Esperion Therapeutics Inc (ESPR) 2023 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question-and-answer session. Please be advised that today's conference may -- conference call may be recorded. I would now like to hand the conference call over to Alexis Callahan, Head of Investor Relations at Esperion. Please go ahead, Alexis.

    女士們先生們,感謝你們的支持和歡迎。此時,所有參與者都處於只聽模式。演講結束後,將進行問答環節。請注意,今天的會議可能會進行電話會議錄音。我現在想將電話會議交給 Esperion 投資者關係主管 Alexis Callahan。請繼續,亞歷克西斯。

  • Alexis Callahan

    Alexis Callahan

  • Thank you, operator. Good morning and welcome to Esperion's Second Quarter 2023 Earnings Conference Call. With us today are Sheldon Koenig, President and CEO; and Ben Halladay, CFO. Other members of the executive team will be available for Q&A following our prepared remarks.

    謝謝你,接線員。早上好,歡迎參加 Esperion 2023 年第二季度收益電話會議。今天與我們在一起的有總裁兼首席執行官 Sheldon Koenig;和首席財務官本·哈拉迪 (Ben Halladay)。在我們準備好的發言後,執行團隊的其他成員將接受問答。

  • I want to remind callers that the information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to 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. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 1, 2023.

    我想提醒來電者,今天電話中討論的信息受《私人證券訴訟改革法》安全港條款的保護。我提醒聽眾,管理層將做出前瞻性聲明。由於與業務相關的風險和不確定性,實際結果可能與我們的前瞻性陳述中明示或暗示的結果存在重大差異。這些前瞻性陳述完全符合今天的新聞稿和我們向美國證券交易委員會提交的文件中所包含的警示性陳述。本次電話會議的內容包含時效性信息,僅截至本次直播之日(2023 年 8 月 1 日)準確。

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

    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絡直播之後發生的事件或情況的義務。謹此提醒,本次電話會議和網絡廣播正在錄製和存檔。我們今天早上早些時候發布了一份新聞稿,詳細介紹了今天電話會議的內容。您可以在我們網站的投資者頁面上找到副本。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首席執行官謝爾登·科尼格 (Sheldon Koenig)。

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Thank you, Alexis and good morning, everyone. Thank you for joining us today to discuss our second quarter results and the recent progress we've made. Our business is continuing to grow each quarter. We are pleased to report total revenue for the second quarter of $25.8 million, which is a 37% increase year-over-year. We reported $20.3 million in U.S. revenue, reflecting 49% year-over-year growth. We attribute the strength of our U.S. business to increased awareness of our brands and our clinical data, as well as solid execution of our commercial strategy as we prepare for full launch.

    謝謝你,亞歷克西斯,大家早上好。感謝您今天加入我們討論我們第二季度的業績以及我們最近取得的進展。我們的業務每個季度都在持續增長。我們很高興地報告第二季度總收入為 2580 萬美元,同比增長 37%。我們公佈的美國收入為 2030 萬美元,同比增長 49%。我們將美國業務的優勢歸功於我們的品牌和臨床數據知名度的提高,以及在我們準備全面推出時堅定執行我們的商業戰略。

  • Second quarter retail prescription equivalents for NEXLETOL and NEXLIZET grew 26% year-over-year. And we've been regularly hitting new weekly highs in prescriptions since our ACC presentation in the first quarter, bolstered by additional data released in the second quarter.

    第二季度 NEXLETOL 和 NEXLIZET 的零售處方當量同比增長 26%。自第一季度 ACC 報告以來,在第二季度發布的更多數據的支撐下,我們的處方量經常創下每週新高。

  • New-to-brand prescriptions have also continued to grow, driven first by the robustness of our clear outcomes, cardiovascular risk reduction data presented at ACC in March and second, by the impressive primary prevention data presented at ADA in June. In the period from ACC through the end of June, we showed 60% growth in new-to-brand prescriptions. For the second quarter, NBRX increased by 28% quarter-over-quarter.

    新品牌處方藥也在持續增長,這首先是由於我們明確的結果的穩健性,即3 月份在ACC 上公佈的心血管風險降低數據,其次是由於6 月份在ADA 上公佈的令人印象深刻的一級預防數據。從 ACC 到 6 月底,我們的新品牌處方增長了 60%。第二季度,NBRX 環比增長 28%。

  • Let me next walk you through some additional key highlights from the quarter. As I just mentioned, we saw continued RPE growth in the second quarter of 26% year-over-year. We are pleased with this trend, which we've been able to accomplish with the current label and promotional footprint. As promised, we submitted our regulatory filings during the second quarter in both the U.S. and EU to meaningfully expand our labels in both jurisdictions. Our clinical and regulatory teams worked tirelessly to compile the vast amount of data required for these submissions and which comes out of the outcomes trial of this scale and we're proud of their execution.

    接下來讓我向您介紹本季度的一些其他關鍵亮點。正如我剛才提到的,我們看到第二季度 RPE 同比持續增長 26%。我們對這一趨勢感到滿意,我們已經能夠通過當前的標籤和促銷足跡來實現這一趨勢。正如所承諾的那樣,我們在第二季度向美國和歐盟提交了監管文件,以有意義地擴大我們在這兩個司法管轄區的標籤。我們的臨床和監管團隊不知疲倦地工作,彙編了這些提交所需的大量數據,這些數據來自這種規模的結果試驗,我們為他們的執行感到自豪。

  • We anticipate a standard 10-month review for both submissions and therefore, expect regulatory approvals of expanded labels in both the U.S. and EU in the first half of 2024. We are continuing to pave the way for the significant growth we believe will result following label change. Our targeted commercial approach involves strategically presenting relevant analysis to the right audiences at a regular cadence, which enables us to effectively educate the market and target different segments of the population.

    我們預計對這兩項提交進行標準的10 個月審查,因此,預計美國和歐盟的擴展標籤將於2024 年上半年獲得監管部門的批准。我們正在繼續為我們相信將在標籤發布後帶來的顯著增長鋪平道路改變。我們有針對性的商業方法包括定期向正確的受眾戰略性地提供相關分析,這使我們能夠有效地教育市場並針對不同的人群。

  • In June, we presented impressive new primary prevention data at the American Diabetes Association congress, which showed significant and clinically meaningful reduction in cardiovascular risk and LDL cholesterol. This means that our therapies are not only effective in patients who have already had a cardiovascular event but who are at high risk of one and meaningfully expand our addressable market.

