Esperion Therapeutics Inc (ESPR) 2024 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by and welcome. (Operator Instructions) Please be advised that today's conference call may be recorded. I would now like to turn the call over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. You may begin.

    女士們、先生們,謝謝你們的支持,歡迎你們。(操作員指示)請注意,今天的電話會議可能會被錄音。現在,我想將電話轉給 Esperion Therapeutics 投資者關係總監 Alina Venezia。你可以開始了。

  • Alina Venezia - Head of Investor Relations

    Alina Venezia - Head of Investor Relations

  • Thank you, operator. Good morning, and welcome to Esperion's fourth-quarter and full-year 2024 earnings conference call. With us on today's call 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.

    謝謝您,接線生。早安,歡迎參加 Esperion 2024 年第四季和全年財報電話會議。參加今天電話會議的有總裁兼執行長 Sheldon Koenig;以及財務長 Ben Halladay。在我們準備好發言後,其他執行團隊成員將參加問答環節。

  • 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,其中還有一份我們將參考的簡報的副本。

  • I want 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 statements due to the risks and uncertainties associated with the business.

    我想提醒來電者,今天電話會議上討論的資訊屬於《私人證券訴訟改革法案》安全港條款的保護範圍。我提醒聽眾,管理階層將會做出前瞻性的陳述。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所明示或暗示的結果有重大差異。

  • 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, March 4, 2025. 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.

    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述的警告性聲明。本次電話會議的內容包含時間敏感訊息,僅截至本次直播之日(2025 年 3 月 4 日)準確。我們不承擔修改或更新任何前瞻性陳述以反映本次電話會議和網路廣播日期之後的事件或情況的義務。

  • 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.

    提醒一下,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,然後開放熱線回答您的問題。我現在將電話轉給謝爾頓。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Thank you, Alina. Good morning, everyone, and thank you for joining us. As I've noted in prior calls, 2024 was a transformational year for Esperion as we received the expanded labels for our bempedoic acid products in the US, supported global expansion with our partners in key markets and significantly strengthened our financial structure to enhance our balance sheet and provide us with financial and operational flexibility to support our future growth.

    謝謝你,阿麗娜。大家早安,感謝大家的收看。正如我在之前的電話會議中提到的那樣,2024 年對於 Esperion 來說是轉型之年,因為我們在美國獲得了苯海拉明酸產品的擴展標籤,支持了我們與主要市場合作夥伴的全球擴張,並顯著加強了我們的財務結構,以增強我們的資產負債表並為我們提供財務和營運靈活性,以支持我們未來的成長。

  • Importantly, the advances and improvements we made during 2024 formed a strong foundation from which we can focus on our bold vision for the future that is centered around three strategic pillars for building a blockbuster company: continued revenue growth, operating profitability, and portfolio expansion and pipeline advancement.

    重要的是,我們在 2024 年取得的進步和改進奠定了堅實的基礎,在此基礎上,我們可以專注於我們對未來的大膽願景,該願景圍繞打造一家轟動一時的公司三大戰略支柱:持續的收入增長、運營盈利能力以及產品組合擴展和產品線推進。

  • Focusing on our first pillar, increasing revenue and operating profitability, let us turn now or look at our progress and plans moving forward with the sales and marketing of our bempedoic acid products in the US and global markets.

    專注於我們的第一個支柱,增加收入和營業盈利能力,現在讓我們來看看我們在美國和全球市場上銷售和行銷苯甲酸產品的進展和計劃。

  • In March 2024, we received US FDA approval for the expanded labels for NEXLETOL and NEXLIZET, making them the only FDA-approved non-statins to lower LDL-cholesterol and reduce the risk of myocardial infarction and coronary revascularization in both primary and secondary prevention patients.

    2024 年 3 月,我們獲得美國 FDA 批准擴大 NEXLETOL 和 NEXLIZET 的標籤,使其成為唯一獲得 FDA 批准的用於降低 LDL 膽固醇並降低一級和二級預防患者心肌梗塞和冠狀動脈血運重建風險的非他汀類藥物。

  • Since that time, we have consistently posted double-digit sequential quarterly growth in total retail prescription equivalents or TRPEs. During the fourth quarter of 2024, we achieved 12% sequential quarterly growth in TRPEs compared to the third quarter of 2024, substantially expanded payer access and now have more than 173 million lives covered in the US.

    自那時起,我們的零售處方藥當量(TRPE)總量一直保持兩位數的季度連續成長。2024 年第四季度,與 2024 年第三季度相比,我們的 TRPE 實現了 12% 的連續季度增長,大幅擴大了付款人的使用範圍,目前已覆蓋美國超過 1.73 億人。

  • We are also proud that NEXLETOL and NEXLIZET have been recently added as preferred agents to the US Department of Defense Uniform Formulary, now accessible to the 9 million active duty dependents and retirees covered under this program.

    我們也感到自豪的是,NEXLETOL 和 NEXLIZET 最近被添加為美國國防部統一處方集的首選藥物,現在該計劃覆蓋的 900 萬現役軍人家屬和退休人員都可以使用。

  • In tandem, we increased our prescriber base by 10% from last quarter and now have more than 25,000 healthcare providers writing scripts. The large and growing prescriber base is an important indicator of potential future growth as we have the opportunity to grow their base as they prescribe our products to more and more of their eligible patients.

    同時,我們的處方數量比上一季增加了 10%,目前有超過 25,000 名醫療保健提供者在開處方。龐大且不斷成長的處方者群體是未來潛在成長的重要指標,因為隨著他們向越來越多符合條件的患者開出我們的產品,我們就有機會擴大他們的基礎。

  • We expect to continue to build on this momentum throughout 2025 and believe that the established cardiovascular clinical benefits of our products, combined with an expanding awareness among healthcare providers and ever improving and growing patient access will support increasing TRPEs and revenues.

    我們預計在 2025 年將繼續保持這一勢頭,並相信我們產品已確立的心血管臨床益處,加上醫療保健提供者日益增強的認知度以及不斷改善和增長的患者可及性,將支持增加 TRPE 和收入。

  • To drive both physician and patient awareness of the prevalence of statin intolerance, we are introducing a series of lead behind resources that highlight the fact that up to 30% of patients are statin intolerant and showcase the evidence that demonstrate how NEXLETOL and NEXLIZET can effectively manage these patients at high risk of cardiovascular disease.

    為了讓醫生和患者意識到他汀類藥物不耐受的普遍性,我們推出了一系列領先的資源,強調多達 30% 的患者對他汀類藥物不耐受的事實,並展示了 NEXLETOL 和 NEXLIZET 如何有效管理這些心血管疾病高風險患者的證據。

  • Our goal is to continue to underscore the persistent unmet need while promoting our safe and effective solution. Consequently, to further aid health care professionals in the management of partial statin intolerance, we are developing triple combination products in the US that would provide physicians with the flexibility of a suite of options that include monotherapy NEXLETOL; dual-therapy NEXLIZET; and triple combination therapy, bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin.

    我們的目標是繼續強調持續未滿足的需求,同時推廣我們的安全有效的解決方案。因此,為了進一步幫助醫療保健專業人員管理部分他汀類藥物不耐受,我們正在美國開發三聯產品,為醫生提供一系列選擇的靈活性,包括單一療法 NEXLETOL;雙重療法 NEXLIZET;以及三聯療法,即貝哌酸、依折麥布和阿托伐他汀或瑞舒伐他汀。

  • This represents an exciting opportunity to expand our role in the cardiovascular prevention market as the published literature suggest triple combination products can lower LDL-cholesterol in excess of 60%. This level of efficacy has the potential to rival both existing and emerging injectable and oral therapies, offering a valuable oral option for both patients and physicians.

    這代表著我們在心血管預防市場中擴大影響力的一個令人興奮的機會,因為已發表的文獻表明三重組合產品可以降低超過 60% 的 LDL 膽固醇。這種療效水平有可能與現有和新興的注射和口服療法相媲美,為患者和醫生提供有價值的口服選擇。

  • Now turning to the meaningful progress we're making internationally through our partnerships. We are looking ahead to an exciting year of continued growth in Europe and new product approvals and launches in key geographies.

