Q2 2024 Esperion Therapeutics Inc Earnings Call

August 12, 2024

Operator: Ladies and gentlemen, thank you for standing by, and welcome to Esperion's second quarter 2024 earnings conference call. At this time, all participants are on a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to turn the conference call over to Alina Venezia, Director of Investor Relations. Please go ahead.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to Esperion's second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode.

Ladies and gentlemen, thank you for standing by.

Unknown Executive: And welcome to a Spirits 2nd quarter 2024 earnings conference call.

Speaker Change: I'm just here in the second quarter 'twenty 'twenty four earnings conference 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 today's conference call maybe recorded I would now like to.

Unknown Executive: At this time, more participants on the list and only mode. Following the presentation, there'll be a question-and-answer session. Please be advised that this conference call may be recorded.

Operator: Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference call over to Alina Venezia, Director of Investor Relations. Please go ahead.

Unknown Executive: I would not like to end the conference call over to Alina Venencia, Director of Investulations. Please go ahead.

And the conference call over to Joe.

Speaker Change: Alina Valencia director of Investor Relations. Please go ahead.

Alina Venencia: Thank you, operator. Good morning, and welcome to a Spirits 2nd quarter 2024 earnings conference call. With us today are Sheldon Koenig, President and CEO, and then Halladay, the F.O. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. A copy can be found on our investor page of our website, together with the copy of the presentation that we will also be referencing.

Alina Venezia: Thank you, operator. Good morning, and welcome to Esperion's second quarter 2024 earnings conference. With us today are Sheldon Koenig, President and CEO, and Ben Halladay, CFO. Other members of the executive team will be available for Q&A following our prepared remarks. 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, together with a copy of the presentation that we will also be referencing.

Alina Valencia: Thank you operator, good morning, and welcome to experience second quarter 2020 earnings conference call with US today are Sheldon Koenig, President and CEO and then holiday CFO.

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

Speaker Change: We issued a press release earlier this morning detailing the content of today's call a copy can be found on our investor page of our website together with a copy of the presentation that we will also be referencing I wanted to remind callers that the information discussed on the call today is covered under the safe Harbor provision of the private Securities Litigation reform.

Alina Venencia: I wanted to remind callers that information discussed on the call today is covered under the safe harbor provision 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 statement due to the 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.

Alina Venezia: I wanted 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 caution listeners that management will be making forward-looking statements. However, actual results could differ materially from those stated or implied by our forward-looking statements due to the risks and uncertainties associated with the business.

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

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

Alina Venezia: 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, August 12, 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.

Alina Venezia: These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filing. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 12, 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. Thank you, Alina. And good morning, everyone.

Speaker Change: 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 August 12, 2024, we undertake no obligation to revise or.

Alina Venencia: The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 12, 2024. We undertake no obligations to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast.

Speaker Change: 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 an archive.

Unknown Executive: 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.

Speaker Change: 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.

Sheldon Koenig: I'll now turn the call over to Sheldon. Thank you, Alina. Good morning, everyone. Thank you for joining us today to review the meaningful progress we have made during the second quarter and to review our plans moving forward to continue to submit Nexletal and Nexosit. The second quarter was an undeniably watershed period as we successfully executed our strategic initiatives across all areas of the business, key to building a spirit on into a leading biopharmaceutical company, improving outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The second quarter was highlighted by double-digit increases in US product revenue, significant progress by our partners in expanding international access to Nilendo and Dustendi, and importantly, the monetization of our European royalties from our partner, Daiichi Sankyo Europe, or DSE.

Sheldon Koenig: Thank you, Alina, and good morning, everyone. Thank you for joining us today to review the meaningful progress we have made during the second quarter and to review our plans moving forward to continue to cement Nexlitol and Nexlizet as cornerstone therapies in reducing cardiovascular risk. The second quarter was an undeniably watershed period as we successfully executed our strategic initiatives across all areas of the business, key to building Esperion into a leading biopharmaceutical company and improving outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Sheldon Koenig: Thank you for joining us today to review the meaningful progress we have made during the second quarter and to review our plans moving forward to continue to cement Nexlitol and Nexlozet as cornerstone therapies in reducing cardiovascular risk. The second quarter was an undeniably watershed period as we successfully executed our strategic initiatives across all areas of the business, key to building Esperion into a leading biopharmaceutical company and improving outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Sheldon: Thank you Elena and good morning, everyone. Thank you for joining us today to review the meaningful progress we have made during the second quarter and to review our plans moving forward to continue to submit yet football and next was that as cornerstone therapy, reducing cardiovascular risk.

Sheldon: The second quarter wasn't undeniably watershed period, as we successfully executed our strategic initiatives across all areas of the business key to building <unk> into a leading biopharmaceutical company improving outcomes for patients with or at risk for cardiovascular and cardio metabolic diseases.

Sheldon Koenig: The second quarter was highlighted by double-digit increases in U.S. product revenue, significant progress by our partners in expanding international access to Nalendo and Ustendi, and, importantly, the monetization of our European royalties from our partner Daiichi Sankyo Europe, or DSE, and the early discounted payoff and termination of our existing Revenue Interest Purchase Agreement, or RIPA, with Oberlin. This strategic transaction significantly enhances our balance sheet and better positions us to focus on optimizing our U.S. commercialization efforts.

Sheldon Koenig: The second quarter was highlighted by double-digit increases in U.S. product revenue, significant progress by our partners in expanding international access to Nalendo and Ustendi, and, importantly, the monetization of our European royalties from our partner Daiichi Sanctio Europe, or DSE, and the early discounted payoff and termination of our existing Revenue Interest Purchase Agreement, or RIPA, with Oberlin. This strategic transaction significantly enhances our balance sheet and better positions us to focus on optimizing our U.S. commercialization efforts. Ben will discuss this transformational transaction in greater detail later.

Sheldon: The second quarter was highlighted by double digit increase this U S product revenue significant progress by our partners and expanding international access junior lender and Sandy and importantly, the monetization of our European royalties from our partner Daiichi Sankyo, Europe or Dfc and the.

Sheldon Koenig: And the early discounted payoff and termination of our existing revenue interest purchase agreement or RIPPA with Oberlin. The strategic transaction significantly enhances our balance sheet and better positions us to focus on optimizing our US commercialization efforts. Then we'll discuss this transformational transaction in greater detail later. Now let me turn to our progress with our US commercialization efforts, which are gaining momentum as validated by US product revenue growth in the second quarter of 2024 of 14% sequential and 39% year-over-year growth. This growth was driven by the expanded new labels we received in late March. Our prior labels for Nexolet and Nexolet Hall were limited to LDL cholesterol reduction in the population of patients that already had a CV event and were on statin therapy.

Sheldon: Early discounted pay off and termination of our existing revenue interest purchase agreement or ripped up with oberland.

Sheldon: This strategic transaction significantly enhances our balance sheet and better positions us to focus on optimizing our U S commercialization efforts.

Sheldon Koenig: Ben will discuss this transformational transaction in greater detail later. Now, let me turn to our progress with our U.S. commercialization efforts, which are gaining momentum as validated by U.S. product revenue growth in the second quarter of 2024 of 14% sequential and 39% year-over-year growth. This growth was driven by the expanded new labels we received in late March. Our prior labels for Nexlizet and Nexlitol were limited to LDL cholesterol reduction in a population of patients that already had a CV event and were on statin therapy.

Sheldon: I will discuss this transformational transaction in greater detail later.

Sheldon Koenig: Now let me turn to our progress with our U.S. commercialization efforts, which are gaining momentum as validated by U.S. product revenue growth in the second quarter of 2024 of 14% sequential and 39% year-over-year growth. This growth was driven by the expanded new labels we received in late March. Prior labels for Nexlizet and Nexlitol were limited to LDL cholesterol reduction in a population of patients that already had a CV event and were on statin therapy. Our expanded labels have three significant differences. One includes CV risk reduction benefits. 2.

Sheldon: Now, let me turn to our progress with our U S commercialization efforts, which are gaining momentum as validated by U S product revenue growth in the second quarter of 2024% to 14% sequential and 39% year over year growth.

Sheldon: This growth was driven by the expanding new labels, we received in late March.

Sheldon: Our private labels for next was that an extra tall, we're limited to LDL cholesterol reduction in a population of patients that already had a CV event and we are on statin therapy.

Sheldon Koenig: Our expanded labels have three significant differences. One includes CV risk reduction benefits. Two, expand to patient population by including primary prevention and three, enables use in patients that are unable to tolerate or maximize statin therapy. Nexolet Hall and Nexolet are now the first oral non-statin LDL cholesterol-lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients. We have the opportunity to bring the benefits of Nexolet Hall and Nexolet to the 70 million patients eligible under the expanded new labels. To support these broad expanded labels and drive awareness and ultimately prescriptions, we increase our field sales team.

Sheldon Koenig: Our expanded labels have three significant differences. One, they include CV risk reduction benefits. Two, expands the patient population by including primary prevention. And three, enables use in patients that are unable to tolerate or maximize statin therapy. Nexotol and Nexozet are now the first oral non-statin LDL cholesterol lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.

Sheldon: Our expanded labels have three significant differences one.

<unk> CV risk reduction benefit to expand the patient population by including primary prevention and three enables use in patients that are unable to tolerate or maximized statin therapy.

Sheldon Koenig: Expands the patient population by including primary prevention, and 3. Enables use in patients that are unable to tolerate or maximize statin therapy. Since Nexotol and Nexozet are now the first oral non-statin LDL cholesterol lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients, we have the opportunity to bring the benefits of Nexlital and Nexlizet to the 70 million patients eligible under the expanded new labels.

Speaker Change: Yes, so tau and <unk> that are now the first oral non statin LDL cholesterol lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.

Sheldon Koenig: We have the opportunity to bring the benefits of Nexlital and Nexlizet to the 70 million patients eligible under the expanded new labels. To support these broad expanded labels and drive awareness and ultimately prescriptions, we have increased our field sales team. Critical to continued growth in prescriptions and product sales is broadened payer access. Here, we have done excellent work partnering with major payers to update utilization management criteria to include the recent label update. The majority of payer updates began on June 1st, and we were finalized by mid-July, with more than 80% of UM criteria now in place.

Speaker Change: We have the opportunity to bring the benefits of <unk> in Mexico is that to the 70 million patients eligible under the expanded new labels.

Sheldon Koenig: To support these broad expanded labels and drive awareness and ultimately prescriptions, we increased our field sales team. Critical to continued growth in prescriptions and product sales is broadened payer access. Here, we have done excellent work partnering with major payers to update utilization management criteria to include the recent label update. The majority of payer updates began on June 1st, and we were finalized by mid-July, with more than 80% of UM criteria now in place.

Speaker Change: To support these broad expanded label and drive awareness and ultimately prescriptions, we increased our field sales team critical.

Sheldon Koenig: Critical to continued growth in prescriptions and product sales is broad and payer access. Here, we have done excellent work partnering with major payers to update utilization management criteria to include the recent label updates. The majority of payer updates began on June 1st, and we were finalized by mid July, with more than 80% of UM criteria now in place. Today, I am pleased to report that more than 114 million lives now have paid or UM criteria updated to reflect the new label updates. We also continue to garner new formulary coverage, resulting in 92% preferred commercial coverage and increased our Medicare preferred coverage to greater than 50%.

Speaker Change: Critical to continued growth in prescriptions and product sales has broadened payer access.

Speaker Change: Here, we have done excellent work partnering with major payers to update utilization management criteria to include the recent label update.

Speaker Change: The majority of payer updates began on June one and we were finalized by mid July with more than 80% of U M criteria now in place.

Sheldon Koenig: To date, I am pleased to report that more than 114 million lives now have payer UM criteria updated to reflect the new label update. We also continue to safeguard our new formulary coverage, resulting in 92% preferred commercial coverage and increasing our Medicare preferred coverage to greater than 50%. This strong payer acceptance, which aligns with our new outcomes label, underscores payers' recognition of the clinical benefit and economic value our products bring to both patients and the health care system, respectively.

Sheldon Koenig: To date, I am pleased to report that more than 114 million lives now have payer UM criteria updated to reflect the new label update. We also continue to safeguard our new formulary coverage, resulting in 92% preferred commercial coverage and increased our Medicare preferred coverage to greater than 50%. This strong payer acceptance, which aligns with our new outcomes label, underscores payers' recognition of the clinical benefit and economic value our products bring to both patients and the health care system, respectively.

Speaker Change: To date I am pleased to report that more than 114 million lives now have payer UN criteria updated to reflect the new label updates.

Speaker Change: We also continued to garner new formulary coverage, resulting in 92% preferred commercial coverage and increased our Medicare preferred coverage to greater than 50%.

