Esperion Therapeutics Inc (ESPR) 2025 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome. (Operator Instructions)

女士們、先生們，謝謝你們的支持，歡迎你們。（操作員指示）

Please be advised that today's conference call will be recorded. I would now like to hand the conference over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. Please go ahead.

請注意，今天的電話會議將會被錄音。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 first-quarter 2025 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. We issued a press release earlier this morning detailing the content of today's call.

謝謝您，接線生。早安，歡迎參加 Esperion 2025 年第一季財報電話會議。參加今天電話會議的有總裁兼執行長 Sheldon Koenig 和財務長 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。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。

A copy can be found on the Investor page of our website, together with a copy of the presentation that we will also be referencing. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to 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.

您可以在我們網站的投資者頁面上找到一份副本，同時還可以找到我們將參考的簡報的副本。我想提醒來電者，今天電話會議中討論的資訊屬於《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。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。

The content of the conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 6, 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. 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.

電話會議內容包含時間敏感訊息，僅截至本次直播之日（2025 年 5 月 6 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。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。

I'll now turn the call over to Sheldon.

我現在將電話轉給謝爾頓。

Thank you, Alina. Good morning, everyone, and thank you for joining us. Throughout the first quarter, we continued to make progress across our three pillars for growth: revenue growth, portfolio expansion and pipeline advancement. We posted year-over-year net US product sales growth, enhanced reimbursement and access efforts, introduced new marketing initiatives targeting both physicians and patients and advanced our ACLY pipeline with our declaration of our lead indication in primary sclerosing cholangitis known as PSC.

謝謝你，阿麗娜。大家早安，感謝大家的收看。整個第一季度，我們在三大成長支柱方面繼續取得進展：營收成長、產品組合擴張和產品線推進。我們公佈了美國產品淨銷售額同比增長、加強了報銷和准入力度、推出了針對醫生和患者的新營銷計劃，並通過宣布我們在原發性硬化性膽管炎（PSC）中的領先適應症推進了我們的 ACLY 管道。

Turning to our progress and plans moving forward with our first pillar, increasing revenue and operating profitability let me start with the sales and marketing of our bempedoic acid products in the US and global markets. We are pleased with our performance this past quarter, which despite an overall flat lipid market in the US, saw green shoots of progress with significant strides in expanding our reach, both domestically and internationally. Total revenue for the first quarter 2025 grew 63% year-over-year to $65 million after adjusting for a onetime milestone received in the first quarter 2024.

談到我們在第一支柱——增加收入和營業盈利方面的進展和計劃，讓我先從我們苯甲酸酯產品在美國和全球市場的銷售和行銷開始。我們對上個季度的表現感到滿意，儘管美國脂質市場整體持平，但我們在國內和國際業務拓展方面取得了長足進步。經 2024 年第一季收到的一次性里程碑調整後，2025 年第一季的總營收年增 63%，達到 6,500 萬美元。

US net product revenue grew 41% year-over-year to $34.9 million, driven by the expanded label and commercial initiatives started in 2024. First quarter 2025 script growth increased 2% sequentially compared to fourth quarter 2024. This was somewhat muted by the impact of a flat lipid lowering market in the first quarter of 2025 that experienced seasonal headwinds due to changes in Medicare Part D and higher out-of-pocket costs as patients need to meet their annual insurance deductibles.

受 2024 年開始的擴大標籤和商業計劃的推動，美國淨產品收入年增 41% 至 3,490 萬美元。2025 年第一季劇本成長率與 2024 年第四季相比季增 2%。2025 年第一季降脂市場表現平淡，這在一定程度上抑制了這一成長。由於醫療保險 D 部分的變化以及患者需要滿足年度保險免賠額而導致的自付費用增加，降脂市場經歷了季節性逆風。

In the US, we expanded our field reimbursement support team threefold and now have 15 seasoned payer access specialists strategically aligned with the 15 sales regions to support our growing prescriber base and educate on the favorable reimbursement landscape for our products. Our market access team achieved a number of victories this quarter.

在美國，我們將現場報銷支援團隊擴大了三倍，目前擁有 15 名經驗豐富的付款人訪問專家，與 15 個銷售區域進行策略協調，以支持我們不斷增長的處方者群體，並介紹我們產品的有利報銷前景。我們的市場准入團隊本季取得了多場勝利。

We had more than 30 plans, including several of the nation's largest insurance removed prior authorizations, implemented electronic step edits and included new formulary additions. These milestones highlight the strong clinical profile and competitive pricing of NEXLETOL and NEXLIZET, instilling greater confidence in healthcare providers to prescribe these treatments. These achievements not only broaden access for patients but also reinforce our commitment to improving cardiovascular health on a large scale.

我們有 30 多個計劃，其中包括幾家全國最大的保險公司取消了先前的授權，實施了電子步驟編輯並增加了新的處方集。這些里程碑凸顯了 NEXLETOL 和 NEXLIZET 強大的臨床特性和具有競爭力的價格，增強了醫療保健提供者開出這些治療方法的信心。這些成就不僅擴大了患者的治療機會，也加強了我們大規模改善心血管健康的決心。

In further support of our sales and marketing efforts, we are particularly pleased to report that NEXLETOL and NEXLIZET were recently added to the new 2025 ACC AHA multi-society guidelines for the management of patients with acute coronary syndrome or ACS. Bempedoic acid earned Level 1a recommendations, the highest level of guidance indicating strong recommendation, where benefit greatly outweighs risk for patients with ACS already on maximally tolerated statin therapy and in patients with ACS who are statin intolerant.

