Esperion Therapeutics Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 7, 2023

There are 12 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Experian Therapeutics Third Quarter 2023 Financial Results Call. 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 may be recorded. I would now like to hand the conference over to Ms.

Operator

Callahan, Head of Investor Relations at Experian. Please go ahead, Alexis.

Speaker 1

Thank you, operator. Good morning, and welcome to Asperion's Q3 2023 earnings conference call. With us today are Sheldon Koenig, President and CEO and Ben Holliday, CFO. Other members of the executive 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.

Speaker 1

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. The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, November 7, 2023. We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances after the day of this conference call and webcast. As a reminder, this conference call and web A copy can be found on the Investor page of our website.

Speaker 1

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 Koenig, President and Chief Executive Officer.

Speaker 2

Thank you, Alexis, and good morning, everyone. Thank you for joining us today to discuss our Q3 results and the progress we continue to make. We are pleased to report another strong quarter. Total revenue was $34,000,000 which represents a 79% increase year over year. U.

Speaker 2

S. Net revenue came in at $20,300,000 which represents a 45% increase year over year and was driven by a 33% year over year increase in retail prescription equivalents. We are proud of the continued strength of our U. S. Business into the second half of the year and believe this reflects the robustness of our clinical data, The efficacy of our life saving medications, Nexlipol and Nexlipizet, as well as disciplined execution of our commercial strategy.

Speaker 2

We're also pleased to build upon our momentum and use of brand prescriptions in the 7 months following our clear outcomes readout at ACC in March, bolstered by the cadence of additional impressive data releases and publications since then, most recently at the European Society of Cardiology Congress in August. From March through the end of September, new to brand prescriptions grew 61% With momentum continuing from the Q2 into the Q3. Next, let me walk through additional highlights from the quarter. As I already mentioned, we delivered continued RPE growth in the Q3 of 33% year over year, demonstrating consistent growth even with our narrow indication. After submitting our regulatory filings to include cardiovascular risk reduction In Nexo's call and Nexo's at Labels last quarter, we're pleased to announce FDA acceptance of our submission with a PDUFA or approval date of March 31st, which is ahead of when we originally anticipated approval.

Speaker 2

Lastly, regulatory review of our cardiovascular risk reduction label submission In the EU remains on track and we continue to anticipate its approval in the first half of twenty twenty four. During the Q3, we continued to disseminate new data from clear outcomes to educate the market about the benefits of our products. We presented 2 new analysis at the European Society of Cardiology in August that further support cardiovascular risk reduction. The first analysis demonstrated that bepedomic acid reduces total major adverse cardiovascular events, Reinforcing the value of long term benpedomic acid use and reducing not just the first, but multiple events over time. The second analysis also demonstrated that femtoselic acid reduces time to 1st major adverse cardiovascular events In patients with diabetes, it does not increase the rate of new onset diabetes, which is a key differentiating feature compared to statins and underscores its safety and efficacy in patients both with and without diabetes.

Speaker 2

Patients with diabetes who are At increased risk for cardiovascular events constituted a large proportion of the primary prevention population that we studied in clear outcomes. So this finding is important. These analyses continue to demonstrate the efficacy and safety of rambodetic acid, Further differentiate it from existing LDL cholesterol lowering therapies and highlighting its 1st in class mechanism of action. It is not an overstatement to say that our focus is on expanding our label to include cardiovascular risk reduction, which is we've always said is the real growth catalyst. And following that is when we will begin to see accelerated prescription growth.

Speaker 2

To that end, our entire organization is now focused on preparing for this update and we've begun laying the groundwork to make changes to our sales organization so So that we can hit the ground running the moment we receive approval of our new expanded label. Next, our ongoing conversations with payers are Continuing to pay off with recent wins for improved coverage and utilization management criteria that aligns with Clear Outcomes data. It is encouraging to see these types of mid cycle changes with national and regional payers, which are not common, and we look forward to continued progress. Finally, we announced a strategic collaboration with ACC and Amgen to launch the cholesterol screening campaign With a goal of increasing awareness of the importance of LDL screening to help healthcare practitioners more easily identify patients with high risk of a cardiac event Based on our clear outcomes data, we believe we have the potential to benefit a much larger group of patients And as characterized by our current label, which is quite narrow and indicated only for a small subset of patients. The label we anticipate receiving in March We'll add a broad cardiovascular risk reduction indication in both primary and secondary populations as well as remove current limitations.