    現在來談談我們透過合作在國際上所取得的有意義的進展。我們期待歐洲在新的一年繼續保持成長勢頭,並在主要地區獲得新產品的批准和推出。

  • First, we are particularly pleased that our Japanese partner, Otsuka Pharmaceutical, has submitted a new drug application for the manufacture and sale of our bempedoic acid product in Japan for LDL-cholesterol lowering. They expect approval and national health insurance pricing in the second half of 2025. The Japanese market is the world's third largest cardiovascular prevention market, and we believe the royalties on Japanese product sales will be a meaningful revenue contributor over time.

    首先,我們特別高興的是,我們的日本合作夥伴大塚製藥已提交新藥申請,在日本生產和銷售我們的用於降低低密度脂蛋白膽固醇的苯海拉明酸產品。他們預計該法案將於 2025 年下半年獲得批准並確定國家健康保險定價。日本市場是世界第三大心血管預防市場,我們相信,隨著時間的推移,日本產品銷售的特許權使用費將成為有意義的收入貢獻者。

  • Turning now to the European market. Our European partner, DSE, continues to successfully market NILEMDO and NUSTENDI and has demonstrated strong revenue growth. Our royalty revenue from DSE increased 9% sequentially to $9.7 million in the fourth quarter of 2024.

    現在轉向歐洲市場。我們的歐洲合作夥伴 DSE 繼續成功行銷 NILEMDO 和 NUSTENDI,並表現出強勁的收入成長。2024 年第四季度,我們從 DSE 獲得的特許權使用費收入環比增長 9%,達到 970 萬美元。

  • For the full year of 2024, royalty revenue increased 116% year over year to $32.6 million. As of the end of December, approximately 453,000 patients have been treated with our therapies in Europe, representing 19% sequential growth over the past three months since September. This continued expansion gives us confidence that with our label expansion, we can build a sizable market in the US. The tech transfer for both NILEMDO and NUSTENDI are also progressing nicely.

    2024 年全年特許權使用費收入年增 116%,達到 3,260 萬美元。截至 12 月底,歐洲約有 453,000 名患者接受了我們的治療,自 9 月以來的三個月內比上季增加了 19%。這種持續的擴張讓我們有信心,隨著我們品牌的擴張,我們可以在美國建立一個相當大的市場。NILEMDO 和 NUSTENDI 的技術轉移也進展順利。

  • Yesterday, we are pleased to announce that we partnered with CSL Seqirus to commercialize NEXLETOL and NEXLIZET in Australia and New Zealand. Under the terms of the agreement, we received an upfront payment and are eligible for near-term milestones along with a profitable transfer price on product sales.

    昨天,我們很高興地宣布,我們與 CSL Seqirus 合作,在澳洲和紐西蘭商業化 NEXLETOL 和 NEXLIZET。根據協議條款,我們收到了預付款,並有資格獲得近期里程碑以及產品銷售的有利轉讓價格。

  • This is an important market for our products as cardiovascular disease affects 1.2 million people and the leading cause of death in Australia. In New Zealand, an estimated 175,000 adults are living with cardiovascular disease, and one-in-three deaths are caused by cardiovascular disease.

    這是我們產品的重要市場,因為心血管疾病影響 120 萬人,也是澳洲最大的死亡原因。在新西蘭,估計有175,000名成年人患有心血管疾病,三分之一的死亡是由心血管疾病引起的。

  • Furthering our international expansion, we entered into a licensing agreement with Neopharm Israel for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Israel and expect to file an NDA for marketing approval in Israel in the first half of 2025. In addition, we filed new drug submissions to Health Canada for NEXLIZET and NEXLIZET and anticipate market approval in the fourth quarter of 2025.

    為了進一步拓展國際業務,我們與 Neopharm Israel 簽訂了授權協議,獲得在以色列獨家銷售 NEXLETOL 和 NEXLIZET 的權利,並預計將於 2025 年上半年提交 NDA 以獲得在以色列的營銷批准。此外,我們向加拿大衛生部提交了 NEXLIZET 和 NEXLIZET 的新藥申請,預計將於 2025 年第四季獲得市場批准。

  • Collectively, our international partnerships are delivering increasing royalty revenue, further demonstrating the global potential of our bempedoic acid products and supporting our strategic focus on driving revenue growth and operating profitability.

    總的來說,我們的國際合作夥伴關係正在帶來越來越多的特許權使用費收入,進一步證明了我們的苯海拉明酸產品的全球潛力,並支持我們推動收入成長和營運獲利能力的策略重點。

  • Finally, we continue to reinforce the cardiovascular risk reduction benefits of our products with the ongoing presentation and publication of compelling clinical data. In the coming weeks, we look forward to presenting two post-hoc analysis from our CLEAR Outcomes study and poster presentations at the upcoming American College of Cardiology's Annual Scientific Session being held in Chicago. Importantly, we will be presenting these data to an audience of key physicians who play a critical role in treatment decisions.

    最後,我們透過持續展示和發布令人信服的臨床數據,繼續強化我們產品降低心血管風險的益處。在接下來的幾週內,我們期待在即將於芝加哥舉行的美國心臟學會年度科學會議上展示我們 CLEAR 結果研究的兩項事後分析和海報展示。重要的是,我們將向在治療決策中發揮關鍵作用的關鍵醫生展示這些數據。

  • In addition, we will have an interactive exhibit booth, allowing health care professionals to engage with our clinical and commercial teams to gain deeper insights into the cardiovascular benefits of our bempedoic acid products. For those attending this year's ACC, we welcome you to visit us at our booth.

    此外,我們將設立一個互動展位,讓醫療保健專業人員與我們的臨床和商業團隊互動,以更深入地了解我們的貝培多酸產品對心血管的益處。對於參加今年 ACC 的人士,我們歡迎您參觀我們的展位。

  • Turning our attention to our other pillars for growth, portfolio expansion and pipeline advancement, our commitment to R&D strengthens all three strategic pillars: continued revenue growth, operating profitability, and portfolio expansion and pipeline advancement. With a strengthened balance sheet, we are well positioned to in-license or acquire synergistic cardiometabolic assets while continuing to advance our clinical pipeline.

    將我們的注意力轉向其他成長支柱、產品組合擴展和產品線推進,我們對研發的承諾加強了所有三大策略支柱:持續的收入成長、營運獲利能力以及產品組合擴展和產品線推進。憑藉增強的資產負債表,我們有能力獲得授權或收購具有協同作用的心臟代謝資產,同時繼續推動我們的臨床研發管線。

  • Leveraging our leadership in ACLY biology, we are actively exploring new therapeutic opportunities and developing next-generation inhibitors designed to address serious diseases, including rare and orphan chronic liver and kidney diseases.

    利用我們在 ACLY 生物學領域的領導地位,我們正在積極探索新的治療機會並開發旨在治療嚴重疾病(包括罕見和孤兒慢性肝腎疾病)的下一代抑制劑。

  • We look forward to sharing more details on our clinical development plans at our R&D Day on April 24, 2025, where we will announce a lead indication and introduce our first candidate for development. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the fourth quarter. Ben?

    我們期待在 2025 年 4 月 24 日的研發日上分享有關我們臨床開發計劃的更多細節,屆時我們將宣布一項主要適應症並介紹我們的第一個開發候選藥物。在了解了業務概況之後,我將把電話轉給本,讓他詳細回顧我們第四季的財務進展。本?

  • Benjamin Halladay - Chief Financial Officer

    Benjamin Halladay - Chief Financial Officer

  • Thank you, Sheldon. Good morning, everyone, and thank you for joining us today. During 2024, we executed two transformational financial transactions that fundamentally reshaped our capital structure, providing us with enhanced operational and financial flexibility. These improvements, coupled with our fortified balance sheet, empower us to focus on investing in our three pillars for growth to build a leading global biopharmaceutical powerhouse.