為了進一步支持我們的銷售和行銷工作，我們特別高興地報告，NEXLETOL 和 NEXLIZET 最近被添加到新的 2025 ACC AHA 多社會指南中，用於管理患有急性冠狀動脈綜合徵或 ACS 的患者。貝培多酸獲得了 1a 級推薦，這是最高級別的指導，表示強烈推薦，對於已經接受最大耐受劑量他汀類藥物治療的 ACS 患者和對他汀類藥物不耐受的 ACS 患者來說，益處大大超過風險。

Bempedoic acid also earned a Level 2a recommendation, meaning that moderate evidence exists and the recommendation is reasonable for patients with ACS who are already on maximally tolerated statin therapy. Here again, a non-statin lipid-lowering therapy is recommended to reduce the risk of MACE. Inclusion in these guidelines allows us to more effectively market our bempedoic acid products to healthcare practitioners. Combined with expanded payer coverage, reduction on prior authorization requirements and the available reimbursement support resources, we believe we have significantly improved the access environment for patients and physicians alike. To better leverage this broader patient access, we recently introduced a series of payer and provider tactics that highlight the fact that up to 30% of patients are statin intolerant and showcasing evidence to demonstrate how NEXLETOL and NEXLIZET are the only approved therapy that proven to reduce cardiovascular events in statin-intolerant patients.

Bempedoic acid 也獲得了 2a 級推薦，這意味著存在中等證據，並且對於已經接受最大耐受劑量他汀類藥物治療的 ACS 患者，該推薦是合理的。再次，建議採用非他汀類降血脂療法來降低 MACE 風險。納入這些指南使我們能夠更有效地向醫療保健從業者推銷我們的苯海拉明酸產品。結合擴大付款人覆蓋範圍、減少事先授權要求和可用的報銷支援資源，我們相信我們已經顯著改善了患者和醫生的獲取環境。為了更好地利用這種更廣泛的患者獲取途徑，我們最近推出了一系列付款人和提供者策略，強調多達 30% 的患者對他汀類藥物不耐受的事實，並展示證據證明 NEXLETOL 和 NEXLIZET 是唯一被批准的、被證明可以減少他汀類藥物不耐受患者心血管事件的療法。

Our goal is to underscore the persistent unmet need while promoting our safe and effective therapies. As a result of our efforts, we began seeing a shift in prescribing behavior starting in March. Early Q2 trends are encouraging with prescription volume currently tracking approximately 8% higher than Q1.

我們的目標是強調持續未滿足的需求，同時推廣我們的安全有效的治療方法。由於我們的努力，我們從三月開始看到處方行為發生了轉變。第二季初期的趨勢令人鼓舞，目前處方量比第一季高出約 8%。

We expect this growth to continue as momentum builds and patient access improves further particularly as co-pay levels continue to decline. To further support healthcare practitioners in the management of their LDL-cholesterol levels, we are excited by the opportunity for the triple combination product we are developing in the US, as it will 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.

我們預計，隨著勢頭增強和患者就醫機會的進一步改善，特別是共同支付水平持續下降，這種增長將持續下去。為了進一步支持醫療保健從業者管理他們的 LDL 膽固醇水平，我們對在美國開發的三重組合產品的機會感到興奮，因為它將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 和三重組合療法貝伐酸、依折麥布和阿托伐他汀或瑞舒伐他汀。

We view this as a compelling opportunity to expand our role in the cardiovascular prevention market as the published literature suggests that the triple combo products can lower LDL-cholesterol in excess of 60%. This level of efficacy has the potential to rival existing injectable and emerging oral therapies, offering a valuable oral option for both patients and physicians.

我們認為這是一個擴大我們在心血管預防市場中作用的絕佳機會，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的注射療法和新興的口服療法相媲美，為患者和醫生提供有價值的口服選擇。

We expanded our partnerships with regulatory experts and others in the field to advance this important work with a goal to complete the clinical requirements and commercialize this triple combination in 2027.

我們擴大了與監管專家和該領域其他人士的合作夥伴關係，以推進這項重要工作，目標是在 2027 年完成臨床要求並將這種三聯療法商業化。

Moving on to international markets, where we and our partners are making great strides. We continue to see compelling growth from our partner, Daiichi Sankyo Europe, where they are making meaningful progress expanding the use of NILEMDO and NUSTENDI to benefit patients at risk of cardiovascular disease who cannot manage their LDL-cholesterol levels.

進入國際市場後，我們和我們的合作夥伴正在取得長足進展。我們繼續看到合作夥伴第一三共歐洲公司取得令人矚目的成長，他們在擴大 NILEMDO 和 NUSTENDI 的使用方面取得了有意義的進展，使那些無法控制 LDL 膽固醇水平的心血管疾病風險患者受益。

In addition, we are looking ahead to an exciting year of continued growth in Europe and new product approvals and launches across a number of key geographies. Our royalty revenue from DSE increased 8% from the fourth quarter of 2024 to $10.5 million in the first quarter of 2025. As of the end of February, approximately 472,500 patients have been treated with our therapies in Europe. The ongoing growth in these European markets give us confidence that with our label expansion, we can build a sizable market in the US.

