Esperion Therapeutics' CEO Discusses Q4 2013 Results - Earnings Call Transcript

Mar. 5.14 | About: Esperion Therapeutics (ESPR)

Esperion Therapeutics Inc (NASDAQ:ESPR)

Q4 2013 Results Earnings Conference Call

March 05, 2014 04:30 PM ET

Executives

Mindy Lo - Investor Relations

Tim Mayleben - President and CEO

Rick Bartam - Controller

Marianne Andreach - VP of Strategic Marketing & Product Planning

Analysts

Jonathan Eckard - Citi

Jason Butler - JMP Securities

Brian Klein - Stifel

Operator

Good day, ladies and gentlemen. And welcome to the Esperion Therapeutics Inc Fourth Quarter and 2013 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) As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Mindy Lo Esperion Therapeutics’ [Clinician] and Investor Relation. Please go ahead.

Mindy Lo

Thanks Kate. Good day everyone and welcome to the Esperion Therapeutics fourth quarter and 2013 year-end earnings call. This is our first quarterly call since our IPO last June and we look forward to speaking with you each quarter. I'm Mindy lo from Esperion and with me today are Tim Mayleben, our President and CEO, Marianne Andreach, our Vice President of Strategic Marketing & Product Planning and Rick Bartam, our Controller. As a reminder, this conference call is being recorded. To access the playback of this webcast, please go the investor’s section of the Esperion website at www.esperion.com.

Before reviewing the structure of this afternoon’s webcast, 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 forward-looking statements, future risks and uncertainties associated with the company’s --.

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, March 05, 2014. Esperion undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. We issued a press release earlier today detailing the content of today’s call. A copy can be found at www.esperion.com in the investor’s section. We’ll begin the prepared comments from our team and then we’ll open the call for your questions.

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

Tim Mayleben

Thank you, Mindy. I’d also like to welcome all of you to Esperion’s first quarterly conference call. On today’s call I’ll provide an overall update on the ETC-1002 development program and also insight into upcoming results and milestones. Rick will then review highlights from the fourth quarter and the full year 2013 financial results. And then as Mindy indicated, we’ll open the call to your questions.

Let me begin by noting that 2013 was a highly productive and important year for Esperion with more successes both clinically and financially than in any other year since we were founded in April 2008. Among our 2013 business highlights, we of course completed a $33 million private financing last April and $80 million initial public offering in June, both leaving us very well funded to rapidly advance ETC-1002 through clinical development.

Also in the second half of 2013, Esperion was added to a number of indices including the NASDAQ Biotechnology Index, the Russell Global, Russell 3000, Russell 2000 and Micro Cap indices, as well as the MSCI Micro Cap indices.

Our clinical and scientific colleagues were especially productive in 2013 and want to highlight some of the things that they accomplished publishing and presenting multiple Phase 2a clinical study results that in the aggregate included data from 242 patients that were treated with ETC-1002. Results demonstrated for example consistent and significant reductions in LDL-cholesterol as high as 43% and statin like reductions in levels of hsCRP, a key marker of information associated with cardiovascular disease.

We also published the study in the Journal of Lipid Research that demonstrated for the first time the effect of 1002 in reducing chronic inflammation in preclinical models of inflammation. We published full results from the 03 study in patients with hypercholesterolemia; this was in the Journal of the American College of Cardiology.

We published full safety and efficacy results of the 05 clinical study for the treatment of patients with hypercholesterolemia and type 2 diabetes; this was in the Journal of ATVB. And as some of you know, Dr. Ronald Goldberg of the University of Miami and Miller School Medicine published an editorial in that same issue of ATVB and this is the March issue.

This was in response to the publication of the 05 study noting that 1002 was a novel approach to the management of patients with hypercholesterolemia and type-2 diabetes due to the effect of 1002 not only on LDL-cholesterol levels, but also subclinical information without worsening glycemic control and that’s something that you’ve heard us emphasize before.

We presented full results from the 06 study in patients with hypercholesterolemia and a history of statin intolerance. Of course this is an oral presentation at the 2013 American Heart Association scientific sessions. And we released positive top-line results from the 07 study of 1002 which was an add-on to statin therapy in patients with hypercholesterolemia. And we initiated the first clinical study in our Phase 2b program, which you’ve heard us refer to as the 08 study, this is in patients rather with hypercholesterolemia and a history with or without statin intolerance and statin intolerance is defined intolerance to two or more statins due to muscle-related adverse events. The goals of this study are to compare the LDL lowering, LDL-cholesterol lowering efficacy of 1002 with ezetimibe, that’s the active control and a common therapy for statin intolerance and of course to characterize the tolerability of 1002 as well.

