Tarsus Pharmaceuticals, Inc. (TARS) 2026 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon, and welcome to Tarsus' first quarter 2026 financial results conference call. As a reminder, this call is being recorded. (Operator Instructions)

    下午好,歡迎參加 Tarsus 2026 年第一季財務業績電話會議。提醒各位,本次電話會議將被錄音。(接線員指示)

  • At this time, I would like to turn the call over to David Nakasone, Head of Investor Relations, to lead off the call. David, you may begin.

    此刻,我想把電話會議交給投資人關係主管 David Nakasone 來開場。David,請開始。

  • David Nakasone - Head - Investor Relations

    David Nakasone - Head - Investor Relations

  • Thank you. Before we begin, I encourage everyone to visit the Investors section of the Tarsus website to view the earnings release and related materials we will be discussing today.

    謝謝。在開始之前,我鼓勵大家造訪 Tarsus 官網的投資人專區,查看我們今天將討論的財報新聞稿與相關資料。

  • Joining me on the call this afternoon are Bobby Azamian, our Chief Executive Officer and Chairman; Aziz Mottiwala, our Chief Commercial Officer; and Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer.

    今天下午與我一同參與電話會議的有:我們的執行長兼董事長 Bobby Azamian;首席商務長 Aziz Mottiwala;以及首席財務長兼首席策略長 Jeff Farrow。

  • I'd like to draw your attention to slide 3, which contains our forward-looking statements. During this call, we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional details.

    請各位注意投影片第 3 頁,其中包含我們的前瞻性聲明。在本次電話會議中,我們將發表以前瞻性陳述為主的內容,這些陳述係基於我們目前的預期與信念。這些陳述受某些風險與不確定性影響,我們的實際結果可能出現重大差異。我鼓勵各位參閱我們向 SEC 提交文件中所載的風險因素,以取得更多細節。

  • With that, I'll turn the call over to Bobby.

    接下來,我把電話會議交給 Bobby。

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Good afternoon, and thank you for joining us. We are off to a strong start in 2026, with a quarter that reflects the continued momentum of XDEMVY's launch and the strength of our key growth drivers. We've always believed XDEMVY would be revolutionary and our strong first quarter results reflect that.

    下午好,感謝各位加入我們。我們在 2026 年有一個強勁的開局,本季反映了 XDEMVY 上市後持續的動能,以及我們關鍵成長驅動因素的強度。我們一直相信 XDEMVY 會帶來革命性改變,而我們強勁的第一季成果也印證了這一點。

  • Every key metric we track, including the number of writers, depth of prescribing, awareness and evidence generation continue to grow substantially quarter-over-quarter. These are the same drivers we have committed to delivering on, and we are on track to achieve our full-year guidance, reach blockbuster status in the next couple of years and realize $2 billion in peak sales potential. In the first quarter of 2026, XDEMVY delivered more than $145 million in net product sales, an increase of more than 85% year-over-year, reflecting consistent patient outcomes and expanding eye care physician or ECP utilization across their practices.

    我們追蹤的每一項關鍵指標,包括開立處方的醫師數、處方深度、認知度與證據生成,皆持續呈現顯著的季對季成長。這些正是我們承諾要交付的驅動因素;我們正按計畫達成全年財測指引,並在未來幾年達到重磅藥(blockbuster)地位,實現 20 億美元的峰值銷售潛力。在 2026 年第一季,XDEMVY 淨產品銷售額超過 1.45 億美元,年增超過 85%,反映出一致的病患治療結果,以及眼科照護醫師(ECP)在其診所中更廣泛的使用。

  • Having spent time in the field and at several medical conferences over the past few months, I can tell you what we're hearing directly from ECPs. They describe XDEMVY as one of the most impactful medicines they've ever used with consistent outcomes, clear utility across their practices and broad access that is nearly universal. Said differently, it works, it's easy to use and access is outstanding.

    過去幾個月我花時間在第一線並參加了數場醫學會議,我可以告訴各位我們直接從 ECP 那裡聽到的回饋。他們形容 XDEMVY 是他們用過最具影響力的藥物之一,療效結果一致、在其診所中具有明確的實用性,且可近性廣泛,幾乎是普遍可得。換句話說,它有效、使用方便,而且取得性非常出色。

  • When those elements come together, behavior changes. ECPs are no longer looking only for the most symptomatic cases, they are beginning to screen every patient for collarettes. And that is what ultimately drives a larger addressable market over time, more patients identified and more patients treated.

    當這些要素結合在一起時,行為就會改變。ECP 不再只針對症狀最明顯的個案,他們開始為每位病患篩檢是否有 collarettes(睫毛圓柱狀皮屑)。而這正是最終隨時間推進而擴大可服務市場的關鍵:辨識出更多病患,並治療更多病患。

  • What we're building at Tarsus, however, is not a one-product story. We have developed a disciplined, repeatable playbook for identifying diseases with clear root causes and significant unmet need and transforming how they're treated. That playbook is driving the future of our pipeline.

    然而,我們在 Tarsus 所打造的並不是單一產品的故事。我們已建立一套嚴謹、可重複的作戰手冊,用於辨識具有明確根本病因且存在重大未被滿足需求的疾病,並改變其治療方式。這套作戰手冊正在驅動我們研發管線的未來。

  • In the first quarter of 2026, we initiated Calliope, an approximately 700 participant Phase 2 trial of TP-05 for the potential prevention of Lyme disease. Enrollment is progressing well, with the first wave of participants already dosed, and we expect top line data during the first half of 2027, which would support readiness for a Phase 3 trial.

    在 2026 年第一季,我們啟動了 Calliope 試驗,這是一項約 700 名受試者的 TP-05 第二期臨床試驗,用於評估其在萊姆病潛在預防上的應用。收案進展良好,第一批受試者已完成給藥;我們預期在 2027 年上半年取得主要(top line)數據,這將支持我們為第三期試驗做好準備。

  • Lyme disease represents one of the largest and fastest-growing unmet needs in infectious disease prevention, affecting millions of Americans each year. Yet there are no FDA-approved prophylactic options available today. It seems like I can't go a week without reading something in the news about the impact of the disease and the increasing burden on the US healthcare system.

    萊姆病是感染性疾病預防領域中最大且成長最快的未被滿足需求之一,每年影響數以百萬計的美國人。然而,目前尚無任何 FDA 核准的預防性(prophylactic)選項。我幾乎每週都會在新聞中讀到關於該疾病影響以及其對美國醫療體系日益加重負擔的報導。

  • TP-05 is a first-of-its-kind investigational oral on-demand prophylactic designed to target and kill ticks before they transmit disease, and we believe it has the potential to fundamentally shift the current paradigm from management to disease prevention. We've seen tremendous interest in this program from patients, potential partners, federal agencies and the broader medical community, reflecting both the scale of the opportunity and the need for a new approach.

    TP-05 是同類首創的口服、按需使用之研究性預防用藥(on-demand prophylactic),其設計目標是在蜱蟲傳播疾病之前就將其鎖定並殺死;我們相信它有潛力從根本上改變目前由「疾病管理」轉向「疾病預防」的典範。我們已看到病患、潛在合作夥伴、聯邦機構以及更廣泛醫療社群對此計畫展現高度興趣,反映出機會規模之大以及對新方法的迫切需求。

  • Another program I hear increasing excitement about is TP-04, particularly with the initiation of our Phase 2 KORE study in ocular rosacea. Ocular rosacea is another significant and underdiagnosed disease, affecting an estimated 15 million to 18 million Americans with no FDA-approved treatment today. Similar to Demodex blepharitis, or DB, it is a mite-driven disease that impacts the area around the eye, including the eyelids and surrounding skin that can meaningfully affect how patients look, feel and see.

    我也聽到另一個計畫的熱度持續升高,那就是 TP-04,特別是在我們於眼部酒糟(ocular rosacea)啟動第二期 KORE 研究之後。眼部酒糟是另一種重要且常被低估診斷的疾病,估計影響約 1,500 萬至 1,800 萬名美國人,而目前尚無 FDA 核准的治療方式。與蠕形蟎睑緣炎(Demodex blepharitis,或 DB)類似,它是由蟎蟲驅動的疾病,影響眼周區域,包括眼瞼及周圍皮膚,可能對病患的外觀、感受與視覺造成實質影響。

  • We hear it all the time from ECPs, a treatment like TP-04 could be game-changing and they can't wait to offer their patients an option like this. TP-04 is a novel, sterile investigational ophthalmic gel designed to treat Demodex mites, the root cause of disease, and we believe it has the potential to become another first and only FDA-approved medicine for an underdiagnosed and underappreciated eye disease. The KORE study is progressing as planned, and we continue to expect top line data in the first half of 2027.

