Esperion Therapeutics Inc (ESPR) 2023 Q4 法說會逐字稿

Good morning, ladies and gentlemen.

早安，女士們，先生們。

Thank you for standing by and welcome to Esperion's fourth-quarter 2023 earnings conference call.(Operator Instructions)

感謝您的耐心等待並歡迎參加 Esperion 2023 年第四季財報電話會議。（操作員說明）

Please be advised that today's conference call may be recorded.

請注意，今天的電話會議可能會被錄音。

I would now like to hand the conference over to Alexis Callahan, Head of Investor Relations.

我現在想將會議交給投資者關係主管 Alexis Callahan。

Please go ahead, Alexis.

請繼續，亞歷克西斯。

Thank you, operator.

謝謝你，接線生。

Good morning, and welcome to Esperion's fourth quarter and full year 2023 earnings conference call.

早上好，歡迎參加 Esperion 第四季和 2023 年全年財報電話會議。

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

今天與我們在一起的有總裁兼執行長 Sheldon Koenig；在我們準備好的演講之後，財務長本·哈拉迪(Ben Halladay) 和執行團隊的其他成員將接受問答，我們今天早上早些時候發布了一份新聞稿，詳細介紹了今天電話會議的內容。

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.

您可以在我們網站的投資者頁面上找到一份副本，以及我們也將參考的簡報的副本。

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

我想提醒來電者，今天電話中討論的資訊受《私人證券訴訟改革法案》安全港條款的保護。

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

我提醒聽眾，管理階層將做出前瞻性聲明。

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

由於與業務相關的風險和不確定性，實際結果可能與我們的前瞻性陳述中明示或暗示的結果有重大差異。

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

這些前瞻性陳述完全符合今天的新聞稿和我們向美國證券交易委員會提交的文件中所包含的警示性陳述。

The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, February 27, 2024, and 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.

本次電話會議的內容包含時間敏感信息，僅截至本次直播之日（2024 年 2 月 27 日）準確，我們不承擔修改或更新任何前瞻性陳述以反映直播後發生的事件或情況的義務。這次電話會議和網路廣播的日期提醒一下，本次電話會議和網路廣播正在錄音和存檔。

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

我們將以準備好的發言開始通話，然後打開電話詢問您的問題。

I'll now turn the call over to Sheldon Koenig, President and Chief Executive Officer.

現在我將把電話轉給總裁兼執行長謝爾登·科尼格 (Sheldon Koenig)。

Thank you, Alexis, and good morning, everyone.

謝謝你，亞歷克西斯，大家早安。

Thank you for joining us today to discuss our fourth quarter and full year results and the significant progress we continue to make.

感謝您今天加入我們討論我們第四季度和全年的業績以及我們繼續取得的重大進展。

We are pleased to report another strong quarter as well as key material events in January that we believe put our company on solid footing and further position us for continued long-term success.

我們很高興地報告又一個強勁的季度以及 1 月份的關鍵重大事件，我們相信這些事件使我們公司奠定了堅實的基礎，並進一步為我們取得持續的長期成功奠定了基礎。

Starting with our quarterly performance, total revenue was $32.3 million, which represents a 72% increase year-over-year US net revenue came in at $20.8 million, which represents a 39% increase year-over-year, driven by a 44% year-over-year increase in retail prescription equivalents.

從我們的季度業績開始，總收入為 3230 萬美元，同比增長 72%；美國淨收入為 2080 萬美元，同比增長 39%，同比增長 44% -零售處方當量同比增長。

We believe the continued growth seen in both the US and in our global territories is a testament to the strength of our clinical data, the unmet need in the market and our teams and partners' abilities to execute listed here are several recent accomplishments worth calling out.

我們相信，美國和全球地區的持續成長證明了我們臨床數據的實力、市場上未滿足的需求以及我們的團隊和合作夥伴的執行能力，這裡列出的是近期值得一提的成就。

We delivered another strong quarter that positions us for continued success in the long term and significantly transforms our capital position and investment profile.

我們又實現了一個強勁的季度，這使我們能夠在長期內持續取得成功，並顯著改變我們的資本狀況和投資狀況。

Prescription growth continued at a strong pace, and we're proud of the momentum that we sustained through the end of the year.

處方藥持續強勁成長，我們對年底保持的勢頭感到自豪。

Additionally, we resolved our pending litigation with DSC and expanded our partnership on mutually beneficial terms.

此外，我們還解決了與 DSC 的未決訴訟，並以互惠互利的方式擴大了我們的合作夥伴關係。

We further strengthened our balance sheet with additional capital, emphasizing our strong cash position and bringing in several new long-term biotech investors.

我們透過額外資本進一步強化了我們的資產負債表，強調我們強大的現金狀況，並引入了一些新的長期生技投資者。

Our label expansion approvals remain on track in both the US and Europe.

我們在美國和歐洲的標籤擴展批准仍在進行中。

We published additional important data from our CLEAR Outcomes trial, and we remain focused on preparation for our new label, expanding our commercial organization to ensure we're ready to fully capitalize on the opportunity when we receive approval next month.

我們發布了 CLEAR Outcomes 試驗的更多重要數據，我們仍然專注於為新標籤做準備，擴大我們的商業組織，以確保我們準備好在下個月獲得批准時充分利用這個機會。

At January third, we announced a settlement agreement and an amendment to our collaboration with Daiichi Sankyo Europe, which Mark the resolution of our pending litigation settlement was mutually beneficial and reflects both parties' commitment to our ongoing partnership to deliver our medications to patients worldwide and address global unmet need.