Speaker 2

From a commercial perspective, our addressable patient population will significantly increase when we get our new CVOT label next year. Right now, our therapies are only indicated for about 10,000,000 secondary prevention patients with documented ASCVD or HEFH And you are on a maximally tolerated statin therapy. Our new label that we anticipate by March 31st We'll reflect our clear outcomes data and enable us to be indicated for an additional 20,000,000 high risk primary prevention patients. And these 30,000,000 patients in total will be our primary focus. There are another 40,000,000 patients in the U.

Speaker 2

S. Who are untreated and at high risk for an event and those patients represent additional potential upside. We look forward to being able to address the needs of millions of patients who are currently still unable to achieve their LDL cholesterol goals on current therapies alone. With that, I will now hand it over to Ben Halliday, our Chief Financial Officer, for a more detailed overview of our Q3 performance.

Speaker 3

Thank you, Sheldon. Earlier this morning, we issued a press release containing our financial results for the Q3, which is available on the Investor page of our website. Please note that unless otherwise specified, my comments reflect results for the Q3 ended September 30, 2023. As Sheldon already mentioned, we posted strong overall 3rd quarter results. We're pleased to have delivered another quarter of continued growth in retail prescription equivalents, Which increased 33% year over year and 8% quarter over quarter, which was accomplished even with our narrow indication and promotional footprint.

Speaker 3

The weekly RPE trend also shows persistent strength, largely remaining above the 10,000 RPE mark and repeatedly setting new weekly highs. Growth also continued globally, not just in the U. S. Our European partner again delivered another strong quarter of sales growth in its territories, which highlights the value our important medicines are bringing to patients worldwide. At the end of August, 158,000 patients have now been treated with our therapies in Europe, representing sequential 3 month growth of 26% since May.

Speaker 3

I'll also note that the bulk of this growth has come from existing territories versus newly launched territories, Three additional countries were granted approvals during the Q3, the Netherlands, Slovakia and Spain, and we look forward to reaching patients in these new markets in the coming months. Turning to our full financial results for the quarter. We reported U. S. Product revenue of $20,300,000 representing an increase of 45% year over year.

Speaker 3

Collaboration revenue, which includes combined royalty and partner revenue, was $13,700,000 an increase of approximately 174% year over year. Much of this increase was due to tablet shipments that were pushed from the Q2 to the Q3 as we mentioned in our last earnings call. Finally, total revenue for the Q3 was $34,000,000 an increase of 79% year over year. Turning to expenses. Cost of goods sold for the Q3 was $13,400,000 an increase of 106% year over year, also driven by the timing of tablet shipments as I just mentioned.

Speaker 3

R and D expense was $14,900,000 a decrease of 49% year over year, reflecting substantially lower costs following the closeout of our CLEAR outcome study. SG and A expense was $33,200,000 an increase of 33% year over year, reflecting higher legal and promotional costs. We continue to track in line with our guidance, expecting full year 2023 operating expenses to be between $225,000,000 $245,000,000 which is comprised of $100,000,000 to $110,000,000 in R and D expense and $125,000,000 to $135,000,000 in SG and A expense. Finally, cash equivalents and investment securities available for sale totaling $114,800,000 as of September 30, 2023, compared with $166,900,000 on December 31, 2022. I'll note that we ended the quarter with a higher cash balance than we which reflects a continuing dedication to disciplined expense management even while we continue to invest in initiatives to prepare us to capitalize on our new label as soon as we receive it.

