Milestone Pharmaceuticals Inc (MIST) 2025 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Milestone Pharmaceuticals fourth quarter and year-end 2025 corporate update conference call. (Operator Instructions)

女士們、先生們，早安，歡迎參加 Milestone Pharmaceuticals 2025 年第四季及全年公司業績更新電話會議。（操作說明）

As a reminder, this conference is being recorded. I will now turn the call over to your host, Michael Wood of LifeSci Advisors. You may now begin your conference.

再次提醒，本次會議正在錄影。現在我會把電話交給主持人，LifeSci Advisors 的 Michael Wood。現在您可以開始會議了。

Thank you, operator. Good morning, everyone, and welcome to the Milestone Pharmaceuticals full year 2025 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 year ended December 31, 2025, and recent corporate highlights. The release can be accessed on the Investors Media section of the company's website, milestone pharma.com.

謝謝接線生。各位早安，歡迎參加 Milestone Pharmaceuticals 2025 年全年財務業績和業務更新電話會議。今天早些時候，該公司發布了一份新聞稿，概述了截至 2025 年 12 月 31 日的年度財務業績和近期公司亮點。投資者可在本公司網站 milespharma.com 的「投資者媒體」部分查閱該新聞稿。

Before I begin, I'd like to remind everyone 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.

在開始之前，我想提醒大家，本次電話會議中提出的一些資訊包含證券法意義上的前瞻性陳述。這些前瞻性陳述涉及重大風險和不確定性，可能導致實際臨床項目、未來結果、進展、時間安排、表現或成就與此類前瞻性陳述所表達或暗示的內容有重大差異。

These risks and uncertainties associated with Milestone's business and factors it 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 earnings report on Form 10-K for the year ended December 31, 2025, filed with the SEC today.

Milestone 的業務及其可能導致或促成此類差異的因素所相關的這些風險和不確定性，已在公司向美國證券交易委員會提交的文件中進行了詳細描述，包括今天向美國證券交易委員會提交的截至 2025 年 12 月 31 日止年度的 10-K 表格收益報告中的「風險因素」部分。

Speaking on the call this morning will be Joseph Oliveto, President and Chief Executive Officer; Lorenz Muller, Chief Commercial Officer; 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. So I'd now like to turn the call over to Joseph Oliveto. Joe, please go ahead.

今天早上參加電話會議的有：總裁兼執行長 Joseph Oliveto；商務長 Lorenz Muller；財務長兼企業發展執行副總裁 Amit Hasija。此外，公司首席醫療官大衛·巴魯查博士也將在問答環節中出席。現在我想把電話交給約瑟夫·奧利維托。喬，請繼續。

Thank you, Michael. Good morning, and welcome, everyone, to our 2025 year-end earnings call. December 2025 marked a transformational event for Milestone Pharmaceuticals with the FDA approval of CARDAMYST, etripamil nasal spray for paroxysmal super ventricular tachycardia or more specifically for the conversion of SVT to normal sinus rhythm in adults. Milestone is entering an exciting new phase of growth as we focus on bringing this important new therapy to patients and building a strong commercial franchise.

謝謝你，麥可。各位早安，歡迎參加我們2025年終業績電話會議。2025 年 12 月，Milestone Pharmaceuticals 迎來了一個具有變革意義的事件，FDA 批准了 CARDAMYST（依曲帕米鼻噴劑），用於治療陣發性室上性心動過速，更具體地說，用於將 SVT 轉復為成人正常竇性心律。Milestone 正進入一個令人興奮的新增長階段，我們將專注於把這種重要的新療法帶給患者，並建立強大的商業特許經營權。

The FDA approval of CARDAMYST was the culmination of years of clinical development and scientific commitment. And as such, I'd like to reiterate my appreciation and thank all the people who help make this happen. This includes the clinical trial investigators and clinical support staff, our partners who conducted the various clinical, manufacturing and regulatory programs. The patients who participated in the studies and, of course, my colleagues here at Milestone, who put in the hard work and dedication to bring us to where we are today.

CARDAMYST 獲得 FDA 批准，是多年臨床開發和科學投入的最終成果。因此，我想再次表達我的感激之情，並感謝所有幫助促成此事的人。這包括臨床試驗研究人員和臨床支援人員，以及進行各種臨床、生產和監管計畫的合作夥伴。參與研究的患者，當然還有我在 Milestone 的同事們，他們付出了辛勤的努力和奉獻，才使我們取得了今天的成就。

We see the FDA approval of CARDAMYST as a foundation for value creation. Let me expand on what I mean. First, our commercial team is now executing on the launch of CARDAMYST, the first new therapeutic option in 30 years for more than 2 million patients with PSVT. Our goal is that this new product will become a trusted and essential tool for health care providers and their patients. Our commercial strategy this year is focused on driving new patient starts and achieving commercial coverage, which, if successful, is expected to accelerate prescription growth.

我們認為 CARDAMYST 獲得 FDA 批准是創造價值的基礎。讓我進一步解釋一下我的意思。首先，我們的商業團隊正在執行 CARDAMYST 的上市計劃，這是 30 年來首個針對 200 多萬 PSVT 患者的新治療方案。我們的目標是讓這款新產品成為醫療保健提供者及其患者信賴和不可或缺的工具。今年我們的商業策略重點是推動新患者開戶和實現商業保險覆蓋，如果成功，預計將加速處方藥的成長。

The strategy also includes ensuring patients have a good initial experience with CARDAMYST. We were successful in having CARDAMYST available in the market in late January, approximately six weeks after approval, and we began our promotional launch a few weeks later by mid-February. While we're only about a month or so into the launch, we are very encouraged about the initial feedback from prescribers, and Lorenz will be providing more details than what we are seeing regarding the launch later in this call.

