Milestone Pharmaceuticals Inc (MIST) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Greetings. Welcome to the Milestone Pharmaceuticals 2Q '26 earnings conference call. (Operator Instructions) Please note this conference is being recorded.

    各位好。歡迎參加 Milestone Pharmaceuticals 2026 年第二季(2Q '26)財報電話會議。(接線員指示) 請注意,本次會議將被錄音。

  • I will now turn the conference over to Michael Wood from LifeSci Advisors. Thank you, Michael. You may begin.

    現在我將把會議交給 LifeSci Advisors 的 Michael Wood。謝謝你,Michael。你可以開始了。

  • Michael Wood - Analyst

    Michael Wood - Analyst

  • Thank you, and good morning, everyone, and welcome to Milestone Pharmaceuticals' second-quarter 2026 financial results and business update conference call. Earlier this morning, the company issued a press release providing an overview of its financial results for the quarter ended June 30, 2026, and recent corporate highlights.

    謝謝,各位早安,歡迎參加 Milestone Pharmaceuticals 2026 年第二季財務結果與業務更新電話會議。今天稍早,公司已發布新聞稿,概述截至 2026 年 6 月 30 日止季度的財務結果以及近期公司重點進展。

  • The release can be accessed on the Investors & Media section of the company's website, milestonepharma.com. Before we begin, I would like to remind you that some of the information presented on this conference call contains forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause actual clinical programs, future results, progress timing, performances, or achievements to differ materially from those expressed or implied by such forward-looking statements.

    該新聞稿可於公司網站 milestonepharma.com 的「投資人與媒體」專區查閱。在開始之前,我想提醒各位,本次電話會議中所呈現的部分資訊,依證券法規屬於前瞻性陳述。這些前瞻性陳述涉及重大風險與不確定性,可能導致實際的臨床計畫、未來結果、進度時程、表現或成就,與此等前瞻性陳述所明示或暗示者存在重大差異。

  • These risks and uncertainties associated with Milestone's business, and factors that could cause or contribute to such differences, are described in detail in the company's filings with the SEC, including in the Risk Factors section of the Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 20, 2026.

    與 Milestone 業務相關的這些風險與不確定性,以及可能造成或促成此等差異的因素,已在公司向美國證券交易委員會(SEC)提交的文件中詳述,包括截至 2025 年 12 月 31 日止年度之 Form 10-K 年報「風險因素」章節;該年報已於 2026 年 3 月 20 日向 SEC 提交。

  • Speaking on the call today will be Joseph Oliveto, President and Chief Executive Officer; Lorenz Muller, Chief Commercial Officer; and Amit Hasija, Chief Financial Officer and EVP of Corporate Development. In addition, Dr. David Bharucha, the company's Chief Medical Officer, will also be available during the Q&A session.

    今天出席電話會議的講者包括:總裁兼執行長 Joseph Oliveto;商務長 Lorenz Muller;以及財務長暨企業發展執行副總裁 Amit Hasija。此外,公司醫務長 David Bharucha 醫師也將在問答環節中出席。

  • I will now turn the call over to Joseph Oliveto. Please go ahead.

    現在我將把電話會議交給 Joseph Oliveto。請開始。

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Thank you, Michael. Good morning, everyone, and thank you for joining us today to hear about our progress through the second-quarter. Until this year, patients experiencing sudden attacks of paroxysmal supraventricular tachycardia, or PSVT, had no FDA-approved self-administered treatment available to them. Now a growing population of patients in the US have Cardamyst in their homes, in their workplaces, in their pockets, or wherever it's convenient for them to have on hand to treat their PSVT.

    謝謝你,Michael。各位早安,感謝各位今天加入我們,一同了解我們在第二季的進展。在今年之前,遭遇陣發性上心室性心動過速(paroxysmal supraventricular tachycardia,PSVT)突發發作的患者,並沒有任何獲得 FDA 核准、可自行給藥的治療可用。如今,美國越來越多患者在家中、工作場所、口袋裡,或任何方便隨身備用之處備有 Cardamyst,以治療其 PSVT。

  • Today, we're excited to report on our first full financial quarter since our commercial launch in mid-February. We've seen growing evidence that physicians, patients, and payers recognize the value of Cardamyst as a new treatment paradigm for PSVT. I'll start by taking you through total scripts, the number of unique prescribers, and patients filling prescriptions, and we'll report these figures for the quarter, compare them to the prior quarter, and add them for the first half results.

    今天,我們很高興報告自 2 月中旬商業化上市以來的第一個完整財務季度表現。我們看到越來越多證據顯示,醫師、患者與支付方皆認可 Cardamyst 作為 PSVT 新治療典範的價值。我將先帶各位回顧總處方量、開立處方的獨立醫師人數,以及領藥患者人數;我們將報告本季度數據,與前一季度比較,並彙總上半年結果。

  • Realize that the first-quarter is a partial quarter and first half figures represent approximately 4.5 months of promotion between mid-February and the end of June. I'll also provide an update on market access coverage and how it has changed since our last investor call in May. For the second-quarter of 2026, ending June 30, we continue to view the breadth of prescriber experience as one of the more important positive early indicators for the launch.

    請注意,第一季為部分季度,而上半年數據約代表自 2 月中旬至 6 月底約 4.5 個月的推廣期間。我也將更新市場准入(market access)給付覆蓋情況,以及自我們 5 月上次投資人電話會議以來的變化。對於截至 6 月 30 日的 2026 年第二季,我們仍認為處方醫師的經驗覆蓋廣度,是本次上市初期較重要的正面指標之一。

  • More than 600 unique healthcare professionals wrote prescriptions for Cardamyst in the second-quarter, compared with approximately 200 in the first-quarter, for a total of greater than 800 unique prescribers across the first half of the year. We recorded more than 1,200 total prescriptions in Q2, compared with approximately 300 in the first-quarter, bringing the total prescriptions for the first half of 2026 to more than 1,500.

    第二季有超過 600 位獨立醫療專業人員為 Cardamyst 開立處方,相較第一季約 200 位;因此上半年累計獨立處方醫師總數超過 800 位。我們在第二季記錄到超過 1,200 張總處方量,相較第一季約 300 張,使得 2026 年上半年總處方量超過 1,500 張。

  • And more than 1,000 patients received Cardamyst in the second-quarter, compared with nearly 300 in the first-quarter, for a total of more than 1,300 patients in the first half of the year. As of today, we have secured formulary coverage representing more than 50% of commercially insured lives. Most of this progress of additional coverage has come very recently, specifically in July and August.

    第二季有超過 1,000 名患者取得 Cardamyst,相較第一季接近 300 名;因此上半年累計患者總數超過 1,300 名。截至今日,我們已取得處方集(formulary)覆蓋,涵蓋超過 50% 的商業保險承保人數。這些新增覆蓋的大部分進展都發生在近期,特別是在 7 月與 8 月。

  • During the second-quarter, coverage remained relatively unchanged at approximately 25% of commercially insured lives, which we reported on at our May investor call. Our recent crossing of the 50% commercially insured mark is an important achievement, which will enable increased access to Cardamyst for patients in those plans, as well as providing us with increased confidence for gaining coverage from additional plans. Lorenz will share further insights about the launch, but before turning the call over to Lorenz, I'll provide an update on the AFib-RVR program.

    在第二季期間,覆蓋率相對沒有太大變化,約為商業保險承保人數的 25%,我們已在 5 月投資人電話會議中報告過。我們近期跨越商業保險覆蓋 50% 的里程碑是一項重要成就,將使這些方案中的患者更容易取得 Cardamyst,同時也讓我們對於爭取更多方案覆蓋更具信心。Lorenz 將分享更多關於上市推進的洞見;但在把電話會議交給 Lorenz 之前,我先更新 AFib-RVR 計畫的進展。

  • From the start of our development of this novel compound and delivery system, our aim has been to shift appropriate acute care for tachycardias from the current treatment state, which is reactive and healthcare setting intensive, to one that is proactive and patient empowering by enabling patients to treat themselves outside the hospital.

    自我們開始開發這一新型化合物與給藥系統以來,我們的目標一直是將適當的心動過速急性照護,從目前「被動反應、且高度依賴醫療場域」的治療現況,轉變為「主動且賦能患者」的模式,讓患者能在醫院之外自行治療。

  • We are now at an exciting intersection of both fulfilling that promise for patients with PSVT and having begun the registrational Phase 3 stage of evaluating etripamil in the broader population of patients, those who experience atrial fibrillation with rapid ventricular rate, or AFib-RVR. We have begun our pivotal Phase 3 trial evaluating etripamil for treatment of AFib-RVR as announced in our last earnings release.

