Esperion Therapeutics Q1 2024 Earnings Call Transcript

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May 7, 2024

There are 14 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference over to Tiffany Aldrich, Associate Director of Corporate Communications at Esperion.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Good morning, and welcome to Asperion's Q1 2024 Earnings Conference Call. With us today are Sheldon Koenig, President and CEO and Ben Halliday, CFO. Other members of the executive team will be available for Q and A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call.

Speaker 1

A copy of that release can be found on the Investor page of our website, together with a copy of the presentation that we will also be referencing. I want 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 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 business. These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings.

Speaker 1

The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 7, 2024. We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. I'll now turn the call over to Sheldon.

Speaker 2

Thank you, Tiffany, and good morning, everyone. Thank you for joining us today to discuss our Q1 results and the meaningful progress we continue to make. We are proud to report that we drove strong growth this quarter to start 2024, positioning us for long term growth and success. In the Q1, we delivered total revenue of $137,700,000 which includes the $100,000,000 litigation related settlement received from DSE in January. I'll note that even excluding this payment, this was the highest revenue generating quarter for ongoing business in our company's history.

Speaker 2

U. S. Net revenue was $24,800,000 which represents a 46% increase year over year, driven by a 43% increase in retail prescription equivalents. On March 22, we received FDA approval of broad new labels for Nexlutol and Nexlazet that reflect new indications for cardiovascular risk reduction and expanded LDL cholesterol lowering in both primary and secondary prevention patients. These new labels make Nexlatol and the only LDL lowering non statins approved for cardiovascular risk reduction in both primary and secondary prevention patients and can now be taken with or without a statin.

Speaker 2

With these differentiated profiles, we are confident that these new labels position nexlitol and nexlizet as the non statins of first choice in treating patients with or at risk for cardiovascular disease. These new labels are also significant in their ability to bridge what we call the statin gap, which encompasses the tens of millions of patients at risk for cardiovascular disease who are unable or unwilling to take recommended statin therapy. These approvals expand our potential addressable population to more than 70,000,000 patients in the U. S. Alone.

Speaker 2

The FDA approvals came on the heels of a positive CHMP opinion, and we continue to anticipate a similar and positive decision from the European Commission based on the EMA assessment on our European cardiovascular risk reduction label submissions by the end of the Q2 2024. And on the topic of ex U. S. Progress, I'll note that we have initiated the tech transfer process with our partner DSE for the manufacturing and supply of our tablets in Europe, and we expect that process to be complete in the second half of next year. Ahead of the highly anticipated FDA approvals, we were preparing on all fronts to be ready to capitalize on our new label the moment we have them, and we have hit the ground running.

Speaker 2

I'm pleased to share that all commercialization initiatives that we previously mentioned are now in place. We launched our Lipid Lurkers consumer campaign and promotional digital tools. Our field teams have been fully trained and certified on our new indications and resources and participated in an in person launch meeting last month. We initiated partnerships to bolster our patient service platform to ensure healthcare practitioners can prescribe for appropriate patients while we await payer utilization management criteria changes, which usually take 1 to 2 quarters. On that note, I am pleased to share that we recently received confirmation of utilization management updates aligning to our new label from 2 large payers.

Speaker 2

1 commercial payer with 23,000,000 lives that will reflect the new label June 1, and 2 of the largest Medicare payers that represent 8000000 lives each, immediately updated within a week of the label change. We anticipate additional payers to align with our new labels on an ongoing weekly basis. In summary, we've made significant progress and while it's still early, we're encouraged by the positive initial momentum we've seen thus far in the 1st few weeks of Q2. With that, I will now hand it over to Ben for a more detailed review of our Q1 financial performance.

Speaker 3

Thank you, Sheldon. Earlier this morning, we issued a press release containing our financial results for the Q1, which is available on the Investor page of our website. Please note that unless otherwise specified, my comments reflect results for the Q1 ended March 31, 2024. As Sheldon mentioned, we are proud of our performance and strong results we delivered in the Q1, including new to brand prescriptions. Our momentum continues to accelerate, which underscores the fact that outcomes data matters and we're thrilled that data is now incorporated into our new label, which means we can now actively promote that data for the first time and that we'll now be able to reach millions more patients in need.