該策略還包括確保患者在使用 CARDAMYST 時獲得良好的初始體驗。我們在 1 月下旬成功將 CARDAMYST 推向市場，大約在獲得批准六週後，我們在 2 月中旬開始了推廣活動。雖然產品上市才一個月左右，但我們對處方醫生的初步回饋感到非常鼓舞，Lorenz 將在本次電話會議稍後提供比我們目前所看到的更多有關產品上市的細節。

Second, we believe the FDA approval of CARDAMYST will enable us to leverage our comprehensive clinical data and seek marketing approvals in other parts of the world. The regulatory process here in the US is seen as the gold standard, and we believe that having an FDA approval adds to the credibility of CARDAMYST. We filed a Marketing Authorization Application, or MAA, for etripamil nasal spray or TACHYMIST, as it will be known in Europe in the fourth quarter of 2025.

其次，我們相信 CARDAMYST 獲得 FDA 批准後，我們將能夠利用我們全面的臨床數據，並在世界其他地區尋求市場准入批准。美國的監管流程被視為黃金標準，我們相信獲得 FDA 批准會提升 CARDAMYST 的信譽。我們已提交了依曲帕米鼻噴劑（或 TACHYMIST，在歐洲將於 2025 年第四季上市）的上市許可申請 (MAA)。

We announced the EMA's acceptance of that application in January, and we are engaged with the reviewers, and we expect that review and the decision from that review to occur in the first half of 2027. Moving on to our finances. Milestone Pharmaceutical is well capitalized, and we are reporting today a strengthened balance sheet that we believe supports the successful launch of CARDAMYST and provides us with expected operating runway into late 2027.

我們在 1 月宣布 EMA 已接受該申請，我們正在與審查人員進行溝通，預計審查和審查決定將於 2027 年上半年做出。接下來談談我們的財務狀況。Milestone Pharmaceutical 資金雄厚，我們今天公佈的資產負債表已得到加強，我們相信這將支持 CARDAMYST 的成功上市，並為我們提供到 2027 年底的預期營運資金。

We are reporting a pro forma estimated cash figure of $200 million. This includes the year-end audited cash and cash equivalents and short-term investments, plus the funds we received in early 2026, and from the RTW royalty payment, exercises of a portion of the warrants from our last financing and the sale of shares through our ATM program.

我們報告的預計現金流為 2 億美元（按備考數據）。這包括年末經審計的現金及現金等價物和短期投資，加上我們在 2026 年初收到的資金，以及 RTW 特許權使用費、上次融資中部分認股權證的行使和透過我們的 ATM 計劃出售股份所得。

The figure does not include estimated burn to date in Q1. Amit Hasija, our CFO, will provide the details on our financials later in the call. And lastly, we've recently enhanced our leadership team with the addition of David Sandoval to the position of General Counsel and Chief Compliance Officer.

該數字不包括第一季迄今為止的估計燃燒量。我們的財務長 Amit Hasija 將在稍後的電話會議中提供有關我們財務狀況的詳細資訊。最後，我們最近加強了領導團隊，David Sandoval 加入了公司，擔任總法律顧問兼首席合規官。

David has an established track record with more than 15 years, leading legal and compliance functions across the life sciences sector. We believe this experience will be extremely valuable as we scale our operations and build the infrastructure to support long-term growth. With that, I'd like to turn the call over to Lorenz for some additional color on the launch.

David 在生命科學領域擁有超過 15 年的法律和合規職能領導經驗，績效卓越。我們相信，隨著我們擴大營運規模並建立支持長期成長的基礎設施，這項經驗將極為寶貴。接下來，我想把電話交給洛倫茲，讓他再詳細介紹一下發表會的狀況。

Thank you, Joe. And thank you to all of you for joining us this morning on our update. From a commercial perspective, we're excited to be underway bringing CARDAMYST or etripamil nasal spray to patients who have not had a new treatment option for literally decades. CARDAMYST is the first FDA-approved self-administered therapy specifically designed for acute PSVT treatment. Many patients with PSVT often rely on emergency departments for acute care.

謝謝你，喬。也感謝各位今天早上收看我們的記者會。從商業角度來看，我們很高興能夠開始為幾十年來沒有新治療方案的患者帶來 CARDAMYST 或 etripamil 鼻噴劑。CARDAMYST 是第一個獲得 FDA 批准的、專門用於治療急性 PSVT 的自我給藥療法。許多患有陣發性室上性心搏過速 (PSVT) 的患者通常需要依靠急診進行急性治療。

CARDAMYST is an intranasal treatment option supported by robust efficacy and safety data that patients can administer themselves at the onset of symptoms. Our commercial strategy is focused on targeting high-prescribing cardiologists, electrophysiologists and advanced practice providers who manage PSVT.

CARDAMYST 是一種鼻內治療方案，具有強大的療效和安全性數據支持，患者可在症狀出現時自行使用。我們的商業策略重點是瞄準開處方量大的心臟科醫生、電生理學家和治療陣發性室上性心動過速的高級執業醫師。

With our sales force of approximately 60 representatives, we are targeting around 10,000 providers who we estimate will manage half of the 1 million patients with PSVT who will receive treatment for their condition in 2026. In support of these efforts, we have also been proactively engaging with payers to demonstrate the value proposition of CARDAMYST for PSVT, including the potential to reduce costly emergency department visits and hospital utilization.

我們擁有約 60 名銷售代表，目標是約 10,000 名醫療服務提供者，我們估計他們將管理 2026 年將接受治療的 100 萬 PSVT 患者中的一半。為了支持這些努力，我們也積極與支付者接觸，以展示 CARDAMYST 對 PSVT 的價值主張，包括減少昂貴的急診就診和住院治療的潛力。

We believe the PSVT market represents a clearly defined opportunity within cardiovascular specialty pharma. And our commercialization plan is designed to drive early trial and usage and achieve broad coverage while establishing a durable franchise in acute arrhythmia management.

