Mineralys Therapeutics, Inc. (MLYS) 2026 Q2 法說會逐字稿

Welcome to the Mineralys Therapeutics second quarter 2026 conference call. Reminder, this conference is being recorded.

歡迎參加 Mineralys Therapeutics 2026 年第二季財報電話會議。提醒您，本次會議正在錄音。

It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

現在我很榮幸介紹今天的主持人——LifeSci Advisors 的 Dan Ferry。先生，請開始。

Thank you. I would like to welcome everyone joining us today for our second quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our second quarter 2026 financial results and business updates.

謝謝。我想歡迎今天加入我們 2026 年第二季電話會議的各位。今天下午，在市場收盤後，我們發布新聞稿，提供 2026 年第二季財務結果與業務最新進展。

A replay of today’s call will be available on the investors section of our website approximately one hour after its completion. After our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company’s business. These forward-looking statements are qualified by the cautionary statements contained in today’s press release and our SEC filings, including our annual report on Form 10-K and subsequent filings.

今天電話會議的重播將於結束後約一小時，在我們網站的投資人專區提供。在我們的準備發言之後，我們將開放問答。在開始之前，我想提醒各位，本次電話會議與網路直播將包含關於公司的前瞻性陳述。由於與公司業務相關的風險與不確定性，實際結果可能與這些前瞻性陳述所述或暗示者有重大差異。這些前瞻性陳述受今日新聞稿以及我們向 SEC 提交之文件（包括 Form 10-K 年報及其後續申報文件）中的警示性聲明所限制。

Please note that these forward-looking statements reflect our opinions only as of today, August 11, 2026. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events.

請注意，這些前瞻性陳述僅反映我們截至今日（2026 年 8 月 11 日）的觀點。除法律要求外，我們明確聲明不承擔因新資訊或未來事件而更新或修訂這些前瞻性陳述的任何義務。

I would now like to turn the call over to Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.

現在我想把電話會議交給 Mineralys Therapeutics 執行長 Jon Congleton。

Thank you, Dan. Good afternoon, everyone. Welcome to our second quarter 2026 financial results and corporate update conference call. I’m joined today by Adam Levy, our Chief Financial Officer, and Eric Warren, our Chief Commercial Officer.

謝謝你，Dan。各位下午好。歡迎參加我們 2026 年第二季財務結果與公司最新進展電話會議。今天與我一同出席的還有我們的財務長 Adam Levy，以及商務長 Eric Warren。

I’ll begin with an overview of the business and recent milestones. Eric will then provide a commercial update, and Adam will review our second quarter financial results before we open the call for your questions.

我將先概述業務與近期里程碑。接著 Eric 將提供商務最新進展，Adam 將回顧我們第二季財務結果，之後我們將開放各位提問。

Before I get started with the business update, I would like to take a moment to welcome Dr. Terry Ferguson to the team. Terry joins us as Chief Medical Officer, succeeding Dr. David Rodman, who will continue to play an important role as a full-time strategic advisor to the company. Terry brings more than 35 years of experience in cardiovascular medicine, clinical development, and executive leadership.

在我開始業務更新之前，我想先花點時間歡迎 Terry Ferguson 醫師加入團隊。Terry 將以醫務長身分加入我們，接替 David Rodman 醫師；David 將繼續以全職策略顧問身分在公司扮演重要角色。Terry 在心血管醫學、臨床開發與高階管理領導方面擁有超過 35 年的經驗。

He served as cardiovascular therapeutic area head at Amgen and held senior cardiovascular leadership roles at AstraZeneca and The Medicines Company. He also spent more than 20 years on the faculty of the Texas Heart Institute and in cardiovascular medicine.

他曾在安進（Amgen）擔任心血管治療領域負責人，並在阿斯特捷利康（AstraZeneca）與 The Medicines Company 擔任心血管領域資深領導職務。他也在德州心臟研究所（Texas Heart Institute）任教並從事心血管醫學工作超過 20 年。

Terry’s deep expertise in cardiovascular medicine and a proven track record of advancing innovative therapies positions him well to lead our medical and late-stage clinical activities as we continue preparing for the potential commercialization of lorundrostat.

Terry 在心血管醫學方面的深厚專業，以及推進創新療法的卓越實績，使他非常適合領導我們的醫學與後期臨床活動，因為我們持續為 lorundrostat 的潛在商業化做準備。

I want to thank David for his dedication and hard work over the past several years. During his time as Chief Medical Officer, he guided the development of lorundrostat from proof of concept through the pivotal program and our recent New Drug Application filing with the FDA.

我想感謝 David 在過去幾年中的投入與辛勤付出。在他擔任醫務長期間，他引導 lorundrostat 的開發從概念驗證推進至關鍵性試驗計畫，並完成我們近期向 FDA 提交的新藥申請（NDA）。

In the second quarter, our focus was on commercial launch readiness, the evaluation of partnering opportunities, and the next steps in the clinical development of lorundrostat. In the third quarter, we continue to build our commercial infrastructure as we approach our December 22 PDUFA date.

在第二季，我們的重點在於商業上市準備、評估合作夥伴機會，以及 lorundrostat 臨床開發的下一步。在第三季，隨著我們接近 12 月 22 日的 PDUFA 日期，我們將持續建置商業基礎設施。

Turning to our clinical progress, our Transform-HTN open-label extension trial continues to generate valuable long-term safety and efficacy data that further supports lorundrostat’s potential best-in-class profile. in May, we presented a post hoc analysis from our pivotal Launch-HTN trial at the European Society of Hypertension’s annual meeting.

談到臨床進展，我們的 Transform-HTN 開放標籤延伸試驗持續產出有價值的長期安全性與有效性資料，進一步支持 lorundrostat 具備同類最佳（best-in-class）的潛力。5 月，我們在歐洲高血壓學會（European Society of Hypertension）年會上發表了來自關鍵性 Launch-HTN 試驗的事後（post hoc）分析。

The analysis focused on participants with chronic kidney disease, a high-risk and difficult-to-treat patient population. Despite entering the trial with more severe hypertension and greater use of background antihypertensive therapies, these participants experienced statistically and clinically meaningful blood pressure reductions comparable to those observed in the broader trial population.

該分析聚焦於慢性腎臟病患者，這是一個高風險且難以治療的族群。儘管這些受試者入組時高血壓更嚴重，且使用更多背景降壓治療，他們仍出現具統計與臨床意義的血壓下降幅度，且與整體試驗族群所觀察到的結果相當。

In addition, participants with baseline albuminuria achieved a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio, an important marker of kidney injury and disease progression. Just a few weeks later, at the Endocrine Society’s annual meeting, ENDO 2026, we presented late-breaking proteomic data from our Launch-HTN and Advance-HTN trials demonstrating that lorundrostat was associated with significant reductions in multiple biomarkers of heart failure risk.

此外，基線有白蛋白尿的受試者，其尿白蛋白／肌酸酐比（UACR）在安慰劑校正後降低 52%，這是腎臟損傷與疾病進展的重要指標。僅數週後，在內分泌學會年會 ENDO 2026 上，我們發表了來自 Launch-HTN 與 Advance-HTN 試驗的最新蛋白體學（proteomic）資料，顯示 lorundrostat 與多項心衰竭風險生物標記的顯著下降相關。

While exploratory in nature, these coordinated biomarker changes provide additional biological evidence that lorundrostat use may favorably modulate disease pathways implicated in heart failure. We believe these findings further strengthen our understanding of the broader biological implications of aldosterone and the potential for lorundrostat to provide benefits in hypertension and related comorbidities.

