Esperion Therapeutics Inc (ESPR) 2024 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome. (Operator Instructions) Please be advised that today's conference call may be recorded.

女士們、先生們，感謝你們的支持與歡迎。 （操作員說明）請注意，今天的電話會議可能會被錄音。

I would now like to hand the conference over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. Please go ahead.

現在我想將會議交給 Esperion Therapeutics 投資者關係總監 Alina Venezia。請繼續。

Thank you, operator. Good morning, and welcome to Esperion's third-quarter 2024 earnings conference call. 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.

謝謝你，接線生。早安，歡迎參加 Esperion 2024 年第三季財報電話會議。今天與我們在一起的有總裁兼執行長 Sheldon Koenig；和財務長 Ben Halladay。在我們準備好的發言後，執行團隊的其他成員將接受問答。

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.

我們今天早上早些時候發布了一份新聞稿，詳細介紹了今天電話會議的內容。您可以在我們網站的投資者頁面上找到一份副本，以及我們也將參考的簡報的副本。

I want to remind callers that the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to 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.

我想提醒來電者，今天電話中討論的資訊受《私人證券訴訟改革法》安全港條款的保護。我提醒聽眾，管理階層將做出前瞻性聲明。由於與業務相關的風險和不確定性，實際結果可能與我們的前瞻性陳述中明示或暗示的結果有重大差異。這些前瞻性陳述完全符合今天的新聞稿和我們向美國證券交易委員會提交的文件中所包含的警示性陳述。

The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 7, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast.

本次電話會議的內容包含時間敏感信息，僅截至本次直播之日（2024 年 11 月 7 日）準確。次電話會議和網路直播。

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.

謹此提醒，本次電話會議和網路廣播正在錄製和存檔。我們將以準備好的發言開始通話，然後打開電話詢問您的問題。

I now turn the call over to Sheldon.

我現在把電話轉給謝爾頓。

Thank you, Alina. Good morning, everyone, and thank you for joining us.

謝謝你，阿麗娜。大家早安，感謝您加入我們。

As I look back over the past year, I continue to be so proud of all our team has accomplished. It has truly been a watershed year for Esperion, in which we successfully expanded our NEXLETOL, NEXLIZET labels to include broad new indications for primary and secondary cardiovascular risk reduction, scaled up our commercial team and launched these new indications and broaden payer access and implemented marketing programs that have enhanced awareness of our new indications among healthcare providers to drive prescription growth. As a result of our team's collective efforts, we have posted double-digit prescription growth in both quarters since the launch.

當我回顧過去的一年時，我仍然為我們團隊所取得的所有成就感到自豪。對於Esperion 來說，這確實是一個分水嶺的一年，我們成功擴展了NEXLETOL、NEXLIZET 標籤，納入了降低原發性和繼發性心血管風險的廣泛新適應症，擴大了我們的商業團隊並推出了這些新適應症，並擴大了付款人准入範圍並實施了行銷這些計劃提高了醫療保健提供者對我們新適應症的認識，以推動處方成長。由於我們團隊的集體努力，自推出以來，我們的處方量在兩個季度都實現了兩位數的成長。

In addition, we've supported international growth and further expansion of NILEMDO and NUSTENDI which continued to be impressive and support our continued confidence in the global market opportunity for our bempedoic acid products. And importantly, we substantially strengthened our balance sheet by monetizing the European royalties on our bempedoic acid product sales and allocated the proceeds for their early discounted payoff and termination of our previous revenue interest facility.

此外，我們也支持 NILEMDO 和 NUSTENDI 的國際成長和進一步擴張，這繼續令人印象深刻，並支持我們對 bempedoic 酸產品的全球市場機會的持續信心。重要的是，我們透過將 bempedoic 酸產品銷售的歐洲特許權使用費貨幣化，大幅加強了我們的資產負債表，並將收益分配給他們的早期折扣支付和終止我們先前的收入利息安排。

We also continue to focus on additional ways to fortify our capital structure. Any one of these accomplishments would be meaningful on its own. Collectively, they have transformed Esperion and laid a strong foundation from which to build and grow global revenues for our bempedoic acid products and to expand and advance our very promising clinical development program of ACLY inhibitors.

我們也繼續關注加強資本結構的其他方法。這些成就中的任何一項本身都是有意義的。總的來說，他們改變了 Esperion，並為我們的 bempedoic 酸產品建立和增加全球收入以及擴大和推進我們非常有前途的 ACLY 抑制劑臨床開發計劃奠定了堅實的基礎。

Now, let me turn to our progress with our US commercialization efforts, which are gaining additional momentum as demonstrated by US net product revenue growth of NEXLIZET and NEXLETOL in Q3 2024 of 10% sequential and 53% year-over-year growth. These increases were driven by the meaningful progress we continue to make during the first six months of the launch for our label expansions. As a reminder, our expanded labels have three significant differences. They now include CV risk reduction benefits, expand the patient population by including primary prevention and enable use patients that are unable to tolerate or maximize statin therapy.

現在，讓我談談我們在美國商業化努力的進展，這些努力正在獲得額外的動力，NEXLIZET 和NEXLETOL 在美國的淨產品收入在2024 年第三季度環比增長10%，同比增長53% 就證明了這一點。這些成長是由我們在品牌擴張推出的前六個月中繼續取得的有意義的進展所推動的。提醒一下，我們的擴展標籤有三個顯著差異。它們現在包括降低心血管風險的益處，透過一級預防來擴大患者群體，並使無法耐受或最大化他汀類藥物治療的患者能夠使用。

We have done an exceptional job building a strong foundation with the three key pillars for success: payers, physicians and patients. We understand the necessity to remain committed to addressing the needs of each of these constituencies in order to successfully bring the benefits of NEXLETOL and NEXLIZET to the 70 million patients eligible under the expanded labels.

