Fennec Pharmaceuticals Inc. (FENC) 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 morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals' first quarter 2026 earnings and corporate update conference call. (Operator Instructions) As a reminder, today's conference call is being recorded.

    各位女士、先生,早安,歡迎參加 Fennec Pharmaceuticals 2026 年第一季財報暨公司營運更新電話會議。(接線員指示)提醒各位,今天的電話會議將被錄音。

  • I would now like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade. Please begin.

    現在我想將會議交給 Fennec 的財務長 Robert Andrade。請開始。

  • Robert Andrade - Chief Financial Officer

    Robert Andrade - Chief Financial Officer

  • Thank you, operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fennec Pharmaceuticals' first quarter 2026 earnings conference call today, during which we will review our financial results as well as provide a general business update.

    謝謝接線員,各位早安。感謝各位加入。我們很高興今天主持 Fennec Pharmaceuticals 2026 年第一季財報電話會議,會中我們將回顧財務結果,並提供一般性的業務更新。

  • Joining me from Fennec this morning is our Chief Executive Officer and Board Member, Jeff Hackman. I am also pleased to welcome our Chief Commercial Officer, Terry Evans, who is joining our earnings call for the first time. Terry is a seasoned commercial and operations leader with a proven track record for delivering significant revenue growth and leading high-performing teams.

    今天早上與我一同出席的還有 Fennec 的執行長暨董事會成員 Jeff Hackman。我也很高興歡迎我們的商務長 Terry Evans,他是首次參加我們的財報電話會議。Terry 是資深的商務與營運領導者,具備帶動顯著營收成長並領導高績效團隊的實績。

  • Terry's industry experience spans all facets of commercial operations, including sales, sales management, operations, market access, trade, specialty pharmacy and data analytics. He has more than 25 years of commercial leadership experience with companies including Currax Pharmaceuticals, Horizon Therapeutics, and Medicis.

    Terry 的產業經驗涵蓋商務營運的各個面向,包括銷售、銷售管理、營運、市場准入、通路(trade)、專科藥局與數據分析。他擁有超過 25 年的商務領導經驗,曾任職於 Currax Pharmaceuticals、Horizon Therapeutics 以及 Medicis 等公司。

  • Since joining Fennec in the fourth quarter of 2024, Terry has played a pivotal role in reshaping and strengthening our commercial organization. He has helped to sharpen our execution, enhance our field presence and position the team to capitalize on the opportunities ahead. Later in the call, Terry will speak to how recent efforts will support Fennec's next phase of growth. Additionally, our Chief Medical Officer, Dr. Pierre Sayad, will join us for the Q&A portion of today's call.

    自 2024 年第四季加入 Fennec 以來,Terry 在重塑並強化我們的商務組織方面扮演關鍵角色。他協助提升我們的執行力、強化前線佈局,並讓團隊能把握未來的機會。稍後在會議中,Terry 將說明近期的努力如何支持 Fennec 下一階段的成長。此外,我們的醫務長 Pierre Sayad 醫師也將在今天的問答環節加入。

  • Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. References to these risks and uncertainties are made in today's press release and disclosed in the company's periodic and current event filings with the United States Securities and Exchange Commission.

    在開始之前,我想提醒各位,本次電話會議中公司將發表前瞻性陳述,這些陳述受到風險與不確定性影響,可能導致實際結果與前瞻性陳述中討論的結果有所差異。關於這些風險與不確定性的說明,已載於今日新聞稿,並揭露於公司向美國證券交易委員會提交的定期與重大事件申報文件中。

  • In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days.

    此外,本次電話會議中所作的任何前瞻性陳述僅代表我們截至今日的觀點,不應被依賴為代表任何後續日期的觀點。我們明確聲明不負有更新或修訂任何前瞻性陳述之義務。本電話會議將錄音並於 Fennec 官網 www.fennecpharma.com 提供音訊重播,並於未來 30 天內可供收聽。

  • I will now turn the call over to Jeff Hackman.

    現在我將把電話會議交給 Jeff Hackman。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Thank you, Robert, and good morning, everyone. Thanks for joining the call here today. We are encouraged by our strong start to the year and believe 2026 is a defining period for Fennec. Our conviction is rooted in the progress across many multiple fronts. We've made important strategic enhancements to our business for 2026 that are strengthening our execution across the organization and positions us to continue to build momentum as the year unfolds.

