Q3 2023 Esperion Therapeutics Inc Earnings Call

[music].

Speaker 1: Ladies and gentlemen, thank you for standing by and welcome to the Spirion therapeutic third quarter 2023 financial results call. At this time, all participants are now listening only mode. Following the presentation, there'll 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 Alexis Calhane, head of investor relations at the Spirion. Please go ahead, Alexis.

Ladies and gentlemen, thank you for standing by and welcome to Spirit in Therapeutics third quarter 2023 financial results call. At this time all participants are in a listen only mode. Following the presentation there'll be a question and answer session. Please be advised that today's conference maybe recorded I would now like to hand, the conference over to <unk>.

Alexis Callahan head of Investor Relations. Please go ahead Alexis.

Speaker 2: Thank you, operator. Good morning and welcome to Aspirion's third quarter 2023 earnings conference call.

Thank you operator good morning.

And welcome to the Sperry on the third quarter 2023 earnings Conference call.

Speaker 2: With us today are Sheldon Koenig, President and CEO , and Ben Holiday, CFO .

With us today are Sheldon Koenig, President and CEO and Ben Holiday CFO.

Speaker 2: Other members of the executive team will be available for Q&A following our prepared remarks.

Other members of the executive team will be available for Q&A following our prepared remarks.

Speaker 2: I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act.

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.

Speaker 2: I caution listeners that management will be making forward-looking statements.

I caution listeners that management will be making forward looking statements.

Speaker 2: Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business.

Actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the business.

Speaker 2: These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filing.

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 a 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.

The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast November 7th 2023.

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.

Speaker 2: As a reminder, this conflict call and webcast are being recorded and archived. We issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of our website.

As a reminder, this conference call and webcast are being recorded an archive we.

Issued a press release earlier this morning detailing the content of today's call.

A copy can be found on the investor page of our website.

Speaker 2: We will begin the call with prepared remarks and then open the line for your questions.

We will begin the call with prepared remarks, and then open the line for your questions.

Speaker 2: I'll now turn the call over to Shelvin Canig, President and Chief Executive Officer.

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 third-quarter result and the progress we continue to make. Thank you.

Thank you Erika and good morning, everyone. Thank you for joining us today to discuss our third quarter results and the progress we continue today.

Speaker 3: We are pleased to report another strong quarter. Total revenue was $34 million, which represents a 79% increase year over year. US net revenue came in at $20.3 million, which represents a 45% increase year over year, and was driven by a 33% year over year increase in retail prescription equivalent.

We are pleased to report another strong quarter total revenue was $34 million, which represents a 79% increase year over year U S. Net revenue came in at $23 million, which represents a 45% increase year over year and was driven by a 33% year over year increase in <unk>.

Retail prescription equivalents.

Speaker 3: 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, Nexotol and Nexosit, as well as discipline execution of our commercial strategy.

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 lifesaving medications neck and neck with that as well as disciplined execution of our commercial strategy.

Speaker 3: We're also pleased to build upon our momentum and use of grant prescriptions in the seven months following our clear outcomes read out at ACC in March. Both are by the cadence of additional impressive data releases and publication since then. Most recently at the European Society of Cardiology, Congress, and August .

We're also pleased to build upon our momentum in new to brand prescription in the seven months following our care 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 for March.

Speaker 3: From March through the end of September , new to brand prescriptions grew 61% with momentum continuing from the second quarter into the third quarter.

And it's September new to brand prescriptions grew 61% with momentum continuing from the second quarter into the third quarter.

Speaker 3: Next, let me walk through additional highlights from the quarter. As I already mentioned, we delivered continued RPE growth in the third quarter of 33% year over year, demonstrating consistent growth even with our narrow indication.

Next let me walk through additional highlights from the quarter.

Already mentioned, we delivered continued RPE growth in the third quarter, a 33% year over year, demonstrating consistent growth, even with our narrow indication.