此外，我們期待歐洲在新的一年繼續保持成長勢頭，並在多個主要地區獲得新產品的批准和推出。我們從 DSE 獲得的特許權使用費收入較 2024 年第四季成長 8%，達到 2025 年第一季的 1,050 萬美元。截至二月底，歐洲約有 472,500 名患者接受了我們的治療。這些歐洲市場的持續成長讓我們有信心，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。

In addition, the tech transfer for both NILEMDO and NUSTENDI are also progressing nicely. Our Japanese partner, Otsuka Pharmaceuticals, submitted for approval of our bempedoic acid product in Japan for LDL-cholesterol lowering and remain on track for approval and National Health Insurance pricing in the second half of 2025.

此外，NILEMDO和NUSTENDI的技術轉移也進展順利。我們的日本合作夥伴大塚製藥已提交日本批准我們的貝哌多酸產品用於降低低密度脂蛋白膽固醇，並將於 2025 年下半年獲得批准和國民健康保險定價。

The Japanese market is the world's third largest cardiovascular prevention market and we believe the royalties on Japanese project sales will be a meaningful revenue contributor over time. Looking to the progress we made during the first quarter 2025, we expanded the breadth of our global reach by entering commercial partnerships with CSL Squires in Australia and New Zealand. As an update, Neopharm Israel filed for regulatory approval during the first quarter and expects to receive approval in early 2026.

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，日本專案銷售的特許權使用費將成為一項有意義的收入貢獻者。展望 2025 年第一季的進展，我們透過與澳洲和紐西蘭的 CSL Squires 建立商業合作夥伴關係，擴大了全球影響力。最新消息是，Neopharm Israel 已於第一季申請監管部門批准，預計將於 2026 年初獲得批准。

In addition, Esperion filed submissions for approval in Canada, for NEXLETOL and NEXLIZET, and we anticipate market approval in the fourth quarter of 2025. Our international partnerships continue to deliver increasing royalty revenue further demonstrating the global potential of our bempedoic acid products and supporting our strategic focus to drive revenue growth and operating profitability.

此外，Esperion 已向加拿大提交了 NEXLETOL 和 NEXLIZET 的批准申請，我們預計將於 2025 年第四季獲得市場批准。我們的國際合作夥伴關係繼續帶來不斷增長的特許權使用費收入，進一步證明了我們的苯甲酸酯產品的全球潛力，並支持我們推動收入成長和營運獲利能力的策略重點。

Turning to advancing the pipeline pillar. We recently hosted our R&D Day in New York where we introduced our novel program targeting PSC. PSC is a rare progressive liver disease with no approved therapies and represents a major unmet need with an estimated $1 billion annual market opportunity.

轉向推進管道支柱。我們最近在紐約舉辦了研發日，介紹了針對 PSC 的新計畫。PSC 是一種罕見的進行性肝病，目前尚無核准的治療方法，代表著巨大的未滿足需求，預計每年的市場機會為 10 億美元。

This program reflects our strategy to expand into high-need, high-value indications and highlights the broader potential of ACLY biology. The R&D Day event was very engaging and featured KOL discussions, a patient advocacy representative for the PCS community, a patient video and an engaging Q&A session.

該計劃體現了我們向高需求、高價值適應症擴展的策略，並凸顯了 ACLY 生物學的更廣泛潛力。研發日活動非常引人入勝，其中包括 KOL 討論、PCS 社群的病患權益代表、病患影片和引人入勝的問答環節。

I encourage those of you who may have missed it to listen to the archive of the event that is available on the Investor Relations section of our website.

我鼓勵那些可能錯過活動的人收聽我們網站投資者關係部分提供的活動存檔。

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

在了解了業務概況之後，我將把電話轉給本，讓他詳細回顧一下我們第一季的財務進展。

Ben?

本？

Thank you, Sheldon. Good morning, everyone, and thank you for joining us today. Our first quarter 2025 financial results can be found in the press release we issued this morning and more detail will be included in our upcoming 10-Q. First quarter 2025 total revenue was $65 million, a decrease of 53%. This decrease was driven by a onetime settlement agreement milestone with DSE, which we received in the first quarter of 2024.

謝謝你，謝爾頓。大家早安，感謝大家今天加入我們。我們的 2025 年第一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-Q 中。2025 年第一季總營收為 6,500 萬美元，下降 53%。這一下降是由於我們在 2024 年第一季與 DSE 達成了一次性和解協議里程碑。

Excluding the settlement agreement milestone, total revenue grew 63%. US net product revenue was $34.9 million compared to $24.8 million for the comparable period in 2024, an increase of approximately 41%. Q1 product revenue growth in the US was impacted by several factors, including changes to Medicare Part D and patient deductible requirements.

不計和解協議里程碑，總收入成長了 63%。美國淨產品收入為 3,490 萬美元，而 2024 年同期為 2,480 萬美元，成長約 41%。美國第一季產品收入成長受到多種因素的影響，包括醫療保險 D 部分的變化和患者免賠額要求。

Every year, during the first quarter, we experienced lower product revenue as patients fulfill their insurance deductibles impacting branded prescription fills. This year with changes to the IRA and confusion around Medicare made this season trend particularly burdensome. Despite these seasonal headwinds, we remain committed to navigating these complexities and ensuring patient access to our innovative cardiovascular health solutions. Beginning in March, we have seen a clear shift in prescribing behavior that signals a return to our typical growth trajectory. Early Q2 data shows prescription volume tracking approximately 8% above Q1 levels, and we expect this upward trend to continue.