Sheldon Koenig: The strong payer acceptance that aligns with our new outcomes label underscores the payer's recognition of the clinical benefit and economic value our products bring to both patients and the health care system, respectively. As a result of this enhanced patient access and streamline prescription process, we expect increasing physician confidence in prescribing Nexital and Nexosit. We should translate into increasing product sales in the upcoming quarters and beyond.

Speaker Change: This strong payer acceptance that aligns with our new outcomes label.

Speaker Change: Underscores the payers' recognition of the clinical benefit and economic value our products bring to both patients and the healthcare system respectively.

Sheldon Koenig: As a result of this enhanced patient access and streamlined prescription process, we expect increasing physician confidence in prescribing Nexlital and Nexlizet, which should translate into increasing product sales in the upcoming quarters and beyond. With payer access advancing, our next important commercial initiative is to ensure that we are further educating our health care providers, or HCPs. In tandem, we have a campaign aimed at empowering patients to talk to their HCP about their CV risk. We are using a variety of digital and traditional sales and marketing tactics that are gaining traction. For example, our expanded sales force has been targeting specific subsets of primary care physicians and cardiologists with in-person detailing.

Sheldon Koenig: As a result of this enhanced patient access and streamlined prescription process, we expect increasing physician confidence in prescribing Nexlitol and Nexlizet, which should translate into increased product sales in the upcoming quarters and beyond. With payer access advancing, our next important commercial initiative is to ensure that we are further educating our healthcare providers, or HCPs. In tandem, we have a campaign aimed at empowering patients to talk to their HCP about their CV risk. We are using a variety of digital and traditional sales and marketing tactics that are gaining traction.

Speaker Change: As a result of this enhanced patient access and streamline prescription process, we expect increasing physician confidence in prescribing <unk> and net flows that.

Speaker Change: Which should translate into increased new product sales in the upcoming quarters and beyond.

Sheldon Koenig: With payer access advancing, our next important commercial initiative is to ensure we are further educating our health care providers or HEPs. In tandem, we have a campaign aimed at empowering patients to talk their HTTP about their CV risk. We are using a variety of digital and traditional sales and marketing tactics that are gaining traction. For example, our expanded sales force has been targeting specific subsets of primary care physicians and cardiologists within-person detailing. We also gained meaningful traction with our digital campaign where the legalized eight digital channels including search, email, peer-to-peer, EHR, point of care, banners, and social media to reach over 90% of our targeted health care providers.

Sheldon Koenig: We also gained meaningful traction with our digital campaign, where the team utilized eight digital channels, including search, email, peer-to-peer, EHR, point-of-care, banners, and social media, to reach over 90% of our targeted healthcare providers. As a result of these combined initiatives by our managed care, sales force, and marketing teams, we now have more than 21,000 HCPs writing scripts, and total retail prescription equivalents increased by approximately 11% in the last four weeks of June compared to the prior four weeks of May. I'll note that we can use this comparison because there were five weeks in May this year.

Speaker Change: With payer access advancing our next important commercial initiative is to ensure we are further educating our healthcare providers or hcp's in tandem. We are a campaign aimed at empowering patients to talk their HCP about their CV risk.

Speaker Change: We are using a variety of digital and traditional sales and marketing tactics that are gaining traction.

Sheldon Koenig: For example, our expanded sales force has been targeting specific subsets of primary care physicians and cardiologists with in-person detailing. We also gained meaningful traction with our digital campaign, where the team utilized eight digital channels, including search, email, peer-to-peer, EHR, point-of-care, banners, and social media, to reach over 90% of our targeted health care providers. As a result of these combined initiatives by our managed care, sales force, and marketing teams, we now have more than 21,000 HCPs writing scripts, and total retail prescription equivalents increased by approximately 11% in the last four weeks of June compared to the prior four weeks of May. I'll note that we use this comparison because there were five weeks in May this year.

Speaker Change: For example, our expanded sales force has been targeting specific subsets of primary care physicians and cardiologists with in person detailing.

Speaker Change: We also gained meaningful traction with our digital campaign with a team utilized eight digital channels, including search email peer to peer EHR point of care banners and social media to reach over 90% of our targeted healthcare providers.

Sheldon Koenig: As a result of these combined initiatives by our managed care, sales force, and marketing teams, we now have more than 21,000 HCPs writing scripts and total retail prescription equivalence increasing approximately 11% in the last four weeks of June compared to the prior four weeks of May. I'll note that we used this comparison because there were five weeks and made this year. This is truly a Herculean effort, and we are proud of the tremendous progress we have made throughout the launch so far. We have a tremendous opportunity ahead of us and our well-polished to build Nexatol and Nexoset into blockbuster products for a variety of reasons.

Speaker Change: As a result of these combined initiatives by our managed care sales force and marketing teams. We now have more than 21000, Hcp's, writing scripts and total retail prescription equivalents, increasing approximately 11% in the last four weeks of June compared to the prior.

Speaker Change: Four weeks of May.

Speaker Change: I will note that we use this comparison because they were five weeks in may this year.

Sheldon Koenig: This is truly a Herculean effort, and we are proud of the tremendous progress we have made in the launches so far. We have a tremendous opportunity ahead of us and are well-positioned to build Nexatol and Nexozet into blockbuster products for a variety of reasons. First and foremost, we have compelling clinical data from the CLEAR Outcome Study that supports and validates safety and efficacy in reducing cardiovascular risk and lowering lipids in primary and secondary prevention patients. Second, there is a large underserved patient population of 70 million people at risk who need better treatment options.

Sheldon Koenig: This is truly a Herculean effort, and we are proud of the tremendous progress we have made in the launches so far. We have a tremendous opportunity ahead of us and are well-positioned to build Nexatol and NexLizet into blockbuster products for a variety of reasons. First and foremost, we have compelling clinical data from the CLEAR Outcomes Study that supports and validates safety and efficacy in reducing cardiovascular risk and lowering lipids in primary and secondary prevention patients. Second, there is a large, underserved patient population of 70 million people at risk who need better treatment options.

This is truly a herculean effort and we are proud of the tremendous progress we have made throughout the launch so far.

Speaker Change: We have a tremendous opportunity ahead of us and are well poised to build next vitol and next was that it's a blockbuster products for a variety of reasons first and foremost we have compelling clinical data from the clear outcome study that supports and validate safety and efficacy in reducing cardiovascular risk reduction.

Sheldon Koenig: First and foremost, we have compelling clinical data from the Clear Outcome study that supports and validates safety and efficacy in reducing cardiovascular risk reduction and lipid lowering in primary and secondary prevention patients. Second, there is a large underserved patient population of 70 million people at risk who need better treatment options. Finally, we have the right people and programs to drive this market and are taking all the right steps to successfully penetrate it. I say this because we have a team who have all either led or been a part of successful pharmaceutical product launches during their careers and have confidence in this team strategy and execution capabilities.

Speaker Change: And lipid lowering in primary and secondary prevention patients.

Speaker Change: There is a large underserved patient population of 70 million people at risk who need better treatment options.

Sheldon Koenig: Finally, we have the right people and programs to drive this market and are taking all the right steps to successfully penetrate it. I say this because we have a team who have all either led or been a part of successful pharmaceutical product launches during their careers, and I am confident in this team's strategy and execution capabilities. Importantly, we are managing this launch methodically, understanding that we need all the pieces in place for payers, physicians, and patients to be successful. We see this like a flywheel. The initial rotations take time and effort, but the subsequent rotations create momentum that compounds.

Speaker Change: Finally, we have the right people and programs to drive this market and are taking all the right steps to successfully penetrate it I say this because we have a team who have all either led or been a part of successful pharmaceutical product launches during their careers and I am confident in this team's strategy and execution capabilities.

Sheldon Koenig: Importantly, we are managing this launch in a methodical way, understanding that we need to have all the pieces in place for payers, physicians, and patients to be successful. We see this like a flywheel. The initial rotations take time and effort, but the subsequent rotations create momentum that compounds. We are off to a strong start and are confident that the work we are undertaking today will translate into increasing scripts and ultimately into accelerated product revenue.

Speaker Change: Importantly, we are managing this launch in a methodical way understanding that we need to have all the pieces in place for payers physicians and patients to be successful.

Speaker Change: See this like a flywheel the initial locations take time and effort, but the subsequent rotations create momentum that compounds.

Sheldon Koenig: We are off to a strong start and are confident that the work we are undertaking today will translate into increased scripts and ultimately into accelerated product revenue. Let me now turn to the progress we and our partners are making internationally. Starting with the EU, where our partner DSE is making important strides. DSE received its approved expanded labels for Nalemdo and Nustendi from the European Commission, which reflect new indications for cardiovascular risk reductions and expanded LDL cholesterol lowering in primary and secondary prevention patients. They have begun launching these new labels in European territories, with most areas anticipated to be launched by year-end 2024 and Italy in 2025.

Sheldon Koenig: We are off to a strong start and are confident that the work we are undertaking today will translate into increased scripts and ultimately into accelerated product revenue. Let me now turn to the progress we and our partners are making internationally. Starting with the EU, where our partner DSC is making important strides. DSC received its approved expanded labels for Nalemdo and Nustendi from the European Commission, which reflect new indications for cardiovascular risk reductions and expanded LDL cholesterol lowering in primary and secondary prevention patients. They have begun launching these new labels in European territories, with most areas anticipated to be launched by year-end 2024 and Italy in 2025.

Speaker Change: We are off to a strong start and are confident that the work. We are undertaking today will translate into increase in scripts and ultimately into accelerated product revenue.

Sheldon Koenig: Let me now turn to the progress we at our partners are making internationally. Starting with the EU, what our partner DSE is making important strides. DSE received its approved expanded labels from the Lemdo and New Stendi, from the European Commission, which reflects the new indications for cardiovascular risk reductions and expanded LDL cholesterol lowering in primary and secondary prevention patients. They have begun launching these new labels in European territories, with most areas anticipated to be launched by year end 2024 and Italy in 2025. We expect this to be a substantial market for DSE, as 80 percent of patients in Europe are unable to reach the online recommended levels for LDL cholesterol, despite taking statins.

Sheldon Koenig: We expect this to be a substantial market for DSE, as up to 80% of patients in Europe are unable to reach guideline recommended levels for LDL cholesterol despite taking statins. We are confident that with the strength of the approved indications, DSC will be able to position Nalendo and Yostandi as the first and only non-statin, lipid-lowering medicine approved for CV risk reduction, both in primary and secondary cardiovascular prevention in GSE will have a medical and commercial presence at the upcoming European Society of Cardiology Congress at the end of this month in London.

Let me now turn to the progress we at our partners are making internationally, starting with the EU, where our partner DSC is making important strides.

Sheldon Koenig: We expect this to be a substantial market for DSE, as up to 80% of patients in Europe are unable to reach guideline-recommended levels for LDL cholesterol despite taking statins. We are confident that with the strength of the approved indications, DSC will be able to position Nalendo and Yostandi as the first and only non-statin, lipid-lowering medicine approved for CV risk reduction, both in primary and secondary cardiovascular DSC will have a medical and commercial presence at the upcoming European Society of Cardiology Congress at the end of this month in London.

Speaker Change: <unk> received its approved expanded labels from the lender and you study from the European Commission, which reflects the new indications for cardiovascular risk reduction and expanded LDL cholesterol lowering in primary and secondary prevention patients.

Speaker Change: They have begun launching these new labels and European territories.

Speaker Change: Most areas anticipated it to be launched by year end 2020 for Italy in 2025.

Speaker Change: We expect this to be a substantial market for DSA is up to 80% of patients in Europe are unable to reach guideline recommended levels for LDL cholesterol, despite taking statin.

Sheldon Koenig: We are confident that with the strength of the approved indications, DSE will be able to position the Lemdo and New Stendi as the first and only non-statin lipid-lowering medicine approved for CD risk reduction, both in primary and secondary cardiovascular prevention in Europe. DSE will have a medical and commercial presence at the upcoming European Society of Cardiology Congress at the end of this month in London. This exciting Congress is the largest cardiovascular medical meeting of the year and is well attended by key opinion leaders from around the globe, including the United States. Consequently, we expect the efforts DSE will make at ESC to also benefit our efforts to enhance the awareness and visibility of our products among U.S.

Speaker Change: We are confident that with the strength of the approved indications DSC will be able to position the Orlando any study as the first and only non statin lipid lowering medicine approved for CV risk reduction both in primary and secondary cardiovascular prevention in Europe.

Speaker Change: DSC will have a medical and commercial presence at the upcoming European Society of Cardiology Congress at the end of this month in London. This exciting Congress has the largest cardiovascular medical meeting of the year and as well attended by key opinion leaders from around the globe, including the United States.