    我們經常從 ECP 那裡聽到:像 TP-04 這樣的治療可能會改變遊戲規則,他們迫不及待想為病患提供這樣的選擇。TP-04 是一款新穎、無菌的研究性眼用凝膠,旨在治療蠕形蟎(Demodex mites)這一疾病的根本原因;我們相信它有潛力成為另一款針對一種診斷不足且未受足夠重視之眼部疾病的「首款且唯一」FDA 核准藥物。KORE 研究正按計畫推進,我們仍預期在 2027 年上半年取得主要(top line)數據。

  • Turning back to XDEMVY. The drivers are clear: broader physician adoption, a DTC campaign, bringing more patients through the door and an expanding evidence base, all pointing to a larger treatable population over time. But XDEMVY is only one piece of a larger story. We are deliberately building Tarsus to create and lead new categories in eye care and beyond with the pipeline and playbook to do it repeatedly.

    回到 XDEMVY。驅動因素很明確:更廣泛的醫師採用、DTC(直接面向消費者)行銷活動、帶動更多病患就診,以及不斷擴大的證據基礎,這些都指向可治療族群將隨時間擴大。但 XDEMVY 只是更大故事中的一部分。我們正有意識地打造 Tarsus,憑藉研發管線與作戰手冊,在眼科照護及其他領域創造並引領新類別,並能反覆做到。

  • And with that, I'll pass it to Aziz.

    接下來,我把時間交給 Aziz。

  • Aziz Mottiwala - Chief Commercial Officer

    Aziz Mottiwala - Chief Commercial Officer

  • Thanks, Bobby. As just highlighted, in Q1, we delivered more than $145 million in XDEMVY net product sales, an increase of more than 85% year-over-year, and we meaningfully outperformed the market. Additionally, every key metric we track has grown. And as we've moved into the second quarter, prescriptions continue to grow with some of the highest weekly numbers since launch. Our outstanding performance continues to be driven by three key factors: increasing depth of prescribing, expansion of the patient funnel and ongoing evidence generation.

    謝謝,Bobby。如剛才所強調的,我們在第一季實現 XDEMVY 淨產品銷售額超過 1.45 億美元,年增超過 85%,且我們的表現顯著優於市場。此外,我們追蹤的每一項關鍵指標都在成長。進入第二季後,處方量持續增加,並出現自上市以來最高的一些單週數據。我們的卓越表現持續由三大關鍵因素驅動:處方深度提升、病患漏斗擴張,以及持續的證據生成。

  • In terms of depth of prescribing, we continue to see growth, not just in the number of ECPs prescribing XDEMVY, but in how often they prescribe. In the first quarter, nearly half of our 15,000 target ECPs prescribed XDEMVY at least once a week, up approximately 10% from Q4 2025.

    就處方深度而言,我們持續看到成長,不僅是開立 XDEMVY 的 ECP 人數增加,也包括他們開立處方的頻率提升。在第一季,我們 15,000 名目標 ECP 中,近一半每週至少開立一次 XDEMVY,較 2025 年第四季約提升 10%。

  • As Bobby noted, ECPs continue to see incredible outcomes with XDEMVY and are looking for more patients they can serve across their practices. At the American Society of Cataract and Refractive Surgery, or ASCRS Conference, we met with countless physicians and heard in several podium discussions that they are broadly incorporating DB screening and treatment as part of their routine pre-operative procedures, where every cataract patient is assessed prior to surgery.

    如 Bobby 所指出,ECP 仍持續在 XDEMVY 上看到令人驚豔的治療成果,並正在尋找其各自診所體系中可服務的更多患者。在美國白內障與屈光手術學會(American Society of Cataract and Refractive Surgery,ASCRS)年會上,我們與無數醫師交流,並在多場講台討論中聽到,他們正廣泛將 DB 的篩檢與治療納入例行術前流程,亦即每位白內障患者在手術前都會接受評估。

  • To further accelerate the growth we're seeing within our existing base of ECPs, we are preparing to deploy our key account leaders or KALs. This is a highly targeted investment focused on our largest and highest potential practices, where ECPs are actively prescribing and there remains significant opportunity to expand utilization. This role attracted exceptional talent from across the industry, and we expect this team to be a meaningful driver of incremental growth starting in the second half of 2026. Additionally, retreatment rates are increasing to the mid-teens range as ECPs formalize long-term DB management protocols. As a reminder, we expect steady-state retreatment rates of approximately 20%.

    為了進一步加速我們在既有 ECP 基礎中所看到的成長,我們正準備部署關鍵客戶主管(key account leaders,KAL)。這是一項高度精準的投資,聚焦於我們規模最大且潛力最高的診所,這些診所的 ECP 正積極開立處方,且仍有顯著機會擴大使用量。此職務吸引了業界各方的傑出人才,我們預期該團隊將自 2026 年下半年起,成為推動增量成長的重要動能。此外,隨著 ECP 建立長期 DB 管理流程,再治療率正提升至約中十位數百分比區間。提醒一下,我們預期穩態的再治療率約為 20%。

  • Turning to direct-to-consumer or DTC. Our DTC campaign is delivering strong and improving return on investment or ROI that is exceeding our expectations and is at the higher end of benchmarks. This is also reinforced by what we consistently hear from ECPs. More and more patients are coming into the office proactively asking about DB and XDEMVY. Further, we continue to see millions of visitors to the XDEMVY.com website and high-value engagement, including quiz completion and use of the Find a Doctor tool is up nearly 40% quarter-over-quarter, continuing to exceed even our own lofty expectations.

    接著談直接面向消費者(direct-to-consumer,DTC)。我們的 DTC 活動帶來強勁且持續改善的投資報酬率(return on investment,ROI),不僅超出我們預期,也位於基準值的高端。這也與我們從 ECP 持續聽到的回饋相互印證。越來越多患者主動到診所詢問 DB 與 XDEMVY。此外,我們持續看到數以百萬計的訪客造訪 XDEMVY.com 網站,且高價值互動表現亮眼,包括完成測驗以及使用「尋找醫師」工具的次數,較前一季成長近 40%,持續超越我們自身原本就很高的期待。

  • With over a year of experience, we now have a much clearer understanding of what specifically maximizes DTC performance, and we're applying those learnings to continuously improve how and where we deploy our investment, focusing on the channels and messages that generate the highest value engagement. In short, we're amplifying what's already working.

    在累積一年以上的經驗後,我們對於哪些因素能具體最大化 DTC 成效已有更清晰的理解,並正將這些學習應用於持續優化投資的投放方式與投放位置,聚焦於能帶來最高價值互動的渠道與訊息。簡而言之,我們正在放大已經有效的做法。

  • Additionally, we have several exciting new things planned in the coming weeks, including a creative refresh and expanded disease state messaging designed to help even more patients recognize their symptoms, normalize DB and ultimately drive more patients into the office. We're also continuing to make investments in evidence generation that reinforce the broad utility of XDEMVY and expand how ECPs think about DB.

    此外,未來幾週我們規劃了多項令人振奮的新舉措,包括創意素材更新,以及擴大疾病狀態訊息傳遞,旨在協助更多患者辨識自身症狀、將 DB 視為常見且可處理的狀況,並最終帶動更多患者走進診間。我們也持續投資於證據生成,以強化 XDEMVY 的廣泛適用性,並擴展 ECP 對 DB 的認知與思考方式。

  • One key example is the data we presented at ASCRS on the association between DB with chalazion and hordeolum, conditions that are estimated to impact several million patients in the US. These conditions can cause patients significant discomfort, impact their vision and lead to invasive procedures in ECP offices. This data showed that a large portion of patients assessed also had underlying DB, more than 70% overall and even higher in recurrent cases. And we're hearing directly from doctors that they're excited about this data and are proactively screening and treating these patients.