Speaker 3

For the 5th quarter in a row, we again delivered continued growth in retail prescription equivalents, which increased 43% year over year and 6% quarter over quarter. And as a reminder, almost entirely dependent on our prior label and promotional footprint that has only recently ramped up. The weekly RPE trend again reflects this momentum and remained above the 12,000 RPE mark for all of March, a new high for us. Growth outside the U. S.

Speaker 3

Also continued at an impressive clip. Our partner DSE delivered yet another strong quarter of sales growth in its territory, highlighting the value and growth of potential of our global franchise. At the end of February, approximately 255,000 patients have now been treated with our therapies in Europe, representing a sequential 3 month growth of 26% since November. While most of this growth was generated from existing territories, DSC continues to expand, launching in the Czech Republic in the Q1. I'll also note progress by our Asia region partner, Saichi Sankyo Company Limited, which gained approvals in Myanmar and Thailand in the Q1.

Speaker 3

Turning to our financial results for the quarter. We reported U. S. Net product revenue of $24,800,000 representing an increase of 46% year over year. Collaboration revenue, which includes combined royalty and partner revenue, was $113,000,000 an increase of 11.48 percent year over year.

Speaker 3

This growth includes the $100,000,000 settlement received in January in connection with our litigation resolution. Excluding milestone payments, combined royalty and partner revenue grew 110% year over year. Finally, total revenue for the Q1 was $137,700,000 an increase of 4.67% year over year. I'll note that this includes the previously mentioned $100,000,000 settlement, excluding Milestone total revenue grew 65% year over year. Turning to expenses.

Speaker 3

Cost of goods sold for the Q1 was $10,100,000 a decrease of 14% year over year, driven primarily by lower unit tablet costs for sales in the U. S. And supply to our international partners. R and D expense was $13,400,000 a decrease of 57% year over year, reflecting substantially lower costs following the closeout of our CLEAR outcomes trial. SG and A expense was $42,000,000 an increase of 40% year over year, reflecting higher headcount as we began to ramp up our in house sales force, bonuses and promotional costs in anticipation of the launch of the expanded labels from Nexlithol and Nexlazette.

Speaker 3

Finally, cash and cash equivalents totaled $226,600,000 as of March 31, 2024, compared with $82,200,000 on December 31, 2023, reflecting a strong balance sheet with sufficient capital to support our commercial operations and drive continued long term growth. We also reiterate our 2024 expense guidance continuing to expect R and D expense to be between $45,000,000 $55,000,000 SG and A expense to be between $180,000,000 $190,000,000 and total OpEx expense to be between $225,000,000 245 $1,000,000 Although we have meaningfully strengthened our balance sheet in the Q1, we will continue to remain disciplined with expense management, ensuring sufficient returns are being generated across the company. And with that, let me now hand it back over to you, Sheldon.

Speaker 2

Thank you, Ben. In closing, we continue to deliver on our commitment and execute on our strategic plan to achieve the blockbuster status we know our franchise is capable of. We delivered another strong quarter of growth and ended the quarter with sufficient capital to support our commercial initiatives and drive continued long term growth. We received approval for broad new labels and launched commercial initiatives to capitalize on the opportunity we now have to reach the millions of patients in need of our therapies. In summary, I remain extremely confident that we will continue to drive patient and shareholder impact and value creation by capitalizing on this momentum throughout this year and into the future.

Speaker 2

And I thank the entire Experion team for helping us get to this pivotal moment. Operator, we are now ready for Q and A.

Operator

Thank Our first question comes from the line of Dennis Ding with Jefferies. Your line is open.

Speaker 4

Hi, good morning and thanks for taking our questions. 2 for me. Maybe one on the if you guys can just comment on the prescription habits from doctors since the label update. Have you seen any shift in PCPs versus cardiologists that you want to call out? And if you are seeing any enthusiasm among the primary prevention doctors?

Speaker 4

And then secondly on scripts, they've kind of looked generally flat since the label update. So I'm just wondering if you have a comment on what happened over the last month and when you expect that script that weekly script growth to reaccelerate? Thank you.

Speaker 5

Hi, Dennis. It's Eric. I'll take this one. So first of all, yes, there's a lot of enthusiasm for the new label and that primary prevention is generating a lot of enthusiasm as well. Just a reminder that we are the only non statin that's FDA approved to lower LDL C and to decrease the risk of MI and coronary revascular in those primary prevention as well as secondary prevention patients.