Speaker 3: After submitting our regulatory filing to include cardio vascular risk reduction in next one talk and next was at label last quarter. We're pleased to announce FDA acceptance of our submission with a producer or approval date of March 31st, which is ahead of when the original inauguration would rhutinate also Minnesota federal

After submitting our regulatory filings to include cardiovascular risk reduction in excellent top and expose that labor last quarter. We're pleased to announced FDA acceptance of our submission with the produce that where approval date of March 31, which is ahead of when we originally anticipated approval.

Speaker 3: 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 2024.

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 2024.

Speaker 3: During the third quarter, we continue to disseminate new data from clear outcomes to educate the market about the benefits of our products. We presented two new analysis at the European Society of Cardiology in August . That further support Cardio and Asura Rich's reduction.

During the third quarter, we continued to disseminate new data from clear outcome.

Just take the market about the benefits of our products. We presented two new analysis at the European Society of Cardiology in August that further support cardiovascular risk reduction.

Speaker 3: The first analysis demonstrated that Ben Pagodic acid reduces total major adverse cardiovascular events. Reinforcing the value of long-term Ben Pagodic acid use in reducing not just the first but multiple events over time.

The first analysis demonstrated that peppershrike asset reduces total major adverse cardiovascular event reinforcing the value of long term capital like acid use in reducing not just the first but multiple events over time.

Speaker 3: The second analysis also demonstrated that Femton-Joyg acid reduced the time to first major adverse cardiovascular events in patients with diabetes and does not increase the rate of new onset diabetes, which is a key differentiating feature compared to satan and underscores its safety and efficacy in patients both with and without diabetes.

Second analysis also demonstrated that Patrick take acid reduce the time to first major adverse cardiovascular events in patients with diabetes and does not increase the rate of new onset diabetes, which is a key differentiating feature compared to statin and underscores its safety and efficacy in patients both with.

With and without diabetes.

Speaker 3: Patients with diabetes who are at increased risk with cardiovascular events constituted a large proportion of the primary prevention population that we studied in clear outcomes. So this finding is important. These analysis continue to demonstrate the efficacy and safety of reproductive gases further differentiating it from existing LEL tests for all-learning therapies and highlighting its first-in-class mechanism of action.

Patients with diabetes, who are at increased risk for cardiovascular events constituted a large proportion of the primary prevention population that we studied and clear outcomes. So this finding is important these.

The analysis continued to demonstrate the efficacy and safety of <unk> that further differentiate yet from existing LDL cholesterol lowering therapy and highlighting its first in class mechanism of action.

Speaker 3: It is not an overstatement to say, but our focus was on expanding our label to include cardiovascular risk reduction, which is a week. Always said is the real growth catalyst.

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 as a real growth catalyst.

Speaker 3: And finally, Matt, is when you will begin to see accelerated prescription growth.

Following that as well you will begin to see accelerated prescription growth.

Speaker 3: To that end, our entire organization is now focused on preparing for this update. And we've been gotten laying the groundwork to make changes to ourselves organization. So that we can hit the ground running the moment we receive approval of our new expanded label.

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 that we can hit the ground running at the moment, we receive approval of our new expanded label.

Speaker 3: Next are ongoing conversations with pairs are continuing to pay off. With recent wins for improved coverage and utilization management criteria that aligns with clear out-of-the-stata. It is encouraging to see these types of mid-cycle changes with national and regional pairs, which are not common, and we look forward to continue progress.

Net 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 comment and we look forward to continued progress.

Speaker 3: Finally, we announced the 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 a high risk of a cardiac event who could benefit from treatment.

Finally, we announced a strategic collaboration with ACC and Amgen to launch the cholesterol SBA campaign with a goal of increasing awareness of the importance of LVL screening to help healthcare practitioners more easily identify patients at high risk of a cardiac event, who could benefit from treatment.

Speaker 3: Based on our clear outcome data, we believe we have potential to benefit a much larger group of patients than a characterized by our current label, which is quite narrow and indicated only for a small sub-settipation.

Based on our clear outcomes data, we believe we have the potential to benefit a much larger group of patients that is characterized by our current label, which is quite narrow and indicated only for a small subset of patients.