我們做了出色的工作，為成功的三個關鍵支柱奠定了堅實的基礎：付款人、醫生和病人。我們理解有必要繼續致力於滿足這些群體的需求，以便成功地將 NEXLETOL 和 NEXLIZET 的益處帶給 7000 萬符合擴展標籤資格的患者。

Starting with the payers, where we initially focused on making sure the utilization management criteria or UM, for the expanded labels were in place. As of mid-July, more than 8% of UM criteria were updated to reflect the new label updates and more importantly, a significantly less burdensome prior authorization process was put in place. The updates totaled more than 114 million lives. Since then, we have grown that number to more than 165 million patient lives across all payers who have updated their UM criteria. This is a foundational building block to secure reimbursement and removing significant restrictions and barriers to access, so physicians can now prescribe NEXLETOL and NEXLIZET with increased confidence.

從付款人開始，我們最初專注於確保擴展標籤的利用率管理標準或 UM 到位。截至 7 月中旬，超過 8% 的 UM 標準已更新，以反映新標籤的更新，更重要的是，還實施了顯著減輕繁重的事先授權流程。這些更新總計超過 1.14 億人的生命。從那時起，我們已將這一數字增加到所有更新了 UM 標準的付款人的患者數量已超過 1.65 億。這是確保報銷並消除重大限制和准入障礙的基礎，因此醫生現在可以更有信心地開出 NEXLETOL 和 NEXLIZET 處方。

Another milestone achievement on this front was the expansion of our commercial and Medicare formulary coverage for NEXLETOL and NEXLIZET. In early September, we made new additions to Medicare formularies at Optum, United AARP and CVS SilverScript coupled with our earlier coverage with Humana, we currently have access to more than 65% of Medicare insured lives and more than 92% of commercially insured lives under the new labels and UM criteria. Again, we expect this expanded payer coverage to drive further increases in physician confidence to prescribe NEXLETOL and NEXLIZET, ultimately leading to higher product sales in the upcoming quarters and beyond.

這方面的另一個里程碑成就是擴大了我們的 NEXLETOL 和 NEXLIZET 的商業和醫療保險處方覆蓋範圍。 9 月初，我們在Optum、United AARP 和CVS SilverScript 的Medicare 處方集中添加了新內容，再加上我們之前與Humana 的承保，目前我們可以覆蓋超過65% 的Medicare 受保人以及超過92% 的商業受保人。我們再次預計，付款人覆蓋範圍的擴大將進一步增強醫生開出 NEXLETOL 和 NEXLIZET 處方的信心，最終導致未來幾個季度及以後的產品銷量更高。

In tandem, we further advanced our sales and marketing campaigns aimed at educating healthcare providers about the clinical benefits of NEXLETOL and NEXLIZET and empowering patients to talk with their clinicians about their cardiovascular risk. We continue to optimize our commercial tactics and remain efficient in allocating resources to initiatives that are yielding the most favorable ROIs.

同時，我們進一步推進了銷售和行銷活動，旨在教育醫療保健提供者了解 NEXLETOL 和 NEXLIZET 的臨床益處，並讓患者能夠與臨床醫生討論他們的心血管風險。我們繼續優化我們的商業策略，並保持有效地將資源分配給能夠產生最有利投資回報率的計劃。

As a result of these combined initiatives by our managed care, sales force and marketing teams, in these first six months of launch, we now have nearly 24,000 healthcare practitioners writing scripts with total retail prescription equivalents increasing approximately 12% and new-to-brand prescriptions approximately 18% compared to the second quarter. This is just the type of momentum we want to see in the first six months of launch to drive accelerated growth in the coming quarters and into the new year.

由於我們的管理式醫療、銷售人員和行銷團隊採取了這些綜合舉措，在推出的前六個月裡，我們現在有近24,000 名醫療保健從業人員正在編寫處方，總零售處方當量增加了約12% ，新品牌與第二季相比，處方藥增加了約 18%。這正是我們希望在推出後的前六個月看到的勢頭，以推動未來幾季和新的一年的加速成長。

In fact, our October 2024 results further validate this trajectory, with total retail prescription equivalents up 17% and new-to-brand prescriptions rising 20% compared to the first four weeks of the third quarter. This positive trend speaks to the effectiveness of our strategy, and we remain focused on sustaining this momentum to drive continued growth and long-term success.

事實上，我們 2024 年 10 月的業績進一步驗證了這一趨勢，與第三季前 4 週相比，零售處方當量總額增加了 17%，新品牌處方增加了 20%。這一積極趨勢證明了我們策略的有效性，我們將繼續致力於維持這一勢頭，以推動持續成長和長期成功。

Notably, the three reasons that give us continued confidence in the blockbuster opportunity for NEXLETOL and NEXLIZET and our ability to realize that potential remain unchanged. One, we have compelling data from the CLEAR Outcomes study that support and validate the safety and efficacy of NEXLETOL and NEXLIZET to reduce cardiovascular risk. Two, there is a massive underserved patient population of 70 million people at risk who need additional treatment options. And three, we have the right plan and the right people to drive adoption in this market and successfully execute our strategy.

值得注意的是，使我們對 NEXLETOL 和 NEXLIZET 的重磅機會持續充滿信心的三個原因以及我們實現這一潛力的能力保持不變。第一，我們從 CLEAR Outcomes 研究中獲得了令人信服的數據，這些數據支持並驗證了 NEXLETOL 和 NEXLIZET 降低心血管風險的安全性和有效性。第二，有大量未充分服務的患者群體，其中有 7000 萬人面臨風險，需要額外的治療選擇。第三，我們有正確的計劃和合適的人員來推動這個市場的採用並成功執行我們的策略。

Let me now shift to the tremendous international progress we and our partners are making. In Europe, our partner, DSE, continues to post strong prescription and revenue growth as evidenced by approximately 19% sequential increase in our royalty revenue, which was $8.9 million in the third quarter of 2024. DSE received its approved expanded labels for NILEMDO and NUSTENDI from the European Commission in May and consequently kicked off their country launches with the new indications for cardiovascular risk reduction and expanded LDL-cholesterol lowering in primary and secondary prevention patients. With up to 80% of patients in Europe unable to reach guideline recommended levels for LDL-cholesterol despite taking statins, there is a meaningful market opportunity for DSE.