    六月,我們在美國糖尿病協會大會上展示了令人印象深刻的新一級預防數據,該數據顯示心血管風險和低密度脂蛋白膽固醇顯著降低且具有臨床意義。這意味著我們的療法不僅對已經發生心血管事件的患者有效,而且對心血管事件高危患者也有效,並有意義地擴大了我們的潛在市場。

  • This primary prevention analysis was also simultaneously published in the prestigious journal of the American Medical Association, reinforcing its clinical significance. We also presented new intention to treat and on-treatment analysis at the Endocrine Society congress, demonstrating improved outcomes and consistency of benefit which is comparable to statins and better than PCSK9 inhibitors. We will continue to present results throughout the year at the highest level congresses and meetings we believe are the right fit, including 2 late-breaker presentations at the European Society of Cardiology in August.

    這項一級預防分析也同時發表在美國醫學會權威雜誌上,增強了其臨床意義。我們還在內分泌學會大會上提出了新的治療意向和治療分析,證明了改善的結果和益處的一致性,與他汀類藥物相當,優於 PCSK9 抑製劑。我們將繼續全年在我們認為合適的最高級別大會和會議上展示結果,包括 8 月份在歐洲心髒病學會舉行的 2 場最新演講。

  • We are pleased to share that our partnership with Currax launched in early Q3, as did another 20 in-house sales force members who joined Esperion in new territories. We look forward to seeing increased traction over time as these new additions ramp up their territories in subsequent quarters.

    我們很高興與大家分享,我們與 Currax 的合作夥伴關係於第三季度初啟動,另外 20 名內部銷售人員在新地區加入了 Esperion。隨著這些新成員在接下來的幾個季度擴大其領土範圍,我們期待看到隨著時間的推移,吸引力會越來越大。

  • Lastly, we continue to have positive conversations with payers and to date, we've now presented outcomes status to pharmacy benefit managers and national payers who represent over 80% of total U.S. pharmacy (inaudible). Feedback has been extremely positive across the board and payers are already adapting utilization management criteria to reflect our CVOT data. Based on our CLEAR Outcomes data, we believe we have the potential to benefit a much larger group of patients than is characterized by our current label. Our current label is indicated for a small subset of patients with diagnosed atherosclerotic cardiovascular disease, ASCVD and heterozygous familial hypercholesterolemia, who cannot meet their goal on a maximally tolerated statin.

    最後,我們繼續與付款人進行積極的對話,迄今為止,我們現已向藥品福利管理者和占美國藥房總數 80% 以上的全國付款人(聽不清)展示了結果狀態。全面的反饋非常積極,付款人已經在調整利用率管理標準以反映我們的 CVOT 數據。根據我們的 CLEAR Outcomes 數據,我們相信我們有潛力使比我們當前標籤所描述的更多的患者群體受益。我們目前的標籤適用於一小部分被診斷為動脈粥樣硬化性心血管疾病、ASCVD 和雜合子家族性高膽固醇血症的患者,這些患者無法達到最大耐受他汀類藥物的目標。

  • Our new and expanded label will add a broad cardiovascular risk reduction indication in both primary and secondary population as well as remove current limitations, including the requirement of a maximally tolerated statin therapy. From a commercialization perspective, label expansion means we will be able to meaningfully increase our addressable patient population. Our CLEAR Outcomes data increases the total addressable population to approximately 70 million patients in the U.S. alone. Currently, our label covers approximately 10 million patients with documented ASCVD who are on maximally tolerated statin and who are still not at their LDL-cholesterol goal. Our new label will enable us to treat not only that population but also an additional 15 million high-risk, primary prevention patients who are taking a statin, plus 5 million patients with ASCVD or at high risk for ASCVD and who are statin intolerant.

    我們新的和擴展的標籤將為初級和次級人群增加廣泛的心血管風險降低適應症,並消除當前的限制,包括最大耐受他汀類藥物治療的要求。從商業化的角度來看,標籤擴展意味著我們將能夠有意義地增加我們的目標患者群體。我們的 CLEAR Outcomes 數據僅在美國就將可尋址人群總數增加到約 7000 萬患者。目前,我們的標籤涵蓋約 1000 萬患有 ASCVD 的患者,他們正在服用最大耐受的他汀類藥物,但仍未達到 LDL 膽固醇目標。我們的新標籤不僅能夠治療該人群,還能治療另外 1500 萬正在服用他汀類藥物的高風險一級預防患者,以及 500 萬 ASCVD 或 ASCVD 高風險且對他汀類藥物不耐受的患者。

  • In total, our post label change focus will be on these 30 million patients with additional potential upside from the untreated high-risk patient population, which represents another 40 million patients. We are confident that NEXLETOL and NEXLIZET have blockbuster commercial potential and we look forward to being able to reach even more patients who are unable to achieve their LDL-cholesterol goals on current therapies alone.

    總的來說,我們標籤變更後的重點將放在這 3000 萬患者上,而未經治療的高危患者群體(代表另外 4000 萬患者)還有額外的潛在優勢。我們相信 NEXLETOL 和 NEXLIZET 具有巨大的商業潛力,我們期待能夠惠及更多僅靠當前療法無法實現 LDL-膽固醇目標的患者。

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

    現在,我將把它交給我們的首席財務官 Ben Halladay,以更詳細地概述我們第二季度的業績。

  • Benjamin Halladay - CFO

    Benjamin Halladay - CFO

  • Thank you, Sheldon. Earlier this morning, we issued a press release containing our financial results for the second quarter, which is available on the Investor page of our website. Please note that unless otherwise specified, my comments reflect results for the second quarter ended June 30, 2023.

    謝謝你,謝爾頓。今天早上早些時候,我們發布了一份新聞稿,其中包含第二季度的財務業績,可在我們網站的投資者頁面上查看。請注意,除非另有說明,我的評論反映的是截至 2023 年 6 月 30 日的第二季度的結果。

  • Overall, we posted strong second quarter results. We demonstrated persistent growth in retail prescription equivalents during the quarter, which increased 26% year-over-year and 16% quarter-over-quarter. The weekly RPE trend is also impressive and we're proud to have recently surpassed the 10,000 RPE mark, reflecting continuing positive reception of our CVOT data.

    總體而言,我們發布了強勁的第二季度業績。本季度我們的零售處方當量持續增長,同比增長 26%,環比增長 16%。每週 RPE 趨勢也令人印象深刻,我們很自豪最近突破了 10,000 RPE 大關,這反映出我們的 CVOT 數據持續受到積極歡迎。

  • Our European partner continues to report strong growth of our therapies in its territory, showcasing the value these important medicines bring to clinicians and the patients they care for. At the end of May, 123,000 patients have now been treated with our therapies in Europe, representing sequential 3-month growth of 26% since February. We also had a new territory addition at the end of the second quarter with our products launching in Italy.