每年第一季度，我們的產品收入都會下降，因為病患履行保險免賠額會影響品牌處方的配藥。今年，由於 IRA 的變化和圍繞醫療保險的混亂，這個季節的趨勢變得特別沉重。儘管存在這些季節性不利因素，我們仍致力於克服這些複雜因素並確保患者能夠獲得我們創新的心血管健康解決方案。從三月開始，我們看到處方行為發生了明顯轉變，這標誌著我們恢復了典型的成長軌跡。第二季初期數據顯示，處方量比第一季高出約 8%，我們預計這一上升趨勢將持續下去。

Collaboration revenue was $30.1 million compared to $113 million for the comparable period in 2024, a decrease of approximately 73%, driven by the settlement agreement milestone with DSE, offset partially by increases to our royalty sales within our partner territories and product sales to our collaboration partners from our supply agreements.

合作收入為 3,010 萬美元，而 2024 年同期為 1.13 億美元，下降約 73%，這主要得益於與 DSE 達成的和解協議里程碑，但部分抵消了我們在合作夥伴地區內的特許權使用費銷售額的增加以及根據供應協議向合作夥伴銷售產品的增加。

Excluding the settlement agreement milestone, collaboration revenue grew 97% from the comparable period. Turning to the rest of the P&L. For the first quarter 2025, research and development expenses were $12.6 million compared to $13.4 million for the comparable period in 2024, a decrease of 6%. Selling, general and administrative expenses were $43 million compared to $42 million for the comparable period in 2024, an increase of 2%.

不計和解協議里程碑，合作收入較同期成長 97%。轉向損益表的其餘部分。2025 年第一季研發費用為 1,260 萬美元，而 2024 年同期為 1,340 萬美元，下降了 6%。銷售、一般及行政開支為 4,300 萬美元，而 2024 年同期為 4,200 萬美元，成長 2%。

The increase quarter-over-quarter was primarily related to increased marketing and consulting costs. We entered 2025 in a very strong financial position with cash and cash equivalents of $114.6 million as of March 31, 2025. We are reiterating our full year 2025 operating expense guidance, which is expected to be approximately $215 million to $235 million, including $15 million in non-cash expenses related to stock compensation.

環比成長主要與行銷和諮詢成本的增加有關。進入 2025 年，我們的財務狀況非常強勁，截至 2025 年 3 月 31 日，現金和現金等價物為 1.146 億美元。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。

With that, I will now turn the call back over to Sheldon for closing remarks.

現在，我將把電話轉回給謝爾頓，請他作最後發言。

Sheldon?

謝爾頓？

As we conclude today's earnings call, I want to take a moment to reflect on the meaningful progress we've made and the exciting journey ahead. Our commitment to revolutionizing cardiovascular risk reduction through our innovative bempedoic acid products is unwavering. In addition, we are excited by the opportunities to leverage our leadership in ACLY biology and look forward to advancing our newly introduced pipeline as has groundbreaking potential.

在今天的收益電話會議結束時，我想花點時間回顧一下我們所取得的有意義的進展和未來令人興奮的旅程。我們堅定不移地致力於透過創新的苯海拉明酸產品徹底改變心血管風險降低方式。此外，我們對利用我們在 ACLY 生物學領域的領導地位的機會感到興奮，並期待推進我們新推出的具有突破性潛力的管道。

Our focus on innovation, collaboration and expansion will continue to guide us as we strive to make cardiometabolic prevention accessible to everyone everywhere. We are confident that our strategic initiatives will propel us towards a future where millions of lives are positively impacted by our efforts.

我們將繼續專注於創新、協作和擴展，努力讓世界各地的每個人都能獲得心臟代謝預防。我們相信，我們的策略性舉措將推動我們走向一個未來，我們的努力將為數百萬人的生活帶來正面影響。

Thank you to our shareholders, partners and team members for your steadfast support. Your commitment to our mission inspires us every day, and we are excited to share our continued progress with you in the coming year. Together, we are making a difference, and I look forward to the incredible advancements we will achieve.

感謝股東、合作夥伴和團隊成員的堅定支持。您對我們使命的承諾每天都激勵著我們，我們很高興在未來一年與您分享我們不斷取得的進步。我們正在共同創造改變，我期待著我們將取得令人難以置信的進步。

Operator, we are now ready to open the call to questions

接線員，我們現在可以開始提問了

(Operator Instructions)

（操作員指示）

Dennis Ding, Jefferies.

丹尼斯丁，傑富瑞。

Hi, good morning. Congrats on the progress. And I have two questions. One is on BD. I guess, when should we expect the new BD deal and perhaps remind us of your cash outlook for the remainder of this year, if you'll have to wait for the Otsuka milestones before executing a deal.

