from the end of Phase 2? And I guess the related question, how much of the Phase 3 kind of clinical plan will depend on the commercial strategy being completed?

Marianne, would you take that?

Sure. You know, that's a great question, Andrew. One of the things when you think about commercial strategy, it's one of the reasons that Tim and I and the team all started working together a few years ago, is we started to think about what that marketplace is going to look like. So, being a part of a company where you actually have the opportunity to be there as a Phase 3 program is designed, as a plan is put together for an end-of-phase 2 meeting, that some of the initial thinking that we've had as a company relative to commercial strategy has come into play as we think about those. And we will continue to build this out as we go forward, because we are thinking about the patients, as we said on the call; we are thinking about the physicians, we're thinking about the payers. And the thinking on that has to start in order to optimize the opportunity offered by the end-of-phase 2 meeting and the design and execution of Phase 3.

Great. Thanks and congrats again on all the progress.

And our next question comes from the line of Joel Beatty from Citi.

Hi, guys. This is actually Tennant on for Joel. A couple of quick questions. On the blood pressure in 014, I was wondering how that was being measured? And then, also, when thinking about sort of the design of a Phase 3 trial, what sort of incremental change there you would need to see in order to sort of include that in the Phase 3? And potentially what would be significant enough to maybe even get inclusion in a label?

Yes, thank you for the questions. I'll take the second parts of you question first, and then Marianne, if you could take the first part of the question, that would be great. So, I just want to clarify something that Marianne highlighted in her prepared comments, which is that -- I'm sorry, in answer to an earlier question, though, which is that this is -- the way to think about the 014 study with respect to blood pressure is that it is primarily a safety study on looking at blood pressure.

So, we're not developing a hypertension drug, we're not looking to get lowering blood pressure into the label. We want to demonstrate that on a very important safety biomarker, which is, of course -- I'm sorry, just a very important biomarker, which is blood pressure, that we are having either neutral or positive effect. So, if we can achieve that in this study, along with the dramatic LDL cholesterol lowering that we have seen previously with 180 milligram dose ,which is that either high 20% or 30% LDL cholesterol lowering, then that's a big deal. Because we will effectively have ruled out in a prospectively designed study that there would be a blood pressure concern in our Phase 3 program, which, again, we've seen positive, slightly positive effects in our Phase 2a studies. Marianne, would you talk to the specifics of how we're measuring this in the 014 study?

Sure. Thanks, Tim. With respect to how we're going to look at blood pressure, we're going to start by using cuff measurements, which is the traditional method in a physician's office, how the physician or the nurse will measure blood pressure in a patient. What we are also going to do to really ensure we get the best possible, highest quality data out of the study is that, in addition, at baseline and then at the end of treatment we're going to be using an automated blood pressure monitoring system that measures blood pressure continuously over 24 hours. So, this way we have a very precise measurement to help define the baseline blood pressure as well as the end-of-treatment blood pressure to ascertain the changes that Tim talked about, whether or not the ETC-1002 has a neutral or slightly positive effect, which we are interpreting primarily as a safety signal to help support the very positive safety and tolerability profile we have already for ETC-1002.

Got it. Okay, terrific. Very thorough and very helpful. And another question, I guess, on sort of the end-of-phase 2 meeting. Is there more sort of conversation potentially about a partner, and is that something a partner might be interested in joining in on, or would that be subsequent to the end-of-phase 2 meeting?

So, with respect to partnering, Ken, and thanks for that question. It's one that, from a business standpoint, we obviously give a lot of thought and consideration to particularly because ETC-1002 has performed so spectacularly, in particular in our recent Phase 2b studies, that it has obviously increased the value of the program in our own minds, but also in the minds of investors as well. And so we are certainly very confident in our own ability to conduct an end-of-phase 2 meeting, come out of that end-of-phase 2 meeting with a solid Phase 3 development plan. But having said that, we are open to partnering with a larger company to really maximize the value of 1002, and by extension, Esperion Therapeutics. So, continue to be very open. Timing-wise, we do think that coming out of the end-of-phase 2 meeting, or this time around the end-of-phase 2 meeting is an interesting inflection point. Because coming out of the end-of-phase 2 meeting, of course we will have a Phase 3 ready asset, if you will, or a Phase 3 program, and so that will be a -- what we think of as a natural point to have some interesting business discussions.