雖然屬於探索性分析，這些一致的生物標記變化提供了額外的生物學證據，顯示使用 lorundrostat 可能有利地調節與心衰竭相關的疾病途徑。我們相信，這些發現進一步加深我們對醛固酮更廣泛生物學影響的理解，以及 lorundrostat 在高血壓及相關共病中可能帶來效益的潛力。

We continue to evaluate further clinical development for lorundrostat, and we will keep you informed on our progress as appropriate. We also completed several corporate initiatives that enabled our long-term value creation objectives.

我們將持續評估 lorundrostat 的進一步臨床開發，並在適當時機向各位更新進展。我們也完成了數項公司層面的措施，以支持我們的長期價值創造目標。

During the quarter, we announced an agreement to repurchase the potential future royalty payments due to Tanabe Pharma Corporation related to lorundrostat. Under the terms of the agreement, Mineralys agreed to pay Tanabe $200 million upfront and up to $100 million once certain commercial milestones are met. Our aggregate potential future milestone payments to Tanabe are now up to $265 million. We believe this represented a unique strategic opportunity to enhance the long-term value of lorundrostat as we approach commercialization.

在本季期間，我們宣布達成協議，回購與 lorundrostat 相關、原本可能需支付給田邊製藥株式會社（Tanabe Pharma Corporation）的未來權利金款項。依協議條款，Mineralys 同意先行支付田邊 2 億美元，並在達成特定商業里程碑後再支付最多 1 億美元。我們對田邊的未來里程碑付款總額上限現為 2.65 億美元。我們相信，這是一項獨特的策略性機會，可在我們接近商業化之際提升 lorundrostat 的長期價值。

Concurrently, we completed a $150 million equity offering and entered into a $500 million committed senior secured term loan facility with funds managed by Pharmakon Advisors. Beyond funding the royalty repurchase, this facility provides Mineralys with access to additional capital and financial flexibility, while positioning Mineralys to capture the long-term value of lorundrostat.

同時，我們完成了 1.5 億美元的股權發行，並與 Pharmakon Advisors 管理的基金簽訂 5 億美元的承諾式優先擔保定期貸款融資（committed senior secured term loan facility）。除為權利金回購提供資金外，該融資亦使 Mineralys 得以取得額外資本與財務彈性，並讓 Mineralys 能夠掌握 lorundrostat 的長期價值。

As we look ahead to the remainder of the year, we believe lorundrostat is entering an exciting new phase in its evolution. We have continued to build the clinical evidence supporting lorundrostat, enhanced the long-term value of the asset, expanded our access to capital, and continue to make meaningful progress preparing for a potential commercial launch. In parallel, we continue to evaluate partnering opportunities and engage in strategic discussions to enhance value and enable us to reach more patients who could benefit from lorundrostat.

展望今年剩餘時間，我們認為 lorundrostat 正進入其發展歷程中令人振奮的新階段。我們持續累積支持 lorundrostat 的臨床證據、提升該資產的長期價值、擴大資本取得管道，並在為潛在商業上市做準備方面持續取得實質進展。同時，我們也持續評估合作夥伴機會並進行策略性討論，以提升價值並讓更多可能受益於 lorundrostat 的患者得以使用。

With that, I will turn the call over to Eric to provide a commercial update.

接下來，我將把電話會議交給 Eric，由他提供商務最新進展。

Great. Thank you, Jon. Approximately 20 million adults in the US have uncontrolled or resistant hypertension. Despite the availability of numerous antihypertensive therapies, these patients remain unable to achieve their blood pressure goal. These patients face significant increased cardiovascular and cardiorenal risk, highlighting the need for new treatment options that address an underlying driver of disease.

好的。謝謝你，Jon。美國約有 2,000 萬名成人患有未控制或難治性高血壓。儘管已有多種降壓治療可用，這些患者仍無法達到其血壓目標。這些患者面臨顯著升高的心血管與心腎風險，凸顯出需要新的治療選項，以處理疾病的根本驅動因素。

Our extensive market research continues to reinforce the value proposition lorundrostat could offer if approved. Physicians consistently tell us they are seeking new therapies that deliver meaningful and durable blood pressure reductions, demonstrate a favorable tolerability profile, and fit naturally within existing treatment algorithms.

我們廣泛的市場研究持續強化一項觀點：若獲核准，lorundrostat 可提供具吸引力的價值主張。醫師一再告訴我們，他們正在尋求能帶來具臨床意義且持久的血壓降低、具良好耐受性特徵，並能自然融入既有治療流程的新療法。

We believe lorundrostat’s clinical profile aligns well with these expectations and differentiates the compound from both currently available and emerging therapies. Over the past several quarters, we have systematically executed against the key elements of our commercial launch plan.

我們相信 lorundrostat 的臨床特徵與這些期待高度一致，並使該化合物相較於目前已上市及正在開發中的療法更具差異化。在過去幾個季度中，我們已系統性地推進商業上市計畫的關鍵要素。

As a result, many of the foundational components of our commercial infrastructure are now in place, and our efforts are increasingly focused on final launch readiness and execution. First, we have established strong relationships with leading hypertension specialists and Key Opinion Leaders who we believe will play an important role in shaping clinical practice following a potential approval.

因此，我們商業基礎建設的許多核心組成如今已到位，而我們的工作也日益聚焦於上市前的最終就緒與執行。首先，我們已與領先的高血壓專科醫師及關鍵意見領袖建立穩固關係；我們相信，在潛在核准後，他們將在形塑臨床實務方面扮演重要角色。

Second, we have made significant progress in our initial payer engagement activities. The payers we have engaged with to date collectively account for the vast majority of covered lives in the United States. Our discussions have centered on clinical and economic burden associated with uncontrolled hypertension and the value proposition supported by lorundrostat’s clinical data package. These conversations continue to reinforce our belief that payers recognize the unmet need in this patient population.

第二，我們在初期的支付方（payer）互動方面已取得顯著進展。截至目前我們接觸的支付方，合計涵蓋了美國絕大多數的受保人群。我們的討論聚焦於未控制高血壓所帶來的臨床與經濟負擔，以及 lorundrostat 臨床資料套件所支持的價值主張。這些對話持續強化我們的信念：支付方已認知到此患者族群存在未被滿足的醫療需求。

Third, we are well underway in the development of a differentiated launch campaign that is designed to educate both healthcare providers and patients. We have done extensive research to understand the optimal messaging, resources, and communication platforms that will drive rapid adoption.

第三，我們正積極推進一項具差異化的上市宣傳活動之開發，旨在同時教育醫療照護提供者與患者。我們已進行大量研究，以了解能促成快速採用的最佳訊息傳遞、資源配置與溝通平台。

Lastly, we are in the final stages of building the field organization that will support our launch. Our experienced sales leadership team is now in place, bringing a track record of successfully launching and commercializing cardiovascular therapies.

最後，我們正處於建立支援上市之外勤組織的最後階段。我們具經驗的銷售領導團隊現已到位，並擁有成功上市與商業化心血管療法的實績。

We have also completed detailed geographic mapping to identify the regions with the highest concentrations of physicians treating patients with uncontrolled or resistant hypertension, allowing us to optimize field deployment.

我們也已完成詳細的地理區域盤點，以辨識治療未控制或抗藥性高血壓患者之醫師最集中的地區，從而使我們能最佳化外勤部署。

Perhaps most importantly, we expect our sales organization to be staffed in advance of our December PDUFA target date, positioning us to execute swiftly and decisively following a potential approval.

或許最重要的是，我們預期在 12 月的 PDUFA 目標日期之前完成銷售組織的人員配置，使我們能在潛在核准後迅速且果斷地執行。

We’ve built our commercial organization around clear objectives, which are to ensure physicians have the education, resources, and support needed to identify appropriate patients, and if approved, make lorundrostat available to those patients as efficiently as possible. We continue to be encouraged by the feedback we are receiving from physicians, payers, and thought leaders and believe Mineralys is well-positioned to execute a successful commercial launch.