嗨，早安。恭喜你取得進展。我有兩個問題。一個在BD上。我想，我們應該什麼時候期待新的 BD 交易，也許請提醒我們您今年剩餘時間的現金前景，如果您必須等待大塚里程碑才能執行交易。

And then my second question is on the triple. Is that your way of playing defense by specifically leveraging convenience for when ovacetropiv gets approved in 2027 because from an efficacy perspective, like as your triple gets 60% plus LDL reduction in 1 pill, but albicetropib can get there or higher with two. So is that how you see the value proposition here for the triple 1 versus 2 pills?

我的第二個問題是關於三重的。這是你們利用 2027 年 Ovactropiv 獲批時的便利性來進行防禦的方式嗎？因為從療效的角度來看，就像你們的三重療法只需服用一片藥就能使 LDL 降低 60% 以上，但阿比西托品需要服用兩片才能達到這個水平或更高。那麼，這就是您看待三聯 1 藥片與二聯 2 藥片的價值主張嗎？

Thank you.

謝謝。

Hey Dennis, thanks for joining. Appreciate the question. On the BD side, so to answer your question, we're, I think, making very good progress there. I've said before, we're not going to set a time line just because we don't want to feel like we have to execute a deal to get a deal done. We want to wait for the right deal that makes sense for this company.

嘿，丹尼斯，謝謝你的加入。感謝你的提問。在 BD 方面，回答你的問題，我認為我們在那裡取得了非常好的進展。我之前說過，我們不會設定時間表，因為我們不想覺得必須執行協議才能達成協議。我們希望等待對這家公司有意義的交易。

I will say they are not predicated on having the Otsuka milestones in hand. Everything we've been looking at would be sort of separate from that. And when we see the right asset that makes sense in the commercial bag that we can put it in, then we're going to execute it and not necessarily weight around just for some other time line here.

我想說的是，他們並不指望能取得大塚製藥的里程碑。我們所關注的一切都與此有所不同。當我們看到適合放入商業包中的正確資產時，我們就會執行它，而不一定只是為了這裡的其他時間線而權衡。

Thanks, Ben. Thanks, Dennis. As it relates to the triple combination, keep in mind, Dennis, and we've talked about this before that -- and there's publications that support us the triple combination, we've seen LDL lowering in excess of 60%, actually, in some cases, up to 70%. It's definitely something as it relates to a play of convenience, it's 1 pill. And it also has really the potential of being the most efficacious LDL lowering drug on the market.

謝謝，本。謝謝，丹尼斯。至於與三聯療法相關的內容，請記住，丹尼斯，我們之前已經討論過這個問題 - 並且有一些出版物支持三聯療法，我們已經看到 LDL 降低超過 60%，實際上，在某些情況下甚至高達 70%。這絕對是一種權宜之計，只需一顆藥丸。而且它也確實有可能成為市場上最有效的降低 LDL 的藥物。

So that's how we look at it is it's just 1 pill that a patient has to take. And as you know, many patients are taking sometimes 6 to 7 medications. In this case, they would only have to take one. I'm not going to make comments compared to ovacetropib. That's a product in development, and we'll just have to wait to see if that product actually comes to the market.

所以我們認為這只是患者需要服用的一顆藥丸。如您所知，許多患者有時要服用 6 至 7 種藥物。在這種情況下，他們只需選擇一個人。我不會對 ovacetroib 做出評論。這是一款正在開發的產品，我們只需等待，看看該產品是否真的會上市。

Joe Pantginis, H.C. Wainwright.

喬潘特吉尼斯、H.C. 溫賴特。

Everybody, good morning. Thanks for taking the questions. So first, on the sales front, you're up to about 15% right now, as you said, I wanted to get a sense of do you feel it's rightsized you're continuing to wait to see on the potential expansion of sales to consider expanding your sales force? Number one. And then number two, I think more importantly, as you continue to talk about education around NEXLETOL, I'll provide one example and maybe you have others as well.

大家早安。感謝您回答這些問題。首先，在銷售方面，正如您所說，現在您的銷售額已經增長了約 15%，我想了解一下，您是否認為銷售額已經達到了合適的規模，您是否會繼續等待觀察銷售額的潛在擴張情況，以考慮擴大銷售隊伍？第一。第二，我認為更重要的是，當您繼續談論有關 NEXLETOL 的教育時，我會提供一個例子，也許您還有其他例子。

So with regard to the education, what are you seeing with regard to any potential variability with regard to physicians defining statin intolerance? And are there any other key factors that still need to be tackled with regard to education? Thanks.

那麼，就教育而言，您認為醫師對他汀類藥物不耐受的定義有哪些潛在的差異？在教育方面還有哪些關鍵因素需要解決？謝謝。

Sure. Thanks, Joe, so let me start with the sales force. So right now, we have approximately 155 sales representatives and we do think that is the right amount. We've commented before that we have found the right balance between personal promotion and digital promotion, and we do return on investment analysis on all those. So we're constantly monitoring those investments.

當然。謝謝喬，那麼讓我先從銷售人員開始。因此，目前我們大約有 155 名銷售代表，我們確實認為這是合適的數量。我們之前曾評論說，我們已經找到了個人推廣和數位推廣之間的適當平衡，並且我們對所有這些都進行了投資回報分析。因此我們一直在監控這些投資。

You started off with 15. I think what you were talking about with the 15 field reimbursement managers, that is new. They were effective on April 1. We have 15 sales regions across the nation. And we did have six field reimbursement managers, but we've expanded that to 15 where we have 1 in each sales region.

