Mindy Lowe – IR Tim Mayleben – President and CEO Rick Bartam – Controller Marianne Andreach – VP, Strategic Marketing & Product Planning.
Jonathan Eckard – Citi Jason Butler – JMP Securities Brian Klein – Stifel Nicolaus Chad Messer – Needham & Company Steve Byrne – Bank of America.
Good day, ladies and gentlemen and welcome to the Esperion Therapeutics Third Quarter 2014 Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. I would now like to introduce your host for today’s conference Ms. Mindy Lowe with Esperion.
You may begin..
Thank you, Amanda. Good day, everyone and welcome to the Esperion Therapeutics third quarter 2014 conference call. 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 to Investors Section of the 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 the risks and uncertainties associated with the company’s business.
These forward-looking statements are qualified in their entirety by the cautionary statements contained in today’s press release and the company’s SEC filings. The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, November 10, 2014.
Esperion undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. We issued a press release earlier today detailing the content of today’s call. A copy can be found at esperion.com within the investor’s section.
We’ll begin with prepared comments from our team and then we’ll open the call for your questions. Following today’s call, the management team will be available for any follow-up question. Please be e-mail me directly at mlowe@esperion.com so that I can schedule 15 minutes for you to speak with the team.
Now I’d like to turn the call over to Esperion’s President and CEO Tim Mayleben.
Tim?.
Thank you, Mindy. Good afternoon everyone. I’d like to welcome you to our call. And thank you for joining us today as we provide you with an update on our third quarter of 2014.
I’m going to start with an update on the 1002 program, provide some context on the PPAR designation and the process for reviewing the two-year carcinogenicity studies we will receive this quarter, make some general comments on the LDL cholesterol space and summarize our upcoming milestones.
Rick will review a summary of our financial results from the third quarter and then we will open the call to your questions. So, first, I want to highlight that October was truly transformational for Esperion.
We reported positive top-line results from the Phase 2b 008, clinical study in patients with hypercholesterolemia with or without statin intolerance results that exceeded our own high internal expectations.
1002 treated patients achieved LDL cholesterol lowering of up to 30% as monotherapy compared with 21% in the Ezetimibe group and LDL reductions of almost 50% 1002 was added to Ezetimibe. The full results from the 008 study were submitted for presentation at our major medical meeting scheduled to be held in the first part of 2015.
Two weeks after those results were announced, we completed our first and only follow-on offering totaling almost $100 million at a nice premium to the IPO price, sufficiently funding Esperion and the 1002 program into 2018 and through the completion of our Phase 3 program.
Over the past few months, we’ve also achieved a couple of additional 1002 development program milestones. In July, we initiated the Phase 2 014 study in 144 patients with both hypercholesterolemia and hypertension.
As you may recall, a retrospective analysis of our Phase 2a program showed a statistically significant reduction in systolic blood pressure with 1002 in patients with elevated blood pressure.
This post hoc analysis generated a prospective hypothesis for this Phase 2 clinical study, the 014 study is a randomized double-blind parallel group multicenter study evaluating 180 mg of 1002 as monotherapy compared with placebo for six weeks. Top line results are expected in Q2 of 2015.
Then in October we completed randomization in our Phase 2b 009 clinical trial with 134 patients. These are patients with hypercholesterolemia who are already on stable standard therapy. The randomized double-blind parallel group multicenter study is evaluating parallel doses of 1002 added on to standard therapy over 12 weeks.
Top line results from this study will be available in March of 2015. Finally, I’m sorry, I lost my place here. Let me turn now to the PPAR designation and the two year carcinogenicity studies.
I want to remind you that all small molecule drugs intended for lifetime use in patients are required to complete two-year carcinogenicity studies prior to approval. These studies are reviewed and approved at FDA by ECAC which is their Executive Carcinogenicity Assessment Committee.
Now, FDA asked us to do our carcinogenicity studies in parallel with our Phase 2 clinical program since they identified 1002 as a potential PPAR in 2009 at the time of the IND filing.
Our understanding is that FDA identified 1002 as a potential PPAR because of the chemical structure which has some physical resemblance to other PPARs and they were findings in animal studies that indicated PPAR like activity. However, we have not seen any PPAR signals in our clinical program, with almost 600 patients treated with 1002.
