Esperion Therapeutics Q4 2023 Earnings Call Transcript

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February 27, 2024

There are 8 speakers on the call.

Operator

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to Aspirin's 4th Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. Following the presentation, there will be a question and answer session.

Operator

Please be advised that today's conference call may be recorded. I would now like to hand the conference over to Alexis Callahan,

Speaker 1

Head

Operator

of Investor Relations. Please go ahead.

Speaker 2

Thank you, operator. Good morning, and welcome to Aspirion's 4th quarter and full year 2023 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 2

A copy 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 2

The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, February 27, 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 Koenig, President and Chief Executive Officer.

Speaker 3

Thank you, Alexis, and good morning, everyone. Thank you for joining us today to discuss our Q4 full year results and the significant progress we continue to make. We are pleased to report another strong quarter as well as key material events in January that we believe put our company on solid footing and further position us for continued long term success. Starting with our quarterly performance, total revenue was $32,300,000 which represents a 72% increase year over year. U.

Speaker 3

S. Net revenue came in at $20,800,000 which represents a 39% increase year over year, driven by a 44% year over year increase in retail prescription equivalents. We believe the continued growth seen in both the U. S. And in our global territories is a testament to the strength of our clinical data, the unmet need in the market and our teams and partners abilities to execute.

Speaker 3

Listed here are several recent accomplishments worth calling out. We delivered another strong quarter that positions us for continued success in the long term and significantly transforms our capital position and investment profile. Prescription growth continued at a strong pace and we're proud of the momentum that we sustained through the end of the year. Additionally, we resolved our pending litigation with DSE and expanded our partnership bringing in several new long term biotech investors. Our label expansion approvals remain on track in both the U.

Speaker 3

S. And Europe. We published additional important data from our CLEAR outcomes trial and we remain focused on preparation for our new label, expanding our commercial organization to ensure we're ready to fully capitalize on the opportunity when we receive approval next month. On January 3, we announced the settlement agreement and an amendment to our collaboration with Daiichi Sankyo Europe, which marked the resolution of our pending litigation. Our settlement was mutually beneficial and reflects both parties' commitment to our ongoing partnership to deliver our medications to patients worldwide and address global unmet need.

Speaker 3

Importantly, we believe the closure of this matter significantly strengthens our investment profile, reduces costs associated with the litigation and is an excellent outcome for both parties. It provides for significant near term cash payments, inventory and gross margin savings and potentially extends our European product lifecycle while generating additional potential royalty streams in the DS territories. The net result of all components of our agreement provides both near and long term value and allows us to continue focusing on running our business. Combining our year end cash balance with the $100,000,000 settlement payment received in January and proceeds from our recent offering, we significantly strengthened our liquidity position, which enables us to invest in initiatives that support the long term success of Aspirion. With the litigation now resolved and the infusion of additional cash, we are poised for significant growth in 2024.

Speaker 3

Now let me turn to our upcoming label expansion, which we anticipate will include a new broad cardiovascular risk reduction indication, expand access to the primary prevention patient population or those at risk of an event, not just those who have already had 1 and remove the statin use requirement. These are significant changes to our current label, supported by our robust clear outcomes data and are expected to drive substantial future growth. I'm pleased to share that reviews of our pending applications with the FDA and EMA are progressing extremely well and these positive discussions remain in line with our strategic goals. We are on track with an FDA PDUFA date of March 31, with an expected decision by the EMA on our European label likely coming in the Q2. Based on our existing label and narrow indication, our current addressable market is around 10,000,000 patients in the U.

Speaker 3

S. Upon approval of our new anticipated label, our models predict an opportunity that triples to around 30,000,000 patients. That figure, however, does not include an additional 40,000,000 untreated individuals who are at high risk and who are still not at their LDL cholesterol goal. We see vast potential for our products to help millions more patients in the future, reiterating our eagerness for the FDA's anticipated approval. Today, I'd like to outline the 5 core pillars that will ensure our life saving products, nexlitol and nexlizet reach the appropriate patients.