1 月3 日，我們宣布了一項和解協議以及對我們與第一三共歐洲公司合作的修訂，這標誌著我們懸而未決的訴訟和解的解決方案是互惠互利的，並反映了雙方對我們持續合作夥伴關係的承諾，即向世界各地的患者提供我們的藥物，以及解決全球未滿足的需求。

Importantly, we believe the closure of this matter significantly strengthens our investment profile, reduces costs associated with the litigation and is an excellent outcome for both parties.

重要的是，我們相信此案的結束將顯著增強我們的投資狀況，降低與訴訟相關的成本，對雙方來說都是一個極好的結果。

It provides for significant near term cash payments, inventory and gross margin savings and potentially extend our European product lifecycle while generating additional potential royalty streams in the DS territory.

它可以提供大量的短期現金支付、庫存和毛利率節省，並有可能延長我們的歐洲產品生命週期，同時在 DS 領域產生額外的潛在特許權使用費流。

The net result of all components of our agreement provides both near and long-term value.

我們協議所有組成部分的最終結果提供了近期和長期價值。

It allows us to continue focusing on running our business combining our year-end cash balance.

它使我們能夠繼續專注於結合年終現金餘額來經營我們的業務。

With the $100 million settlement payment received in January and proceeds from our recent offering, we significantly strengthened our liquidity position, which enables us to invest in initiatives that support the long-term success of Esperion.

憑藉 1 月份收到的 1 億美元和解付款以及我們最近發行的收益，我們顯著增強了我們的流動性狀況，這使我們能夠投資於支持 Esperion 長期成功的舉措。

With the litigation now resolved and the infusion of additional cash, we are poised for significant growth in 2024. Now let me turn to our upcoming label expansion, which we anticipate will include a new broad cardiovascular risk reduction indication, expand access to the primary prevention patient population or those at risk of an event, not just those who have already had one and they moved the stat use requirements.

隨著訴訟現已解決並注入額外現金，我們準備在2024 年實現顯著增長。現在讓我談談我們即將推出的標籤擴展，我們預計將包括新的廣泛心血管風險降低適應症、擴大初級預防的覆蓋範圍患者群體或有事件​​風險的人，而不僅僅是那些已經發生過事件的人，並且他們改變了統計數據的使用要求。

These are significant changes to our current label, supported by our robust clear outcomes data and are expected to drive substantial future growth.

這些是對我們目前標籤的重大改變，並得到我們強大、清晰的結果數據的支持，預計將推動未來的大幅成長。

I'm pleased to share that reviews of our pending applications with the FDA and EMA are progressing extremely well.

我很高興地告訴大家，FDA 和 EMA 對我們待審申請的審查進展非常順利。

And these positive discussions remain in line with our strategic goals.

這些積極的討論仍然符合我們的策略目標。

We are on track with an FDA PDUFA date of March 31, with an expected decision by the EMA on our European label, likely coming in the second quarter based on our existing label and narrow indication, our current addressable market is around 10 million patients in the US upon approval of our new anticipated label our models predict an opportunity that triples to around 30 million patients.

我們預計FDA PDUFA 日期為3 月31 日，預計EMA 對我們的歐洲標籤做出決定，根據我們現有的標籤和狹窄的適應症，可能會在第二季度做出決定，我們目前的目標市場約為1,000 萬名患者在美國批准我們的新預期標籤後，我們的模型預測機會將增加兩倍，達到約 3,000 萬名患者。

That figure, however, does not include an additional 14 million untreated individuals who are at high risk and who are still not at their LDL-cholesterol goal.

然而，這個數字不包括另外 1,400 萬未經治療的高風險族群，他們的 LDL 膽固醇水平仍未達到目標。

We see vast potential for our products to help millions more patients in the future, reiterating our eagerness for the FDA's anticipated approval today, I'd like to outline the five core pillars that will ensure our life-saving products, [Nexletol, Nexlizet] that reach the appropriate patients.

我們看到我們的產品在未來幫助數百萬患者的巨大潛力，重申我們對 FDA 今天預期批准的渴望，我想概述確保我們拯救生命的產品的五個核心支柱，[Nexletol，Nexlizet]到達適當的患者。

One, our expanded label, our anticipated new label will reflect clear outcomes data and will also create a differentiated and expanded indication that includes high risk primary prevention patients to all new promotion, current commercial resources for Nexletol, Nexlizet.

一是我們擴展的標籤，我們預期的新標籤將反映明確的結果數據，還將創建一個差異化和擴展的適應症，包括高風險一級預防患者的所有新促銷、Nexletol、Nexlizet 的當前商業資源。

And next was that our focus on LDL cholesterol reduction in patients with ASCVD on maximally tolerated statins.

接下來我們關注的是使用最大耐受他汀類藥物來降低 ASCVD 患者的 LDL 膽固醇水平。

It's still not at their LDL cholesterol goal.

它仍然沒有達到他們的低密度脂蛋白膽固醇目標。

Based on the anticipated new label, the team has prepared a powerful suite of promotional tools that will communicate the clear outcomes data across the expected new and expanded patient population.

根據預期的新標籤，團隊準備了一套強大的促銷工具，將在預期的新患者和擴大的患者群體中傳達清晰的結果數據。

Extensive market research has been conducted to ensure the right sequence of data will be communicated at the right time three deeper reach.

我們已經進行了廣泛的市場研究，以確保正確的資料順序能夠在正確的時間傳達三層更深入的影響。

I'm proud to announce that we've completed our sales force expansion and have recently deployed 60 new territory managers into the field bringing our team up to 150 representatives.