    謝謝你,Robert,各位早安。感謝今天加入電話會議。我們對今年強勁的開局感到振奮,並相信 2026 年將是 Fennec 的關鍵定義期。我們的信心來自於多個面向的進展。我們已為 2026 年對業務進行重要的策略性強化,這些強化正在提升全組織的執行力,並使我們能在今年推進過程中持續累積動能。

  • On the commercial front, we're seeing encouraging early indicators, including positive experiences through our full-service patient support program, Fennec HEARS, as well as trends that support our confidence in the opportunity ahead, and Terry will provide more color on those dynamics shortly.

    在商務面,我們看到令人鼓舞的早期指標,包括透過我們全方位病患支持計畫 Fennec HEARS 所帶來的正向經驗,以及支持我們對未來機會保持信心的趨勢;Terry 稍後將就這些動態提供更多說明。

  • Beyond commercial execution, we continue to be encouraged by growing clinical interest in PEDMARK and its broader potential. We are pleased to have recently announced a third investigator-initiated study with the University of Arizona Cancer Center to evaluate PEDMARK in adolescent and young adults or AYA and adult patients in head and neck and testicular cancers receiving cisplatin.

    除了商務執行之外,我們也持續受到臨床界對 PEDMARK 日益增加的興趣及其更廣泛潛力所鼓舞。我們很高興近期宣布與亞利桑那大學癌症中心合作的第三項研究者發起試驗(investigator-initiated study),評估 PEDMARK 用於接受順鉑(cisplatin)治療的青少年與年輕成人(AYA)以及成人頭頸癌與睪丸癌患者。

  • The news follows recent initiations of two other institution-led clinical studies with Tampa General Hospital Cancer Institute and City of Hope. We believe that the data insights generated through these studies and others to come will help support broader clinical adoption of PEDMARK to prevent ototoxicity in AYA and adult cancer patients receiving cisplatin-based treatments.

    此消息緊接著另外兩項由機構主導的臨床研究近期啟動,合作單位包括 Tampa General Hospital Cancer Institute 與 City of Hope。我們相信,這些研究以及未來更多研究所產生的數據洞見,將有助於支持 PEDMARK 在接受以順鉑為基礎治療的 AYA 與成人癌症患者中,用於預防耳毒性(ototoxicity)的更廣泛臨床採用。

  • Additionally, four abstracts from key opinion leaders evaluating the utility of PEDMARK in preventing cisplatin-induced ototoxicity or permitted hearing loss were accepted for the presentation at this year's ASCO Annual Meeting. Collectively, these studies are continuing to the momentum and the growing body of evidence supporting potential use of PEDMARK in new patient populations and tumor types.

    此外,四篇由關鍵意見領袖評估 PEDMARK 在預防順鉑誘發耳毒性(或允許的聽力損失)效用的摘要,已獲接受並將於今年 ASCO 年會發表。整體而言,這些研究正延續動能,並持續累積證據,支持 PEDMARK 在新的病患族群與腫瘤類型中的潛在使用。

  • As a reminder, PEDMARK is currently approved for pediatric patients one month of age and older with localized non-metastatic solid tumors and is also recognized by the National Cancer -- or National Comprehensive Cancer Network with a 2A recommendation for use in AYA patients. With regards to Japan, we had a positive informal PMDA meeting earlier this quarter. We continue to be in conversations and to explore partnering opportunities in that region.

    提醒各位,PEDMARK 目前已核准用於 1 個月大及以上、罹患局部非轉移性實體腫瘤的兒科患者;同時也獲得美國國家癌症——或稱國家綜合癌症網絡(National Comprehensive Cancer Network, NCCN)對 AYA 患者使用的 2A 級推薦。至於日本方面,我們在本季稍早與 PMDA 進行了一次正向的非正式會議。我們仍持續對話並探索該地區的合作夥伴機會。

  • So in summary, we're making meaningful progress across the drivers that matters most to our long-term success; expanding clinical momentum, strengthening commercial execution and maintaining a solid financial foundation. Taken together with what we are observing early in Q2, we believe we are well positioned to deliver sustained growth throughout this year.