Speaker 3

1, our expanded label. Our anticipated new label will reflect clear outcomes data and will also create a differentiated and expanded indication that includes high risk primary prevention patients. 2, all new promotion. Current promotional resources for NexoPal and NexoZet are focused on LDL cholesterol reduction in patients with ASCVD on maximum tolerated statins and still not at their LDL cholesterol goal. Based on the anticipated new label, the team has prepared a powerful suite of promotional tools that will communicate the clear outcomes data across the expected new and expanded patient population.

Speaker 3

Extensive market research has been conducted to ensure the right sequence of data will be communicated at the right time. 3, deeper reach. I'm proud to announce that we've completed our sales force expansion and have recently deployed 60 new territory managers into the field, bringing our team up to 150 representatives. These motivated individuals together with improved digital resources will allow us to expand our depth and breadth to reach a target universe of 45,000 healthcare providers comprised of both primary care providers and specialists. 4, patient activation.

Speaker 3

We've created a bold new consumer campaign to drive awareness and ensure appropriate patients have discussions with our healthcare providers about NexoTol and NexoZette. And 5, payer access and reimbursement. Finally, we continue to align payers' utilization management criteria with our anticipated label to include primary prevention and primary hyperlipidemia, while at the same time enhancing our patient service programs to support both patients and healthcare providers alike. We're also pleased to announce that ICER, the Institute For Clinical and Economic Review, just determined NexoZet as a cost effective therapy, which adds support for its value proposition to payers. We believe our recent achievements and changes we've implemented set us up for long term sustained growth.

Speaker 3

Shown here are a series of important commercial, clinical, regulatory and financial milestones that we expect to be achieved along the way. You'll see that this steady stream of catalysts begin to form a roadmap for long term value growth. We've already expanded our sales force and anticipate label expansions in both the U. S. And Europe.

Speaker 3

With expected new global labels, anticipate guidelines to be updated. In addition, we expect to file INDs or investigational new drug applications for our next generation ACLY inhibitors to lay the groundwork for growing our product pipeline beyond bempedoic acid. Furthermore, our partners will continue launching our products in even more new territories on a regular cadence, creating additional revenue streams and bolstering our growing global franchise. Longer term, the optimization of our balance sheet and partnership related cost savings should enable us to continue to enhance our capital position over time. We also see meaningful revenue contribution stemming from the potential for a triple combination therapy in Europe, additional milestone payments from our network of partners, additional ex U.

Speaker 3

S. Opportunities and continued growth stemming from further advancement of our preclinical pipeline. On that note, I'm excited to announce our intent to hold an R and D Day later this year to review our pipeline of next gen ACLY inhibitors in more depth. With that, I will now hand it over to Ben Halliday, our Chief Financial Officer, for a more detailed review of our Q4 performance.

Speaker 1

Thank you, Sheldon. Earlier this morning, we issued a press release containing our financial results for the Q4, which is available on the Investor page of our website. Please note that unless otherwise specified, my comments reflect results for the Q4 ended December 31, 2023. As Sheldon already mentioned, we posted strong 4th quarter results and ended the year with continued momentum, including a new to brand prescriptions. We ended the year on a strong note, which really emphasizes the point that outcomes data matters.

Speaker 1

And we're excited for that data to be incorporated into our new label next month and for what it means for patient access and our ability to actively promote the data for the first time. We again delivered another quarter of continued growth in retail prescription equivalents, which increased 44% year over year and 8% quarter over quarter and was accomplished even with our current label and promotional footprint before recently ramping up our in house sales force. The weekly RPE trend also reflects this momentum and touched the 12,000 RPE mark late in the Q4, a new weekly high. Turning to growth outside the U. S.

Speaker 1

Our partner DSE again delivered another strong quarter of sales growth in its territories, underscoring the value our approved medicines are bringing to the patients globally. At the end of November, approximately 202,000 patients have now been treated with our therapies in Europe, representing sequential 3 month growth of 28% since August. I will note that most of this growth has been generated from existing territories. That said, DSC commercially launched in 3 new territories during the Q4, the Netherlands, Slovakia and Spain and gained approval in Czech Republic as well. In addition, Daiichi Sankyo launched in Hong Kong during the Q4 marking the 1st country in the Asia region to launch.

Speaker 1

Turning to our full financial results for the quarter. We reported U. S. Net product revenue of $20,800,000 representing an increase of 39% year over year. Collaboration revenue, which includes combined royalty and partner revenue, was $11,500,000 an increase of 195% year over year.