    謝謝你,謝爾頓。大家早安,感謝大家今天加入我們。2024 年,我們進行了兩項轉型金融交易,從根本上重塑了我們的資本結構,為我們提供了增強的營運和財務靈活性。這些改進,加上我們增強的資產負債表,使我們能夠專注於投資我們的三大成長支柱,打造全球領先的生物製藥巨頭。

  • In June 2024, we closed on a royalty purchase agreement with OMERS Life Sciences, receiving approximately $304.7 million in cash in exchange for 100% of our royalty interest from DSE royalty sales. OMERS will receive the DSE royalty stream net bempedoic acid product sales in Europe until it has received an aggregate amount equal to 1.7 times its investment. Thereafter, all future payments on DSE royalties will revert back to Esperion.

    2024 年 6 月,我們與 OMERS Life Sciences 達成了特許權使用費購買協議,以 DSE 特許權使用費銷售中獲得的 100% 特許權使用費權益為交換條件,獲得了約 3.047 億美元現金。OMERS 將獲得 DSE 在歐洲的淨苯甲酸產品銷售特許權使用費流,直到獲得相當於其投資 1.7 倍的總金額。此後,所有未來支付的 DSE 版稅都將歸還給 Esperion。

  • Proceeds from the royalty purchase agreement facilitated early payout and termination of the Oberland secured facility, removing all liens and covenants associated with that agreement. In December 2024, we executed a series of financing transactions that supported the repayment of the majority of our $265 million convertible debt facility.

    特許權使用費購買協議的收益促進了 Oberland 擔保貸款的提前支付和終止,從而消除了與該協議相關的所有留置權和契約。2024 年 12 月,我們執行了一系列融資交易,以支持償還大部分 2.65 億美元的可轉換債務。

  • The transactions included a $150 million secured term loan facility led by funds managed by Athyrium Capital and joined by funds managed by HealthCare Royalty and a new $100 million convertible note with accredited investors. We used the proceeds from the loan and approximately $60 million of the proceeds from the note to repay $210 million of the existing convertible debt with the remaining approximately $27 million of the net proceeds for general operating purposes.

    交易包括一筆 1.5 億美元的有擔保定期貸款,由 Athyrium Capital 管理的基金牽頭,HealthCare Royalty 管理的基金跟投,以及一筆由合格投資者出資的 1 億美元新可轉換票據。我們利用貸款收益和約 6,000 萬美元的票據收益償還了 2.1 億美元的現有可轉換債務,剩餘約 2,700 萬美元的淨收益用於一般營運用途。

  • Our fourth-quarter 2024 financial results can be found in the press release we issued this morning and more detail will be included in our upcoming 10-K. Fourth quarter 2024 total revenue was $69.1 million, an increase of 114% compared to $32.3 million in the fourth quarter of 2023. US net product revenue of $31.6 million compared to $20.8 million for the comparable period in 2023, an increase of approximately 52%.

    我們的 2024 年第四季財務業績可以在我們今天上午發布的新聞稿中找到,更多詳細資訊將包含在我們即將發布的 10-K 中。2024 年第四季總營收為 6,910 萬美元,較 2023 年第四季的 3,230 萬美元成長 114%。美國淨產品收入為 3,160 萬美元,而 2023 年同期為 2,080 萬美元,成長約 52%。

  • We have continued to demonstrate double-digit RPE growth with a 12% increase from last quarter and 8% growth in new-to-brand prescriptions. We have previously discussed the impact of the Medicare coverage gap, and in Q4 2024, we experienced an exceptional impact due to the number of new Medicare contracts we initiated in 2024. With the anticipated Medicare reform this year and the removal of the coverage gap, we are confident that quarterly revenue growth will more closely align with RPE growth going forward.

    我們的 RPE 繼續呈現兩位數成長,較上一季成長 12%,新品牌處方成長 8%。我們之前討論過醫療保險覆蓋缺口的影響,2024 年第四季度,由於我們 2024 年簽訂的新醫療保險合約數量眾多,我們受到了異常影響。隨著今年預期的醫療保險改革和覆蓋範圍差距的消除,我們相信未來季度收入成長將與 RPE 成長更加緊密地保持一致。

  • Collaboration revenue was $37.6 million compared to $11.5 million for the comparable period in 2023, an increase of approximately 227%. This revenue growth reflects the strong momentum we are seeing from our partner, DSE, as well as a onetime milestone from Otsuka upon the JNDA submission.

    合作收入為 3,760 萬美元,而 2023 年同期為 1,150 萬美元,成長約 227%。這項營收成長反映了我們的合作夥伴 DSE 所展現出的強勁勢頭,以及大塚在 JNDA 提交後所取得的一次性里程碑。

  • Turning to the rest of the P&L. For the fourth quarter 2024, research and development expenses were $11 million compared to $17.7 million for the comparable period in 2023, a decrease of 38% primarily attributable to our CLEAR Outcomes study that was completed in 2023.

    轉向損益表的其餘部分。2024 年第四季度,研發費用為 1,100 萬美元,而 2023 年同期為 1,770 萬美元,下降了 38%,這主要歸因於我們於 2023 年完成的 CLEAR Outcomes 研究。

  • Selling, general, and administrative expenses were $36.9 million compared to $45.4 million for the comparable period in 2023, a decrease of 19%. The decrease was primarily related to increased legal litigation expenses, reflecting onetime legal expenses from the legal resolution of the fourth quarter 2023, partially offset by increased compensation costs related to the ramp-up of our sales force associated with our commercial launch and promotional costs. We continue to manage expenses prudently and expect expenses to remain similar to current levels in 2025.

    銷售、一般及行政費用為 3,690 萬美元,而 2023 年同期為 4,540 萬美元,下降了 19%。減少的主要原因是法律訴訟費用增加,反映了 2023 年第四季度法律解決產生的一次性法律費用,但與我們的商業發布和促銷成本相關的銷售隊伍擴大導致的薪酬成本增加部分抵消了這一減少。我們將繼續審慎管理開支,並預計 2025 年的開支將保持與目前水準相似。

  • We entered 2025 in a very strong financial position with cash and cash equivalents of $144.8 million as of December 31, 2024. With the expected milestones from our global partners, we believe we will finish 2025 with an even stronger cash position.

    進入 2025 年,我們的財務狀況非常強勁,截至 2024 年 12 月 31 日,現金和現金等價物為 1.448 億美元。憑藉全球合作夥伴所期望的里程碑,我們相信,到 2025 年,我們的現金狀況將更加強勁。

  • We are reiterating our full-year 2025 operating expense guidance, which is expected to be approximately $215 million to $235 million, including $15 million of noncash expenses related to stock compensation. With that, I will now turn the call back over to Sheldon for closing remarks. Sheldon?

    我們重申 2025 年全年營運費用指引,預計約為 2.15 億美元至 2.35 億美元,其中包括與股票薪酬相關的 1,500 萬美元非現金費用。現在,我將把電話轉回給謝爾頓,請他作最後發言。謝爾頓?

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Our advances in 2024 formed the foundation for us to successfully execute three strategic pillars for growth that will drive our mission forward. These pillars are supported by innovation, collaboration, and expansion. These are not just words. They represent our commitment to advancing cardiovascular prevention and improving patient outcomes.

    我們在 2024 年的進步為我們成功執行推動我們使命前進的三大策略成長支柱奠定了基礎。這些支柱由創新、協作和擴展來支撐。這些不僅僅是言辭。它們代表了我們對推動心血管預防和改善患者預後的承諾。

  • Innovation is at the heart of what we do. We continue to implement cutting-edge sales and marketing programs to reach more healthcare providers and patients. Our strengthened financial position supports our goal to acquire, or in-license synergistic products and we are investing in novel research and development to bring new life-saving technologies to market.

    創新是我們工作的核心。我們繼續實施尖端的銷售和行銷計劃,以接觸更多的醫療保健提供者和患者。我們增強的財務狀況支持了我們收購或授權協同產品的目標,我們正在投資新穎的研究和開發,以將新的救生技術推向市場。

  • Collaboration is essential in our field. At Esperion, we continue to forge strong partnerships with leading healthcare providers, industry experts, and global partners. Together, we are executing a robust strategy that supports our vision and amplifies our impact.