現在讓我談談我們和我們的合作夥伴正在取得的巨大國際進展。在歐洲，我們的合作夥伴DSE 持續保持強勁的處方和收入成長，我們的特許權使用費收入環比增長約19%（2024 年第三季為890 萬美元）即可證明。和NUSTENDI 擴展標籤歐盟委員會於 5 月發布了該藥物，並隨後在其國家啟動了降低心血管風險的新適應症，並擴大了一級和二級預防患者的低密度脂蛋白膽固醇降低範圍。儘管服用他汀類藥物，歐洲仍有高達 80% 的患者無法達到 LDL 膽固醇指南建議水平，因此 DSE 存在有意義的市場機會。

Beyond Europe, our partner, Daiichi Sankyo Company, Limited, gained approval for NILEMDO in Taiwan on October 7, 2024. The totality of expected country launches enhances the global awareness of the cardiovascular benefits of our bempedoic acid products and is expected to incrementally contribute to royalty revenue over time.

除歐洲之外，我們的合作夥伴第一三共有限公司(Daiichi Sankyo Company, Limited) 於2024 年10 月7 日在台灣獲得了NILEMDO 的批准。我們的bempedoic 酸產品對心血管益處的認識，並預計將逐步為以下領域做出貢獻：隨著時間的推移，特許權使用費收入。

Our Japanese partner, Otsuka Pharmaceutical, remains on track to file a new drug application in Japan by year-end 2024, with expected approval and national health insurance pricing anticipated in 2025. We are enthusiastic about the continued momentum in Japan as it is one of the largest markets for lipid-lowering therapy. This is a substantial market for Otsuka as well as a valuable royalty contributor for Esperion growth in the future.

我們的日本合作夥伴大塚製藥仍有望在 2024 年底前在日本提交新藥申請，預計將於 2025 年獲得批准並實現國民健康保險定價。脂治療市場。對於大塚來說，這是一個龐大的市場，也是 Esperion 未來成長的寶貴特許權使用費貢獻者。

Turning to our own efforts internationally, we expect to file a new drug application for approval in Canada this month and are optimistic about finalizing a partnership soon. Additionally, we expect potential submissions and our partnerships in Australia and Israel in the first half of 2025. Collectively, these advances expand the global commercial opportunity for our bempedoic acid products, incrementally add to growing global revenue and position Esperion as an attractive potential partner with a compelling value position.

談到我們自己在國際上的努力，我們預計本月將在加拿大提交新藥申請以供批准，並對很快完成合作夥伴關係感到樂觀。此外，我們預計將於2025 年上半年在澳洲和以色列提交潛在申請並建立合作夥伴關係。使Esperion 成為有吸引力的潛在合作夥伴令人信服的價值定位。

Finally, we continue to build a growing body of scientific and clinical knowledge that supports the cardiovascular risk reduction benefits of our products. To that end, we are delighted to be presenting key data at the American Heart Association Scientific Sessions, which will be taking place next week in Chicago. The AHA Scientific Sessions draw approximately 18,000 healthcare providers, including primary care physicians for more than 100 countries. This offers Esperion an exceptional opportunity to showcase the clinical benefits of NEXLETOL and NEXLIZET before an audience of key physicians we aim to influence to prescribe our therapeutics.

最後，我們繼續建立越來越多的科學和臨床知識，以支持我們的產品降低心血管風險的益處。為此，我們很高興在下週於芝加哥舉行的美國心臟協會科學會議上展示關鍵數據。 AHA 科學會議吸引了約 18,000 名醫療保健提供者，其中包括來自 100 多個國家的初級保健醫生。這為 Esperion 提供了一個絕佳的機會，向主要醫生觀眾展示 NEXLETOL 和 NEXLIZET 的臨床益處，我們的目標是影響他們開出我們的治療藥物。

We were honored to have been selected for an oral featured presentation in the Late Breaker/Featured Science Track where our products will be highlighted in a presentation titled Bempedoic Acid and Limb Outcomes in Statin-Intolerant Patients with Peripheral Artery Disease: New insights from the CLEAR Outcomes trial. We also have three poster presentations at AHA, statin intolerance due to muscle symptoms affects management of patient insights from the CLEAR Outcomes trial, liver steatosis and liver fibrosis predict major adverse cardiovascular events in the CLEAR Outcomes trial and effectiveness of lipid-lowering therapy with bempedoic acid plus ezetimibe in a real-world cohort.

我們很榮幸被選為Late Breaker/特色科學軌道的口頭專題演講，我們的產品將在題為Bempedoic Acid 和不耐受他汀類藥物的外周動脈疾病患者的肢體結果的演講中重點介紹：來自CLEAR 的新見解結果審判。我們也在AHA 上進行了三場海報展示，肌肉症狀導致的他汀類藥物不耐受影響CLEAR Outcomes 試驗中患者見解的管理，肝臟脂肪變性和肝纖維化預測CLEAR Outcomes 試驗中的主要不良心血管事件以及Bempedoic 降血脂治療的有效性在現實世界隊列中使用酸加依折麥布。

In addition to these US presentations, DSE has a strong medical and commercial showing at the European Society of Cardiology Congress or ESC, in late August. ESC 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 made at ESC will also benefit our efforts to enhance the awareness and visibility for our product among US healthcare practitioners.