    我們的歐洲合作夥伴繼續報告我們的療法在其領土上的強勁增長,展示了這些重要藥物為臨床醫生及其護理的患者帶來的價值。截至 5 月底,歐洲已有 123,000 名患者接受了我們的療法治療,自 2 月份以來連續 3 個月增長了 26%。我們還在第二季度末增加了新的地區,我們的產品在意大利推出。

  • Turning to our financial results for the quarter. As of June 30, 2023, cash, cash equivalents and investment securities available for sale totaled $138.5 million compared to $166.9 million on December 31, 2022. We reported U.S. product revenue of $20.3 million, representing an increase of 49% year-over-year. Collaboration revenue, which includes combined royalty and partner revenue was $5.5 million, an increase of 4% year-over-year. Finally, total revenue for the second quarter was $25.8 million, an increase of 37% year-over-year.

    轉向我們本季度的財務業績。截至2023 年6 月30 日,可供出售的現金、現金等價物和投資證券總額為1.385 億美元,而2022 年12 月31 日為1.669 億美元。我們報告的美國產品收入為2,030 萬美元,同比增長49% 。合作收入(包括特許權使用費和合作夥伴收入合計)為 550 萬美元,同比增長 4%。最後,第二季度總收入為2580萬美元,同比增長37%。

  • Turning to expenses. Cost of goods sold for the second quarter was $6.8 million, which is 26% lower than last year, driven primarily by decreased product sales for our collaboration partners due to the timing of tablet shipments. We've already seen an acceleration of shipments through July, which will be additive to our original expectation for the third quarter. We anticipate an increase in tablet sales over the next 12 months and therefore, expect cost of goods sold to mirror this elevated demand. R&D expense was $22.1 million, a decrease of 32% year-over-year, reflecting lower costs following the readout of our CLEAR Outcomes study. SG&A expense was $34 million, an increase of 15% year-over-year, reflecting upfront trading costs for our contract sales force as well as higher legal costs.

    轉向開支。第二季度的銷售成本為 680 萬美元,比去年下降 26%,這主要是由於平板電腦發貨時間導致我們的合作夥伴的產品銷售減少。我們已經看到 7 月份的出貨量加速增長,這將超出我們對第三季度的最初預期。我們預計未來 12 個月平板電腦銷量將增加,因此預計銷售成本將反映這種需求的增長。研發費用為 2,210 萬美元,同比下降 32%,反映出我們的 CLEAR Outcomes 研究結果公佈後成本下降。 SG&A 費用為 3400 萬美元,同比增長 15%,反映了我們合同銷售人員的前期交易成本以及更高的法律成本。

  • We still expect full year 2023 operating expenses to be between $225 million and $245 million and we are tracking in line with that guidance. This total breaks out to $100 million to $110 million in R&D expense and $125 million to $135 million in SG&A expense. As a reminder, our operating expenses are expected to be first half loaded and to moderate in the back half of the year.

    我們仍然預計 2023 年全年運營支出將在 2.25 億美元至 2.45 億美元之間,並且我們正在按照該指導進行跟踪。研發費用總額為 1 億至 1.1 億美元,SG&A 費用為 1.25 億至 1.35 億美元。提醒一下,我們的運營支出預計將在上半年負荷,並在今年下半年有所放緩。

  • I wanted to further elaborate on expenses and our approach to prudent cash management now and over the next year. First, we have guided to having sufficient cash runway through mid-2024, which will take us beyond when we currently expect to receive approval of our new and expanded label and corresponding milestone payments. Second, while we are not changing our expense guidance for 2023, we did outperform our internal spending expectations in the second quarter and we will continue to look for opportunities to generate additional efficiencies in the back half of 2023 without impacting the quality of the full commercial launch we are planning next year.

    我想進一步詳細說明支出以及我們現在和明年審慎現金管理的方法。首先,我們計劃在 2024 年中期之前擁有充足的現金跑道,這將使我們超越目前預計獲得新的和擴展的品牌批准以及相應的里程碑付款的時間。其次,雖然我們不會改變 2023 年的支出指引,但我們在第二季度的表現確實超出了內部支出預期,我們將繼續尋找機會在 2023 年下半年提高效率,而不影響整個商業的質量。我們計劃明年推出。

  • These levers include internal cost control as well as slower pipeline investment, which will occur against the backdrop of continued sales growth. Our plan is for continued execution of these initiatives for the remainder of the year as we approach full-scale commercialization in mid-2024. With our sights set on the massive potential of our NEXLETOL and NEXLIZET franchise, we are steadily and prudently working to reach our goal.

    這些槓桿包括內部成本控制以及較慢的管道投資,這將在銷售持續增長的背景下發生。我們的計劃是在今年剩餘時間內繼續執行這些舉措,並在 2024 年中期實現全面商業化。我們著眼於 NEXLETOL 和 NEXLIZET 特許經營權的巨大潛力,我們正在穩步、謹慎地努力實現我們的目標。

  • 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。

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Thank you, Ben. I'll now provide additional corporate updates from the quarter. First, we recently received a letter from the FDA regarding the finality of the determined regulatory review period for our requested patent term extension which will extend our composition of (inaudible) patent by another 5 years through mid-2031. As no oppositions were filed, we anticipate receiving the certificate of extension in the next several months.

    謝謝你,本。我現在將提供本季度的其他公司最新動態。首先,我們最近收到了FDA 的一封信,內容涉及我們所請求的專利期限延長所確定的監管審查期的最終結果,這將使我們的(聽不清)專利組合再延長5 年,直至2031年中期。由於沒有提出異議,我們預計將在接下來的幾個月內收到延期證書。

  • Second, the court has set an April 2024 trial date to hear the amended complaint our legal team at Gibson Dunn filed against our European partner as we requested. We are pleased that our case is being treated with a sense of urgency and remain confident that this matter will be resolved in our favor and that we will receive the $300 million milestone payment we believe we are contractually entitled to.

    其次,法院已確定 2024 年 4 月的審判日期,以聽取我們 Gibson Dunn 法律團隊根據我們的要求對我們的歐洲合作夥伴提出的修改後的投訴。我們很高興我們的案件得到了緊迫感的處理,並堅信此事將以對我們有利的方式得到解決,並且我們將收到我們認為根據合同規定有權獲得的 3 億美元里程碑付款。

  • Lastly, I want to emphasize our focus on head down execution of our strategic plan. We once again delivered on our promises for continued growth and prudent expense management in the second quarter. We still expect the true sales inflection to come following label expansion and are diligently working for that goal and preparing for full commercial launch.

    最後,我想強調我們的重點是認真執行我們的戰略計劃。我們再次兌現了第二季度持續增長和審慎費用管理的承諾。我們仍然預計真正的銷售拐點將在品牌擴張之後出現,並正在努力實現這一目標並為全面商業發布做好準備。

  • Next, I would like to reiterate our plan to achieve blockbuster status for our franchise. First, robust data. Our landmark 14000-patient Outcomes trial generated a remarkable amount of high-quality data, which enables us to produce powerful subgroup analysis that are extremely relevant to health care providers. Next, our data will be used to support a highly differentiated label. Following this label expansion, we expect to see updates to physician treatment guidelines across the globe and a meaningful shift in adjunctive therapy utilization. Finally, we are continuing to execute on our strategic plan, prudently investing in growth initiatives and working to educate health care providers and payers alike, ahead of our label expansion next year.