    我們現在正處於令人振奮的交會點:一方面,我們正為 PSVT 患者實現這項承諾;另一方面,我們也已進入註冊性第三期(registrational Phase 3)階段,評估 etripamil 在更廣泛患者族群中的效果,也就是出現心房顫動合併快速心室率(atrial fibrillation with rapid ventricular rate,AFib-RVR)的患者。如我們在上次財報新聞稿中所宣布,我們已啟動評估 etripamil 用於 AFib-RVR 治療的關鍵性第三期試驗。

  • Thanks to the efforts of the Milestone clinical team, our lead clinical sites are now active and we expect our first patients to be enrolled shortly. We believe AFib-RVR represents a substantially larger opportunity for etripamil to help patients than it has for PSVT. Atrial fibrillation is a growing problem in the US, estimated to impact over 10 million people.

    在 Milestone 臨床團隊的努力下,我們的主要臨床試驗中心現已啟動,我們預期很快將納入首批受試者。我們相信,相較於 PSVT,AFib-RVR 對 etripamil 協助患者而言代表著更大的機會。心房顫動在美國是日益嚴重的問題,估計影響超過 1,000 萬人。

  • Of this, we estimate an addressable population with burdensome symptomatic RVR of 3 to 4 million patients. Somewhat like PSVT, patients with AFib-RVR experience symptomatic episodes and currently for AFib have limited and suboptimal self-administered treatment options. As a result, many of these episodes are managed in the emergency department using intravenous therapies or even electrical cardioversion.

    其中,我們估計具有負擔性、具症狀之 RVR 的可觸及族群約為 300 萬至 400 萬名患者。與 PSVT 有些相似,AFib-RVR 患者會出現具症狀的發作,而目前針對 AFib 的可自行給藥治療選項有限且不理想。因此,許多此類發作是在急診室以靜脈注射治療,甚至以電復律方式處置。

  • We're looking to leverage the strong and unique foothold that we have established in the cardiovascular space to address these current limitations. The design of our Phase 3 AFib study, called ReVeRA-301, follows the same approach that was the basis for our successful Phase 3 program in PSVT. Patients self-administer study medication, either etripamil or placebo in a double-blinded fashion, at home in response to their symptoms using the same 70-milligram dose and repeat dose regimen that is already approved for Cardamyst in PSVT.

    我們希望運用我們在心血管領域已建立的強大且獨特立足點,來解決這些現有限制。我們第三期 AFib 研究(名為 ReVeRA-301)的設計,沿用我們在 PSVT 成功第三期計畫所採用的相同方法。患者在家中依症狀自行給藥,以雙盲方式使用研究藥物(etripamil 或安慰劑),並採用與 Cardamyst 已獲核准用於 PSVT 相同的 70 毫克劑量與重複給藥方案。

  • Many of the operational components of the study and many of the clinical sites are the same as those that were performed and performed well in our PSVT program. We believe this continuity between the two programs lowers our executional risk and reflects the experience we, meaning our team, the clinical investigators, and our collaboration partners, have built across the etripamil program.

    本研究的許多營運組成與許多臨床試驗中心,與我們在 PSVT 計畫中所執行且表現良好的部分相同。我們相信,兩個計畫之間的這種延續性可降低我們的執行風險,並反映出我們——也就是我們的團隊、臨床研究者以及合作夥伴——在 etripamil 計畫中累積的經驗。

  • Our regulatory approach in AFib using our Phase 3 study is a single-study supplemental new drug application, or sNDA. This is an efficient registrational pathway to a potential label expansion, and we will provide further updates on this program as it progresses. In addition to our progress toward an indication for AFib-RVR, we are progressing towards regulatory decisions in PSVT in Europe and China.

    我們在 AFib 的法規申請策略,是以第三期研究作為單一研究的補充新藥申請(supplemental new drug application,sNDA)。這是一條有效率的註冊途徑,可望實現適應症標籤擴增;我們將在計畫推進過程中提供更多更新。除了朝向取得 AFib-RVR 適應症的進展之外,我們也正推進 PSVT 在歐洲與中國的法規審查決策。

  • If successful, these will expand access to etripamil globally. Our marketing application with the European Medicines Agency, or EMA, remains on track for a decision expected in the first half of 2027. For China, the engagement with the Chinese regulators is being carried by our partner, Everest Medicines.

    若成功,這些將擴大全球對 etripamil 的可及性。我們向歐洲藥品管理局(EMA)提交的上市許可申請仍按計畫推進,預計將於 2027 年上半年作出決定。在中國方面,與中國監管機構的溝通由我們的合作夥伴 Everest Medicines 負責推進。

  • I will now turn the call over to Lorenz to cover our commercial progress in more detail.

    我現在把電話交給 Lorenz,請他更詳細說明我們的商業化進展。

  • Lorenz Muller - Chief Commercial Officer

    Lorenz Muller - Chief Commercial Officer

  • Thank you, Joe, and good morning, everyone. Building on Joe's remarks, I will highlight what we are seeing 6 months into the launch and specifically how we are well positioned to accelerate in the coming months. We're excited about the progress of our work towards securing commercial coverage for Cardamyst, which is a critical goal that can define success in the first year of a drug launch.

    謝謝你,Joe,各位早安。承接 Joe 的發言,我將重點說明我們在上市 6 個月後所觀察到的情況,特別是我們如何已做好準備在未來幾個月加速推進。我們對於推動 Cardamyst 取得商業保險給付覆蓋的工作進展感到振奮;這是一項關鍵目標,可能決定藥品上市第一年的成敗。

  • As of Q2, we had secured coverage for an estimated 25% of commercial lives, which primarily accounted for the early win we achieved at the end of Q1 with Express Scripts. In the weeks since the quarter closed, we have seen a meaningful step up in coverage. As of last week, approximately half of commercially insured lives are now covered, driven by formulary decisions at UnitedHealthcare and several other prominent commercial insurers that use either Express Scripts or Optum Rx as their pharmacy benefit manager.

    截至第二季,我們已為估計 25% 的商業保險受保人群取得覆蓋,這主要反映了我們在第一季末與 Express Scripts 達成的早期成果。自本季結束以來的數週內,我們看到覆蓋率出現顯著提升。截至上週,約有一半的商業保險受保人群已納入覆蓋,主要由 UnitedHealthcare 以及其他數家使用 Express Scripts 或 Optum Rx 作為藥房福利管理機構(PBM)的知名商業保險公司之處方集決策所帶動。

  • It is important to see our focused and persistent market access work gain traction, and we remain optimistic about securing the last of the major PBMs and associated insurance providers, as well as pulling through additional plans who work with ESI and Optum Rx. The receptivity among payers is an important signal. We believe it tells us that they appreciate the clinical value of Cardamyst and anticipate that demand will continue to grow.

    看到我們聚焦且持續的市場准入工作逐步取得進展非常重要;我們仍對於拿下最後一家主要 PBM 及其相關保險提供者、以及帶動更多與 ESI 和 Optum Rx 合作的方案納入覆蓋保持樂觀。付款方的接受度是一個重要訊號。我們認為,這表明他們認可 Cardamyst 的臨床價值,並預期需求將持續成長。

  • As Joe mentioned at the top of the call, we're also very encouraged by the growing breadth of prescribers we've seen to date, and just as importantly, that electrophysiologists are strongly engaged in prescribing Cardamyst for their patients. Recognized as the key opinion leaders in the treatment of tachycardias, these physicians represent many of the early adopters of Cardamyst.

    如同 Joe 在電話會議一開始提到的,我們也對目前看到的處方醫師群體日益擴大感到非常鼓舞;同樣重要的是,心臟電生理專科醫師在為其病患開立 Cardamyst 方面高度投入。這些醫師被公認為治療心動過速的關鍵意見領袖,亦代表 Cardamyst 的許多早期採用者。

  • This experience among electrophysiologists is important because as awareness of Cardamyst continues to grow, use and endorsement by this subspecialty will influence demand generation in general cardiology. In terms of demand generation, in Q2 we have seen steady, consistent growth in prescriptions for Cardamyst. In addition to electrophysiologists, our sales efforts have established a broad and growing receptive base of prescribers that include clinical and interventional cardiologists as well as advanced practice providers, such as nurse practitioners, within cardiology practices.