除了這些美國演講之外，DSE 在 8 月下旬舉行的歐洲心臟病學會大會 (ESC) 上也展示了強大的醫療和商業表現。 ESC 是年度最大的心血管醫學會議，吸引了包括美國在內的全球各地的重要意見領袖參加。因此，我們預計 DSE 在 ESC 所做的努力也將有利於我們提高我們產品在美國醫療保健從業者中的認知度和知名度。

Beyond ESC, DSE reported final 2-year real-world results from the MILOS German cohort at DGK Herztage 2024 in Hamburg, Germany in late September. The data demonstrate a strong increase in the achievement of LDL-cholesterol goals with the addition of bempedoic acid. The ongoing publication and presentation of data in support of the cardiovascular benefits of our products strongly validates our clinical value proposition and enhances awareness of their benefits among a growing physician base who are responsible for prescribing our products to their patients. We will look forward to updating you on our further progress over the coming months.

除了 ESC 之外，DSE 還在 9 月下旬在德國漢堡舉行的 DGK Herztage 2024 上報告了 MILOS 德國隊列的 2 年最終真實結果。數據表明，添加 bempedoic 酸可顯著提高 LDL 膽固醇目標的實現。支持我們產品對心血管益處的數據的持續發布和展示有力地驗證了我們的臨床價值主張，並提高了負責向患者開具我們產品處方的不斷增長的醫生群體對其益處的認識。我們期待在未來幾個月向您通報我們的進一步進展。

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

在了解了業務概況後，讓我將電話轉給 Ben，詳細審查我們第三季的財務進度。本？

Thank you, Sheldon. Good morning, everyone, and thank you for joining us today.

謝謝你，謝爾頓。大家早安，感謝您今天加入我們。

As Sheldon mentioned earlier, we continue to build and solidify the foundation of our business, and this year has been a banner year for taking the right steps that will allow us to grow and succeed in long term. Most notably, over the past six months, we focus on strengthening our balance sheet by monetizing the European royalties on our bempedoic acid product sales and allocating the proceeds for the early discounted payoff and termination of a previous revenue interest facility. This company will always be focused on solidifying our financial position, and that work continues into the fourth quarter.

正如謝爾頓之前提到的，我們繼續建立和鞏固我們的業務基礎，今年是採取正確步驟的標誌性一年，這將使我們能夠長期成長和成功。最值得注意的是，在過去的六個月中，我們專注於透過將我們的bempedoic 酸產品銷售的歐洲特許權使用費貨幣化並將收益分配給早期折扣支付和終止先前的收入利息設施來加強我們的資產負債表。該公司將始終專注於鞏固我們的財務狀況，這項工作將持續到第四季。

I will now provide a brief overview of the results, noting that additional information can be found in our press release issued earlier this morning and 10-Q that will be filed shortly. Please note that unless otherwise specified, my comments reflect results for the third quarter ended September 30, 2024.

我現在將簡要概述結果，並指出可以在今天早上早些時候發布的新聞稿和即將提交的 10-Q 中找到更多資訊。請注意，除非另有說明，我的評論反映的是截至 2024 年 9 月 30 日的第三季的結果。

Total revenue for the third quarter 2024 was $51.6 million compared to $34 million for the comparable period in 2023. US net product revenue was $31.1 million compared to $20.3 million for the comparable period in 2023, an increase of approximately 53%. Sequential quarterly net revenue growth was 10%. Our steady revenue growth, combined with the rise in total retail prescription equivalents and an 18% increase in new-to-brand prescriptions speaks to the success of our launch and the potential of these drugs.

2024 年第三季的總營收為 5,160 萬美元，而 2023 年同期為 3,400 萬美元。季度淨收入連續成長 10%。我們穩定的收入成長，加上零售處方當量總額的成長以及新品牌處方增加 18%，證明了我們推出的成功以及這些藥物的潛力。

To date, we have expanded our coverage to include more than 165 million patient lives. We activated these managed care contracts with the understanding that we would face an immediate impact to our previously undiscounted business with the expectation that we will outpace this initial cost with significant future growth. While we're feeling the gross to net headwinds of these changes now, the decisions we made are essential to building a pipeline of patients necessary for future growth.

迄今為止，我們已將覆蓋範圍擴大至超過 1.65 億名患者。我們啟動了這些管理式醫療合同，因為我們知道我們之前未折現的業務將面臨直接影響，並預計我們將在未來實現顯著增長，超過初始成本。雖然我們現在感受到這些變化帶來的整體和淨阻力，但我們做出的決定對於建立未來成長所需的患者管道至關重要。

We are expecting the pull-through to come from this effort in the coming quarters with additional contracts serving as another key tactic to advance our brand strategy. While it will take time, this approach sets us up for long-term success. We are already beginning to see acceleration in prescribing as a result of these recent Medicare contracts and our comprehensive marketing and sales strategy. This approach is delivering results with recent data showing a 17% increase in total retail prescription equivalents and a 20% rise in new-to-brand prescriptions for the first four weeks of the fourth quarter compared to the first four weeks of the third quarter.

我們預計未來幾季的這項努力將帶來成效，額外的合約將成為推進我們品牌策略的另一項關鍵策略。雖然這需要時間，但這種方法將為我們長期成功奠定基礎。由於最近的這些醫療保險合約以及我們全面的營銷和銷售策略，我們已經開始看到處方的加速。這種方法正在取得成果，最近的數據顯示，與第三季的前 4 週相比，第四季的前 4 週零售處方當量總額增加了 17%，新品牌處方增加了 20%。

Collaboration revenue was $20.5 million compared to $13.7 million for the comparable period in 2023, an increase of approximately 50% primarily due to increased royalty sales growth within our partner territories and increased product sales to our collaboration partners from our supply agreements. We're making solid progress with DSE on the tech transfer to enable them to independently manufacture NILEMDO and NUSTENDI for European distribution. This will lead to a significant reduction in our future COGS for the products and reduce working capital costs once finalized.