    其中一個關鍵例子,是我們在 ASCRS 發表的數據,探討 DB 與霰粒腫(chalazion)及麥粒腫(hordeolum)之間的關聯;據估計,這些疾病在美國影響數百萬名患者。這些狀況可能造成患者明顯不適、影響視力,並導致在 ECP 診所接受侵入性處置。該數據顯示,被評估的患者中有相當大比例同時存在潛在的 DB,整體超過 70%,在復發病例中比例更高。我們也直接從醫師端聽到,他們對這些數據感到振奮,並正主動對這類患者進行篩檢與治療。

  • The takeaway is simple. Our ongoing evidence generation is doing exactly what we intended, expanding our market opportunity by giving ECPs more compelling reasons to look for and treat DB across a broader and larger set of patients.

    重點很簡單。我們持續進行的證據生成正如預期發揮作用:透過提供 ECP 更具說服力的理由,在更廣泛且更大的患者族群中尋找並治療 DB,從而擴大我們的市場機會。

  • As we look ahead, there is great momentum across the key drivers of the business, and we expect to build on that momentum with the deployment of our KAL team, the scaling ROI of our DTC campaign, new patient-focused initiatives and additional evidence that further supports the broad utility of XDEMVY. And as Jeff will discuss, these drivers give us confidence in achieving full-year guidance while continuing to expand the long-term opportunity for XDEMVY.

    展望未來,業務的關鍵驅動因素皆呈現強勁動能;我們預期將透過部署 KAL 團隊、提升 DTC 活動的 ROI 規模效益、推出以患者為核心的新計畫,以及提供更多進一步支持 XDEMVY 廣泛適用性的證據,來延續並放大這股動能。正如 Jeff 將會說明,這些驅動因素讓我們有信心達成全年指引,同時持續擴大 XDEMVY 的長期機會。

  • Over to you, Jeff.

    交給你了,Jeff。

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Thanks, Aziz. Building on what Bobby and Aziz outlined, we delivered net product sales of $145.4 million, reflecting strong year-over-year growth from growing demand for XDEMVY and exceptional execution by our team.

    謝謝,Aziz。延續 Bobby 與 Aziz 所概述的內容,我們實現了 1.454 億美元的產品淨銷售額,反映出 XDEMVY 需求成長所帶動的強勁年增,以及團隊卓越的執行力。

  • As expected and highlighted on our year-end earnings call, the first quarter included typical seasonal dynamics, such as deductible resets and higher out-of-pocket costs as well as some impact from severe winter weather, particularly in the Northeast part of the country. Despite these factors, our underlying demand remains significantly stronger than our peers.

    如預期且我們在年終財報電話會議中所強調,第一季包含典型的季節性因素,例如自付額重置與自付費用提高,此外嚴峻冬季天候亦帶來部分影響,尤其是在美國東北部地區。儘管有這些因素,我們的基本需求仍明顯強於同業。

  • According to third-party data, peers experienced double-digit prescription declines versus our low single digits. And as we entered the second quarter, XDEMVY prescription trends rebounded to all-time highs.

    根據第三方數據,同業處方量出現雙位數下滑,而我們僅為低個位數下滑。進入第二季後,XDEMVY 的處方趨勢反彈至歷史新高。

  • Turning to other revenue items. License fees and collaboration revenues were $16.7 million in the quarter. This includes a one-time $15 million regulatory milestone payable by our partner, Grand Pharma, following the approval of TP-03 for DB in Greater China, as well as approximately $1.7 million related to the required China withholding tax. This approval represents an important step toward helping the more than 40 million people in the region affected by DB and underscores our commitment to serving patients. Over time, we do expect to generate additional royalties from this partnership, although they are not expected to be meaningful in 2026 or 2027 as Grand Pharma seeks to secure payer coverage. We look forward to supporting Grand Pharma as they prepare for commercial launch later this year. For additional details on our Q1 financial performance, please refer to the earnings release issued earlier today.

    接著談其他收入項目。本季授權費與合作收入為 1,670 萬美元。其中包含我們合作夥伴 Grand Pharma 因 TP-03 於大中華區獲准用於 DB 而支付的一次性 1,500 萬美元法規里程碑款,另包含約 170 萬美元與中國預扣稅要求相關的金額。此項核准是朝向協助該地區超過 4,000 萬名受 DB 影響人士的重要一步,也凸顯我們服務患者的承諾。隨時間推進,我們預期可自此合作關係取得額外權利金收入,但由於 Grand Pharma 正尋求取得支付方給付覆蓋,該等權利金在 2026 或 2027 年預期不會具有重大貢獻。我們期待在 Grand Pharma 準備於今年稍晚進行商業上市之際提供支持。關於我們 2026 年第一季財務表現的更多細節,請參閱我們今日稍早發布的財報新聞稿。

  • Looking ahead, we reiterate our full-year 2026 guidance of net product sales of $670 million to $700 million, SG&A expenses of $545 million to $565 million, including approximately $40 million in stock-based compensation, R&D expenses of $115 million to $135 million, including stock-based compensation of approximately $20 million and gross margins of approximately 93%. Our guidance reflects continued strength in the underlying fundamentals of the business, including increased depth of prescribing, expansion of the patient funnel, continued execution by our exceptional sales force, including the deployment of our new key account leaders and ongoing evidence generation expanding the addressable patient population.

    展望未來,我們重申 2026 全年指引:產品淨銷售額 6.70 億至 7.00 億美元,銷售、一般及行政(SG&A)費用 5.45 億至 5.65 億美元(其中約 4,000 萬美元為股份基礎給付),研發(R&D)費用 1.15 億至 1.35 億美元(其中股份基礎給付約 2,000 萬美元),以及毛利率約 93%。我們的指引反映出業務基本面持續強勁,包括處方深度提升、患者漏斗擴大、我們卓越銷售團隊的持續執行力(包含新 KAL 的部署),以及持續的證據生成以擴大可觸及的患者族群。

  • From a quarterly perspective, growth in 2026 is expected to follow patterns consistent with our prior experience and broader sector dynamics. That is strong growth in the second quarter, more modest growth in the third quarter and robust growth in the fourth quarter.

    從季度角度來看,2026 年的成長預期將遵循與我們過往經驗及更廣泛產業動態一致的模式。也就是第二季強勁成長、第三季較為溫和成長、第四季再度呈現強勁成長。

  • Finally, turning to the pipeline. As Bobby mentioned, we initiated our Phase 2 Calliope trial, evaluating TP-05 for the potential prevention of Lyme disease during the first quarter. Lyme disease is the most common vector-borne disease in the United States with more than 35 million people considered to be at high or moderate risk of contracting the disease and hundreds of thousands of new cases diagnosed annually. Yet there are still no FDA-approved prophylactic options.

    最後,談到研發管線。如 Bobby 所提及,我們在第一季啟動了第二期 Calliope 試驗,評估 TP-05 在萊姆病潛在預防上的效果。萊姆病是美國最常見的媒介傳播疾病,超過 3,500 萬人被認為具有感染該疾病的高或中度風險,每年診斷出數十萬例新病例。然而,目前仍沒有任何 FDA 核准的預防性選項。

  • What makes TP-05 compelling is not just the size of the market, but the strength of the science and the differentiated nature of our approach. This oral on-demand investigational therapeutic is designed to directly target the root cause of Lyme disease by potentially killing ticks before disease transmission occurs, an approach that is simple, fast and practical for patients. In fact, it is already approved for Lyme disease prevention in dogs and cats and may have benefited from prophylactic Lyme therapies just like TP-05. From a financial and operational standpoint, we are advancing this program with a clear development path and defined milestones, including expected top line data in the first half of 2027.

    TP-05 的吸引力不僅在於市場規模,更在於其科學基礎的扎實,以及我們方法的差異化特性。這款口服、按需使用的研究性治療,旨在直接針對萊姆病的根本原因,透過在疾病傳播發生前可能殺死蜱蟲來達到預防效果;此方法對患者而言簡單、快速且實用。事實上,它已獲准用於犬貓的萊姆病預防,且可能已從類似 TP-05 的預防性萊姆病療法中受益。從財務與營運角度來看,我們正以清晰的開發路徑與明確的里程碑推進此計畫,包括預期於 2027 年上半年取得主要(top line)數據。

  • Similarly, our ocular rosacea program continues to progress as planned, with top line data also anticipated in the first half of next year. Outside of the US, we continue to advance our global expansion efforts for TP-03 and are on track to complete the key technical work required to support potential future filings. At the same time, we are taking a thoughtful approach to timing and evaluating next steps in the context of the broader geopolitical, regulatory and macro access environment.

