Esperion Therapeutics (NASDAQ:ESPR)
Q1 2014 Earnings Conference Call
May 12, 2014 17:00 ET
Mindy Lo – IR
Tim Mayleben – President and CEO
Roger Newton – Chief Scientific Officer
Marianne Andreach – VP, Strategic Marketing & Product Planning
Rick Bartam – Controller
Jonathan Eckard – Citi
Jason Butler – JMP Securities
Brian Klein – Stifel
Jeremiah Shepard – Credit Suisse
Welcome to the Esperion Therapeutics First Quarter 2014 Conference Call. (Operator Instructions). I would now like to turn the conference over to Ms. Mindy Lo from Esperion. Ma'am please begin.
Good day everyone and welcome to the Esperion Therapeutics first 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. As a reminder, this conference call is being recorded. To access the playback of this webcast, please visit the investor’s section of the Esperion website at www.esperion.com.
Before we get started I would like 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, future 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 12, 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?
Thank you Mindy. I would also like to welcome you all on the call and thank you for joining us today to discuss highlights from Esperion’s first quarter. I will start by providing you a brief update on the ETC-1002 development program. Review the non-clinical long term product safety results, highlight a few of our scientific and clinical presentations and publications and then cover key dates for our upcoming clinical and non-clinical results. Rick will then review a summary of the financial results from the first quarter and then we will take questions as following.
On our conference call in early March I told you that 2014 would be a data rich and eventful year, I also said that the Esperion team is focused on delivering a number of important clinical and non-clinical milestones throughout 2014. As I will outline in more detail in a few minutes I’m very pleased to tell you that we’re on track to meet these key milestones for 2014.
First I want to highlight again for you just how unique 1002 really is. It is the only oral, once-daily small molecule therapy in the world today in mid to late stage clinical development for lowering LDL cholesterol. We say that 1002 is an NCE or a new chemical entity and it represents a new class of therapies for lowering LDL cholesterol. Now what makes this class so interesting is that it is the first non-statin oral therapy to ever show both 30% to 40% LDL cholesterol lowering and hsCRP reduction.
As you’ve heard us say we believe 1002 will be the drug of choice for approximately 2 million to 7 million patients who either cannot tolerate statins or who are unable to achieve their LDL cholesterol goal on statin therapy.
Let’s turn now to the segments of our clinical trials. First I’m very pleased to tell you that we completed the screening and randomization for the Phase 2b 08 study in patients with hypercholesterolemia with or without statin tolerance. The trial of older enrolled and randomized approximately 350 patients at sites across the U.S.
As you recall the original plan was a randomized a total of 322 patients. The primary objective of this study is to assess the LDL cholesterol lowering efficacy at 1002 therapy versus ezetimibe monotherapy in patients with hypercholesterolemia with or without statin tolerance and treated for 12 weeks.
I’m also pleased to report that in March and on plan we initiated the Phase 2b 09 add-on to statin study in a 132 patients with hypercholesterolemia who are taking a low to moderate dose of one of four different statins. The primary objective of the study is to assess the LDL cholesterol lowering efficacy of 1002 in patients with hypercholesterolemia already receiving statin therapy.
Let’s now turn to our non-clinical long term chronic safety results, first, off the six months safety study in rats and the 12 months safety study in monkeys are now complete as the final reports will be shared with the FDA later this quarter.
We have also completed the two year carcinogenicity studies in both mice and rate. Though of course, these studies will be finalized in Q4 this year and discussed with FDA next year as part of our End-of-Phase 2 meeting.
Overall I can tell you that we’re very satisfied with the outcomes of these studies and I want to highlight the following. First, sharing on the [ph] unexpected findings in these studies. 1002 was well tolerated over the treatment periods and then all doses tested in these studies. Final reports and results will be filed and discussed with the agency in the months ahead.
As we stated previously we expect to discuss the partial clinical holds with FDA during our upcoming End-of-Phase 2 meeting in Q2 of 2015.