我們以明確目標打造商業組織：確保醫師具備所需的教育、資源與支援，以辨識合適患者，並在獲核准後，盡可能有效率地讓 lorundrostat 提供給這些患者。我們持續受到來自醫師、支付方與意見領袖的回饋所鼓舞，並相信 Mineralys 已具備成功推動商業上市的良好條件。

I’ll now turn it over to Adam to review our second quarter financial results.

接下來我把時間交給 Adam，請他回顧我們第二季的財務結果。

Thank you, Eric. Good afternoon, everyone. Today, I will discuss select portions of our second quarter 2026 financial results. Additional details can be found in our Form 10-Q, which will be filed with the SEC today. We ended the quarter with cash, cash equivalents, and investments of $661.4 million as of June 30, 2026, compared to $656.6 million as of December 31, 2025. We believe that our current cash, cash equivalents, and investments will be sufficient to fund our planned operations, including the commercial launch of lorundrostat into 2028.

謝謝你，Eric。各位下午好。今天我將說明我們 2026 年第二季財務結果中的部分重點。更多細節可參閱我們的 Form 10-Q，我們將於今日向美國證券交易委員會（SEC）提交。截至 2026 年 6 月 30 日，我們季度末的現金、約當現金及投資為 6.614 億美元，相較於 2025 年 12 月 31 日的 6.566 億美元。我們相信目前的現金、約當現金及投資足以支應我們規劃中的營運需求，包括 lorundrostat 的商業上市，並可支應至 2028 年。

R&D expenses for the quarter ended June 30, 2026, were $221.4 million compared to $38.3 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily due to the $200 million upfront payment to Tanabe in June 2026 in connection with the license agreement amendment.

截至 2026 年 6 月 30 日止季度的研發（R&D）費用為 2.214 億美元，相較於截至 2025 年 6 月 30 日止季度的 3,830 萬美元。研發費用增加主要係因 2026 年 6 月就授權協議修訂案向 Tanabe 支付 2 億美元的預付款。

The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased clinical supply, manufacturing, regulatory, and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 2025.

增加的原因亦包括：因人員編制成長與薪酬提高而增加的 60 萬美元人事相關費用，以及增加的 20 萬美元臨床供應、製造、法規及其他成本。上述增加部分被較低的 1,780 萬美元臨床前與臨床成本所抵銷，主要係因 lorundrostat 關鍵性（pivotal）計畫於 2025 年第二季結束。

G&A expenses were $24.7 million for the quarter ended June 30, 2026, compared to $8.5 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to $8 million in higher professional fees, $8 million in increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.2 million of increased other administrative expenses.

截至 2026 年 6 月 30 日止季度的一般及行政（G&A）費用為 2,470 萬美元，相較於截至 2025 年 6 月 30 日止季度的 850 萬美元。G&A 費用增加主要係因專業服務費增加 800 萬美元、因人員編制成長與薪酬提高而增加的 800 萬美元人事相關費用，以及其他行政費用增加 20 萬美元。

Total other income net was $5 million for the quarter ended June 30, 2026, compared to $3.5 million for the quarter ended June 30, 2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances, partially offset by $0.8 million of interest in amortization expenses related to the senior secured term loan entered into in June 2026.

截至 2026 年 6 月 30 日止季度的其他收益淨額為 500 萬美元，相較於截至 2025 年 6 月 30 日止季度的 350 萬美元。增加主要係因平均現金餘額較高而使投資利息收入增加 230 萬美元，但部分被 2026 年 6 月簽訂之優先擔保定期貸款（senior secured term loan）相關利息攤銷費用 80 萬美元所抵銷。

Net loss was $241.1 million for the quarter ended June 30, 2026, compared to $43.3 million for the quarter ended June 30, 2025. The increase was primarily due to the factors impacting our expenses that I just described.

截至 2026 年 6 月 30 日止季度的淨損為 2.411 億美元，相較於截至 2025 年 6 月 30 日止季度的 4,330 萬美元。增加主要係由我剛才所描述、影響我們費用的因素所致。

With that, I will ask the operator to open the call for questions. Operator?

接下來，我請接線員開放提問。接線員？

(Operator Instructions)

（接線員指示）

Richard Law, Goldman Sachs.

Richard Law，高盛。

Hey, guys. Yeah, congrats on all the progress as we approach PDUFA. I also want to extend out welcome to Terry, and look forward to working with him. So a couple questions from me. I see that you guys have a lot of postings on the territorial manager positions.

嗨，各位。是的，隨著我們接近 PDUFA，恭喜你們取得所有進展。我也想向 Terry 表示歡迎，並期待與他合作。我這邊有幾個問題。我看到你們在區域經理（territorial manager）職位上有很多招募公告。

How are you finding the quality of candidates after baxdrostat launch, which I assume will be competing for talent there as well? Also, are there any key attributes that you guys are looking for regarding hypertension experience or on certain drugs? Also, when are you guys going to start hiring for the rest of the sales reps, given the launch is nearing in four months?

在 baxdrostat 上市之後，你們覺得候選人的品質如何？我猜那邊也會在人才方面與你們競爭。另外，你們在高血壓相關經驗或特定藥物方面，有沒有在尋找哪些關鍵特質？再者，鑑於距離上市只剩四個月，你們打算何時開始招募其餘的業務代表？

Rich, this is Jon. Thanks for the question. I have to admit it was a little bit garbled, so I am going to paraphrase your question back and tell me if I got it on point. I think your question is about the field sales force, the phenotype we are looking for, and our likelihood of having those in position ahead of the PDUFA. Is that the paraphrase of your question?

Rich，我是 Jon。謝謝你的問題。我得承認剛剛有點聽不清楚，所以我先把你的問題用自己的話重述一次，你再告訴我是否抓到重點。我理解你的問題是關於外勤銷售團隊、我們在尋找的人才樣貌，以及我們在 PDUFA 之前把人員到位的可能性。這樣重述對嗎？

Yeah, exactly. So basically, how are you guys finding the quality of candidates, given that baxdrostat launch already been happening? So I assume there’s competition for talent there.

對，完全正確。基本上就是，在 baxdrostat 已經開始上市的情況下，你們覺得候選人的品質如何？所以我假設那邊也會在人才方面競爭。

Yeah, no.

對，不會。

So what are you guys looking for in terms of experience? Also, when are you guys going to hire the rest of the sales force, given that the launch is four months away?

那你們在經驗方面在找什麼？另外，鑑於距離上市只剩四個月，你們何時會招募其餘的銷售團隊？

Yeah, I think as Eric alluded to, our goal is to have the team in position ahead of the PDUFA date. I will tell you, I am really excited about the quality of not only the sales representatives, territory managers that we are seeing, but also of the first-line sales managers.

是的，我想如 Eric 所提到的，我們的目標是在 PDUFA 日期之前，讓團隊就位。我可以告訴你，我對我們目前看到的不只是業務代表、區域經理的素質感到非常興奮，也對第一線銷售主管的素質感到非常興奮。

I think Mineralys represents the kind of exciting opportunity that attracts high-level talent that are energized by the kind of innovation that lorundrostat represents and the impact that it could have on millions of patients.

我認為 Mineralys 代表了一種令人振奮的機會，能吸引被 lorundrostat 所代表的創新、以及其可能對數百萬患者帶來的影響所激勵的高階人才。

So I think that in and of itself becomes a very exciting offering that attracts high-level talent. I will tell you there is not one phenotype that we are looking for. There is certainly a lot of cardiovascular experienced reps that are out there.