Sheldon Koenig: This exciting Congress is the largest cardiovascular medical meeting of the year and is well attended by key opinion leaders from around the globe, including the United States. Consequently, we expect the efforts DSC will make at ESC to also benefit our efforts to enhance the awareness and visibility of our products among U.S. healthcare professionals. Beyond Europe, our partner Daiichi Sankyo Company Limited, or DS-ASCA, gained approval for Nexotol and Nexozet in Thailand and for Nalendo and Yustendi in Macau, and submitted new drug applications in Korea.

Sequentially, we expect the efforts DSC will make at ESC to also benefit our efforts to enhance the awareness and visibility of our products.

Sheldon Koenig: HCPs. Beyond Europe, our partner, Daiichi Sankyo Company Limited, or G.F. Asuka gained approval for Nexotal and Nexosit in Thailand and from the Lemdo and New Stendi in Macau and submitted new drug applications in Korea. Well, these are smaller regions we expect to see incremental growth in our world. Our Japanese partner, Otsuko Pharmaceutical, announced that the primary endpoint of LDL cholesterol reduction from baseline at week 12 was achieved in their phase 3 clinical trial in Japan for benpidoric acid as a treatment for hypercholesterolemia. Otsuko plans to file a new drug application in Japan, in the second half of 2024, with expected approval and national health insurance pricing anticipated in 2025.

Speaker Change: Hcp's.

Speaker Change: Beyond Europe, our partner Daiichi Sankyo company limited or <unk> gained approval for <unk> in Thailand, and from the lender and you study in Macau and submitted new drug applications in Korea. While these are smaller regions, we expect to see incremental growth in our royalties from these product launches.

Sheldon Koenig: While these are smaller regions, we expect to see incremental growth in our royalties from these product launches. Our Japanese partner, Otsuka Pharmaceutical, announced that the primary endpoint of LDL cholesterol reduction from baseline at week 12 was achieved in their phase 3 clinical trial in Japan for bempedoic acid as a treatment for hypercholesterolemia. Otsuka plans to file a new drug application in Japan in the second half of 2024, with expected approval and national health insurance pricing anticipated in 2025.

Sheldon Koenig: While these are smaller regions, we expect to see incremental growth in our royalties from these product launches. Our Japanese partner, Otsuka Pharmaceutical, announced that the primary endpoint of LDL cholesterol reduction from baseline at week 12 was achieved in their phase three clinical trial in Japan for bempedoic acid as a treatment for hypercholesterolemia. Otsuka plans to file a new drug application in Japan in the second half of 2024, with expected approval and national health insurance pricing anticipated in 2025.

Speaker Change: Our Japanese partner Otsuka pharmaceutical announced that the primary endpoint of LDL cholesterol reduction from baseline at week 12 was achieved in their phase III clinical trial in Japan for <unk> asset as a treatment for hypercholesterolemia.

<unk> plans to file a new drug application in Japan in the second half of 2024 with expected approval of National Health insurance pricing anticipated in 2025.

Sheldon Koenig: We are enthusiastic about the continued momentum in Japan as it is one of the largest markets for lipid-lowering therapies. This could be a substantial market for Otsuka as well as a valuable royalty contributor for Esperion growth in the future. Our Esperion team continues to make strides expanding the global reach of benpendoic acid for use in cardiovascular risk reduction in patients with or at high risk for cardiovascular disease.

Sheldon Koenig: We are enthusiastic about the continued momentum in Japan, as this is one of the largest markets for lipid-lowering therapies. This could be a substantial market for Otsuko, as well as a valuable royalty contributor for espion growth in the future. Our espionting continues to make strides expanding the global reach of benpidoric acid for use in cardiovascular risk reduction in patients with or at high risk for cardiovascular disease. We continue to advance our work to file new drug applications in Canada, Australia, and Israel and are on track for these submissions by the end of this year. We are continually evaluating opportunities for additional collaborations of partnerships around the world, and given the label expansions for benpidoric acid and the worldwide total addressable markets for cardiovascular risk reduction, we believe we are an attractive partner with a compelling value proposition.

Speaker Change: We are enthusiastic about the continued momentum in Japan as it is one of the largest markets for lipid lowering therapies.

Speaker Change: This can be a substantial market for otsuka as well as a valuable royalty contributor for <unk> growth in the future.

Sheldon Koenig: Our Esperion team continues to make strides expanding the global reach of benbedoic acid for use in cardiovascular risk reduction in patients with or at high risk for cardiovascular disease. We continue to advance our work to file new drug applications in Canada, Australia, and Israel and are on track for these submissions by the end of this year. We are continually evaluating opportunities for additional collaborations and partnerships around the world.

Speaker Change: Our experienced team continues to make strides expanding the global reach of <unk> asset for use in cardiovascular risk reduction in patients with or at high risk for cardiovascular disease.

Sheldon Koenig: We continue to advance our work to file new drug applications in Canada, Australia, and Israel and are on track for these submissions by the end of this year. We are continually evaluating opportunities for additional collaborations and partnerships around the world, and given the label expansions for benpendoic acid and the worldwide total addressable market for cardiovascular risk reduction, we believe we are an attractive partner with a compelling value proposition. Finally, we continue to build a growing body of scientific and clinical knowledge that support the cardiovascular risk benefits of our bempedoic acid products.

Speaker Change: Continue to advance our work to file new drug applications in Canada, Australia and Israel.

Speaker Change: And are on track for these submissions by the end of this year.

Speaker Change: We are continually evaluating opportunities for additional collaborations and partnerships around the world and given the label expansions for <unk> acid and the worldwide total addressable market for cardiovascular risk reduction. We believe we are an attractive partner with a compelling value proposition.

Sheldon Koenig: And given the label expansions for bempedoic acid and the worldwide total addressable market for cardiovascular risk reduction, we believe we are an attractive partner with a compelling value proposition. Finally, we continue to build a growing body of scientific and clinical knowledge that support the cardiovascular risk benefits of our benpendoic acid products. To that end, we are pleased to have two data sets published in peer-reviewed journals over the past months, including an article titled Comparative Cardiovascular Benefits of Benpendidoic Acid and Statin Drugs that was published in the Journal of the American College of Cardiology.

Sheldon Koenig: Finally, we continue to build a growing body of scientific and clinical knowledge that supports the cardiovascular risk benefits of our benpidoric acid products. To that end, we are pleased to have two data sets published in peer-review journals over the past months, including in article titles, comparative cardiovascular benefits of benpidoric acid and statin drugs that was published in the Journal of the American College of Cardiology. This analysis of clear outcomes data demonstrated the cardiovascular risk reduction benefit of benpidoric acid treatment predicted per unit decrease in LDL cholesterol is comparable to that team in statin trials. Another article on the impact of the COVID-19 pandemic on conduct and results of clear outcomes trial was published in the Journal of Clinical Cardiology.

Speaker Change: Finally, we continue to build a growing body of scientific and clinical knowledge that support the cardiovascular risk benefit of <unk> acid products to that end. We are pleased to have two datasets published in peer reviewed journals over the past months, including an article titled Comparative cardiovascular benefits of empathetic asked.

Sheldon Koenig: To that end, we are pleased to have two datasets published in peer-reviewed journals over the past months, including an article titled Comparative Cardiovascular Benefits of Bempedoic Acid and Statin Drugs that was published in the Journal of the American College of Cardiology. This analysis of clear outcomes data demonstrated that the cardiovascular risk reduction benefit of benpidioic acid treatment predicted per unit decrease in LDL cholesterol is comparable to that seen in statin trials. Another article on the impact of the COVID-19 pandemic on the conduct and results of clear outcomes trials was published in the Journal of Clinical Cardiology.

Speaker Change: And statin drugs that was published in the journal of the American College of Cardiology.

Sheldon Koenig: This analysis of clear outcomes data demonstrated the cardiovascular risk reduction benefit of benpidioic acid treatment predicted per unit decrease in LDL cholesterol is comparable to that seen in statin trials. Another article on the impact of the COVID-19 pandemic on the conduct and results of the Clear Outcomes trial was published in the Journal of Clinical Cardiology. This analysis confirms the benefit of benbedoic acid and suggests that the global COVID-19 pandemic may have underestimated the benefit of benbedoic acid on both MACE-4 and MACE-3 based on the contribution of undetermined deaths that likely represented COVID-19 infection or pandemic-related fatalities.

This analysis of clear outcomes data demonstrated the cardiovascular risk reduction benefit advantage like asset treatment predicted per unit decrease in LDL cholesterol is comparable to that seen in statin trials.

Speaker Change: Another article on the impact of the COVID-19 pandemic on conduct and results of clear outcomes trial was published in the journal of clinical Cardiology. This analysis confirms the benefit of benzoic acid and suggest that the global COVID-19 pandemic may have underestimated the benefit of <unk> acid on both Mays four.

Operator: And welcome to a Spirits 2nd quarter, 2024 earnings conference call. At this time, more participants on the list and only mode. Following the presentation, there'll be a question and answer session. Please be advised that this conference call may be recorded.

Sheldon Koenig: This analysis confirms the benefit of benbedoic acid and suggests that the global COVID-19 pandemic may have underestimated the benefit of benbedoic acid on both MACE-4 and MACE-3 based on the contribution of undetermined deaths that likely represented COVID-19 infection or pandemic-related fatalities.

Sheldon Koenig: This analysis confirms the benefit of benpidoric acid and suggests that the global COVID-19 pandemic may have underestimated the benefit of benpidoric acid on both MACE 4 and MACE 3 based on the contribution of undetermined deaths that likely represented COVID-19 infection or pandemic-related fatalities. We will continue to publish our data and present it at key medical meetings and look forward to updating you on the progress over the months.

Alina Venencia: I would not like to end the conference call over to Alina Venencia, Director of Investulations. Please go ahead. Thank you, operator.

Speaker Change: And these three based on the contribution of undetermined deaths that likely represented COVID-19 infection or pandemic related fatalities.

Alina Venencia: Good morning, and welcome to a Spirits 2nd quarter, 2024 earnings conference call. With us today are Sheldon Koenig, President and CEO and then Halladay, the F.O. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. A copy can be found on our investor page of our website together with the copy of the presentation that we will also be referencing.

Sheldon Koenig: We will continue to publish our data and present it at key medical meetings and look forward to updating you on the progress over the month. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the second quarter.

Sheldon Koenig: We will continue to publish our data and present it at key medical meetings and look forward to updating you on the progress over the months. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the second quarter.

Speaker Change: We will continue to publish our data and presented at key medical meetings and look forward to updating you on our progress over the months.

Benjamin Halladay: With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the second quarter.

Speaker Change: With that overview of the business, let me turn the call over to Dan for a detailed review of our financial progress during the second quarter.

Benjamin Halladay: Ben? Thank you, Sheldon.

Benjamin Halladay: Thank you, Sheldon. Before I get into the details of the quarterly results, I want to highlight the transformational transaction we completed at the end of the quarter. We were excited to monetize our European royalty stream from DSC for a variety of reasons, not the least of which is that it allows us more control to leverage our balance sheet and capital structure. As we reported, proceeds from the Royalty Purchase Agreement facilitated an early payout and termination of the Oberland RIPA, removing all liens and covenants associated with the agreement, avoiding a significant headwind of payment step-ups in 2025, and dramatically improving the liquidity outlook of the company.

Benjamin Halladay: Before I get into the details of the quarterly results, I want to highlight the transformational transaction we completed at the end of the quarter. We were excited to monetize our European royalty stream from DSC for a variety of reasons, not the least of which is it allows us more control to leverage our balance sheet and capital structure. As we reported, proceeds from the royalty purchase agreement facilitated early payout and termination of the Oberland RIPPA, removing all liens and covenants associated with the agreement, avoiding a significant headwind of payment step-ups in 2025, and dramatically improving the liquidity outlook of the company.

Dan: Thank you Sheldon before I get into the details of the quarterly results I want to highlight the transformational transaction. We completed at the end of the quarter. We were excited to monetize our European royalty stream from DSC for a variety of reasons not the least of which is it allows us more control to leverage our balance sheet and capital structure.

Alina Venencia: I wanted to remind callers that information discussed on the call today is covered under the safe harbor provision of the Private Security's 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 statement due to the 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.

As we reported proceeds from the royalty purchase agreement facilitated early payout and termination of the overland report, removing all liens and covenants associated with the agreement avoiding a significant headwind of payments step ups in 2025 and dramatically improving the liquidity outlook of the company.

Benjamin Halladay: While we have made significant progress over the past two years in extending our cash runway, this is the single most important action we have taken to build our financial foundation for future growth. With that, let me now turn to our solid financial performance for the second quarter of 2024. I will provide a brief overview of the results, noting that additional information can be found in our press release issued early this morning and the 10-Q that will be filed shortly.