Now let me try to put the non-clinical results in context and I want you to keep in mind that 1002 continues to demonstrate its efficacy in terms of LDL cholesterol lowering and its safety and tolerability in multiple clinical studies and across a very broad dose range. In terms of the implication of the most recent results on the overall safety of 1002 I want to remind you that in the 1002 clinical development program we have not experienced any safety or tolerability concerns. There has not been any treatment related FAEs [ph] reported to-date. The adverse events with 1002 have been strikingly similar to those observed in placebo and the very modest shift in hemoglobin, uric acid, alkaline phosphatase and homocysteine have not led to any clinical sequelae. Overall we continue to be very pleased with both the safety and the tolerability profile of 1002.
So to summarize the Phase 2a efficacy data for 1002 have been extremely promising, our tolerability profile has been excellent and the most recent non-clinical results from the chronic safety studies reinforce our confidence in the safety and tolerability profile. We continue to believe 1002 is playing an important role in lowering LDL cholesterol levels in statin and tolerant patients and this is a patient population which we believe has the highest unmet medical need in hypercholesterolemia today.
We look forward to sharing with you top line results from the 08 and 09 studies in the fourth quarter of this year.
Now let me take a few moments just to mention that three posters featuring 1002 Phase 2b data were presented at the 2014 Annual Scientific Sessions of the National Lipid Association in Orlando, Florida earlier this month.
The posters provided additional details from previously presented Phase 2 studies of 1002 and the new data regarding blood pressure reduction with 1002. But first poster detail that 1002 lowers LDL cholesterol, reduce hsCRP, and was well tolerated in all four of our Phase 2a studies. The second poster outlined that 1002 demonstrated a 32% lowering of LDL cholesterol, and reduction of 42% in hsCRP levels.
1002 was well tolerated and muscle related adverse events were similar for both 1002 and placebo groups and again this is in a statin intolerant patient population. The third poster shows 1002 significantly reduced systolic blood pressure by almost 7 millimeters of mercury compared to placebo. This was in a pooled subgroup analysis of the four Phase 2a studies involving patients with hypercholesterolemia and with mildly elevated blood pressure.
All three posters are available in their entirety on the investor section of our website, abstracts presented at the meeting have been published in the June issue of the Journal of Clinical Lipidology and these presentations further highlight in detail the characteristic efficacy of this novel drug in patients with hypercholesterolemia and the continued good safety and tolerability of the therapy even at the highest doses.
A manuscript on what’s (indiscernible) was also recently published. It's entitled LDL cholesterol reduction in patients with hypercholesterolemia by modulation of adenosine triphosphate citrate lyase or what you hear us refer to as ATP citrate lyase and adenosine monophosphate activated protein or AMPK.
This is going to appear in an upcoming issue of a prestigious journal called the Current Opinion in Lipidology.
Finally I just want to recap again for you the key dates for our upcoming clinical and non-clinical results. In Q4, we are going to report top line results from the Phase 2b 08 study. Also in Q4 we expect to report top line results from the Phase 2b 09 study and finally in Q4 we will provide summary results from the two year carcinogenicity studies which we completed earlier this month. 2014 is going to be a pivotal year with these clinical and non-clinical results reporting out by year-end.
I want to turn the call over to Rick now to review the summary financial results from the first quarter of 2014. Rick?
Thanks Tim. As Tim mentioned earlier we’re on track to meet our milestones for 2014 and I’m pleased to report that we continue to be conservative with our capital resources used in operation. Our net loss for the quarter ended March 31, 2014 with 7.9 million compared with 4.2 million in the first quarter of 2013 which equates to a loss of $0.51 per share.
This is primarily related to increases in R&D cost for the advancement of 1002 in the 08 study initiation of the 09 study and increases in public company operating cost. I also want to make some comments on estimated spend for the rest of the year. We expect our R&D and G&A cost for the remainder of the year to be approximately 24.5 million and 7.5 million respectively in addition to the first quarter results.