Speaker 3: The label we anticipate receiving the March will add a broad cardiovascular risk reduction indication in both primary and secondary populations as well as remove current limitations.

The label, we anticipate receiving remarks, while it broad cardiovascular risk reduction indication in both primary and secondary population as well as related to current limitations.

Speaker 3: 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 million secondary prevention patients with documented ASCD or HESH. And who are on the maximum color age stat in therapy.

From a commercial perspective, our addressable patient population will significantly increase when we get our new Cbot label next year right now our therapies are only indicated for about $10 million secondary prevention patients with documented CVD or age.

And who are the maximally tolerated statin therapy.

Speaker 3: are 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 million high risk primary prevention patients. And these 30 million patients in total will be our primary focus.

Our new label that we anticipate by March 31st will reflect our clear outcomes data and enable us to be indicated for an additional 20 million high risk primary prevention patients.

These 30 million patients in total will be our primary focus.

Speaker 3: There are another 40 million patients in the US 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 LVL plus troubles on current therapies alone.

There are another 40 million patients in the U S, who are untreated and at high risk for an event and those patients represent additional potential upsides we.

We look forward to being able to address the needs of millions of patients who are currently still unable to achieve their LDL cholesterol goal on current therapies alone.

Speaker 3: With that, I will now hand it over to Ben Halliday, our Chief Financial Officer, for a more detailed overview of our third quarter performance.

With that I will now hand, it over to Ben holiday, our Chief Financial Officer for a more detailed overview of our third quarter performance.

Speaker 3: Thank you, Shelvin. Earlier this morning, we issued a press release containing our financial results for the third quarter, which is available on the investor page of our website. Please note that unless otherwise specified, my comments reflect results for the third quarter ended September 30th, 2023.

Thank you Sheldon earlier. This morning, we issued a press release containing our financial results for the third quarter, which is available on the investor page of our website.

Please note that unless otherwise specified my comments reflect results for the third quarter ended September 32023.

Speaker 3: As Sheldon already mentioned, we posted strong overall third quarter results. We're pleased to have delivered another quarter of continued growth and retail prescription equivalence, which increased 33% year over year and 8% quarter over quarter, which was accomplished even with our narrow indication and promotional footprints.

As Sheldon already mentioned, we posted strong overall third 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 haf.

The weekly RPE trend also shows persistent strength largely remaining above the 10000, RPE mark and repeatedly setting new highs.

Speaker 3: Growth also continued globally, not just in the US. 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 three month growth of 26% since May.

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 of our important medicines are bringing to patients worldwide.

At the end of August 158000 patients have now been treated with our therapies in Europe, representing sequential three months 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 making it even more impressed.

I'll also note that the bulk of this growth has come from existing territories versus newly launched territories, making it even more impressive.

Speaker 4: Three additional countries were granted approvals during the third quarter. The Netherlands, Slovakia, and Spain, and we look forward to reaching patients in these new markets in the Calingmas.

Three additional countries were granted approvals during the third quarter, the Netherlands, Slovakia in Spain, and we look forward to reaching patients in these new markets in the coming months.

Speaker 4: Turning to our full financial results for the quarter, we reported US product revenue of $20.3 million, representing an increase of 45% year-rear.

Turning to our full financial results for the quarter, we reported U S product revenue of $20 3 million, representing an increase of 45% year over year.

Speaker 4: Collaboration revenue, which includes combined royalty and partner revenue, was $13.7 million, an increase of approximately 174% year-over-year.

Collaboration revenue, which includes combined royalty and partner revenue was $13 7 million, an increase of approximately 174% year over year.

Speaker 4: Much of this increase was due to tablet shipments that were pushed from the second quarter to the third quarter as we mentioned in our last earnings fall.

Much of this increase was due to tablet shipments that were pushed from the second quarter to the third quarter as we mentioned in our last earnings call.

Speaker 4: Finally, total revenue for the third quarter was $34 million dollars and increase of 79% year-rear.

Finally total revenue for the third quarter was $34 million, an increase of 79% year over year.