Speaker 3

We believe we are currently well positioned to have sufficient cash to continue funding operations and support our full scale commercial launch next year. We will continue to diligently manage expenses, look for ways to generate efficiencies and potentially slow spend in certain areas as needed. And with that, let me now hand it back over to you, Sheldon.

Speaker 2

Thank you, Ben. I'll now provide additional corporate updates from the quarter. As some of you may have seen, we filed a Rule 12 motion 2 weeks ago in our litigation case, which asserts that the language in our license agreement is unambiguous and can be ruled solely based on the contract itself and the pleadings filed to date and request that ruling accordingly. Permission to file this motion was a prerequisite and the fact that we were granted permission was a win for us. In terms of next steps, All filings are due by November 22, after which a ruling could occur in the days or weeks to follow, which means that we could potentially have any answer by the end of the year.

Speaker 2

I'll just note that this motion does not affect our current case timeline and we remain scheduled for trial on April 15. Next, a reminder of our plan to reach blockbuster status for our franchise, which we have every confidence in achieving. In short, We have robust data generated through a landmark 14,000 patient trial. That data is being used to support a highly differentiated label, which we anticipate approval of by March 31. In the meantime, we're excited on a strategic plan to continue to drive growth and educate healthcare providers and I'll wrap up our comments today by reiterating that we continue to deliver on the commitments the leadership team has made.

Speaker 2

We are steadily executing on our strategic plan to unlock the blockbuster potential this franchise is capable of. We have more work to do, but I'm pleased with the progress we've made. I'm confident in our ability to succeed and look forward to demonstrating And with that, operator, we are now ready for Q and A.

Operator

Thank you. Please stand by while we compile the Q and A roster. One moment for our first question please. Your first question comes from the line of Dennis Ding with Jefferies. Your line is now open.

Speaker 4

Hi, Dennis. Thanks for taking Hey, good morning. Thanks for taking our questions. 2 for me, if I may. Number 1, just on the U.

Speaker 4

S.-based business, Can you comment on some of the underlying gross to net trends that may have impacted Q3 and maybe Talk about your outlook for Q4. And then question number 2 is on the litigation case with Daiichi. Appreciating that there could be a positive ruling on the Rule 12C dynamic. When could the milestone actually hit Experion's balance sheet Given Daiichi would likely appeal after that and we get a lot of investor questions on how long would that appeal process actually take And when could money actually hit Esperion's balance sheet? So maybe just clarify that for us as investors.

Speaker 4

Thank you.

Speaker 5

Hey, Dennis. It's Ben. Great to talk to you. Thanks for the question. On gross to net, in Q3, we saw some typical seasonality that we'd from a product in this market.

Speaker 5

I'll note, we've done a good job improving gross to nets from last year into this year. And I think we're in a pretty steady state at this point. Going forward, there's still room for improvement and looking into Q4 and beyond, Yes, that will all come with volume. So I wouldn't see that as an immediate term, but over the longer term, we do expect it to continue to improve.

Speaker 2

And, Dennis, this is Sheldon. I will take the second as it relates to the litigation. First of all, as a reminder, as you mentioned, We are able to win the motion as related to 12 that was a few weeks ago. The opposition has until November 22 to actually file their side of it and then the court will make a ruling. Again, I just want to Our confidence in the case that we have here and we feel really good about it.

Speaker 2

As it relates to when we would see money, etcetera, Keep in mind that this milestone was not to be actually recognized until later in the Q1 of 2024, Early Q2. And so right now, if I think about the timeline, We don't want to get to this because we have to take every day as it comes as it relates to litigation, but I'm confident that we remain on that same timeline As it relates to us receiving the milestone.

Speaker 4

Got it. Thank you.

Operator

Thank you. One moment for our next question please. And our next question comes from the line of Tom Schroeder with BTIG, your line is now open.

Speaker 4

Good morning. Thank you for taking the call. I wanted to ask a little bit about Slide 5. It's kind of striking. You got this big bump at ACC, where I think we all knew there was fair bit of interest, but it's been relatively flat.