Let me give you couple of examples. 1002 dramatically lowers LDL cholesterol and doesn’t affect either triglycerides or HDL cholesterol, which are the classic PPAR alpha signals. 1002 also desecrates adiponectin, increased body weight or cause edema, again, all classical signals for PPAR gamma activity.
So, to summarize, FDA identified 1002 a potential PPAR back in 2009, 1002 with a very weak PPAR, and has been tested in eight clinical trials in over 600 patients to date. And we’ve not observed any dose limiting safety concerns that restrict development.
So, with respect to the carci studies, we started our carcinogenicity studies in Q2 of 2012 and in Q2 of this year, we completed the in-life portion of these studies in both rats and mice. We will receive final reports for these studies from our outside CRO this quarter and we’re on target to submit the reports to FDA by early 2015.
Now, let me make a few general comments about the LDL cholesterol lowering space. First, we know that cardiovascular disease is still the number one cause of death in the U.S. despite the fact that with statins and other therapies, the risk of cardiovascular disease death has declined by 60% over the last 30 years.
LDL cholesterol continues to be the number one modifiable lipid risk factor for cardiovascular disease, not triglycerides, not HDL cholesterol. Almost 80 million people in the U.S. have hypercholesterolemia or elevated LDL cholesterol. And of those approximately half or almost 40 million people are on some type of LDL cholesterol lowering therapy.
Despite the availability of statins and non-statin drugs like Ezetimibe, approximately 13 million patients in the U.S. are not yet at their LDL cholesterol goal. And as we like to remind you, of these approximately 70%, the majority of the market, almost 8 million patients need less than 30% additional LDL cholesterol lowering to get to their goal.
And we know that 1002 dramatically lowers LDL cholesterol as monotherapy 30% to 40%. 1002 works with Ezetimibe to lower LDL cholesterol by almost 50%. And we know that it can work with thermostat to lower LDL cholesterol by greater than 50%. We know that FDA accepts LDL cholesterol as a surrogate marker for cardiovascular disease risk.
We like to remind everyone that no small molecule, no small molecule LDL cholesterol lowering drug approved by FDA and there have been 15 over the past 27 years has ever been required to start or complete an outcome study prior to approval.
Most other biomarkers are not so fortunate to be accepted as surrogate markers by FDA, not triglycerides, not HDL cholesterol, not obesity and not diabetes. A lot of ink has been spilled over the past few years speculating about whether FDA still accepts LDL cholesterol as the surrogate marker for cardiovascular disease risk reduction.
We consult with regulatory experts and of course our team has a ton of experience in this therapeutic area. We remain confident that FDA continues to accept LDL cholesterol as a surrogate marker for cardiovascular disease risk reduction. But we also acknowledge that this could change in the future.
And over the next six months, there are multiple data points in this therapeutic area that will be available to those of us in the industry and the experts at FDA.
But as of today, we plan to develop 1002 as an oral once-daily small molecule therapy for patients with hypercholesterolemia and expect 1002 to be approved based on its demonstrated ability to dramatically lower LDL cholesterol. So to summarize, we are thrilled by the results from the Phase 2b 008 clinical study.
They clearly exceeded our expectations. The results confirmed, once again that 1002 significantly lowered LDL cholesterol by 30% to 40% and reduces hsCRP by up to 40%, without the potential for muscle related side-effects in patients with not yet well-controlled LDL cholesterol levels.
We’re particularly excited about the potential of the oral combination of 1002 and Ezetimibe, which showed LDL cholesterol lowering of almost 50%. We’re exceptionally pleased to be sufficiently funded through 2018 and the completion of the Phase 3 program for 1002.
We’re confident that 1002 can play a very important role in cost effectively and conveniently, conveniently providing LDL cholesterol lowering to patients with hypercholesterolemia including those with statin intolerance of patient population with a very high level of unmet medical need.
1002 concluded this monotherpy or in combination with the most popular oral LDL cholesterol lowering drugs on the market today. With that, I’ll turn the call over to Rick for a review of the financial highlights from the third quarter.
Rick?.