    心臟電生理專科醫師的使用經驗很重要,因為隨著 Cardamyst 的知名度持續提升,該次專科的使用與背書將影響一般心臟科的需求生成。就需求生成而言,我們在第二季看到 Cardamyst 的處方量穩定且持續成長。除心臟電生理專科醫師外,我們的銷售推廣也建立了廣泛且持續擴大的、願意採用的處方醫師基礎,包括臨床心臟科與介入心臟科醫師,以及心臟科診所內的進階實務提供者(APP),例如護理師執業者(NP)。

  • As we move through the second half of the year, our efforts will continue to grow this base of new prescribers while simultaneously focusing on the early adopters of Cardamyst with the goal of driving greater depth of prescribing, encouraging the healthcare providers already using Cardamyst to prescribe it more consistently across their eligible patients.

    隨著我們進入下半年,我們的工作將持續擴大這個新處方醫師基礎,同時聚焦於 Cardamyst 的早期採用者,目標是提升處方深度,鼓勵已在使用 Cardamyst 的醫療照護提供者,能更一致地在其符合適應症的病患中開立。

  • A second area of our launch strategy that we are initiating is targeted patient activation. With coverage now at approximately 50% of commercially insured lives, we believe we've reached an important tipping point where patients can have greater confidence in accessing Cardamyst. We've also learned from market research that when patients ask their healthcare provider about Cardamyst, there is a high likelihood that they will receive it.

    我們上市策略的第二個面向是我們正在啟動的精準病患啟動(patient activation)。目前覆蓋率約達商業保險受保人群的 50%,我們認為已到達一個重要的臨界點,使病患對取得 Cardamyst 更有信心。我們也從市場調查得知,當病患向其醫療照護提供者詢問 Cardamyst 時,他們很有可能會獲得該藥。

  • With that foundation in place, we believe that now is the right time to begin building patient awareness through our enhanced Cardamyst.com experience and targeted digital advertising. This investment will encourage interested patients to speak with their healthcare providers and download resources that make Cardamyst affordable for commercially insured patients.

    在此基礎之上,我們認為現在是透過強化的 Cardamyst.com 使用體驗與精準數位廣告來建立病患認知的適當時機。這項投資將鼓勵有興趣的病患與其醫療照護提供者討論,並下載相關資源,以協助商業保險病患負擔得起 Cardamyst。

  • Together, we believe that enhanced promotion to healthcare providers as a result of learnings from the first 6 months of launch, combined with newly initiated patient activation efforts, will support an acceleration of demand for Cardamyst in the quarters ahead.

    我們相信,根據上市前 6 個月的學習而強化對醫療照護提供者的推廣,再加上新啟動的病患啟動措施,將支持未來幾季 Cardamyst 需求加速成長。

  • I'll now turn the call over to Amit for a review of our financials.

    我現在把電話交給 Amit,請他回顧我們的財務狀況。

  • Amit Hasija - Chief Financial Officer, Executive Vice President of Corporate Development

    Amit Hasija - Chief Financial Officer, Executive Vice President of Corporate Development

  • Thank you, Lorenz. As of June 30, 2026, we had cash, cash equivalents, and short-term investments of $170.6 million, compared with $106 million at December 31, 2025. We expect cash, cash equivalents, and short-term investments to be sufficient to cover operating expenses and capital expenditure into the future, the second half of 2027. Product revenue for the three months and six months ended June 30, 2026, was $0.6 million and $0.8 million respectively.

    謝謝你,Lorenz。截至 2026 年 6 月 30 日,我們的現金、約當現金及短期投資為 1.706 億美元,相較於 2025 年 12 月 31 日的 1.06 億美元。我們預期現金、約當現金及短期投資足以支應營運費用與資本支出至未來,即 2027 年下半年。截至 2026 年 6 月 30 日止三個月及六個月的產品營收分別為 60 萬美元與 80 萬美元。

  • There is no product revenue recorded in the three or six-month periods ended June 30, 2025. Research and development expense net of tax credits was $3.5 million for the second-quarter of 2026, compared with $3.7 million for the same period in 2025. After six months ended June 30, 2026, research and development expense was $6.8 million compared with $8.6 million for the same period in 2025.

    截至 2025 年 6 月 30 日止三個月及六個月期間並未認列任何產品營收。2026 年第二季研發費用(扣除稅額抵減後)為 350 萬美元,較 2025 年同期的 370 萬美元略降。截至 2026 年 6 月 30 日止六個月,研發費用為 680 萬美元,較 2025 年同期的 860 萬美元下降。

  • The decrease was a result of a decrease in outside service costs related to drug development and research. Selling, general and administrative expense was $22.6 million for the second-quarter of 2026 compared with $8.9 million for the second-quarter of 2025. For the six months ended June 30, 2026, selling, general and administrative expense was $43.3 million compared with $24.4 million for the same period in 2025.

    下降主要是由於與藥物開發與研究相關的外部服務成本降低。2026 年第二季銷售、一般及行政費用為 2,260 萬美元,較 2025 年第二季的 890 萬美元增加。截至 2026 年 6 月 30 日止六個月,銷售、一般及行政費用為 4,330 萬美元,較 2025 年同期的 2,440 萬美元增加。

  • The increase was a result of additional personnel costs, professional costs, and other operational expenses related to the launch of Cardamyst. Net loss for the second-quarter of 2026 was $28.6 million, or 21 cents per share, compared with a net loss of $13 million, or 20 cents per share, for the second-quarter of 2025. For the six months ended June 30, 2026, net loss was $54.7 million, or 41 cents per share, compared with $43.7 million, or 51 cents per share, for the same period in 2025.

    增加主要是由於與 Cardamyst 上市相關的新增人員成本、專業服務成本及其他營運費用。2026 年第二季淨損為 2,860 萬美元,或每股 21 美分;相較之下,2025 年第二季淨損為 1,300 萬美元,或每股 20 美分。截至 2026 年 6 月 30 日止六個月,淨損為 5,470 萬美元,或每股 41 美分;相較之下,2025 年同期為 4,370 萬美元,或每股 51 美分。

  • For further details on our financial results, please refer to our quarterly report on Form 10-Q for the quarter ended June 30, 2026, which was filed with the SEC this morning.

    如需我們財務結果的更多細節,請參閱我們今早向美國證券交易委員會(SEC)提交的、截至 2026 年 6 月 30 日止季度之 Form 10-Q 季度報告。

  • I'll now turn the call back over to Joe for closing remarks.

    我現在把電話交回給 Joe,請他做結語。

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Thank you, Lorenz and Amit. Today we've reported on numbers and metrics that we are following closely and I'm sure we'll discuss further. Let's remember why we're here and the value of our product. I'd like to share some recent anecdotes we've received from the field about PSVT patients and their experience with Cardamyst.

    謝謝你,Lorenz 和 Amit。今天我們報告了我們密切追蹤的數字與指標,我相信我們還會進一步討論。讓我們記得我們為何在此,以及我們產品的價值。我想分享一些我們最近從第一線收到、關於 PSVT 病患及其使用 Cardamyst 經驗的軼事。

  • This includes having received stories from patients with self-described history of, quote, unquote, multiple trips to the emergency department who successfully converted to normal sinus rhythm on Cardamyst and without the trip to the ED. We heard recently from a medical assistant who, after she recounted the specifics of the patient's success story, which I unfortunately can't share the details, finished the note with she, meaning the patient, is excited, the doctor is excited, and I'm excited, and I needed to let you know.

    其中包括一些病患的故事:他們自述曾「多次前往急診室」,但在使用 Cardamyst 後成功轉為正常竇性心律,且無需前往急診。我們最近也聽到一位醫療助理的回饋:在她敘述該病患成功案例的具體情況後(很遺憾我無法分享細節),她在備註最後寫道:她——也就是病患——很興奮,醫師很興奮,而我也很興奮,我必須讓你知道。

  • And another patient who actually made a special trip back to his provider's office only to share the great success he had with Cardamyst. These stories serve as powerful reminders of the transformational impact we're having on patients' experience with PSVT. They lift us up and reinforce our commitment to the cardiology patient community.

    還有另一位病患,甚至特地回到其醫療提供者的診所,只為了分享他使用 Cardamyst 所獲得的巨大成功。這些故事有力地提醒我們,我們正在為病患的 PSVT 體驗帶來多麼具轉變性的影響。它們鼓舞我們,並強化我們對心臟科病患社群的承諾。

  • And we can't help but believe stories like these also lift healthcare providers up because they can offer an innovative option that their patients are excited about. In closing, the first half of the year has given us a solid foundation to build on. We have established a broad and growing receptive base of prescribers, which we believe tells us the clinical value of Cardamyst is resonating.