Dan: While we have made significant progress over the past two years and extending our cash runway. This is the single most important action, we have taken to build our financial foundation for future growth.

Benjamin Halladay: With that, let me now turn to our solid financial performance for the second quarter of 2024. I will provide a brief overview of the results, noting that additional information can be found in our press release issued early this morning and 10-Q that will be filed shortly. Please note that unless otherwise specified, my comments or reflect results for the second quarter ended June 30th, 2024.

Benjamin Halladay: Please note that, unless otherwise specified, my comments reflect results for the second quarter ended June 30, 2024. Total revenue for the second quarter of 2024 was $73.8 million compared to $25.8 million for the comparable period in 2021. U.S. net product revenue was $28.3 million compared to $20.3 million for the comparable period in 2023, an increase of approximately 39%. Sequential quarterly net revenue growth was 14%.

Benjamin Halladay: Please note that, unless otherwise specified, my comments reflect results for the second quarter ended June 30, 2024. Total revenue for the second quarter of 2024 was $73.8 million, compared to $25.8 million for the comparable period in 2021. U.S. net product revenue was $28.3 million, compared to $20.3 million for the comparable period in 2023, an increase of approximately 39%. Sequential quarterly net revenue growth was 14%.

Dan: With that let me now turn to our solid financial performance for the second quarter of 2024.

Speaker Change: I will provide a brief overview of the results, noting that additional information can be found in our press release issued early this morning, and 10-Q that will be filed shortly.

Benjamin Halladay: We believe this revenue growth, along with the total retail prescription equivalence growth in June that Sheldon just discussed, is an early indicator of our progress with the launch and the potential for these drugs. Collaboration revenue was $45.5 million compared to $5.5 million for the comparable period in 2023, an increase of approximately 727% primarily due to revenue recognized from our settlement agreement with DSE for the European Commission approval, increased product sales to our collaboration partners, and royalty sales growth within our partner territory. We are working with DSE on the technology transfer to support their ability to manufacture an Alemdo Industendi on their own for European distribution.

Speaker Change: Note that unless otherwise specified my comments reflect results for the second quarter ended June 32024.

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

Benjamin Halladay: Total revenue for the second quarter of 2024 was $73.8 million compared to $25.8 million for the comparable period in 2023. US net product revenue was $28.3 million compared to $20.3 million for the comparable period in 2023, an increase of approximately 39%. Sequential quarterly net revenue growth was 14%. We believe this revenue growth, along with the total retail prescription equivalence growth in June that Sheldon just discussed, are an early indicator of our progress with a launch and the potential for these drugs.

Speaker Change: Total revenue for the second quarter of 2024 was $73 8 million compared to $25 8 million for the comparable period in 2023.

Sheldon Koenig: I'll now turn the call over to Sheldon. Thank you, Alina.

Sheldon Koenig: Good morning, everyone. Thank you for joining us today to review the meaningful progress we have made during the second quarter and to review our plans moving forward to continue to submit Nexletal and Nexosit. The second quarter was an undeniably watershed period as we successfully executed our strategic initiatives across all areas of the business, key to building a spirit on into a leading biopharmaceutical company, improving outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Speaker Change: U S net product revenue was $28 $3 million compared to $20 3 million for the comparable period in 2023, an increase of approximately 39%.

Speaker Change: Sequential quarterly net revenue growth was 14%.

Benjamin Halladay: We believe this revenue growth, along with the total retail prescription equivalence growth in June that Sheldon just discussed, is an early indicator of our progress with the launch and the potential for these drugs. Collaboration revenue was $45.5 million, compared to $5.5 million for the comparable period in 2023, an increase of approximately 727%, primarily due to revenue recognized from our settlement agreement with DSC for the European Commission approval, increased product sales to our collaboration partners, and royalty sales growth within our partner territories.

Speaker Change: We believe this revenue growth along with the total retail prescription equivalents growth in June that Sheldon just discussed are an early indicator of our progress with the launch and the potential for these drugs.

Speaker Change: Okay.

Benjamin Halladay: Collaboration revenue was $45.5 million compared to $5.5 million for the comparable period in 2023, an increase of approximately 727%. Primarily due to the revenue recognized from our subtle in agreement with DSE for the European Commission approval, increase product sales to our collaboration partners and royalty sales growth within our partner territories. We are working with DSE on the tech transfer to support their ability to manufacture an Alemdo and Nusdendi on their own for European distribution. This will significantly reduce our future cause for the product and reduce working capital costs once completed.

Collaboration revenue was $45 5 million compared to $5 5 million for the comparable period in 2023, an increase of approximately 727% primarily due to the revenue recognized from our settlement agreement with DSC for the European Commission approval increased product sales to our collaboration partners and royalty sales growth within our part.

Sheldon Koenig: The second quarter was highlighted by double-digit increases US product revenue, significant progress by our partners in expanding international access to Nilendo and Dustendi, and importantly, the monetization of our European royalties from our partner, Daiichi Sancio Europe, or DSE. And the early discounted payoff and termination of our existing revenue interest purchase agreement or RIPPA with Oberlin. The strategic transaction significantly enhances our balance sheet and better positions us to focus on optimizing our US commercialization efforts.

Speaker Change: In your territories.

Benjamin Halladay: We are working with DSE on the technology transfer to support their ability to manufacture an Alemdo Industendi on their own for European distribution. This will significantly reduce our future costs for the product and reduce working capital costs once completed. We hope to complete this work in 2025 and for DSE to be producing their own product by the end of next year.

Speaker Change: We are working with DSC on the tech transfer to support their ability to manufacture and alimta understand the on their own for European distribution.

Speaker Change: This will significantly reduce our future cogs for the product and reduce working capital costs once completed.

Benjamin Halladay: We hope to complete this work in 2025 and for DSE to be producing their own product by the end of next year.

Speaker Change: We hope to complete this work in 2025 and for DSA to be producing their own product by the end of next year.

Sheldon Koenig: Then we'll discuss this transformational transaction in greater detail later. Now let me turn to our progress with our US commercialization efforts, which are gaining momentum as validated by US product revenue growth in the second quarter of 2024 of 14% sequential and 39% year over year growth. This growth was driven by the expanded new labels we received in late March. Our prior labels for Nexolet and Nexolet Hall were limited to LDL cholesterol reduction in the population of patients that already had a CV event and were on statin therapy.

Benjamin Halladay: Turning to the rest of the P&L for the second quarter of 2024, research and development expenses were $11.5 million compared to $22.1 million for the comparable period in 2023, a decrease of 48%. Primarily attributable to our clear outcome study that was completed in 2023.

Benjamin Halladay: Turning to the rest of the P&L, for the second quarter of 2024, research and development expenses were $11.5 million compared to $22.1 million for the comparable period in 2023, a decrease of 48%, primarily attributable to our Clear Outcomes Study that was completed in 2020. Selling general and administrative expenses were $44.2 million compared to $34 million for the comparable period in 2023, an increase of 30%. The increase is primarily related to increased commercial headcount in addition to bonus payments and promotional costs.

Benjamin Halladay: This will significantly reduce our future costs for the product and reduce working capital costs once completed. We hope to complete this work in 2025 and for DSE to be producing its own product by the end of next year. Turning to the rest of the P&L, for the second quarter of 2024, research and development expenses were $11.5 million compared to $22.1 million for the comparable period in 2023, a decrease of 48%, primarily attributable to our clear outcome study that was completed in 2022. Selling general and administrative expenses were $44.2 million compared to $34 million for the comparable period in 2023, an increase of 30%.

Speaker Change: Turning to the rest of the P&L for the second quarter of 2020 for research and development expenses were $11 5 million compared to $22 1 million for the comparable period in 2023, a decrease of 48% primarily attributable to our clear outcome study that was completed in 2023.

Benjamin Halladay: Selling, general and administrative expenses were $44.2 million compared to $34 million for the comparable period in 2023, an increase of 30%. The increase is primarily related to increased commercial headcount in addition to bonus payments and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to the current levels.

Speaker Change: Selling general and administrative expenses were $44 2 million compared to $34 million for the comparable period in 2023, an increase of 30%.

Benjamin Halladay: The increase is primarily related to increased commercial headcount in addition to bonus payments and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to the current level. The company incurred a one-time loss on extinguishment of debt of $53.2 million due to the accounting for the termination of the Overland River.

Speaker Change: The increase was primarily related to increased commercial head count in addition to bonus payments and promotional costs.

Benjamin Halladay: We continue to manage expenses prudently and expect expenses to remain similar to the current level. The company incurred a one-time loss on extinguishment of debt of $53.2 million due to the accounting for the termination of the Oberlin RIPA. Total net loss for the quarter was $61.9 million compared to a net loss of $49.9 million for the comparable period in 2020. Basic and diluted net loss per share was $0.33 compared to a basic and diluted net loss per share of $0.46 for the comparable period in 2020.

Speaker Change: Continue to manage expenses prudently and expect expenses to remain similar to the current levels.

Sheldon Koenig: Our expanded labels have three significant differences. One, includes CV risk reduction benefits. Two, expand to patient population by including primary prevention and three, enables use in patients that are unable to tolerate or maximize statin therapy. Nexolet Hall and Nexolet are now the first oral non-statin LDL cholesterol lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients. We have the opportunity to bring the benefits of Nexolet Hall and Nexolet to the 70 million patients eligible under the expanded new labels.

Benjamin Halladay: The company incurred a one-time loss on extinguishment of debt of $53.2 million due to the accounting of the termination of the Overland River.

Speaker Change: The company incurred a onetime loss on extinguishment of debt of $53 2 million due to the accounting of the termination of the overland robot.

Benjamin Halladay: Total net loss for the quarter was $61.9 million compared to a net loss of $49.9 million for the comparable period in 2023. Basic and diluted net loss per share was $33, compared to a basic and diluted net loss per share of $46 for the comparable period in 2023.

Benjamin Halladay: Total net loss for the quarter was $61.9 million compared to a net loss of $49.9 million for the comparable period in 2020. Basic and diluted net loss per share was $0.33 compared to a basic and diluted net loss per share of $0.46 for the comparable period in 2020. Turning to our balance sheet, as of June 30, 2024, we had $189.3 million in cash and cash equivalents. By removing the Oberlin RIPA, we are in a much better position to address the remaining debt on our balance sheet.

Speaker Change: Total net loss for the quarter was $61 9 million compared to a net loss of $49 9 million for the comparable period in 2023.

Speaker Change: Basic and diluted net loss per share was <unk> 33, compared to a basic and diluted net loss of share of <unk> 46 for the comparable period in 2023.

Benjamin Halladay: Turning to our balance sheet, as of June 30th, 2024, we had $189.3 million in cash and cash equivalents. By removing the Overland River, we are in a much better position to address the remaining debt on our balance sheet.

Benjamin Halladay: Turning to our balance sheet, as of June 30th, 2024, we had $189.3 million in cash and cash equivalents. By removing the Oberlin RIPA, we are in a much better position to address the remaining debt on our balance sheet. We are reiterating our full year 2024 operating expense guidance, which is expected to be approximately $225 million to $245 million, including $20 million of non-cash expenses related to stock compensation. Now, let me turn the call back to Sheldon for his final closing remarks. Sheldon.

Speaker Change: Turning to our balance sheet as of June 32024, we had $189 $3 million in cash and cash equivalents.

Speaker Change: By removing the overland rip out we're in a much better position to address the remaining debt on our balance sheet.

Sheldon Koenig: To support these broad expanded labels and drive awareness and ultimately prescriptions, we increase our field sales team. Critical to continued growth in prescriptions and product sales is broad and payer access. Here, we have done excellent work partnering with major payers to update utilization management criteria to include the recent label updates. The majority of payer updates began on June 1st and we were finalized by mid July with more than 80% of UM criteria now in place.

Benjamin Halladay: We are reiterating our full year 2024 operating expense guidance, which is expected to be approximately $225 million to $245 million, including $20 million of non-cash expenses related to stock compensation. Now, let me turn the call back to Sheldon for his final closing remarks. In closing, we are proud of the tremendous progress we have made throughout the first half of 2024, and we are looking forward to an exciting second half of the year as we continue to grow our U.S. product sales, expand internationally, and strive to reach our goals to create and deliver innovative options to reduce the risk of cardiovascular disease for patients around the world.

Speaker Change: We are reiterating our full year 2020 for operating expense guidance, which is expected to be approximately $225 million to $245 million, including $20 million of noncash expenses related to stock compensation.

Sheldon Koenig: Now, let me turn the call back to Sheldon for final closing remarks. Sheldon? Thank you, Ben.

Speaker Change: Now, let me turn the call back to Sheldon for final closing remarks Sheldon.