    接下來,我想重申我們為我們的特許經營權實現重磅地位的計劃。首先,穩健的數據。我們具有里程碑意義的 14000 名患者結果試驗產生了大量高質量數據,這使我們能夠進行與醫療保健提供者極其相關的強大亞組分析。接下來,我們的數據將用於支持高度差異化的標籤。在標籤擴展之後,我們預計將看到全球醫生治療指南的更新以及輔助治療利用的有意義的轉變。最後,在明年我們的標籤擴張之前,我們將繼續執行我們的戰略計劃,審慎地投資於增長計劃,並努力教育醫療保健提供者和付款人。

  • I would like to wrap up our comments today with a reminder of the commitment this leadership team has made and continues to deliver on. First, we promised to deliver consistent growth following our company reorganization in the fall of 2021. We did just that. Second, we promised to show accelerating growth following our CVOT readout in the spring of 2023. We are doing that. And third, we promised to demonstrate exponential growth following label expansion and full commercial launch in mid-2024 and we will do just that.

    在結束我們今天的評論時,我想提醒大家注意這個領導團隊已經做出並將繼續履行的承諾。首先,我們承諾在 2021 年秋季公司重組後實現持續增長。我們確實做到了。其次,我們承諾在 2023 年春季公佈 CVOT 數據後將顯示加速增長。我們正在這樣做。第三,我們承諾在 2024 年中期進行品牌擴張和全面商業推出後,將呈現指數級增長,我們將做到這一點。

  • Plenty of work remains to be done but I am proud of the progress we have made thus far. I want to thank the entire Esperion team for its tireless work and commitment to this vision. I have unwavering confidence in our ability to succeed and look forward to demonstrating continued progress towards our goals. And with that, operator, we are now ready for Q&A.

    還有大量工作要做,但我對我們迄今為止取得的進展感到自豪。我要感謝整個 Esperion 團隊的不懈努力和對這一願景的承諾。我對我們取得成功的能力充滿信心,並期待著在實現我們的目標方面不斷取得進展。至此,操作員,我們現在準備好進行問答了。

  • Operator

    Operator

  • (Operator Instructions) Our first question will come from the line of Dennis Ding from Jefferies.

    (操作員說明)我們的第一個問題將來自 Jefferies 的 Dennis Ding。

  • Yuchen Ding - Equity Associate

    Yuchen Ding - Equity Associate

  • Two for me. Maybe talk about the April 2024 trial date and how set in stone is that date and could that be delayed in anyway by the judge or Daiichi? And then #2, around your OpEx guidance. You've reiterated your guidance this year. But I'm curious how much more could this be managed, particularly on the R&D line. It seems like your guidance is implying R&D spend to be at around $25 million a quarter in the second half. What is this really being spent on, appreciating you have 2 preclinical assets and how much more could this be managed?

    給我兩個。也許可以談談 2024 年 4 月的審判日期,以及該日期是如何確定的,法官或 Daiichi 是否可以推遲?然後#2,圍繞您的運營支出指導。您重申了今年的指導方針。但我很好奇這還可以管理多少,特別是在研發方面。您的指導似乎意味著下半年的研發支出約為每季度 2500 萬美元。考慮到您擁有 2 項臨床前資產,這筆錢真正花在了什麼地方?還可以管理多少?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • I'll take the first part of your question and I'll turn it over to Ben for the second part of the question. So regarding the court date, first, let me emphasize again, as we said in our prepared remarks, we are very happy about the fact that the court [solve] our way, as you know. I think we had spoken to you about this. Daiichi Sankyo was pushing for a trial date of October of 2024 or later. And we had always targeted the April '24 time line because that is when the milestone would have been due anyhow. So with that said, right now, both of the parties are focused on really just pushing forward with an eye on the March 1 close of discovery and that's really what's going to be happening over the next several months. All the parties will be focused on fact discovery, exchanging documents, et cetera.

    我將回答你問題的第一部分,然後將其交給 Ben 來回答問題的第二部分。因此,關於開庭日期,首先,讓我再次強調,正如我們在準備好的發言中所說,我們對法院按照我們的方式[解決]這一事實感到非常高興,正如您所知。我想我們已經和你談過這件事了。第一三共正在爭取 2024 年 10 月或更晚的審判日期。我們一直以 24 月 24 日的時間表為目標,因為無論如何,這個里程碑都會在那時到期。話雖如此,現在雙方都專注於推動進展,著眼於 3 月 1 日的發現結束,這確實是未來幾個月將會發生的事情。各方將專注於事實發現、交換文件等。

  • And if there is updates that are material to the case, we'll certainly update you. But again, as I mentioned in the additional part of my answer, we're very excited about the fact that the court awarded us the April 2024 trial date. Ben?

    如果有對案件重要的更新,我們一定會向您通報最新情況。但正如我在回答的附加部分中提到的,我們對法院將審判日期判給我們 2024 年 4 月這一事實感到非常興奮。本?

  • Benjamin Halladay - CFO

    Benjamin Halladay - CFO

  • Dennis, thanks for the question. So in regards to R&D expense, we still have a fair amount of levers we can pull there and room to toggle things up or down as needed. For the second half of the year, we have some expense that is still sort of lingering from the Outcomes trial closeout that should wrap up in the next month or 2 here. But then for the rest of the year, it's mostly related to the preclinical assets and some of our production validation expense. So there's a fair amount of variability that we can move up or down in both of those things.

    丹尼斯,謝謝你的提問。因此,就研發費用而言,我們仍然有相當多的槓桿可以利用,並且有空間根據需要上下調整。今年下半年,我們有一些費用仍因成果試驗收尾而揮之不去,這些費用應該在下個月或兩個月內結束。但在今年剩下的時間裡,這主要與臨床前資產和我們的一些生產驗證費用有關。因此,我們可以在這兩件事上上下移動相當大的可變性。

  • Operator

    Operator

  • Our next question comes from the line of Serge Belanger from Needham.

    我們的下一個問題來自李約瑟的 Serge Belanger。

  • Serge D. Belanger - Senior Analyst

    Serge D. Belanger - Senior Analyst

  • First question, I guess, a follow-up on the legal proceedings with your partner. Do you expect a resolution around this April 2024 court date or could it potentially drag out a little longer from there? And then secondly, given the higher volumes of prescriptions and sales that we've seen since the ACC meeting, can you just talk about the overall impact on gross to net, if it has improved? And where do you expect them to be over time?