所以我認為，光是這一點本身就成為一個非常令人興奮、能吸引高階人才的提案。我可以告訴你，我們並不是在尋找某一種單一的「典型樣貌」。市場上確實有很多具心血管領域經驗的業務代表。

But we are also looking for those kind of individuals that we believe align to our values, the purpose that we have, and are energized by the opportunity. So I am very comfortable with the quality of candidate and our ability to hit that target of having the full team in position ahead of the PDUFA.

但我們也在尋找那些我們相信能與我們的價值觀、我們的使命相契合，並且對這個機會充滿熱情的人。因此，我對候選人的品質以及我們在 PDUFA 之前讓完整團隊就位、達成該目標的能力非常有信心。

Fantastic. Then just to follow up on that, how are you seeing the payers in terms of, are they waiting for lorundrostat’s approval before deciding on how to manage both ASI products? Is there anything that you guys are seeing that baxdrostat doing well or not doing well with payers or other commercial aspects that you can do differently or better? Thank you.

太棒了。那接著追問一下，從付款方（payers）的角度來看，你們觀察到他們是否在等待 lorundrostat 獲批之後，才決定如何管理這兩個 ASI 產品？你們是否看到 baxdrostat 在付款方或其他商業面向上有哪些做得好或做得不好的地方，讓你們可以做得不同或更好？謝謝。

I will give a quick thought, and then I will turn it over to Eric. I think the feedback we are getting from our national account team that was in place in Q1 of this year continues to be very bullish on access for this kind of innovation, particularly in the third and fourth line position. But Eric can give you maybe some more specifics behind that.

我先簡短說一下，然後交給 Eric。我認為，我們從今年第一季就已到位的全國客戶團隊所收到的回饋，仍然非常看好這類創新在可近性（access）方面的前景，特別是在第三線與第四線治療定位上。不過 Eric 也許可以就此提供更具體的細節。

Yeah. Thanks, Jon. Rich, so from a payer perspective, it is still early for baxdrostat, obviously, but I think it is encouraging to see that there is recognition of the innovation that the ASI class brings. We haven’t seen a lot of payer decisions yet, but we are firmly in a position to believe that both of these agents will be in an equivalent position that will give HCPs the ability to choose. And that is where our differentiated profile comes into play.

是的。謝謝，Jon。Rich，從付款方的角度來看，baxdrostat 當然還很早，但令人鼓舞的是，付款方已經認可 ASI 類別所帶來的創新。我們還沒有看到很多付款方的決策，但我們相當有把握相信，這兩個藥物都會處於相當的地位，讓醫療照護專業人員（HCPs）能夠自行選擇。而這正是我們差異化特徵能發揮作用之處。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

Hey, guys. Thanks so much for taking my question. Two from me. You said in the past that the label and post-marketing conversation typically start a couple of months out, prior to PDUFA. Has that process begun, and has anything in the, at least your initial conversation changed, in terms of what you expect to negotiate in the label?

嗨，各位。非常感謝讓我提問。我有兩個問題。你們過去曾說過，標籤（label）與上市後（post-marketing）的討論通常會在 PDUFA 前幾個月開始。這個流程是否已經開始？以及至少在你們初步對話中，對於你們預期在標籤上需要協商的內容，有沒有任何改變？

Second question is on pricing. When do you actually plan to lock in that decision, and would you communicate that ahead of the launch or at the launch? Thank you.

第二個問題是關於定價。你們實際上打算何時敲定這個決策？你們會在上市前或上市時對外溝通嗎？謝謝。

Yeah. Thanks, Mike. The label and post-approval commitments, that typically occurs a couple of months ahead of the PDUFA. I would expect sometime in the October, November timeframe. I would say, I would characterize the current dialogues with the agency, no surprises from us. I think the data package that we put together was robust, from the pivotal studies Launch-HTN, Advance-HTN, including Explore-CKD in the open label extension. So we feel very confident with the package that we have, and I think the dialogues to date have been regular course.

是的。謝謝，Mike。標籤與核准後承諾（post-approval commitments）通常會在 PDUFA 前大約兩個月進行。我預期會在 10 月、11 月左右。我會這樣形容目前與主管機關的對話：對我們而言沒有任何意外。我認為我們整理的資料包很扎實，包含關鍵性研究 Launch-HTN、Advance-HTN，以及在開放標籤延伸試驗中的 Explore-CKD。因此我們對手上的資料包非常有信心，而截至目前的對話也都屬於例行程序。

From a pricing standpoint, obviously we’ve seen the price of baxdrostat, and we’re continuing to do our analysis. We weren’t overly surprised by the price point they came out with. It’s in that non-specialty tier pricing area. But I would not anticipate us sharing the price until approval and subsequently probably around launch.

就定價而言，顯然我們已看到 baxdrostat 的價格，而我們也持續在做分析。他們公布的價格點並沒有讓我們太意外。它落在非專科（non-specialty）層級的定價區間。但我不預期我們會在獲批之前公布價格；之後大概會在上市前後再對外說明。

Jason Gerberry, Bank of America.

Jason Gerberry，美國銀行（Bank of America）。

Hey, guys. Thanks for taking my questions. Couple from me. Just in terms of the early AstraZeneca launch, any learnings as you interrogate the data so far in terms of perhaps good, bad, or just too early to formulate any conclusions?

嗨，各位。謝謝回答我的問題。我有幾個問題。就 AstraZeneca 早期的上市表現而言，當你們檢視目前的數據時，有沒有任何心得（好的、壞的），還是說現在下結論仍然太早？

Then as a follow-up to the point you raised about confidence around parity payer access. I’m not sure you can say much, but directionally, I’m just curious, I guess, sort of the gross-to-net deductions in order to achieve parity access. Is that coming in perhaps in line, better, worse than maybe you would’ve expected, say, 6 to 12 months ago? Thanks.

接著追問你們提到對付款方可近性達到同等（parity）的信心。我不確定你們能透露多少，但我想從方向性角度了解，為了達到同等可近性所需的毛到淨（gross-to-net）扣減幅度如何？相較於你們在 6 到 12 個月前的預期，是大致符合、較好，還是較差？謝謝。

Yeah, Jason, I will take the first part and have Eric address your question about payer access. I think your point you made, it is still early days to gauge from the numbers that you see the same things we do publicly on the baxdrostat launch.

是的，Jason，我先回答第一部分，然後請 Eric 回答你關於付款方可近性的問題。我同意你提出的觀點：現在仍是早期階段，僅從你看到的數字——也就是我們同樣從公開資訊看到的 baxdrostat 上市數據——還很難做出判斷。

I will tell you anecdotally, I think there is enthusiasm and excitement for this new class of therapy. It has been over 20 years since there has been a meaningful introduction of an antihypertensive therapy. We know there are significant patients, 20 million, on two or more meds that cannot get to goal right now, and we know the implications of that.

但我可以從一些軼事觀察告訴你，我認為市場對這個新療法類別抱持熱情與興奮。距離上一次有意義地引入新的降血壓治療，已經超過 20 年了。我們知道有大量患者——約 2,000 萬人——正在使用兩種或以上藥物仍無法達標，而我們也知道這會帶來什麼影響。

I think the enthusiasm that we are seeing anecdotally in the marketplace for this class of drugs speaks for the opportunity that I know we are excited about with lorundrostat. But as to the payer dialogues, I will let Eric comment.

我認為，我們在市場上從軼事層面看到對這一類藥物的熱度，正說明了我們對 lorundrostat 所感到興奮的機會所在。至於付款方的對話，我讓 Eric 來評論。

Yeah. Payer dialogues have been very positive. I would say the level of rebate that we are hearing that is coming from baxdrostat is very consistent with what we expected, and that is obviously on the commercial side.

是的。與付款方的對話一直非常正面。我會說，我們聽到 baxdrostat 所提供的回扣水準與我們的預期非常一致，而這顯然是在商業保險（commercial）端。

From the Medicare side, so far it looks like access is this medical exception, which then allows us to go to label. So far, again, without giving any kind of precise indicators of what we are doing, generally as we would expect, Jason.