    同樣地,我們的眼部酒糟性皮膚炎(ocular rosacea)計畫也持續按計畫推進,預計明年上半年也將公布主要(top line)數據。在美國以外地區,我們持續推進 TP-03 的全球擴張工作,並正按進度完成支援未來潛在申報所需的關鍵技術工作。同時,我們也以審慎方式掌握時程,並在更廣泛的地緣政治、監管與宏觀市場准入環境下評估下一步。

  • Before I hand the call off to Bobby, I want to restate that we firmly believe that we are well positioned for the remainder of 2026 with strong and growing underlying demand for XDEMVY and a robust and advancing pipeline with top line results in the first half of 2027.

    在我把電話交給 Bobby 之前,我想再次重申:我們堅信,憑藉 XDEMVY 強勁且持續成長的基本需求,以及具韌性並持續推進的產品線(pipeline),且預計於 2027 年上半年取得主要結果(top line results),我們在 2026 年剩餘期間具備良好布局。

  • With that, I'll turn it back to Bobby for closing remarks.

    那麼,我把電話交回給 Bobby 作結語。

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Thanks, Jeff. Tarsus continues to execute on one of the most successful launches in eye care, and we've delivered so much so that the addressable market continues to expand beyond our initial estimates. More patients are being identified, more patients are being treated and more physicians are continuing to embed XDEMVY into routine care. This is a direct result of how we deepened utilization in ECP practices, meaningfully grown awareness about DB and generated compelling clinical evidence showing just how important it is to treat the condition. We are now applying that same category-creating model across our pipeline, including in Lyme disease prevention and ocular rosacea as we work to replicate the success of XDEMVY and establish Tarsus as a leader in creating new standards of care.

    謝謝,Jeff。Tarsus 持續執行眼科照護領域最成功的上市之一;我們的成果顯著,以至於可觸及市場(addressable market)持續擴大,超出我們最初的估計。更多患者被辨識出來、更多患者正在接受治療,且更多醫師持續將 XDEMVY 納入日常照護流程。這直接源於我們如何在 ECP 診所深化使用、顯著提升對 DB 的認知,並產出具說服力的臨床證據,顯示治療此疾病的重要性。我們現在正將同樣的「創造品類」模式應用到整體產品線上,包括萊姆病預防與眼部酒糟性皮膚炎,致力複製 XDEMVY 的成功,並將 Tarsus 建立為制定新照護標準的領導者。

  • Operator, please open the line for questions.

    接線員,請開放提問。

  • Operator

    Operator

  • (Operator Instructions) Dennis Ding, Jefferies.

    (接線員指示) Dennis Ding,Jefferies。

  • Dennis Ding - Analyst

    Dennis Ding - Analyst

  • We have two. So on the second quarter, I was surprised that you guys didn't give bottle guidance. But when I look at consensus, which is $168 million, it should imply around 145,000 to 150,000 dispensed bottles. That's about 13% or 14% quarter-over-quarter growth and similar to the Q2 bounce that we saw in 2025. How do you feel about those numbers? And does our math make sense?

    我們有兩個問題。關於第二季,我很意外你們沒有提供瓶數(bottle)指引。但我看市場一致預期是 1.68 億美元,這應該意味著大約 14.5 萬到 15 萬瓶的發藥瓶數(dispensed bottles)。這大約是季增 13% 或 14%,也類似我們在 2025 年看到的 Q2 反彈。你們怎麼看這些數字?我們的推算合理嗎?

  • And then number two. Glaukos has a Phase 2 readout later this year for DB. They're delivering physostigmine, which is approved for glaucoma. So you've mentioned before that you've looked at all these different assets. So I'm curious when you think about the potential tolerability issues there since the drug actually constrict pupil. So in your own due diligence, are vision changes or blurry vision a liability with that asset?

    第二個問題。Glaukos 今年稍晚會有 DB 的二期(Phase 2)讀出。他們在遞送 physostigmine,這個藥已核准用於青光眼。你們之前提過你們看過各種不同資產。所以我好奇,考量到該藥實際上會使瞳孔收縮,對其潛在耐受性問題你們怎麼看?在你們自己的盡職調查中,視覺改變或視力模糊會是那個資產的風險(liability)嗎?

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Dennis, this is Jeff. And I'll take the first part of the question and then turn it over to Bobby for the second part. As we've moved into full-year guidance, we stepped away from the quarterly updates in terms of bottles dispensed gross to net, absent some material change, right, where we don't believe we're going to be able to meet that guidance. And so our expectation is really just to continue to provide updates on the guidance that we provided earlier. So we still believe in the full-year guidance, both on the revenue side and the SG&A side.

    Dennis,我是 Jeff。我先回答問題的第一部分,然後把第二部分交給 Bobby。在我們進入全年指引後,除非出現重大變化——也就是我們認為可能無法達成該指引——否則我們就不再按季度更新已發藥瓶數以及從總額到淨額(gross to net)的相關資訊。因此,我們的預期就是持續就先前提供的指引進行更新。我們仍然相信全年指引,無論是營收端或 SG&A 端。

  • To your question on growth between Q1 and Q2, just a reminder that 2025 was the second full year of launch, and we were starting from a bigger or a smaller base at that point in terms of total bottles. So we shouldn't expect a 30% growth similar to what we saw between Q1 and Q2. So take into account the fact that we are starting on a bigger base now and make your adjustments accordingly.

    至於你問到 Q1 到 Q2 的成長,提醒一下:2025 年是上市後第二個完整年度,當時在總瓶數的基期上是更大或更小(相較現在)的一個起點。因此,我們不應期待像 Q1 到 Q2 之間那樣的 30% 成長。請把我們現在是從更大的基期出發這個因素納入考量,並據此調整你的推估。

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Yes. Thank you, Dennis. This is Bobby. And with respect to how we see the landscape, we're really focused on XDEMVY. We've been creating a really important marketing category for patients, and we see that growing. I think the evidence we're generating around XDEMVY is robust with more to come. So we believe that XDEMVY's profile is going to be the standard of care for the foreseeable future. We certainly track everything we see in terms of pipeline, and we're not surprised that people are also looking at this market.

    是的。謝謝你,Dennis。我是 Bobby。就我們如何看待競爭版圖而言,我們真正聚焦在 XDEMVY。我們一直在為患者打造一個非常重要的行銷品類,而我們看到它正在成長。我認為我們圍繞 XDEMVY 所產出的證據非常扎實,後續還會有更多。因此,我們相信 XDEMVY 的產品特性(profile)在可預見的未來將會是照護標準(standard of care)。我們當然會追蹤我們看到的所有研發管線動態,也不意外其他人同樣在關注這個市場。

  • But in terms of XDEMVY's effectiveness, its safety, the product profile, it's just such a great standard of care. I hear time and again, like I did in the field this quarter, just how this is the best medicine a lot of doctors have seen. So we're really focused on building on that success and creating a lasting standard of care.

    但就 XDEMVY 的有效性、安全性與產品特性而言,它就是一個非常出色的照護標準。我一次又一次聽到——就像我這一季在第一線聽到的——很多醫師都說這是他們見過最好的藥之一。所以我們非常專注於在這個成功基礎上持續擴大,並建立一個長久的照護標準。

  • Operator

    Operator

  • Graig Suvannavejh, Mizuho Group.

    Graig Suvannavejh,瑞穗集團(Mizuho Group)。

  • Samuel Lee - Equity Analyst

    Samuel Lee - Equity Analyst

  • This is Sam on for Graig. And congrats on the quarter. Maybe two from us. First, how much of the current growth you're seeing coming from the expansion use cases under, call the Demodex blepharitis umbrella? Specifically, we're interested in the cataract surgery patient population.

    我是代替 Graig 的 Sam。恭喜本季表現。我們可能有兩個問題。第一,目前你們看到的成長有多少來自於「蠕形蟎睑緣炎(Demodex blepharitis)」這個範疇下的擴展使用情境(expansion use cases)?我們特別關注白內障手術患者族群。

  • And then second. Given the reaffirmed guidance of $670 million to $700 million, can you walk us through some of the assumptions and drivers required to achieve that guidance across prescription growth, gross to net normalization and overall run rate through the balance of the year?