我們認為，PSVT 市場代表心血管專科製藥領域一個明確的機會。我們的商業化計畫旨在推動早期試驗和使用，實現廣泛覆蓋，同時在急性心律不整管理領域建立持久的品牌。

So let me now update you on the positive momentum we're seeing in the market during these early stages of the launch of CARDAMYST. Overall, we are confident and excited about the first few months since the approval, driven by three achievements. First, as Joe said, we make CARDAMYST conveniently available to patients through retail pharmacies across the country within six weeks of FDA approval.

現在讓我向大家報告一下 CARDAMYST 上市初期市場所取得的正面動能。總體而言，我們對獲批後的頭幾個月充滿信心和興奮，這主要得益於三項成就。首先，正如喬所說，我們會在獲得 FDA 批准後的六週內，透過全國各地的零售藥局方便地向患者提供 CARDAMYST。

Second, we hired, trained and deployed our national sales force within two months enabling them to start delivering thousands of details per week by the middle of February. And finally, we have ample evidence that ahead of contracted coverage, our investments in reimbursement support are all online and functioning as we had intended, helping providers to write and patients to fill prescriptions.

其次，我們在兩個月內完成了全國銷售團隊的招募、培訓和部署，使他們能夠在二月中旬開始每週提供數千份銷售細節。最後，我們有充分的證據表明，在合約生效之前，我們對報銷支持的投資全部上線並按預期運行，幫助醫療服務提供者開處方，幫助患者配藥。

These early achievements are important because they directly support the 3 pillars of commercial success that you've heard me talk about in the past. And those are making CARDAMYST easily accessible and affordable for patients making CARDAMYST easy to prescribe for providers and limiting the need for payers to actively manage the use of CARDAMYST.

這些早期成就之所以重要，是因為它們直接支撐著我過去談到的商業成功的三個支柱。這些措施使得 CARDAMYST 對患者來說更容易獲得且價格合理，使得 CARDAMYST 對醫療服務提供者來說更容易開立處方，並減少了支付方主動管理 CARDAMYST 使用的必要性。

So let's now drill down into the actual launch. While it's still very early, what we are seeing at this stage supports our confidence, prescriptions are being written, wholesalers are ordering replenishment product and patients are walking out of pharmacies with CARDAMYST in hand, strongly suggesting that retail distribution is working.

現在讓我們深入了解一下實際的發布情況。雖然現在還處於非常早期的階段，但我們目前所看到的現象增強了我們的信心：處方正在被開出，批發商正在訂購補貨產品，患者正在拿著 CARDAMYST 走出藥房，這強烈表明零售分銷是有效的。

On the demand generation side, our sales force is delivering well over 1,000 engagements with targeted providers each week showing that they can get in front of high-value customers just a month into the promotional launch. In this first month of promotion, we've seen over 150 prescriptions filled generated by over 100 unique prescribers.

在需求創造方面，我們的銷售團隊每週與目標供應商進行超過 1000 次互動，這表明他們能夠在促銷活動開始僅一個月後就接觸到高價值客戶。在推廣活動的第一個月，我們已經收到超過 150 張處方，這些處方由超過 100 位不同的醫生開立。

Most of the prescriptions filled to date are new patient starts and have been written by providers who are targeted by our sales force. We believe that these numbers give us an early indication that our sales operations have good initial functionality. In the future, and as our promotional efforts progress, I will continue to report on prescriptions and prescribers, including total prescriptions, unique prescribers and new patient starts as well as update on contracted coverage by payers.

到目前為止，大部分處方都是新患者的處方，這些處方都是由我們銷售團隊的目標客戶——醫療服務提供者開立的。我們認為，這些數字初步顯示我們的銷售營運具有良好的初始功能。未來，隨著我們推廣工作的推進，我將繼續報告處方和處方醫生的情況，包括處方總數、不同的處方醫生和新患者開戶情況，以及支付方合約承保範圍的最新情況。

On the coverage front, as I mentioned a few minutes ago, we have data to indicate that our reimbursement support architecture is working, even without contracted coverage in place yet. Prescriptions are being written, prior authorizations are being prepared, medical exceptions are being submitted, and there has been inbound activity on our reimbursement support line.

關於醫保覆蓋範圍，正如我幾分鐘前提到的，我們有數據顯示，即使還沒有簽訂醫保合同，我們的報銷支持體係也正在發揮作用。處方正在開具，事先授權正在準備，醫療例外情況正在提交，我們的報銷支援熱線也接到了諮詢電話。

The investments we made to help facilitate script fulfillment early on at launch are working in the way we design them. As an example of this, I want to share an anecdote of a nationally known electrophysiologist whose name you would all recognize. wanted to prescribe CARDAMYST for one of his patients.

我們在專案啟動初期為幫助劇本順利完成而進行的投資，正按我們預期的方式發揮作用。舉例來說，我想分享一個全國知名的電生理學家（你們一定都聽過他的名字）的故事。他想開CARDAMYST這種藥給他的一個病人。

His first two attempts to fill the prescription at retail pharmacies failed were once he tapped into milestone support services with the help of his local sales rep, he was able to get the patient CARDAMYST that same day. For each successful case study, however, there are at least an equal number of examples where we know of demand from a doctor, but the normal rigors of insurer controls block or delay access to the patient receiving the drug despite the physician's desire for their patient to have it.

他前兩次嘗試在零售藥局配藥都失敗了，後來在當地銷售代表的幫助下，他聯繫了里程碑支援服務，當天就為病人拿到了 CARDAMYST。然而，對於每一個成功的案例研究，至少有同樣多的例子表明，我們知道醫生有需求，但保險公司的常規嚴格控制阻礙或延遲了患者獲得藥物，儘管醫生希望他們的病人能夠獲得這種藥物。

We continue to work on pull-through of these scripts, both by supporting physicians office staff with assistance in completing the prior authorization or medical exception paperwork and of course, by working toward gaining coverage. This natural dampening of prescription fills and buildup of prescriptions in queue for eventual filling is fully within our expectations based on our extensive prelaunch interactions with payers.