在 Medicare 端，目前看起來的可近性是透過「醫療例外」（medical exception），進而讓我們能依照標籤適應症來使用。同樣地，在不提供任何我們具體作法的精確指標前提下，整體而言都如我們所預期，Jason。

Seamus Fernandez, Guggenheim Securities.

Seamus Fernandez，Guggenheim Securities。

Hi, guys. This is Evan Lang on for Seamus Fernandez. Just two from me. Just, I guess first off, as you’re speaking with KOLs and doing your outreach, what’s really resonating with KOLs about the profile here? Then second, congrats to Terry for joining. I’m just curious, I know it’s extremely early, but curious what the priority list will be as he gets settled. Thanks.

嗨，各位。我是代 Seamus Fernandez 提問的 Evan Lang。我有兩個問題。首先，當你們與關鍵意見領袖（KOLs）交流並進行外展時，這個產品特徵（profile）中，最能引起 KOLs 共鳴的是什麼？第二，恭喜 Terry 加入。我知道現在還非常早，但想請教他在逐步上手後，優先事項清單大概會是什麼？謝謝。

Yeah. The question, and again, I apologize, the audio is not the best. I think your question was the profile they get most excited about with the lorundrostat. I think it’s pretty clear it’s aligned to the attributes that matter to physicians when treating their patients. That is the blood pressure reduction, which we know is extremely meaningful and we think best in class with lorundrostat, combined with safety and tolerability.

是的。這個問題，而且再次抱歉，音訊不是很好。我想你的問題是，他們對 lorundrostat 最感到興奮的是哪一種特徵組合。我認為很清楚，這與醫師在治療病患時最在意的屬性是一致的。也就是降血壓效果——我們知道這極具臨床意義，而且我們認為 lorundrostat 在同類中最佳——再加上安全性與耐受性。

So in other words, the patients need to be able to not only get the blood pressure reduction, but get it in a way that is safe and can be adhered to over a long period of time. So, we continue to believe that that profile that we’ve seen from our clinical program reinforces a profile that meets the needs of physicians as they’re treating these patients third line and later.

換句話說，病患不僅需要達到降血壓，還需要以安全、且能在長期內遵從治療的方式來達成。因此，我們仍然相信，我們臨床計畫所看到的這一特徵組合，強化了能滿足醫師需求的產品輪廓，特別是在醫師以第三線及之後的治療來處理這些病患時。

As to Terry, yeah, we’re very excited. I’m actually thrilled to be able to expand the expertise that we’re able to apply to Mineralys and lorundrostat by retaining Dave in a strategic advisory full-time role to really help continue to investigate translational opportunities for lorundrostat.

至於 Terry，是的，我們非常興奮。我其實很高興能夠透過讓 Dave 以全職的策略顧問角色留任，來擴大我們可運用於 Mineralys 與 lorundrostat 的專業，真正協助我們持續探索 lorundrostat 的轉譯醫學機會。

We know aldosterone plays a significant role beyond just hypertension, but across cardiorenal metabolic disorders. But having Terry come in with his expertise in latter stage development and very specifically medical affairs, I think does nothing but just augment and build on the success we’ve had to date. We’ve got our medical affairs team in place right now.

我們知道醛固酮的作用不僅限於高血壓，還涵蓋心腎代謝疾病。但讓 Terry 以其在後期開發、且非常聚焦於醫療事務方面的專長加入，我認為只會進一步增強並延續我們迄今為止的成功。我們目前已建立好醫療事務團隊。

Adding Terry’s expertise over 35 years of either clinical work or industry work, I just think really amplifies the message, the resonance, the relationships he has with KOLs. I think is going to be a significant build for us as we continue to prepare lorundrostat for a successful commercial launch.

加入 Terry 在超過 35 年的臨床或產業工作經驗，我認為確實能放大我們的訊息、提升共鳴，並強化他與 KOL 的關係。我認為這將在我們持續為 lorundrostat 的成功商業上市做準備時，帶來顯著助益。

John, I just wanted to add one thing. So in addition to the efficacy and the safety, the Advance data are really resonating well with the KOL audience. So having a unique data set really does differentiate us in their minds.

John，我只是想補充一點。除了療效與安全性之外，Advance 的數據在 KOL 族群中也引起很好的共鳴。因此，擁有一套獨特的資料集，確實能在他們心中讓我們與眾不同。

Great. Thanks. Maybe one follow-up. Just curious in terms of anything you can provide in terms of the number of reps you guys are targeting out of the gate, especially as you’re kind of thinking about your efforts here. Thanks.

很好。謝謝。也許再追問一個問題。想請教你們在一開始就鎖定的業務代表人數方面，是否能提供任何資訊，尤其是你們在思考這些推進工作時。謝謝。

Yeah. Our focus is really on those prescribers that are going to control a significant volume of third line or later prescribing. We’ve talked about in the past, that’s plus or minus 50,000 physicians. So we’ll ensure that we have a very strong share of voice within those predominant prescribers of the latter lines of treatment. We haven’t guided to a specific number. We may in due course, but at this point in time, we just want to hold some of those cards a little bit closer to our vest.

是的。我們的重點確實是那些能掌握大量第三線或更後線處方量的開立者。我們過去談過，大約正負 50,000 位醫師。因此，我們會確保在這些以後線治療為主的核心開立者中，擁有非常強的聲量占比。我們尚未對外指引具體人數。未來適當時機可能會，但就目前而言，我們希望把其中一些資訊先保留在手上。

Annabel Samimy, Stifel.

Annabel Samimy，Stifel。

Hi, this is Kyle speaking for Annabel. Maybe two questions on the label. Exactly what are you guys looking for in terms of a differentiator label in comparison, again, to Sphex/Venti? Based on, I know you mentioned discussions are early, but based on your current interactions, what do you think is required to warrant a language specifically calling out resistant hypertension or CKD? Do you think having a dedicated randomized controlled trial like Advance-HTN or Explore-CKD could be the new mover? Thanks.

你好，我是 Kyle，代 Annabel 發言。關於標籤（label）我有兩個問題。相較於 Sphex/Venti，你們在差異化標籤方面究竟想要達成什麼？我知道你提到目前討論還早，但基於你們目前的互動，你認為要在標籤文字中明確提到「難治性高血壓」或「CKD」需要什麼條件？你認為像 Advance-HTN 或 Explore-CKD 這樣的專門隨機對照試驗，是否可能成為推動因素？謝謝。

Yeah, Kyle, thanks for the question. From a label standpoint, I think there will be a few similarities. I think the indication will look fairly similar. That is for inadequately controlled blood pressure on top of background meds. I think we will get the similar treatment as far as the outcomes claim related to that blood pressure reduction that is become standard based on FDA guidance.

是的，Kyle，謝謝你的問題。就標籤而言，我認為會有一些相似之處。我認為適應症看起來會相當類似。也就是在既有背景用藥之上，血壓仍控制不佳。我認為在與降血壓相關的結果宣稱方面，我們也會獲得類似的處理方式；依據 FDA 指引，這已成為標準。

I think where there is going to be an opportunity for differentiation in all of this obviously is dependent upon dialogues with the agency, but is the representation not just of Launch-HTN, which is the largest hypertension trial conducted with an ASI, but also Advance-HTN, which as Eric said, is very unique and distinct from, frankly, a lot of studies done in hypertension, given the nature of that trial where we were confirming uncontrolled and resistant hypertension based on moving subjects to an AHA-approved background treatment and only randomizing after they cannot get control even on an optimized treatment.