你一開始有 15 個。我認為您與 15 位現場報銷經理談論的內容是新的。這些措施於 4 月 1 日起生效。我們在全國有15個銷售區域。我們確實有 6 名現場報銷經理，但我們已經將其擴展到 15 名，每個銷售區域有 1 名。

And we think that is going to be -- and we've already seen something that's very successful because it really helps physicians think about how they have to fill out prior authorization. And so it's just another way of supporting limiting barriers to prescribing. So we're excited about that. Regarding education, so it's very interesting. We've been very focused on statin intolerance.

我們認為這將是——我們已經看到了一些非常成功的事情，因為它確實幫助醫生思考如何填寫事先授權。因此，這只是支持限制處方障礙的另一種方式。所以我們對此感到很興奮。關於教育，所以這很有趣。我們一直非常關注他汀類藥物不耐受問題。

We have a new piece out there that our representatives are using the National Lipid Association earlier in the year came out and actually to find that statin intolerance is about 30% of the population. So a significant amount of folks just do not want to take a statin or can't tolerate a statin. And so what we're finding is that physicians are really responding to the fact that the NLA is put out there. It's actually in our detail aid. And we go to physicians' offices, just to give you a real life story to your point and tell them, doctor, the patients are sitting in your waiting room, you know, I'm sure that many of them can't take a statin or they're just tolerating taking a statin, but they really can't take it.

我們有一個新發現，我們的代表利用今年稍早發布的國家脂質協會的數據，實際上發現他汀類藥物不耐受的人口約佔 30%。因此，相當多的人只是不想服用他汀類藥物或不能耐受他汀類藥物。因此，我們發現醫生確實對 NLA 的推出做出了積極的反應。它實際上在我們的詳細援助中。我們去醫生辦公室，只是為了給你講一個真實的故事來說明你的觀點，並告訴他們，醫生，病人坐在你的候診室裡，你知道，我確信他們中的許多人不能服用他汀類藥物，或者他們只是忍受服用他汀類藥物，但他們真的不能服用。

And here, now this is an opportunity where you can prescribe NEXLETOL and NEXLIZET. And I can tell you that message is gaining a lot of traction. So the education -- and we're just starting, by the way, there are some other things that we have planned that we'll continue to update you through the year. But we're not only focusing on physicians, but we're also looking at ways to activate the consumer.

現在，您可以有機會開出 NEXLETOL 和 NEXLIZET 處方。我可以告訴你，這個訊息正在獲得很大的關注。因此，教育——順便說一下，我們才剛剛開始，我們還計劃了一些其他的事情，我們將在今年繼續向你們更新資訊。但我們不僅關注醫生，我們還在尋找激活消費者的方法。

Fantastic. Thanks a lot, Sheldon.

極好的。非常感謝，謝爾頓。

Jason Zemansky, Bank of America.

美國銀行的傑森·澤曼斯基。

Good morning. Congrats on the quarter, I wanted to ask, is the triple combination the right approach here? And I ask this because on one hand, as you've just mentioned, there are patients who aren't necessarily interested in taking the statin and on the other hand, there does seem to be a growing buzz or interest in lipoprotein A and reducing that, which is again, something that both the PCS K9s and the CETPs have had success lowering. So in terms of looking at the landscape down the road, where does the triple fall into place here?

早安.恭喜本季，我想問一下，三重組合是正確的方法嗎？我之所以問這個問題，是因為一方面，正如您剛才提到的，有些患者並不一定對服用他汀類藥物感興趣；另一方面，人們似乎對降低脂蛋白 A 的關注度或興趣日益增加，而 PCS K9 和 CETP 都已成功降低了脂蛋白 A 的含量。那麼，從未來的發展來看，三重性在這裡處於什麼位置呢？

Yeah. So thanks, Jason. So yes, we actually do think it's the right approach for the products that we have. Keep in mind that we also lower hsCRP, which is a marker of inflammation. We actually showed a 22% reduction in hsCRP in our endpoint and our clear Outcomes study.

是的。所以謝謝你，傑森。所以是的，我們確實認為這是適合我們現有產品的正確方法。請記住，我們也會降低 hsCRP，它是發炎的標記。事實上，我們在終點和明確結果研究中顯示 hsCRP 減少了 22%。

And not only are we excited about this, but our partners at Daiichi Sankyo are excited about this. There's going to be more news coming as it relates to this in the fall, as we've mentioned before. As you know, with Lp(a), there's a lot of science around it. I think we're still waiting to see the data. We thought we'd see some data this year.

不僅我們對此感到興奮，而且我們在第一三共的合作夥伴也對此感到興奮。正如我們之前提到的，秋天將會有更多與此相關的新聞發布。如你所知，Lp(a) 背後有許多科學原理。我認為我們仍在等待數據。我們認為今年會看到一些數據。

We'll see it next year. But I think hsCRP, Lp(a), these are all important markers. As we've mentioned in the past, cardiovascular disease is the number one killer, and we can do something about it today with NEXLIZET and NEXLETOL and that's what we're focused on. We're focused on getting our drugs prescribed today and next year and the year after, triple combination, the LDL efficacy. As you know, LDL efficacy is still a primary endpoint that the FDA considers for registering the drug.