我們繼續努力推動這些處方的實施，一方面為醫生辦公室工作人員提供協助，幫助他們完成事先授權或醫療例外文件，另一方面，當然，我們也努力爭取獲得保險覆蓋。處方配藥量的自然減少以及待配藥處方的積壓，完全符合我們根據與支付方在上市前進行的廣泛溝通所預期的。

Let me give you some details of the support systems we have in place to help patients in advance of contracted coverage. CARDAMYST launched with the support of a patient assistance platform as we continue to negotiate with insurers for formulary placement and coverage.

讓我向您詳細介紹一下我們為幫助患者在合約生效前做好準備而設立的支援系統。CARDAMYST 在病患援助平台的支持下推出，我們將繼續與保險公司協商藥品目錄納入和承保範圍。

The program provides benefits verification, reimbursement support and co-pay assistance for eligible patients with commercial insurance that covers CARDAMYST, reinforcing Milestone's commitment to making CARDAMYST affordable for patients who need it. So in summary, our strategy in this launch year is to demonstrate that there is real demand for CARDAMYST.

該計劃為符合條件的商業保險涵蓋 CARDAMYST 的患者提供福利核實、報銷支持和共同支付援助，從而強化了 Milestone 致力於讓需要 CARDAMYST 的患者能夠負擔得起的承諾。總而言之，我們今年的策略是證明 CARDAMYST 確實有市場需求。

To achieve this, we will continue to focus on ensuring that physicians want to and can prescribe CARDAMYST. Patients can access and afford the product and payers can see real demand building in the marketplace. While we are now about a month into launch, it's too early to comment on trends or identify durable patterns, especially because we do not yet have contracted coverage in place.

為了實現這一目標，我們將繼續致力於確保醫生願意並且能夠開立 CARDAMYST 處方。患者能夠獲得並負擔得起該產品，而支付方也能看到市場上真正的需求正在增長。雖然我們已經上線大約一個月了，但現在評論趨勢或確定持久模式還為時過早，尤其是因為我們還沒有簽約。

So we are encouraged by what we are seeing, but not extrapolating yet from very early launch data. We see the current period as being informative but not yet representative. In the coming months, we expect prescription volume to increase and commercial coverage to expand over time with more meaningful progress in the back half of the year, and that should further support the launch trajectory.

所以，我們對目前看到的情況感到鼓舞，但還不能根據非常早期的發射數據來推論。我們認為當前時期具有參考價值，但尚不具代表性。在接下來的幾個月裡，我們預計處方量將會增加，商業覆蓋範圍也會隨著時間的推移而擴大，並在今年下半年取得更有意義的進展，這將進一步支持產品的上市進程。

I'll now turn the call over to Amit to review the financials.

現在我將把電話交給阿米特，讓他審核財務數據。

Thank you, Lorenz. We recognized $1.5 million in milestone revenue in the fourth quarter and full year 2025. There is no revenue comparables in 2024. That full year revenue reflects a milestone earned under our license and collaboration agreement with Corxel following FDA approval in the US for CARDAMYST in PSVT.

謝謝你，洛倫茲。我們在 2025 年第四季和全年確認了 150 萬美元的里程碑收入。2024年沒有可比較收入數據。這項全年收入反映了我們根據與 Corxel 的許可和合作協議所取得的里程碑式成就，此前 CARDAMYST 已獲得美國 FDA 批准用於治療 PSVT。

R&D expense, net of tax credits, was $5.5 million in the fourth quarter of 2025 compared to $3.9 million in the fourth quarter of 2024. For the full year R&D expense was $18.1 million compared to $14.4 million in 2024. The year-over-year increase was primarily due to higher consulting and outside services costs, partially offset by lower personnel-related costs.

2025 年第四季研發支出（扣除稅收抵免）為 550 萬美元，而 2024 年第四季為 390 萬美元。全年研發支出為 1,810 萬美元，而 2024 年為 1,440 萬美元。年比增幅主要歸因於諮詢和外部服務成本上升，部分被人員相關成本下降所抵銷。

G&A expense was $5.1 million in the fourth quarter of 2025 compared to $4.0 million in the prior quarter. For the full year, G&A expense was $17.3 million compared to $16.7 million in 2024. The increase was primarily driven by higher outside service costs and higher personnel costs. Commercial expense was $8.2 million in the fourth quarter of 2025 compared to $4.4 million in the fourth quarter of 2024. For the full year, commercial expense was $28.3 million compared to $11 million in 2024.

2025 年第四季一般及行政費用為 510 萬美元，而上一季為 400 萬美元。全年一般及行政費用為 1,730 萬美元，而 2024 年為 1,670 萬美元。成長的主要原因是外部服務成本和人員成本上升。2025 年第四季的商業支出為 820 萬美元，而 2024 年第四季為 440 萬美元。全年商業支出為 2,830 萬美元，而 2024 年為 1,100 萬美元。

This increase primarily reflects additional personnel costs, professional costs and other operational costs associated with preparation for the launch of CARDAMYST. Net loss for the fourth quarter of 2025 was $17.4 million or $0.16 per share compared to $12.4 million or $0.19 per share in the fourth quarter of 2025.

這一成長主要反映了與 CARDAMYST 的推出準備工作相關的額外人員成本、專業成本和其他營運成本。2025 年第四季淨虧損為 1,740 萬美元，即每股虧損 0.16 美元，而 2025 年第四季淨虧損為 1,240 萬美元，即每股虧損 0.19 美元。

For the full year, net loss was $63.1 million or $0.75 per share compared to $41.5 million or $0.67 per share in 2024. As of December 31, 2025, we had $106 million in cash, cash equivalents and short-term investments. On January 12, 2026, we closed the sale of the royalty interest under our royalty purchase and sale agreement with RTW and received $75 million in cash in exchange for the royalty interest in CARDAMYST.