    總結來說,我們在對長期成功最重要的驅動因素上取得實質進展:擴大臨床動能、強化商務執行,以及維持穩健的財務基礎。結合我們在第二季初期所觀察到的情況,我們相信公司已具備良好條件,在今年持續實現成長。

  • With that, I will turn it over to Terry for a detailed commercial update.

    接下來,我將把時間交給 Terry,請他提供更詳細的商務更新。

  • Terry Evans - Chief Commercial Officer

    Terry Evans - Chief Commercial Officer

  • Thank you, Jeff. As Jeff just noted, we're encouraged by the momentum we're seeing in the business and believe our first quarter performance reflects the benefits of the key strategic enhancements we've made across the commercial organization.

    謝謝你,Jeff。正如 Jeff 剛才提到的,我們對業務所展現的動能感到鼓舞,並相信第一季的表現反映了我們在商務組織各面向所做關鍵策略強化的成果。

  • In late Q4 2025, we launched an initiative called Project Ignite. This was a strategic decision based on successful cross-functional initiatives put in place at the start of 2025. Building on the shared insights and strong commercial execution, we use data to evaluate opportunities to optimize both reach and frequency.

    在 2025 年第四季末,我們啟動了一項名為 Project Ignite 的計畫。這是一項策略性決策,建立在 2025 年初所推動、且已成功落地的跨部門計畫之上。基於共享洞見與強勁的商務執行,我們運用數據評估機會,以最佳化觸及範圍與拜訪頻率。

  • Our Q1 investment in 14 new territories and 4 frontline managers expanded our ability to engage health care professionals, support adoption and drive sustained momentum across priority markets. Much of the quarter involved the foundational work required to bring those investments fully online, recruiting and onboarding new talent, completing training and integrating these team members into our commercial model. The recruitment and onboarding process concluded at our national meeting in early March. This was an important milestone to align the expanded organization around our strategy, sharpen execution and ensure the team entered the field equipped and ready to execute.

    我們在第一季投資新增 14 個銷售區域與 4 位第一線主管,擴大了我們與醫療專業人員互動的能力,支持採用並在重點市場推動持續動能。本季多數時間投入於使這些投資全面上線所需的基礎工作,包括招募與到職導入新人才、完成訓練,並將這些團隊成員整合進我們的商務模式。招募與到職導入流程在 3 月初的全國會議上告一段落。這是一個重要里程碑,使擴編後的組織能與我們的策略對齊、強化執行,並確保團隊進入市場時已具備工具並準備好落實執行。

  • There is a natural ramp period with any field force expansion and we view much of Q1 as laying that groundwork. The expansion of our customer-facing team has allowed us to reach with greater frequency, a larger prescriber target base, increasing from 1,300 to now over 5,000 targets. We know the AYA market is promotionally sensitive and effectively communicating the unmet need around CIO is our number one priority. This creates a pathway for practices to help change the standard of care for all appropriate patients receiving cisplatin.

    任何前線團隊擴編都會有自然的爬坡期,我們將第一季的大部分視為打底。擴大面向客戶的團隊後,我們得以更高頻率觸及更大的處方目標族群,目標數從 1,300 位提升至目前超過 5,000 位。我們知道 AYA 市場對推廣活動相當敏感,而有效傳達與 CIO 相關的未被滿足需求是我們的首要任務。這將為臨床實務提供一條路徑,協助改變所有適用且接受順鉑治療患者的照護標準。

  • We believe we're executing in Q2 with a strengthened commercial footprint that is now positioned to drive greater impact through increased reach, frequency and account penetration. Importantly, we're already seeing encouraging signs from these investments through our HCP targeting efforts.

    我們相信第二季在更強化的商務佈局下執行,已能透過提升觸及範圍、拜訪頻率與帳戶滲透率來帶動更大的影響力。重要的是,我們已透過對醫療專業人員(HCP)的目標鎖定工作,看到這些投資帶來的令人鼓舞跡象。

  • To bring our cross-functional model to life, one recent example illustrates how coordinated engagement can translate into adoption over time. About a year ago, our medical team initiated engagement with a KOL from a leading academic center who was familiar with CIO, but not aware of PEDMARK as a preventative treatment option.