    在我們的領域中合作至關重要。在 Esperion,我們繼續與領先的醫療保健提供者、行業專家和全球合作夥伴建立牢固的合作夥伴關係。我們共同實施一項強有力的策略,以支持我們的願景並擴大我們的影響力。

  • Expansion is our promise to reach more patients and communities. We are growing our US revenue, entering new markets by enhancing our global footprint, and have plans to add to our portfolio. Our goal is to make cardiometabolic prevention accessible to everyone, everywhere. As we look to the future, I am confident these pillars will guide us to new heights. Our commitment to excellence, our passion for innovation, and our dedication to our mission will continue to drive our success.

    擴張是我們接觸更多患者和社區的承諾。我們正在增加美國收入,透過擴大全球影響力進入新市場,並計劃擴大我們的產品組合。我們的目標是讓世界各地的每個人都能進行心臟代謝預防。展望未來,我相信這些支柱將引導我們邁向新的高度。我們對卓越的承諾、對創新的熱情以及對使命的奉獻將繼續推動我們的成功。

  • Before we open the call to your questions, I want to take a moment to thank our shareholders, partners, and team members for your unwavering support. Together, we are making a difference in the lives of millions, and I look forward to sharing our continued progress with you throughout the coming year. Operator, we are ready to open the call to questions.

    在我們開始回答您的問題之前,我想花點時間感謝我們的股東、合作夥伴和團隊成員的堅定支持。我們共同努力,改變數百萬人的生活,我期待在新的一年與大家分享我們不斷取得的進步。接線員,我們已準備好開始回答問題。

  • Operator

    Operator

  • (Operator Instructions) Dennis Ding, Jefferies.

    (操作員指示) 丹尼斯丁,傑富瑞。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • Hi, good morning. Congrats on all the progress. I have one question on the triple combo in the US. Have you agreed with the FDA on the regulatory path forward here and we need to have to run CVOT? And then does the triple combo impact to 2031 LOE, which I think is based off of composition matter plans?

    嗨,早安。祝賀你取得的所有進展。我對美國的三重組合有一個疑問。您是否同意 FDA 對此後的監管路徑的看法,我們需要運行 CVOT 嗎?那麼三重組合會對 2031 LOE 產生影響嗎?我認為這是基於組成事項計劃的?

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Yeah. Thanks, Dennis. So right now, we're not going to provide any additional details related to our discussions with the FDA. We'll be sharing more of that, probably in the fall time frame. What I can tell you is it does not necessitate a CVOT and does not necessitate any heavy lift as it relates to doing any type of clinical studies.

    是的。謝謝,丹尼斯。因此目前,我們不會提供任何與我們與 FDA 討論相關的額外細節。我們將會分享更多相關信息,大概在秋季。我可以告訴你的是,它不需要 CVOT,也不需要進行任何類型的臨床研究所需的繁重工作。

  • So stay tuned. We're very excited about it. I'll ask Ben how they do comment as it relates to impact on LOE. Ben?

    敬請關注。我們對此感到非常興奮。我會問本,他們對它對 LOE 的影響有何評論。本?

  • Benjamin Halladay - Chief Financial Officer

    Benjamin Halladay - Chief Financial Officer

  • Yeah. Similar to what Sheldon just said. We're going to release more information over the course of the year. However, I will say this is a very important step to the life cycle management of bempedoic acid and further substantiates and solidifies our position in potentially extending our patent.

    是的。和謝爾頓剛才說的類似。我們將在今年發布更多資訊。然而,我要說的是,這對苯海拉明酸的生命週期管理來說是非常重要的一步,進一步證實並鞏固了我們在延長專利方面的地位。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • Okay. Got it. Very helpful. And if I can have one follow-up. For US bempedoic acid revenue in 2025, is it reasonable to assume that quarterly revenue growth can accelerate this year since volumes should pick up from improved access and the typical gross net pressure that you traditionally see going through the year has now smoothed out with the Part D redesign? Thank you.

    好的。知道了。非常有幫助。我是否可以進行一次跟進。對於 2025 年美國苯海拉明酸的收入,是否可以合理地假設今年季度收入增長能夠加速,因為隨著獲取途徑的改善,銷量應該會回升,而且傳統上全年出現的典型淨壓力現在已經隨著 D 部分的重新設計而趨於平穩?謝謝。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Ben?

    本?

  • Benjamin Halladay - Chief Financial Officer

    Benjamin Halladay - Chief Financial Officer

  • Yeah. I think you'll continue to see the same study and, I would call it, significant growth that we've seen in the past. On the gross to net fact, I mentioned it in the prepared remarks. You'll see that smooth out of the gross to net and so you should see more of a 1:1 translation of RPE growth to revenue growth, which when you look at the second half of the year, that was our biggest headwind going through there. So compared to 2024, I think that second half growth will be much more consistent and much more steady, which is a net positive for us.

    是的。我認為你會繼續看到同樣的研究,我會稱之為我們過去所看到的顯著增長。關於總額與淨額的事實,我在準備好的發言中提到。您會看到總額與淨額之間的平滑變化,因此您應該會看到 RPE 成長與收入成長之間的 1:1 轉換,當您回顧下半年時,這是我們面臨的最大阻力。因此,與 2024 年相比,我認為下半年的成長將更加一致、更加穩定,這對我們來說是淨利好。

  • Operator

    Operator

  • Joe Pantginis, HC Wainwright.

    喬潘特吉尼斯、HC溫賴特。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • Hi, good morning, everyone. Thanks for taking the question. A couple of questions if you don't mind. So first, with regard to US sales, how should we view your efforts to build efficiencies into COGS?

    大家好,早安。感謝您回答這個問題。如果您不介意的話,我有幾個問題。那麼首先,關於美國銷售,我們應該如何看待您為提高 COGS 效率所做的努力?

  • Benjamin Halladay - Chief Financial Officer

    Benjamin Halladay - Chief Financial Officer

  • So I can take that one. From the US side, our COGS have been very consistent. To put some numbers behind it, our price per tablet hasn't really changed since beginning of 2024. When you look at COGS, really the biggest driver is some of that gross to net deterioration in the second half as well as the, I would say, proportion of DSE tablet sales.

    所以我可以接受這個。從美國方面來看,我們的銷貨成本一直非常穩定。從數字上看,自 2024 年初以來,我們每台平板電腦的價格實際上並沒有變化。當你查看 COGS 時,實際上最大的驅動因素是下半年毛利率與淨利率的下降,以及我認為 DSE 平板電腦銷售的比例。

  • We are constantly evaluating how we can drive our per tablet cost down. That's a longer-term discussion as we start validating some of these cheaper and lower cost suppliers. However, that, again, is a longer-term discussion. And I think once we've completed the tech transfer, that's when you really will see that gross margin benefit as we remove most of these low-margin sales off our books.

    我們一直在評估如何降低每台平板電腦的成本。這是一個長期的討論,因為我們開始驗證一些更便宜、成本更低的供應商。然而,這又是一個長期的討論。我認為,一旦我們完成技術轉讓,您就會真正看到毛利率收益,因為我們會將大部分低利潤銷售從帳簿上剔除。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • No, that's very helpful. And then I guess, maybe some feedback from the field if you don't mind. I guess as you're really detailing in marketing here with the launch really in play now, I guess, I would phrase it this way, what are the key yeses that you're getting right now from new prescribers, number one? And what are the key knows, if you will, presumably education is still the main reason for not prescribing yet or any other factors you'd like to share with us?

    不,這非常有幫助。然後我想,如果您不介意的話,也許可以聽聽來自現場的一些回饋。我想,正如您在行銷中詳細介紹的那樣,現在產品發布已經真正開始,我想,我會這樣說,首先,您現在從新處方者那裡得到的關鍵肯定是什麼?那麼,關鍵問題是什麼呢?如果您願意的話,大概教育仍然是尚未開處方的主要原因,或者您想與我們分享其他任何因素嗎?