    而且我們不禁相信,像這樣的故事也同樣能鼓舞醫療照護提供者,因為他們可以提供一個讓病患感到興奮的創新選項。總結來說,上半年為我們奠定了堅實的基礎。我們已建立起廣泛且持續成長、對我們具接受度的開立處方醫師基礎;我們相信這顯示 Cardamyst 的臨床價值正在引起共鳴。

  • We have expanded commercial coverage to roughly half of commercially insured lives and fully expect to pull through more commercial coverage. Together with continuously improving refined sales and marketing strategies, our goal is to continue to accelerate growth in the second half of the year. Thank you. Looking beyond the PSVT launch, we are particularly excited about initiating our Phase 3 AFib-RVR study and in enrolling the first patient soon. We will share that news as soon as it's available.

    我們已將商業保險給付覆蓋擴展至約一半的商業保險人口,並完全預期能帶動更多商業給付落地。結合持續精進、更加成熟的銷售與行銷策略,我們的目標是在下半年持續加速成長。謝謝。在 PSVT 上市之外,我們也特別期待啟動我們的第三期 AFib-RVR 研究,並很快納入第一位病患。一旦消息可公布,我們將立即分享。

  • That concludes our remarks, and we will now open the call for questions.

    以上為我們的說明,接下來我們將開放提問。

  • Operator

    Operator

  • (Operator Instructions) Ritu Baral, TD Cowen.

    (接線員指示) TD Cowen 的 Ritu Baral。

  • Athena Chan - Analyst

    Athena Chan - Analyst

  • Hi guys, this is Athena Chan on for Ritu Baral. I wanted to get more color on your prescribing trends, especially on the 600 new or unique prescribers through Q2. What percentage of them were high volume writers versus one-time prescribers and how are you seeing the breakdown between prescribing trends between cardiologists, electrophysiologists, and nurse practitioners kind of shifting throughout this launch?

    嗨,各位好,我是代替 Ritu Baral 的 Athena Chan。我想更深入了解你們的處方趨勢,特別是截至第二季新增或獨特開立者達 600 位。其中高處方量開立者相較於一次性開立者各占多少比例?另外,在這次上市期間,你們觀察到心臟科醫師、心臟電生理醫師,以及護理師(nurse practitioners)之間的處方趨勢分布有何變化?

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Hey, Athena, thanks for the question. To come back to specific numbers through Q2, we're at around 800 unique prescribers. That is a strength that leads us as a forward indicator for that prescription growth going forward. And we did report that 800 unique prescribers prescribed to about 1,300 patients over that first 4.5 months through June 30. So just doing the math, you can see a lot of those writers are, if you will, one-time writers.

    嗨,Athena,謝謝你的問題。回到截至第二季的具體數字,我們大約有 800 位獨特開立者。這是一項優勢,我們將其視為未來處方成長的領先指標。我們也回報過,這 800 位獨特開立者在截至 6 月 30 日的前 4.5 個月內,為約 1,300 位病患開立處方。所以簡單算一下,你可以看出其中很多開立者可以說是一次性開立者。

  • We see this as a strength. As we've gotten out into the field, we've probably reached about half of our targets. Recall that we have about 10,000 high-value targets on our call list. Of those targets, we also have explained that we call on the whole office, and there's about 16,000 what we call affiliate members associated with the offices of those targets. So, a call universe of about 26,000, of which we've reached about half, let's say.

    我們將此視為一項優勢。隨著我們走入市場第一線,我們大概已接觸到約一半的目標。請記得,我們的拜訪名單上約有 10,000 名高價值目標。在這些目標之中,我們也說明過,我們會拜訪整個診所,而與這些目標診所相關、我們稱為「關聯成員」的人員約有 16,000 名。因此,整體可拜訪的對象約 26,000 名,其中我們大約已接觸到一半。

  • So, of the 10,000 targets, about half have been called on, about 800 have written so far, which we think is a good number for that high-value target list. And as I had said, a fair number of them were one-timers. We've also seen promotional response that Lorenz will talk about, and I'll also ask him to talk about the diversity of writers, but he had mentioned in the call script the value of the electrophysiologist, so he'll also comment on that.

    因此,在 10,000 名目標之中,大約一半已被拜訪過;截至目前約有 800 名已開立處方,我們認為以這份高價值目標名單而言是個不錯的數字。如我所說,其中相當一部分是一次性開立者。我們也看到推廣帶來的反應,Lorenz 會談到;我也會請他談談開立者的多元性。他在講稿中提到心臟電生理醫師(electrophysiologist)的價值,因此他也會就此補充。

  • Lorenz Muller - Chief Commercial Officer

    Lorenz Muller - Chief Commercial Officer

  • Yes, thanks, Athena. Regarding the mix, I mean, we're pleasantly surprised that it's broad. Not only is it a significant number of writers, but also it's a healthy mix of clinical cardiologists, interventional cardiologists, nurse practitioners, what we call APPs, but also electrophysiologists, as I alluded to in the prepared remarks. You know, we always expected EPs to treat these patients, but we didn't expect them to write as early and as broadly because, you know, let's face it, their job is to do ablations, right?

    是的,謝謝你,Athena。就組成來看,我們很高興地發現分布相當廣。不僅開立者數量可觀,組成也很健康,包含一般臨床心臟科醫師、介入性心臟科醫師、護理師、我們所稱的 APP(進階實務提供者),也包含心臟電生理醫師,正如我在事先準備的發言中所提到的。你知道,我們一直預期 EP 會治療這些病患,但我們沒預期他們會這麼早、且這麼廣泛地開立處方,因為坦白說,他們的工作是做消融術(ablation),對吧?

  • And so we always expected some use, but we're seeing, I think, more than we even expected, which I think is an early sign of, you know, a good sign for the market where we've got the thought leaders that are getting experience and then going to be advocating for it. On the promotional response, we also obviously measure this.

    因此我們一直預期會有一些使用,但我們看到的使用量,我認為甚至超出我們的預期;我覺得這是市場的早期訊號,也是個好現象,因為意見領袖正在累積使用經驗,接著會為其背書與倡議。至於推廣反應,我們當然也有衡量。

  • We're now six months in, so we're starting to get a small number of doctors that are getting 5, 6, 7, 8, 10 calls. And we are pleased to see real response, meaning as you get more promotions, you do get more prescriptions. And again, that's across the board. It's not isolated to EPs or cardiologists, but I can tell you that EPs have a strong promotional response, meaning when they hear about the drug, it's a calcium channel blocker. They see these patients frequently, and they have a real use case for it, prescribing it relatively early in what we typically see for cardiology launches.

    我們現在上市已六個月,因此開始出現少數醫師已接受 5、6、7、8、甚至 10 次拜訪。我們很高興看到確實的反應,也就是說,推廣次數越多,處方量就越多。而且這是全面性的。這並非只集中在 EP 或心臟科醫師身上;但我可以告訴你,EP 的推廣反應很強,也就是當他們聽到這個藥,它是一種鈣離子通道阻斷劑。他們經常見到這些病患,且有很明確的使用情境,因此相較於我們通常在心臟科產品上市時看到的情況,他們算是相對早期就開始開立。

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Yes. So, Athena, just to put a wrap on it, what that means for us going forward is we would still expect to see continued breadth and growth of breadth of prescribers as seen by prescribers that write after one or two calls, but given the promotional response, now it directs us to go with more frequent calling where it's appropriate and we see that there should be benefits once you get beyond five or six calls to actually have further writing. So it's a double-pronged approach that'll start going forward where depth will be added to breadth.

    是的。所以,Athena,總結一下,這對我們未來的意義是:我們仍預期開立者的廣度會持續擴大並成長,因為有些醫師在一到兩次拜訪後就會開立;但鑑於推廣反應,這也引導我們在適當之處提高拜訪頻率。我們看到一旦超過五到六次拜訪,確實能帶來更多持續開立的效益。因此未來會採取雙軌策略:在擴大廣度的同時,也加深深度。

  • Athena Chan - Analyst

    Athena Chan - Analyst

  • Got it. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • Ted Tenthoff, Piper Sandler.

    Piper Sandler 的 Ted Tenthoff。

  • Ted Tenthoff - Analyst

    Ted Tenthoff - Analyst

  • I wanted to get a sense, it may still be a little bit early, but just kind of any commentary you have on pricing and whether or not there's gross-to-net discounting that you're seeing. And then also, again, still maybe a little bit early, but any early indications on repeat use? I'm trying to kind of get back to sort of the real-world numbers that you used for annual attack rate.