我們明年就會看到。但我認為 hsCRP、Lp(a) 這些都是重要的標記。正如我們過去提到的，心血管疾病是頭號殺手，我們今天可以透過 NEXLIZET 和 NEXLETOL 來解決這個問題，這也是我們關注的重點。我們專注於今天、明年和後年開出處方藥，三重組合，降低 LDL 療效。如您所知，LDL 療效仍然是 FDA 註冊該藥物時考慮的主要終點。

So yes, it's absolutely the right play, and we look forward to bringing it to market.

所以是的，這絕對是正確的做法，我們期待將其推向市場。

But again, for patients who aren't interested in taking a statin, I mean, is this the option for them?

但是，對於那些不想服用他汀類藥物的患者來說，這是他們的選擇嗎？

Well, so the nice thing now is we have, and as we said in our prepared remarks, we have a suite of alternatives, which is something that the competition doesn't have. The beauty of the CLEAR Outcome study is it gave us a label where you can take our drug with a statin or you can take our drug without a statin. The other thing that you may recall, have the clear Outcome study is that we are the only oral and only non-statin that has both primary and secondary prevention. And so this allows a physician to have greater flexibility, and we've done market research to support that.

好吧，現在的好處是，正如我們在準備好的演講中所說的那樣，我們有一套替代方案，這是競爭對手所沒有的。CLEAR Outcome 研究的優點在於它為我們提供了一個標籤，你可以將我們的藥物與他汀類藥物一起服用，也可以不與他汀類藥物一起服用。您可能還記得的另一件事是，明確的結果研究表明，我們是唯一具有一級和二級預防的口服藥物和非他汀類藥物。因此，這為醫生提供了更大的靈活性，我們已經做了市場調查來支持這一點。

Got it, thanks for the call.

明白了，謝謝您的來電。

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·費茲傑拉。

Hi, good morning, everybody. As it relates to the ACC AHA multi-society guidelines, can you talk about historically how adoption may have changed based on other therapies that have been added to these recommendations just essentially trying to figure out how instrumental it is to physician uptake and adoption.

大家好，早安。由於它與 ACC AHA 多社會指南相關，您能否從歷史上談談，基於添加到這些建議中的其他療法，採用情況可能發生了怎樣的變化，本質上只是想弄清楚它對醫生的接受和採用有多大作用。

Yeah. Thank you, Kristen. So I think right now, it's a little bit too early to comment as it relates to other products. But I can tell you with us with initial feedback, this is also something that we have included in our detailing of the product. So it's kind of a one-two punch where we can talk about the NLA recommendation or the statement of statin intolerance, but we can also talk about this new guideline.

是的。謝謝你，克里斯汀。因此我認為現在評論與其他產品的關係還為時過早。但我可以根據初步回饋告訴您，這也是我們在產品詳細說明中包含的內容。因此，這就像是一種雙重打擊，我們可以談論 NLA 建議或他汀類藥物不耐受的聲明，但我們也可以談論這項新指南。

And I can tell you that having that message as it relates to both of those is very impactful to not only cardiologists who really follow the guidelines, more so than primary care, but we are seeing that primary care physicians are also very responsive to this as well. So for us, it's been, I would say, again, very early, but feedback from the field is that it's been very meaningful.

我可以告訴你，與這兩者相關的這一信息不僅對真正遵循指南的心臟病專家影響很大，而且對初級保健醫生也有很大的影響，而且我們看到初級保健醫生對此也非常敏感。所以對於我們來說，我想說，這還為時過早，但來自現場的回饋表明，這非常有意義。

Thank you.

謝謝。

Serge Belanger, Needham.

塞爾日·貝朗格，尼德漢姆。

Hi, good morning, everyone. This is John on for Serge today. So I just wanted to touch on first seasonal market dynamics for NEXLETOL and NEXLIZET. Obviously, there's a little bit of a slowdown in 1Q. You mentioned the flat lipid market, changes in Med Part D, et cetera. Just curious qualitatively, whether you think this was worse this year than in years prior?

大家好，早安。今天由 John 代替 Serge 發言。所以我只想談談 NEXLETOL 和 NEXLIZET 的第一個季節性市場動態。顯然，第一季出現了一些放緩。您提到了脂質市場的穩定、Med Part D 的變化等等。只是從品質上好奇，您是否認為今年的情況比前幾年更糟？

And did this in any way kind of portend a bigger bounce back for 2Q.

這是否預示著第二季將出現更大反彈？

Yeah. Thanks, John. No doubt this was definitely worse than years prior. And part of it was just because of the IRA and a lot of it was new, but let me turn it over to BJ, who can also give us some more color on it.

是的。謝謝，約翰。毫無疑問，這肯定比前幾年更糟。部分原因是因為愛爾蘭共和軍，而且很多都是新情況，但讓我把它交給 BJ，他也可以給我們更多細節。

Yeah, John, the prescription growth was impacted by a variety of seasonal factors, which included the annual insurance deductibles and the reset. But there was also an added confusion also around the inflation Reduction Act and those related adjustments. But from an emerging positive trends starting in March, we have observed improving trends, including reductions in patient co-pays, which positively influences prescription uptake. And we're also seeing really great feedback and early signs from our targeted payer initiatives aimed at also increasing prescribing among previous nonwriters. So we're really, from an out-of-pocket perspective, we've seen this decrease in elevated levels and observed this in January and February and really looking forward to that trend continuing.