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • Joe, it's Eric. I'll take this one. So the yeses, as you state, are based upon the efficacy of the clinical profile of the products that we have. NEXLETOL and NEXLIZET do something that other products don't do, and they have that outcome benefit from a primary and secondary prevention perspective.

    喬,我是艾瑞克。我要這個。因此,正如您所說,這些答案是基於我們現有產品的臨床特徵的功效。NEXLETOL 和 NEXLIZET 具有其他產品所不具備的功能,並且從初級和二級預防的角度來看,它們具有效果益處。

  • And they've also been studied in a really unique population, these partial and complete statin-intolerant patients. So those are the drivers of yes, if you will, the distinct profile that we have, the unique population that we've been studied in.

    他們還在一個非常獨特的群體中進行了研究,這些對他汀類藥物部分和完全不耐受的患者。所以,如果你願意的話,這些都是我們獨特的特徵、我們所研究的獨特人群的驅動因素。

  • In terms of the opportunities, we continue to educate on the improved coverage that we have. So as you know, the coverage started to improve towards the midpoint of last year and still represents an opportunity for us to get the word out that coverage is better.

    就機會而言,我們將繼續就我們已經改善的覆蓋範圍進行教育。如您所知,覆蓋率在去年年中開始改善,這仍然為我們提供了一個機會,讓我們可以向公眾宣傳覆蓋率已經有所提高。

  • But overall, tons of excitement in the field. Just in Houston for a 1S meeting, and our team has been doing a fantastic job, and it's motivated. And the customers are responding well.

    但總體而言,該領域充滿了令人興奮的事情。剛剛在休士頓參加了 1S 會議,我們的團隊表現非常出色,而且充滿動力。顧客的反應也很好。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • I just wanted to add. We actually just had, also Joe, gotten some feedback directly from the field. There's one physician in New Jersey that was -- after he had seen some of the new data and the piece that Eric showed, a very large practice, so just to give you a real live example, said, wow, I should really not be starting these patients going from a statin to ezetimibe. I should be going right to NEXLIZET. It's almost like this population health management.

    我只是想補充一下。事實上,我們和喬也只是直接從現場得到了一些回饋。新澤西州有一位醫生,在看到一些新數據和埃里克展示的資料後,(這裡舉一個真實的例子)他說,哇,我真的不應該讓這些病人從他汀類藥物換成依折麥布。我應該直接去 NEXLIZET。這幾乎就像是人口健康管理。

  • They're also actually going back now and looking at patients who've been on the statin for at least six months who've tried and have found and have not taken anything, almost complete statin failure, if you will. And they're writing NEXLIZET for these patients as well.

    他們現在實際上也在回頭觀察那些已經服用他汀類藥物至少六個月的患者,這些患者嘗試過但發現沒有任何效果,可以說他汀類藥物幾乎完全失效了。他們也為這些患者開了 NEXLIZET。

  • Because to Eric's point, that's what's really unique. You can use this as a monotherapy. You can use this in combination. So that's real live feedback from the field that we're getting now.

    因為按照艾瑞克的觀點,這才是真正獨特的。您可以將其用作單一療法。您可以結合使用它們。這就是我們現在從現場獲得的真實回饋。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • No, that's actually very helpful feedback. I appreciate it. And then just a quick question here, probably can't provide too much visibility is, I guess, can you describe the level of maturity at least with regard to your discussions for potential in-licensing?

    不,這實際上是非常有用的回饋。我很感激。然後這裡有一個簡單的問題,可能無法提供太多的透明度,我想,您能否至少就潛在許可的討論描述一下成熟度?

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Yeah. So we've been actually looking at this since last year. And as you know, Joe, we mentioned this at JPMorgan. I think it was a small bullet and lost upon folks. But where we are right now is we are doing a landscape analysis.

    是的。所以我們其實從去年就開始關注這個問題了。喬,如你所知,我們在摩根大通提到這一點。我認為它是一顆小子彈,並且沒有被人們注意到。但我們現在正在進行景觀分析。

  • We've been looking at products that are either late-stage Phase 3, soon to be approved or already approved. And I would say we're far along. But we want to make sure that it's the right product.

    我們一直在關注處於第三階段後期、即將獲得批准或已獲得批准的產品。我想說我們已經走得很遠了。但我們想確保它是正確的產品。

  • And as you know, I think the one thing that really differentiates us as a company is that we are a company. We have medical affairs. We have a sales force. We have a compliance department. We have manufacturing. A lot of these companies, they don't have the infrastructure, and that's where we think we can really add value.

    正如你所知,我認為我們作為一家公司真正與眾不同之處在於我們是一家公司。我們有醫療事務。我們有一支銷售團隊。我們有一個合規部門。我們有製造業。許多這樣的公司都沒有基礎設施,而我們認為這正是我們可以真正增加價值的地方。

  • So we're still looking at these different companies. We want to make sure we pick the right one, and we'll continue to update you. But we're really excited about the fact that we can leverage what we have in order to do this.

    所以我們仍在關注這些不同的公司。我們希望確保我們選擇正確的一個,並且我們將繼續向您更新最新情況。但我們真的很高興能夠利用現有的資源來實現這一目標。

  • Joseph Pantginis - Analyst

    Joseph Pantginis - Analyst

  • That's great. I appreciate all the color.

    那太棒了。我欣賞所有的色彩。

  • Operator

    Operator

  • Tom Shrader, BTIG.

    BTIG 的湯姆·施拉德 (Tom Shrader)。

  • Thomas Shrader - Analyst

    Thomas Shrader - Analyst

  • Good morning. I wanted to make sure what I think I just heard that you think it's attractive to help sell somebody else's product. Is that a big opportunity given there were such a dearth of cardiovascular sales forces right now?

    早安.我想確認一下我剛才聽到的你認為幫助銷售別人的產品很有吸引力。鑑於目前心血管銷售人員如此匱乏,這是否是一個巨大的機會?

  • And then I have a second question for Sheldon that I think you were close to. When Merck added a statin to ZETIA, did that drive ZETIA sales? And can you give us a sense of how much so we can think about what the growth opportunity of your next combination is?

    然後我還有第二個問題想問謝爾頓,我想你已經接近回答了。當默克公司在 ZETIA 中添加他汀類藥物時,這是否推動了 ZETIA 的銷售?您能否向我們介紹一下,以便我們思考下一個組合的成長機會是什麼?

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • Hi, Tom. It's Eric. I'll take the first part of that. So the answer is yes, whether that's us commercializing someone's compound or whether we're actually acquiring an asset, the key is we've built a really compelling commercial infrastructure, as Sheldon mentioned, in addition to other elements of the company. We've got a team that's proven their ability to generate 50% year-over-year growth, a team that covers about 20,000 HCPs, including cardiologists and primary care and has a digital footprint that goes to not only clinicians, but patients.

    你好,湯姆。我是埃里克。我將討論第一部分。所以答案是肯定的,無論是我們將某人的化合物商業化,還是我們實際上收購資產,關鍵是我們已經建立了一個真正引人注目的商業基礎設施,正如謝爾頓提到的,除了公司的其他要素之外。我們擁有一支已證明能夠實現 50% 同比增長的團隊,該團隊覆蓋約 20,000 名 HCP,包括心臟病專家和初級保健專家,其數位足跡不僅覆蓋臨床醫生,還覆蓋患者。

  • So when you think about these companies that have assets in late-stage development or under regulatory review, maybe just starting to be commercialized, that's a pretty compelling value proposition for those organizations and for us to be able to infuse additional assets that complement the existing portfolio enables us to be really efficient with that. So hopefully, that answers your question.