Speaker 4: Turning to expenses. Cost of good sold for the third quarter was $13.4 million, an increase of 106% year over year, also driven by the timing of tablet shipments as I just mentioned.

Turning to expenses cost of goods sold from the third quarter was $13 4 million an increase of 106% year over year also driven by the timing of tablet shipments as I just mentioned.

Speaker 4: R&D expense was $14.9 million dollars, a decrease of 49% in your year, reflecting substantially lower costs following the close out of our clear outcome study.

R&D expense was $14 9 million, a decrease of 49% year over year, reflecting substantially lower costs. Following the close out of our clear outcome study.

Speaker 4: S.G.N.A. expense was $33.2 million, an increase of 33% year-over-year, reflecting higher legal and promotional costs.

SG&A expense was $33 2 million, an increase of 33% year over year, reflecting higher legal and promotional costs.

Speaker 4: We continue to track in line with our guidance, expecting full year 2023 operating expenses to be between $225 and $245 million, which is comprised of $100 to $110 million in R&D expense, and $125 to $135 million from S.G.N.A.

We continue to track in line with our guidance expecting full year 2023 operating expenses to be between 225, and $245 million, which is comprised of $100 million to $110 million of R&D expense and $125 million to $135 million in SG&A expense.

Speaker 4: Finally, cash equivalent and investment securities available for sale totaling $114.8 million as of September 30th, 2023, compared with $166.9 million on December 31st, 2022.

Finally, cash equivalents and investment securities available for sale totaling $114 8 million as of September 32023.

Compared with $166 9 million on December 31, 2022.

Speaker 4: I'll note that we ended the quarter with a higher cash balance than we expected, which reflects the 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.

I'll note that we ended the quarter with a higher cash balance than we expected, which reflects the 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 4: We believe we are currently well positioned to have sufficient cash to continue funding operations and support a 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.

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 yourselves.

Speaker 3: Thank you, Ben. I'll now provide additional corporate updates from the quarter. At some of you may have seen, we filed a Rule 12C motion two weeks ago in our litigation case, which asserts that the language in our license agreement is only ambiguous and can be ruled on solely based on the contract itself and the pleading filed today, and request that ruling accordingly. Permissions to file this motion wasn't prerequisite, and the fact that we were granted permission was in wind for up.

Thank you Ben I will now provide additional corporate updates from the quarter.

Some of you may have seen we filed April 12th the motion two weeks ago, and our litigation case, which a third that's the language in our license agreement is unambiguous and can be rolled on solely based on the contract itself and the pleading filed to date and request that really accordingly.

Emission to filed with Moshe was a prerequisite and the fact that we were granted permission was a way for us.

Speaker 3: In terms of next steps all filings are due by November 22nd after which are 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. I'll just note that this motion does not affect our current case timeline and we remain scheduled for trial on April 15th.

In terms of next steps all filings are due by November 22nd after which a ruling could occur in the days or weeks to follow which means that we could potentially have an answer by the end of the year ill. Just note that this motion does not affect our current case timeline and we remain scheduled for trial in April 15th.

Speaker 3: 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 31st. In the meantime, we're excited on a strategic plan to continue to drive growth and educate healthcare providers and payers alike ahead of that new label.

Next a reminder of our plants reached blockbuster status for our franchise, which we have every confidence in achieving in short we have robust data generated through our landmark 14000 patient trial that data is being used to support a highly differentiated label, which we anticipate approval by March 31 in the meantime, we're.

On a strategic plan to continue to drive growth and educate healthcare providers and payers alike ahead that new label.

Speaker 3: I'll wrap up our comments today by reiterating that we continue to deliver on the commitment to leadership team has made. We are steadily executing on our strategic plan to unlock the blockbuster potential this franchise is capable of.

I'll wrap up our comments today by reiterating that we continued to deliver on the commitments. The leadership team has made.

Steadily executing on our strategic plan to unlock the blockbuster potential this franchise is capable of.