    我想第一個問題是與你的伴侶的法律訴訟的後續行動。您預計 2024 年 4 月的開庭日期左右會達成解決方案嗎?還是可能會拖延更長的時間?其次,考慮到自 ACC 會議以來我們看到的處方量和銷售量增加,您能否談談對毛淨額的總體影響(如果有所改善)?隨著時間的推移,您預計它們會在哪裡?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Yes. Serge, again, I'll take the legal question. I'll turn it over to Ben as it relates to gross to net. As it relates to, I think, what your -- the question is, is there a appeal that's possible even though we have the court date of April. What we've been told by our law team is that appellate courts really tend to give deference in certain respects to trial court decisions. And in the event of a DSC appeal, we would actually have the option of seeking post-judgment interest on the amount owed, especially if regulatory approval is granted before any approval is resolved. Again, though, I think that -- what's most important is the fact that this trial is going to be heard sooner versus later. And I cannot ever express my confidence enough that we feel that courts will see it in our favor.

    是的。 Serge,我再次回答法律問題。我會把它交給本,因為它與毛淨值有關。我認為,這與您的問題有關,即使我們的開庭日期是四月,是否也可以上訴。我們的法律團隊告訴我們,上訴法院確實傾向於在某些方面尊重初審法院的判決。如果出現 DSC 上訴,我們實際上可以選擇就所欠金額尋求判決後利息,特別是如果在任何批准解決之前獲得監管部門批准。不過,我再次認為,最重要的是,這項審判將儘早審理,而不是稍後審理。我無法充分錶達我的信心,我們認為法院會認為這對我們有利。

  • We believe we have a very strong case. And again, we have the timing that we had always wanted. So that's the best I can answer that now. And again, as I said before, we will always update folks on the progress that we're making as it relates to the litigation. Ben, do you want to comment on gross to net?

    我們相信我們有一個非常有力的理由。再說一次,我們得到了我們一直想要的時機。所以這是我現在能回答的最好的答案。再次強調,正如我之前所說,我們將始終向人們通報我們在訴訟方面取得的進展。 Ben,你想對gross to net 發表評論嗎?

  • Benjamin Halladay - CFO

    Benjamin Halladay - CFO

  • Yes. So for gross to net, we've been in a good place for a while now. We've had kind of this laser focus on managing gross to net and controlling what's within our control for that. I would say we're in a pretty -- we're in very good shape and we're in steady state at this point and will be for a little while. Increased volumes will help but it's more to the 1- or 2-year horizon that they will help, not necessarily in the immediate quarter terms. So I would say as volumes increase post label expansion and the following years, we'll see more incremental improvements but for -- we've been in the same state for a while now.

    是的。因此,就總淨值而言,我們已經處於良好狀態已有一段時間了。我們非常注重管理總收入和淨收入,並控制我們可以控制的範圍。我想說我們的狀態非常好,我們目前處於穩定狀態,並且會持續一段時間。銷量的增加會有所幫助,但更多的是在一兩年內,而不一定是在最近的季度。因此,我想說,隨著標籤擴張後銷量的增加以及接下來的幾年,我們將看到更多漸進式改進,但我們已經處於同樣的狀態有一段時間了。

  • Operator

    Operator

  • Your next question comes from the line of Joseph Thome from Cowen.

    您的下一個問題來自 Cowen 的 Joseph Thome。

  • Joseph John-Charles Thome - MD & Senior Research Analyst

    Joseph John-Charles Thome - MD & Senior Research Analyst

  • Maybe the first one since the ACC presentation, maybe how have you seen -- where have you seen these prescriptions, this increase in prescriptions coming from? Is this increased depth at current prescribers? Are you getting new physicians prescribing the therapy? And then I know you mentioned next year, leading up to the full scale launch, hopefully after these label expansions are granted. Can you talk about how much you would potentially increase your footprint? And maybe how much of that relies on the Daiichi milestone?

    也許是自 ACC 演示以來的第一個,也許您是如何看到的——您在哪裡看到這些處方,處方的增加來自哪裡?當前處方者的深度是否增加了?您是否正在讓新醫生開出治療處方?然後我知道你提到明年,全面推出之前,希望在這些標籤擴展獲得批准之後。您能談談您的足跡可能會增加多少嗎?也許其中有多少依賴於第一核電站的里程碑?

  • And then last, really quick question. Obviously, you talked about the appeal. But as we think about that April court date, when should we expect sort of the initial decision on the trial outcome? Is that in the order of 3 months or longer? Kind of how should we think about that first read from that trial if that happens in April?

    最後一個非常簡短的問題。顯然,您談到了上訴。但當我們考慮四月份的開庭日期時,我們應該什麼時候才能對審判結果做出初步決定?是3個月或更長時間嗎?如果這種情況發生在四月份,我們應該如何看待該試驗的第一次閱讀?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Eric, do you want to take the first 2 and I'll take the legal question.

    埃里克,你想回答前兩個問題嗎?我將回答法律問題。

  • Eric J. Warren - Chief Commercial Officer

    Eric J. Warren - Chief Commercial Officer

  • Absolutely. Thanks for the question, Joe. So with regards to prescribing. So we're seeing both depth and breadth increases and we're seeing it across cardiology and primary care. Right now, we're at about an equal split between primary care and cardiology. So really pleased with the changes that we've seen post ACC. And remember, we still have a relatively small commercial footprint and we're on a current label. With regards to footprint changes over time, we recently, as Sheldon mentioned, in the opening comments, added about 20 individuals to the sales team that went into effect July 5 that's for the back half of this year. And we've got plans to make further additions to the sales force prior to the anticipated label. We also did put the Currax team into place as part of that co-promotion that we've talked about and that 72 individuals that have [P2] responsibility for our products.

    絕對地。謝謝你的提問,喬。所以關於處方。因此,我們看到深度和廣度都在增加,而且我們在心髒病學和初級保健領域都看到了這種情況。目前,初級保健和心髒病學之間的差距大致相等。我們對 ACC 後看到的變化非常滿意。請記住,我們的商業足跡仍然相對較小,並且我們使用的是當前標籤。關於足跡隨時間的變化,正如 Sheldon 在開場評論中提到的,我們最近在銷售團隊中增加了約 20 名人員,該計劃於 7 月 5 日生效,即今年下半年。我們計劃在預期的標籤發布之前進一步增加銷售隊伍。我們還確實將 Currax 團隊部署到位,作為我們所討論的聯合促銷的一部分,並且 72 個人對我們的產品負有 [P2] 責任。

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Great. Thanks, Eric. Joe, regarding your question of how long would it take to make a decision? Simple answer is, we actually believe that, that decision can happen very quickly. It could be a matter of days, possibly a week. But again, this is really a case of focusing on contract language in Section 9.2 of the contract. And we've made that public in the second complaint that we had filed. So it would occur pretty rapidly.