Speaker 4

Does that speak to how hard it is to talk to physicians that aren't converts already? And is that what you think the label will help with? And then maybe if you have any information, do you Have any way to track physicians who at some level are interested in the drug, but won't go through a slightly arduous Payment process, do you collect any of that data interest beyond people who actually get all the way through the reimbursement process? Thanks.

Speaker 6

Hey, Tom, it's Eric. I'll answer your question. So first of all, the ACC POP that we had It's tremendous. We've been able to build upon that. So quarter after quarter, we saw an increase in TRPEs of 8%.

Speaker 6

I want to remind you that the team is unable the commercial team is unable to talk about the new data. So you're absolutely right. When that label changes, not only will we expand the population, but will unlock our ability to actually talk About these data, we've done quantitative research where we show significant changes in prescribers intent To prescribe and I believe Sheldon showed at a meeting not too many months ago an ATU that we did that tracks The desire to make our product standard of care and that tremendously increases Once we're able to communicate those data and once we have the managed care changes that ultimately align with those changes that we'll have from an indication perspective.

Speaker 2

And the conference was the H. C. Wainwright Conference, Tom, if you want to go back and take a look at that, it's archived.

Speaker 7

Got it. All right. Thank you.

Operator

Thank you. One moment for our next question, please. And our next question comes from the line of Troy Langford with TD Cowen. Your line is now open.

Speaker 8

Hi, congrats on all the progress this quarter and thanks so much for taking our questions.

Speaker 3

I just have one about

Speaker 8

the label change next year. So when that does occur next year, exactly how quickly do you think we could start to see that uptick in prescription numbers that you all just mentioned? Do you think it will More like the inflection that we saw right after ACC or do you think it could take a couple of months after the sales team has the ability to formally promote the data before we see that

Speaker 6

Thanks for your question. It's Derek again. So no doubt the team will be ready. The team has been spending The vast majority of their time now preparing for this label change across every function, ensuring that we're a well oiled machine With these new data and ultimately new indications, there does need to be some payer changes that happen in order to realize The full potential. So I would look for some improvements right away.

Speaker 6

But as we start unlocking that access that aligns With the broader label is when you can start to see the even greater changes that we anticipate.

Speaker 9

Joanna? Thank you for the question. This is Joanne Fudi, the Chief Medical Officer. The other thing that's really critical as we think about the label is timing. So we've announced that the PDUFA date is March 31st.

Speaker 9

That precedes the American College of Cardiology, and I think you all recognize How significant this year's American College of Cardiology has been for getting our message out. So we anticipate similarly having The opportunity with the American College of Cardiology in 2024 to leverage not only our new label, but all the noise. We had over 1,000,000,000 impressions from last year's agency and we're looking forward to similar uptake this year or coming year in 2024.

Speaker 7

Great. Thanks.

Speaker 3

Thank you.

Operator

Thank you. One moment for our next question please. Our next question comes from the line of Jason Zimansky with Bank of America. Your line is now open.

Speaker 10

Perfect. Congrats on the quarter and thanks so much for taking our question. I wanted to ask a follow-up on an earlier comment you've made. Obviously, the 12 ruling was a win, but as acknowledged by your attorneys in the filing, there's a challenge to litigating indefinitely. And If the proceedings are extended for whatever reason, be it an appeal or whatnot, are there contingency plans in place to support The relaunch, and then a follow-up, if I may.

Speaker 2

Sure. Ben, do

Speaker 4

you want to?

Speaker 5

Yes. Happy to take that one, Jason. So as far as kind of pushing out our cash runway and being able to help manage both the launch and funding that litigation, we have drivers that are ahead of us. Most of our spend next year hasn't even been contractually locked into. So, we can delay spending like on preclinical pipeline, some of our smaller R and D projects, even with the sales force ramp up without fully hampering the commercial launch here.