Speaker 1

Finally, total revenue for the Q4 was $32,300,000 an increase of 72% year over year. Turning to expenses. Cost of goods sold for the Q4 was $11,500,000 an increase of 174% year over year, driven primarily by higher tablet shipments to our partners to support new country launches. R and D expense was $17,700,000 a decrease of 46% year over year, reflecting substantially lower costs following the closeout of our CLEAR outcomes trial. SG and A expense was $45,400,000 an increase of 88% year over year, reflecting higher legal and promotional costs as well as higher headcount as we began to ramp up our in house sales force.

Speaker 1

Of note, we incurred $13,100,000 in one time legal expenses related to our litigation resolution with DSC that are non recurring in nature. Finally, cash equivalents and investment securities available for sale totaled $82,200,000 as of December 31, 2023, compared with $166,900,000 on December 31, 2022, although that figure did not include the settlement related cash payment received in January nor the proceeds from our recent public offering. Today, we are also reiterating the 2024 expense guidance we put forth last month. For the full year 2024, we 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 to be between $225,000,000 $245,000,000 I'll note that total operating expenses are expected to come in the same level as last year. We've just shifted dollars from our R and D budget to the SG and A budget reflect the closeout of the clear outcomes and ramping up the commercial activities to support our new and expanded label.

Speaker 1

While we have materially strengthened our balance sheet in recent weeks, we remain disciplined when it comes to expense allocation, ensuring investments we make, including those to support our commercial launch, are generating sufficient returns. And with that, let me now hand it back over to you, Sheldon.

Speaker 3

Thank you, Ben. I'd like to close by reiterating that we continue to deliver on our commitments and execute on our strategic plan to achieve blockbuster status. Sales are continuing to accelerate following publication of our clear outcomes data last year, and we anticipate a true inflection to occur after we receive approval of our new and expanded labels in the U. S. And Europe later this year.

Speaker 3

Our strategic plan also consists of an expansion of our product pipeline as we further develop our next gen ACLY inhibitors. We will further expand on our pipeline later this year. But in short, we are excited about our next gen platform and the potential therapeutic areas to which it could be applicable. Further development of these assets could help us expand beyond lipids and enter into new markets with significant unmet need, increase our addressable markets, extend our product lifecycle and open the door to additional partnering opportunities as well as help us achieve long term sustainable growth. In summary, I'm excited for what I believe lies in store for us, both now and in the future, and our past has never been clear or brighter.

Speaker 3

And with that, operator, we are now ready for Q and A.

Operator

Thank you. And our first question coming from the line of Sergey Belanger with Needham. Your line is open.

Speaker 4

Hi, good morning. Thanks for taking my questions. I guess for Sheldon, we're about 30 days away or so from the PDUFA for the label expansion. Maybe just talk about the cadence of activities that would follow that label extension given that there's DCC and what the plan is to in terms of payers and formulary coverage? Thanks.

Speaker 4

Great.

Speaker 3

Yes. Thank you, Serge, and good morning. So yes, we are about 30 days away from our PDUFA date. And just again, want to reiterate, do not see any issues at all of getting there. We've had some very positive interactions with the FDA.

Speaker 3

So again, feeling really confident about our label and the strategy that we've laid out regarding the label. You heard about our 5 pillars that we mentioned in in our prepared remarks as we get ready to launch this new label, which we've always said will be an inflection point for us. As it relates to payers, we've been out talking to payers since the last ACC, March 4th. I'm happy to say we've made great progress with the payers. We've seen some payers already making changes in anticipation of the new label.

Speaker 3

I think what's also interesting in our prepared remarks, we mentioned that iCER just recently came out and made reference to NexoZet as being a cost effective therapy and essentially should be made available on all formularies. So that's something we'll also reimburse with payers. So we feel very confident about our payer strategy and the interactions that we have had with them. To your point for ACC, again, we get the label, the new label end of March. ACC is around the April 5 timeframe and we will be using ACC as a way to really launch that new label and really make a big splash regarding the new label.

Speaker 3

And Serge, it's Eric. If I can add that day 1, our sales force will be ready to go. So April 1, we have a full day of training to ensure that that team deploys rapidly. As Sheldon mentioned, we have the ACC where we'll deploy the new campaign as well as we'll have speaker programs and scientific interaction. And then we'll transition to middle of April to have a launch meeting and start digital as well as consumer programs.