We estimate that our full year EPS will be a loss of approximately $2.50 per share on 15.4 million shares outstanding. Now turning to our balance sheet, we ended the quarter with approximately 68.2 million in cash and investment securities and no debt. As we stated in our last earnings call in March we continue to 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 more.
With that I will turn the call back over to Tim.
Thank you Rick. Just before we open the call to your questions I want to announce that we will be hosting our inaugural Investor Day in New York City in late July. We will distribute details regarding the event in the coming weeks and hope that you will join us to learn more about Esperion and especially the 1002 program.
We will now open the call to your questions. Howard if you would pull for questions please.
(Operator Instructions). Our first question or comment comes from the line of Jonathan Eckard from Citi. Your line is open.
Jonathan Eckard – Citi
I guess I was just wondering, I think you’re going to present the data from the (indiscernible) studies later in the year and I think you also mentioned about talking with the FDA in the first quarter, is that when you’ve both the (indiscernible) and that data in hand, can we have that discussion?
I think just to clarify a couple of things, one with respect to the non-clinical safety results from the animal studies we’re not planning to present those, we’re planning to provide those or submit them to the FDA which is what we would normally do what sponsor would normally do with those drug safety results. So that’s what we plan to do. In fact we expect to be able to do that this quarter. As I mentioned in our prepared comments which again were brief but happy to take any additional questions that you might have on those. We wouldn’t have any unexpected findings there. I think as you’ve heard us say earlier we didn’t see any fatality that we had seen in that -- what we’re calling an anomaly in the early study and then you’re right, we will have the carcinogenicity studies available in the fourth quarter and we plan to provide all of those to the FDA as part of our End-of-Phase 2 briefing package.
Jonathan Eckard – Citi
Okay and then -- I’m not trying to have you point to more definitive time but both Phase 2b’s are going to be reading out in the fourth quarter, they both started on different timelines. Is there any reason to think that one -- the one that started for us is going to be the one they are going to see first during that three month period or how should we be thinking about those coming out -- when we see the data?
We have been trying to keep general focus on Q4 but I think it's reasonable to except that we will see the 08 results earlier than the 09 results, before we see the 09 results. I think that is the right way to think about it.
Thank you. Our next question or comment comes from the line of Jason Butler from JMP Securities. Your line is open.
Jason Butler – JMP Securities
And acknowledging that you don’t [ph] want to linger too much on the non-clinical safety studies. Could you may be put into context for exactly what you were or could have been looking for -- and these are the reasons specifically related to the first of the two clinical holds, for those clinical holds. If you can just put into context why the FDA put that clinical hold in place and what you were looking for potentially from these studies?
I think just to go back for yours and others benefits, the partial clinical hold that you’re referring to related to the upper dosing beyond 240 milligrams and I think what we had previously indicated was that the partial clinical hold was related to exposure levels or fatality [ph] in this 13 week monkey study. And if you recall that was at the 60 milligram per kilogram per day dose. To summarize, that I just summarized in our prepared comments we did not see any of that in the most recent study which was consistent with the results that we had seen in prior studies but I should probably also go back and just remind you and I know we have not always been clear about this but keep in mind that the partial clinical hold that I think you’re asking about and which we have commented on has not impacted the development or impeded our clinical development of 1002. We have not intended to go beyond the 240 milligram dose, so it was really more of a theoretical exposure issue that the FDA was addressing and a practical one and of course we have been responsive to that both in terms of our clinical designs, not going above that 240 but we fully expect that this data is pretty conclusive that whatever we saw in the prior study was more of an anomaly and that these data are more consistent with the prior data and are conclusive at this stage and which is as I said earlier that we will be submitting it to the FDA and really asking them to look at the relevance of that product.