Thanks Tim. As of September 30, 2014 Esperion had approximately $58 million in cash and investment securities and approximately $5 million in debt outstanding under our new credit facility.
As a result of our following offering completed last month, we received net proceeds of approximately $92 million bringing our cash and investment securities balance to nearly $150 million in October.
These proceeds in combination with our quarter ending cash and investment securities balance have provided us with sufficient capital to fund the Phase 3 development program from 1002 and our operations in the 2018.
Our net loss for the nine months ended September 30, 2014 was $26.9 million compared to $16.4 million in the prior year comparative period. The change was primarily related to increases in R&D cost of the advancement of 1002 in the 008 and 009 and 014 studies and increases in public company operating costs.
We currently have approximately 20.4 million shares of common stock outstanding with another 2 million to be issued upon the exercise of options and more. Lastly, I have few final comments for those of you with financial projection models.
As we reported earlier today, EPS for the three months and nine months ended was a loss of $0.64 and $1.75 per share respectively. We expect our R&D cost for the fourth quarter to be approximately $8 million. We expect our G&A cost for the fourth quarter to be approximately $2.5 million.
We estimate that our full year EPS will be a loss of approximately $2.30 per share. And as a result of the closing of our equity offering, we expect to end this year with approximately $140 million in cash and investment securities.
As I mentioned earlier, we expect our current cash and investment securities will be sufficient to fund 1002 through the completion of a Phase 3 program and our operations into 2018. Finally, for those of you looking to head to next year’s projection, we plan to provide financial guidance for the full-year 2015 early next year.
With that, I’ll turn the call back over to Tim..
Thank you, Rick. Before we open the call to your questions, let me just highlight our key milestones for the month ahead. First, by early 2015 we will submit a two-year carcinogenicity reports to FDA. In March, we will report top-line results from the Phase 2b 009, add-on to statin clinical trials.
In Q2 of 2015, we will report top-line results from the Phase 2, 014 clinical trials in patients with hypercholesterolemia and hypertension. We expect to hold our end of Phase 2 meeting with FDA in mid-2015 and we expect to initiate our Phase 3 program for 1002 by Q4 of 2015.
And one final point, I just want to mention that we will – we are planning to hold an Investor Webcast event next Monday, next Monday November 17, from Chicago. Webcast access information and additional details will be sent out by us tomorrow. We will now open the call to your questions. Amanda, please pull for questions..
(Operator Instructions). Our first question comes from Jonathan Eckard with Citi. Your line is now open, please go ahead..
Hi, thanks for taking the question guys, sorry for the background noise..
Hi Jon..
I was just wondering for the partial clinical hold is around the PPAR, is it in your view the carc study sufficient to address this item fully or when you go and meet with the FDA eventually, I remember you had some assessment from a KOL that previously had advised even the FDA on these agents? Do you think it would be necessary to bring something like that or is the carc study and the data you have in hand sufficient to address this?.
Thanks for the question, Jon. So we believe and of course we have our internal expert, Narendra Lalwani, who is our Chief Operating Officer and had a very deep background in drug safety in particular. But yes, it’s our understanding that the two year carcinogenicity studies will be fully responsive to address the PPAR partial clinical hold..
Great. And then quickly, after you guys get the results of the 008 study, do you have any kind of new ideas based on findings from that study of how you might kind of enhance the figure Phase 3 programs optimize what could be a potential label for the drug? Thank you very much..
Yes, no, that’s an interesting question, Jon. I think couple of things to highlight there. So, we’re still evaluating the results from that study. Again, I think is, we noted, it’s a data rich set of information and we’ll continue to evaluate that. The other aspect is the 009 results which will be coming out in the first quarter.
And so, I think a combination of the 009 results and full analysis of the 008 results will drive further insights into how we might plan the Phase 3 program. So stay tuned, stay tuned..
All right. Thank you very much..
Our next question comes from Jason Butler with JMP Securities. Your line is now open..
Hi, thanks for taking the question..
Hi Jason..
Just a follow-up on the last Phase 2b study 008.
Could you give us any additional insights into the secondary findings of study yet, for example the drug’s impact on other markers of cardio metabolic risk?.
Jason, we can’t at this point. We would ultimately love to but there is still an awful lot of analysis that is ongoing. And of course we are in a position where we want to be able to present those full results at a major medical meeting.