    我想了解一下,可能還稍微早,但想請你們評論一下定價,以及你們是否看到毛額到淨額(gross-to-net)的折讓。另外,同樣可能還有點早,但是否有任何重複使用(repeat use)的早期跡象?我想回推你們用於年發作率(annual attack rate)的那些真實世界數據。

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Yes, so I'll start. I'll ask Amit to add any additional color on average selling prices. And I'll start there, though. Foundationally, this is a market that hasn't had any new development, certainly on the drug side for decades. So we consciously went into this market knowing that, knowing that it is a market that has to be broken into and woken up a little bit.

    好的,我先回答。我也會請 Amit 補充平均銷售價格方面的更多細節。我先從這裡開始。從根本來說,這個市場在數十年來都沒有新的開發,尤其是在藥物端。因此我們有意識地進入這個市場,並了解這是一個需要被打開、也需要被喚醒一些的市場。

  • And the thought process was the value prop would ring true across the continuum of patients, physicians, and payers. And we made a bet, and we continue to believe that's the right strategy, to try to make the drug easy to get as we work through coverage. So we're really happy to report very recent 50% coverage, but through the second-quarter, which is what these numbers are on, Ted, really, while we're happy to get Express Scripts early in the quarter and eventually see that pulled through, the second-quarter, we really had relatively low coverage, if you think about it, right?

    我們的思考是,價值主張會在病患、醫師與支付方的整個鏈條上都能成立。我們做了一個押注,且我們仍相信這是正確策略:在我們推進給付覆蓋的同時,盡量讓病患容易取得這個藥。因此我們很高興回報近期已達到 50% 覆蓋;但就第二季(也就是這些數字所反映的期間)而言,Ted,雖然我們很高興在該季初期就拿下 Express Scripts,並最終看到其落地帶動,但在第二季我們的覆蓋其實相對偏低,如果你這樣想的話,對吧?

  • 25% of commercially covered lives, about half of the overall population. So we're talking about a small piece of the overall population. As a result of that, our strategy was to allow for a fair amount of copay mitigation. And when you don't have a lot of coverage, that means a lot of denial conversion, meaning that, you know, the script is basically given away and we don't make any revenues from it.

    商業保險涵蓋人數的25%,約為整體人口的一半。所以我們談的是整體人口中的一小部分。因此,我們的策略是允許相當程度的自付額(copay)減免。而當你的涵蓋率不高時,就意味著會有大量的拒付轉換(denial conversion),也就是說,你知道,處方基本上等於是送出去,我們從中沒有任何營收。

  • So that really swamps out your average selling price over that period while coverage is low. With Q3 now starting and we're just getting, and I mean literally, in July and even in July, just the other day, we got more coverage. July into mid-August here, that's growing down 50%. As that grows, we think that amount of denial conversion and overall copay mitigation will start to come down over time.

    因此,在涵蓋率偏低的那段期間,這會大幅拉低你的平均銷售價格。隨著第三季(Q3)開始,我們才剛開始取得更多涵蓋;我的意思是,真的就在7月,甚至就在7月的前幾天,我們又拿到更多涵蓋。從7月到這裡的8月中旬,這個比例成長到50%以下。隨著涵蓋率提升,我們認為拒付轉換的量以及整體自付額減免,會隨時間逐步下降。

  • It's hard to predict exactly when, but we still believe we got the right strategy. Let's make it easy to get the drug. Let's make it a good experience for doctors and patients when they get it. And not having a good experience means going through a lot of paperwork. So we try to limit that until we can get coverage. And that's when we'll start to see increases in average selling price kick up as we get better coverage and less denial conversion.

    很難精準預測會在何時發生,但我們仍相信我們採取了正確的策略。讓取得藥物變得容易。讓醫師與病人在拿到藥物時有良好的體驗。而沒有良好體驗就代表要處理大量文書作業。所以在我們取得涵蓋之前,我們會盡量減少這些流程。而當我們取得涵蓋後,隨著涵蓋改善、拒付轉換減少,我們就會開始看到平均銷售價格上升。

  • Ted Tenthoff - Analyst

    Ted Tenthoff - Analyst

  • That makes a lot of sense.

    這很有道理。

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Yes, you talked about also repeat use, right? And if we look at just the numbers, Q1, very early, 300 scripts, 300 patients, Q2, I guess we had 1,500 scripts over 1,300 patients. So good signal that we're starting to see repeat use per patient, which is a great sign. And obviously, as time goes by, we'll see that more and more, right? We've seen it in our clinical trials. We expect that to happen in the real world as well.

    是的,你也談到重複使用(repeat use),對吧?如果我們只看數字,第一季(Q1)非常早期,300張處方、300位病人;第二季(Q2),我想我們有1,500張處方、涵蓋1,300多位病人。所以這是個很好的訊號,顯示我們開始看到每位病人的重複用藥,這是非常正面的跡象。而且很明顯,隨著時間推進,我們會看到這種情況越來越多,對吧?我們在臨床試驗中已經看到了。我們也預期在真實世界中同樣會發生。

  • Ted Tenthoff - Analyst

    Ted Tenthoff - Analyst

  • Great, excellent. Thanks for all that additional color.

    很好,非常棒。謝謝你補充這些額外的說明。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    Mohit Bansal,富國銀行(Wells Fargo)。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • I just wanted to understand, so a couple of questions there. So number one, I just want to understand the difference between commercial covered life, that is 25%, versus the covered life here. Is this the step added which is an issue, which is the difference between these two, or are there any other things? And would the covered life be the same as commercially covered lives at some point?

    我只是想了解一下,所以這裡有幾個問題。第一,我想了解「商業保險涵蓋人數」(commercial covered lives)25%與這裡提到的「涵蓋人數」(covered lives)之間的差異。這兩者的差異是否在於新增了步驟(step added)造成的問題,還是還有其他因素?而「涵蓋人數」在某個時間點會不會等同於「商業保險涵蓋人數」?

  • Would love to get some clarification there. And the second question is, basically, so far for the 25% commercially covered lives, the kind of rebates and all, are they in the ballpark of what you were thinking before, or are there some differences there?

    希望能請你釐清一下。第二個問題是,基本上到目前為止,針對這25%的商業保險涵蓋人數,相關的回扣(rebates)等等,是否大致落在你們先前預期的範圍內,還是有一些差異?

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Yes, no, great questions, and I'll clarify that, Mohit. It was really a simple concept. Essentially, SVT is about half of our population is under 65, and about half of our population is over 65. When that breaks down into coverage, it's actually, to be very specific, a little bit more like 45% commercial, 45% Medicare, and about 10% other, which is, you know, kind of Medicaid and government-type programs like that. So that is what I was talking about when I talked about the whole population.

    是的,很好的問題,我來釐清一下,Mohit。這其實是一個很簡單的概念。基本上,SVT 的族群大約一半在65歲以下,另一半在65歲以上。當把它拆成保險涵蓋結構時,具體來說,大概是45%商業保險、45% Medicare(聯邦醫療保險),以及約10%其他,也就是你知道的 Medicaid(醫療補助)與這類政府型計畫。所以這就是我在談整體人口時所指的內容。

  • And when you think of commercially covered lives, you think about that being about half of the overall population. And stuff like that comes starting in '27, and we'll get there. And that's why we've always focused investors, analysts, and even prescribers to really starting with commercial because we expect commercial coverage to come sooner than Medicare coverage would come, and that's playing out.

    而當你想到「商業保險涵蓋人數」時,你會把它視為約占整體人口的一半。而像那樣的事情會從2027年開始,我們會走到那一步。這也是為什麼我們一直把投資人、分析師,甚至開立處方的醫師的焦點放在先從商業保險開始,因為我們預期商業保險的涵蓋會比 Medicare 的涵蓋更早到來,而目前的發展也確實如此。

  • With regard to the rebates, the short answer is yes. We think, and we've always said, that we've priced this product such that with moderate rebates, you know, we would be able to have good coverage and have reasonable out-of-pockets for patients. And at least with the initial coverage we have so far, which is now approaching 50% or now exceeded 50% of commercially covered lives, it's right in the ballpark of what we thought.

    至於回扣(rebates),簡短的答案是:是的。我們認為,而且我們一直都說,我們對這個產品的定價是這樣設計的:在中度回扣的情況下,我們仍能取得良好的涵蓋,並讓病人的自付額維持在合理水準。至少就目前我們已取得的初期涵蓋而言——現在正接近50%,或已超過商業保險涵蓋人數的50%——結果大致符合我們原先的預期。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Awesome. Thank you very much. Appreciated.

    太棒了。非常感謝。感激不盡。

  • Operator

    Operator

  • Tiago Fauth, Raymond James.