Speaker 3: We have more work to do, but I'm pleased with the progress we've made. I am confident in our ability to succeed and look forward to demonstrating continued progress toward our goals. And with that operator, we are now ready for Q&A.

We have more work to do but I'm pleased with the progress we've made.

Confident in our ability to succeed and look forward to demonstrating continued progress towards our goals.

Operator, we are now ready for Q&A.

Thank you.

Speaker 1: To ask a question, you'll need to press star 11 on your telephone. To withdraw your question, please press star 11 again. Please wait for your name to be announced. Please stand by. We'll recompile the Q&A roster. One moment for our first question, please.

To ask a question you will need to press star one on your telephone to withdraw your question. Please press star one again, please wait for your name to be announced please standby, while we compile the Q&A roster one moment for your first question. Please.

Okay.

Speaker 1: The first question comes from the line of Dennis Ding with Jeffrey Schoenlearnis now open.

Your first question comes from the line of Dennis <unk> with Jefferies. Your line is now open.

Speaker 5: I want to thank certain people. Hey, good morning, thanks for thinking our questions.

Thanks for taking.

Hey, good morning, Thanks for taking our questions.

Speaker 5: Two for me, if I may, number one, just on the US based business. Can you comment on some of the underlying gross in the trends that may have impacted Q3 and maybe part about your outlook for Q4? And then question number two is on the litigation case with Daiichi. I'm appreciating that there could be a positive rolling on the Roll 12C dynamic.

Two for me if I may number one just talk of U S based.

Can you comment on some of the underlying gross to net trends.

Impacted Q3, and maybe talk about your outlook for Q4.

Then question number two is on the litigation case with Dai Ichi.

Appreciating that there could be a positive.

Ruling on the <unk> policy.

Dynamic.

One.

Speaker 5: When could the milestone actually hit the stereo balance?

When could the milestone actually pit experience balance sheet, given daiichi would likely appeal after that and we're getting a lot of investor questions on how long without appeal process actually take and when could money actually experienced balance sheet. So maybe just clarify that.

Speaker 5: given Daiichi would likely appeal after that and you know we get a lot of investor questions on how long would that appeal process actually take and when could money actually hit.

Speaker 5: balance sheet. So maybe just clarify that for us.

For us investors. Thank you.

Speaker 6: Hey Dennis, it's Ben. Great to talk to you. Thanks for the question. On growth to nets, you know, in Q3 we saw some typical seasonality that we'd expect from a product in this market.

Hey, Devin it's been great to talk to you. Thanks for the question.

On gross to net in Q3, we saw some typical seasonality that we would expect from a product in this market.

Speaker 6: You know, I'll know we've done a good job improving growth and it's from in 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 at the Q4 and beyond. That'll 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.

You all know we've done a good job improving gross to net from last year into this year.

And I think we're in a pretty steady state at this point going forward Theres still room for improvement and looking into Q4 and beyond 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.

Okay.

Speaker 3: And Dennis, this is Sheldon. I will take the second as a relates to the litigation. First of all, as a reminder, as you mentioned, we were able to win the motion as related to 12C.

And.

Dennis Sheldon I'll 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 it related to <unk>.

Speaker 3: That was a few weeks ago, the opposition has till November 22nd to actually file their side of it. And then the court will make a ruling again. I just wanted to express our confidence in the case that we have here and we feel really good about it. As it relates to when we would see money, et cetera. Keep in mind, this milestone was not to be actually recognized until later in the first quarter of 2024.

That was a few weeks ago.

Opposition has till November 22nd to actually file their size of it and then the court will make a ruling again I just wanted to express our confidence in the case that we have here and we feel really good about it as it relates to when we would see money et cetera keep in mind. This milestone was not to be actually.

Recognized until later in.

In the first quarter of 2024.

Speaker 1: early second quarter. And so, you know, right now, if I think about the timeline, you know, we don't want to get to this because we have to take every day as it comes as a relation to litigation. But I'm confident that, you know, we remain on that same timeline as it relates to us receiving a milestone. All right, thank you. Thank you. One moment for our next question, please.

Early second quarter, and so right now if I think about the timeline.