Speaker 5

So enthusiasm is strong. We see right now a balanced prescribing between primary care as well and then cardiologists, but do expect that primary care prescribing to increase. And remember, it's about utilization management criteria as well. So those progressive increases that we'll see as payers start to enable prescribing for those populations. I'm encouraged by the early qualitative feedback.

Speaker 5

And then the last 2 weeks, as you've probably seen, we have seen week over week growth. So expect it to take a little bit of time, but expect progressive increases again as those payer changes increase. But customer enthusiasm is incredibly high.

Speaker 6

And Dennis, I just wanted to add that we're super early in the game. Our representatives were trained on the label, actually received the first view of the label early April. And then they're essentially off territory for 2 weeks in April because we had an all company meeting, we also had our training and they actually received the full detail aid in the 3rd week of April. They were detailing off of the label. So just to reiterate, what Eric is saying, we're actually very encouraged in what we're seeing right now.

Speaker 6

And as we said in our prepared remarks, very confident about growth as we continue through the quarters.

Speaker 4

Got it. And then maybe if I can follow-up, in terms of the script reacceleration around when do you expect that to occur? Because when you look at the last 2 weeks, they have been growing 1% to 5%. But I'm just wondering if that could grow more and when the soonest that could happen? Thanks.

Speaker 5

Yes, Dennis. So again, progressive increases are what I would anticipate. And it really will be as those the bulk of utilization management changes. We anticipate about 2 quarters to get the majority of aligned with a new label. So progressive increases with full kind of growth realization when we have that alignment.

Speaker 4

Got it. Thanks and congrats on all the progress.

Speaker 5

Thanks Dennis.

Operator

Thank you. Please standby for our next question. Our next question comes from the line of Serge Belanger with Needham. Your line is open.

Speaker 7

Hi, good morning. Thanks for taking my questions. First one, as the utilization management gets updated across the payers with the new label, can you just remind us what it's going to look like and whether you expect it to be pretty standard across all the payers covering benedolic acid? And secondly, I think Medicare coverage for the product has lagged the commercial coverage. Can you just give us an update on when you expect Medicare coverage to pick up on the product?

Speaker 7

Thanks.

Speaker 5

Yes. Thanks, Serge. So as you're aware and as we've stated in the past that the prior utilization management criteria has required patient to have ASCVD or be a secondary prevention patient. When the utilization management changes start to happen, we will see the primary prevention patient included as well. We've also had pretty significant statin requirements or maximally tolerated statin requirements that we anticipate to ease as well based upon the outstanding new label that we have.

Speaker 5

With regards to Medicare, as Sheldon mentioned in the opening remarks, we did see already a Medicare payer change and update their utilization management criteria. And there will be many more of those on the horizon over the course of the next two quarters. So very encouraging and hopefully that answered your question Serge.

Speaker 6

Eric, if I could just add, this was a new so we had one that updated their criteria and then we had one that is one of the largest Medicare providers that was an absolute new win. So it gets our coverage closer to 50% in Medicare. So we're very happy about that.

Speaker 7

Great. And then maybe just one follow-up. So as the Medicare coverage ramps up, do you expect any impacts to gross to net going forward?

Speaker 3

Serge, this is Ben. I'll take that. Not a meaningful one, I would say. Medicare coverage gap is always something that affects us and has in the past. But I think as a sort of distribution of the total, it's not going to be a meaningful impact to growth in that.

Speaker 7

Got it. Thank you.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Tom Shrader with BTIG. Your line is open.

Speaker 8

Good morning. Congratulations. It looks like we're close now. So I had sort of a very general question. You're in the market with a statin alternative.

Speaker 8

I think we all use this vague number of 10% of patients have some trouble with statins. Do you have updates on that number? Are you finding that that number is close or very off or and does it differ between undertreated and treated patients? I'm just wondering if we can borrow some of your market surveillance. Thank you.

Speaker 9

So Tom, this is Joanne Froudy. From the standpoint of statin intolerance, I think what we're understanding is that statin intolerance is a broad range. So your 10% number may speak to individuals who are completely unable or unwilling to take a statin. When we look at the opportunity for our therapy, it is in individuals who can't take a statin at all, right, which has that kind of number, a 10%. But in fact, in individuals who can't escalate their dose of attack the lower dose to maximally tolerated.