Sheldon Koenig: In closing, we are proud of the tremendous progress we have made throughout the first half of 2024, and we are looking forward to an exciting second half of the year as we continue to grow our U.S. product sales, expand internationally, and strive to reach our goals to create and deliver innovative options to reduce the risk of cardiovascular disease for patients around the world. Our accomplishments to date are a culmination of the hard work of our talented and dedicated Esperion team, who are passionately committed to reaching goals and making a difference in patients' lives.

Sheldon Koenig: In closing, we are proud of the tremendous progress we have made throughout the first half of 2024, and we are looking forward to an exciting second half of the year. As we continue to grow our U.S. product sale, expand internationally and strive to reach our goals to create and deliver innovative options to reduce the risk of cardiovascular disease for patients around the globe. Our accomplishments to date are a culmination of the hard work of our talented and dedicated to the spirit on team who are passionately committed to reaching goals and making the difference in patients' lives.

Sheldon: Thank you Ben at closing we are proud of the tremendous progress we have made throughout the first half of 2024, and we are looking forward to an exciting second half of the year as we continued to grow our U S product sales expand internationally and strive to reach our goal is to create and deliver innovative options to reduce the risk of cardiovascular disease.

Sheldon Koenig: Today, I am pleased to report that more than 114 million lives now have paid or UM criteria updated to reflect the new label updates. We also continue to garner new formulary coverage resulting in 92% preferred commercial coverage and increased our Medicare preferred coverage to greater than 50%. The strong payer acceptance that aligns with our new outcomes label underscores the payer's recognition of the clinical benefit and economic value our products bring to both patients and the health care system respectively.

Sheldon: <unk> for patients around the globe.

Benjamin Halladay: Our accomplishments to date are a culmination of the hard work of our talented and dedicated Esperion team, who are passionately committed to reaching goals and making a difference in patients' lives. Importantly, we could not have made these achievements without the ongoing support from our stakeholders.

Speaker Change: Our accomplishments to date are a culmination of the hard work of our talented and dedicated <unk> team, who are passionately committed to reaching goals and making a difference in patients' lives.

Sheldon Koenig: Importantly, we could not have made these achievements without the ongoing support from our stakeholders. We are on an exciting journey together, and I look forward to sharing more successes with you in the future. Again, we thank you for your ongoing trust and support. Operator, we are now ready for Q&A. Thank you.

Sheldon Koenig: Importantly, we cannot have made these achievements without the ongoing support from our stakeholders. We are on an exciting journey together, and I look forward to sharing more successes with you in the future. Again, we thank you for your ongoing trust and support.

Speaker Change: We could not have made these achievements without the ongoing support from our stakeholders.

Sheldon Koenig: We are on an exciting journey together, and I look forward to sharing more successes with you in the future. Again, we thank you for your ongoing trust and support. Operator, we are now ready for Q&A. Ladies and gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 11 again.

Speaker Change: On an exciting journey together and I look forward to sharing more successes with you in the future again, we thank you for your ongoing trust and support operator, we are now ready for Q&A.

Sheldon Koenig: As a result of this enhanced patient access and streamline prescription process, we expect increasing physician confidence in prescribing nexital and nexosit. We should translate into increasing product sales in the upcoming quarters and beyond. With payer access advancing our next important commercial initiative is to ensure we are further educating our health care providers or HEPs. In tandem, we have a campaign aimed at empowering patients to talk their HTTP about their CV risk.

Unknown Executive: Operator, you are now ready for Q&A. Thank you.

Operator: Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1-1 again. Please stand by while we compile the Q&A roster. Now, the first question coming from the line of Dennis Dingwood, Jeffrey Thielen, is open.

Unknown Executive: Please, Angel, and to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press Star 11 again.

Speaker Change: Thank you, ladies and gentlemen to ask a question you will need to press star one on your telephone and wait for your name to be announced soon.

Kenny Rocker: Enjoy your question simply press Star one again, please standby, while we compile to Kenny rocker.

Operator: Please stand by while we compile the Q&A room. Now, the first question comes from the line of Dennis Ding with Jeffrey Thiel on his phone. Hi, good morning.

Unknown Executive: Please, then, why will we complicate in your answer?

Eric Warren: Now, first question coming from the line up, and a single Jeffrey seal on a cell phone. Hi, good morning. Thanks for taking our questions. Two for me, maybe. I can just share a little bit about the feedback from doctors who are on the ground around just getting PAs approved, and there's been any directional improvements recently, and it has not been going to your expectations. And then, number two, just curious on your thoughts on the moments in the last or June 1st, and what more or less we needed to do for scripts to pick up. Thank you.

Kenny Rocker: Now first question coming from the line of Kenneth Zhang with Jefferies. Your line is open.

Dennis Dingwood: Hi, good morning, thanks for taking our questions. Two for me, maybe, can you just share a little bit about the feedback from doctors who are on the ground around just getting PAs approved, and if there's been any directional improvements recently, and has that been meeting your expectations? And then, number two, just curious about your thoughts on the momentum after June 1st and what more work we need to do for Scripps to pick up.

Dennis Ding: Thanks for taking our questions. Two for me, maybe, can you just share a little bit about the feedback from doctors who are on the ground around just getting PAs approved, and if there's been any directional improvements recently, and has that been meeting your expectations? And then, number two, just curious about your thoughts on the momentum after June 1 and what more work we need to do for Eric. Do you want to take that? I sure do. Good morning, Dennis.

Sheldon Koenig: We are using a variety of digital and traditional sales and marketing tactics that are gaining traction. For example, our expanded sales force has been targeting specific subsets of primary care physicians and cardiologists within person detailing. We also gained meaningful traction with our digital campaign where the legalized eight digital channels including search, email, peer-to-peer, EHR, point of care, banners, and social media to reach over 90% of our targeted health care providers. As a result of these combined initiatives by our managed care, sales force and marketing teams, we now have more than 21,000 HCPs writing scripts and total retail prescription equivalence increasing approximately 11% in the last four weeks of June compared to the prior four weeks of May.

Kenneth Zhang: Hi, Good morning, Thanks for taking my questions two from me and maybe.

Speaker Change: Can you just share a little bit about the feedback from doctors, who are on the ground around just getting <unk>.

Critical if theres been any directional improvements recently.

Speaker Change: I've been going to your expectations and then number two just curious on your thoughts on the momentum that says Jim first and what more.

Speaker Change: More work do you need to do for scripts to pick up thank you.

Eric Warren: Eric, do you want to take that? I sure do.

Eric Warren: Thank you. Eric, do you want to take that? I sure do. Good morning, Dennis.

Speaker Change: Eric do you want to take that.

Eric Warren: I sure do. Good morning, Dennis.

Eric Warren: Good to hear your voice. So with regard to physicians on the ground, you know, clearly, over the past four years prior to the label change, it wasn't always easy to get our products, especially for some of the patients that they wanted to use them in, specifically for the statin intolerant or for those primary prevention patients. But as a result of the label change and the work that BJ and her team have done, progressively improving, and as you noted, a pretty significant improvement on June 1. It takes a little time for clinicians to kind of regain that confidence, if you will, but they are progressively improving in their confidence. And I did see your primary care survey. I thought that was accurate.

Eric Warren: Good morning, Dennis. I could hear your voice. So, with regards to physicians on the ground, so clearly over the past four years prior to the label change, it wasn't always easy to get our products, especially for some of the patients that they wanted to use it, and specifically in the statin intolerant or in those primary prevention patients. But as a result, the label change in the work that BJ and our team have done, progressively improving, and as you noted, a pretty significant improvement in June 1, takes a little time for clinicians to kind of regain that confidence, if you will. But they are progressively improving in their confidence.

Eric: Sure do good morning, Dennis good to hear your voice so with regards to physicians on the ground. So clearly over the past four years prior to the label change.

Speaker Change: Isn't always easy to get our products, especially for some of the patients that they wanted to use it and specifically in the statin intolerant or in those primary prevention patients.

Speaker Change: But as a result of the label change and the work that BJ and her team have done.

Speaker Change: Progressively improving and as you noted a pretty significant improvement in June one it takes a little time for clinicians to regain that confidence if you will but they are progressively improving and their confidence and I did see your primary care survey I thought that was accurate.

Sheldon Koenig: I'll note that we used this comparison because there were five weeks and made this year. This is truly a Herculean effort and we are proud of the tremendous progress we have made throughout the launch so far. We have a tremendous opportunity ahead of us and our well-polished to build Nexatol and Nexoset into blockbuster products for a variety of reasons. First and foremost, we have compelling clinical data from the Clear Outcome study that supports and validates safety and efficacy in reducing cardiovascular risk reduction and lipid lowering in primary and secondary prevention patients.

Eric Warren: And I did see your primary care survey. I thought that was accurate. And that shows that there is still opportunity for us to reach these physicians, not only with the clinical message to get them excited about the brands, but also to get them over the edge from prescribing in an access perspective. With regards to the momentum in June, so yes, as you saw, a great pickup in June, directly related to Salesforce execution, but also the improvements that we had from a prior authorization, a UM perspective. I expect our growth to continue. I'm happy with that, what we saw in June. I'm happy with the overall 14% that we delivered from Q1 to Q2, and I continue to expect progressive improvements in growth.

Eric Warren: And that shows that there is still an opportunity for us to reach these physicians, not only with the clinical message to get them excited about the brands, but also to get them over the edge from a prescribing and an access perspective. With regard to the momentum in June, so yes, as you saw, a great pickup in June directly related to Salesforce execution, but also the improvements that we had from a prior authorization, and UM perspective. I expect our growth to continue. I'm happy with that and what we saw in June.

Speaker Change: And that shows that there is still opportunity for us to reach these physicians that only with the clinical message to get them excited about the brands, but also to get them over the edge.

Speaker Change: Prescribing and access perspective.

Speaker Change: With regards to the momentum.

Speaker Change: So yes as you saw a great pick up in June and directly related to Salesforce execution, but also the improvements that we had from a prior authorization AUM perspective.

Sheldon Koenig: Second, there is a large underserved patient population of 70 million people at risk who need better treatment options. Finally, we have the right people and programs to drive this market and are taking all the right steps to successfully penetrate it. I say this because we have a team who have all either led or been a part of successful pharmaceutical product launches during their careers and have confident in this team strategy and execution capabilities.

Speaker Change: I expect our growth to continue I'm happy with that and what we saw in June and I'm happy with the overall, 14% that we delivered from Q2 Q1 to Q2.

Eric Warren: I'm happy with the overall 14% that we delivered from Q1 to Q2, and I continue to expect progressive improvements in growth. Thank you. Thanks, Dennis. And our next question coming from the lineup is from Serge Belanger with Nehem.

Speaker Change: I continue to expect a progressive improvements in growth.

Sheldon Koenig: Importantly, we are managing this launch in a methodical way, understanding that we need to have all the pieces in place for payers, physicians and patients to be successful. We see this like a flywheel. The initial rotations take time and effort, but the subsequent rotations create momentum that compounds. We are off to a strong start and are confident that the work we are undertaking today will translate into increasing scripts and ultimately into accelerated product revenue.

Unknown Executive: Thank you. Thanks, Senator.

Speaker Change: Thank you.

Dennis: Thanks Dennis.

Unknown Executive: Thank you.

Thank you.

Unknown Executive: And our next question coming from Delano, first challenger with me. How do you want to solve it?

Operator: And our next question comes from the line of Serge Belanger with Needham. Your line is open.

Speaker Change: And our next question coming from the line of Serge Belanger with Needham Your line is open.

Serge Belanger: Your line is open. Hey, good morning. Congratulations on the progress. I guess first on the coverage with the, and great work on the commercial side, and you're expanding on the Medicare side. Remind us, what is the breakdown between those two segments for this market opportunity, and how much of a focus is it for?

Serge Belanger: Good morning. Congratulations on the progress. A couple questions for us. I guess first on the coverage. I've done some great work on the commercial side, and we are expanding on the Medicare side. Can you remind us what the breakdown between those two segments is for this market opportunity and how much of a focus is it for the company to continue expanding on the Medicare coverage side? And then secondly, can you remind us of how many scripts are currently going through your specialty pharmacies trying to figure out what we're missing out when we're looking at the data? I think the data's up. Thank you.

Unknown Executive: Good morning. I'm back on the program. A couple of questions for us. I guess first on the coverage with you, done some great work on the commercial side and are expanding on the Medicare side. Remind us what is the breakdown between those two segments for this market opportunity and how much of a focus is it for the company on the Medicare coverage side. And then secondly, can you rewind us how many scripts are currently going through your specialty pharmacies, trying to figure out what we're missing out when we're looking at the data sets.