合作收入為2,050 萬美元，而2023 年同期為1,370 萬美元，增長了約50%，這主要是由於我們合作夥伴區域內的特許權銷售增長增加，以及透過我們的供應協議向合作夥伴銷售的產品增加。我們與 DSE 在技術轉移方面取得了紮實的進展，使他們能夠獨立生產 NILEMDO 和 NUSTENDI 並在歐洲分銷。一旦最終確定，這將導致我們未來產品的銷貨成本大幅降低，並降低營運資金成本。

Turning to the rest of the P&L, for the third quarter of 2024, research and development expenses were $10.4 million compared to $14.9 million for the comparable period in 2023, a decrease of 30%, primarily attributable to our CLEAR Outcomes study that was completed in 2023.

至於損益表的其餘部分，2024 年第三季的研發費用為 1,040 萬美元，而 2023 年同期為 1,490 萬美元，下降了 30%，這主要歸功於我們於 2023 年完成的 CLEAR Outcomes 研究。 。

Selling, general and administrative expenses were $40 million compared to $33.2 million for the comparable period in 2023, an increase of 20%. The increase is primarily related to increased commercial head count in addition to bonus payments and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to current levels.

銷售、一般及管理費用為 4,000 萬美元，而 2023 年同期為 3,320 萬美元，成長 20%。除了獎金和促銷費用外，這一增長主要與商業人員數量的增加有關。我們繼續審慎管理費用，並預計費用將維持在目前水準。

Total net loss for the quarter was $29.5 million compared to a net loss of $41.3 million for the comparable period in 2023.

本季淨虧損總額為 2,950 萬美元，而 2023 年同期淨虧損為 4,130 萬美元。

Basic and diluted net loss per share was $0.15 compared to basic and diluted net loss per share of $0.37 for the comparable period in 2023.

每股基本和稀釋淨虧損為 0.15 美元，而 2023 年同期基本和稀釋每股淨虧損為 0.37 美元。

Turning to our balance sheet, as of September 30, 2024, we had $144.7 million in cash and cash equivalents. We are reiterating our full-year 2024 operating expense guidance, which is expected to be approximately $225 million to $245 million, including $20 million in non-cash expenses related to stock compensation.

轉向我們的資產負債表，截至 2024 年 9 月 30 日，我們擁有 1.447 億美元的現金和現金等價物。我們重申 2024 年全年營運支出指引，預計約為 2.25 億至 2.45 億美元，其中包括與股票薪酬相關的 2,000 萬美元非現金支出。

Now, let me turn the call back to Sheldon for closing remarks. Sheldon?

現在，讓我把電話轉回給謝爾頓，讓他發表結束語。謝爾頓？

Thank you, Ben.

謝謝你，本。

We continue to be especially pleased with our progress advancing the launch of these expand indications in cardiovascular risk reduction, confident that the foundation we are building today will serve to support significant future growth and expansion globally. In the near term, we are laser focused on ensuring the continued successful launch of our expanded labels in the US, while in tandem, expanding our global reach through partnerships and collaborations. Longer term, we plan to advance our promising pipeline where we have the potential to leverage our established leadership in ACLY biology to explore new therapeutic opportunities and develop next-generation inhibitors optimized to address multiple life-threatening diseases.

我們仍然對我們在推動這些降低心血管風險的擴展適應症的推出方面取得的進展感到特別高興，並相信我們今天建立的基礎將有助於支持未來在全球範圍內的重大增長和擴張。短期內，我們的重點是確保我們的擴展品牌在美國繼續成功推出，同時透過夥伴關係和協作擴大我們的全球影響力。從長遠來看，我們計劃推進我們有前景的產品線，我們有潛力利用我​​們在ACLY 生物學領域的既定領導地位來探索新的治療機會並開發針對多種危及生命的疾病進行優化的下一代抑制劑。

We look forward to providing a detailed update on our plans and timelines for the development of our innovative pipeline as we move into 2025. Looking ahead, we are confident in our strategy and our ability to deliver long-term value to both the patients we serve and to our shareholders. As always, we appreciate your continued support as we execute on these initiatives.

進入 2025 年，我們期待提供有關我們創新產品線開發的計劃和時間表的詳細更新。一如既往，我們感謝您在我們執行這些舉措時給予的持續支持。

Operator, we are now ready for Q&A.

接線員，我們現在準備好進行問答了。

(Operator Instructions) Dennis Ding, Jefferies.

（操作員說明）Dennis Ding，Jefferies。

I had a question on bempedoic acid. So it seems like prescriptions are starting to pick up in the fourth quarter, and that's very encouraging. What's been driving that strength? And do you think you can work through some of the headwinds in Q4, like from the holidays and even Hurricane Milton at the beginning of Q4? And what's your level of confidence that Q4 revenue will be higher than Q3 given some of the price headwinds towards the end of the year?

我有一個關於 bempedoic 酸的問題。因此，處方似乎在第四季度開始增加，這是非常令人鼓舞的。是什麼推動了這種力量？您是否認為您可以克服第四季度的一些不利因素，例如假期，甚至第四季度初的颶風米爾頓？考慮到年底的一些價格阻力，您對第四季營收將高於第三季的信心有多大？

Dennis, it's Eric. Yes, absolutely. So Q3, again, double-digit growth on all metrics. The start of Q4 really strong. You saw the metrics that we posted.

丹尼斯，是艾瑞克。是的，絕對是。因此，第三季所有指標均達到兩位數成長。第四季的開局非常強勁。您看到了我們發布的指標。

What's driving that? The pull-through of the access. So as we've mentioned before, we've improved the quality and quantity of access. It's taken a little bit for physicians to believe it based upon the prior years of more difficult access.