全年淨虧損為 6,310 萬美元，即每股虧損 0.75 美元，而 2024 年淨虧損為 4,150 萬美元，即每股虧損 0.67 美元。截至 2025 年 12 月 31 日，我們擁有 1.06 億美元的現金、現金等價物和短期投資。2026 年 1 月 12 日，我們根據與 RTW 的特許權使用費購買和銷售協議完成了特許權使用費權益的出售，並收到了 7500 萬美元現金，以換取 CARDAMYST 的特許權使用費權益。

Subsequent to year-end, we also raised approximately $10.9 million in net proceeds through our previously announced at-the-market offering program and received a further $8 million in net proceeds to the exercise of warrants. Taking these additional funds into accounts gives us a pro forma cash number of approximately $200 million. We believe this supports a successful launch of CARDAMYST and provides us with expected operating runway into late 2027.

年末之後，我們也透過先前宣布的以市價發行計畫籌集了約 1,090 萬美元的淨收益，並透過行使認股權證獲得了另外 800 萬美元的淨收益。考慮到這些額外資金，我們得出的預期現金流約為 2 億美元。我們相信這將有助於 CARDAMYST 的成功發布，並為我們提供了 2027 年底的預期營運空間。

I'll now turn the call over to Joe Oliveto for some concluding statements.

現在我將把電話交給喬·奧利維托，請他做一些總結性發言。

Thank you, Amit. We at Milestone Pharmaceuticals believe we are well positioned at a pivotal moment. With CARDAMYST, we have the opportunity to change paroxysmal supraventricular tachycardia is treated in powering patients with a self-administered option, reducing reliance on emergency department care and establishing leadership in acute cardiovascular therapy. That concludes our prepared remarks, and we'll now open up the call to questions.

謝謝你，阿米特。Milestone Pharmaceuticals 認為，我們正處於一個關鍵時刻，並佔據了有利位置。透過 CARDAMYST，我們有機會改變陣發性室上性心搏過速的治療方式，為患者提供自我給藥的選擇，減少對急診護理的依賴，並在急性心血管治療領域確立領先地位。我們的發言稿到此結束，現在開始接受提問。

(Operator Instructions)

（操作說明）

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Hi guys, thanks for taking the question. This is [Athena Chin] on for Ritu Baral. A couple of questions on the CARDAMYST launch. How has feedback been to date between the different prescribers that you're targeting? And where are you seeing the most adoption? And on Coverage, what are the leading reasons for coverage denial. Thank you.

大家好，感謝你們回答這個問題。這是 Athena Chin 為 Ritu Baral 所做的報導。關於 CARDAMYST 的發布，我有幾個問題。到目前為止，您所針對的不同處方醫師之間的回饋如何？你發現哪些地區的採用率最高？關於保險覆蓋範圍，被拒保的主要原因是什麼？謝謝。

Yes. Great to hear you, Athena. Thanks for taking the time to hear the update. And with regard to prescribers, we're actually seeing a broad mix across cardiology, electrophysiology. And as Lorenz had mentioned, specifically in the script, the APPs who are the nurse practitioners and physicians' assistants.

是的。很高興聽到你的消息，雅典娜。感謝您抽空收聽最新情況。至於處方醫生，我們實際上看到心臟病學、電生理學等領域的醫生組成非常廣泛。正如洛倫茲在劇本中特別提到的那樣，APPs指的是護理師和醫師助理。

I think we've guided even before the approval that we thought that the APPs would be a key group for this product. They're very engaged with the patient and hearing from the patient even between visits. So we're seeing a breadth across those specialty groups. And then I think your second question was reasons for coverage denial. It's a bit of a mix right now, and it's early days, I would say.

我認為，早在獲得批准之前，我們就已經表明，APPs 將是該產品的關鍵群體。他們非常關注患者，即使在兩次就診之間也會傾聽患者的回饋。因此，我們看到這些專業群體涵蓋範圍很廣。然後，我認為你的第二個問題是關於拒保的原因。目前情況比較複雜，而且現在還處於早期階段。

So each plan is -- basically just has a basic kind of block until review, I would say, is what we're seeing most. And what that translates to is a lot of paperwork for confirmation that this could be a patient that could be applicable for CARDAMYST. Extra paperwork on do they have PSVT? Have they had events? Have they visited the emergency, those are some examples of what we see, and those were expected.

所以，每個計劃基本上都只是在審核之前有一個基本的封鎖狀態，我認為這是我們看到的最常見的情況。這意味著需要大量的文書工作來確認該患者是否符合 CARDAMYST 的治療條件。需要額外文件證明他們是否患有PSVT？他們有舉辦過活動嗎？他們是否去過急診室？這些都是我們看到的例子，而這些都在意料之中。

Got it, thanks for the additional color.

明白了，謝謝你補充的顏色。

Ted Tenthoff, Piper Sandler.

泰德·滕索夫，派珀·桑德勒。

Great, thanks. Good morning, guys, and congrats on the launch really, really extending time for the company. Picking up on that last question, how long is it taking for reimbursement to kick in. And what is Milestone doing to kind of make sure patient get drug in that delay period?

太好了，謝謝。各位早安，祝賀你們成功發布，這真的大大延長了公司的營運時間。接上一個問題，報銷要多久才能到帳？Milestone公司採取了哪些措施來確保患者在等待期內能夠獲得藥物？

How does that work for -- are they getting drug and it's just they then have to kind of fight to get it paid for. And then secondly, when it comes to supply, what can you tell us about manufacturing supply and sort of how that side of the business is looking?