So we’ll be a little bit restricted to disclose too much because we don’t want to compromise that ability to present there..
Yes, understood.
And then just thinking about the carcinogenicity study results that you’ll get this quarter, is it your mind or based on what you know today, is there any risk that you won’t get those reports in 4Q, and if you get those reports and there’s an unexpected finding, do you think that’s a 4Q disclosable event, or could that be an early ‘15 event as well?.
Yes, no, that’s a very good question, very good question Jason. And I think again, just to try to be clear about this because I think we’ve gone back and forth on it a little bit. So, we will for sure, to answer your first question, we will for sure get those reports this quarter from the outside CRO.
So, we have confirmed that direct communication with the outside CRO. With respect to whether there will be a disclosable event, the only – I think we’ve used the term negative reassurance. If there is something significant in there that would negatively impact the development of 1002, then we will – we have an obligation to disclose that, right.
I mean, that would be our obligation. But again, the FDA will make final determination of that, we are going to submit those reports to FDA as we said by early 2015..
That’s very helpful. Thanks Tim.
Just last question from me, and I know I’m not necessarily asking an answerable question here, but just wondering if you guys could give any thoughts or interpretations of today’s disclosure from Merck, that they’ve seen the un-blinded data from IMPROVE-IT, and don’t believe there’s any Vytorin intangible assets that have been impaired?.
I’ll ask Marianne to just comment briefly. And you’re right. It’s not an answerable question but perhaps can just speculate a little bit..
Yes, thanks Jason. With respect to what Merck – what was issued today from Merck in their report is something that really doesn’t tell us anything about the study. And I think it’s just another thing for us to stay tuned and watch to see what happens on Monday when they present the full results.
I don’t think it says anything there is a lot speculation as you know. And I don’t think we need to add to that..
Okay, great. Thanks for taking the questions..
Thank you, Jason..
Our next question comes from Brian Klein with Stifel. Your line is now open..
Great. Thank you very much and congratulations on a nice quarter..
Hi, thanks Brian..
So building off of Jason’s question, maybe Marianne to ask it a different way, can you help us speculate on how a positive IMPROVE-IT study might help or hurt 1002, and conversely, how a negative IMPROVE-IT outcome might impact 1002?.
Great question, thanks Brian. If there is going to be a positive outcome associated with IMPROVE-IT meaning the therapy is say statistically significant reduction in outcomes observed in the treatment group that received both thermostat and Ezetimibe is yet again another validation of the solid LDL hypothesis that Tim described in a lot of detail.
With respect to a negative, I think one of the things that you could possibly interpret from what was said today by Merck is that you can exclude a true negative result, a neutral or accruable result will just probably tell us that the hypothesis still hold whether or not the trial is designed and executed to address the hypothesis remains a question..
Okay, thanks. And then, maybe one for you, Tim.
In terms of the potential Phase 3 program that you’re contemplating, what’s the gating factor to starting that study, and is there a possibility to have that trial or trials initiate before the fourth quarter of next year?.
Thanks for that question Brian. We’re looking at each other here because we’re certainly exploring internally with the team, we’re certainly exploring ways to start sooner. And we’re certainly not ready at this stage to talk in any detail about those. But it’s certainly on our mind. And we have different thoughts on how to accomplish that.
But we have some additional work to do before we can talk with any definition about what that might look like..
Okay, great. Thanks for taking my questions..
Thank you..
(Operator Instructions). Our next question comes from Chad Messer with Needham & Company. Your line is now open..
Great. Thanks for taking my question. I apologize if there’s any background noise..
Hi Chad..
Hi. Given that the reduction of LDL cholesterol I think is really well-established by your Phase 2 program, I kind of look at stage 3 as really being a test of longer-term safety, which is kind of the one piece that we haven’t had yet.
I was just wondering if there was any team consensus on what you think the highest risk might be, hemoglobin, liver enzymes, something else I’m not thinking of, as you go into the Phase 3 program, in if there’s one risk you could wave a magic wand and take off the table, what would it be?.
It’s an interesting question. And I think the thing that we like most about 1002 is the safety and tolerability profile that it has demonstrated so far, has really been benign Chad.