All right, got it. Terrific. That is very helpful color and very much appreciated you taking the questions.

Operator: And our next question comes from the line of Brian Klein from Stifel.

Just a quick question. Do you have any plans either within the Phase 3 program or in addition to develop ETC-1002 particularly targeting diabetic patients, or do you plan to do additional work there?

Brian, thanks for that question. So, the answer is that we do have a continuing interest in this patient population that is diabetic hypercholesterolemics, as we have been referring to them. We, for those who don't recall, we had done a small Phase 2a study called the 05 Study, which has now been both presented and published, and in that study we had showed intriguing results that patients taking ETC-1002 hypercholesterolemic diabetic patients showed almost a 40% LDL cholesterol lowering as monotherapy. And so we are continuing to evaluate the next best study for further delineating the benefits that ETC-1002 would have in that patient population, but we are not ready to talk publicly about those yet, or at least about that study yet.

We also have plans to include diabetic hypercholesterolemics in our Phase 3 program as well. And, Brian, we will be in a position to talk more specifically about that either at our investor day coming up here at the end of July or at our conference call and webcast following the approval of the minutes from the end-of-Phase 2 meeting with FDA.

Great. Thanks so much.

And our next question comes from the line of Chad Messer from Needham & Company.

Great. Thanks for taking my question. A lot of them have been answered, but I did want to go back to talk a little bit about your objectives with Myrtle Potter. You know, understand this is to develop the commercial strategy, but I'm trying to figure out what someone else could possibly know that Marianne doesn't. Seriously, is this to conduct your own primary research? I mean, how are you going to be using them, if you could give a little bit more detail in the coming months and years?

Yes, I'll make an initial comment and then I will ask Marianne to comment more specifically. I think in particular I will just highlight that Myrtle and her team have over the years been responsible for building several, several billion-dollar brands. And you've heard us talk about ETC-1002 and having multi-billion-dollar market potential, and that is, of course, the result of the clinical efficacy and safety profile, but it's also the result of really powerful branding and positioning, which is what we've retained Myrtle Potter & Company to help us do. And, Marianne, maybe you could comment more specifically on some of the things that we are focused on there.

Yes, absolutely. Well, first of all, than you, Chad. That was very sweet. But, you know, it's interesting, when we sit and talk with Myrtle and her team, as Tim had outlined, they have very broad experience, also. And we think about where we are right now and where we need to be, and we need -- we have a top-notch clinical team supporting the clinical development of ETC-1002. We have a top-notch finance team that is carrying that function forward. And for commercial, because that is so important to this product in this space, we need a good team. And as we thought about this, what made sense for us at this time was to begin to work with Myrtle and her team so we can bring a broad set of thinking both about the therapeutic area as well as the typical marketing strategies that we would want to employ as we take this process through. So, it's to give the necessary strength that we need and depth and breadth of experience to support the commercialization strategy development for 1002 beginning now.

And I would add just one other thing, Chad, and that is, this is both an offensive and a defensive measure for us. And by that I mean we are -- we have the potential to be masters of our own destiny here, and so this is an offensive measure to say that if we're responsible for our own and controlling our own destiny, then we want to work with the very best in the world. If the future holds that we partner or do something else strategic with the asset and with the program, then the ability to evaluate potential partners, commercial strategies and plans is doubly enabled by having our own very well thought out and considered plan as we evaluate potential partners for co-commercialization here in the US, and then ex-US commercialization efforts.

All right, great. Thanks for that. And then just two real quick ones, if I may. I actually somehow got dropped on the call and there was a question being answered at the time about the 240 milligram partial hold. At one point you hoped to hear back in the sort of May time frame. I was just wondering if you still thought that was to be the case or if you could just quickly update me on whatever time frame you had laid out when I was kicked off?