我很自豪地宣布，我們已經完成了銷售隊伍的擴張，並且最近在該領域部署了 60 名新的區域經理，使我們的團隊代表人數達到 150 名。

These motivated individuals, together with improved digital resources, will allow us to expand our depth and breadth to reach a target universe of 45,000 health care providers comprised of both primary care providers and specialists for patient activation.

這些積極主動的個人，加上改進的數位資源，將使我們能夠擴大我們的深度和廣度，以涵蓋 45,000 名醫療保健提供者的目標群體，其中包括初級保健提供者和患者激活專家。

We've created a bold new consumer campaign to drive awareness and ensure appropriate patients have discussions with our health care providers about Nexletol and Nexlizet and five payer access and reimbursement.

我們發起了一項大膽的新消費者活動，以提高意識並確保適當的患者與我們的醫療保健提供者就 Nexletol 和 Nexlizet 以及五個付款人的使用和報銷進行討論。

Finally, we continue to align payers utilization management criteria with our anticipated label to include primary prevention and primary hyperlipidemia, while at the same time enhancing our patient service programs to support both patients and healthcare providers alike were also pleased to announce that [ICE or] the Institute for Clinical and Economic Review just determined that for that as a cost effective therapy, which adds support for its value proposition to payers, we believe our recent achievements and changes we've implemented set us up for long term, sustained growth.

最後，我們繼續將付款人利用管理標準與我們預期的標籤保持一致，包括初級預防和初級高脂血症，同時加強我們的患者服務計劃以支持患者和醫療保健提供者也很高興地宣布[ICE或]臨床和經濟評論研究所剛剛確定，作為一種具有成本效益的療法，它增加了對付款人對其價值主張的支持，我們相信我們最近取得的成就和我們實施的變革將為我們實現長期、持續的成長。

Shown here are a series of important commercial clinical regulatory and financial milestones that we expect to be achieved along the way, you'll see that this steady stream of catalysts begin to form a roadmap for long-term value growth.

這裡顯示的是我們期望在此過程中實現的一系列重要的商業臨床監管和財務里程碑，您將看到這種源源不斷的催化劑開始形成長期價值成長的路線圖。

We've already expanded our sales force and anticipate label expansions in both the US and Europe.

我們已經擴大了銷售隊伍，並預計在美國和歐洲擴大品牌規模。

With expected new global labels, we anticipate guidelines to be updated.

隨著預計出現新的全球標籤，我們預計指南也會更新。

In addition, we expect to file INDs or investigational new drug applications for our next-generation ACLY inhibitors to lay the groundwork for growing our product pipeline beyond bempedoic acid.

此外，我們預計將為我們的下一代 ACLY 抑制劑提交 IND 或研究性新藥申請，為擴大我們的產品線超越 bempedoic 酸奠定基礎。

Furthermore, our partners will continue launching our products in even more new territories on a regular cadence creating additional revenue streams and bolstering our growing global franchise.

此外，我們的合作夥伴將繼續定期在更多新地區推出我們的產品，創造額外的收入來源並支持我們不斷增長的全球特許經營權。

Longer term, the optimization of our balance sheet and partnership related cost savings should enable us to continue to enhance our capital position over time.

從長遠來看，資產負債表的優化和合作夥伴關係相關的成本節約應該使我們能夠隨著時間的推移繼續增強我們的資本狀況。

We also see meaningful revenue contribution stemming from the potential for a triple combination therapy in Europe, additional milestone payments from our network of partners, additional ex-US opportunities and continued growth stemming from further advancement of our preclinical pipeline.

我們還看到，歐洲三聯療法的潛力帶來了有意義的收入貢獻，我們的合作夥伴網絡提供了額外的里程碑付款，美國以外的其他機會以及我們臨床前管道的進一步推進帶來的持續增長。

On that note, I'm excited to announce our intent to hold an R&D Day later this year to review our pipeline of next-gen ACLY inhibitors in more depth.

在這一點上，我很高興地宣布我們打算在今年稍後舉辦研發日活動，以更深入地審查我們的下一代 ACLY 抑制劑產品線。

With that, I will now hand it over to Ben Halladay, our Chief Financial Officer, for a more detailed review of our fourth quarter performance.

現在，我將把它交給我們的財務長本·哈拉迪 (Ben Halladay)，以更詳細地審查我們第四季度的業績。

Thank you, Sheldon.

謝謝你，謝爾頓。

Earlier this morning, we issued a press release containing our financial results for the fourth quarter, which is available on the Investor page of our website.

今天早些時候，我們發布了一份新聞稿，其中包含第四季度的財務業績，可在我們網站的投資者頁面上查看。

Please note that unless otherwise specified, my comments reflect results for the fourth quarter ended December 31, 2023.

請注意，除非另有說明，我的評論反映的是截至 2023 年 12 月 31 日的第四季度的結果。

As Sheldon already mentioned, we posted strong fourth quarter results and ended the year with continued momentum included in new-to-brand prescriptions.

正如謝爾頓已經提到的，我們發布了強勁的第四季度業績，並以新品牌處方的持續增長勢頭結束了這一年。

We ended the year on a strong note, which really emphasizes the point that outcomes data matters, and we're excited for that data to be incorporated into our new label next month and for what it means for patient access and our ability to actively promote the data for the first time, we again delivered another quarter of continued growth in retail prescription equivalents, which increased 44% year over year and 8% quarter over quarter and was accomplished even with our current label and promotional footprint before recently ramping up our in-house sales force weekly.