So looking to the near future and specifically 2014, we plan to deliver on a number of important clinical and non-clinical milestones so as eventful as 2013 was for us, we are looking at 2014 being more eventful with more meaningful data, so let me just highlight those.

First of all we’re going to complete the 08 Phase 2b study and report top-line results in the fourth quarter of this year, the fourth quarter of 2014. This month we’re initiating the 09 study, this is the Phase 2b clinical study and that is our second Phase 2b clinical study and we expect to report top-line results by year-end.

This study of parallel doses of 1002 both 120 and 180 milligrams per day is going to be over 12 weeks like the 08 study. In this case we’re adding 1002 onto low and moderate doses of statin therapy in patients with hypercholesterolemia. And as to design to demonstrate the ability of 1002 to achieve incremental LDL-cholesterol lowering in patients with elevated levels of LDL cholesterol as a bad cholesterol.

Finally starting next quarter, so starting in the second quarter and continuing in the fourth quarter of this year, we expect to report results from some of our more high profile non-clinical studies. So let me repeat that again, I just spoke earlier about our clinical studies that are going to be reporting out. We’re also going to be reporting results from some of the more high profile non-clinical studies.

So that's going to include a long-term 12 months, monthly toxicology study and of course by the end of the year, our two year carcinogenicity studies. So again in summary 2014 is going to be a pivotal year for ETC-1002 with both clinical and non-clinical results starting to report out next quarter and through the end of the year.

So with that I’ll turn the call over to Rick for a brief review of the financial highlights from the fourth quarter and 2013. Rick?

Rick Bartam

Thanks Tim. Our net loss for the year ended December 31, 2013 is $26.1 million compared to $11.7 million in the prior year. This is primarily related to increases in R&D costs with the advancement of ETC-1002 and the completion of the 06 and 07 studies, the initiation of the 08 study in October as well as increases in public company operating costs.

As of December 31, 2013 Esperion had approximately $78 million in cash and investment securities and no debt. We expect that our current cash, cash equivalents and investment securities will be sufficient to fund our operations through the end of 2015.

We currently have 15.4 million shares of common stock outstanding with another 1.7 million to be issued upon the exercise of options and warrants.

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

Tim Mayleben

Okay, thanks Rick. We'll open the call take to questions now. So if you would please pull for any questions that folks may have.

Question-and-Answer Session

Operator

Ladies and gentlemen, we will now open up the line for question-and-answer portion of the call. (Operator Instructions) And our first question comes from the line of Jonathan Eckard with Citi. Your line is open.

Jonathan Eckard - Citi

Thanks for taking the question. So, the first one I was going to ask was regarding the chronic tox studies. Could you remind us what the gross margin of CP is for the dosing margin is in the chronic tox study over the 120 and 180 dose disease in Phase 2b? And then maybe just mechanistically regarding with regard to ETC-1002 if there were going to be histological changes for example biological system based on how the drug works, what could you expect like you can, if you’re going to see something what would you guys be expecting to see if it did happen? That would helpful. And then I have another question regarding the Goldberg editorial.

Tim Mayleben

Okay. So let me just -- this is Tim, Jon. Thanks for your questions. Let me just take a stab at the first couple of questions. So just to remind you the not just you but to remind everybody the high dose that we have in our toxicology studies is 60 milligrams per kilogram per day which just sort of rough numbers calculates out to about 4.5 grams per day for human dosing. So at 120 that’s quite a bit I am trying to do the math in my head but I think it’s 20 to 30 times and if the 180 it’s closer to the 20 then the 30, but some very nice margins there.

In terms of what we would expect to see if we would see anything in our long-term toxicology studies. I think the thing that we always come back to is there is a long history 40, 50 years of history in this therapeutic area with LDL lowering drugs and what you typically see what’s been seen in the literature, in fact we were just reviewing some of these articles recently what you typically see in some of these studies is, in most of these studies is because liver is the target organ you see increases in liver weights and then you see some either hypertrophy or hyperplasia in some of the liver cells. But again there is variability among different lipid regulating drugs. But I think that’s probably the headline that most likely those are the things that you see because again the liver is the target organ.