Sure. I'm sorry you were kicked off. So, what we had said is, just to update timing-wise, that we hope to be able to complete that discussion and bring it to conclusion in the second quarter, but certainly by the time of our end-of-phase 2 meeting. I had mentioned in my prior comments that the FDA is not on a time clock with respect to this, because it doesn't impact -- they recognize it doesn't impact the development of ETC-1002 because we're not dosing above 240 milligrams. So, they are on a different time clock than they were for the PPAR, partial clinical hold, which, of course, they responded to very rapidly back in January.

All right. Thanks for the updates and congratulations on the progress.

Operator: And our next question comes from the line of Steve Byrne from Bank of America.

Is your contract with Myrtle Potter include helping you evaluate potential commercial partners and potentially terms?

Steve, thanks for the question. It is very broad, and certainly we will leverage Myrtle and her team's expertise as we do evaluate commercial proposals from potential partners. So, the answer to that is yes.

Okay. And you had mentioned in you introductory remarks, Tim, that the scope of that work was to evaluate the monotherapy and the doublet opportunity or fixed dose combination. Is there a reason that scope is not also evaluating a potential commercial strategy for the triplet fixed dose combo?

Oh, I'm sorry. I'm sorry if I misspoke there. There is an S on the end of the fixed dose combinations, so not just 1002 monotherapy, but fixed dose combinations, but meant to pluralize it by saying, yes, we recognize that there is potential for multiple fixed dose combinations including, as you suggest, the triplet combination as well.

Okay, sorry, that was my mistake. And then with respect to a cardiovascular outcomes study, you've been very clear about your view on the necessity of such a study and whether the agency would require one. It's an agency that has, particularly that division, has been fairly conservative in recent years. Is there an opportunity for you to know their view and come to a landing with them on whether there will or will not be a requirement for an outcomes study as part of the Phase 3 program before you walk into that meeting, and that if you need one, then you can go in with various designs in mind?

Sure, very good question, Steve. I would, again, just remind everybody that our position on the necessity for a CV outcomes trial hasn't changed, that we still maintain that historical precedence is that no LDL cholesterol-lowering therapy has ever been required to start or complete a CV outcomes trial prior to approval. And, of course, what has been disclosed by the PCSK9 sponsors, which are the newest LDL cholesterol-lowering therapies not yet approved, but certainly on the verge of approval, is that the agency has required -- again, we have not been part of these discussions. What we have heard is that they are required to have their CV outcomes trial substantially ongoing, which has been interpreted by the investment community to be 25% of events accumulated by the time of approval.

We have more recently heard and been confirmed that substantially underway, or substantially ongoing actually translates into 25% enrolled, 25% enrolled by the time of approval, not 25% of events accrued at the time of approval. And as you might suspect, that's substantially different than what has been interpreted by the investment community. But with respect to whether we can communicate officially with FDA leading up to our end-of-Phase 2 meeting, I think the answer to that is no. We will have indirect indication from FDA as a result of the advisory committee meetings that I referenced in our prepared comments on June 9 and 10, where we believe FDA will -- and the advisory committee members -- will discuss the LDL cholesterol-lowering hypothesis and by extension the need or the requirement for CV outcomes trials prior to approval for LDL cholesterol-lowering therapies. So, within the next 30 days or so, I think we will get our first indication, but we won't get the direct confirmation of that, Steve, we don't expect until the completion of our end-of-phase 2 meeting. And, of course, once we know that, we will be out talking with you and others about what we've heard.

Okay, thank you.

Operator: We will now conclude the Q&A portion of the call. As mentioned earlier, please email Marianne at mandreach@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.

Thank you, Carmen. I want to thank all of you for joining our call today and for your continued interest in 1002, and also your support of Esperion. I also just want to take a few minutes here to extend my heartfelt thanks to each and every Esperion colleague. We are a very small team, as you know, but we wouldn't be here without each individual's hard work, their passion to bring 1002 through development and eventual approval. And we are all truly blessed by these efforts. We look forward to continuing to update you on our progress throughout the rest of a very exciting 2015, and that will end today's call.

Ladies and gentlemen, this concludes today's conference call for Esperion Therapeutics. You may now disconnect. Have a great day.