We don't want to get to that because we have to take every day as it comes as it relates to the litigation, but I'm confident that.

We remain on that same timeline as it relates to us receiving a milestone.

Yeah.

Got it thank you.

Thank you one moment for our next question. Please.

And our next question comes from the line of.

Tom Shrader with <unk>. Your line is now open.

Speaker 4: Good morning. Thank you for taking the call. I wanted to ask a little bit about slide five. It's kind of striking. You got this big bump at ACC where I think we all knew there was a fair bit of interest, but it's been relatively flat. Does that speak to how hard it is to talk to physicians that aren't converts already?

Hi, Good morning, Thank you for taking the call I wanted to ask a little bit about slide five it's kind of striking.

<unk> got this big bump at ACC, where I think we all knew there was a fair bit of interest, but it's been relatively flat because that speaks to how hard it is to talk to physicians that arent converts already.

Speaker 7: 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.

And is that what you think the label will help with and then maybe if you have any information do you have.

Have any way to track physicians, who at some level are interested in the drug but wont go through was slightly our juress payment process.

Any of that data interest beyond people, who actually get all the way through the reimbursement process.

Speaker 8: Hey Tom, it's Eric. I'll answer your question. So

Hey, Tom it's Eric.

Speaker 8: First of all, the ATC pop that we had was tremendous.

Answer to your question so far.

First of all the ACC pop that we had.

Speaker 8: We've been able to build upon that. So quarter after quarter, we saw an increase in TRPEs of 8%.

With tremendous.

We've been able to build upon that.

So quarter after quarter, and we saw an increase in TRP.

Speaker 8: 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, that 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.

8% I want to remind you that the team is unable to the commercial team is unable to talk about.

The new data. So you are 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 and prescribers intent.

Speaker 8: And I believe Sheldon showed at a meeting not too many months ago, an ATU that we did that...

At prescribed.

I believe Sheldon showed tandem.

Meeting not too many months ago.

<unk> that we did that tracks the desire to make our products standard of care and that's tremendously increases once we're able to communicate those data and once we have the managed care changes that ultimately aligned with those changes that will have some.

Speaker 8: 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 will have from an indication perspective.

<unk> perspective.

Speaker 9: And the conference was the H.C. Wayne Wright conference time. If you want to go back and take a look at that, it's archived. Thank you.

Yeah.

And the cost per ask what the HC Wainwright conference. Tom If you want to go back and take a look at that it's archived.

Got it alright, thank you.

Thank you one moment for our next question. Please.

Speaker 1: And our next question comes from the line of Troy Langford with P.D. Cowan. Your line is now open.

And our next question comes from the line of Troy Lankford with PD Cowen. Your line is now open.

Speaker 10: I can grandson all the progress in this quarter and thanks so much for taking our questions. I just have one about the label change next year. So when that does occur next year, exactly how quickly do you think we get to start to see that uptick in prescription numbers that you all just mentioned? Do you think it will look more like the infection 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 more substantial increase.

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

I just have one about 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 look 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 more.

Potential increase.

Speaker 8: Thanks for your question. It's Eric 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. So, across every function, ensuring that we're a well oiled machine with these new new data and ultimately new indication.

I will say thanks for your question, it's Eric again, so no doubt the team will be ready the team thats been spending at the vast majority of their time now preparing for this label change to aircraft every function ensuring that we are a well oiled machine.

These new new data and ultimately new indications.

Speaker 8: 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. 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. Perfect.?

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, but as we start unlocking that access that aligns with the broader label is when you can start to see.

Even greater changes that we anticipate.

Speaker 11: Thank you for the question. This is Joanne Poudi, the Chief Medical Officer. The other thing that's really critical, is we think about the label as timing. So we've announced that the producer date is March 31st. That precedes the American College of Cardiology, and I think you all recognize how significant this year's American College of Cardiology has to.

Joanna.

Thank you for the question Julien <unk>, our Chief Medical Officer, and the other thing that's really critical as we think about the labeling.