    偉大的。謝謝,埃里克。喬,關於你需要多長時間才能做出決定的問題?簡單的答案是,我們實際上相信,這個決定可以很快做出。這可能是幾天的事,也可能是一周的事。但同樣,這確實是一個關注合同第 9.2 條中合同語言的案例。我們已在提交的第二份投訴中公開了這一點。所以它會很快發生。

  • Operator

    Operator

  • And our next question will come from the line of Tom Shrader from BTIG.

    我們的下一個問題將來自 BTIG 的 Tom Shrader。

  • Thomas Eugene Shrader - MD & Healthcare Analyst

    Thomas Eugene Shrader - MD & Healthcare Analyst

  • You mentioned primary prevention scripts. Is that a meaningful percentage yet? And is any of that reimbursed? Or are those self-take patients? And where are you in patient support? We have co-pay card issues for a long time. Is patient support stable now? And can you give us a sense of what the average co-pay is?

    您提到了初級預防腳本。這是一個有意義的百分比嗎?這些費用有報銷嗎?還是那些自取的病人?您在患者支持方面的表現如何?我們長期以來一直存在共同支付卡問題。現在患者支持穩定嗎?您能否讓我們了解一下平均共付額是多少?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Eric, if you want to start that? And BJ?

    埃里克,你想開始嗎?還有北京?

  • Eric J. Warren - Chief Commercial Officer

    Eric J. Warren - Chief Commercial Officer

  • Yes, sure. So first question, Tom, with regards to primary prevention. So primary prevention isn't within our current label with the exception of the HeFH patient. And our focus has been on the ASCVD patient that's on massively tolerated statin, that's not yet their goal. With that said, there is a lot of pent-up demand for primary prevention. As you know, our CLEAR Outcomes data incorporated primary prevention patients, which is going to put us in a really strong position for when we have the label change. But right now, our focus has not been primary prevention based upon our current label and on payer contracts. BJ?

    是的,當然。湯姆,第一個問題是關於初級預防的。因此,除了 HeFH 患者之外,一級預防不屬於我們目前的標籤範圍。我們的重點是接受大量耐受他汀類藥物的 ASCVD 患者,但這還不是他們的目標。話雖如此,初級預防仍有大量被壓抑的需求。如您所知,我們的 CLEAR 結果數據納入了一級預防患者,這將使我們在標籤更改時處於非常有利的位置。但目前,我們的重點並不是基於我們當前的標籤和付款人合同的一級預防。北京?

  • Betty Jean Swartz - Chief Strategy Officer

    Betty Jean Swartz - Chief Strategy Officer

  • Sure. Tom, as Sheldon mentioned in his prepared remarks, our CLEAR results have been extremely positive from payers. And with that said, our prior authorization steps and approval rates continue to improve and PA submission rates are up over 8% with NEXLETOL, NEXLIZET approval with key national payers with an increase as much as 16% at some of them. Our average co-pay, we do have a co-pay buy-down card but we probably are more like a $20 for each, bringing that down for commercial patients.

    當然。湯姆,正如謝爾頓在他準備好的發言中提到的那樣,付款人對我們的 CLEAR 結果非常積極。話雖如此,我們的事先授權步驟和批准率繼續提高,NEXLETOL、NEXLIZET 獲得主要國家付款人的批准,PA 提交率提高了 8% 以上,其中一些付款人的批准率提高了 16%。我們的平均共付額,我們確實有一張共付額購買卡,但我們可能更像是每人 20 美元,這降低了商業患者的負擔。

  • We also have a suite of services under our NEXTSTEP Navigator services that include a pilot that we have done with reimbursement support, helping to educate offices. So all on an upswing and all really showing that NEXLETOL, NEXLIZET is the clear next step after statin.

    我們還在 NEXTSTEP Navigator 服務下提供了一套服務,其中包括我們在報銷支持方面進行的試點,幫助教育辦公室。因此,一切都在上升,所有這些都真正表明,NEXLETOL、NEXLIZET 是繼他汀類藥物之後明確的下一步。

  • Operator

    Operator

  • Our next question will come from the line of Jason Zemansky from Bank of America.

    我們的下一個問題將來自美國銀行的傑森澤曼斯基。

  • Jason Eron Zemansky - VP

    Jason Eron Zemansky - VP

  • Congratulations on the quarter. I know we keep hopping on this but a couple more on the legal dispute, appreciating there's a limit to what you can disclose here. But is there any dialogue between the 2 parties outside of the specifics of the case itself? To what extent do you think -- or what -- to what extent would you be amenable to resolving the issues prior to the trial date? And while you really haven't disclosed many of the specifics regarding Daiichi's comments here, any sense of their flexibility on the willingness to forgo the trial itself?

    祝賀本季度。我知道我們一直在關注這一點,但還有更多關於法律糾紛的內容,我們很高興您在這裡可以披露的內容是有限的。但除了案件本身的具體情況之外,雙方之間是否有任何對話?您認為——或者說——您願意在審判日期之前在多大程度上解決這些問題?雖然你確實沒有透露有關第一核評論的許多細節,但他們對放棄審判本身的意願是否有靈活性?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Great. Jason, thank you for your question. So as it relates to having any type of discussions or settlement discussions with DSC, right now, we can't comment on our legal strategy in the ongoing suit. Our goal, again, is to secure the full $300 million that we are contractually owed and that's what we're focusing on. And then following the EMEA approval, which is expected in the first half of 2024, as we mentioned in the prepared remarks and some of my answers earlier today, that puts us right in the timing of the April court date as well.

    偉大的。傑森,謝謝你的提問。因此,由於它涉及與 DSC 進行任何類型的討論或和解討論,目前我們無法評論我們在正在進行的訴訟中的法律策略。我們的目標還是要全額償付合同規定的 3 億美元,這也是我們關注的重點。然後,正如我們在準備好的發言和我今天早些時候的一些回答中提到的,預計 EMEA 將於 2024 年上半年獲得批准,這也使我們正確地確定了 4 月份的開庭日期。

  • So I think that's the best we can tell you at this point. And just as it relates to settlement or what would we approve or what would we take, et cetera, obviously, if we had something like that, it's my fiduciary responsibility to take something like that to the Board. At this time, that doesn't exist. And right now, as I mentioned, we're focusing on discovery and focusing on that court date in April.