是的，約翰，處方增長受到多種季節性因素的影響，其中包括年度保險免賠額和重置。但通貨膨脹削減法案及其相關調整也帶來了額外的混亂。但從 3 月開始出現的正面趨勢來看，我們觀察到了改善趨勢，包括患者共同支付費用的減少，這對處方藥的吸收產生了正面影響。我們還看到了來自目標付款人計劃的非常好的反饋和早期跡象，這些計劃旨在增加以前非作家的處方量。因此，從實際支出的角度來看，我們確實看到了高水準的下降，並在一月和二月觀察到了這種情況，我們真的期待這種趨勢能夠繼續下去。

And to add just a little bit more color, BJ and team also did research, John, with Medicare providers to see what was causing this confusion? And what's there a confusion and all the feedback and these are from all the top Medicare providers in the United States, there is confusion amongst consumers of what do they have to pay, what was the true out-of-pocket expense. At 1 point, you may recall back in January, there is rhetoric that Medicare was going to be shut down, which also created confusion. So there's a lot of different dynamics, and that's what made it probably the worst that we've ever seen.

為了增加一些色彩，BJ 和他的團隊也與醫療保險提供者進行了研究，約翰，看看是什麼導致了這種混亂？令人困惑的是，所有的回饋都來自美國所有頂級醫療保險提供者，消費者對他們必須支付的費用以及真正的自付費用感到困惑。您可能還記得，今年 1 月曾有傳言稱，醫療保險將被關閉，這也造成了混亂。因此存在著許多不同的動態，這可能是我們所見過的最糟糕的情況。

Great. Yeah. Thanks for the color. And then just quickly to touch on the triple combo. Do you have any time lines at this point as to when it could reach market and what any sort of regulatory framework would look like here to get it approved?

偉大的。是的。謝謝你的顏色。然後快速談一下三重組合。目前，您是否有關於該產品何時可以上市的時間表，以及需要什麼樣的監管框架才能獲得批准？

Sure. Yeah. So in our prepared remarks, the timing is we'd like to see this product hit in 2027. The regulatory aspects of this is that this is just really a bioequivalence and stability. There's no clinical study that's necessary in order to get the product onto the market. But I think the biggest question there is the timing, and that's 2027.

當然。是的。因此，在我們的準備好的評論中，我們希望看到這款產品在 2027 年上市。其監管方面實際上只是生物等效性和穩定性。無需進行臨床研究即可將產品推向市場。但我認為最大的問題是時機，也就是 2027 年。

Jessica Fye, JP Morgan.

傑西卡費伊 (Jessica Fye)，摩根大通 (JP Morgan)。

Hey guys, good morning. Thanks for taking my question. I was hoping you could help us think about the gross margin trajectory over the remainder of this year and the next few years. And just kind of in addition to which direction the numbers are going, kind of explain to us what's behind the evolution in gross margin as well? Thank you.

大家好，早安。感謝您回答我的問題。我希望您能幫助我們思考今年剩餘時間和未來幾年的毛利率走勢。除了數字的變化方向之外，您能否向我們解釋一下毛利率變化背後的原因？謝謝。

Yeah. Jess, this is Ben. So our gross margin is largely influenced by the proportion of what sales we see between the US and those tablet sales to our partners, mainly DSE, which I think we mentioned before are at the flat to negative margin. So as the tech transfer progresses, we'll see those margins improve.

是的。傑西，這是本。因此，我們的毛利率在很大程度上受到美國銷售額和我們合作夥伴（主要是 DSE）的平板電腦銷售額比例的影響，我認為我們之前提到過，DSE 的利潤率持平或為負。因此，隨著技術轉移的進展，我們將看到利潤率的提高。

And we'll also see improvement on the working capital side as we start transitioning some of that to I think that's kind of a multiyear progression. It's not going to be overnight. I won't comment this quarter, we did have some cost adjustments in COGS, which inflated it, I would say, more so than typical. And we do not expect those to recur again in Q2. But I think we'll continue to see improving margins as the tech transfer goes on over the next year or so here.

隨著我們開始將部分營運資金轉變為營運資金，我們也將看到營運資金的改善，我認為這將是一個多年的進展。這不會是一夜之間的事。我不會對本季度發表評論，我們確實對 COGS 進行了一些成本調整，我想說，這比通常情況下更加誇大了。我們預計這些情況不會在第二季再次發生。但我認為，隨著未來一年左右技術轉移的進行，我們將繼續看到利潤率的提高。

And ultimately, we'll come back to what I would say are a normal pharmaceutical margin for a biotech company in this space.

最終，我們將回到我所說的這個領域生技公司的正常醫藥利潤率。

Thank you.

謝謝。

I'm not showing any further questions in the queue. I'd like to turn the call back over to Sheldon for any closing remarks.

我不會在隊列中顯示任何其他問題。我想將電話轉回給謝爾頓，請他做最後發言。

Thank you, operator, and thank you all again for your time and attention this morning. We are looking forward to participating in the Citizens JMP Life Science Conference later this week and hope to have the opportunity to connect with many of you then.

謝謝接線員，再次感謝大家今天上午的時間和關注。我們期待本週晚些時候參加公民 JMP 生命科學會議，並希望有機會與你們中的許多人建立聯繫。

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 for your support.

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，並感謝您的支持。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。祝大家有個愉快的一天。