我認為在這一切之中，差異化的機會當然取決於與主管機關的對話，但會在於不僅呈現 Launch-HTN（這是以 ASI 進行的最大型高血壓試驗），也呈現 Advance-HTN；如 Eric 所說，Advance-HTN 非常獨特，坦白說與許多高血壓研究不同，因為該試驗的設計是在將受試者調整至 AHA 核准的背景治療後，確認其仍為控制不佳與難治性高血壓，且只有在即使接受最佳化治療仍無法控制後才進行隨機分派。

I think Advance-HTN certainly will be a part of our discussions with the agency as an important data set to include in the label on top of Launch-HTN. I believe data from Explore-CKD is also informative to physicians who are prescribing an ASI in a subject who may have lower kidney function based on the eGFR.

我認為 Advance-HTN 肯定會成為我們與主管機關討論的一部分，作為在 Launch-HTN 之外、可納入標籤的重要資料集。我也相信 Explore-CKD 的數據，對於在 eGFR 較低、腎功能較差的受試者中開立 ASI 的醫師而言，同樣具有參考價值。

We know the label for baxdrostat speaks to eGFR I believe down to 45, and Explore-CKD went down to 30. We will be making a point to the agency that it is important that physicians have guidance from the label that would reflect that.

我們知道 baxdrostat 的標籤提到 eGFR 我記得可低至 45，而 Explore-CKD 則低至 30。我們會向主管機關強調，讓醫師能從標籤獲得反映這一點的指引是很重要的。

We know collectively, if you look at the efficacy data, even just from Launch-HTN, there are clear differentiators based on the absolute and placebo-adjusted reductions in systolic BP, as well as milder cases of electrolyte change, specifically hyperkalemia. We believe that the data set that we have generated to date creates good evidence for differential points within the label, but obviously those will all be part of discussions with the FDA.

我們也知道，整體而言，如果你看療效數據，即便只看 Launch-HTN，也能看到明確的差異化：包括收縮壓在絕對值與安慰劑校正後的降幅，以及較輕微的電解質變化案例，特別是高血鉀。我們相信，迄今所產生的資料集，為標籤中的差異化要點提供了良好證據，但顯然這些都將納入與 FDA 的討論。

Mohit Bansal, Wells Fargo.

Mohit Bansal，Wells Fargo。

Great. Thank you very much for taking my question. Before I start, thank you very much, David, for all your help over the years and congrats, Terry, for the new role. Looking forward to work with you. I have a couple of questions here.

很好。非常感謝讓我提問。在開始之前，非常感謝 David 這些年來的所有協助，也恭喜 Terry 擔任新職務。期待與你合作。我這裡有幾個問題。

Number one, assuming that you get similar label to baxdrostat, is there anything in the clinical data or the trials like Advance-HTN or the differentiated trial that you could use to appeal to certain specialties? Or it would probably be seen more similar than different from that aspect.

第一，假設你們拿到與 baxdrostat 類似的標籤，在臨床數據或像 Advance-HTN 這類試驗、或其他差異化試驗中，是否有任何內容可以用來吸引特定專科？或者從這個角度看，可能會被視為相似多於不同。

The second one is, AstraZeneca is running this primary aldosteronism trial and that could read out for baxdrostat next year. How do you see that trial, in case it is positive, impacting the class or specific molecule? How do you see the result of that trial impacting the positioning there? Thank you.

第二，AstraZeneca 正在進行一項原發性醛固酮增多症試驗，明年可能會有 baxdrostat 的讀出結果。如果該試驗結果為正，你認為它會如何影響整個類別或特定分子？你認為該試驗結果會如何影響其市場定位？謝謝。

Yeah, Mohit, thanks for the questions. To your first question, I do think there are some distinct points within the label that can create differentiation. I think overall, the aldosterone synthase inhibitors are going to be a transformative new introduction to the treatment of hypertension.

是的，Mohit，謝謝你的問題。針對你的第一個問題，我確實認為標籤中有一些明確要點可以形成差異化。我認為整體而言，醛固酮合成酶抑制劑將會是高血壓治療領域一項具變革性的全新引入。

We’re seeing really pronounced and clinically meaningful reductions in similar patient types. Those on two or more background meds that are failing to get to goal. But within those similarities, and in really the two key areas that are fundamental to a prescriber, blood pressure reduction, and safety signals, specifically hyperkalemia, I think they each have favorable views relative to lorundrostat.

我們看到在相似的病患類型中，出現非常顯著且具臨床意義的降幅。也就是那些已使用兩種或以上背景用藥、但仍無法達標的患者。但在這些相似性之中，且就對處方醫師而言最根本的兩個關鍵面向——降血壓效果與安全性訊號（特別是高血鉀）——我認為相較於 lorundrostat，它們各自的觀感都較為有利。

And you’ve seen the market research we’ve done where we put up the results of BaxHTN relative to Launch-HTN, and there’s about a two to one preference for the profile that emerged with lorundrostat relative to baxdrostat based on those two fairly similar trials.

而且你也看過我們做的市場調查：我們把 BaxHTN 的結果與 Launch-HTN 並列比較，基於這兩個相當類似的試驗，相較於 baxdrostat，對於 lorundrostat 所呈現出的產品特徵（profile）大約有二比一的偏好。

And again, presuming that data from Launch-HTN is in the label, which we anticipate, I think that gives us, from a promotional standpoint and an educational standpoint, an opportunity to really show the benefit of using the most selective ASI with what we think is an ideal half-life of 10 to 12 hours. So I believe that’s how it’s going to translate.

再者，假設 Launch-HTN 的數據會納入標籤（我們也預期會如此），我認為這在推廣與教育層面，讓我們有機會真正展示：使用選擇性最高的 ASI，並搭配我們認為理想的 10 到 12 小時半衰期所帶來的效益。所以我相信這就是它將如何轉化到市場上的方式。

From a primary aldosterone perspective with the PA study, I think there’s a lot of interesting movement as far as how PA was originally characterized to being a secondary form of hypertension to where dysregulated aldosterone is really more of a spectrum.

從原發性醛固酮增多症（PA）的角度、就 PA 研究而言，我認為在 PA 最初被描述為一種繼發性高血壓，到如今「醛固酮失調」其實更像是一個光譜，這之間有很多有趣的變化。

I think the data we generated to date is going to resonate with physicians that are looking to address dysregulated aldosterone, whether it’s classified as typical PA or dysregulated or elevated aldosterone. So it’ll be interesting to see that data but I know that physicians that are treating patients who have aldosterone as a driver of their uncontrolled or resistant hypertension are certainly excited about the lorundrostat profile.

我認為我們迄今產生的數據，會引起希望處理醛固酮失調的醫師共鳴，不論它被歸類為典型 PA，或是醛固酮失調／升高。所以看到那些數據會很有意思；但我知道，對於治療那些以醛固酮作為其未控制或難治性高血壓驅動因素的患者之醫師而言，他們確實對 lorundrostat 的產品特徵感到興奮。

Rami Katkhuda, LifeSci Capital.

Rami Katkhuda，LifeSci Capital。

Hi, guys. Thanks for taking my questions as well. I guess given the December PDUFA, how should we be thinking about the cadence of payer coverage through 2027? Is there a risk that missing the initial Medicare Part D formulary cycle could make next year more of an access-building year?

嗨，各位。也謝謝你們回答我的問題。我想，考量到 12 月的 PDUFA，我們應該如何看待到 2027 年期間保險給付覆蓋的推進節奏？如果錯過最初的 Medicare Part D 處方集（formulary）週期，是否會有風險使得明年更像是一個建立可近性（access-building）的年度？

Secondly, when do you expect the next major hypertension guideline updates to be, and how important could a formal inclusion of ASIs be for the class?