    所以我認為這是我們目前能告訴你的最好的信息。正如它涉及和解或我們會批准什麼或我們會採取什麼等等,顯然,如果我們有類似的事情,我的信託責任就是將類似的事情提交給董事會。目前,這種情況並不存在。現在,正如我提到的,我們專注於證據開庭,並專注於四月份的開庭日期。

  • Jason Eron Zemansky - VP

    Jason Eron Zemansky - VP

  • Maybe as a follow-up then, any contingency plans here in terms of potentially finding an alternative EU partner or something along those lines?

    也許作為後續行動,這裡有任何可能尋找替代歐盟合作夥伴或類似措施的應急計劃嗎?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Yes. Really, there's nothing that we're doing as it relates to that. As we mentioned today, Daiichi Sankyo, our partner is doing a great job in selling the product. They've been showing continuous growth since they've been marketing this product for over 2 years. And I think that's something that's important on both sides, both the Esperion side, as we mentioned, we're focusing on heads down execution. They are as well. And this is why we're seeing the significant growth. And as we have always been saying that after a statin, NEXLETOL, NEXLIZET, where next? And we're seeing that both in the U.S. and also outside of the U.S. and Europe.

    是的。確實,我們沒有做任何與此相關的事情。正如我們今天提到的,我們的合作夥伴第一三共在產品銷售方面做得非常出色。自從營銷該產品兩年多以來,他們一直表現出持續增長。我認為這對雙方都很重要,無論是 Esperion 一方,正如我們提到的,我們都專注於埋頭執行。他們也是。這就是我們看到顯著增長的原因。正如我們一直在說的,在服用他汀類藥物、奈克樂、奈克利則之後,下一步在哪裡?我們在美國以及美國和歐洲以外的地區都看到了這種情況。

  • Operator

    Operator

  • (Operator Instructions) Our next question comes from the line of Joe Pantginis from H.C. Wainwright.

    (操作員說明)我們的下一個問題來自 H.C. 的 Joe Pantginis。溫賴特。

  • Joseph Pantginis - Director of Research & MD of Equity Research

    Joseph Pantginis - Director of Research & MD of Equity Research

  • So 2, if you don't mind. So first for Ben, just curious with your cost management commentary during your prepared comments. Any more specifics with regard to, you said, pipeline impacts. And then maybe for Eric and Sheldon, maybe getting a little more into the weeds on the detailing process. As you've been sharing the data and you've obviously seen some impact with regard to prescriptions on the CLEAR Outcomes data, what is the relative percentage or any details you could provide from physicians that essentially say, love the data but I'm going to wait for the full approval before changing my prescribing habits?

    所以2,如果你不介意的話。首先,本,只是對您在準備好的評論中的成本管理評論感到好奇。關於您所說的管道影響的更多細節。然後,也許對於埃里克和謝爾頓來說,也許可以更多地了解細節過程的雜草。由於您一直在共享數據,並且您顯然已經看到了處方對 CLEAR Outcomes 數據的一些影響,您可以從醫生那裡提供的相對百分比或任何詳細信息基本上是說,喜歡這些數據,但我在改變我的處方習慣之前要等待完全批准嗎?

  • Benjamin Halladay - CFO

    Benjamin Halladay - CFO

  • Yes. So as far it goes for pipeline spending, we've done a great job here, sort of meaningfully progressing those assets while managing the spend. We've gotten very smart about where we put our money and sort of leveraging big data and AI technologies to maximize where we're putting that. I think it's something that we can spend as much as little on as we want but still leverage a lot of the work that we've had and move those forward. Even if we do spend as much as we want, it's still, I would say, a reasonable amount but it is something that we can toggle. And I mentioned in the prepared comments, we have cash runway until middle of next year and I think we can potentially extend that further depending on how much we invest in both pipeline and some of the commercial stuff that we're doing.

    是的。就管道支出而言,我們在這裡做得很好,在管理支出的同時有意義地推進了這些資產。我們已經非常聰明地了解我們的資金投入,並利用大數據和人工智能技術來最大限度地利用我們的資金。我認為我們可以在這方面花盡可能少的錢,但仍然可以利用我們已經開展的大量工作並推動這些工作向前發展。即使我們確實想花多少就花多少,我想說,這仍然是一個合理的數額,但這是我們可以切換的。我在準備好的評論中提到,我們的現金跑道到明年年中為止,我認為我們有可能進一步延長這一期限,具體取決於我們在管道和我們正在做的一些商業項目上的投資量。

  • Eric J. Warren - Chief Commercial Officer

    Eric J. Warren - Chief Commercial Officer

  • And then I'll take the second part. Thanks, Joe, It's Eric. So with regards to the detailing process, our sales team, as well as our commercial team marketing via digital activities have continued to focus on the current strategy which is the ASCVD patient that's on maximally tolerated statin, it's not a goal. Unfortunately, because our label isn't updated, our commercial teams do not have the ability to discuss the CLEAR Outcomes data. They have been able to hand out a reprint from GAMA as well as from the New England Journal but not engaged in discussions. So they've been on strategy. But with that said, we're seeing these increases based upon a clinician appreciation for the data.

    然後我將開始第二部分。謝謝,喬,我是埃里克。因此,就細節流程而言,我們的銷售團隊以及通過數字活動進行營銷的商業團隊繼續關注當前的策略,即 ASCVD 患者服用最大程度耐受的他汀類藥物,這不是目標。不幸的是,由於我們的標籤未更新,我們的商業團隊無法討論 CLEAR Outcomes 數據。他們已經能夠分發來自 GAMA 和《新英格蘭日報》的轉載,但沒有參與討論。所以他們一直在製定策略。但話雖如此,我們看到這些增長是基於臨床醫生對數據的評價。

  • So our goal is to continue to execute on this. With that said, there is a lot of desire to expand the treatment patient population. I've mentioned in the past, some of the key limitations that we have but that maximally tolerated statin as well as shedding the focus just on ASCVD and pulling in that high-risk primary prevention.

    所以我們的目標是繼續執行這一點。話雖如此,人們非常希望擴大治療患者群體。我過去曾提到過,我們有一些關鍵的局限性,但最大限度地耐受他汀類藥物以及放棄僅關注 ASCVD 並引入高風險一級預防。

  • So I'm very pleased with what we're seeing now but this isn't with us promoting CLEAR Outcomes data. When that happens, we'll expand the population, we'll expand the type of evidence we're able to talk about and we will expand the commercial footprint. So that's the exponential growth phase that we talked about.

    所以我對我們現在看到的情況非常滿意,但這並不是我們推廣 CLEAR Outcomes 數據。當這種情況發生時,我們將擴大人口,我們將擴大我們能夠談論的證據類型,我們將擴大商業足跡。這就是我們談論的指數增長階段。

  • Operator

    Operator

  • And our next question will come from the line of Jason Butler from JMP Securities.