Sheldon Koenig: Company to continue expanding on the Medicare coverage side. And then, secondly, can you remind us of how many scripts are currently going through your specialty pharmacy? Unknown Speaker

Serge Belanger: Hi, good morning.

Speaker Change: Back on the progress a couple of questions for you.

Speaker Change: Yes.

Speaker Change: On the coverage.

Speaker Change: That's some great work on the commercial side and are expanding on the Medicare side.

Sheldon Koenig: Let me now turn to the progress we at our partners are making internationally. Starting with the EU, what our partner DSE is making important strides. DSE received its approved expanded labels from the Lemdo and New Stendi, from the European Commission, which reflects the new indications for cardiovascular risk reductions and expanded LDL cholesterol lowering in primary and secondary prevention patients. They have begun launching these new labels in European territories with most areas anticipated to be launched by year and 2024 and Italy in 2025.

Speaker Change: Remind us what is the breakdown between those two segments for this market opportunity.

Speaker Change: And how much of a focus.

Speaker Change: For the company.

Speaker Change: And then on the Medicare coverage side.

And then secondly.

Speaker Change: Can you remind us.

Speaker Change: How many scripts are currently going through your specialty pharmacy.

Speaker Change: I'm trying to figure out.

Sheldon Koenig: Unknown Speaker, we're missing out when we're looking at the Freedom Datacenter. So maybe I can start this, and I'll turn it over to BJ. First of all, Serge, as you mentioned, our coverage is continuing to increase. Just from a commercial perspective, we have over 90% of the plans covered. From a Medicare perspective, we have over 50% covered.

Speaker Change: What we're missing when we're looking at.

Speaker Change: I think the dataset.

Unknown Executive: Thank you.

Sheldon Koenig: So maybe I can start this, and I'll turn it over to BJ. First of all, a surge, as you mentioned, our coverage is continuing to increase just from a commercial perspective. We have over 90% of the plans covered from a Medicare perspective. We have over 50% covered. And we're pretty much there as far as maximizing all of our coverage. There's one Medicare account that we're still working with that we feel good about, so stay tuned there. But just from an overall coverage perspective, we're in a great place. And just to reiterate what Eric said earlier, as you know, one of our greatest headwinds, previous to our new label, were the utilization management criteria.

Sheldon Koenig: So maybe I can start this, and I'll turn it over to BJ. First of all, Serge, as you mentioned, our coverage is continuing to increase. Just from a commercial perspective, we have over 90 percent of the plans covered. From a Medicare perspective, we have over 50 percent covered. And, you know, we're pretty much there as far as maximizing all of our coverage. There's one Medicare account that we're still working with that we feel good about, so stay tuned there.

Speaker Change: So maybe I can start this and I'll turn it over to BJ at first of all a surge as you mentioned our coverage is continuing to increase just from a commercial perspective, we have over 90% of the plans covered from a Medicare perspective.

Sheldon Koenig: We expect this to be a substantial market for DSE as at the 80 percent of patients in Europe are unable to reach the online recommended levels for LDL cholesterol, despite taking statins. We are confident that with the strength of the approved indications, DSE will be able to position the Lemdo and New Stendi as the first and only non-statin lipid lowering medicine approved for CD risk reduction, both in primary and secondary cardiovascular prevention in Europe.

BJ: We have over 50.

BJ: 50% covered and.

Sheldon Koenig: And, you know, we're pretty much there as far as maximizing all of our coverage. There's one Medicare account that we're still working with that we feel good about, so stay tuned there. But, you know, just from an overall coverage perspective, we're in a great place. And just to reiterate what Eric said earlier, you know, as you know, one of our greatest headwinds previous to our new label was the utilization management criteria. That has gotten a lot easier. In some areas, there are, you know, for some accounts, there are no prior authors.

BJ: We're pretty much there as far as maximizing all of our coverage. There is one Medicare account that we're still working with that we feel good about so stay tuned there but.

Sheldon Koenig: But You know, just from an overall coverage perspective, we're in a great place. And just to reiterate what Eric said earlier, you know, as you know, one of our greatest headwinds previous to our new label was the utilization management criteria. That has gotten a lot easier. In some areas, there are, you know, for some accounts, there are no prior authorizations. As it relates to Aspen, what I would say is, remember, that was a bridge that we set up so that until we have this coverage, patients could get their medications until maybe their PA was approved, et cetera.

Just from an overall coverage perspective, we're in a great place and just to reiterate what Eric said earlier.

Sheldon Koenig: DSE will have a medical and commercial presence at the upcoming European Society of Cardiology Congress at the end of this month in London. This exciting Congress is the largest cardiovascular medical meeting of the year and is well attended by key opinion leaders from around the globe, including the United States. Consequently, we expect the efforts DSE will make at ESC to also benefit our efforts to enhance the awareness and visibility of our products among U.S. HCPs.

Speaker Change: As you know one of our greatest headwinds previous trying new label, where the utilization management criteria.

Sheldon Koenig: That has gotten a lot easier in some areas. There are, you know, for some accounts, there are no prior authorizations.

That has gotten a lot easier in some areas. There are some accounts there are no prior authorizations.

Sheldon Koenig: As it relates to Aspen, what I would say is, remember, that was a bridge that we set up so that until we had this coverage, patients could get their medications until maybe their PA was approved, et cetera. So that was really a great stopgap measure from the team, and maybe I'll turn it over to BJ if she wants to add any more color as it relates to prescriptions going through Aspen, et cetera. Thank you, Sheldon.

Sheldon Koenig: As it relates to Aspen, what I would say is remember that was a bridge that we set up so that until we have this coverage, patients could get their medications until maybe their PA was approved, etc. So that was really a great stopgap measure from the team.

Speaker Change: As it relates to as Ben what I would say is remember that was a bridge that we set up so that until we have this coverage pace.

Patients could get their medications until maybe there what's approved et cetera. So that was really a great stop gap measure from the team and maybe I'll turn it over to BJ. If she wants to add any more color as it relates to prescriptions going through Aspen et cetera, yes.

Sheldon Koenig: So, that was really a great stopgap measure from the team, and maybe I'll turn it over to BJ if she wants to add any more color as it relates to prescriptions going through Aspen, et cetera. Yeah, thank you. Sheldon. I would say surge that.

Sheldon Koenig: Beyond Europe, our partner, Daiichi Sankyo Company Limited, or G.F. Asuka, gained approval for Nexotal and Nexosit in Thailand and from the Lemdo and New Stendi in Macau and submitted new drug applications in Korea. Well, these are smaller regions we expect to see incremental growth in our world Our Japanese partner, Otsuko Pharmaceutical, announced that the primary endpoint of LDL cholesterol reduction from baseline at week 12 was achieved in their phase 3 clinical trial in Japan for benpidoric acid as a treatment for hypercholesterolemia.

BJ: And maybe I'll turn it over to BJ if she wants to add any more color as related to prescriptions going through Aspen, etc.

BJ: Yeah, thank you, Sheldon.

Sheldon Koenig: Yeah, thank you, Sheldon. I would say, Serge, that Medicare is the most important channel for adjunct lipid-lowering treatments.

Sheldon Koenig: I would say, Serge, that Medicare is the most important channel for adjunct lipid-lowering treatments, and so we are laser-focused on garnering more coverage there. Stay tuned. Positive negotiations continue there, so where we're at 50% now, we continue to have that as a key focus going forward. Sheldon captured Aspen correctly.

BJ: I would say surge that Medicare is the most important channel to the adjunct lower lipid lowering treatment. And so we are laser focus to go on or more coverage there and stay tuned. Positive negotiations continue there. So we're at 50% now. We continue to have that as a key focus going forward.

BJ: Thank you Sheldon.

BJ: I'd say surge that Medicare is in this important channel.

BJ: The agile <unk> lipid lowering.

BJ: Treatment and so we are laser focused to garner more coverage there and.

Speaker Change: Stay tuned.

Speaker Change: Positive negotiations continue there so where were at 50% now we continue to have that as a key focus.

Sheldon Koenig: We used that, you know, that was a great tactic for us to bridge patients while payers were updating their UM criteria, but we were so pleased that payers really accelerated those reviews, and so less and less patients went in there because of the payers now updating, and we're getting patients on payer-paid prescriptions. So hopefully that answers your question. Our next question comes from the line-up, Jason Zemansky, Woodbank of America, Yolanda Strickland. Hey, good morning.

BJ: And so we are laser-focused on garnering more coverage there, and stay tuned. Positive negotiations continue there. So we're at 50% now. We continue to have that as a key focus going forward. Sheldon captured Aspen correctly.

BJ: Sheldon captured Aspen correctly. We use that, you know, that was a great tactic for us to bridge patients while payers were updating their UM criteria, but we were so pleased that payers really accelerated those reviews, and so less and less patients went in there because of the payers now updating, and we're getting patients on payer-paid prescriptions. So hopefully that answers your questions first. Thank you.

Speaker Change: Any forward shelving captured Aspen correctly.

Speaker Change: Is that that was a great tactic for us to bridge patients while payers were updating your U M criteria, but we are still pleased that payers really accelerated those reviews, and so less and less patients went in there because of the payers now updating and we're getting patients on payer paid prescriptions hopefully.

Sheldon Koenig: Otsuko plans to file a new drug application in Japan, in the second half of 2024, with expected approval a national health insurance pricing anticipated in 2025. We are enthusiastic about the continued momentum in Japan, as this is one of the largest markets for lipid lowering therapies. This could be a substantial market for Otsuko, as well as a valuable royalty contributor for espion growth in the future. Our espionting continues to make strides expanding the global reach of benpidoric acid for use in cardiovascular risk reduction in patients with or at high risk for cardiovascular disease.

Speaker Change: That answers your question.

Speaker Change: Thank you.

Speaker Change: Yeah.

BJ: We used that. That was a great tactic for us to bridge patients while payers were updating their UM criteria. But we were so pleased that payers really accelerated those reviews. And so less and less patients went in there because of the payers now updating, and we're getting patients on payer-paid prescriptions. So hopefully that answers your question.

Cameron Bozdog: Now the next question coming from the line of Jason Samantha with Bank of America, you're on Aspen. Hey, good morning. This is Cameron on for Jason. Congrats on the quarter, and thanks for taking our question. So, with regards to BA, when you think about launches in the cardiovascular space, you know, they often require sometimes longer to ramp relative to other indications like oncology. Some curious what you expect dynamic to look like here for uptake, who you expect growth to continue to be more steady or their factors that could potentially support a more near term inflection.

Speaker Change: Thank you and our next question coming from the line of Jason.

Speaker Change: Jason Smith with Bank of America. Your line is open.

Operator: Thank you. Our next question comes from the line of Jason Zemansky with Bank of America. Your line is open.

Sheldon Koenig: This is Cameron on for. Congratulations on the quarter and thanks for taking our questions. So with regard to BAA, when you think about launches in the cardiovascular space, you know, they often require a longer ramp relative to other indications like oncology.

Speaker Change: Hey, Good morning. This is Cameron on for Jason Congrats.

Sheldon Koenig: We continue to advance our work to file new drug applications in Canada, Australia, and Israel and are on track for these submissions by the end of this year. We are continually evaluating opportunities for additional collaborations of partnerships around the world and given the label expansions for benpidoric acid and the worldwide total addressable markets for cardiovascular risk reduction, we believe we are an attractive partner with a compelling value proposition.

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

Speaker Change: So with regards to when you think about launches in the cardiovascular space, they often require sometimes longer to ramp relative to other indications like oncology.

Jason Zemansky: So I'm curious, what do you expect the dynamics to look like here for uptake? Maybe you expect growth to continue to be more steady? Or are there factors that could potentially support a more near-term influx?

Speaker Change: I'm curious what do you expect dynamic to look like here for uptake maybe do you expect growth to be continue continued to be more steady.

Speaker Change: Or are there factors that could potentially support a more near term inflection.

Cameron Bozdog: Thank you.

Speaker Change: No.

Eric Warren: I'm happy.

Jason Zemansky: Hey, good morning. This is Cameron on behalf of Jason.

Eric Warren: I'm happy. Sorry. Sorry, Eric. I was going to just leave this off and then turn it over to you. I was on mute here.

Eric Warren: Sorry, Eric. I was going to just leave this off and then to hear from you.

Sheldon Koenig: Finally, we continue to build a growing body of scientific and clinical knowledge that support the cardiovascular risk benefits of our benpidoric acid products. To that end, we are pleased to have two data sets published in peer-review journals over the past months, including in article titles, comparative cardiovascular benefits of benpidoric acid and statin drugs that was published in the journal of the American College of Cardiology. This analysis of clear outcomes data demonstrated the cardiovascular risk reduction benefit of benpidoric acid treatment predicted per unit decrease in LDL cholesterol is comparable to that team in statin trials.