Speaker 9

And those taken together start to get us numbers closer to the 30%. I can't speak to the market. Eric, if you'd like to speak to that, that's fine. But from a clinical perspective, the numbers are closer and we'll be publishing data and have published data in that realm showing that it's probably closer to a 30% if we think about complete and partial statin intolerance.

Speaker 5

And that's part of our education process, Tom, as well as to let HCPs know that statin intolerance isn't just the inability to take any statin, but it is that inability to And as we go out and communicate appropriate patients, as And as we go out and communicate appropriate patients, that is definitely a patient that we're focused on.

Speaker 8

And just a quick follow-up. So is undertreated the bigger opportunity because they're clearly under the care of a physician and know their lipid numbers?

Speaker 5

Yes. It's I mean, there's clearly a recognition that patients can't achieve their goals with current therapies. So those that are actively treating our primary focus. As we've said, there is roughly a 70,000,000 eligible patient population as a result of our label change. We're focused on 30,000,000 of those patients and those are patients that are actively engaged in therapy.

Speaker 8

Perfect. Great. Thank you.

Operator

You're welcome. Thank you. Please standby for our next question. Our next question comes from the line of Jessica Fye with JPMorgan. Your line is open.

Speaker 10

Hey guys, good morning. Thanks for taking my question. I wanted to ask about volume trends. So we saw clear inflection in volume on the back of ACC last year and we're sort of just starting to annualize over that albeit with the approval now in hand. So should we expect another inflection in volume, thanks to the ability to promote or maybe more of a continuation of the trajectory the franchise has been on?

Speaker 10

Or is it reasonable to think about a deceleration given just the tougher comps? Maybe I'll stop there.

Speaker 6

Hi, Jess, it's Sheldon. I'll start with this. So we've always said that with our label, you would see a meaningful inflection of our business. Even before our label, we said that we would show continued quarterly growth. Again, keep in mind in the Q1, the results that we're showing today, it doesn't even include what we've we didn't have the new label yet.

Speaker 6

So, I think if I understand your question correctly, the outlook is we will continue to show acceleration in the growth of our products based upon the new label that we have. As Eric just previously mentioned, we know that we have a patient population of close to 70,000,000 patients who can benefit from this drug and additional LDL lowering and risk reduction. What we haven't talked about is the actual pace of that growth. It's not going to happen as a quick inflection, but we're going to see meaningful growth, more aggressive growth as we march through the quarters.

Operator

Great. Thank you. Thank you. Please standby for our next question. Our next question comes from the line of Jason Butler with Citizens JMP.

Operator

Your line is open.

Speaker 11

Hi, morning. Thanks for taking the questions. This is Jose for Jason. And just a very quick one from us. Have any of the payers pushed back an increase in access following the label expansion?

Speaker 5

Yes, it's Eric. I can start this one off. So I'd say our discussions have been very positive so far. I haven't heard of any negative receptivity from a payer perspective. Obviously, payers have their own timelines.

Speaker 5

So some of them may operate sooner than others. But based upon the cadence of how this was handled initially there were medical discussions and then those translated into confirmation post label change and then business discussions. And so far, all these discussions have been very favorable.

Speaker 11

Very helpful. Thanks. And just a very quick one on the commercial efforts. So now that all the Yes

Speaker 5

Yes. So we've made the adjustments to the sales force. So we're at the number that we anticipate staying at for a while, which is at 150. As a reminder, with the sales force, our personal promotion as well as our digital footprint, we're able to cover about 45,000 HCPs. So we've got a good infrastructure in place.

Speaker 5

In terms of how do we measure success? Well, first of all, we have to have discussions with our HCPs. So we're looking at both the commercial the actually the digital reach as well as the personal reach. And our teams have been very successful in having those discussions with the targeted HCPs. The digital footprint has been strong.

Speaker 5

We've seen over 19,000,000 impressions between HCPs and consumers over the 1st 5 weeks. So those are very encouraging metrics. So obviously, those are some early indicators, but the significant indicators will be actually watching those share increases happen over the upcoming weeks quarters.

Speaker 11

Very helpful. Thanks for taking the question.

Speaker 5

You're welcome.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Joe Pantginis with H. C. Wainwright.

Operator

Your line is open.

Speaker 12

Hey, everybody. Good morning. Thanks for taking the questions. So I wanted to approach the question also from the statin intolerance or long term side effects and sort of overall concern from some patients in general where right now all the focus is on HCPs and their views about the new label and we're expecting to see that growth inflection as you guys are as well. So I guess I would ask the question from the following standpoint.