    第二,鑑於你們重申 6.7 億到 7.0 億美元的指引,你們能否帶我們梳理一下要達成該指引所需的一些假設與驅動因素,包括處方成長、總額到淨額(gross to net)正常化,以及今年剩餘期間的整體運行速率(run rate)?

  • Aziz Mottiwala - Chief Commercial Officer

    Aziz Mottiwala - Chief Commercial Officer

  • Yes. So when we think about the market and how the product is performing, one of the great things that we highlighted in the prepared comments and what we're hearing very clearly from physicians here is the continued expansion of use throughout the patient population. So we started early on with some of the most obvious cases, dry eye, cataract surgery, contact lens intolerance. We're definitely seeing a lot of utilization across all of those segments.

    好的。當我們思考市場以及產品表現時,我們在事先準備的發言中強調的一個亮點,以及我們從醫師端非常清楚聽到的,是在整體患者族群中的使用持續擴大。我們早期從一些最明顯的案例切入,例如乾眼、白內障手術、隱形眼鏡不耐受。我們確實看到在上述所有區隔都有大量使用。

  • And we've really shifted our strategy now to not only go after those segments to even go more broadly, right? There's 25 million Americans out there, and they're coming into the funnel. And we think about not just cataract, dry eye, we think about, as we mentioned, patients that have hordeolum or chalazion, for example, and even other cases. So I think the way to think about this is physicians are using this across every segment that we've highlighted, and they continue to expand to new segments. And that's where our evidence generation strategy will fuel.

    而我們現在也真正把策略轉向:不僅鎖定那些區隔,還要更廣泛地推進,對吧?美國有 2,500 萬人,他們正在進入我們的漏斗(funnel)。我們不只看白內障、乾眼;我們也會如同提到的,關注例如有麥粒腫(hordeolum)或霰粒腫(chalazion)的患者,甚至其他情境。所以我認為應該這樣理解:醫師正在我們所強調的每個區隔中使用這個產品,並且持續擴展到新的區隔。而這正是我們的證據產出策略將會推動的方向。

  • In terms of some key drivers, I'll let Jeff speak to the mechanics, but I would highlight that coming off of this quarter, we saw progression in every metric we track commercially, depth of prescribing, all of our consumer metrics, which sets us up nicely for the rest of the year where we have our key account leaders deploying. They'll start to make an impact in the third quarter and in the back half of the year. And we've got some exciting things on our direct-to-consumer initiatives as well. So a lot more drivers to come.

    就一些關鍵驅動因素而言,我會讓 Jeff 談談機制面,但我想強調的是:在本季之後,我們看到我們商業端追蹤的每一項指標都有進展,包括處方深度(depth of prescribing)以及所有消費者端指標,這讓我們在今年剩餘期間有很好的布局;我們的關鍵客戶主管(key account leaders)也正在部署。他們將在第三季以及下半年開始產生影響。此外,我們在直面消費者(direct-to-consumer)的計畫上也有一些令人振奮的進展。因此,後續還會有更多驅動因素。

  • And I'll let Jeff speak to the mechanics in terms of the guidance.

    我會請 Jeff 來說明指引在執行層面的細節。

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Yes. Aziz, one other thing I would add -- this is Bobby. Based on what I hear, these drivers are really playing out. As we've mentioned, I'm hearing doctors that are really treating regardless of symptoms, treating with any comorbidity in the setting of cataract surgery. I'm so excited about the evidence that we generated and evidence to come. I think chalazion is one of those examples where there's just lots of reasons to treat, and that's really leading to the expansion of the patient population that's the addressable market here.

    是的。Aziz,我還想補充一點——我是 Bobby。根據我聽到的情況,這些驅動因素確實正在發酵。如同我們提過的,我聽到醫師們在白內障手術的情境下,只要有任何共病,即使沒有症狀也會積極治療。我對我們已產生的證據以及未來將產生的證據感到非常振奮。我認為霰粒腫就是其中一個例子:有很多理由需要治療,而這也確實推動了可服務市場中可觸及病患族群的擴大。

  • And so Jeff, I'll pass to you.

    那麼 Jeff,我交給你。

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Thanks, Sam, for your question. Yes, in addition to sort of the broad strokes that Aziz mentioned in terms of growing depth of prescribing, DTC impact, evidence generation that Bobby just highlighted and the impact of the KAL team, that will sort of impact the growth over the quarter, particularly in the back half of the year. But we continue to see the seasonality that we saw last year and the year prior to that.

    Sam,謝謝你的提問。是的,除了 Aziz 提到的那些較宏觀的面向——例如處方深度的提升、DTC 的影響、Bobby 剛強調的證據產出,以及 KAL 團隊的影響——這些都會在本季帶動成長,尤其是在今年下半年更為明顯。不過,我們仍持續看到與去年及前年相同的季節性。

  • So much like we saw last year, Q1 was tempered, but we saw some nice robust growth in the second quarter as the deductibles sort of got blown through by the individual patients. And then we also see growth in the summertime, but much more tempered growth than, say, between Q1 and Q2. And then Q4 tends to be one of our highest growth quarters as patients come into the end of the year. They've run through their deductibles, and they're trying to use up their FSA. So we anticipate that type of impact on a seasonal basis as well.

    因此就像去年一樣,第一季的表現較為溫和,但第二季隨著個別病患的自付額(deductibles)逐步用完,我們看到相當不錯、且更為強勁的成長。夏季也會有成長,但相較於第一季到第二季之間,成長幅度會更溫和。而第四季通常是我們成長最高的季度之一,因為病患接近年底時會回診。他們已經用完自付額,並且想把 FSA(彈性支出帳戶)用掉。因此我們也預期季節性會帶來這類影響。

  • Operator

    Operator

  • Francois Brisebois, LifeSci Capital.

    LifeSci Capital 的 Francois Brisebois。

  • Francois Brisebois - Equity Analyst

    Francois Brisebois - Equity Analyst

  • Congrats on the quarter. Just a couple of questions. I'm getting some questions on ocular rosacea. And I was just wondering, when you mentioned it's a root cause of the disease, I think with blepharitis, you guys in the trials and whatnot were plugging eyelashes and you can legitimately see the mites and then its pathognomonic sign when you see the collarettes now. But is there -- how comfortable do we feel that ocular rosacea is -- Demodex mites are causing the ocular rosacea?

    恭喜本季表現。我有幾個問題。我收到一些關於眼部酒糟(ocular rosacea)的提問。我想確認一下:你們提到它是疾病的根本原因。我認為在眼瞼炎(blepharitis)方面,你們在試驗等研究中會拔睫毛,確實能看到蟎蟲;而現在看到袖套樣皮屑(collarettes)也成了具特異性的典型徵象。但在這裡——我們對於「眼部酒糟是由蠕形蟎(Demodex mites)所造成」這件事,有多大的把握?

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Yes. Thank you, Frank, and I appreciate that question. I know you've tracked our story for a long time, and you've seen the playbook that we've really applied in the development of XDEMVY, and we're applying that same playbook in OR. And to your point, it starts with a disease that has a clear root cause and clearly identifiable patients. And we see that in OR.

    是的。謝謝你,Frank,我很感謝這個問題。我知道你長期追蹤我們的故事,也看過我們在 XDEMVY 開發上真正採用的作戰手冊,而我們也正把同樣的作戰手冊用在 OR 上。如你所說,起點是一個具有明確根本原因、且病患可清楚辨識的疾病。我們在 OR 上也看到了這一點。

  • To your question, we see that the majority of patients with OR have Demodex. And it is harder to measure. You don't have the benefit of a collarette that you can pull from around the eye, but you do have clear signs. And those are signs of inflammation, signs of redness, erythema and telangiectasia, they're called. And we know that when patients have those signs, they're very likely to have Demodex as an underlying root cause. So that's really the basis of our approach here.