Speaker 3

So we've got a full slate of activities planned, but day 1 is when we're beginning them.

Speaker 4

Great. And maybe just a follow-up. In terms of gross to nets, how stable have they been through 2023? And maybe just talk what kind of impact do you expect in the Q1 and whether they can improve once you have the label update and additional product volumes?

Speaker 1

Yes. Hey, Serge, it's Ben. Thanks for the question. So I would say throughout 2023, we saw gross to nets that were extremely in line with our expectations in regards to seasonality and where we think a healthy gross to net should be. Going into 2024, we expect that to be mostly the same.

Speaker 1

We'll see some incremental improvements in certain areas like distribution fees that volume typically helps bring down. But overall, we don't expect any major change and we should see the same sort of seasonality that we saw this year.

Speaker 4

All right. Thank you.

Operator

Thank you. And our next question coming from the line of Tom Schroeder with BTIG. Your line is open.

Speaker 5

Good morning. Thank you for taking my call. About the new label, so you've already had the maximum statin requirement or language dropped. Has that had any effect on how payers treat the drug? And I guess what I'm I think what I'm hearing from you guys is that once you can market the CVOT, the real driver is going to be the pull from physicians that they want the drug, which will be the big lever for getting payers to make it available more easily.

Speaker 5

Is that correct? Or is it at the payer level that you really need to do your work? Thanks.

Speaker 3

Yes. Great. Thanks, Tom. Let me start and then I'll ask BJ also if there's comments to be made. So as you stated, at the end of December, we saw that the FDA did what I would call a harmonization of labels and they removed the maximum tolerated dose of statin and they essentially acknowledge that we had outcomes very different from the label we'll be getting at the end of March, which will have the clear outcomes data.

Speaker 3

Now with that said, there were some accounts, it actually acted as a catalyst for accounts to be prepared for the new label and some of them went forward and did make changes and removed ezetimibe Step Edit for instance. But to your point and one of the reasons why we've always said the new label would be a catalystinflection point is keep in mind, we're the only drug besides statins that studied not only secondary prevention, but primary prevention. That's a big differentiation from drugs like ezetimibe and PCSK9. And keep in mind also in part of our strategy for our label is that you can use NexoZet on its own or you can use it with a statin. So a doctor has choices now.

Speaker 3

And again for those primary prevention patients, it's extremely important. Now we've talked to payers about this as mentioned in the last question. They're very receptive to what our new label will look like. We've talked to them. Of course, we won't know what our final label is until we get it.

Speaker 3

But we've talked to them of what it could look like and what we would need for them to do to change criteria. And for the most part, they've been very agreeable. And that will really then lessen the barrier of physicians being able to get the drug. That's what the label does. It makes it easier for physicians to get this drug.

Speaker 3

Our label right now is very narrow and very restrictive. As we mentioned in our prepared remarks, the population goes from 10,000,000 to 30,000,000 plus patients. I just would say, Tom, improving payer coverage certainly matters as a priority and we've been streamlining consistency in utilization management. We actually have had criteria improve just since CVOT presentations, the interim label with over 16 plan ins both regionally and nationally. We are well poised for the new label and we're very excited and those discussions have been continuing since last year's ACC to current day and all the payers are anticipating the new label.

Speaker 3

So we feel very confident in that regard.

Speaker 5

Okay. Thank you.

Operator

Thank you. And our next question coming from the line of Jason Jumansky from Bank of America. Your line is open.

Speaker 6

Good morning. Thank you so much for taking our questions and congrats on the quarter. 2 if I may please. I was hoping first you could provide some color on the specific impact of FDA's label revision in December. I appreciate the holidays were right there.

Speaker 6

But was there any lift or acceleration either in interest or sales at that point with the loosening of restrictions?

Speaker 3

Yes. Hey, Jason, it's Eric. So we did drive that 8% growth, which is relatively consistent to prior quarters with the exception of 2nd quarter. But as you know, that change that we saw removed the maximally tolerated requirement, but it still kept statins and full payer changes didn't happen with regards to that removal. So I would say it kept us growing on the cadence that we were growing, but it didn't have a dramatic inflection.