我們以強烈的基調結束了這一年，這確實強調了結果數據的重要性，我們很高興這些數據下個月將被納入我們的新標籤中，以及它對患者訪問和我們積極促進的能力意味在著什麼首次公佈這些數據後，我們再次實現了零售處方藥等價物又一個季度的持續增長，同比增長44%，環比增長8%，即使在我們當前的標籤和促銷足蹟之前，我們也實現了這一目標. -每週房屋銷售人員。

Our PE trend also reflects this momentum and touch the 12,000 RPE mark late in the fourth quarter and new weekly highs.

我們的本益比趨勢也反映了這一勢頭，並在第四季度末觸及 12,000 RPE 大關和新的周高點。

Turning to growth outside the US, our partner GSC again delivered another strong quarter of sales growth in its territories.

談到美國以外的成長，我們的合作夥伴 GSC 在其地區再次實現了強勁的季度銷售成長。

Underscoring the value our approved medicines are bringing to the patients globally.

強調我們批准的藥物為全球患者帶來的價值。

At the end of November, approximately 202,000 patients have now been treated with our therapies in Europe, representing sequential three-month growth of 28% since August.

截至 11 月底，歐洲約有 202,000 名患者接受了我們的療法治療，自 8 月以來連續三個月增加了 28%。

I will note that most of this growth has been generated from existing territories.

我要指出的是，大部分成長來自現有領土。

That said, DSE commercially launched in three new territories during the fourth quarter.

也就是說，DSE 於第四季在三個新地區進行了商業推出。

The Netherlands Slovakia and Spain and gained approval in [Czech] of public as well.

荷蘭、斯洛伐克和西班牙，以及[捷克]公眾的認可。

In addition, Daiichi Sankyo launched in Hong Kong during fourth quarter, marking the first country in the Asia region to launch.

此外，第一三共於第四季在香港推出，成為亞洲地區第一個推出該產品的國家。

Turning to our full financial results for the quarter, we reported US net product revenue of $20.8 million, representing an increase of 39% year over year collaboration revenue, which includes combined royalty and partner revenue was $11.5 million, an increase of 195% year over year.

轉向本季的完整財務業績，我們報告美國產品淨收入為2080 萬美元，年增39%，其中合作收入同比增長39%，其中包括特許權使用費和合作夥伴收入合計為1150 萬美元，同比增長195%年。

Finally, total revenue for the fourth quarter was $32.3 million, an increase of 72% year-over-year.

最後，第四季總營收為3,230萬美元，較去年同期成長72%。

Turning to expenses, cost of goods sold for the fourth quarter was $11.5 million, an increase of 174% year over year, driven primarily by higher tablet shipments to our partners to support new country launches.

說到費用，第四季度的銷售成本為 1,150 萬美元，年增 174%，這主要是由於我們向合作夥伴增加了平板電腦出貨量，以支持新國家/地區的發布。

R&D expense was $17.7 million, a decrease of 46% year over year, reflecting substantially lower costs following the close out of our clear Outcomes trial.

研發費用為 1,770 萬美元，年減 46%，反映出我們明確的結果試驗結束後成本大幅下降。

SG&A expense was $45.4 million, an increase of 88% year over year, reflecting higher legal and promotional costs as well as higher headcount as we began to ramp up our in-house sales force.

SG&A 費用為 4,540 萬美元，年增 88%，反映出法律和促銷成本的增加，以及隨著我們開始擴大內部銷售隊伍而增加的員工人數。

Of note, we incurred $13.1 million in one-time legal expenses related to our litigation resolution with DSC that are nonrecurring in nature.

值得注意的是，我們與 DSC 的訴訟解決方案相關的一次性法律費用為 1,310 萬美元，這些費用屬於非經常性費用。

Finally, cash equivalents and investment securities available for sale totaled $82.2 million as of December 31, 2023, compared with $166.9 million on December 31, 2022.

最後，截至 2023 年 12 月 31 日，可供出售的現金等價物和投資證券總額為 8,220 萬美元，而 2022 年 12 月 31 日為 1.669 億美元。

Although that figure does not include the settlement related cash payment we received in January, nor the proceeds from our recent public offering today, we are also reiterating the 2024 expense guidance we put forth last month.

儘管該數字不包括我們 1 月收到的與和解相關的現金付款，也不包括我們今天最近公開發行的收益，但我們也重申了我們上個月提出的 2024 年費用指引。

For the full year 2024.

2024 年全年。

We expect R&D expense to be between $45 million and $55 million, SG&A expense to be between $180 million and $190 million and total OpEx to be between $225 million and $245 million.

我們預計研發費用將在 4,500 萬美元至 5,500 萬美元之間，SG&A 費用將在 1.8 億美元至 1.9 億美元之間，總營運支出將在 2.25 億美元至 2.45 億美元之間。

Although the total operating expenses are expected to come in the same level of last year.

儘管總營運費用預計與去年持平。

We've just shifted dollars from our R&D budget to the SG&A budget to reflect the close out of the clear Outcomes and ramping up the commercial activities to support our new and expanded label.

我們剛剛將資金從研發預算轉移到銷售、一般管理預算，以反映明確成果的結束，並加強商業活動以支持我們新的和擴展的品牌。

While we have materially strengthened our balance sheet in recent weeks, we remain disciplined when it comes to expense allocation, ensuring the investments we make, including those to support our commercial launch are generating sufficient returns.

儘管最近幾週我們大幅加強了資產負債表，但我們在費用分配方面仍保持紀律，確保我們所做的投資（包括支持我們商業發布的投資）產生足夠的回報。

And with that, let me now hand it back over to you, Sheldon.