    我們的下一個問題將來自 JMP 證券的 Jason Butler。

  • Jason Nicholas Butler - MD, Director of Healthcare Research & Equity Research Analyst

    Jason Nicholas Butler - MD, Director of Healthcare Research & Equity Research Analyst

  • Just wondering if you could give us any more color about the reimbursement dynamics since ACC. Have you seen any changes in approval rate or time from treatment decision to getting reimbursed drug? Or any other color that supports that the process is getting easier for physicians and patients? And then just one on, I guess, treatment ordering. Is there any changes that you're seeing in when the drug is being used now versus before ACC?

    只是想知道您能否給我們提供有關 ACC 以來報銷動態的更多信息。您是否看到批准率或從治療決定到獲得報銷藥物的時間有任何變化?或者任何其他顏色可以表明該過程對醫生和患者來說變得更加容易?然後,我想,就只有一項治療預約了。與 ACC 之前相比,現在使用該藥物時您發現有什麼變化嗎?

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • BJ, you want to answer the first part and Eric the second?

    BJ,你想回答第一部分,埃里克回答第二部分嗎?

  • Betty Jean Swartz - Chief Strategy Officer

    Betty Jean Swartz - Chief Strategy Officer

  • Sure. Yes. So certainly, when you see the demand, this has been noticed by the payers and based on the presentations that we've had, with over 85% of the pharmacy life, what we have seen is actually an increase of our prior authorization rates being approved, as well as just an overall with key national payers as much as up to 16% with this. Certainly educating the offices and what we've put a laser focus on, is educating the offices just on the prior authorization requirements and really certain tactics and really spending some time on that education, which has also helped with the approval rate. So we anticipate again, the closer we get and with the label we will continue to improve but we've actually seen a great improvement versus last quarter and over the last year.

    當然。是的。因此,當然,當您看到需求時,付款人已經註意到這一點,並且根據我們所做的演示,在超過85% 的藥房壽命中,我們所看到的實際上是我們的事先授權率的增加批准,以及主要國家付款人的總體比例高達 16%。當然,對各辦公室進行教育,我們重點關注的是對各辦公室進行事先授權要求和特定策略的教育,並在教育上花費一些時間,這也有助於提高批准率。因此,我們再次預計,隨著標籤的臨近,我們將繼續改進,但實際上我們已經看到與上季度和去年相比有了很大的進步。

  • Eric J. Warren - Chief Commercial Officer

    Eric J. Warren - Chief Commercial Officer

  • And then, Jason, with regards to any dynamic changes since ACC. So as I mentioned, we've seen increases in both cardiology as well as primary care. I would say, from a percentage perspective, there's been increased cardiology excitement because they have been recipients of the data. Still, again, the focus is on the ASCVD patient on maximally tolerated statin (inaudible). We have seen increases in NEXLETOL, still NEXLIZET is our leader, if you will. But we've seen increases in NEXLETOL, again based upon the press as well as the association between NEXLETOL and CLEAR Outcomes. So our label will expand for both brands and we anticipate, again, exponential growth post label change.

    然後,Jason,關於 ACC 以來的任何動態變化。正如我所提到的,我們看到心髒病學和初級保健的數量都有所增加。我想說,從百分比的角度來看,心髒病學的興奮度有所增加,因為他們是數據的接收者。儘管如此,重點仍然是對最大耐受他汀類藥物的 ASCVD 患者(聽不清)。我們已經看到 NEXLETOL 的增加,如果您願意的話,NEXLIZET 仍然是我們的領導者。但我們已經看到 NEXLETOL 的增加,這也是基於媒體以及 NEXLETOL 和 CLEAR Outcomes 之間的關聯。因此,我們的標籤將針對這兩個品牌進行擴展,並且我們再次預計標籤變更後將出現指數級增長。

  • Jason Nicholas Butler - MD, Director of Healthcare Research & Equity Research Analyst

    Jason Nicholas Butler - MD, Director of Healthcare Research & Equity Research Analyst

  • And Eric, just a quick follow-up there. The increased use of NEXLETOL, does that -- any evidence that you're being used before ezetimibe in that -- in those scenarios? Or any color there?

    埃里克(Eric),請快速跟進。 NEXLETOL 的使用增加,是否有任何證據表明您在這些情況下先於依折麥布使用?或者有什麼顏色嗎?

  • Eric J. Warren - Chief Commercial Officer

    Eric J. Warren - Chief Commercial Officer

  • Yes. So starting to, Jason. So we have and we've done many surveys, quantitative surveys where ezetimibe tends to go down based upon seeing the CLEAR Outcomes data, still early. But yes, ezetimibe, as you know, has about a 6% outcomes benefit in that secondary prevention population and you're very familiar with our CLEAR Outcomes data. So ezetimibe will come down, still early now. And again, we're not promoting any of the CLEAR Outcomes benefits.

    是的。所以開始吧,傑森。因此,我們已經做了很多調查,定量調查,基於看到 CLEAR Outcomes 數據,依折麥布往往會下降,但還為時過早。但是,是的,正如您所知,依折麥佈在二級預防人群中具有大約 6% 的結果獲益,並且您非常熟悉我們的 CLEAR 結果數據。所以依折麥布將會下降,現在還早。再次強調,我們不會宣傳 CLEAR Outcomes 的任何好處。

  • Operator

    Operator

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

    謝謝。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,讓其作結束語。

  • Sheldon L. Koenig - President, CEO & Director

    Sheldon L. Koenig - President, CEO & Director

  • Great. Thank you so much. First of all, I just want to thank everybody for their interest and their questions and your support of Esperion. Just a couple of key points I would leave you with. And again, what we've demonstrated this quarter is the fact that we've delivered growth across all KPIs. We obviously beat expectations. We are very happy with where we see our prescriptions growing. And as we said before, this is without even having the full label approval behind us. We're on track with our key litigation milestones, again, the case being scheduled in April of 2024. It's a significant win for us.

    偉大的。太感謝了。首先,我想感謝大家的關注、提問以及對 Esperion 的支持。我只想告訴您幾個關鍵點。再說一次,我們本季度所展示的是我們在所有 KPI 上都實現了增長。我們顯然超出了預期。我們對處方數量的增長感到非常滿意。正如我們之前所說,這甚至沒有得到我們背後的完整標籤批准。我們再次步入關鍵訴訟里程碑的軌道,案件定於 2024 年 4 月審理。這對我們來說是一次重大勝利。

  • And then lastly, again and we're seeing it currently, after a statin, we're next. And that's really supported by the 14,000-patient CLEAR Outcomes study. So thank you again and look forward to talking to all of you soon. Have a great day.

    最後,我們目前看到,在他汀類藥物之後,我們是下一個。 14,000 名患者參與的 CLEAR Outcomes 研究確實支持了這一點。再次感謝您,並期待很快與大家交談。祝你有美好的一天。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。大家,祝你有美好的一天。