Jonathan Eckard - Citi

Okay. Just to be clear I mean all the chronic tox studies, most the liver are LDLs and lowering drugs in the past has had similar things…

Tim Mayleben

Right. So that’s a great point Jon I think we are always talking in the context of drugs that regulate LDL, that lower LDL. And so when we are talking about ETC-1002 we are always trying to put it in the context of other successful lipid regulating drugs and other successful Lipid regulating drugs have shown these kinds of characteristics and so. And again we have the great benefit of Roger who has worked in this space of this therapeutic area for 30 plus years. And a team consultants and advisors that have similar experience with not only Lipitor but other lipid regulating drugs. And so we are more than capable of putting these results and the things that we are seeing in context. And again if we are seeing things that surprise us we’re obviously going to let folks know.

Jonathan Eckard - Citi

Yes. And just asking just so that whatever the results maybe, hopefully clear but just the interpretation of them can be clear once they are out. So the answer, that’s very helpful, thanks. And then the other one was regarding the Goldberg editorial which was very interesting and talks to highlight several interesting things about the drugs mechanism. One thing that Dr. Goldberg is recognizing is not (inaudible) trials. You mentioned something about, something to the degree of the drugs hitting the pathway stuff and so the utility combination with statins maybe unclear, I forget the exact wording, but maybe you could talk a little bit about that and why that or may not be the case in your guys, yes.

Tim Mayleben

Yes, I am going to let Marianne take that one Jon.

Marianne Andreach

Hi Jon. When we were reviewing the editorial the first time we thought some of the things that Dr. Goldberg referred to relative to the mechanism of action, we paid a lot of attention. He brought this editorial based upon his review of the available literature for him and information.

And some other things that were included in the editorial relative to mechanism may not be precisely correct. So when you look at something that is written like this, this is someone entirely independent the company. And as you’ve pointed out quite correctly, he is not a PI, he is not a consultant with Esperion, he is not someone we have even reached out to as a key opinion leader. So he is taking this from the information he sees and how he interprets that. So obviously this provides an opportunity to perhaps begin a dialogue with him about what is going on with the mechanism of the product, so that he can better understand how ETC-1002 works, especially the potential as an add on to statin therapy.

Jonathan Eckard - Citi

Thank you very much. I wouldn’t take away from the editorial but those are the couple of comments along the (inaudible) that caught my eye and I was just wondering where do you stand there. So thank you very much. So I’ll get back in queue.

Tim Mayleben

Hey thanks for your questions, Jon.

Operator

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

Jason Butler - JMP Securities

Hi guys thanks for taking the question. I guess just a follow-up on the editorial comments on mechanism. One thing that may be could be taken as a positive, where his comments on the similarities between the mechanism and the AMPK activity of metformin and from a safety perspective that could be seem to give comfort. Do you have any views on his comments there?

Marianne Andreach

Well, as you can see from, if you know anything about Dr. Goldberg, he is highly experienced, not just in the lipid area, but also in the diabetes area. And has always been a proponent of metformin. So understanding that context and comparing 1002 to metformin within the editorial, we see it’s positive.

Tim Mayleben

And Jason, I think to that you’ve heard Roger say, many times that the AMP kinase is a very interesting target for cancer metabolism now as well. And so we have taken comfort not only from the developments in that space, but obviously also, folks like Dr. Goldberg that are very experienced with a known AMP kinase activator metformin.

Jason Butler - JMP Securities

Great. And now you are essentially weeks away from starting the statin add-on Phase 2b, can you just walk us through again how the changes in treatment guidelines have impacted your thinking around study protocol there and if at all?

Tim Mayleben

Jason, you are -- I’m smiling as you were asking that question because I think if you go back to November when the guidelines first came out, there was I think I would characterize it as tremendous confusion about what the guidelines would mean, there was a lot of controversy about those guidelines. And that seems to have dissipated over the last 4 months or 5 months since those were initially published. And we have heard repeatedly not only from other sponsors or developers of drugs in this space, but also from a number of KOLs and other physicians that we talk to pretty regularly.

And there is -- the jury is still out on when and how those new guidelines are going to be implemented. And so as it relates to the add-on to statin opportunity, I think our bent is probably similar to the actions or lack of actions of PCSK9 sponsors, which is there still are a lot of people who are taking statins that are not able to get to their goal using a pre ACC/AHA guideline phrase that we usually use. And that is a medical need.