Speaker 3

Like we anticipate when we're going to have the updated label in April 1. So as Sheldon stated, not only is it a quantity of patient change going from 10 to 30, potentially 70, but it's a quality incorporating that primary prevention and fully removing the statin requirement. And Jason, I would add that the thing about the new label that we'll have at the end of March is it will be the first time that our representatives, our medical liaisons, etcetera, can actually speak to clear outcomes data. So the growth that Eric spoke to and the growth that we demonstrated through 2023 has always been on the what I would say again the very restrictive label that we had. So, we never thought of and we try to actually take time with folks to explain the label change from December, do not confuse that with what the label change will be at the end of March, because that's what really opens the door for us as it relates to new patients and really being able to maximize the value of our products.

Speaker 6

Got it. And then so obviously the NCE, one date passed last week. So generic companies can technically file for ANDAs of for generic versions of Nexlutol and Nexlutet. Wanted to ask, have you received any Paragraph IV notifications from generic manufacturers?

Speaker 3

We are aware of the date that you mentioned and it's something that we've been expecting, but no, we have not received

Operator

Thank you. And our next question coming from the line of Nason with JPMJ. Your line is open.

Speaker 7

Hey guys, this is Nasun on for Jessica Fye. Congratulations on a good quarter. Can you talk about how the shift in OUS manufacturing to DSE, like how long that shift will take? And could we maybe see impact from that in 2024? And also you mentioned there is an update of guidelines that could be on the horizon.

Speaker 7

I think how soon do you expect to see that potentially happening? And then for OpEx in 4Q, the R and D guideline, Is that a like is that as low as the company could go or is there some further development cost for the pipeline included in there? Thank you.

Speaker 3

Ben, do you want to start with yes.

Speaker 1

Yes. So I'll answer the manufacturing and the OpEx question. So on the manufacturing transition to DSE, it's a tech transfer, which typically takes anywhere 16 to 18 months. We've been in discussions with them about the timeframe and moving that along as quickly as possible. I think it's in both parties' interest and both parties are very excited to get it done.

Speaker 1

But that said, it will time. We're working through the specifics of the plan, but there is a possibility we'll start seeing some of the working capital benefits towards the end of the year. I wouldn't expect any of the gross margin savings to happen until next year when we're further along in the tech transfer though. And then on the OpEx guidance for R and D, we do that guidance does include the preclinical pipeline spend. So that's all inclusive.

Speaker 1

But I will say we have sort of meaningfully managed that OpEx down and we're pretty lean at this point.

Speaker 3

I would just go to further add that we actually were in Munich about 2 weeks ago. We met with their manufacturing folks to do a kickoff of the tech transfer. It was a really good meeting and we're off to a really good start with their team and working together to get this done. Related to guidelines, again, we have no impact on guidelines. We're somewhat at the mercy of the folks that write the guidelines.

Speaker 3

There was some thought that guidelines would have come out in 2023. There's a potential maybe it could be 2024. I do think once our new label comes out, there will be consensus statements, etcetera. But as it relates to when the actual new guidelines come out, we'll have to wait and see. But as you probably have seen, there's been a lot of literature, a lot of things being both done, not only in the United States, but in Europe, as it relates to the use of bepanoic acid and where to use bepanoic acid, it's been very favorable.

Speaker 3

As a matter of fact, in Germany, they actually last year issued through their HTA authorities that you cannot use the PCSK9 until you've actually used bebodoyic acid first. So stay tuned as we get more updates on U. S. Guidelines, etcetera. We will definitely update you on that.

Operator

Thank you. And I'm showing no further questions in the queue at this time. I will now turn the call back over to Sheldon Koenig for any closing remarks.

Speaker 3

Thank you so much. Well, thank you everybody. We really appreciate you taking the time and interest in Experion Therapeutics. Again, I just want to remind everyone that we have a large catalyst coming in essentially less than a month with our new label. We had a very strong quarter and that quarter is really going to and has created strong momentum as we enter into the Q1 of 2024.

Speaker 3

And with that said, we also have a steady stream of catalysts for our long term continued growth. So thank you again and talk to you soon. Take care.

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Esperion Therapeutics Q4 2023
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