第二，下一次高血壓重大治療指引更新，你們預期會在何時？而 ASI 若能正式納入指引，對這個藥物類別的重要性會有多大？

Yeah. I’ll take the second question, Rami, on the guidelines, and Eric can comment on the first one as far as the cadence of coverage. We’ve been identifying and working with the committee members, making sure that they have the information that is required as they contemplate guideline inclusion.

好的。Rami，我先回答第二個關於指引的問題，至於第一個關於給付覆蓋節奏的部分，Eric 可以補充。我們一直在辨識並與委員會成員合作，確保他們在考量是否納入指引時，具備所需的資訊。

I think probably five years ago, there was a more rigorous cadence of every four or five years, an update of the guidelines. What we’ve heard from those committee members is they’re going to try to be more reactive to new information like the ASIs.

我想大概五年前，指引更新的節奏更為嚴謹，大約每四到五年更新一次。我們從那些委員會成員那裡聽到的是，他們會嘗試對像 ASI 這類新資訊更具反應性。

I would anticipate, sometime in 2027, an update of those guidelines that would reflect where the ASIs should fit within that. I think that’s where we made some really discreet and important choices from the clinical development of lorundrostat.

我預期大約在 2027 年的某個時間點，這些指引會更新，並反映 ASI 應該如何被納入其中。我認為這也是我們在 lorundrostat 的臨床開發上做出一些非常明確且重要選擇的地方。

Not only Launch-HTN providing real-world case studies, but also Advance-HTN for those specialists that are optimally treating patients and yet still failing to help them get to goal. Advance-HTN that we did with the Cleveland Clinic was specifically designed and executed with the guidelines in mind.

不僅 Launch-HTN 提供了真實世界的案例研究，還有 Advance-HTN，針對那些由專科醫師以最佳方式治療、但仍無法幫助患者達標的情況。我們與克里夫蘭診所（Cleveland Clinic）進行的 Advance-HTN，是特別以指引為考量來設計並執行的。

I think we’ve got a very strong case for lorundrostat. That may be a benefit that extends to the class. I think fundamentally, the ASIs, given the clinically meaningful reduction that we’re seeing, will have a really clear place within the guidelines for patients, certainly at latter line of treatment.

我認為我們為 lorundrostat 建立了非常強而有力的論點。這可能也會成為擴及整個類別的益處。我認為從根本上來看，鑑於我們看到具臨床意義的降幅，ASI 在指引中會有非常明確的位置，對患者而言，當然會是在較後線的治療。

Eric can talk about cadence of coverage.

Eric 可以談談給付覆蓋的推進節奏。

Yeah. You’ve characterized it well. So a progressive increase in coverage over the course of 2027 with commercial outpacing Medicare. It’s important to note, as I said before, that Medicare relies upon medical exception, which has a very favorable approval rate.

好的。你的描述很到位。因此在 2027 年期間，給付覆蓋會逐步增加，且商業保險的進展會快於 Medicare。需要強調的是，如我先前所說，Medicare 主要依賴醫療例外（medical exception），而其核准率非常有利。

It’s important to note, and I didn’t say this before, but we’ll also stand up a field reimbursement manager team to support prior authorizations, and we’re making a good emphasis and focus on patient support to ensure that the patient gets on therapy quickly, and there’s tools to help navigate the process. So progressive increase is the core message, commercial first, Medicare coming along, but Medicare exceptions are pretty straightforward.

另外也要強調一點——我之前沒提到——我們也會建立一支外勤給付支援經理（field reimbursement manager）團隊，來協助事前授權（prior authorization），並且我們會非常重視並聚焦於病患支持，確保患者能快速開始治療，同時提供工具協助他們完成流程。所以核心訊息是逐步增加：商業保險先行、Medicare 隨後跟上，但 Medicare 的例外申請其實相當直接。

Tara Bancroft, TD Cowen.

Tara Bancroft，TD Cowen。

Hi. Good afternoon. I want to follow up on one of the first questions that was asked. I am curious in what ways you think you could improve access and adoption as second to market relative to baxdrostat, especially as it comes to pricing. Is it possible maybe to price at a discount and take more share that way? I know you have previously communicated the SGLT2 class as good pricing comps for the Street to anchor to, but maybe should we anchor more so to AstraZeneca now? Thanks so much.

嗨。午安。我想追問一開始有人問到的其中一個問題。我很好奇，作為相較於 baxdrostat 的第二個上市者，你們認為可以透過哪些方式改善可近性與採用率，尤其是在定價方面。是否可能用折扣定價，藉此取得更多市占？我知道你們先前曾提到 SGLT2 類別是華爾街可用來作為定價參考的良好同類比較，但我們現在是否應該更以 AstraZeneca 作為錨定？非常感謝。

Yeah. Let me give some high-level thoughts and Eric can follow up. I have been asked before, does baxdrostat pricing create an anchor? I do not know if it is an anchor. I think it is informative. I think the key element was in the rationale that we, looking from the outside in, saw with the baxdrostat pricing was not specialty tier, which we think was critical to ensure access to patients. We will continue to evaluate that. We are going to continue to do our analysis of it. Maybe Eric can speak to some of that work we are going to continue to do.

好的。我先提供一些高層次的想法，Eric 也可以補充。之前有人問過我：baxdrostat 的定價是否會形成一個錨點？我不確定它是否是一個錨點。我認為它具有參考性。我認為關鍵要素在於：從外部觀察，我們看到 baxdrostat 定價背後的邏輯之一，是它沒有落在專科用藥層級（specialty tier），而我們認為這對確保患者可近性至關重要。我們會持續評估這點。我們會繼續做相關分析。也許 Eric 可以談談我們接下來會持續進行的一些工作。

Yeah. I mean, I will just reinforce, the baxdrostat price is very consistent with the research that we conducted, with payers as well as ad boards that we convened. From a pricing perspective, we have got a pretty good sense of where we will price, but we are still in the final stages of finalizing that.

好的。我的意思是，我只想再次強調：baxdrostat 的價格與我們所做的研究非常一致，包括與保險支付方（payers）以及我們召集的顧問委員會（ad boards）。就定價而言，我們對於定價區間已經有相當清楚的掌握，但我們仍在最後階段完成定案。

Again, a core tenant is to maximize ultimate value, not create a downward pricing spiral. I will not get into too much more than that, but just want to reinforce that, again, pricing of baxdrostat is very consistent with our expectations and we are finalizing our strategy. But we definitely need to make sure that we are preserving value.

同樣地，一個核心原則是最大化最終價值，而不是造成向下的價格螺旋。我不會再深入太多，但我想再次強調：baxdrostat 的定價與我們的預期非常一致，而我們正在敲定策略。但我們確實需要確保我們在維持價值。

Matthew Caufield, H.C. Wainwright.

Matthew Caufield，H.C. Wainwright。

Hi. Thank you, guys. One question that we haven’t really covered is looking back to Explore-CKD, what could be the next important catalysts or possible timeframes for further lorundrostat evaluation in CKD patients? Is that something on the radar at this stage, kind of above and beyond the PDUFA and launch focus? Thanks.

嗨。謝謝各位。有一個我們尚未真正涵蓋的問題是：回頭看 Explore-CKD，接下來在 CKD 患者中進一步評估 lorundrostat 的下一個重要催化劑或可能時間點會是什麼？在這個階段，除了 PDUFA 與上市推進的重點之外，這是否仍在你們的雷達上？謝謝。

Yeah. Matt, Matthew, thank you for the call. This is why I’m excited to have both Terry and Dave here. Dave obviously has five and a half years experience with lorundrostat, and we’re going to be able to augment that with Terry’s cardiovascular experience and medical affairs experience as well as clinical development.