Terry: I am happy Alright, sorry, Eric I was kind of just leave the thoughts and then Terry. Thank you I was on mute here.

Sheldon Koenig: I was on mute here. First of all, thanks for your question. You know, I would refer you to slide nine of our corporate deck, which is available, which aligns to our prepared remarks. And again, what you'll see is this 14% growth, and we've shown double-digit growth quarter over quarter.

Sheldon Koenig: First of all, thanks for your question. I would refer you to slide nine of our corporate deck, which is available, which aligns with our prepared remarks. And again, what you'll see is this 14 percent growth. And we've shown double-digit growth quarter over quarter. So we're seeing that ramp up now. And, you know, just taking a look at the launch angle that we have, we're going to continue to see that momentum, and you're going to continue to see prescriptions go higher. And Eric, I'll turn it over to you because I know you've done some analysis. Yeah. Yeah. Thanks. And thanks for your question. So absolutely.

Speaker Change: First of all thanks for your question, Yes, I would refer you to slide nine of our corporate deck, which is available which aligns to our prepared remarks and again, what youll see is the 14% growth and we've shown double digit growth quarter over quarter.

Eric Warren: So we're seeing that ramp up now, and you know, just taking a look at the launch angle that we have, we're going to continue to see that momentum, and you're going to continue to see prescriptions go higher. And Eric, I'll turn it over to you because I know you've done some analysis. Yeah, yeah, thanks, and thanks for your questions. So absolutely. It takes a little bit more time than oncology to reach peak in this market, but we're confident in our ability to deliver continuous growth, you know, quarter over quarter, year over year. I did look at some other cardiovascular analog products that had significant CVOT trials that resulted in a label change and looked at their growth over the course of three years. I also looked at their one year growth.

Speaker Change: So we're seeing that ramp up now.

Speaker Change: And just taking a look at the launch angle.

Speaker Change: We have we're going to continue to see that momentum.

Youre going to continue continue to see prescriptions go higher and Eric I'll turn it over to you because I know you've done some analysis, yes, yes, thanks and thanks for your question. So absolutely it takes a little bit more time than oncology at to reach peak in this market.

Cameron Bozdog: Congratulations on the quarter and thanks for taking our question. So, with regard to BA, when you think about launches in the cardiovascular space, you know, they often require a longer ramp relative to other indications like oncology. So I'm curious, what do you expect the dynamics to look like here for uptake? Maybe you expect growth to continue to be more steady? Or are there factors that could potentially support a more near-term inflection?

Eric Warren: It takes a little bit more time than oncology in this market, but we're confident in our ability to deliver continuous growth, quarter over quarter, year over year. I did look at some other cardiovascular analog products that had significant CVOT trials that resulted in a label change and looked at their growth over the course of three years, and also looked at their one-year growth, and we're tracking right on, if not ahead, of where these competitive analogs are.

Sheldon Koenig: Another article on the impact of the COVID-19 pandemic on conduct and results of clear outcomes trial was published in the journal of clinical cardiology. This analysis confirms the benefit of benpidoric acid and suggests that the global COVID-19 pandemic may have underestimated the benefit of benpidoric acid on both Mace 4 and Mace 3 based on the contribution of undetermined deaths that likely represented COVID-19 infection or pandemic related fatalities. We will continue to publish our data and present it at key medical meetings and look forward to updating you on the progress over the months.

Eric Warren: I'm happy. Oh, sorry, Eric. I was going to just leave this off and then turn it over to you. I was on mute here.

We're confident in our ability to deliver continuous growth quarter over quarter year over year.

Eric: I did look at some other cardiovascular analogs products that had significant cbot trial that resulted in a label change and looked at their growth over the course of three years also looked at their one year growth and we're tracking right on if not ahead of where these.

Eric Warren: And we're tracking right on, if not ahead of where these competitive analogs are. Also, remind you from a PCS K9 perspective in repata, they're nine years into this mission and they're still not peaked yet. So really confident in our ability to deliver progressive continuous growth and realize the full potential is small these molecules.

Eric: Competitive analogs are also remind you from my PCF canine perspective in <unk> that there are nine years into this mission and Theyre still not peaked yet so really confident in our ability to deliver a progressive continuous growth and realize the full potential of smart these molecules.

Ben Halladay: With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the second quarter. Ben? Thank you, Sheldon.

Eric Warren: I'll also remind you from a PCSK9 perspective, in Repatha, they're nine years into this mission, and they're still not peaking yet, so I'm really confident in our ability to deliver progressive, continuous growth and realize the full potential of these molecules. And our next question comes from the lineup. Thelma Shrader with BTIG's Yelena Zolkova. Hi, good morning. This is Sung Hun for Tom.

Ben Halladay: Before I get into the details of the quarterly results, I want to highlight the transformational transaction we completed at the end of the quarter. We were excited to monetize our European royalty stream from DSC for a variety of reasons, not the least of which is it allows us more control to leverage our balance sheet and capital structure. As we reported, proceeds from the royalty purchase agreement facilitated early payout and termination of the Oberland RIPPA, removing all leans and covenants associated with the agreement, avoiding a significant headwind of payment step-ups in 2025, and dramatically improving the liquidity outlook of the company.

Ben Halladay: While we have made significant progress over the past two years in extending our cash runway, this is the single most important action we have taken to build our financial foundation for future growth.

Eric: Okay.

Eric Warren: Thank you.

Unknown Executive: And our next question coming from the line of Thomas Trader with BTIG on his open. Hi, good morning.

Speaker Change: Thank you.

Speaker Change: Our next question coming from the line of Thomas.

Thomas: Thomas <unk> with <unk> Your line is open.

Thelma Shrader: Thanks for taking our questions. So, first, could you just provide any additional color on the growth net and any potential remaining headwinds? And then, for the second question, just wanted to ask about what the market dynamic in Japan is and what the unmet need related to statin tolerances is. Thank you.

Unknown Executive: This is someone for Tom. Thanks for taking our questions. So the two questions for us.

Thomas: Hi, Good morning. This is Tom on for Tom Thanks for taking my questions.

Speaker Change: Two questions.

Unknown Executive: So first, could you just provide any additional color on the growth net and any potential remaining headwind?

Speaker Change: So first could you just provide any additional color on the growth in that and any potential remaining headwind.

Unknown Executive: And for the second question, just want to ask about what the market dynamic in Japan is and what the admin need related to that in tolerance. Thank you.

Speaker Change: And then the second question just wanted to ask about what the market dynamic dynamics in Japan is and what the unmet need related to 10 tolerances. Thank you.

Ben Halladay: With that, let me now turn to our solid financial performance for the second quarter of 2024. I will provide a brief overview of the results, noting that additional information can be found in our press release issued early this morning and 10Q that will be filed shortly. Please note that unless otherwise specified, my comments or reflect results for the second quarter ended June 30th, 2024.

Sheldon Koenig: So I'll go first with Japan, and then we'll hand it over to Ben. How today is released to GTN. The opportunity in Japan, Japan is, as we've said in our prepared remarks, one of the largest markets. That is out there, as a matter of fact, with this idea by Torin. When I ran that brand, that was really kind of the number three market in the world. As it relates to satin tolerance, what we do know globally, and there's a little bit to be around the percentage, is that satin intolerance is anywhere between 15 to 20% of the population that could need a statin.

Sheldon Koenig: First of all, thanks for your question. I would refer you to slide nine of our corporate deck, which is available, which aligns with our prepared remarks. And again, what you'll see is this 14 percent growth. And we've shown double-digit growth quarter over quarter. So we're seeing that ramp up now. And, you know, just taking a look at the launch angle that we have, we're going to continue to see that momentum. And you're going to continue to see prescriptions go higher. And Eric, I'll turn it over to you because I know you've done some analysis.

Sheldon Koenig: So I'll go first with Japan, and then we'll hand it over to Ben Halladay. The opportunity in Japan, Japan is, as we've said in our prepared remarks, one of the largest markets that is out there. As a matter of fact, with Zettia Bytorin, when I ran that brand, that was really kind of the number three market in the world. As it relates to statin intolerance, what we do know globally, and there's a little bit of debate around the percentages, is that statin intolerance is anywhere between 15 to 20 percent of the population that could need a statin.

Speaker Change: So I'll go first with Japan, and then we'll hand it over to Ben holiday as it relates to <unk> the opportunity in Japan, Japan is as we've said in our prepared remarks, one of the largest markets.

Eric Warren: Yeah, yeah. Thanks. And thanks for your question.

Eric Warren: So absolutely it takes a little bit more time than oncology to reach the peak in this market. But we're confident in our ability to deliver continuous growth, you know, quarter over quarter, year over year. I did look at some other cardiovascular analog products that had significant CBOT trials that resulted in a label change and looked at their growth over the course of three years. We've also looked at their one-year growth, and we're tracking right on, if not ahead of, where these competitive analogs are.

Eric Warren: Also, to remind you from a PCSK9 perspective in Repatha, they're nine years into this mission, and they're still not peaking yet. So, really confident in our ability to deliver progressive, continuous growth and realize the full potential of these molecules.

Operator: Thank you. And our next question comes from the lineup. Thelma Shrader with BTIG, your line is open.

Ben Holiday: That is out there as a matter of fact with <unk>. When I ran that brand that was really kind of the number three market in the world.

Ben Halladay: Total revenue for the second quarter of 2024 was $73.8 million compared to $25.8 million for the comparable period in 2023. US net product revenue was $28.3 million compared to $20.3 million for the comparable period in 2023, an increase of approximately 39%. Sequential quarterly net revenue growth was 14%. We believe this revenue growth along with the total retail prescription equivalence growth in June that Sheldon just discussed are an early indicator of our progress with a launch and the potential for these drugs.

Thelma Shrader: Hi, good morning. This is Sung Un to Tom.

Ben Holiday: As it relates to statin intolerance, what we do know globally and there is a little bit debate around the percentages is that statin intolerance is anywhere between 15% to 20% of the population that could need a statin and you've heard us talk about the millions of people out there that need LDL lowering so just thinking about 15% to 20%.

Sheldon Koenig: And you've heard us talk about the millions of people out there that need LDO lowering. So just thinking about 15 to 20% of them, it's very big. But Japan is a great opportunity, fortunate to have Otsuka as a partner and looking forward to their next steps in filing.

Ben Holiday: And it.

Sheldon Koenig: And you've heard us talk about the millions of people out there that need LDL lowering. So just thinking about 15 to 20 percent of them, it's very big. But Japan is a great opportunity.

Ben Holiday: It's very big.

Ben Holiday: But Japan is a it's a great opportunity.

Sheldon Koenig: I'm fortunate to have Otsuka as a partner and looking forward to their next steps in filing. Ben, do you want to speak to GTN? Yeah, thanks, Sheldon. So as far as gross to net goes, you know, we've had a good year; things have remained largely consistent with last year when we saw some significant losses. Did we lose Ben? I think we might have lost Ben Halladay.

Speaker Change: Fortunate to have otsuka as a partner and looking forward to their next steps in filing a ban.

Benjamin Halladay: A band you want to speak to GTN.

Ben Halladay: Collaboration revenue was $45.5 million compared to $5.5 million for the comparable period in 2023, an increase of approximately 727%. Primarily due to the revenue recognized from our subtle in agreement with DSE for the European Commission approval, increase product sales to our collaboration partners and royalty sales growth within our partner territories. We are working with DSE on the tech transfer to support their ability to manufacture an Alemdo and Nusdendi on their own for European distribution. This will significantly reduce our future cause for the product and reduce working capital costs once completed.

Sung Un: Thanks for taking our questions. So, first, could you just provide any additional color on the growth net and any potential remaining headwinds? And then, for the second question, just wanted to ask about what the market dynamic in Japan is and what the unmet need related to statin tolerances is. Thank you.

Speaker Change: Do you want to speak to GTS.

Benjamin Halladay: Yeah, thanks, Sheldon. So, as far as gross to net goes, you know, we've had a good year; things have remained largely consistent with last year, when we saw some significant. I think we might have watched Ben Halladay. Yeah, I think we have Sheldon.

Sheldon Koenig: So I'll go first with Japan, and then we'll hand it over to Ben Halladay as it relates to GTN. The opportunity in Japan, Japan is, as we've said in our prepared remarks, one of the largest markets that is out there. As a matter of fact, with Zettia Bytorin, when I ran that brand, that was really kind of the number three market in the world. As it relates to satin intolerance, what we do know globally, and there's a little bit of debate around the percentages, is that satin intolerance is anywhere between 15% to 20% of the population that could need a statin.