那這到底是怎麼回事──他們拿到毒品後，就得想辦法爭取報銷費用嗎？其次，關於供應方面，您能跟我們說說製造業的供應情況，以及這方面的業務現況嗎？

Yes. Great questions, Ted. Great to hear voice. How long is an interesting question when you're only launch for a week -- for a month or after you only have four weeks of data. And Yes. So I would say the example of that Lorenz gave is a great one, right? They tried twice and then they engage the system and then once you engage the system, we've seen scripts filled within days.

是的。問得好，泰德。很高興聽到你的聲音。如果只發布一周，那麼「持續多久」是一個有趣的問題；如果只發布一個月，或者只有四周的數據，那麼「持續多久」又是一個有趣的問題。是的。所以我覺得洛倫茲舉的例子非常好，對吧？他們嘗試了兩次，然後啟動了系統，一旦啟動系統，我們就看到幾天之內就填滿了處方。

We've seen scripts filled within weeks and four weeks in, we've seen a few scripts not filled yet. We're still working on them. So there is this natural dampening, again, I think we even targeted and signaled to the Street what it is for the industry, which is before you get approval and you have to go through medical exceptions, the benchmarks tell us that more than half of the scripts are not filled, okay?

我們看到有些劇本在幾週內就被填滿了，而四周過去了，我們也看到有些劇本還沒有被填滿。我們仍在努力。所以，自然而然地出現了這種抑製作用。我認為我們甚至已經向華爾街表明了行業面臨的困境，那就是在獲得批准並經過醫療豁免之前，基準告訴我們，超過一半的處方藥都沒有被使用，明白嗎？

So that is the benchmark that we have in our head and we're trying to beat that, obviously, with our programs, which dovetails into the second part of your question, which is what are we doing. So we have the patient support system, we do have our sales representatives guide largely the APPs and the office managers that, that's available to them.

所以這就是我們心中設定的基準，顯然，我們正在努力透過我們的程式來超越它，這與你問題的第二部分不謀而合，那就是我們正在做什麼。所以我們有病患支援系統，我們的銷售代表主要指導高級執業護理師和辦公室經理，讓他們了解這些系統對他們是可用的。

But remember, we're out there also trying to build awareness of the drug. So we're trying to do all this in the same calls and repeat calls. We have co-pay assistance programs, both in the form of co-pay cards, which give us a little bit more data on how these patients are doing and whether they're getting the drug or not.

但請記住，我們也在努力提高人們對這種藥物的認識。所以我們試圖在相同的通話和重複通話中完成所有這些操作。我們有共同支付援助計劃，以共同支付卡的形式發放，這讓我們能夠更多地了解這些患者的狀況以及他們是否獲得了藥物。

We also have electronic systems at the pharmacies where we're yet to see the data on. That data has just lagged by a good month or so. So we haven't seen any of that data yet. So compartmentalized with the question and the uncertainty around how long it takes is we just need time for these data sets to come in.

我們在藥局也安裝了電子系統，但我們還沒有看到相關數據。這些數據只是滯後了一個月左右。所以我們還沒有看到任何相關數據。因此，對於需要多長時間才能獲得這些數據，我們只能給出一個答案：我們需要時間讓這些數據集進來。

A lot of them are informed if it is on a case-by-case basis, which I don't want to get into with the investors. But that's the value of what we're doing now, having three or four different programs online allows us to see on a case-by-case basis, which ones work in which areas of the country and then allows us to be prepared to like move the dial on different programs depending on what we see.

如果具體情況具體分析，很多人會被告知，我不想和投資人討論這個問題。但這就是我們現在所做的事情的價值所在：擁有三到四個不同的在線項目，使我們能夠逐個案例地觀察哪些項目在全國哪些地區有效，然後使我們能夠根據我們所看到的情況，隨時調整不同項目的策略。

That's very helpful. And then the last question was just on supply. Thanks Joe.

那很有幫助。最後一個問題是關於供應方面的。謝謝你，喬。

Yes. No, supply, we're still in -- we're well prepared. We still have supply left over even from the R&D efforts. So those batches are available and being pulled through and out into the market. And we've already gotten on to a routine cadence of next batches going forward. So all working well on the supply side.

是的。不，供應方面，我們仍然有保障——我們準備充分。即使經過研發，我們仍然有剩餘的供應。所以這些批次的產品已經到貨，正在陸續推出市場。我們已經進入了下一批次生產的常規節奏。所以供應方面一切運作良好。

Awesome thanks bud.

太棒了，謝謝兄弟。

Thanks, Ted.

謝謝你，泰德。

Brandon Folkes, H.D. Wainwright.

布蘭登·福克斯，H.D. 溫賴特。

Hi, thanks for taking my questions and congrats on all the progress. A few from me, understanding it's very early on in the launch, but I thought I'd ask this. Given it is early, do you have any sense of when CARDAMYST has been described currently, what it is replacing. Is it the pull in the pockets? Is it newly diagnosed patients?

您好，感謝您回答我的問題，也恭喜您取得的所有進展。我知道現在距離產品發布還很早，但我還是想問幾個問題。鑑於現在還為時過早，您是否了解 CARDAMYST 目前被描述為什麼樣子，它取代了什麼？是口袋裡的拉力嗎？是新確診的患者嗎？

Just any color there would be helpful. And then maybe secondly, I'll just ask this with it because granted. I don't know how much data you have at this stage. But in terms of early real-world feedback, have you heard of any patients having an episode post having CARDAMYST. And if that has happened, has it worked as anticipated?

任何顏色都可以。其次，我可能還會問這個問題，因為這是理所當然的。我不知道你目前掌握了多少數據。但就早期真實世界的回饋而言，您是否聽說過任何患者在接受 CARDAMYST 治療後出現病情發作？如果這種情況已經發生，那麼它是否達到了預期效果？

Yes. Great questions. I don't have great feedback on a specific patient group that's getting it. It is broad. We have heard of -- so there's not going to be any trends here, but some examples, we have heard of patients getting it before an ablation. We've heard of patients getting yet just as a routine course of they've been waiting for it.