    針對你的問題,我們看到 OR 的多數病患都有 Demodex。而它確實比較難量測。你沒有像 collarette 那樣、可以從眼周拉出來觀察的優勢,但你仍然有明確的徵象。那些徵象包括發炎、泛紅;也就是所謂的紅斑(erythema)與毛細血管擴張(telangiectasia)。我們知道當病患出現這些徵象時,他們很可能以 Demodex 作為潛在的根本原因。這就是我們在此採取方法的基礎。

  • I will also add, we're hearing a lot of great interest in OR as well. When I'm out in clinics or talking to doctors about XDEMVY, they raise OR. They say, I'm looking at these patients. I have something great for the added margin, but I don't have anything for the inflammation around their eyes. And they're seeing how important this disease is now that they're taking a post look around the eyes. So we see basically an opportunity to create a category with a very similar playbook to your question.

    我也補充一下,我們也聽到市場對 OR 有很高的興趣。當我在診所或與醫師談 XDEMVY 時,他們會提到 OR。他們說:我看到這些病患。我有很好的方式處理額外的眼瞼邊緣(added margin),但對於眼周的發炎我沒有任何手段。而當他們在術後更仔細地觀察眼周時,也更能體會這個疾病的重要性。所以就你的問題而言,我們基本上看到一個機會:用非常類似的作戰手冊來建立一個新類別。

  • Francois Brisebois - Equity Analyst

    Francois Brisebois - Equity Analyst

  • Great. And then just on the endpoint side, just to kind of compare it to what you guys have done in the past, the collarette cure rate was very interesting for blepharitis. But in this case, can you just -- you talked about the size. Can you just remind us maybe what the endpoints are and the comfort on the regulatory side of those endpoints?

    很好。接著在終點指標(endpoint)方面,想把它和你們過去做的比較一下:在眼瞼炎中,collarette 的治癒率(cure rate)非常有意思。但在這個情況下,你能否——你剛談到規模。能否提醒我們這次的終點指標是什麼,以及在法規端對這些終點指標的把握度如何?

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Absolutely. So we are enrolling patients by OR, and we're looking at OR endpoints. And so those are those same telangiectasias and erythema. We've aligned with the FDA that we need to look at those endpoints, and we need to see an improvement in one of them. And that's really how we're structuring the trial, and that's the bar we expect for success in the Phase 2 trial that we're conducting.

    當然可以。我們是以 OR 來納入受試者,並且觀察 OR 的終點指標。也就是同樣的毛細血管擴張與紅斑。我們已與 FDA 對齊:需要評估這些終點指標,並且必須在其中一項看到改善。這就是我們設計試驗的方式,也是我們對正在進行的第二期(Phase 2)試驗成功門檻的預期。

  • Francois Brisebois - Equity Analyst

    Francois Brisebois - Equity Analyst

  • Great. If I could sneak in a last one, too, I promise. In terms of the second quarter, Jeff, thanks for kind of breaking out second quarter -- first quarter seasonality, second, third and fourth. But in the second quarter, can you give any granularity as to what is to be expected maybe in the months of the second quarter?

    很好。如果我可以再塞最後一個問題,我保證。關於第二季,Jeff,謝謝你把第二季——以及第一季的季節性、第二、第三與第四季——拆開來說明。但在第二季,你能否提供一些更細的資訊,例如第二季各月份可能會出現什麼樣的情況?

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • In terms of revenue, Frank?

    你是指營收方面嗎,Frank?

  • Francois Brisebois - Equity Analyst

    Francois Brisebois - Equity Analyst

  • Yes. Or sometimes there are some weeks or whatnot that are definitely harder or there's the summer months with holidays and conference time and stuff. I'm just wondering any granularity on what goes on in that second quarter that maybe we should pay close attention to.

    是的。或者有時候某些週會特別難,或是暑假月份有假期、會議季等因素。我只是想問:第二季內部的運作是否有任何更細的觀察點,是我們應該特別留意的?

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Got it. Yes. No, part of that was the impact of the spring break time frame, which we've already passed through, by and large part in the early part of April. So that's kind of behind us. And so there are some conferences that could pull some of the doctors out of the office, but we don't anticipate that to be much greater than what we've seen historically. So you can sort of think about this as on a growth trajectory upwards for the rest of the quarter here.

    了解。是的,其中一部分是春假期間的影響;而我們基本上已經度過了那段時間,主要是在四月初。所以那部分算是過去了。因此,確實會有一些會議可能讓部分醫師暫時離開診所,但我們預期不會比歷史經驗更嚴重。所以你可以把它視為:本季剩餘時間的成長軌跡將持續向上。

  • Francois Brisebois - Equity Analyst

    Francois Brisebois - Equity Analyst

  • Okay. Great. And do you guys break out how your patients are broken down between like for age groups? Is it the older crowd or you actually -- just because it seems like this does get worse with time, right? I think after seven years old, everyone has this. So is it mostly the older or the younger crowd that you guys are treating?

    好的。很好。你們會不會拆分病患的年齡層分布?是年長族群居多,還是其實——只是因為看起來這個狀況會隨時間變得更嚴重,對吧?我想大概七歲之後,每個人都有這個。所以你們主要治療的是年長族群還是年輕族群?

  • Aziz Mottiwala - Chief Commercial Officer

    Aziz Mottiwala - Chief Commercial Officer

  • Sure. Frank, the disease. We see utilization across quite a wide array of patients. You can think about your cataract patients that's typically an aging patient. So we see a lot of utilization there. But you think about patients in contact lenses or dry eye, and that spans the entire patient population. So while there is a higher propensity in elderly patients, you're right about that. We see more and more younger patients, professionals that are working, looking at the screen all day, noticing their eyes are bothering them. They see the ad. They're motivated to go talk to their doctor. So we're seeing utilization across the front. And I think that cataract is obviously an elderly population, but everywhere else, you're seeing a pretty diverse population of patients getting treated.

    當然可以。Frank,關於這個疾病。我們看到的使用情況涵蓋相當廣泛的病患族群。你可以想像白內障病患,通常是年長族群。所以我們在那裡看到很多使用。但你再想想配戴隱形眼鏡或乾眼症的病患,這涵蓋了整個病患族群。所以雖然年長病患的傾向較高,你說得沒錯。我們也看到越來越多較年輕的病患、正在工作的專業人士,整天盯著螢幕,注意到眼睛不舒服。他們看到廣告。他們就有動機去和醫師討論。所以我們看到各方面的使用都在發生。我認為白內障顯然是年長族群,但在其他地方,你會看到相當多元的病患族群正在接受治療。

  • Francois Brisebois - Equity Analyst

    Francois Brisebois - Equity Analyst

  • Okay. Great. Sorry, I think I promised one last question, but I guess I lied. That's all good for me,

    好的。很好。抱歉,我想我答應最後一個問題,但看來我說謊了。我這邊就到這裡,

  • Operator

    Operator

  • Jenna Davidner, Barclays.

    Jenna Davidner,巴克萊。

  • Jenna Davidner - Analyst

    Jenna Davidner - Analyst

  • I had one on Lyme disease. And as Bobby mentioned, there's a lot of elevated concern right now around ticks. So I was just curious if you could remind us what your strategic priorities for this program are and whether or not this might make sense to partner out? And just given the elevated concern that there's no FDA-approved prophylactic treatment, do you think there's any pathway towards an accelerated approval timeline?

    我有一個關於萊姆病的問題。如 Bobby 提到的,現在大家對蜱蟲的擔憂升高很多。所以我想請教,你能否提醒我們這個專案的策略優先事項是什麼,以及是否適合尋求合作夥伴?另外,鑑於目前的高度關注且沒有 FDA 核准的預防性治療,你認為是否有任何途徑可以走向加速核准的時程?

  • Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

    Bobak Azamian - Chairman of the Board, President, Chief Executive Officer, Co-Founder

  • Thank you so much, Jenna. Yes, thanks for highlighting the Lyme program. We hear a lot of interest in this program. There's not really a week goes by that I don't see something in the press or the media about Lyme disease and tick season, which has now started. So we're very excited about the program. We've advanced it into this Phase 2 trial that is groundbreaking in many ways, 700 patients across a broad array of participants across geographies. We're looking at using a very novel investigational medicine here, TP-05, which is an oral on-demand. Really, patients can take it where they sit and on demand. And that's, I think, a very unique potential medicine.