Sheldon Koenig: And you've heard us talk about the millions of people out there that need LDL lowering. So just thinking about 15% to 20% of them, it's very big. But Japan is a great opportunity. I'm fortunate to have Otsuka as a partner and looking forward to their next steps in filing. Ben, do you want to speak to GTN?

Sean: Yes, Thanks, Sean.

Speaker Change: As far as gross to net goes we've had a good year things have remained largely consistent with last year. When we when we saw some significant.

Benjamin Halladay: Yeah, thanks, Sheldon. So as far as gross to net goes, you know, we've had a good year, things have remained largely consistent with last year when we saw some significant losses Did we lose Ben?

Speaker Change: Did we lose.

Ben Halladay: We hope to complete this work in 2025 and for DSE to be producing their own product by the end of next year.

Speaker Change: Okay.

unknown: Thanks for watching, and don't forget to like, share, and subscribe to our channel. I think we might have lost Ben Halladay.

Okay.

Speaker Change: Yes.

Ben Halladay: Turning to the rest of the P&L for the second quarter of 2024, research and development expenses were $11.5 million compared to $22.1 million for the comparable period in 2023, a decrease of 48%. Primarily attributable to our clear outcome study that was completed in 2023.

Speaker Change: I think we might have lost Ben holiday.

unknown: Yeah, I think we have Sheldon. Yeah, so maybe I'll go.

Benjamin Halladay: Yeah, I think we have Sheldon. Yeah, so maybe I'll speak to GTN. Sorry, I wasn't sure if the whole site had gone down, and we were texting each other. We don't disclose our gross to net, but I would say that we are at a steady state. We're comfortable where we are now, not only in what we do from a contracting perspective, but what we do with wholesalers, etc. So, you know, we've been managing that appropriately. I think we can go on to the next question. Thank you, and I am showing no further questions in the queue at this time.

Sheldon: Yes, I think we have Sheldon, yes, so maybe I'll ask Pete to GTS, sorry, I wasn't sure if the whole site had gone down and we are attacking each other we.

Sheldon Koenig: Yeah, so maybe I'll speak to GTN. Sorry, I wasn't sure if the whole site had gone down, and we were texting each other.

Benjamin Halladay: Yeah, so maybe I'll speak to GTN. Sorry, I wasn't sure if the whole site had gone down and we were texting each other. We don't disclose our gross to net, but I would say is that we are at a steady state. We're comfortable where we are now, not only from what we do from a contracting perspective, what we do with wholesalers, etc. So, you know, we've been managing that appropriately.

Sheldon Koenig: We don't disclose our gross to net, but I would say that we are at a steady state. We're comfortable where we are now, not only from what we do from a contracting perspective, but what we do with wholesalers, etc. So, you know, we've been managing that appropriately. I think we can go on to the next question.

We don't disclose our gross to net but I would say is that we are at a steady state we're comfortable where we are now.

Ben Halladay: Selling general and administrative expenses were $44.2 million compared to $34 million for the comparable period in 2023, an increase of 30%. The increase is primarily related to increased commercial headcount in addition to bonus payments and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to the current levels.

Sheldon: Not only from what we do from a contracting perspective, what we do with wholesalers et cetera.

Sheldon: So.

Sheldon: We've been managing that appropriately.

Sheldon Koenig: I think we can go on to the next question.

Speaker Change: I think we can go on to the next question.

Ben Halladay: The company incurred a one-time loss on extinguishment of debt of $53.2 million due to the accounting of the termination of the Overland River. Total net loss for the quarter was $61.9 million compared to a net loss of $49.9 million for the comparable period in 2023. Basic and deluded net loss per share was $33, compared to a basic and deluded net loss of share of $46 for the comparable period in 2023.

Unknown Executive: Thank you.

Operator: Thank you. And I am showing no further questions in the queue at this time. Ladies and gentlemen, this does conclude today's conference call. Thank you all for participating, and you may now disconnect.

Unknown Executive: And I'm showing no further questions in the queue at this time.

Speaker Change: Thank you and I'm showing no further questions in the queue at this time, ladies and gentlemen. This does conclude today's conference call. Thank you all for participating and you may now disconnect.

Unknown Executive: Ladies and gentlemen, this doesn't go to today's conference call.

Unknown Executive: Thank you all for participating, and you may now disconnect.

Okay.

Speaker Change: [music].

Speaker Change: Okay.

Ben Halladay: Turning to our balance sheet, as of June 30th, 2024, we had $189.3 million in cash and cash equivalents. By removing the Overland River, we are in a much better position to address the remaining debt on our balance sheet. We are reiterating our full year 2024 operating expense guidance which is expected to be approximately $225 million to $245 million including $20 million of non-cash expenses related to stock compensation.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Sheldon Koenig: Now, let me turn the call back to Sheldon for final closing remarks. Sheldon? Thank you, Ben.

Speaker Change: Yes.

Speaker Change: [music].

Sheldon Koenig: In closing, we are proud of the tremendous progress we have made throughout the first half of 2024, and we are looking forward to an exciting second half of the year. As we continue to grow our U.S, product sale, expand internationally and strive to reach our goals to create and deliver innovative options to reduce the risk of cardiovascular disease for patients around the globe. Our accomplishments to date are a culmination of the hard work of our talented and dedicated to the spirit on team who are passionately committed to reaching goals and making the difference in patients' lives. Importantly, we cannot have made these achievements without the ongoing support from our stakeholders.

Okay.

Speaker Change: [music].

Speaker Change: So.

Sheldon Koenig: We are on an exciting journey together and I look forward to sharing more successes with you in the future. Again, we thank you for your ongoing trust and support.

Operator: Operator, you are now ready for Q&A. Thank you. Please, Angel, and to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 11 again. Please, then, why will we complicate in your answer?

Jeffrey Seal: Now, first question coming from the line up, and a single Jeffrey seal on a cell phone. Hi, good morning. Thanks for taking our questions. Two for me, maybe. I can just share a little bit about the feedback from doctors who are on the ground around just getting PAs approved, and there's been any directional improvements recently, and it has not been going to your expectations. And then, number two, just curious on your thoughts on the moments in the last or June 1st, and what more or less we needed to do for scripts to pick up. Thank you.

Eric Warren: Eric, do you want to take that? I sure do.

Eric Warren: Good morning, Dennis. I could hear your voice. So with regards to physicians on the ground, so clearly over the past four years prior to the label change, it wasn't always easy to get our products, especially for some of the patients that they wanted to use it, and specifically in the statin intolerant or in those primary prevention patients. But as a result, the label change in the work that BJ and our team have done, progressively improving, and as you noted, a pretty significant improvement in June 1, takes a little time for clinicians to kind of regain that confidence, if you will, but they are progressively improving in their confidence.

Eric Warren: And I did see your primary care survey. I thought that was accurate. And that shows that there is still opportunity for us to reach these physicians, not only with the clinical message to get them excited about the brands, but also to get them over the edge from prescribing in an access perspective. With regards to the momentum in June, so yes, as you saw, a great pickup in June, directly related to Salesforce execution, but also the improvements that we had from a prior authorization, a UM perspective. I expect our growth to continue. I'm happy with that, what we saw in June, I'm happy with the overall 14% that we delivered from Q1 to Q2, and I continue to expect progressive improvements in growth.

Eric Warren: Thank you. Thanks, Senator. Thank you.

Delano: And our next question coming from Delano, first challenger with me. How do you want to solve it?

Delano: Good morning. I'm back on the program. A couple of questions for us. I guess first on the coverage with you, done some great work on the commercial side and are expanding on the Medicare side. Remind us what is the breakdown between those two segments for this market opportunity and how much of a focus is it for the company on the Medicare coverage side. And then secondly, Can you rewind us how many scripts are currently going through your specialty pharmacies, trying to figure out what we're missing out when we're looking at the data sets.

Delano: Thank you.

Sheldon Koenig: So maybe I can start this and I'll turn it over to BJ. First of all, a surge as you mentioned, our coverage is continuing to increase just from a commercial perspective. We have over 90% of the plans covered from a Medicare perspective. We have over 50% covered. And we're pretty much there as far as maximizing all of our coverage. There's one Medicare account that we're still working with that we feel good about so stay tuned there.

Sheldon Koenig: But just from an overall coverage perspective, we're in a great place. And just to reiterate what Eric said earlier, as you know, one of our greatest headwinds, previous to our new label, we're the utilization management criteria. That has gotten a lot easier in some areas. There are, you know, for some accounts, there are no prior authorizations. As it relates to Aspen, what I would say is remember, that was a bridge that we set up so that until we have this coverage, patients could get their medications until maybe their PA was approved, etc. So that was really a great stopgap measure from the team.

BJ: And maybe I'll turn it over to BJ if she wants to add any more color as related to prescriptions going through Aspen, etc. Yeah, thank you, Sheldon. I would say surge that Medicare is the most important channel to the adjunct lower lipid lowering treatment. And so we are laser focus to go on or more coverage there and stay tuned positive negotiations continue there. So we're at 50% now. We continue to have that as a key focus going forward.

BJ: Sheldon captured Aspen correctly. We use that, you know, that was a great tactic for us to bridge patients while payers were updating their UM criteria, but we were so pleased that payers really accelerated those reviews and so less and less patients went in there because of the payers now updating and we're getting patients on payer paid prescriptions. So hopefully that answers your questions first. Thank you.

Cameron Bozdog: Now the next question coming from the line off Jason Samantha with Bank of America, you're on Aspen. Hey, good morning. This is Cameron on for Jason. Congrats on the quarter and thanks for taking our question. So with regards to BA, when you think about launches in the cardiovascular space, you know, they often require sometimes longer to ramp relative to other indications like oncology. Some curious what you expect dynamic to look like here for uptake, who you expect growth to be continue continue to be more steady or their factors that could potentially support a more near term inflection.

Cameron Bozdog: Thank you. I'm happy. Sorry Eric. I was going to just leave this off and then to hear from you. I was on mute here. First of all, thanks for your question. You know, I would refer you to slide nine of our corporate deck, which is available, which aligns to our prepared remarks and again, what you'll see is this 14% growth and we've shown double digit growth quarter over quarter. So we're seeing that ramp up now and you know, just taking a look at the launch angle that we have we're going to continue to see that momentum and you're going to continue to see prescriptions go higher and Eric, I'll turn it over to you because I know you've done some analysis.

Cameron Bozdog: Yeah, yeah, thanks and thanks for your questions. So absolutely. It takes a little bit more time than oncology to reach peak in this market, but we're confident in our ability to deliver continuous growth, you know, quarter over quarter year over year. I did look at some other cardiovascular analog products that had significant CVOT trials that resulted in a label change and looked at their growth over the course of three years also looked at their one year growth.

Cameron Bozdog: And we're tracking right on if not ahead of where these competitive analogs are also remind you from a PCS K9 perspective in repata, they're nine years into this mission and they're still not peaked yet. So really confident in our ability to deliver progressive continuous growth and realize the full potential is small these molecules. Thank you.

Thomas Shrader: And our next question coming from the line of Thomas Trader with BTIG on his open.

Thomas Shrader: Hi, good morning. This is someone for Tom. Thanks for taking our questions. So the two questions for us. So first, could you just provide any additional color on the growth net and any potential remaining headwind? And for the second question, just want to ask about what the market dynamic in Japan is and what the admin need related to that in tolerance. Thank you.

Sheldon Koenig: So I'll go first with Japan, and then we'll hand it over to Ben. How today is released to GTN. The opportunity in Japan, Japan is, as we've said in our prepared remarks, one of the largest markets. That is out there, as a matter of fact, with this idea by Torin, when I ran that brand, that was really kind of the number three market in the world. As it relates to satin tolerance, what we do know globally, and there's a little bit to be around the percentage is that satin intolerance is anywhere between 15 to 20% of the population that could need a statin.

Ben Halladay: A band you want to speak to GTN. Yeah, thanks, Sheldon. So as far as gross to net goes, you know, we've had a good year, things have remained largely consistent with last year, when we, when we saw some significant.

Ben Halladay: I think we might have watched Ben Halladay. Yeah, I think we have Sheldon. Yeah, so maybe I'll speak to GTN, sorry, I wasn't sure if the whole site had gone down and we were texting each other. We don't disclose our gross to net, but I would say is that we are at a steady state. We're comfortable where where we are now, not only from what we do from a contracting perspective, what we do with wholesalers, etc. So, you know, we've been managing that appropriately. I think we can go on to the next question.

Operator: Thank you. And I'm showing no further questions in the queue at this time.

Operator: Ladies and gentlemen, this doesn't go to today's conference call.

Operator: Thank you all for participating, and you may now disconnect.

Q2 2024 Esperion Therapeutics Inc Earnings Call

Request a DemoDemo

ESPR

Esperion

Earnings