    因此,當您想到這些擁有處於後期開發階段或正在接受監管審查的資產的公司時,也許它們才剛開始商業化,這對這些組織來說是一個非常有吸引力的價值主張,而對於我們來說,能夠注入補充現有投資組合的額外資產,使我們能夠真正高效地利用這些資產。希望這能回答你的問題。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • And let's be honest, brings in more money to our company as well if we strike the right deal, which we would. Regarding combination therapy. So I think what you're referring to, Tom, is after VYTORIN, Merck actually looked at doing a combination of ezetimibe with Lipitor, which was called LIPTRUZET.

    說實話,如果我們達成正確的交易,它也會為我們公司帶來更多的錢,而我們會的。關於聯合治療。所以我認為你指的是,湯姆,在 VYTORIN 之後,默克公司實際上考慮將依折麥布與立普妥結合起來,製成名為 LIPTRUZET 的藥物。

  • And it was never available in the US because just couldn't find out -- couldn't figure out the right way to package it. But in Europe, it was, and it did very well.

    但它從未在美國上市,因為無法找到——無法找到正確的包裝方法。但在歐洲,它確實如此,而且表現得非常好。

  • I think polypill strategy has come a long way since then. As a matter of fact, the World Health Organization and also the World Cardiology Association have both issued guidelines where similar to where you treat diabetes and hypertension with multiple products, they're recommending in their guidelines that patients start as soon as possible with multiple therapies to manage their LDL-cholesterol.

    我認為多效藥策略自那時起已經取得了長足的進步。事實上,世界衛生組織和世界心臟病學協會都發布了類似於使用多種產品治療糖尿病和高血壓的指南,他們在指南中建議患者盡快開始採用多種療法來控制他們的低密度脂蛋白膽固醇。

  • So now the fact, as we said in our prepared remarks that we have, honestly, a monotherapy, we have NEXLIZET, and soon we'll have a triple combination, it allows physicians and patients to have this flexibility to achieve their goals more rapidly. But the reason why Merck pursued it for the same reason we're pursuing it is because our market research shows that patients and physicians want this.

    所以現在的事實是,正如我們在準備好的演講中所說的那樣,我們確實有一種單一療法,我們有 NEXLIZET,而且很快我們還將有一種三聯療法,它可以讓醫生和患者擁有這種靈活性,從而更快地實現他們的目標。但默克公司追求這一目標的原因與我們追求這一目標的原因相同,因為我們的市場研究表明患者和醫生都希望實現這一目標。

  • Operator

    Operator

  • Jessica Fye, JPMorgan.

    潔西卡費伊(Jessica Fye),摩根大通。

  • Tanhuan Gan - Analyst

    Tanhuan Gan - Analyst

  • This is Tanhuan Gan on for Jess. I have a bunch of questions on the triples. So first of all, why are you starting to pursue these triples just now? And you mentioned in the PR that triple combination products may offer LDL lowering in excess of 60%. So what I'm trying to get at is are there any other ways to differentiate these triples from other products other than the LDL metric?

    這是 Jess 的 Tanhuan Gan。我對三元組有很多疑問。那麼首先,為什麼你現在才開始追求這些三重奏?您在 PR 中提到,三重組合產品可使 LDL 降低 60% 以上。所以我想知道的是,除了 LDL 指標之外,還有其他方法可以將這些三元組與其他產品區分開來嗎?

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Sure. First, let me start with your first question. We view the triple combination as complementary to our existing portfolio, and it definitely supports our path to achieving blockbuster status with the products that we are already commercializing.

    當然。首先,讓我先回答你的第一個問題。我們認為這三重組合是我們現有產品組合的補充,它無疑支持我們利用已經商業化的產品來實現重磅炸彈地位。

  • As it relates to what further differentiates versus just lowering LDL, first of all, I would say, it's all about lowering LDL. If you look at the guidelines, it's about essentially getting patients in Europe. As you know, the guidelines show are at high risk to at least 55 milligrams per deciliter.

    至於它與僅僅降低 LDL 有何區別,首先,我想說,這一切都與降低 LDL 有關。如果你看一下指南,你會發現它主要是關於在歐洲接收患者。如您所知,指引顯示每分升至少 55 毫克的風險很高。

  • Now in the US, there really isn't a goal and guidelines aren't coming out, we have heard until 2026. But most cardiologists and primary care physicians you speak to, they want to get patients down to that 55-milligram per deciliter, especially if they're high risk.

    目前在美國,實際上還沒有一個目標,而且我們聽說要到 2026 年才會推出指導方針。但大多數心臟科醫生和初級保健醫生都希望將患者的血紅素濃度降至每分升 55 毫克,尤其是對於高風險族群。

  • But I think the other differentiating factor with our product that drugs like PCSK9 and future competition do not have is we also lower hsCRP. And there's a lot of information out there regarding lowering hsCRP, which, as you know, is a key marker of inflammation.

    但我認為我們的產品與 PCSK9 等藥物以及未來的競爭對手所不具備的另一個差異因素是,我們也降低了 hsCRP。關於降低 hsCRP 有很多信息,眾所周知,hsCRP 是發炎的關鍵標誌。

  • Also, as you know, we have, at least with bempedoic acid, no effect on glucose. So I think that's also important, and we think that will also play a role as we move forward in the development of this asset. You might have seen also that we submitted a paper recently regarding our effect on those patients who are obese and our efficacy there.

    而且,如您所知,至少對於苯海拉明酸來說,它對葡萄糖沒有影響。所以我認為這也很重要,而且我們認為這在我們推進這項資產的開發過程中也將發揮作用。您可能也看到,我們最近提交了一篇論文,內容涉及我們對肥胖患者的影響及其療效。

  • So there's a lot of effects that bempedoic acid, in combination with other products, in this case a statin, that we think will be very favorable. And I can tell you that this is something payers are looking for as well. It helps them with their NCQA and HEDIS quality measures. So there's a lot of aspects of what this product would bring and why we're developing it now.

    因此,我們認為貝哌酸與其他產品(在本例中是他汀類藥物)結合使用將產生非常有利的效果。我可以告訴你,這也是付款人所期待的。它幫助他們進行 NCQA 和 HEDIS 品質測量。因此,關於該產品將帶來什麼以及我們為什麼要現在開發它,有很多方面。

  • Tanhuan Gan - Analyst

    Tanhuan Gan - Analyst

  • All right. And maybe one more. Can you also briefly comment on the overall development timelines for these triple products? And how long do you think you'll have exclusivity for them?

    好的。也許還有一個。您能否簡要評論一下這三款產品的整體開發時間表?您認為您對他們的獨家經營權能維持多久?

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Yeah. So we're going to speak more around the development timeline in the fall. As we mentioned earlier, as it relates to patent life, it's too early to say. But we'll have more clarity as development progresses on what this means as it relates to extending our patent life.

    是的。因此,我們將在秋季更多地討論開發時間表。正如我們之前提到的,由於這涉及到專利期限,現在說還為時過早。但隨著開發的進展,我們將更清楚地了解這對延長我們的專利壽命意味著什麼。

  • Operator

    Operator

  • Jason Zemansky, Bank of America.

    美國銀行的傑森·澤曼斯基。

  • Jason Zemansky - Analyst

    Jason Zemansky - Analyst

  • Good morning. Thank you so much for taking our questions and congratulations on the progress. I wanted to ask a follow-up on some of your earlier comments, Sheldon, appreciating the momentary from the KOL back in January who mentioned that awareness may be an issue. And I was curious what you're hearing from your sales force from prescribers.

    早安.非常感謝您回答我們的問題,並祝賀我們的進展。謝爾頓,我想就你之前的一些評論進行後續詢問,我很欣賞 1 月份 KOL 提出的關於意識可能是一個問題的言論。我很好奇您從銷售人員和處方醫生那裡聽到了什麼。

  • How familiar are they with bempedoic acid? Do you expect this to inflect anytime soon if it hasn't? And basically, what you're hearing from boots on the ground there?

    他們對苯二甲酸有多熟悉?如果目前還沒有改變,您認為它會很快發生嗎?那麼,您從當地實地人員那裡聽到了什麼消息呢?