現在，讓我把它交還給你，謝爾頓。

Thank you.

謝謝。

Then I'd like to close by reiterating that we continue to deliver on our commitments and execute on our strategic plan to achieve blockbuster status.

最後，我想重申，我們將繼續履行我們的承諾並執行我們的戰略計劃，以實現重磅炸彈的地位。

Sales are continuing to accelerate following publication of our clear outcomes data last year, and we anticipate a true inflection to occur after we receive approval of our new and expanded labels in the US and Europe later this year.

去年發布明確的結果數據後，銷售繼續加速，預計今年稍後我們在美國和歐洲獲得新標籤和擴展標籤的批准後，真正的變化將會發生。

Our strategic plan also consists of an expansion of our product pipeline as we further develop our next-gen ACLY inhibitors.

我們的策略計劃還包括隨著我們進一步開發下一代 ACLY 抑制劑而擴大我們的產品線。

We will further expand on our pipeline later this year.

我們將在今年稍後進一步擴大我們的管道。

But in short, we are excited about our next-gen platform and the potential therapeutic areas to which it could be applicable.

但簡而言之，我們對我們的下一代平台及其可能適用的潛在治療領域感到興奮。

Further development of these assets could help us expand beyond lipids and enter into new markets with significant unmet need, increase.

這些資產的進一步開發可以幫助我們超越脂質並進入需求顯著未滿足的新市場。

Our addressable markets extend our product lifecycle and open the door to additional partnering opportunities as well as help us achieve long-term sustainable growth in summary, I'm excited for what I believe lies in-store for us, both now and in the future.

我們的目標市場延長了我們的產品生命週期，為更多合作機會打開了大門，並幫助我們實現長期可持續成長。總而言之，我對我們現在和未來的前景感到興奮。

And our path has never been clear or brighter.

我們的道路從未如此清晰和光明。

And with that, operator, we are now ready for Q&A.

至此，操作員，我們現在準備好進行問答了。

(Operator Instructions) Serge Belanger, Needham

（操作員說明）Serge Belanger，Needham

Good morning.

早安.

Thanks for taking my questions.

感謝您回答我的問題。

I guess for Sheldon, we're about 30 days away or so from the producer for the label expansion.

我想對 Sheldon 來說，距離製作人進行廠牌擴張大約還有 30 天左右的時間。

Maybe just talk about the cadence of activities that would follow that label expansion, given that there's DCC. and -- what the plan is to do in terms of payers and formulary coverage?

考慮到 DCC 的存在，也許只是談論品牌擴展後的活動節奏。以及－該計劃在付款人和處方保險範圍方面有何作用？

Yes.

是的。

Thank you, Serge, and good morning.

謝謝你，塞爾日，早安。

And so yes, we are about 30 days away from our producer date.

是的，距離生產日期還有大約 30 天。

And just again, wanted to reiterate, I do not see any issues at all getting there.

再次重申，我認為實現這一目標沒有任何問題。

We've had some very positive interactions with the FDA.

我們與 FDA 進行了一些非常積極的互動。

So again, feeling really confident about our label and the strategy that we've laid out regarding the label you heard about our five pillars that we mentioned in our prepared remarks as we get ready to launch this new label, which we've always said will be an inflection point for us as it relates to payers, we've been out talking to payers since the last ACC.

再說一次，我們對我們的品牌和我們針對該品牌制定的策略充滿信心，您聽說過我們在準備推出這個新品牌時提到的五個支柱，我們一直在說這一點這對我們來說將是一個轉捩點，因為它與付款人有關，自上次ACC 以來我們一直在與付款人交談。

March Saforis.

馬奇·薩福里斯。

I'm happy to say we've made great progress with the payers and we've seen some payers already making changes in anticipation of the new label.

我很高興地說，我們與付款人取得了很大進展，並且我們看到一些付款人已經因預期新標籤而做出了改變。

I think what's also interesting in our prepared remarks, we mentioned that I [serge] just recently came out and made reference to next was that as being a cost effective therapy and essentially should be made available on all formularies.

我認為我們準備好的發言中也很有趣，我們提到我[serge]最近剛剛出來並提到下一步是作為一種具有成本效益的療法，基本上應該在所有處方集上提供。

So that's something we'll also reimburse with payers.

因此，我們也會向付款人進行補償。

So we feel very confident about our payer strategy and the interactions that we have had with them.

因此，我們對我們的付款人策略以及我們與他們的互動非常有信心。

To your point for ACC, again, we get the label, the new label end of March.

就你對 ACC 的觀點而言，我們再次獲得了標籤，即三月底的新標籤。

ACC is around the April fifth timeframe.

ACC 大約在 4 月 5 日左右。

And we'll be using ACC as a way to really launch that new label and really make a big splash regarding the new label.

我們將使用 ACC 作為真正推出新品牌並真正引起新品牌轟動的一種方式。

And Serge, it's Eric, if I can add that to day one, our sales force will be ready to go.

Serge，我是 Eric，如果我可以在第一天添加這一點，我們的銷售團隊將做好準備。

So April first, we have a full day of training to ensure that that team deploys rapidly.

因此，四月一日，我們進行了一整天的培訓，以確保團隊快速部署。

As Sheldon mentioned, we have the ACC. where we'll deploy the new campaign as well as we'll have speaker programs and scientific interaction.

正如謝爾頓所提到的，我們有 ACC。我們將在那裡部署新的活動，並舉辦演講節目和科學互動。

And then we'll transition to middle of April to have a launch meeting and start that digital as well as consumer program.