是的。Matt、Matthew，謝謝你的來電。這也是為什麼我很高興 Terry 和 Dave 都在這裡。Dave 顯然在 lorundrostat 方面有五年半的經驗，而我們也能結合 Terry 在心血管領域、醫療事務以及臨床開發方面的經驗來加強。

We know that at this stage, lorundrostat has a really robust and meaningful reduction in systolic BP and blood pressure. We also think, and we’ve talked about this in the past, there’s multiple mechanisms that aldosterone can drive, specifically things like inflammation, fibrosis, and oxidative stress that I think we’ve already seen what that translates to.

我們知道在這個階段，lorundrostat 在降低收縮壓與血壓方面具有非常強勁且具臨床意義的效果。我們也認為——而且我們過去也談過——醛固酮可能透過多種機制發揮作用，特別是像發炎、纖維化與氧化壓力等，我想我們已經看到這些會轉化成什麼樣的結果。

I referred to it in my prepared remarks that in Launch-HTN, we saw a 52% reduction in placebo-adjusted UACR, which is a clear marker of kidney protection. We’ve seen further within the endo presentation benefits from a proteomic standpoint on markers of heart failure.

我在事先準備的發言中提到，在 Launch-HTN 研究中，我們看到安慰劑校正後的 UACR 降低了 52%，這是腎臟保護的明確指標。 我們也在內分泌（endo）簡報中，從蛋白質體學的角度看到在心衰竭標記物方面的進一步益處。

So not only do we have the opportunity to address really the genesis of all of these cardiorenal metabolic syndromes, and that’s blood pressure, but I think there’s an opportunity to really show value beyond just the blood pressure reduction, and that is around elements like heart failure, chronic kidney disease, and related conditions.

因此，我們不僅有機會去處理所有這些心腎代謝症候群的真正起源——也就是血壓——我認為也有機會展現不僅僅是降壓之外的價值，也就是在心衰竭、慢性腎臟病以及相關疾病等面向。

So that’s part of what we’re continuing to analyze at this point. That’s where Dave and some of his translational science team are really digging into what makes sense for the next clinical development of lorundrostat. I think we’ve validated the best-in-class profile as it relates to blood pressure reduction.

所以這也是我們目前持續在分析的一部分。這也是 Dave 和他的一些轉譯科學團隊正在深入研究的方向，看看 lorundrostat 下一步臨床開發什麼最合理。我認為就降壓效果而言，我們已經驗證了其同類最佳（best-in-class）的特徵。

We know where AstraZeneca and Boehringer Ingelheim are going with their ASI SGLT2 combos. I think there are other interesting opportunities that we could pursue and other indications that we’re contemplating. Once we’ve aligned on those final plans, as appropriate, we’ll communicate that to the market.

我們知道 AstraZeneca 和 Boehringer Ingelheim 在他們的 ASI 與 SGLT2 聯合療法（combos）方面的布局方向。 我認為我們也有其他值得探索的機會，以及正在考量的其他適應症。 一旦我們就最終計畫達成一致，並在適當時機，我們會向市場溝通。

Great. Thank you. Very exciting and looking forward to December. Thanks again.

很好。謝謝。非常令人振奮，也期待 12 月。再次感謝。

Dennis Ding, Jefferies.

Dennis Ding，Jefferies。

Hey, guys. Thanks for taking my questions. I have one and then one follow-up. John, you’ve always alluded to and emphasized that you guys are looking for a global partner. Can you go through exactly what you’re looking for in a partner, at least on the US side? And how important is it for a partner to have a presence in nephrology specifically?

嗨，各位。謝謝回答我的問題。我有一個問題，然後還有一個追問。John，你一直提到並強調你們在尋找全球合作夥伴。你能否具體說明你們在合作夥伴身上尋找的是什麼，至少就美國市場而言？另外，合作夥伴在腎臟科（nephrology）方面有布局到底有多重要？

And the reason I bring that up is, and this is my follow-up, is because you’ve talked about leveraging your CKD data to get earlier line use in the third line. And I feel like that could be an area where you can get used more over AstraZeneca. So I’m wondering how much overlap with CKD is there in the cardio setting where you can perhaps go after that population with a cardio sales force? Or maybe it’s a priority for you to go into nephrology in a dedicated way, either on your own or through partners. Thanks so much.

我之所以提這點——這也是我的追問——是因為你們談到利用 CKD 的數據，讓產品在第三線治療中更早被使用。我覺得這可能是一個你們相對於 AstraZeneca 能獲得更多使用的領域。所以我想問，在心血管場景中與 CKD 的重疊程度有多大？你們是否可以用心血管的銷售團隊去切入那群病人？或者對你們而言，是否優先考慮以專門方式進入腎臟科，不論是自己做或透過合作夥伴？非常感謝。

Yeah. Thanks, Dennis. We’ve stated before, and I think you even kind of alluded to it, our goal from a partnering standpoint has tended to be more of a global nature. We’ve stated pretty clearly that the commercialization of lorundrostat outside of the United States would be through a partner.

是的。謝謝你，Dennis。我們之前已經說過——我想你也有提到——從合作的角度來看，我們的目標通常偏向全球性。我們也相當清楚地表示，lorundrostat 在美國以外的商業化將透過合作夥伴來進行。

But ideally, we find a global partner that not only has the commercial interest but also the development interest. As I alluded to in my response to Matthew, I think aldosterone is kind of becoming one of those foundational nodes that are going to be really critical to address cardiorenal metabolic disorders.

但理想情況下，我們希望找到一個全球合作夥伴，不僅有商業化的興趣，也有開發上的興趣。正如我在回覆 Matthew 時提到的，我認為醛固酮正逐漸成為一個基礎性的關鍵節點（foundational node），對於處理心腎代謝疾病將非常重要。

The CKD data that we have is very compelling, very interesting. I do think it does create an opportunity to move earlier in lines of treatment because we know there is just huge overlap of these conditions.

我們手上的 CKD 數據非常有說服力，也非常有意思。我確實認為，這會帶來在治療線別上更早使用的機會，因為我們知道這些疾病之間有非常巨大的重疊。

It is not just hypertension and CKD, but it is hypertension, CKD, it is cardiovascular risk, be it in the form of heart failure or just overall cardiovascular risk. I do not know that there is a specific type or therapeutic area of focus for a partner.

這不只是高血壓與 CKD，而是高血壓、CKD，以及心血管風險——不論是以心衰竭的形式，或是整體的心血管風險。我不確定合作夥伴是否需要特定類型或特定治療領域的聚焦。

I think it is more an understanding of the opportunity that we have near term with lorundrostat to address uncontrolled and resistant hypertension. But then more broadly, the role that aldosterone plays in cardiorenal metabolic as a, frankly, a critical node that needs to be addressed and looking at development opportunities to tap into its full potential.

我認為更重要的是理解我們在短期內透過 lorundrostat 來處理控制不佳與抗藥性高血壓的機會；但更廣泛而言，是理解醛固酮在心腎代謝中所扮演的角色——坦白說，它是一個必須被處理的關鍵節點——並尋找開發機會以釋放其全部潛力。

This concludes the question and answer session. I would like to turn the conference back over to Jon Congleton for closing remarks.

問答環節到此結束。我想把會議交回給 Jon Congleton 作結語。

Thank you, operator. We believe Mineralys is entering an exciting and important period. With our NDA under FDA review, we remain focused on execution as we work towards that December PDUFA target date. I want to thank everybody for joining us today. We look forward to keeping you updated on our progress, and we wish everyone a great evening. Thank you.

謝謝你，接線員。我們相信 Mineralys 正進入一個令人振奮且重要的階段。在我們的 NDA 正由 FDA 審查之際，我們仍專注於執行，並朝著 12 月的 PDUFA 目標日期推進。我要感謝今天加入我們的每一位。我們期待持續向各位更新我們的進展，也祝大家今晚愉快。謝謝。

This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與。