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • Yeah, I'll take this one, Jason. It's Eric. Yes, so every quarter or two, we do something called an ATU, where we look at the awareness, we look at the trial, we look at utilization. We do it with hundreds of HCPs to keep score and how we're doing from a progress perspective.

    是的,我會選擇這個,傑森。我是埃里克。是的,所以每隔一、兩個季度,我們都會做一些叫做 ATU 的事情,我們會觀察認知度、試驗情況和使用率。我們與數百名 HCP 一起這樣做,以記錄分數以及從進展角度了解我們的表現。

  • And we look at awareness on two levels. We look at unaided awareness and then we look at aided awareness. And I think the bottom line is we've progressively seen improvements in our unaided awareness. This is, if you just ask an HCP, what they're aware of without giving them any prompt.

    我們從兩個層面來看意識。我們先觀察無輔助意識,然後再觀察輔助意識。我認為最重要的是我們已經逐漸看到了我們無輔助意識的提升。也就是說,如果您直接詢問 HCP,無需給他們任何提示,他們就知道了什麼。

  • We're roughly where one would expect, and we asked the [ZFs] Associates for those benchmarks. When you look at the aided awareness, we're in the 95% range. So the bottom line is the word is getting out on our products. The team is doing a great job at reaching the universe that we have. Our HCP digital is allowing us to broaden that net.

    我們大致達到了人們所期望的水平,並且我們向 [ZFs] Associates 詢問了這些基準。當您查看輔助意識時,我們處於 95% 的範圍內。所以,最重要的是我們的產品廣泛傳播了。該團隊在探索我們現有的宇宙方面做得非常出色。我們的 HCP 數位技術使我們能夠擴大這一網絡。

  • The efficacy is really what's resonating for us. And as I mentioned earlier in the Q&A, the opportunity for us not only is to communicate that efficacy, but also that expanded coverage that we have.

    功效才是真正引起我們共鳴的。正如我之前在問答中提到的,我們的機會不僅在於傳達這種功效,還在於擴大我們的覆蓋範圍。

  • Jason Zemansky - Analyst

    Jason Zemansky - Analyst

  • Maybe during a recent health care conference, Sheldon mentioned that sales force was appropriately sized. But is this something that would benefit from an increased sales force? Thanks.

    也許在最近的一次醫療保健會議期間,謝爾頓提到銷售團隊的規模合適。但這會因增加銷售團隊而受益嗎?謝謝。

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • Yeah. I would say right now, we're appropriately sized. We continue to evaluate and whether that's changing the size, potentially changing some of the composition of the components of the team. As Sheldon mentioned, our ability to go to systems, for example, and turn on broader utilization. So right now, our focus is on being efficient, achieving profitability with profitability, which is on the near horizon, we'll be able to potentially pull up their levers.

    是的。我想說,現在我們的規模合適。我們將繼續評估這是否會改變團隊規模,是否會改變團隊組成部分的某些組成。正如謝爾頓所提到的,我們有能力進入系統,並實現更廣泛的利用。因此,現在我們的重點是提高效率,透過獲利來實現獲利,這在不久的將來,我們將能夠潛在地提高他們的槓桿率。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • And one other lever I would mention, Jason, is that we've seen that consumers are being activated. And I would say Eric's team has a lot of initiatives that are geared towards consumers. We're actually expanding that. What we're finding is when consumers ask for the drug, they get the drug.

    傑森,我想提到的另一個槓桿是,我們已經看到消費者被啟動了。我想說的是,艾瑞克的團隊有很多面向消費者的舉措。我們實際上正在擴大這一點。我們發現,當消費者要求購買藥物時,他們就會得到藥物。

  • So it's not just going through the traditional physician pathway but also using our digital assets to activate consumers. And that's going very well.

    因此,這不僅是透過傳統的醫生途徑,還要利用我們的數位資產來活化消費者。一切進展順利。

  • Operator

    Operator

  • Serge Belanger, Needham.

    塞爾日·貝朗格,尼德漢姆。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • Hi. Good morning. I guess first question for Ben. Regarding the Medicare contract impact in the fourth quarter, do you expect that to linger into 2025? And then secondly, regarding recent prescription trends, I guess, midway through 1Q here, we're seeing low single-digit growth, a step down from 4Q.

    你好。早安.我想第一個問題應該要問本。關於第四季醫療保險合約的影響,您預計這種影響會持續到 2025 年嗎?其次,關於最近的處方趨勢,我想,在第一季中期,我們看到的是低個位數成長,比第四季有所下降。

  • Just curious what is behind that trend? Is it the typical slowdown of the first quarter? And should that portend a tick down in sales sequentially from 4Q?

    只是好奇這個趨勢背後是什麼?這是第一季典型的經濟放緩嗎?這是否預示著第四季的銷售額將季減?

  • Benjamin Halladay - Chief Financial Officer

    Benjamin Halladay - Chief Financial Officer

  • Yeah. I'll answer the Medicare contract real quick. So the short answer is no. With the changes coming in 2025, the Medicare coverage gap will go away in that sort of see like I said, that seasonality will go away. And we'll have a much more steady and I would say, normalized gross-to-net rate over the course of the year.

    是的。我會很快回答醫療保險合約的問題。所以簡短的回答是「不」。隨著 2025 年的變化,醫療保險覆蓋缺口將會消失,就像我說的,季節性因素也會消失。我想說,我們全年的毛利率和淨利率將會更加穩定,更加正常。

  • So I think we've seen the worst of it now. We do have some additional contracts that came on in January that we've talked about. However, I think we'll see a much more consistent steady and normalized gross to net rate.

    所以我認為我們現在已經看到了最糟糕的情況。我們確實討論過一些一月份簽訂的額外合約。不過,我認為我們將看到更一致、穩定且正常的毛利率與淨利率。

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • And I can take the Q1 start, Serge. It's Eric. Yes. So the year typically starts off a bit slower. One of the key reasons is those deductibles, as you're aware, reset and a patient has to achieve those before they start getting lower prices for their branded products. And it impacts all branded products across the industry.

    我可以參加 Q1 的首發,塞爾吉。我是埃里克。是的。因此,新的一年開始時通常會慢一些。其中一個主要原因是,如您所知,這些免賠額會重置,患者必須達到這些免賠額後才能開始以較低的價格購買其品牌產品。它影響整個行業的所有品牌產品。

  • The good news is they start to reach that point towards where we are now. And March typically is a strong month in the quarter. So we fully anticipate that. Mentioned, again, we were with the field last week. They're energized, they're motivated coming out of that meeting. We continue to hear great stories and the impact that they're having with our customers. So yes, continue to expect growth from us, and January, February tend to typically be light.

    好消息是他們開始達到我們現在所處的水平。三月通常是本季表現強勁的月份。所以我們完全預料到這一點。再次提到,我們上週就在現場。會議結束後,他們充滿活力,鬥志昂揚。我們不斷聽到精彩的故事以及它們對我們的客戶的影響。所以是的,我們將繼續期待成長,而一月和二月的業績通常較為清淡。

  • Operator

    Operator

  • Paul Choi, Goldman Sachs.

    高盛的保羅·崔(Paul Choi)。

  • Paul Choi - Analyst

    Paul Choi - Analyst

  • Hi. Thank you. Good morning and thanks for taking the questions. I had a question regarding the triple development. And is this something that both you and your partner in Europe will be doing concurrently Or is this a separate development program for Esperion proprietary triple?

    你好。謝謝。早上好,感謝您回答問題。我有一個關於三重發展的問題。這是您和您的歐洲夥伴同時進行的事情嗎?或者這是 Esperion 專有三重技術的單獨開發計劃?

  • And then my second question is for Ben. Can you just give us maybe the net interest impact change based on all the recent financings and just sort of what annualizes that? Thank you very much.

    我的第二個問題是問本的。您能否根據最近的所有融資情況,告訴我們淨利息影響的變化情況,以及將其年化的具體方法?非常感謝。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Thanks, Paul. I think it's safe to say, we've talked about this before, and it's been our 10-K that Daiichi Sankyo. Europe is also developing a triple combination. Also in the past and also at JPMorgan, more recently, I talked about the fact that I think when people think about bempedoic acid, they think about just Esperion.