是的。問得好。我沒有關於接受這種治療的特定患者群體的良好回饋。它的範圍很廣。我們聽說過——所以這裡不會有任何趨勢，但有一些例子，我們聽說過一些患者在消融術前接受了這種治療。我們聽說有些患者只是按照常規療程接受了治療，他們一直在等待治療。

And those patients, as we've mentioned before approval, Brandon run the gamut, 2/3 of them are on background medications. A fair number of them have fill in the pocket, in their purse or in their desk draw, whether they use it or not is a question mark. So we've heard all those examples.

正如我們在批准之前提到的，這些患者的情況各不相同，其中 2/3 的患者正在服用背景藥物。相當一部分人的口袋裡、錢包裡或辦公桌抽屜裡都有填充物，但他們是否使用它們是未知數。我們已經聽過所有這些例子了。

But again, too early to say anything that's leading per se right now. I think we're very bullish on the fact that this drug can be used across a whole host of patients, and it really depends on what the APP or the physician believes is best for them. Your second question is really interesting, we're waiting to hear from those patients of having used it and the excitement we know we're going to get.

但話說回來，現在就斷言什麼領先還為時過早。我認為我們非常看好這種藥物可以用於各種各樣的患者，這實際上取決於高級執業護士或醫生認為對他們來說最好的選擇。你的第二個問題很有意思，我們正等著聽聽那些使用過該產品的患者的回饋，以及我們預想中將會獲得的興奮之情。

We know that because we heard it from the clinical trials. I will say, though, we have, as you can imagine, we do pretty heavy social listening out there. So we're on top of what's being said, if you will, on the various pages that these patients talk about and our support group also speaks to patients. Now I don't have that data, but I do, on the social media side, have really uplifting beliefs because even before they treated with CARDAMYST, there was just excitement to get it.

我們知道這一點，是因為我們從臨床試驗中得到了證實。不過，正如你所想，我們在社群媒體上進行了非常深入的監聽。所以，我們密切注意這些患者在各個頁面上談論的內容，我們的支持小組也會與患者交流。現在我沒有那部分數據，但在社群媒體方面，我看到了一些非常令人振奮的消息，因為即使在他們接受 CARDAMYST 治療之前，大家就已經對獲得它感到興奮了。

And remember, Brandon, we always talk about there's two burdens for this condition. One is when you're in it and your heart is going 200 bps a minute or so, and you're feeling it and you have those symptoms. The other burden is when you're not in a condition, but you know there's one coming.

記住，布蘭登，我們總是說這種疾病會帶來兩種負擔。一種情況是，當你身處其中，心跳達到每分鐘 200 次左右，你能感覺到它的存在，並且會出現那些症狀。另一個負擔是，當你身處某種境地，但你知道某種境地即將到來時。

You just don't know when, what you're going to be doing and how bad it's going to be. That's the piece that these patients on the social chat wards are really I think speaking to the fact that they have it and they have, if you will, this comfort or peace of mind to have something. That's been uplifting from -- even -- we saw some of this before we even announced the drug was available. We saw patients getting the drug and being excited about simply having it. I've never had that in my career.

你根本不知道什麼時候會遇到這種情況，會做什麼，以及情況會有多糟。我認為，這些在社交聊天病房的患者真正想表達的是，他們擁有了這種東西，並且，如果你願意的話，他們擁有了這種安慰或安心感。這令人振奮——甚至在我們宣布藥物上市之前，我們就看到了一些這樣的跡象。我們看到患者拿到藥後非常興奮，光是擁有這種藥就讓他們感到高興。我職業生涯中從未遇到過這種情況。

Very helpful. Do you mind if I just sneak one more in. Just on sort of reimbursement. Can you remind us of your contracting strategy here. Do you expect a contract early on in the launch ahead of perhaps significant demand?

很有幫助。介意我再偷偷加一個嗎？只是某種形式的報銷。能否請您介紹一下貴公司的合約策略？你預計產品上市初期，在市場需求旺盛之前，就能拿到合約嗎？

Or given the strength of where your balance sheet is today, are you thinking of perhaps creating significant demand through the patient assistance program and then contracting a little bit later in the launch where you have that demand to put in front of payers. Thank you.

或者，鑑於您目前的資產負債表狀況良好，您是否考慮透過病患援助計畫創造大量需求，然後在產品上市後期再進行一些調整，以便將這些需求擺在支付方面前？謝謝。

Thanks, Brandon. Our strategy has been very clear. We want to drive to coverage because no matter how many programs we put in place until we get coverage, it is a natural dampening as we identified before, more than half of your scripts don't get through. That's the industry benchmarks. We would like to get out of that world as soon as we can and be reasonable about obviously the types of contracts we put in place.

謝謝你，布蘭登。我們的策略非常明確。我們希望盡快實現醫保覆蓋，因為無論我們實施多少計劃，在獲得醫保覆蓋之前，都會像我們之前發現的那樣，自然而然地受到抑制，超過一半的處方都無法通過審核。這是行業基準。我們希望盡快擺脫那種局面，並且顯然會合理地對待我們所簽訂的合約類型。

Our strategy is clearly focused on commercial first. We think we can get those first. And we're very actively engaging payers right now for both commercial and Medicare. It's just the natural lead time for Medicare are longer. So we've always guided to Medicare being more of a 27 type of achievement and commercial starting in '26. We don't guide exactly to when it will start because there are a lot of things outside of our control.