Speaker 5

You will always try and walk a fine line of Funding the stuff that's going to show us an immediate return, but also managing that burn rate and managing those expectations from a cash standpoint. But Truthfully, the litigation is a cost it's not doesn't cost as much as frankly I thought it would and we can manage to keep that going as needed.

Speaker 10

Got you. Thank you for the color. And then maybe as a follow-up on the business, what does a typical Patients starting bempedoic acid currently look like? Are they primary prevention secondary? And then, I mean, how do you expect this to shift When you receive hopefully the label update.

Speaker 6

Yes, Jason. So they're now aligned with our label. They're an ASCVD patient. They're on a documented maximally tolerated statin dose and they're not at their LDL C goal. So that is a Typical approvable patient now.

Speaker 6

I will say that there is a strong desire to prescribe us in a patient that has Primary prevention, so they don't have active ASCVD, but they have risk factors. There's also a strong desire to prescribe us in Patients that are unable or unwilling to take statins. So both of those will go away with the new label as we add in the Primary prevention and as we remove that dependency on maximally tolerated statins.

Speaker 10

Great. Thanks guys.

Operator

Thank you. Thank you. Thank you. One moment for our next question, please. Our next question comes from the line of Serge Belanger with Needham.

Operator

Your line is now open.

Speaker 7

Hi, good morning. I also had a couple of questions on the Rule 12 motion. So you mentioned the trial date in mid April is still on the calendar. Does that remain on the calendar until There is a decision on this motion. And then in terms of the appeals process here, is it the same With the 12 motion as it would be if it went to trough, then I have a couple of follow ups.

Speaker 2

First of all, thank you, Serge, And glad you could make the call. So as it relates to the trial date of April 15, that will remain on the calendar. As a matter of fact, should the ruling once the motion is reviewed and heard, if there is no decision, then No harm, no foul. We remain on the same schedule, which is the April 15 trial date. And then your second was as it relates to appeals.

Speaker 2

As it relates to the appeal process, There is certainly the ability to appeal. Obviously, we've done some research in this area. We just have to take it Day by day as it relates to what would happen in the case of an appeal.

Operator

Okay.

Speaker 7

And then on the business front, maybe just update us on your prior auth rate and whether you expect Any additional formulary coverage ahead of March 31?

Speaker 11

Yes. So, we've had the opportunity to get to almost 90% of the payers with the CVOT data. I'm pleased to say, as Sheldon had outlined as well, Not only have we have new formulary access with very large payers as well as small regional payers, But also the criteria has been aligning with the CVOT data already. With that, our approval rates Have also been quite well since those presentations and since the CVOT date as well. So I can tell you that we're up to approval rates that are very much almost to the 85% range in commercial and equal to that in Medicare.

Speaker 4

Thank you.

Speaker 2

And sir, just one other note, I was thinking while TJ was answering that question regarding your question about 12 motion and appeal. As I mentioned, we would have to see how that goes. But I think you would agree with me that If we win that motion, that's a big win. So we can worry about appeal as it comes, but it's a nice indicator

Operator

And thank you. I would now like to turn the conference back to Mr. Sheldon Koenig, President and Chief Executive Officer, for closing remarks. Great.

Speaker 2

Thank you so much. And again, thank you for everyone for joining today for our Q3 2023 earnings. As you can see, I mean, we're very excited. We have a great story. We had a strong quarter.

Speaker 2

We really built upon our post ACC momentum for Nexplazette and Nexplazette. These are life saving medications. We're looking very forward to the PDUFA date or approval date of March 31. Again, as we mentioned, our litigation remains on track. We hope for a near term solution.

Speaker 2

However, again, if not, the April 15 trial date, we will continue there. It's important to remember, NexoTol and NexoZet are novel therapies with differentiated 1st in class mechanism of action. And again, we're a small company, but we're doing big pharma things and we continue to deliver on all of our commitments. So again, thank you everyone. Have a great day.

Speaker 2

Maybe see some of you at American Heart and we'll talk to you soon. Take care.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.

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