    謝謝,保羅。我想可以肯定地說,我們之前已經討論過這個問題,這是我們與第一三共的 10-K。歐洲也正在開發三聯療法。過去以及最近在摩根大通,我都談到這樣一個事實:我認為當人們想到苯甲酸酯酸時,他們想到的只是 Esperion。

  • We have two other large companies that are also heavily invested in this product. To your point, Daiichi Sankyo and Otsuka. And we've always talked about that it's important for all of us to work together to make this product as big as possible and to achieve the blockbuster status.

    我們還有另外兩家大公司也對產品投入了大量資金。正如您所說,第一三共和大塚。我們一直在說,大家齊心協力,讓這款產品盡可能地成功,並取得轟動效應,這一點非常重要。

  • We talked about and you see in the corporate deck how well Daiichi Sankyo continues to do as well as we do. So not to make it a long answer, but the answer is yes. They're doing it. We're doing it. We're doing it together. And you'll hear more about this as we go into the third quarter. Ben?

    我們討論過,您可以在公司簡報中看到第一三共如何繼續像我們一樣表現出色。因此,不要讓答案太長,但答案是肯定的。他們正在做這件事。我們正在做這件事。我們一起做這件事。進入第三季後,您將聽到更多有關此內容的消息。本?

  • Benjamin Halladay - Chief Financial Officer

    Benjamin Halladay - Chief Financial Officer

  • Yeah. So to answer your question, Paul. So I don't have the exact percentage off hand, but I can follow up with you on that one. But overall, interest expense, we expect to remain roughly consistent with where we were in Q4 going forward.

    是的。那麼,保羅,回答你的問題。因此,我手頭上沒有確切的百分比,但我可以跟進這一點。但總體而言,我們預期未來利息支出將與第四季的水平大致保持一致。

  • I will note that actually, the majority of that is kind of a non-cash interest component related to how we account for the OMERS deal. So consistent and a large portion of it is really just accounting noise. So if you look at Q4, I would expect to carry that forward throughout the year.

    我要指出的是,實際上,其中大部分是與我們如何計算 OMERS 交易相關的非現金利息部分。如此一致,其中很大一部分實際上只是會計噪音。因此,如果你看一下第四季度,我預計這一趨勢將持續全年。

  • Operator

    Operator

  • Kristen Kluska, Cantor Fitzgerald.

    克里斯汀·克魯斯卡,坎托·費茲傑拉。

  • Kristen Kluska - Analyst

    Kristen Kluska - Analyst

  • Hi. Good morning, everybody. For the triple combination studies, I know you cite literature in terms of your expectations of effect. But I'm curious, now that there have been a lot of patients treated in the real world with these therapies, if you're hearing any anecdotes about this being utilized in combination and/or if any physicians have ever approached you about the potential to study such a combination?

    你好。大家早安。對於三重組合研究,我知道您根據對效果的期望引用文獻。但我很好奇,現在現實世界中已經有很多患者接受了這些療法的治療,您是否聽說過有關這些療法聯合使用的軼事,或者是否有醫生與您聯繫過,討論研究這種聯合療法的可能性?

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • Hi, Kristen. It's Eric. Yes, we do have a fair amount of utilization in combination with statins. And as you know, one of the key challenges with statins is either the inability to titrate any -- tolerate any or to tolerate higher doses.

    你好,克里斯汀。我是埃里克。是的,我們確實有相當多的藥物與他汀類藥物合併使用。如您所知,他汀類藥物面臨的一個關鍵挑戰是無法滴定任何劑量—無法耐受任何劑量或無法耐受更高的劑量。

  • So we're hearing clinicians that employ lower doses of these high-intensity statins, atorvastatin, and rosuvastatin, and they add in NEXLIZET to enhance that efficacy. And I think that 60% number that we put forth is conservative. So the numbers tend to typically be higher from what we hear.

    因此,我們聽到臨床醫生使用較低劑量的高強度他汀類藥物、阿托伐他汀和瑞舒伐他汀,並添加 NEXLIZET 來增強療效。我認為我們提出的 60% 這個數字是保守的。因此,從我們聽到的消息來看,實際數字通常會更高。

  • But it positions us incredibly well. When we think about what clinicians want, they want efficacy, they want complementary mechanisms. And as Sheldon said, triple combination employs three mechanisms that work together. Two of them that have proven cardiovascular outcomes in statins and bempedoic acid. So it's a really compelling value proposition, which positions us not only well for patients and our customers, but positions us against the potential competition in the future.

    但它給我們帶來了非常好的定位。當我們思考臨床醫生想要什麼時,他們想要療效,他們想要互補機制。正如謝爾頓所說,三重組合採用了三種協同工作的機制。其中兩種已被證實具有心血管功效的藥物是他汀類藥物和苯海拉明酸。所以這是一個非常引人注目的價值主張,它不僅能讓我們更好地服務病患和客戶,還能讓我們在未來的潛在競爭中佔有優勢。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • And if I just may add, Kristen, is that we also have a cardiovascular advisory board, not too different from what I think our fellow friends in cardiovascular medicine, Amgen, Merck, et cetera, do as well. We have the top key opinion leaders on that advisory board. I can tell you they're very excited about this and what it offers to patients.

    克莉絲汀,如果我可以補充一點的話,我們還有一個心血管諮詢委員會,我認為與心血管醫學領域的朋友們,安進、默克等,他們的做法並沒有什麼不同。我們的顧問委員會中有頂尖的關鍵意見領袖。我可以告訴你,他們對此以及它為患者提供的服務感到非常興奮。

  • Again, it really encompasses kind of where medicine is going in the future with this polypill delivery. It really helps with adherence and compliance as well. So to the latter half of your question, we're very excited about it.

    再次,它確實涵蓋了未來多藥丸給藥方式的醫學發展方向。它確實也有助於堅持和遵守規定。因此,對於您問題的後半部分,我們對此感到非常興奮。

  • Kristen Kluska - Analyst

    Kristen Kluska - Analyst

  • Okay. And just on that note then, how would you be thinking about the dosing regimens of the statins? Just to your point, perhaps balance that you're still getting the added efficacy, but because it's in a combination setting, you may allow for lower dosing so that it becomes more tolerable?

    好的。那麼,就這一點而言,您如何考慮他汀類藥物的給藥方案?就您的觀點而言,也許平衡一下,您仍然可以獲得額外的功效,但是因為它處於組合設定中,您可以允許降低劑量,以便它變得更容易忍受?

  • Eric Warren - Chief Commercial Officer

    Eric Warren - Chief Commercial Officer

  • Yeah. I think. Without giving it all away, I think what you just said makes a lot of sense, Kristen. So lower doses of high-intensity statins in combination with bempedoic acid and ezetimibe to get the best of both worlds. Outcomes, LDL-C reduction, obviously, safety and sparing those high doses of high-intensity stands.

    是的。我認為。我不劇透,但我認為你剛才說的很有道理,克莉絲汀。因此,較低劑量的高強度他汀類藥物與苯海拉明酸和依折麥布合併使用可達到兩全其美的效果。結果,LDL-C 降低,顯然,安全性和避免那些高劑量的高強度站立。

  • Operator

    Operator

  • I show no further questions at this time. I would now like to turn the call back over to Sheldon for closing remarks.

    我目前沒有其他問題。現在我想將電話轉回給謝爾頓,請他做最後發言。

  • Sheldon Koenig - President, Chief Executive Officer, Director

    Sheldon Koenig - President, Chief Executive Officer, Director

  • Thank you, operator, and thank you all again for your time and attention this morning. We are looking forward to our upcoming R&D Day on April 24, and hope to have the opportunity to connect with many of you then. 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. Have a great day and thank you again.

    謝謝接線員,再次感謝大家今天上午的時間和關注。我們期待著 4 月 24 日即將到來的研發日,並希望有機會與大家建立聯繫。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。祝您有愉快的一天並再次感謝您。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。