我們的策略顯然是以商業利益為先。我們認為我們可以先拿到那些。我們目前正在積極與商業保險和聯邦醫療保險的支付方接洽。醫療保險的自然審批週期本來比較長。因此，我們一直引導 Medicare 成為一種 27 型的成就，並從 26 年開始走向商業化。我們無法準確預測何時開始，因為有很多事情是我們無法控制的。

But what I will say is we're very encouraged by the discussions we're having with those commercial plans, they are within expectations of what they told us before we got the approval. Remember, we've had two years of engagement with these plans, showing them the budget impact models, and it's just a matter now of getting on their schedules. But no surprises from what we can see so far, again, early, early days -- on anything related to how they're thinking about the product.

但我可以說的是，我們對與這些商業計劃的討論感到非常鼓舞，這些計劃符合他們在批准之前告訴我們的預期。記住，我們已經就這些計劃進行了兩年的溝通，向他們展示了預算影響模型，現在的問題只是如何將這些計劃納入他們的日程安排。但就目前我們所看到的而言，並沒有什麼意外——當然，現在還處於非常早期的階段——關於他們如何看待這款產品的一切。

Great, thanks very much for taking my questions and congrats on the really good progress.

太好了，非常感謝您解答我的問題，也祝賀您取得如此好的發展。

Thanks, Brandon. I appreciate the interest.

謝謝你，布蘭登。感謝您的關注。

(Operator Instructions)

（操作說明）

Dennis Ding, Jeffries.

丹尼斯丁，傑弗里斯。

Good morning. This is Anthea on for Dennis. And congrats on the progress so far. I wanted to follow up on the prior question regarding contracting strategy. Could you talk a little bit more about what does good formulary positioning look like for CARDAMYST. And how much rebate pressure should we expect you push for broader access? And then separately, what is the patient mix in terms of coverage in terms of commercial versus Medicare?

早安.這裡是安西亞替丹尼斯報道。恭喜你們目前的進展。我想就之前提出的合約策略問題做個後續討論。能否再詳細談談 CARDAMYST 良好的處方集定位是什麼樣的？那麼，為了擴大進入範圍，我們應該預期您會施加多大的退稅壓力？此外，就商業保險和聯邦醫療保險而言，病患的組成如何？

Great. Great to hear you, Ani. Thanks for taking the time out today. So with regard to what good coverage looks like for us, we view it and we've guided pre-approval, and we still guide to -- we want pretty open access, things like prior off to label and attestation of the patient being treated for PSVT, that's expected type of coverage. We would like to see that would be good.

偉大的。很高興聽到你的消息，阿尼。感謝您今天抽出時間。所以，就我們而言，好的保險覆蓋範圍是什麼樣的，我們認為，並且我們已經指導了預先批准，我們仍然指導——我們希望相當開放的獲取途徑，例如在標籤發布之前，以及對正在接受 PSVT 治療的患者進行證明，這是預期的保險覆蓋範圍。我們希望看到這樣的結果。

We've also guided the Street to -- the biggest question for payers is not at all the medical need. They see that clearly. They see the benefits of this to their plan. The biggest question they have is how often will it be used by the patient. And we've provided guidance that this is a drug that's used a handful of times per year.

我們也引導華爾街認識到──對支付方而言，最大的問題根本不是醫療需求。他們對此看得很清楚。他們看到了這樣做對他們計劃的好處。他們最關心的問題是病人會多久使用一次。我們已經提供指導，這種藥物每年只需使用幾次。

They just may want some comfort there. So we've heard of and we would expect good coverage to include at least in the launch year or two, quantity limits and not onerous ones like but ones that would prevent it from being used instead of 5 times per year being used 50 times a year, right?

他們可能只是想在那裡得到一些安慰。所以我們已經聽說過，而且我們也希望好的保險至少在上市的一兩年內會包括數量限制，而且不是像那樣苛刻的限制，而是能防止一年使用次數從 5 次變成 50 次的限制，對吧？

That's what they want to avoid. So quantity limits prior off the label is kind of the standard down the fairway type of coverage we've got it to. And again, that's an average. There will be some plans that are more harsh and some plans that are more open, but that's an average good quality coverage for us with standard pay-to-play type of discounts. With regard to the commercial and Medicare breakdown, roughly think of it as 50-50. It's about 50%, under 65% and about 50% over 65%.

這正是他們想要避免的。所以，在標籤脫落前限制用量是目前我們所採用的標準做法。再次強調，這只是平均值。有些計劃會比較嚴格，有些計劃會比較寬鬆，但對我們來說，這算是平均的高品質保障，而且還有標準的付費折扣。至於商業保險和聯邦醫療保險的組成，大致可以理解為 50/50。大約有 50% 的人低於 65%，還有大約 50% 的人高於 65%。

Great. Thank you.

偉大的。謝謝。

We reach end of our question-and-answer session. I'd like to turn the floor back over to Joe for any further closing comments.

我們的問答環節到此結束。我想把發言權交還給喬，讓他做最後的總結發言。

Well, I really -- this is our first earnings call since the approval, and we're reporting on, I guess, the period before we actually launch. So it is early days, but I'm really excited, I'm really thankful for all of the people that have called in here in support of the company, and I want to really just convey that we're super excited to be now doing earnings calls going forward. We'll look forward to updating you on a quarterly basis, as Lorenz had said on how the launch is going and the progress of the company. So with that, I wish everyone a great rest of the day.

嗯，實際上——這是我們獲得批准後的首次財報電話會議，我們今天匯報的是，我想，我們實際發布產品之前的這段時間的情況。現在還處於早期階段，但我真的很興奮，我非常感謝所有打電話來支持公司的人，我只想表達的是，我們非常高興能夠繼續進行財報電話會議。我們將按照 Lorenz 所說的，每季向您報告產品發布和公司發展進度。那麼，祝大家今天剩下的時間過得愉快。

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議和網路直播到此結束。現在您可以斷開線路了，祝您有美好的一天。感謝您今天的參與。