So, I think, I think there is nothing from the clinical results that we’ve seen even, again, you mentioned hemoglobin and uric acid and things of that nature that we reported as lab values that have modestly changed during different clinical trials that we reported.
But I think we always come back with the very benign, very attractive safety and tolerability profile. I think with all – having said that with all lipid regulating drugs, liver is the target organ.
And so, you expect over time that you will see some adaptation in the liver, you will see and we’ve seen and just like every other lipid regulating drug, you do see changes in liver function test.
But again, when we look at the degree to which that happens, it’s very modest, it’s very infrequent, very consistent with the statins and other lipid regulating drugs. So, I think we actually feel phenomenally good about the safety and tolerability profile.
But I agree with you too that Phase 3 will not really be establishing or re-establishing efficacy. It’s really just to get the long-term safety and tolerability profile..
Alright, great. Thanks for that and congratulations on the progress..
Thank you, Chad..
Our next question comes from Steve Byrne with Bank of America. Your line is now open..
If the IMPROVE-IT study does not show a statistically significant improvement in cardiovascular event rate from the addition of Ezetimibe, do you think that the agency will view that as being a poorly designed study, i.e., not sick enough patients or maybe not powered sufficiently, or do you think that it might lead them to question their views about LDL levels, or the value of it, or the value of a cardiovascular outcome study?.
Hi Steve, this is Tim. Thank you for that question. I think it is, I think the question, that you just asked are on all of our minds. And in my prepared comments I had said a lot of ink has been spilled over the last several years.
I think on exactly those questions, how will, we’ve all tried to put ourselves in the FDA shoes and said if I were an FDA regulator how would I interpret that or how would I respond. And I think we don’t know.
I mean, as much expertise as an experience that we have around the table as many outside consultants and we’re talking about former FDA regulators as well as former heads of regulatory for the largest pharmaceutical companies, no one knows. No one really knows.
And trying to interpret the few comments that have been made over the years by the agency has been a real challenge. Again, I think we’ve been trying to stick to the facts as I outlined in my prepared comments. And I think as we consistently try to do which, is if you look at the actions, the old adage that actions speak louder than words.
If you look at what FDA has done with LDL cholesterol lowering drugs, small molecule LDL cholesterol lowering drugs over the years, they continue to approve these drugs based on their LDL cholesterol lowering ability, period. So, as I said, that may change with results from IMPROVE-IT.
It may change with other events that happen in this therapeutic area over the next six months or so. We don’t know. But we’re as active internal speculators as I know you and others in the community are as well..
And just a question about your Phase 3 program, and I know you don’t have the 009 or 014 studies in yet, and you don’t have those protocols developed. But just a conceptual question about how you might view the long-term safety portion of the study.
You’ve run studies in diabetics with high LDL, those that are hypertensive you have looked at inflammation levels.
Is it something you might consider to look at a really sick population with a high MACE event rate that essentially has all of those co-morbidities to drive up that event rate where you might have some long-term data that could show an impact on the MACE event rate, where you may not have the statistical power of a cardiovascular outcome study, but you’d have a high event rate? Is that something that you might consider?.
It’s, let me say at the start that it’s a little early for us to know or even at this point I think to speculate we will look to the end of Phase 2 meeting with FDA to confirm that. But in the meantime we are talking to a number of outside KOLs about this and a number of outside these full service CROs that have done these kinds of studies as well.
So, we’re actively gathering information but I think it’s just too soon for us to just to speculate on it at this point, Steve. But it is on our minds and it sounds like it’s on yours as well..
Okay. Thank you, Tim..
Thank you, Steve..
We will now conclude the Q&A portion of the call. As mentioned earlier, please e-mail Mindy Lowe at mlowe@esperion.com to schedule a follow-up call with management if there are any questions from today’s discussion. Now I’d like to turn the call back over to Tim Mayleben for closing remarks..
Thank you, Amanda. Again, I just want to thank everybody for joining the call today and also for your continued interest in 1002 and Esperion. And we certainly look forward to continuing to update you on our progress and talk with you next Monday at our webcast on the 17th.
Amanda?.
This concludes today’s conference call for Esperion Therapeutics. You may now all disconnect..