We've announced that the producer David March 31st that precede the American College of Cardiology and I. Thank you all recognize significant this year's American College of Cardiology, Hudson, who were getting our message out.

Speaker 11: for getting our message out. So we anticipate similarly having the opportunity with the American College of Cardiology in 2024.

We anticipate similarly, having the opportunity with the American College of cardiology, 2024th to leverage not only our label, but all the noise. We had over 1 billion impressions from last year.

Speaker 11: to leverage not only our labels, but all the noise. We had over a billion impressions from last year's ACC and we're looking forward to similar updates this year or coming year in 2024. Thank you.

And we're looking forward to similar.

Uptake this year coming year end 2020.

Okay. Thanks.

Thank you.

One moment for our next question please.

Speaker 1: Our next question comes from the line of Jason Szymanski with Bank of America. Your line is now open.

Our next question comes from the line of Jason Szymanski with Bank of America. Your line is now open.

Speaker 12: 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 made. Obviously the 12C ruling was a win but ex-acknowledged by your attorneys and 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.

Perfect Congrats on the quarter and thanks, so much for taking our question.

Wanted to ask a follow up on an earlier comment you've made obviously the <unk> ruling was a win but.

<unk> acknowledged by your attorneys in the filing there.

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 6: So, as far as kind of pushing out our cash runway and being able to help manage both the launch and funding that litigation, you know, we have drivers that are ahead of us. You know, most of our spend next year hasn't even been contractually locked into. So, you know, we can delay spending, like, on preclinical pipeline. Some of our smaller projects, even with the sales force ramp up without fully hampering the commercial launch here. You will always try and walk the fine line of.

Sure.

Happy to take that one Jason.

So as far as kind of pushing out our cash runway and being able to help manage the launch and funding that litigation. We have drivers that are ahead of us.

Most of our spend next year hasnt, even been contractually locked into so.

We can delay spending like on preclinical pipeline and some of our smaller R&D projects, even with the sales force ramp up without fully hampering the commercial launch here.

We'll always try and walk the fine line of funding.

Speaker 6: funding the stuff that's going to show us an immediate return, but also managing that burn rate, managing those expectations from a cash standpoint. But truthfully, the litigation is a cost. It doesn't cost as much as frankly, I thought it would, and we can manage to keep that going at.

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 is not it doesn't cost that much frankly, I thought it would and we can manage to keep that going as needed.

Speaker 12: Gotcha. Thank you for the color. And then maybe as a follow up on the business, what does a typical patient starting Bempadoic 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 up?

Got you. Thank you for the color and then maybe as a follow up on the business.

What does a typical patient starting bump of Delek asset currently look like are they the primary prevention and secondary and then I mean, how do you expect this to shift when you receive hopefully the label update.

Speaker 8: Yeah, Jason, so they're now aligned with our label. They're an ASCBD patient. They're on a documented maximally tolerated statin dose.

Yes, Jason so they're now aligned with our label there are an ASPD patient.

Documented maximally tolerated statin dose.

Speaker 8: and they're not at their LDL-C goal. So that is a typical approvable patient. Now, I will say that there is a strong desire to prescribe us in a patient that has.

And they're not at their LDL C goal that is.

A typical approvable patient now I will say that.

Drawing desire to prescribe and a patient that had.

Speaker 8: primary prevention so they don't have active ASDBD, 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.

Primary prevention, so they don't have active CBD.

TBD, but they have risk factors. There is also a strong desire to prescribers and patients that are unable or unwilling to take status.

So both of those will go away with the new label, if we add in the primary prevention and as we remove that dependency on maximally tolerated statin.

Great. Thanks, guys.

Speaker 1: One moment for our next question please.

One moment for our next question please.

Okay.

Speaker 1: Next question comes from the line of search Belinger with Needham. The line is now open.

Our next question comes from the line of Serge Belanger with Needham. Your line is now open.

Speaker 4: I can learn it. It's also had a couple of questions on the rule 12C motion. So you mentioned the trial date and media pool 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 12C motion as it would be if it went to a trial that I have a couple of polls?