    Tiago Fauth,Raymond James。

  • Tiago Fauth - Analyst

    Tiago Fauth - Analyst

  • Just kind of a follow-up on the commercial coverage improvement. I know we're going to see more impact on that in Q4, but I'm trying to understand how can it translate to prescription both in the US behavior and also net revenue per patient. Is this mostly going to convert some of the prescriptions that are already being written to commercial and you're going to get a higher net revenue per script?

    我想就商業保險涵蓋改善再追問一下。我知道我們會在第四季(Q4)看到更多影響,但我想了解它如何轉化為處方表現——包括美國端的行為,以及每位病人的淨營收。這是否主要是把目前已經開出的部分處方轉成商業保險給付,從而讓每張處方的淨營收更高?

  • Or could this actually be a trigger of better access and more written prescriptions because physicians can actually get a little easier access on that? And just to follow up on ReVeRA, because again, you are using the exact same formulation, you have an existing database, it would be an sNDA. Like what is the remaining risks on that AFib trial? Is it going to be like the symptom endpoint, the patient identification, enrollment, trial execution? Can you just talk about some of the levers there?

    或者,這是否可能實際上觸發更好的可近性,並帶來更多被開立的處方,因為醫師在取得用藥上會更容易一些?另外再追問 ReVeRA,因為你們使用完全相同的配方,也有既有資料庫,會是一個 sNDA。那麼在這個 AFib 試驗上剩餘的風險是什麼?會是症狀終點、病人辨識、收案、試驗執行嗎?你能談談其中一些槓桿(levers)嗎?

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Okay, thanks, Tiago. Three questions as I captured them there. So I think the first was around with improving coverage, how does that impact scripts and revenues essentially, and it impacts both, I would say. Foundationally, I say it would have the most impact on revenues, on improved average selling prices, because as I said before, we'll just have less denial conversion associated with the products, right, which we're doing quite extensively now.

    好的,謝謝你,Tiago。我把你的問題整理為三個。第一個是,隨著涵蓋改善,對處方量與營收的影響本質上是什麼;我會說兩者都會受影響。從根本來看,我認為對營收的影響最大,會反映在平均銷售價格的提升,因為如我先前所說,產品相關的拒付轉換會變少,對吧?而我們目前確實在相當大規模地進行拒付轉換。

  • So we should see with that coverage pulled through in Q3 and impacting Q4, we should start to see eventual improvements in average selling price and better gross-to-net. Very astute though to ask about impacts on scripts as well because what I'll say is that doctors know that new drugs come with access hurdles.

    因此,隨著第三季(Q3)涵蓋的落地並影響到第四季(Q4),我們應該會開始看到平均銷售價格逐步改善,以及更好的毛利到淨利(gross-to-net)。你也很敏銳地問到對處方量的影響;我想說的是,醫師知道新藥通常會伴隨可近性障礙。

  • And when I'm out in the field, the typical call closes with, looks like a great idea, how do I get it, and is it covered? And they fundamentally know that, that involves paperwork, and that involves the work of their office to get it through. And it's a soft variable, Tiago. I can't put an exact number on it, but it's there in their minds.

    當我在外勤時,一般拜訪的結尾通常是:看起來是個很好的想法,我要怎麼拿到?有給付嗎?他們本質上知道,這會牽涉到文書作業,也需要他們診所人員去把流程跑完。這是一個較軟性的變數,Tiago。我無法給出精確數字,但它確實存在於他們的考量之中。

  • So we believe fully that once we, I don't know if this is exactly the time, but once we get to critical mass of coverage, then physicians know it's going to go through. They can, their patients can pick it up at their local pharmacy with a reasonable out-of-pocket and awareness of our copay card, bringing a reasonable amount of out-of-pocket down to $25 is going to go quickly, and it's not going to involve a lot of extra paperwork.

    所以我們完全相信,一旦我們——我不確定現在是否正是那個時間點——但一旦我們達到涵蓋的臨界規模,醫師就會知道處方會順利通過。他們的病人可以在住家附近的藥局領藥,自付額也會合理;再加上對我們自付額補助卡(copay card)的認知,能把合理的自付額降到25美元,流程會很快,而且不需要大量額外的文書作業。

  • So that's in their minds, and we fully believe that'll increase script growth once we start reaching a critical mass of coverage. Now, heading over to ReVeRA, you're exactly right. We take a lot of confidence, and I'll ask David if I miss anything here. We'll take a lot of confidence in the fact that we learned a lot from the SVT program, and we are really using a lot of those same tactics.

    所以這點在他們心裡,我們也完全相信,一旦我們開始達到覆蓋率的臨界規模,處方成長就會加速。接著談到 ReVeRA,你說得完全正確。我們非常有信心——如果我有漏掉什麼我會請 David 補充。我們很有信心的一點是,我們從 SVT 計畫學到了很多,而且我們確實在沿用許多相同的策略。

  • So all the things that we really recognized, wrapped ourselves around the axle on, and went, well, how to identify patients, how to train patients, how to capture data, what monitor to use, how to adjudicate them. All those details that worked very well in that program are going to follow through here. AFib-RVR, though, is different, right? And I would say the main risk that we've identified for investors is that this study has two main differences to the SVT study.

    也就是我們真正意識到、深入鑽研並反覆推敲的所有事情:如何辨識病患、如何訓練病患、如何擷取資料、使用哪種監測器、如何進行判讀裁定。在那個計畫中運作得非常好的所有細節,都會在這裡延續。不過,AFib-RVR 是不同的,對吧?我會說,我們為投資人辨識出的主要風險是:這項研究相較於 SVT 研究有兩個主要差異。

  • The first one being that the secondary endpoint is pivotal to getting the approval, and that is a patient-reported outcome. We have experience with the patient-reported outcomes in SVT, but they weren't as important an endpoint. And here we have to double down and make sure that, that patient-reported outcome performs well and we capture the data as if it was a primary.

    第一個差異是,次要終點對於取得核准是關鍵性的,而那是一個病患回報結果(patient-reported outcome)。我們在 SVT 上有病患回報結果的經驗,但它們不是那麼重要的終點。而在這裡我們必須加倍努力,確保該病患回報結果表現良好,並且以如同主要終點的標準來蒐集資料。

  • So that's a new thing for this program. The other difference between, I would say, the AFib-RVR program and the SVT program is those patients that misdiagnose their event. In the PSVT program, that was about 20%. 80% of the people got it correct. They thought they were in SVT, and they dosed themselves for an SVT event, and about 20% of those events were mischaracterized. They were not actually SVT. They were dosing for something else.

    所以這對這個計畫來說是新的。我會說,AFib-RVR 計畫與 SVT 計畫的另一個差異,是那些把自身事件誤判的病患。在 PSVT 計畫中,這大約是 20%。有 80% 的人判斷正確。他們以為自己處於 SVT,並針對 SVT 事件自行用藥,而其中約 20% 的事件被錯誤歸類。那些其實並不是 SVT。他們是在為其他狀況用藥。

  • That dilution factor will play into the AFib program. We will have to make sure that we limit that in the AFib program. We're all over it. We believe we'll do a great job there, and we've incorporated that into the powering of the study. And we'll be able to see that as the study goes along in a blinded manner. So we'll be able to adjust our tactics as we go forward. But those are the two primary differences between the AFib program and the PSVT program from a tactical standpoint.

    這個稀釋因素也會影響 AFib 計畫。我們必須確保在 AFib 計畫中把它降到最低。我們已全面著手處理。我們相信我們會做得很好,而且我們已把這點納入研究的樣本數/檢定力設計。而且在研究進行過程中,我們能以盲態方式觀察到這個情況。因此我們可以在推進過程中調整策略。但從戰術層面來看,這就是 AFib 計畫與 PSVT 計畫之間的兩個主要差異。

  • Tiago Fauth - Analyst

    Tiago Fauth - Analyst

  • Okay, fantastic. Thanks so much. Appreciate it.

    好的,太棒了。非常感謝。感激不盡。

  • Operator

    Operator

  • Brandon Folkes, HC Wainwright.

    Brandon Folkes,HC Wainwright。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • I just want to clarify, kind of continue on the prescribing trends. You know, are you seeing prescribers undertake almost their own kind of mini patient experience trial and that they write a script awaiting to hear back from the patient to use it more broadly, you know, in which case we hold into the patient having an episode and then along, you know, carrying on.