是什麼推動了這一點？訪問的拉通。正如我們之前提到的，我們提高了訪問的品質和數量。鑑於前幾年的訪問更加困難，醫生們花了一點時間才相信這一點。

But now we're starting to see that increase momentum. I've been out in the field multiple times over the course of the last quarter as have other members of the ELT and we're seeing the excitement of physicians and the ease in getting the product. So very confident in what we're seeing and very confident that Q4 will be even better than Q3.

但現在我們開始看到這種成長勢頭。在上個季度，我和 ELT 的其他成員一樣多次前往現場，我們看到了醫生的興奮以及獲得產品的輕鬆程度。我們對我們所看到的非常有信心，並且非常有信心第四季會比第三季更好。

And Dennis, I would like to add that one thing that we've said for, I think, the past two years is that we will demonstrate growth, continued growth, and we've done that, and we will continue to do that.

丹尼斯，我想補充一點，我認為過去兩年我們說過的一件事是，我們將展示成長，持續成長，我們已經做到了這一點，我們將繼續這樣做。

Serge Belanger, Needham.

塞爾吉·貝蘭格，李約瑟。

Congrats on the progress. A couple of questions from us. I guess now that utilization management criteria has been updated, and we've seen, I think, an important uptick in prescription. Just curious how different is the product being used now? Is it just in a broader set of patients and has it moved up the treatment paradigm relative to the PCSK9 inhibitors?

祝賀取得的進展。我們有幾個問題。我想現在使用管理標準已經更新，我認為我們已經看到處方量顯著增加。只是好奇現在使用的產品有何不同？它是否只是針對更廣泛的患者群體？

And secondly, regarding the Medicare coverage. I think you mentioned you're now at 65%, is that at this current time or that's when we flip the calendar to 2025? And I guess, do you expect to expand beyond that 65% over the next few months?

其次，關於醫療保險覆蓋範圍。我想你提到你現在已經達到 65%，是現在還是我們把日曆翻到 2025 年的時候了？我想，您預計在接下來的幾個月內會擴大到 65% 以上嗎？

Serge, Eric again. So yes, thanks for noting the increased momentum that we've been seeing. Indeed, it's a function of physicians increased confidence, the fact that prescribing has become easier. In terms of patients that are being utilized, so yes, so we've seen that shift from ASCVD patients, which were the patients that our clinicians were bound to with the prior label in UM. We're seeing an increased use in the primary prevention patient or the patient that hasn't had a prior event. We're also starting to see increase in the statin intolerant utilization.

又是謝爾蓋、艾瑞克。所以，是的，感謝您注意到我們所看到的成長勢頭。事實上，這是醫生信心增強的結果，處方變得更容易。就正在使用的患者而言，是的，我們已經看到了 ASCVD 患者的轉變，這些患者是我們的臨床醫生在 UM 中先前標籤所綁定的患者。我們發現初級預防患者或之前沒有發生過事件的患者的使用增加。我們也開始看到他汀類藥物不耐受利用率的增加。

In terms of where we're seeing that utilization come from, we're seeing ezetimibe start to leak some share on its own. We've also seen about a one point decrease in new-to-brand prescriptions or new-to-brand share for PCSK9 since we've had our label change.

就我們所看到的利用率的來源而言，我們看到依折麥布開始自行洩漏一些份額。自從我們更改標籤以來，我們還發現 PCSK9 的新品牌處方或新品牌份額下降了約 1 個百分點。

I just want to add one thing, Serge, before I turn it over to BJ regarding Medicare, and that is there is no doubt in our minds that the bempedoic acid products that these are recognized, they are a recognized place in therapy. And it's the awareness, it just continues and continues to grow. BJ, Medicare?

Serge，在我將有關醫療保險的問題交給 BJ 之前，我只想補充一件事，那就是毫無疑問，我們認為 Bempedoic 酸產品得到了認可，它們在治療中具有公認的地位。這就是意識，它會持續不斷地成長。北京，醫療保險？

That said, Sheldon, I think, Serge, when we started at launch, we were 28% Medicare coverage, where we are now with greater than equal to 65% Medicare coverage. We couldn't be happier with that. Most of those plans accelerated their processes where they would have waited until 2026 to add us or 2025. We anticipate additional Medicare contracts to come through and really activate them. But we also know that right now, we're well poised between the three PBMs and having that coverage, both commercially and with Medicare. We're basically covering 90% of the US national lives with that coverage. So stay tuned, more to come.

也就是說，Sheldon，我想，Serge，當我們開始推出時，我們的醫療保險覆蓋率是 28%，現在我們的醫療保險覆蓋率大於等於 65%。我們對此感到非常高興。這些計劃中的大多數都加快了進程，原本要等到 2026 年或 2025 年才加入我們。但我們也知道，目前我們在三個 PBM 之間做好了準備，並擁有商業和醫療保險的覆蓋範圍。我們基本上涵蓋了 90% 的美國國民生活。所以請繼續關注，更多內容即將推出。

Great. I guess one more for Sheldon. Can you just remind us of the structure of the milestone payments as part of the Otsuka collaboration and what those payments are contingent on?

偉大的。我猜謝爾頓還有一個。您能否提醒我們作為大塚合作一部分​​的里程碑付款的結構以及這些付款的條件是什麼？

Yes. This is Ben. I'm happy to walk through that. So I don't think we've assigned specific amounts to each of the steps, but the steps are filing of the JNDA, approval of the JNDA. There is a milestone based around -- that actually gets included in the US label, but payable once it's approved as well as a pricing milestone. So those will all come, I would say, by the end of 2025 is what we're expecting internally here. And we will have very shortly, I think a lot more clarity on what that timing looks like.

是的。這是本。我很高興能經歷這一切。因此，我認為我們沒有為每個步驟分配具體金額，但這些步驟是提交 JNDA、批准 JNDA。有一個基於的里程碑——實際上已包含在美國標籤中，但一旦獲得批准就需要支付以及定價里程碑。所以我想說，到 2025 年底，這些都會實現，這是我們內在的預期。我認為我們很快就會更清楚地了解這個時間安排。

Jason Zemansky, Bank of America.