And regardless of the new guidelines that came out, they are guidelines, they are not rules. And how physicians and whether physicians ultimately end up adopting them or whether the next version of these guidelines change again to go back to goals, I think we don’t know but we think that the medical need is still there regardless of what the guidelines have promulgated. And I think perhaps the biggest thing and I’ll stop my comments and have you ask further questions if you like on this, but I think our perspective is we’re really trying to operate at a pragmatic drug development level here and I guess there is a need still there and that’s the need that we’re pursuing with the study.

Jason Butler - JMP Securities

Great. Thank you. I appreciate the comments, Tim. Thanks for taking questions.

Tim Mayleben

Thank you, Jason.

Operator

(Operator Instructions) Our next question comes from the line of Brian Klein with Stifel. Your line is open.

Brian Klein - Stifel

Great. Thanks for taking my question guys.

Tim Mayleben

Hi Brian.

Brian Klein - Stifel

Hi. First off, on the non-clinical data. How rapidly do you think you can get that to the FDA and when should we expect a removal of the partial clinical hold to occur?

Tim Mayleben

Yes. Those are very appropriate questions. So, we’ve been saying that we will get the long-term or the chronic tox study reports in the second quarter. We will turn those around pretty quickly, so review them and finalize them and then get them filed with the FDA in the same quarter. So, we expect those to be filed with FDA next quarter.

I think from a practical standpoint though in terms of when the FDA may choose to take a decision to remove the clinical hold, I think that’s not something we have control over. So I don’t want to set anybody’s expectations that it could happen this year. I think our conservative position is that it’s most likely to happen in 2015 with the timing of the end of Phase 2 meeting. If it happens before then, great but we know they have to address it and talk through it at the end of Phase 2 meeting.

Brian Klein - Stifel

Great, thank you. That’s helpful. And then just quickly on the Goldberg editorial as well, just wondering if you have ever tested ETC-1002 with metformin or any of the other currently used diabetic agents, and if you can give us some color there?

Tim Mayleben

Well that is a very prescient question actually because we are -- we have had that discussion internally. We are in the midst of putting together the protocol design for exactly that study. So, I think just to remind everybody, we had done the drug-drug interaction studies with statin, with Atorvastatin last year, had continued that work in the early part of this year with other statins. And our next, literally our next step from a drug-drug interaction standpoint is to evaluate ETC-1002 with metformin. So, it will be again -- it will be classic sort of DDI Phase 1 study but it is -- to your point, it is a question that we want to answer simply because the 005 study results with ETC-1002 as monotherapy were so positive, and just to remind everybody that was the study in hypercholesterolemic diabetics that showed an LDL reduction of 43% after four weeks of treatment. And so very interesting and compelling results that certainly as we talked about before, encourages us to do further development in that patient population that diabetic hypercholesterolemic patient population. But we think an important next step Brian is definitely to do that metformin DDI study with 1002.

Brian Klein - Stifel

Terrific. Thank you for taking my questions.

Tim Mayleben

You bet. Thanks. That was a good one.

Operator

Our next question is a follow up question from the line of Jonathan Eckard with Citi. Your line is open.

Jonathan Eckard - Citi

Thanks for taking my follow up. So this is mainly about the two Phase 2b trails, so the first trial in statin and tolerance, Tim you said that the patients have to be intolerance at least to statins. So, is one other criteria that one of those statins is at the lowest dose or was that not a criteria for that trial?

Tim Mayleben

No, you are exactly right. You are exactly right, John. So, sorry for not making that more clear. It is intolerance to two or more statins, one at the lowest approved dose. And that is, I know we’ve talked one-on-one but for everybody else’s benefit, this is a definition that we have received directly from FDA, so direct communication from FDA with that promulgated definition for statin intolerance.

Jonathan Eckard - Citi

Great, and then the protocol for the statin trial appears like it’s already on clinicaltrials.gov and...

Tim Mayleben

Yes. So, let me just clarify for everybody, so our definition of initiating a trial when we will send out a press release indicating that the trial is started is when we randomized our first patient. But there is again for -- I apologize if you know this, and everybody else knows it as well, but just to clarify, we have an investigators meeting, we qualify all the sites obviously prior to that and then sites are initiated and can start screening patients.

So all of those things have happened and so we will be randomizing patients this month. And if you recall, like I said, we’re just very conservative about our definition of initiating a trial; it’s not when we hold the investigator meeting, it’s not when we get the protocol approved, it’s not even when sites start screening, it’s actually when the first patient is randomized.