    我只是想釐清一下,算是延續處方趨勢的問題。你們是否看到開立處方的醫師幾乎在做他們自己的「迷你病患體驗試用」:先開一張處方,等病患回饋後再更廣泛使用;在這種情況下,我們就得等病患發作一次,然後再繼續推進。

  • What is the physician targeting or prescribing strategy in the back half of this year and into 2027? Does it remain on growing the breadth of prescribing? And then sort of at what stage of the launch do you envision focusing more on the depth of prescribing and seeing that as a significant growth drop?

    今年下半年到 2027 年,醫師端的目標鎖定或開立處方策略是什麼?是否仍以擴大開立處方的廣度為主?那麼在上市推進到哪個階段時,你們會更著重於開立處方的深度,並把它視為顯著的成長驅動?

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Okay, thanks, Brandon. So with regard to that, I love how you put it, you know, their own patient experience trial, are they doing that in their own heads? A little bit yes and no, I'd say. We've heard two things. We have heard and seen that is not in doctors' heads, that they're willing to prescribe very broadly to a swath of patients.

    好的,謝謝你,Brandon。關於這點,我很喜歡你說的方式——他們自己的病患體驗試用,他們是不是在腦中自己做這件事?我會說有一點是、也有一點不是。我們聽到兩件事。我們聽到也看到,這不只是醫師腦中的想法,他們願意對一大群病患相當廣泛地開立處方。

  • And we see that across both electrophysiology and cardiology. There are early adopters who see the value and are just prescribing it. And the question there is just, do they have it top of mind when they have their patients in front of them? And then is this the right patient, right? So we see that, but you're very astute to ask the question because it is very common in cardiology that they actually will wait for their own experience, see how the drug does for their patient, and then write refills or write additional patients, right?

    而且我們在心律電生理與心臟科兩邊都看到這種情況。有些早期採用者看到了價值,就直接開立處方。那裡的問題只是:當病患坐在他們面前時,這個藥是否在他們腦海中是「優先想到」的選項?以及這是不是合適的病患,對吧?所以我們確實看到這點;但你問得很敏銳,因為在心臟科很常見的是,他們會等自己的實際經驗——看看藥對自己的病患效果如何——然後才開續方或再開給更多病患,對吧?

  • So there is a very natural tendency for that. We do see that. We have heard from some doctors. They said, let me try it on one or two patients, see how it goes, and then I'll write more. So we see that as upside for sure because the drug really has performed quite well in our view, in our experience with doctors. And it goes to our strategy of getting it in the hands of patients.

    所以這是一種非常自然的傾向。我們確實看到這樣的情況。我們也聽一些醫師說:讓我先在一兩位病患身上試試看,看看結果如何,之後我會再多開。所以我們把這視為明確的上行空間,因為就我們的觀點、以及我們與醫師互動的經驗來看,這個藥的表現確實相當好。而這也呼應我們的策略:先讓病患拿到藥。

  • It is not like a chronic drug where they can get their experience in the next week. They have to wait for an event, so that's a little bit of a dampener for timing, but we fully expect the drug to do well and that experience to shine through. And similar to those vignettes, these things are very powerful. They, maybe more than a couple of sales calls, they'll remember when a patient or a nurse walks into them and said, oh, patient so-and-so did well, we think that's going to be a multiplier effect.

    它不像慢性用藥那樣,醫師可以在下一週就獲得使用經驗。他們必須等到一次事件發作,所以在時間上會稍微拖慢一些,但我們完全預期這個藥會有很好的表現,而那樣的使用經驗會自然展現出來。而且就像那些案例小故事一樣,這些事情非常有力量。也許比幾次業務拜訪更有效——當某位病患或護理師走進來說「某某病患用得很好」時,他們會記得;我們認為這會產生乘數效應。

  • I'm going to ask Lorenz to expand a little further on our strategy, but the bottom line is we're doing both breadth and depth right now. And again, I'll ask him to expand a little further as to why we're doing that, particularly relative to the promotional response.

    我會請 Lorenz 再多談一點我們的策略,但重點是:我們現在同時在做廣度與深度。同樣地,我也會請他再多說一些我們為什麼這麼做,特別是相對於推廣反應(promotional response)而言。

  • Lorenz Muller - Chief Commercial Officer

    Lorenz Muller - Chief Commercial Officer

  • Yes, thanks, Brandon, for the question. So you know early in the launch there's always two goals, right? You want to get doctors to, you want to raise awareness first and foremost, which is a big driver early on, right? Nothing's been new in this area for 30 years and doctors have gotten very comfortable in how they prescribe. So going in there and initially raising awareness and getting the drug, getting them excited about the drug, which has proven to be relatively straightforward because it's a calcium channel blocker.

    是的,謝謝你的問題,Brandon。所以你知道,在上市初期通常有兩個目標,對吧?你首先要讓醫師——最重要的是提升認知度,這在早期是很大的驅動因素,對吧?這個領域 30 年來都沒有新東西,醫師在處方方式上已經非常習慣、也很舒適。所以我們進去之後,先提升認知、讓他們對這個藥感到興奮;而這點相對容易,因為它是一種鈣離子通道阻斷劑。

  • So that early signal of breadth of prescribing we've been very pleased with and the fact that it's been a sustained growth. It hasn't been a bolus early on and it's flattened out. And that's the natural part of it. But because the drug isn't necessarily top of mind, now what we're doing is where, now that we know where our better targets are, our reps have been out there for four to six months, they know and they've talked to their profiled offices, they know which ones are actively treating SVT, they know how many patients roughly they're treating from all their work with those practices.

    因此,對於處方廣度的早期訊號,我們非常滿意,而且它是持續成長的。它不是一開始衝一波就趨於平坦。這是很自然的過程。但因為這個藥未必會一直是醫師「優先想到」的選項,所以我們現在在做的是:既然我們已知道哪些是更好的目標,我們的業務代表已在外面跑了四到六個月,他們了解並且已與其鎖定的診所溝通過,知道哪些診所正在積極治療 SVT,也透過與這些診所的合作大致掌握他們治療的病患數。

  • They can now go back and when a person has trialed, right, they've tried it on one patient, they'll now go back and start to increase frequency on those targets while continuing to identify new targets that are perhaps a little bit later adopting. Those early adopters, they're going to be focused like a laser on those to increase their volume of prescribing.

    他們現在可以回去,當某位醫師已經試用過——例如先在一位病患身上用過——他們就能回去並開始提高對這些目標的拜訪頻率,同時也持續辨識一些可能採用較晚的新目標。至於那些早期採用者,我們會像雷射一樣聚焦在他們身上,以提高其處方量。

  • You get that repeat use, meaning not refills, that's also a part of the strategy, but making them aware that there are other patients than just the first ones they prescribed for. So it's a kind of a shift from initially doing more prospecting and understanding what the nature of the territories are and where the business is, to now shifting at least some of their effort into increasing frequency to drive more use and shifting doctors from awareness to trial to usage.

    你會看到重複使用,也就是不是續配(refills),這也是策略的一部分;同時也要讓他們意識到,除了他們最初開立處方的第一批病人之外,還有其他病人。因此,這有點像是從一開始更多在做市場開發、了解各個區域的特性以及業務在哪裡,轉變為現在至少把部分精力轉向提高開立頻率,以帶動更多使用,並讓醫師從「知道」走向「試用」再到「使用」。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • Great, thank you very much and congrats on the progress.

    太好了,非常感謝,也恭喜你們的進展。

  • Operator

    Operator

  • (Operator Instructions) Georgia Bank, Jefferies.

    (接線員指示) Georgia Bank,Jefferies。

  • Georgia Bank - Analyst

    Georgia Bank - Analyst

  • Hey, this is Georgia Bank on the line for Dennis Ding. I had one about what you spoke about an acceleration in the second half. I guess how much of that expectation is driven by the recent improvement in coverage versus the new patient awareness initiatives and maybe can you provide more detail on what those patient activities efforts look like and how when would you expect them to begin having a measurable impact on prescription growth.

    嗨,我是 Georgia Bank,代 Dennis Ding 提問。我想問一個關於你們提到下半年加速的問題。我想知道,這個預期有多少是由近期給付覆蓋改善所驅動,相較之下有多少來自新的病人認知推廣計畫?另外,你們能否更詳細說明這些病人端活動的內容,以及你們預期它們何時會開始對處方成長產生可衡量的影響?

  • And then separately on in commercially insured lives in the US, now that you have 50%, I guess, how quickly do you expect commercial coverage to scale from here? And what you'd be watching over the second half of this year in terms of any incremental payer wins.