Okay.

Hi, good morning.

Business I also have a couple of questions on the route <unk> motion.

You mentioned the <unk>.

David maybe April it's 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.

With the <unk> motion as it would be if it went to truck and then I have a couple of follow ups.

Speaker 3: First of all, thanks you, Serge. And glad you could make the call. So as it relates to the trial date of April the 15th, that will remain on the calendar. As a matter of fact, should the ruling that 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.

First of all thank you Sir and.

Glad you could make the call so as it relates to the trial date of April 15th that will remain on the calendar as a matter of fact, it should the ruling.

The motion is reviewed and heard.

If theres no decision then.

No harm no fab, we remain on the same schedule, which is the April 15th trial date.

Speaker 3: And then your second was as relates to appeals. As 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 relates to what would happen in the case of an appeal.

And then your second was as it relates to appeals.

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.

Speaker 5: And then on the business front, maybe just update us on your prior off.

Okay.

And then on.

On the business front, maybe just update us on your prior rock.

Speaker 7: rate and whether you expect any additional formulary coverage ahead of

Rick and whether you expect.

Any additional formulary coverage.

Ahead of <unk>.

March 31.

Speaker 13: Oh yeah, so we have, 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.

Right.

Yes, so we have.

We had the opportunity to get to almost 90% of the payers with the CDP data I'm pleased to say as Sheldon had outlined as well.

Speaker 13: Not only have we have new formular access with very large payers as well as small regional payers, but also the UM criteria has been aligning with the CVOT data already. With that, our approval rates have also...

Not only have we have new formulary access with very large payers as well as small regional players, but also the <unk> criteria has been aligning with the cbot data already with that our approval rate have also.

Speaker 13: been quite well since those presentations and since the CDOT data 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.

Been quite.

Quite well since that those presentations and since the cbot data. So I can tell you that we're up to.

Approval rates that are very much almost to.

85% range in commercial and equal to that in Medicare.

Okay.

Speaker 3: Thank you. And Tara, just one other note, I was thinking while Bezier was answering that question regarding your question about 12C 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 one. So we can worry about appeal as it comes. But it'd be a nice indicator of the case that we have, or the essentially the case that we have here.

Thank you.

And sorry, just one other note I was thinking it might be easier to answer that question regarding your question about <unk> motion.

And appeal as I mentioned, we would have to see how that goes but I think you would agree with me that.

When that motion.

That's the big way, so we can worry about it as it comes but it would be a nice it's a nice indicator.

The case that we are the.

Essentially the case that we have here.

Speaker 1: And thank you. I would now like to turn the conference back to Mr. Sheldon Kohnik, President and Chief Executive Officer for closing remarks.

And thank you.

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

Speaker 3: Great, 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 have a strong quarter. We really built upon our post-ACC momentum for next-positive and next-positive. These are life-saving medications. We're looking very forward to the Padoo Fidate or approval date of March 31st.

Great. 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, we really built upon our post ACC momentum for <unk> and <unk>. These are life saving medications, we're looking very <unk>.

<unk> to the <unk> date or approval date of March 31, again, as we mentioned our litigation remains on track, we hope for a near term solution. However, again, if not the April 15th trial date, we will continue there. It's important to remember next door and next was that our novel therapies with differentiated first in class.

Speaker 3: Again, as we mentioned, our litigation remains on track. We hope for a near term solution. However, again, if not, the April 15 trial date, we will continue there. It's important to remember, next with tall and next with that, our novel therapies with differentiated first in class mechanism of action. 8

Speaker 3: And again, we're a small company, but we're doing big, farma things and we continue to deliver on all of our commitments.

<unk> mechanism of action.

And again, we're a small company, but we're doing big pharma things and we continued to deliver on all of our commitments. So again. Thank you everyone have a great day, maybe see some of you at American Heart and we will talk to you soon take care.

Speaker 3: So again, thank you everyone, have a great day. Maybe see some of you at American Heart, and we'll talk to you soon and take care.

Speaker 1: This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.

And this concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.

Okay.

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