Speaker 12

Are you going to collect data or do you even want to sort of pontificate, if you will, about the role of patients in helping to drive those decisions as they're much more savvy. They have Google and what have you or they're saying, I haven't had an option for a statin up to this point, doctor, but this really looks interesting. What role do you think patients' feedback will have in changing their treatment guidelines?

Speaker 5

It's going to have a significant role, Joe. So as Sheldon mentioned in the opening remarks, we do have a consumer base campaign that we've deployed as well. We call these little creatures the lipid lurkers and they're out there, they're present, wreaking havoc. And we've put those forward in the digital universe. Just from a meta campaign perspective, we've seen 1,600,000 exposures with the lipid lurkers.

Speaker 5

They're present in many other platforms as well. So consumers play a significant role. Obviously, we've got to be very targeted. We don't want to go to the broad consumer universe. We want to go to those who are our target patient.

Speaker 5

And I think the team has done a great job so far at doing just that.

Speaker 6

And Joe, just Go ahead Sheldon. Yes, no, first of all, good morning. What we saw last year too after ACC, we did collect data is that consumers really went out there. When they saw information, etcetera, to your point, consumers are very different. They're well informed now.

Speaker 6

They want to find out more and we saw a lot of them post ACC, head out into their physicians' offices and ask about Nexlazette, Nexlazette. We recently received some research, which shows that they're doing it again. Eric and I were just mentioning when we were in the office that even on our Instagram, our Facebook, we're seeing these lipid lurkers and we're also seeing the new campaign that we have. So, it's definitely a big part of it. And people want to know about, one, do I have to I don't want to take a stronger dose of a statin or I don't want to take a statin because I can't.

Speaker 6

So, they're very savvy about this.

Speaker 12

No, I appreciate that color. Thank you very much.

Operator

Thank you.

Speaker 5

Thanks, Jeff.

Operator

Please stand by for our next question. Our next question comes from the line of Jason Zumansky with Bank of America. Your line is open.

Speaker 13

Thank you. Good morning, team. Congrats on the quarter and thanks for I apologize if I missed this, but to what extent did stocking and inventory build contribute to the quarter's total? And then a follow-up if I may.

Speaker 3

Yes, that's a short answer, Jason. It was none. No effect on quarterly revenue.

Speaker 13

Got it. Perfect. And then what should we be thinking about gross to net trends as you start to bring more payers online, especially given the sizable patient population in primary prevention?

Speaker 3

Yes, I can take that one also. So as far as gross to net goes for the year, we expect it to follow the same cyclicality that we've seen in prior years. And as a reminder, Q1 is our best quarter and Q4 is our worst. So it gets progressively worse over the year, largely driven by the Medicare coverage gap. As far as the actual percentage year over year, I would say it's going to be consistent.

Speaker 3

The payers updating towards the criteria, but in adding that primary prevention doesn't necessarily change the rebate or any of the amount paid to them. It's just the indication that's covered. So as far as the actual gross to net number, we don't really see that changing materially year over year, just it will follow the same cyclicality that it does every year.

Speaker 13

Got it. I guess I was looking for more color as to whether or not payers were looking for more concessions again, given kind of the sizable shift in overall population, I guess, overall moving forward?

Speaker 6

I can take that, Jason. I mean, we've been very pleased, as Eric mentioned, with our interactions with our payers. And the short answer to that is also no. So and I think part of it is just based upon the alignment that we gained when we presented the data at ACC and went to them immediately. This is something that they've been prepared for.

Speaker 6

But there has not been meaningful requests as it relates to what our new label update is, is the best answer I can give you.

Speaker 13

Got it. All right. Perfect. Thank you so much for the color.

Operator

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Sheldon for his closing remarks.

Speaker 6

Great. Thank you, Towanda. Thank you, everyone, again for your time and interest today. Again, we couldn't be more pleased with our Q1 performance, our label approval and for what they mean for millions of primary and secondary prevention patients who are unable to achieve their LDL cholesterol goals with current therapies alone.

Speaker 2

We look forward to continuing to execute

Speaker 6

on our commercial plan and keeping you posted on our progress in the weeks months ahead. Look for us as a host of investor conferences in the upcoming weeks. We have a real busy May in front of us. Take care and see all of you soon. Thank you again.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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