傑森澤曼斯基，美國銀行。

Congratulations on the progress. I was hoping you could provide some color on ongoing payer dynamics. I appreciate you may not be able to provide any details. But if you could please speak to whether there's been an increase in concessions given the expansion of lives covered? And then do you have a sense of what percentage of lives are not required to go through or step through a generic alternative like a statin?

祝賀取得的進展。我希望您能提供一些有關持續付款動態的資訊。感謝您可能無法提供任何詳細資訊。但能否請您談談，隨著覆蓋範圍的擴大，優惠是否有所增加？那麼您是否知道有多少人不需要經歷或逐步經歷他汀類藥物等通用替代品？

Yes. So I can take that. So Jason, I think as we mentioned before, our biggest headwinds for that, let me start with your second part of your question first, if you don't mind. The biggest headwind was that the fact that patients had to go through maximum tolerated dose of statin, that actually changed back in December. But I think the biggest headwind, it goes back to a question that was asked earlier, is that the utilization management, there is a step criteria through ezetimibe as well.

是的。所以我可以接受。所以傑森，我認為正如我們之前提到的，我們最大的阻力，如果你不介意的話，讓我先從你問題的第二部分開始。最大的阻力是患者必須接受他汀類藥物的最大耐受劑量，這一情況實際上在 12 月就發生了變化。但我認為最大的阻力，這又回到了先前提出的一個問題，即利用管理，透過依折麥布也有一個步驟標準。

As part of our new label and as part of our negotiations with payers, that was something that we demanded is that UM criteria would be easier and that we would no longer have to be step edited through ezetimibe, which again, is really the competition. 68% of the adjunct share is ezetimibe. That step edit has been removed in both the commercial and also the Medicare contracts that we have. As a matter of fact, this is quite interesting, in two very large accounts don't even have prior authorization. So SilverScript's Caremark, there's no prior authorization for a physician.

作為我們新標籤的一部分以及我們與付款人談判的一部分，我們要求的是 UM 標準會更容易，而且我們不再需要透過依折麥布進行逐步編輯，這又是真正的競爭。 68%的輔助藥物份額是依折麥布。該步驟編輯已在我們擁有的商業合約和醫療保險合約中刪除。事實上，這很有趣，兩個非常大的帳戶甚至沒有事先授權。所以 SilverScript 的 Caremark 不需要醫生的事先授權。

Aetna, there's no prior authorization for a physician. It's what we have in the field and what the representatives say, and we're seeing it in our prescription performance, getting NEXLIZET and NEXLETOL just got easier. As far as concessions, we did not have to give any concessions at all for any of these changes. And I applaud all of the payers because what it demonstrated to us is that they really recognize the clinical benefits of the CLEAR Outcomes study and our products.

Aetna，醫生沒有事先授權。這就是我們在該領域所擁有的和代表所說的，我們在我們的處方表現中看到了這一點，獲得 NEXLIZET 和 NEXLETOL 變得更加容易。就讓步而言，我們根本不需要為這些變化做出任何讓步。我對所有付款人表示讚賞，因為它向我們表明，他們真正認識到 CLEAR Outcomes 研究和我們產品的臨床益處。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

This is [Tanmay] on for Jessica Fye. I guess the first thing I wanted to ask is, how do you see the net price outlook from here? And should we think of it as stable going forward? And can you also comment quickly on any inventory changes in the US channel in 3Q?

這是 Jessica Fye 的 [Tanmay]。我想我想問的第一件事是，您如何看待這裡的淨價前景？我們是否應該認為它是穩定的？您能否快速評論一下第三季美國通路的庫存變化？

Yes. I'll jump in on both of those. Inventory changes, I will say, non-existent. We were very stable for what was out in the channel at the end of the quarter compared to Q2 and Q1. So really no major changes there.

是的。我會介入這兩件事。我會說，庫存變化不存在。與第二季和第一季相比，本季末通路的情況非常穩定。所以確實沒有重大變化。

As far as net price going forward, we will continue to see our standard Q4 cyclicality from the Medicare coverage gap this year. However, I think one thing that we're looking at next year as we go through the IRA and the benefits that for us expected to hit is that we will see a smoothing out of the gross to net over the course of the year. So not a major change to the overall, but you may or may not see that sort of seasonality from Q1 to Q4 that we see now, which is great for us because that makes it a much more predictable, much more steady and streamlined revenue over the course of the year from a net price perspective.

就未來的淨價而言，我們將繼續從今年的醫療保險覆蓋缺口中看到標準的第四季週期性。然而，我認為明年我們在審查 IRA 時要考慮的一件事是，我們預計將獲得的好處是，我們將在這一年中看到毛額向淨額的平滑。因此，整體而言並不是重大變化，但您可能會或可能不會看到我們現在看到的從第一季到第四季度的季節性，這對我們來說很好，因為這使得收入更加可預測、更穩定、簡化。

Joe Pantginis, H.C. Wainwright.

喬潘吉尼斯，H.C.溫賴特。

This is Lander on for Joe. So just curious about the market dynamics in Japan. What are the expectations in terms of confidence from payers and physicians for distribution and pricing and sales ramp in Japan. Anything different compared to the US, for example, that we should consider?

這是蘭德為喬做的。所以只是對日本的市場動態感到好奇。付款人和醫生對日本分銷、定價和銷售成長的信心有何期望？例如，與美國相比，我們應該考慮什麼不同之處？

Yes. Great. So again, just as a reminder, in Japan, our partner is Otsuka. And as we mentioned, they finished their Phase III clinical trial, which showed statistical significance, and they are in the process right now of filing with the healthcare administration in Japan. Pricing and so forth will come later.