Jason Butler – JMP Securities
And then just again acknowledging these are the two year cost carcinogenicity studies, is there anything that you can -- that you can state from the study reports from the monkey, rat, sort of that you’ve completed. Can you confer about any signal of carcinogenicity or any signal of dysplasia or anything in that line of thinking?
I think that the long term talks as you know was done 52 weeks in monkeys and six months in rat. The intention of that study was not to in any way look at carcinogenicity, that’s a separate design study at different doses and it's done in rats and in mice over a two year period. So there is really no weaker connection that you can make the long term tox studies and the carcinogenicity studies. They are two entirely separate objectives and further supporting the safety of the compound.
Thank you. Our next question or comment comes from the line of Brian Klein from Stifel. Your line is open.
Brian Klein – Stifel
I don’t mean to beat a dead horse here but again in terms of the carcinogenicity and the partial clinical hold I guess my question really is that how quickly do you think that partial hold can be removed? I know that it's not impacting your clinical development right now but it could impact as it heads towards the Phase III program following success in Phase II. So just wanted to get a little bit more clarity on when that could be leveled?
I think -- first of all we can’t and don’t want to speak for the FDA on this. What we have consistently said is that we expect that the time for FDA to respond or to comment on the partial clinical holds is that the End-of-Phase 2 meeting. We continue to believe that because we don’t have any signal from FDA at this stage that they are going to be willing to entertain something sooner than that. If they do we will certainly be out letting you know but at this stage we expect that it's reasonable to expect the FDA to respond at the End-of-Phase 2 meeting.
Brian Klein – Stifel
My next question is in regards to study 09, obviously if we look at 08 you’ve done very successfully -- you’ve completed enrollment of 350 patients and I’m just wondering in 09 study, do you feel that you’re devaluating ETC-1002 in a sufficient number of patients in each arm or is there potentially an opportunity to broaden that trial to a greater number of patients.
It's a good question and in fact it's interesting that you ask it because we have pressed on that internally a few times again comparing I think probably as you’re doing, comparing the size of the few trials and wondering if we need to do something larger. It turns out that the statistics are just so compelling at the approximately 44 patients in arm that we just had not seen the need to increase the size of that trial and maybe offline we can just run through the statistics with you but it does give us really nice power to -- with the 132 patients. So in fact if you want I can just run through that, we have 90% power to show a difference of 15% in LDL cholesterol between the groups. So it's pretty compelling.
Brian Klein – Stifel
And then just last question here. In terms of looking at the competitive landscape and looking at how in particular PCSK9s are undergoing outcome studies. Do you still feel that you will not be required to do an outcome study prior to getting enrolled? Thanks.
And again I think it's one that we have been very consistent with compared to the PCSK9 sponsors we have a very focused clinical development program, we’re focused on the what we call the area of highest unmet need in hypercholesterolemia today. A real specialized population which are the statin intolerant patients. These are patients that are treated primarily by lipidologist or specialized cardiologist and in fact Roger and Marianne were at the National Lipid Association meeting here a couple of weeks ago and they had an entire session just on statin intolerance again because one of the focuses firstly of [ph] lipidologist is the statin intolerant patient population.
So this specialized patient population is our area of clinical focus, it's an area of high end unmet medical needs. There are no other good therapies out there today delivering the kind of LDL cholesterol lowering that statin and ETC-1002 have demonstrated and so we continue to believe that a CV outcomes trial is a post approval event and not a preapproval requirement and happy to discuss that offline with anybody if they would like.
Thank you. Our next question or comment comes from the line of Jason Kantor from Credit Suisse. Your line is open.
Jeremiah Shepard – Credit Suisse
This is Jeremiah filling in for Jason. As regards to the non-clinical study that you guys have discussed. Is there any other non-clinical study that you still have ongoing that the FDA has requested? And then also just a follow-up to that, when do you expect to present the qualitative data the FDA has requested this year?