We feel like that’s the most conservative description of study initiation. So that you are right, it is already on clinicaltrials.gov because we have the investigator meeting and we are screening patients.

Jonathan Eckard - Citi

[I wasn’t going call you out]. And the work you doing is fairly normal and other companies do it. So I was going to ask one thing was one of the inclusion criteria is and again this is the add-on trial is for LDL-C greater or equal to 130 milligrams per deciliter or less than 220 milligrams -- 220 milligrams per deciliter. So may be in the context of, maybe there isn’t a context with the new AHA guidelines, but with that range of LDLs on a statin, how -- can you may be talk about

LDLs on a statin, could you maybe talk about like strategically how that is important versus they can offer 100 or greater or 80 year greater and so forth. Maybe if you could just explain why you pick that range and how it could be strategic going forward?

Tim Mayleben

Yes I know, it's a very good question and one that we probably wouldn't -- we wouldn’t have guided to it if we didn't have the level of experience of drug developers in this space around the table. But you're right; I think one of the keys that we think to drug development in this space is to make sure that the baseline LDL levels for patients coming into our clinical trials are actually relevant. That is patients that have real disease, if you will which real disease indicating that they have relatively uncontrolled LDL levels.

That's important for a number of reasons, one, it turns out if you look at some of the fail studies in this space. And baseline LDL levels are relevant to some of the failures or some of the criticisms of trials that have failed.

And so we think it's really important to make sure that we're not enrolling just any patient, but we're enrolling patients with as we say real disease that is uncontrolled LDL-cholesterol levels. So that one ETC-1002 can show LDL lowering of significance both from a percentage standpoint, but also from a milligram per dose a liter standpoint, because if you look at the literature again, the accumulation of data over the last three plus decades is that the higher the baseline LDL levels that you start out at the more significant cardiovascular disease benefit you can provide. Because you can gets a higher magnitude of LDL lowering absolute -- lowering, as well as percentage lowering.

Jonathan Eckard - Citi

That’s very helpful. Thank you very much.

Tim Mayleben

Yes. Thanks for the question Jon.

Operator

Our next question comes from the line of Jason Kantor with Credit Suisse. Your line is open.

Unidentified Analyst

Good afternoon. This is Jeremy filling in for Jason.

Tim Mayleben

Yes. Hey Jeremy.

Unidentified Analyst

Thanks for taking our questions. In terms of the preclinical studies that you mentioned what level of (inaudible) should we expect from those studies and would you press release those results and then present it later we’re just try to hold out for a specific meeting later on?

Tim Mayleben

No, that’s a very good question Jeremy, because this is a little bit unusual, I think we may have talked about this offline that it’s not typical for companies, any company in the biotechnology industry to typically be talking about non-clinical results. And for example to your last question about presenting these data, non-clinical data typically don’t in fact I don’t think we can think of a situation where non-clinical data have been presented at a scientific meeting perhaps at a or even at the clinical meeting.

So I think the right way for us to think about and for you all to be thinking about this data is probably more from a standpoint of not releasing a whole bunch of data that folks won’t understand they’d be able to put in context. But recognizing that we’ll be providing more negative assurance if you will about the results that if there is anything of significance in those results then we’re going to be out talking about them, but absent that we wouldn’t expect to provide gross details if you will, gross detail in terms of all the study results because as you may know these reports end up as hundreds of pages and of course there is lots of animals in the study and I think it’s important for us to both summarize and put those results in context which is exactly what we intend to do. Does that make sense?

Unidentified Analyst

Yes. No that’s very helpful. And one last question in terms of expenses, the R&D spending level that we saw in Q4 is that indicative of quarterly run rate we could see in 2014 and would that be roughly level or could that increase throughout the year?

Tim Mayleben

Yes. Rick can you take that question?

Rick Bartam

Sure. Thanks Jeremy. We can expect that an R&D run rate for the upcoming year for 2014 will be about 75% of operating expenses. So a little bit more of an uptick than what we are currently seeing.

Unidentified Analyst

Okay. Thank you for taking the questions.

Operator

We will now conclude the Q&A portion of the call; I would like to turn the call back over to Tim Mayleben for closing remarks.

Tim Mayleben

Thank you, Kate. Hey I want to thank everybody for joining the call today and for your continued interest in not only 1002, but also our company Esperion. As I mentioned in our prepared comments, 2014 promises to be a data rich year, very eventful. And we look forward to updating you on our progress as we move through the year. So thanks so much and wish you a good day.

Operator

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

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