是的。偉大的。再次提醒一下，在日本，我們的合作夥伴是大塚。正如我們所提到的，他們完成了 III 期臨床試驗，顯示出統計意義，目前正在向日本醫療保健管理部門提交申請。定價等將稍後公佈。

But what I would like to remind you of is Japan is one of the largest lipid markets in the entire world. And the analog you can even look at is ezetimibe. So more to come on Japan, but right now, we're on track of what we need to do, and there's high expectations by our partner of Otsuka. And as we mentioned in our prepared remarks, that really benefits us as well. That's a significant royalty stream to the organization.

但我想提醒您的是，日本是全球最大的脂質市場之一。您甚至可以看到的類似物是依折麥布。日本還有更多的事情要做，但現在，我們正在做我們需要做的事情，我們的伴侶大塚寄予了很高的期望。正如我們在準備好的發言中所提到的，這也確實使我們受益。這對該組織來說是一筆重要的版稅流。

Perfect. Congrats on the update.

完美的。恭喜更新。

Tom Shrader, BTIG.

湯姆‧施雷德 (Tom Shrader)，BTIG。

Congratulations on the uptick. Back to Medicare, is part of the lag relative to commercial that you negotiate very hard to be in the best tier of Medicare? And can you -- do you know your average co-pay for a Medicare patient versus a commercial patient?

恭喜上漲。回到醫療保險，您為了進入醫療保險的最佳層級而非常努力地談判，這是否是相對於商業的滯後的一部分？您是否知道醫療保險病患與商業病患的平均自付費用？

Yes. Tom, we -- basically for Medicare, it's all about the out-of-pocket cost. And what was happening before, as you know, when we were non-preferred, those out-of-pocket costs were much higher. What we're able to do now is contract, there are probably an average out of pay now with the preferred copay is $45 as opposed to going anywhere from $150 up to $200 before they even reach their deductible. So that's been a great plug for us, and it's great with the physicians, again, to Sheldon's point previously, is giving those physicians the confidence and then getting the product to the patients in the shortest period of time. With commercial, with our co-pay card, that ranges, we really have our co-pay cards, so that's probably more in the $25 range for patients in commercial.

是的。湯姆，我們——基本上對於醫療保險來說，這都是關於自付費用的。如您所知，之前發生的情況，當我們不受歡迎時，那些自付費用要高得多。我們現在能做的就是簽訂合同，現在首選共付額可能平均為 45 美元，而不是在達到免賠額之前就從 150 美元到 200 美元不等。因此，這對我們來說是一個很好的推動力，對醫生來說也很好，正如謝爾登之前所說的那樣，這給了這些醫生信心，然後在最短的時間內將產品提供給患者。對於商業醫療，我們的自付卡，這個範圍，我們確實有我們的自付卡，所以對於商業患者來說，這可能更多在 25 美元的範圍內。

And if I could just may add, what's interesting, Tom, is with these Medicare changes, typically, when Medicare makes a decision, they make a decision today to be implemented a year from now. These decisions were made today and implemented a week from now, a month from now. And again, it goes back to what I said earlier, it really shows the applicability of the clinical profile as a result of our new label from the CLEAR Outcomes study. That was a huge win for us.

如果我可以補充一下，湯姆，有趣的是這些醫療保險的變化，通常，當醫療保險做出決定時，他們今天做出決定，並在一年後實施。這些決定是今天做出的，並在一週後、一個月後實施。再說一遍，這又回到了我之前所說的，它確實顯示了 CLEAR 結果研究的新標籤所帶來的臨床特徵的適用性。這對我們來說是一個巨大的勝利。

And just to follow up. Is the process in Medicare to get in and get an agreement at any price and then to provide data that it should be preferred or is the initial agreement very important for the price -- for the co-pay for a significant duration?

只是為了跟進。醫療保險的流程是要以任何價格進入並達成協議，然後提供應優先考慮的數據，還是初始協議對於價格（對於相當長一段時間內的自付費用）非常重要？

Well, I think what it is, is that it's really more of the status, and we're preferred in Medicare. So I'm not sure if I'm following your question completely, but I'm just looking at the end result and the end result is we have a co-pay that is acceptable for patients to pay and we're in a preferred patient. And I would say just thinking about our market access along commercial and Medicare, we are not disadvantaged to PCSK9. We are not disadvantaged to ezetimibe, et cetera. So that's also important.

嗯，我認為這實際上更多的是地位，我們在醫療保險中受到優先考慮。所以我不確定我是否完全理解你的問題，但我只是看看最終結果，最終結果是我們有一個患者可以接受的共付額，而且我們處於首選狀態病人。我想說，只要考慮到我們在商業和醫療保險方面的市場准入，我們並不處於 PCSK9 的不利地位。我們對依折麥布等並不處於不利地位。所以這也很重要。

Thank you. We are out of time. This concludes the question-and-answer session. I would now like to turn it back to Sheldon Koenig for closing remarks.

謝謝。我們沒時間了。問答環節到此結束。現在我想請謝爾頓·科尼格（Sheldon Koenig）發表閉幕詞。

Thank you, operator, and thank you all again for your time and attention this morning. We will be participating at the upcoming Jefferies London Healthcare Conference on November 19 in London and at the Piper Sandler Healthcare Conference in New York on December 5. So we hope to have opportunity to connect with many of you at these events.

謝謝接線員，再次感謝大家今天早上的時間和關注。我們將參加即將於11 月19 日在倫敦舉行的Jefferies London 醫療保健會議，以及12 月5 日在紐約舉行的Piper Sandler 醫療保健會議。建立聯繫。

And in the meantime, if you have any questions or would like to have a call with the team, just reach out to our Head of Investor Relations, Alina Venezia, and have a great day, and thank you again.

同時，如果您有任何疑問或想與團隊通話，請聯絡我們的投資者關係主管 Alina Venezia，祝您有美好的一天，並再次感謝您。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了該程式。您現在可以斷開連線。