    為了讓我們的跨部門模式具體落地,近期有一個例子說明協同互動如何隨時間推進而轉化為採用。大約一年前,我們的醫學團隊開始與某頂尖學術中心的一位關鍵意見領袖(KOL)互動;他熟悉 CIO,但並不知道 PEDMARK 可作為預防性治療選項。

  • Through multiple scientific exchanges and participation in a sponsored program at ASCO GU alongside the Testicular Cancer Awareness Foundation, awareness evolved into meaningful engagement. And more recently, that relationship was transitioned from medical to field sales. A newly deployed territory manager with our Key Account Director introduced Fennec HEARS, which facilitated this KOL's identification and treatment of his first testicular cancer patient for home infusion. Since then, the engagement is actively expanding across the institution with multiple physicians across tumor types now positioned to prescribe and treat more than 20 patients with PEDMARK.

    透過多次科學交流,以及在 ASCO GU 與睪丸癌宣導基金會(Testicular Cancer Awareness Foundation)共同參與一項贊助計畫,認知逐步轉化為實質互動。而在更近期,這段關係由醫學端移交至前線銷售。一位新部署的區域經理與我們的關鍵客戶總監一同介紹了 Fennec HEARS,促成該 KOL 辨識並為其第一位睪丸癌患者安排居家輸注治療。自此之後,互動正積極擴展至該機構內部,跨多種腫瘤類型的多位醫師目前已具備開立處方並治療超過 20 位 PEDMARK 患者的條件。

  • Now, in parallel, we're working collaboratively on order sets and EMR integration. This example highlights a key principle. Durable growth stems from persistent cross-functional engagement across medical, sales, market access and patient support services. Another example of significant progress is through our market access initiatives, specifically in terms of engaging with GPOs. One of the fastest-growing oncology aggregators in the US has partnered with us to integrate PEDMARK throughout their network with order sets and site activations.

    同時,我們也正協作推進醫囑套組(order sets)與電子病歷(EMR)整合。這個案例凸顯一項關鍵原則:可持續的成長來自於醫學、銷售、市場准入與病患支持服務之間持續且跨部門的互動。另一個顯著進展的例子來自我們的市場准入計畫,特別是在與團體採購組織(GPOs)的互動方面。美國成長最快的腫瘤科整合平台之一已與我們合作,透過醫囑套組與據點啟動(site activations),在其網絡中全面導入 PEDMARK。

  • We have ongoing efforts with other organizations to replicate this model that supports a top-down adoption approach, complementing the expansion of our sales force focused on bottom-up activities. At the macro level, we continue to see a healthy mix of both new and existing prescribers. Many established accounts are becoming more comfortable with PEDMARK, contributing to deeper utilization and increased vials per account.

    我們也正與其他組織持續推進相關工作,以複製此一模式,支持自上而下的採用策略,並與我們擴編後、聚焦自下而上活動的銷售團隊相互補強。從宏觀層面來看,我們持續看到新舊處方醫師的健康組合。許多既有帳戶對 PEDMARK 的使用愈加熟悉,帶動更深度的使用並提升每個帳戶的用藥瓶數。

  • We view that continued adoption and growing depth of use as an important marker of durable demand. In fact, demand in the first quarter was driven by prescribing in three-core tumor types: testicular, cervical and head and neck cancers, and these remain foundational to our commercial opportunity.

    我們認為,持續採用以及使用深度的提升,是衡量需求具備持久性的關鍵指標。事實上,第一季的需求主要由三個核心腫瘤類型的處方所帶動:睪丸癌、子宮頸癌以及頭頸癌,而這些仍是我們商業機會的基礎。

  • Another area we would highlight is cross-functional collaboration across all parts of our organization to convert prescription demand into completed therapy. This collaboration comes together through Fennec HEARS, our full-service hub designed to simplify access and support continuity of care by guiding patients and providers through coverage, reimbursement, nurse-led administration and at-home infusion services. This white glove support and education continue to be a meaningful differentiator as we change the standard of care. That coordinated approach is reflected in the operational metrics we're seeing.