然後我們將在四月中旬召開啟動會議並啟動數位和消費者計畫。

So we've got a full slate of activities planned by day one.

因此，我們從第一天起就規劃好了一系列的活動。

It's when we're beginning them.

這是我們開始的時候。

Okay.

好的。

So maybe just a follow-up in terms of gross to nets.

所以也許只是淨值的後續行動。

How stable have they been through 2023?

2023 年他們的穩定性如何？

And maybe just talk what kind of impact you expect in the first quarter, whether they can improve once you have the label update and additional product volumes?

也許只是談談您預計第一季會產生什麼樣的影響，一旦標籤更新和產品數量增加，它們是否會有所改善？

Yes, Serge, it's Ben.

是的，塞爾日，我是本。

Thanks for the question.

謝謝你的提問。

So I would say throughout 2023, we saw gross to net that were extremely in line with our expectations in regards to seasonality and where we think a healthy gross-to-net should be going into 2024.

因此，我想說，整個 2023 年，我們看到的毛淨額與我們對季節性的預期非常一致，我們認為 2024 年毛淨額應該保持健康。

We expect that to be mostly the same as we'll see some incremental improvements in certain areas like distribution fees, that volume typically it helps bring down.

我們預計這將基本相同，因為我們將看到某些領域（例如分銷費）的一些漸進式改進，通常有助於降低該數量。

But overall, we don't expect any major change or we should see the same sort of seasonality that we saw this year.

但總體而言，我們預計不會出現任何重大變化，或者我們應該會看到與今年相同的季節性。

Thank you.

謝謝。

Thank you. Tom Shrader with BTIG.

謝謝。湯姆·施雷德 (Tom Shrader) 與 BTIG 合作。

Good morning.

早安.

Thank you for taking my call about the new label.

感謝您接聽我關於新標籤的電話。

So you've already had the maximum statin requirement or language dropped, has that had any effect on how payers treat the drug?

那麼您已經達到了他汀類藥物的最高要求或語言被刪除，這對付款人如何對待該藥物有任何影響嗎？

And I guess what I'm I think what I'm hearing from you guys is that once you can market to see what the real driver is going to be the pull from physicians that they want the drug, which will be the big lever for getting payers to to make it available more easily.

我想，我想我從你們那裡聽到的是，一旦你們能夠進行行銷，看看真正的驅動力將是來自醫生的拉力，他們想要這種藥物，這將是一個巨大的槓桿讓付款人更容易使用它。

Is that correct or is it at the payer level that you really need to do your work?

這是正確的還是您真正需要完成工作的付款人等級？

Thanks.

謝謝。

Yeah, great.

很好。

Thanks, Tom.

謝謝，湯姆。

I'll let me start and then I'll ask -- also comments to be made.

讓我開始，然後我會問——還有評論。

So as you stated at the end of December, we saw that the FDA did what I would call harmonization of labels and every move and the maximum tolerated dose of statin.

因此，正如您在 12 月底所說，我們看到 FDA 做了我所說的標籤、每一步以及他汀類藥物最大耐受劑量的協調。

And they essentially acknowledged that we had outcomes very different from the label we'll be getting at the end of March, which will have the clear outcomes data.

他們基本上承認，我們的結果與我們將在三月底獲得的標籤非常不同，後者將具有明確的結果數據。

Now with that said, there were some accounts.

話雖如此，還是有一些帳號的。

It actually acted as a catalyst for accounts to be prepared for the new label and some of them went forward and did make changes and removed that.

它實際上充當了帳戶為新標籤做好準備的催化劑，其中一些帳戶確實做出了更改並刪除了它。

I might step at it, for instance, but to your point, and one of the reasons why we've always said the new label would be a catalyst flash inflection point.

例如，我可能會介入它，但就你的觀點而言，這也是我們總是說新標籤將是催化劑閃現拐點的原因之一。

Keep in mind, we're the only drug besides statins that studied not only secondary prevention but primary prevention.

請記住，我們是除他汀類藥物之外唯一不僅研究二級預防而且研究一級預防的藥物。

That's a big differentiation from drugs like Adomite and PCSK9 and keep in mind also in part of our strategy for our label is that you can use that so that on its own or you can use it with statins, so a doctor has choices now.

這與 Adomite 和 PCSK9 等藥物有很大區別，請記住，我們標籤策略的一部分是，您可以單獨使用它，也可以與他汀類藥物一起使用，因此醫生現在有選擇。

And again, for those primary prevention patients, it's extremely important.

再說一次，對於那些一級預防患者來說，這是極為重要的。

Now we've talked to payers about this.

現在我們已經與付款人討論了此事。

As mentioned in the last question, they're very receptive to what our new label will look like.

正如上一個問題所提到的，他們非常願意接受我們的新標籤。

We've talked to them.

我們已經和他們談過了。

Of course, we won't know what our final label is until we get it.

當然，在得到最終標籤之前我們不會知道它是什麼。

But we've talked to them of what it could look like and what we would need for them to do to change criteria.

但我們已經與他們討論了它可能會是什麼樣子，以及我們需要他們做什麼來改變標準。

And for the most part, they've been very agreeable.

在大多數情況下，他們都非常愉快。

And that will really then lessen the barrier of physicians being able to get the drug.

這確實會減少醫生獲得藥物的障礙。

That's what the label does.

這就是標籤的作用。

It makes it easier for physicians to get this drug on label right now is very narrow and very restrictive.