    非常感謝你,Jenna。是的,謝謝你點出萊姆病專案。我們聽到外界對這個專案有很高的興趣。幾乎沒有哪一週我不會在新聞或媒體上看到關於萊姆病與蜱蟲季的報導,而蜱蟲季現在已經開始了。所以我們對這個專案非常興奮。我們已將它推進到這項第二期試驗,在許多方面都具有突破性:700 名病患,涵蓋不同地理區域、廣泛多元的受試者。我們正在評估一種非常新穎的研究用藥 TP-05,這是一種口服、按需使用的藥物。基本上,病患可以在原地、需要時就服用。我認為這是一個非常獨特、具有潛力的藥物。

  • So in this trial, we're going to get some good data, we hope, on safety, on dosing and really be prepared for a Phase 3, be Phase 3 ready, as I mentioned. And I think that will allow us to really assess where this fits. Our base case is this is better in someone else's hands as it goes to Phase 3. But I think delivering a package with a great robust Phase 2 data set with FDA clarity on the path forward will be important. In terms of the FDA's guidance here, they've been very collaborative. We have other vaccines that have been developed in this space. So we're largely following that guidance. And I think the Phase 3 is TBD based on our Phase 2, but our base case is that we'd have to conduct a large vaccine like Phase 3, and that's something we'd have clarity around as we got ready for that and talk to potential partners.

    因此在這項試驗中,我們希望能取得一些很好的數據,包括安全性、劑量,並真正為第三期做好準備,如我提到的,達到可進入第三期的狀態。我認為這將讓我們能夠真正評估它適合放在什麼位置。我們的基本情境是:當它進入第三期時,交由其他公司來推進會更合適。但我認為,提供一套包含強而有力的第二期數據、並且在 FDA 對後續路徑有明確性之下的完整資料包,將會很重要。就 FDA 在此的指引而言,他們一直非常合作。在這個領域也曾有其他疫苗被開發。所以我們大致上是依循那些指引。而第三期的設計仍有待根據第二期結果決定,但我們的基本情境是需要進行一個大型、類似疫苗的第三期試驗;當我們準備進入那一步並與潛在合作夥伴洽談時,會對此有更清楚的掌握。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    Jason Gerberry,美國銀行。

  • Melanie Fong - Analyst

    Melanie Fong - Analyst

  • This is Melanie on for Jason. So you've mentioned that with the addition of the key account leaders, most of that impact is likely to be seen in the back half of the year. So how should we be thinking about kind of that incremental impact on top of the typical seasonality that you guys flagged with like a stronger second half?

    我是代 Jason 發言的 Melanie。你們提到新增關鍵客戶經理後,多數影響可能會在下半年顯現。那麼,我們應該如何看待這種增量影響,疊加在你們提到的典型季節性之上,例如下半年通常較強?

  • Aziz Mottiwala - Chief Commercial Officer

    Aziz Mottiwala - Chief Commercial Officer

  • Yes. Melanie, I think adding these key account leaders is going to be a great catalyst for us in a lot of ways. We've shown when we've added people, we can get a response right away. We did this when we expanded our sales force prior. We're using a very similar approach. The key account leader is a very unique position in that it's really targeted toward this increasing depth of prescribing we're seeing.

    是的。Melanie,我認為新增這些關鍵客戶經理,會在很多方面成為我們很好的催化劑。我們已經證明,當我們增補人員時,可以立即看到回應。我們之前擴編銷售團隊時就做過。我們採用非常類似的方法。關鍵客戶經理是一個非常獨特的職位,因為它是針對我們所看到的處方深度持續增加而設計的。

  • And the two things I'll tell you there. One is, no one in our called-on audience, no physicians that we're talking to, have capped out yet. So even our top doctors have room to grow. And we're seeing a broader opportunity with doctors being able to prescribe more in general. So these key account leaders are some of the most experienced and sophisticated sales individuals.

    我在這裡想說兩點。第一,我們所接觸的受眾中,沒有任何醫師已經到達上限;也就是說,我們正在溝通的醫師都還沒有「封頂」。所以即便是我們最頂尖的醫師,也仍有成長空間。而且我們看到更廣泛的機會,醫師整體上能夠開立更多處方。因此,這些關鍵客戶經理是最有經驗、也最成熟的銷售人才之一。

  • And again, this is against a very high bar because we have a great sales team. These folks are going to be targeted against the highest opportunity practices that are having good success but could be doing more. So we're able to deploy them and train them. They're in the process of finalizing that training, and then they'll be out there in the third quarter. And I think you're going to start to see that. Now again, it's about 17 to 20 people. So this is not like a massive expansion of the sales force.

    再次強調,這是在非常高的標準之上,因為我們本來就有很棒的銷售團隊。這些人員將聚焦在機會最高的診所:那些已經有不錯成效、但仍可做得更多的單位。因此我們能夠部署並訓練他們。他們正在完成最後的訓練,之後會在第三季投入市場。我認為你將開始看到成效。不過再次說明,這大約是 17 到 20 人。所以這並不是銷售團隊的大規模擴編。

  • But what I think you're going to see is that this is going to catalyze even more depth of prescribing. And it's a key element of this being a driver to get to the targets we have this year. And I'd expect to see that right away, and you'll see that bear through the seasonality, but it doesn't alleviate the impact of seasonality, right? That's a patient flow issue. It's not so much of an execution issue. So I think about this as depth of prescribing change in behavior over time, and allowing us to continue a great growth trajectory. But again, you are going to see seasonality in the quarters, as Jeff mentioned.

    但我認為你會看到的是,這將進一步催化處方深度的提升。而且這是推動我們達成今年目標的一個關鍵要素。我預期會很快看到效果,並且你會看到它在季節性波動中持續發揮作用,但它並不能消除季節性的影響,對吧?那是病患流量的問題。與其說是執行面的問題,不如說是就診流量的問題。所以我把這視為:處方深度的提升、行為隨時間改變,並讓我們能夠延續良好的成長軌跡。但再次強調,如 Jeff 所提到的,你仍會在各季度看到季節性。

  • Operator

    Operator

  • Mazahir Alimohamed, Oppenheimer.

    Mazahir Alimohamed,奧本海默。

  • Mazahir Alimohamed - Equity Analyst

    Mazahir Alimohamed - Equity Analyst

  • Just a couple from us. I guess the first one is, can you give us any additional color on what percentage of prescriptions dispensed in the quarter represent retreatment patients versus new starts? And the second part is, I guess, as you think about the peak sales, the $2 billion peak sales number, how much of that is predicated on retreatment becoming recurring annual behavior, I guess, versus a purely new patient identification?

    我們這邊有兩個問題。第一個是,你能否提供更多細節,說明本季已配藥的處方中,有多少比例是再治療病患,相對於新開始治療的病患?第二部分是,當你們思考峰值銷售額、也就是 20 億美元的峰值銷售數字時,其中有多少是建立在「再治療成為每年重複的行為」這個前提上,相對於純粹依靠辨識新病患?

  • Aziz Mottiwala - Chief Commercial Officer

    Aziz Mottiwala - Chief Commercial Officer

  • Yes, Mazi. So the retreatment is something that we get a lot of questions on and something that we're tracking really closely. It's also something that we've seen progress very nicely over the last several quarters. So as a reminder, what we've said is that we'd expect retreatments to be at steady state around 20%, meaning at any given week of prescriptions, about 20% of the composition would be retreatments.

    是的,Mazi。再治療是我們被問到很多、也在非常密切追蹤的議題。而且我們看到它在過去幾個季度有非常不錯的進展。提醒一下,我們之前說過,我們預期再治療在穩態時大約會在 20% 左右,也就是在任何一週的處方組成中,大約 20% 會是再治療。

  • What we're seeing so far is retreatments averaging in the mid- to high teens. And again, that's up quarter-over-quarter, one of those key metrics. So we're seeing that steadily progress. We'd expect that to even out at around 20%. And then to answer your question, when we think about the long-term potential, you can assume that about a steady state 20%. So in a peak year revenue, 20% of that would be due to retreatments because that implies that steady state 20%.

    到目前為止,我們看到的再治療比例平均落在十幾個百分點的中高段。而且再次強調,這是其中一項關鍵指標,且較上一季有所上升。因此我們看到它穩步推進。我們預期它會在約 20% 左右趨於平穩。接著回答你的問題,當我們思考長期潛力時,你可以假設穩態大約是 20%。因此在營收高峰年度,約 20% 的營收會來自再治療,因為這意味著穩態為 20%。

  • Operator

    Operator

  • Lachlan Hanbury-Brown, William Blair.