So with respect to the non-clinical, any additional non-clinical studies, I’m happy to tell you that we do not have any other required studies non-clinical studies. This is I think we said that this is the last of the studies that we need to do. We recently completed as we said in our prepared comments, the two year carcinogenicity studies. So that really includes that part of development. In terms of presenting the data. I think it would be highly unusual for a maybe unprecedented for a sponsor of a therapy like 1002 to present non-clinical data. At least prior to approval I think sometimes you see papers are written in post-approval about non-clinical results or class results from different classes of drugs.
Our audience for the non-clinical is really the FDA and so we will be submitting these reports to the FDA, as we like to say if there were anything unusual in these results we would be obligated to report those to you as we did and the investors as we did in the S1 with respect to some of the unexpected findings that we had seen in some of our earlier results but that’s not the case here. So don’t look for anything more from us on that other than our submission like I said to the FDA.
Jeremiah Shepard – Credit Suisse
And in regards to the 008, what do you expect in terms of full results from that study? In terms of share potentially or is it more of a --
It is a little bit earlier for us to say conclusively but if you look historically from the time that we report top line results until the time that we have full results, it's generally 5 to 6 months and that’s because our goal is to present those data in a peer reviewed setting and so there is a pretty long lead time for review of manuscripts and publications, sorry, presentations at major meetings. So we will take the additional time to make sure that we’re presenting those in an appropriate peer review setting.
Thank you. (Operator Instructions). Our next question or comment comes from the line of (indiscernible). Your line is open.
I have a question regarding the objectives of the two trials, the 08 and 09 study. One is lowering LDL and the second seems to be meeting the target, so in terms of further development can it be bundled into single indication or will it be a separate indicator or in the first trial in their weight trial, do you want to reach target or do you just want to show that you can reduce LDL significantly?
The two trials for 08 and 09 -- they are primary end points, the primary end points for both is LDL cholesterol lowering. So one is compared to an active comparator and that’s ezetimibe, that’s in the 08 study so it's LDL lowering plus ETC-1002 compared to the LDL cholesterol lowering of ezetimibe. It's not a placebo. Again we’re -- it’s an active comparator in the 08 study. In the 09 study we’re taking patients who are on statin therapy already and we’re comparing the LDL lowering of statins alone with or with the statin alone with the statin plus ETC-1002. So it's still LDL cholesterol lowering at the primary end point but it's incremental LDL lowering on top of the statin. Anything that you would add Marianne?
It's the only thing on top of that George to say with respect to the percentage of patients who get to goal, that’s pretty significant in the secondary end points. The most important thing for us and I think for the investigators and for the patients looking at these studies is the degree of LDL cholesterol lowering that we’re going to be able to achieve in 12 weeks. I think the second piece of it that’s incredibly important as you referenced was to be able to measure how many patients were able to get and establish treatment goal as a result of what group they were randomized to in the trials.
Okay, so basically it sounds like you will be able to bundle, basically it will be 1002 in combination with your standard ezetimibe to get to goal or just to get to a much better level?
The key objective of the 08 study is to evaluate the effective ETC-1002 on LDL cholesterol in comparison with ezetimibe and as you’re noting we also have the two arms for that trial that are going to allow us to explore what the combined effect of ETC-1002 with ezetimibe might be on LDL cholesterol. So the primary endpoint is getting to the monotherapy aspect but this enables us to get first look at what might happen when you put the two together and that ties into the your other comment about is this a way to help patients to better get to goal? So the only way we can understand that is by conducting a trial and as we think about what we want to do in future studies typically our pivotal trials, this will be extra-ordinarily important.
Thank you. I’m showing no additional participants in the queue. I 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.
Thank you Howard. I want to thank all of you for joining our call today and for your continued interest in 1002 and Esperion. 2014 continues to be an exciting year and we look forward to continuing to update you on our progress.
Ladies and gentlemen this concludes today’s conference for Esperion Therapeutics. You may now disconnect. Thank you and have a wonderful day.
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