它使醫生更容易在標籤上獲得這種藥物，目前標籤範圍非常狹窄且限制性很大。

As we mentioned in our prepared remarks, the population goes from 10 million to 30 million plus patients.

正如我們在準備好的發言中提到的，患者人數從 1000 萬增加到 3000 萬以上。

I did say I com improving payer coverage, certainly matters as a priority.

我確實說過我會改善付款人的覆蓋範圍，這當然是優先事項。

And we've been streamlining our consistency in utilization management.

我們一直在簡化利用率管理的一致性。

We actually have had UM criteria improve just in CVOT presentations, the interim label with over 16 claims both regionally and nationally, we are well poised for the new label, and we're very excited and those discussions have been continuing since last year's ACC to current day.

實際上，我們僅在CVOT 演示中就改進了UM 標準，該臨時標籤在地區和國家範圍內擁有超過16 個聲明，我們已為新標籤做好了準備，我們非常興奮，自去年的ACC 以來，這些討論一直在繼續當前日期。

And all the payers are anticipating the new label.

所有付款人都在期待新標籤。

So we feel very confident in that regard.

所以我們對此非常有信心。

Okay.

好的。

Thank you.

謝謝。

Jason Zemansky from Bank of America.

美國銀行的傑森澤曼斯基。

Good morning.

早安.

Thanks for taking our questions and congrats on the quarter.

感謝您回答我們的問題並祝賀本季。

Two, if I may, please.

兩個，如果可以的話，請。

I was hoping first, you could provide some color on the specific impact of FDA's label revision in December.

首先，我希望您能提供一些有關 FDA 12 月標籤修訂的具體影響的資訊。

I appreciate the holidays were right there, but was there any lift or acceleration either in interest or sales at that point with the loosening of restrictions?

我很高興假期就在那裡，但是隨著限制的放鬆，當時的興趣或銷售是否有任何提升或加速？

Hey, Jason, it's Eric.

嘿，傑森，我是艾瑞克。

So we did drive that 8% growth, which is relatively consistent to prior quarters with the exception of second quarter.

因此，我們確實推動了 8% 的成長，這與除第二季度外的前幾季相對一致。

But Tim, as you know, that change that we saw we moved the maximally tolerated at requirement, but it still kept statins and a full payer changes didn't happen with regards to that removal.

但是蒂姆，正如你所知，我們看到的變化是我們在要求中移動了最大容忍度，但它仍然保留了他汀類藥物，並且就該移除而言，並沒有發生全額付款人的變化。

So yes, I would say it it kept us growing on the cadence that we were growing, but it didn't have a dramatic inflection like we anticipate when we're going to have the updated label in April first.

所以，是的，我想說它讓我們以我們正在成長的節奏成長，但它並沒有像我們預期的那樣發生戲劇性的變化，當我們將在四月第一天擁有更新的標籤時。

So as Sheldon stated, not only is it a quantity of patient change going from 10 to 30, potentially 70, but it's a quality incorporating that primary prevention and fully removing VISTA and requirements.

因此，正如 Sheldon 所說，這不僅是患者數量從 10 名變為 30 名，甚至可能是 70 名，而且是一種結合了初級預防並完全消除 VISTA 和要求的品質。

And Jason, I would add that, yes, the thing about the new label that we'll have at the end of March is it will be the first time that our representatives, our medical liaisons, et cetera, can actually speak to clear outcomes data.

傑森，我想補充一點，是的，關於我們將在三月底推出的新標籤，這將是我們的代表、我們的醫療聯絡員等第一次真正能夠說出明確的結果數據。

So the growth that Eric spoke to and the growth that we've demonstrated through 2023 has always been on the what I would say, again, the very restrictive label that we had.

因此，艾瑞克談到的成長以及我們在 2023 年之前所展示的成長一直是我想說的，我們所擁有的非常嚴格的標籤。

So and we never thought of and we tried to actually take time with folks to explain the label change from December do not confuse that with what the label change will be at the end of March because that's what really opens the door for us as it relates to new patients and really be able to maximize the value of our products.

因此，我們從未想過，我們嘗試花時間與人們一起解釋從 12 月開始的標籤變更，不要將其與 3 月底的標籤變更混淆，因為這才是真正為我們打開大門的原因對於新患者來說，真正能夠最大限度地發揮我們產品的價值。

Got it.

知道了。

And then so obviously, the NCE. one date passed last week.

很明顯，NCE。上週已經過了一個日子。

So generic companies can technically file for ANDAs for generic versions of Nextra tall.

因此，仿製藥公司可以從技術上為 Nextra tall 的仿製藥申請 ANDA。

Next lose that wanted to ask, have you received any Paragraph four notifications from generic manufacturers.

接下來想問的是，您是否收到來自仿製藥製造商的第四段通知。

We are aware of the data you mentioned, and it's something that we've been expecting.

我們知道你提到的數據，這也是我們一直在期待的。

But no, we have not received anything today.

但不，我們今天沒有收到任何東西。

Yes, Thank you our next question coming from the line of Nelson with JPM Chase.

是的，謝謝您，我們的下一個問題來自尼爾森和摩根大通的電話。

Your line is open.

您的線路已開通。

Yes, hey, guys.

是的，嘿，夥計們。

This is Nelson on for Jessica Fye And congratulations on a good quarter?

這是尼爾森為傑西卡·菲伊做的節目 祝賀本季表現出色？

And can you talk about how the shift in OUS manufacturing to GSCE., like how long that shift will take?

您能否談談 OUS 製造業如何向 GSCE 轉變，例如這種轉變需要多長時間？

And could you maybe see impact from that in 2024?