    Lachlan Hanbury-Brown,William Blair。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • Maybe just first for Jeff. You had the stronger-than-expected gross to net in the first quarter. Can you maybe elaborate on what drove that? Is that the mix shift? Is it driven by the changes in Medicare or some one-off items?

    也許先問 Jeff 一個問題。你們第一季的毛額到淨額(gross to net)表現強於預期。你能否進一步說明是什麼因素驅動的?是產品/付款方組合的轉變嗎?是由 Medicare 的變動所帶動,還是有一些一次性項目?

  • And then how should we think about that sort of flowing through? We typically have a cadence of gross to net stepping down throughout the year. Should we still expect that? Or is it going to be relatively flat from here?

    另外,我們應該如何看待這種影響的延續?我們通常看到毛額到淨額在一年當中會呈現逐步下滑的節奏。我們仍應該預期如此嗎?還是從這裡開始會相對持平?

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Yes, Lachlan. Good to hear you. We are still not going to be providing gross to net on a quarterly basis now that we've moved over to full-year revenue guidance. And I would just say that we did see the typical seasonality that we usually see in the first quarter in terms of co-pays resetting and driving some additional support there. That said, I think we are still very comfortable that we will be exiting Q4 in that 43% to 45% range. So I would just guide you to the fact that we would expect to be somewhere within that range for the year.

    是的,Lachlan。很高興聽到你的聲音。由於我們已改為提供全年營收指引,我們現在仍不會按季度提供毛額到淨額(gross to net)。我只能說,我們確實在第一季看到了通常會出現的季節性因素,例如自付額(co-pay)重置,進而帶來一些額外的支援需求。話雖如此,我們仍非常有信心在第四季末會落在 43% 到 45% 的區間。因此我會引導你理解為:我們預期全年會在該區間內。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • Okay. Great. And maybe one for Aziz. The continued sort of strong growth in website visits and especially the high-value sort of activities on the website seems pretty encouraging. But has the conversion rate to the extent you can sort of track it, the conversion rate from website visits and these scripts sort of maintained constant, so sort of tracking in line with the increase in visits?

    好的。很好。再問 Aziz 一個問題。網站造訪量持續強勁成長,尤其是網站上的高價值活動(HVA)看起來相當令人鼓舞。但就你們能追蹤的範圍而言,從網站造訪到處方(scripts)的轉換率是否維持穩定,也就是說是否大致隨著造訪量增加而同步?

  • Aziz Mottiwala - Chief Commercial Officer

    Aziz Mottiwala - Chief Commercial Officer

  • Sure. So when we look at DTC, this is an area that's really compelling, an area that we're really excited about the trajectory here. So you highlighted the increased HVAs. We're really pleased because the ROI overall is continuing to improve, and it's already ahead of what the benchmarks are ahead of our expectations. So we don't get into specific conversion metrics, but I'd say the ROI is improving, which implies more patients are getting on therapy, right?

    當然。所以當我們看 DTC(直接面向消費者)時,這是一個非常有吸引力的領域,也是我們對其走勢感到非常興奮的領域。你提到了 HVA 的增加。我們非常滿意,因為整體投資報酬率(ROI)持續改善,而且已經優於基準,也超出我們的預期。我們不會深入具體的轉換指標,但我會說 ROI 正在改善,這意味著有更多病患開始接受治療,對吧?

  • And what you're seeing is Q1 is a patient flow thing, right, where we lost days of weather. So I wouldn't think about the Q1 versus those metrics as the comparator. I think about patients are ready to go. And I think we're seeing the impact of that even early in Q2 with our prescriptions being near our all-time high levels. And I think you're going to continue to see that stack over time.

    另外你看到的是,第一季是一個病患流量的問題,對吧,因為天候因素讓我們少了幾天。所以我不會把第一季與那些指標拿來做直接對比。我會把重點放在病患已經準備好開始。而且我們甚至在第二季初就看到這個影響,因為我們的處方量接近歷史最高水準。我認為你會持續看到這種效應隨時間累積。

  • The great thing about DTC is once you get to a great ROI, and I've seen this on multiple campaigns in my career, you can start to see a stacking effect where these patients are primed and ready to go. And this also validates the strategy of continuing to drive depth of prescribing. The more doctors that are looking for more patients, the better our conversion is going to be. So this is sort of the one-two punch that we're working on, and I think you're seeing positive trajectory on both of those fronts.

    DTC 的好處在於,一旦你達到很好的 ROI——我在職涯中看過多個行銷活動都是如此——你就會開始看到一種疊加效應,這些病患被充分觸達、也已準備好開始。這也驗證了我們持續推動處方深度的策略。越多醫師在尋找更多病患,我們的轉換率就會越好。因此這就是我們正在推進的「一二連擊」,我認為你正看到這兩個面向都呈現正向的走勢。

  • Operator

    Operator

  • Eddie Hickman, Guggenheim.

    Eddie Hickman,Guggenheim。

  • Eddie Hickman - Analyst

    Eddie Hickman - Analyst

  • Congrats on the progress. Just another one on the GTN. As this retreatment cohort expands towards that 20% that you've guided for, does the gross to net profile change between a refill prescription and a new start? Like do you get a better sort of net price realization if a patient sort of is coming back and doesn't need to go through the whole co-pay assistance program? Just sort of curious how that dynamic may shift beyond the sort of typical seasonal gross to net changes you've already talked about?

    恭喜進展。再問一個關於 GTN(毛額到淨額)的問題。隨著再治療族群擴大並朝你們所指引的 20% 邁進時,續方處方與新開始治療之間的毛額到淨額結構會有變化嗎?例如病患回來治療、且不需要走完整個自付額補助計畫時,你們是否能實現更好的淨價(net price)?我只是好奇,除了你們已談到的典型季節性毛額到淨額變動之外,這種動態未來可能如何改變?

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Yes. Great question, Eddie. It's not likely to change on a refill patient. They still have to go through the prior auth proposal as well as potentially provide some co-pay for that product as well. So it's not likely to change much.

    是的。好問題,Eddie。對於續方病患,這不太可能改變。他們仍然必須走事前授權(prior auth)流程,並且也可能仍需要為該產品支付部分自付額(co-pay)。因此不太可能有太大變化。

  • Eddie Hickman - Analyst

    Eddie Hickman - Analyst

  • Got it. And maybe somebody already asked this, but did you sort of talk specifically about which federal agencies have tremendous interest in TP-05 and sort of what that means for the acceleration of that program?

    了解。另外也許有人已經問過,但你們是否能具體談談哪些聯邦機構對 TP-05 有極大興趣,以及這對該計畫加速推進意味著什麼?

  • Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

    Jeffrey Farrow - Chief Financial Officer and Chief Strategy Officer

  • Yes. Sure, Eddie. This is Jeff again. We have a great government affairs team that's been engaged on that side of the house there as you highlighted and Jenna highlighted as well that there's a lot of interest here. And so there's a LymeX group that is looking at opportunities to speed up approvals, particularly in the Phase 3 realm and sort of stepping away from the disease prevention approach that vaccines typically do. And so they're invested in looking at diagnostics and some other areas that can speed up the development pathway there. And then RFK, who is part of the HHS program has made this a high priority as has Makary. So the FDA has really taken an aggressive approach here and is looking to speed therapeutics to market as quickly as we can.

    是的。當然,Eddie。我是 Jeff。我們有一個很強的政府事務團隊,正如你提到的、Jenna 也提到的,這方面確實有很高的興趣,因此團隊一直在那一端積極投入。有一個 LymeX 團體正在尋找加速核准的機會,特別是在第三期(Phase 3)領域,並且某種程度上是跳脫疫苗通常採取的疾病預防路徑。因此他們投入資源在診斷以及其他一些能加速開發路徑的領域。另外,隸屬於 HHS 計畫的 RFK 也將此列為高度優先事項,Makary 亦是如此。因此 FDA 在此採取了相當積極的作法,並希望盡可能快速地將治療產品推向市場。

  • Operator

    Operator

  • And there are no further questions in the queue at this time. Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.

    目前問題隊列中已無其他提問。各位女士、先生,今天的電話會議到此結束。感謝各位參與,現在可以掛線。