    另外,關於美國商業保險承保人數(commercially insured lives),現在你們已達到 50%,我想問接下來你們預期商業給付覆蓋會以多快速度擴大?以及在今年下半年,你們會觀察哪些指標來判斷是否有新增的付款方(payer)勝利?

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Hey, thanks, George. It's a great question, but a difficult one to answer in terms of specificity as to exactly which tactics will drive what impact on scripts. We obviously have those internally, but we view it a little bit as a gestalt, right? We're 6 months into this launch. We've used the first six months here, essentially for prospecting the market and seeing what's working, what's not.

    嗨,謝謝你,George。這是個很好的問題,但要非常具體地回答「哪些戰術會對處方量(scripts)帶來什麼影響」其實很難。我們內部當然有相關分析,但我們更把它視為一種整體效應(gestalt),對吧?我們上市才 6 個月。前六個月基本上是用來開發市場、看看哪些有效、哪些無效。

  • We've saved a fair amount of dry powder for these programs. And we foundationally have a belief that we will get commercial coverage. We thought we would get it sooner than most products. It seems like we're on target for that so far. Hard to say whether it'll continue to be ahead of coverage, and coverage will grow specifically by the end of the year, but we're really bullish, given our interactions on coverage, that it's going well.

    我們為這些計畫保留了相當多的「乾火藥」(資源/彈藥)。而且我們在根本上相信,我們會拿到商業給付覆蓋。我們原本就認為,相較多數產品,我們會更快取得覆蓋。到目前為止看起來我們正朝這個目標前進。很難說到年底覆蓋是否仍會持續領先、以及覆蓋是否會在年底前具體成長到什麼程度;但基於我們在覆蓋方面的互動,我們非常看多,因為進展看起來很順利。

  • And what felt good with Express Scripts and UnitedHealthcare is continuing to feel good with the others. So that's the best I could say with regard to our bullishness towards coverage coming, but exactly when it's really in their hands, not our hands. We love the value prop. I will say, and I'll ask Lorenz to expand a little bit more on the patient activation, that was gated by design for coverage.

    而且,與 Express Scripts 和 UnitedHealthcare 的進展讓人感覺良好,與其他付款方的互動也持續同樣令人振奮。所以,關於我們對覆蓋到來的樂觀程度,大概只能這樣說;但確切時間點真的在他們手上,不在我們手上。我們很喜歡這個價值主張(value prop)。我也想說,並請 Lorenz 多談一些病人啟動(patient activation),這部分在設計上是以覆蓋為前提(gated by design for coverage)。

  • What we did not want to do was start driving patient awareness and ask patients to go into their doctors and ask about Cardamyst if coverage wasn't approaching some critical mass, which we feel at least 50% of commercial coverage gives us that chip to be able to go in and start that. And as coverage goes, those patients going in will have a better experience. So maybe I'll just use that as a foundation and ask Lorenz to expand on that, as well as where the improved call targeting will help out as well.

    我們不希望在覆蓋尚未接近某個臨界規模之前,就開始推動病人認知,並讓病人去找醫師詢問 Cardamyst;我們認為至少達到 50% 的商業給付覆蓋,才讓我們有那個籌碼可以開始推動。而且隨著覆蓋提升,這些病人去就醫時也會有更好的體驗。所以我先用這個作為基礎,請 Lorenz 進一步說明,同時也談談改進的拜訪/通話目標設定(improved call targeting)會如何帶來幫助。

  • Lorenz Muller - Chief Commercial Officer

    Lorenz Muller - Chief Commercial Officer

  • Yes, thanks, George, for the question. So, as Joe said, we've always focused on, you know, gaining coverage, getting physicians aware of the drug, getting experience with it. And at the right time, we felt there was a real opportunity to get patients also aware so that they go into their office, doctors, and ask for the drug.

    好的,謝謝你,George 的提問。如 Joe 所說,我們一直專注於取得覆蓋、讓醫師認識這個藥、並累積使用經驗。在合適的時間點,我們認為也有很大的機會讓病人端提高認知,讓他們走進診間向醫師詢問並要求這個藥。

  • As Joe mentioned, there was a very high grant rate when a patient came in, both in general in cardiology or in other specialties too, but we've actually seen it in our market research where if a patient asks for Cardamyst, it's highly likely that the physician will grant that for them. So the scale of the patient activation campaign, let's be clear, what it's not is DTC.

    如 Joe 提到的,當病人主動提出需求時,核准/同意的比例非常高,不論是在心臟科或其他專科都一樣;而且我們在市場研究中也看到,如果病人要求 Cardamyst,醫師很可能會同意開立。所以病人啟動活動的規模,我們要講清楚:它不是 DTC(直接面向消費者的廣告)。

  • We're not going to do TV ads and all that kind of thing. We don't think the market's ready for that yet. We're doing a very targeted digital marketing campaign that involves advertising to patients where they are, whether it's social media or search or even banner advertising on things like WebMD and other resources, so that we get the patient's attention there.

    我們不會做電視廣告之類的。我們認為市場目前還沒準備好。我們會做非常精準的數位行銷活動,在病人所在的地方投放廣告,不論是社群媒體、搜尋,或是在像 WebMD 等網站與其他資源上做橫幅廣告,藉此吸引病人的注意。

  • Then the payoff is to go to a website where they can get more information, Cardamyst.com, as you can see has been enhanced with a whole front end as a patient campaign and that will allow them to be educated and then there's some things they can do. They are encouraged to opt in to us so we can market to them so we can have a relationship with them.

    接下來的導流是到一個網站,讓他們獲得更多資訊,也就是 Cardamyst.com;你們可以看到它已經強化了整個前端,作為病人活動的入口,讓他們能被教育,並且有一些事情可以做。我們也會鼓勵他們選擇加入(opt in),讓我們可以對他們行銷、與他們建立關係。

  • They're encouraged to go to see their doctor and ask for Cardamyst. There are resources they can download in terms of copay cards and whatnot. So the idea is to make them aware and then allow them to take an action and also build a relationship with them so that we can market to them over time with things like refill reminders or reminding them to go see their doctor, et cetera.

    我們會鼓勵他們去看醫師並詢問 Cardamyst。也有一些資源可供下載,例如自付額補助卡(copay cards)等等。所以概念是先讓他們知道,接著讓他們採取行動,同時建立關係,讓我們能隨時間持續對他們行銷,例如續配提醒,或提醒他們回診等等。

  • So that is going to be a lot of energy this part of the second half of the year to complement everything we're doing on the physician side to continue to drive top-line awareness, top-of-mind awareness of the doc, and continuing to see the broad set of patients in front of them that they can appropriately write Cardamyst for.

    因此,在今年下半年這段期間,我們會投入大量精力,來補強我們在醫師端所做的一切,持續推動整體認知、提高醫師的「第一時間想起」(top-of-mind)程度,並持續讓醫師看到他們面前更廣泛的病人族群,讓他們能在適當情況下開立 Cardamyst。

  • Joseph Oliveto - President, Chief Executive Officer, Director

    Joseph Oliveto - President, Chief Executive Officer, Director

  • Yes. And lastly, I'll just add on to that, George. So, you know, we don't talk about it much. Many investors just ask about the sales force. But the sales force comes with surround sound as well on the HCP. So HCP awareness is still something we are working towards. And, you know, we expect that to go up over time in this surround sound, these, you know, advertising on the sites that physicians are on, where they see educational materials on understanding that there's something new for SVT, I think, is a powerful aspect of our program.

    是的。最後我再補充一下,George。我們其實不太常談這個。很多投資人只問銷售團隊。但銷售團隊也會搭配對醫療照護專業人員(HCP)的「環繞式」推廣。因此,HCP 的認知仍是我們努力的方向。而且我們預期在這種環繞式推廣下,隨時間推進認知會提升;例如在醫師常用的網站上投放廣告,讓他們看到教育素材、理解針對 SVT 有新的選擇,我認為這是我們計畫中很有力的一環。

  • And we've seen that putting that next to a sales representative actually improves the opportunity for a physician to write. So we'll continue to see that pull through in the second half as well.

    我們也看到,把這些推廣放在業務代表拜訪旁邊,確實能提高醫師開立處方的機會。所以我們也會在下半年持續看到這樣的帶動效果。

  • Georgia Bank - Analyst

    Georgia Bank - Analyst

  • Got it. Thank you so much.

    了解。非常感謝。

  • Operator

    Operator

  • This now concludes our question and answer session. Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. Please disconnect your lines and have a wonderful day.

    現在問答環節到此結束。各位女士、先生,感謝各位的參與。今天的電話會議到此結束。請掛斷電話,祝各位有美好的一天。