您能在 2024 年看到它的影響嗎？

And also, you mentioned there's a update of guidelines that could be on the horizon.

而且，您提到可能即將更新指南。

I think how soon do you expect to see that potentially happening and then for OpEx in 4Q, the R&D guideline, is that a it's like is that as low as the company could go?

我認為您預計多久會看到這種情況發生，然後對於第四季度的營運支出，研發指南，這是否是公司可以達到的最低水準？

Or is there some further development cost for the pipeline included in there?

或者其中包含的管道是否還有一些進一步的開發成本？

Thank you.

謝謝。

Ben, do you want to start with?

本，你想開始嗎？

Yes.

是的。

So I'll answer the manufacturing the OpEx question.

所以我將回答製造營運支出的問題。

So on the manufacturing transition to DSC tech transfer, which typically takes anywhere 16 to 18 months.

因此，製造向 DSC 技術轉移的過渡通常需要 16 至 18 個月的時間。

We've been in discussions with them about the timeframe and moving that along as quickly as possible.

我們一直在與他們討論時間表並儘快推進。

I think it's in both parties' interests and both parties are very excited to get it done.

我認為這符合雙方的利益，雙方都對完成這件事感到非常興奮。

Yes.

是的。

But that said, it will take time.

但這需要時間。

We're working through the specifics of the plan, but there is a possibility we'll start seeing some of the working capital benefits towards the end of the year.

我們正在研究該計劃的具體細節，但我們有可能在今年年底開始看到一些營運資金的好處。

And I wouldn't expect any of the gross margin savings to happen until next year when we're further along in the tech transfer, though.

不過，我預計直到明年我們在技術轉移方面取得進一步進展時才會出現任何毛利率節省。

And then on the OpEx guidance for R&D as we do, that guidance does include the preclinical pipeline spend.

然後，在我們所做的研發營運支出指南中，該指南確實包括臨床前管道支出。

And so that's all inclusive, but I will say we have sort of meaningfully manage that OpEx down and work pretty pretty lean at this point.

所以這就是包容性的，但我想說的是，我們已經有效地管理了營運支出，並且在這一點上工作相當精簡。

And I would just go to further add that we actually were in Munich about two weeks ago, we met with their manufacturing folks to do a kickoff of the tech transfer.

我想進一步補充一點，我們實際上大約兩週前在慕尼黑，與他們的製造人員會面，並啟動了技術轉移。

It was a really good meeting and were off to a really good start with their team and working together to get this done related to guidelines.

這是一次非常好的會議，我們與他們的團隊有了一個非常好的開始，並共同努力完成與指導方針相關的工作。

And again, we have no impact on guidelines where somebody at the mercy of the folks that write the guidelines.

再說一次，我們對指導方針沒有任何影響，因為有人受制於編寫指導方針的人的擺佈。

There was some thought that guidelines would have come out in 2023.

有人認為指導方針將於 2023 年發布。

There's a potential maybe it could be 2024.

有可能是 2024 年。

I do think once our new label comes out, there will be consensus statements, et cetera.

我確實認為一旦我們的新標籤問世，就會有共識聲明等等。

But as it relates to when the actual new guidelines come out, we'll have to wait and see.

但由於這與實際的新指南何時推出有關，我們必須拭目以待。

But as you've probably have seen, there's been a lot of literature, a lot of things being both done, not only in the United States but in Europe as it relates to the use of bempedoic acid and where to use bempedoic acid, it's been very favorable.

但正如您可能已經看到的，有很多文獻，很多事情都在做，不僅在美國而且在歐洲，因為它涉及 bempedoic 酸的使用以及在哪裡使用 bempedoic 酸，它是非常有利。

As a matter fact, in Germany, they actually last year issued up through their eight K authorities that you cannot use the PCSK9 until you've actually used that.

事實上，在德國，他們去年就透過 8K 當局發布了規定，在你真正使用 PCSK9 之前，你不能使用它。

But so I guess that first.

但我想首先是這樣。

So And stay tuned as we get more updates on US guidelines, et cetera, we will definitely update you on that.

因此，請繼續關注我們獲得有關美國指南等的更多更新，我們一定會向您通報最新情況。

Thank you.

謝謝。

Thank you.

謝謝。

I'm showing no further questions in the queue at this time.

目前我在隊列中沒有顯示任何其他問題。

I will now turn the call back over to Mr. Sheldon Koenig for any closing remarks.

現在，我將把電話轉回給謝爾登·柯尼格先生，讓他發表結束語。

Thank you so much.

太感謝了。

Well, thank you, everybody.

嗯，謝謝大家。

We really appreciate you taking the time and interest in Esperion Therapeutics.

我們非常感謝您花時間對 Esperion Therapeutics 感興趣。

Again, I just want to remind everyone that we have a large catalyst coming in essentially less than a month with our new label.

再次，我想提醒大家，我們的新標籤在不到一個月的時間內就產生了巨大的催化劑。

We had a very strong quarter, and that quarter is really going to and has created strong momentum as we enter into the first quarter of 2024.

我們度過了一個非常強勁的季度，隨著我們進入 2024 年第一季度，該季度確實將創造強勁勢頭。

And with that said, we also have a steady stream of catalysts for our long-term continued growth.

話雖如此，我們也有源源不絕的催化劑來推動我們的長期持續成長。

So thank you again and talk to you soon.

再次感謝您，並儘快與您聯繫。

Take care.

小心。

Ladies and gentlemen, that does conclude our conference for today.

女士們、先生們，今天的會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。