    我們要特別強調的另一個面向,是我們組織各部門之間的跨職能協作,將處方需求轉化為完成治療。這項協作透過 Fennec HEARS 來整合呈現;Fennec HEARS 是我們的全方位服務樞紐,旨在透過引導病患與醫療提供者完成保險給付範圍、報銷、護理師主導的給藥,以及居家輸注服務,來簡化取得途徑並支持照護的連續性。當我們改變照護標準之際,這種「白手套」式的支援與教育仍是重要的差異化因素。我們所看到的營運指標也反映了這種協調一致的方法。

  • We continue to see strength in infusion volume and vial utilization. This is reflected in a 48% quarter-over-quarter increase in completed infusions through Fennec HEARS and reinforces our ability to translate prescription demand into completed therapy. From a site of care perspective, we're maintaining a productive mix of approximately 50% from both in-office and at-home infusions, which supports access and flexibility for patients and providers.

    我們持續看到輸注量與藥瓶使用量的強勁表現。這反映在透過 Fennec HEARS 完成的輸注次數較前一季增加 48%,並強化了我們將處方需求轉化為完成治療的能力。從照護場域的角度來看,我們維持約 50% 來自院內輸注、約 50% 來自居家輸注的高效組合,這有助於提升病患與醫療提供者的可近性與彈性。

  • Fennec HEARS continues to be an important contributor to momentum in the quarter. Through ongoing operational refinements, we're seeing more patients enter the funnel. Specifically, a higher share of patients are progressing to therapy as reflected in encouraging conversion rates, which are hitting our benchmark of 80% for the first time. Once on treatment, we continue to see strong adherence trends of approximately 80%, which is a huge improvement from where we were one year ago today. With our larger sales footprint, we're able to make substantially more sales calls each day versus previous quarters.

    Fennec HEARS 持續是本季動能的重要貢獻者。透過持續的營運優化,我們看到更多病患進入漏斗。具體而言,更多病患正推進至治療階段,轉換率表現令人鼓舞,且首次達到我們 80% 的基準。一旦開始治療,我們仍看到約 80% 的強勁依從性趨勢,較一年前有大幅改善。隨著我們擴大銷售覆蓋範圍,我們每天能進行的銷售拜訪次數也較前幾季顯著增加。

  • Now as I mentioned before, this is a promotionally sensitive market where reach and frequency make an impact on our business. Early indicators of this success include HEARS patient record monthly enrollments in April. Demand through Fennec HEARS in April alone is more than 50% of the total Fennec HEARS demand for all of Q1. As a result, demand in Q2 is tracking to surpass Q1. Additionally, conversion rates remain above our target of 80% and key community and academic relationships are opening up to our message of CIO prevention. We remain focused on disciplined execution as we build on this momentum throughout the year.

    如我先前提到,這是一個對推廣活動相當敏感的市場,觸及率與頻次會對我們的業務產生影響。這項成功的早期指標包括 4 月 HEARS 病患紀錄的每月註冊數。僅 4 月透過 Fennec HEARS 的需求就已超過第一季整季 Fennec HEARS 總需求的 50%。因此,第二季的需求走勢預期將超越第一季。此外,轉換率仍高於我們 80% 的目標,且關鍵的社區與學術機構關係也正逐步對我們「預防 CIO」的訊息敞開大門。我們將持續專注於紀律執行,並在全年建立在這股動能之上。

  • And with that, I will now turn the call over to Robert for our financial review.

    接下來,我將把電話會議交給 Robert 進行財務回顧。

  • Robert Andrade - Chief Financial Officer

    Robert Andrade - Chief Financial Officer

  • Thank you, Terry. Our press release contains details of our financial results for the first quarter of 2026, which can be viewed on the Investors and Media section of our website. Rather than read through all of those details, my comments today will focus on some key financial results.

    謝謝你,Terry。我們的新聞稿包含 2026 年第一季財務結果的詳細資訊,可在我們網站的「投資人與媒體」專區查閱。我今天的評論不會逐條朗讀所有細節,而是聚焦於幾項關鍵財務結果。

  • For the first quarter of 2026, the company recorded net product sales of $15.1 million compared to $8.8 million in the first quarter of 2025, representing an increase of approximately 73% year-over-year compared with the first quarter of 2025. The first quarter demonstrated continued momentum in delivering PEDMARK to patients with net product sales up for the sixth consecutive quarter since new commercial leadership took over. We saw record new patient enrollments in the March quarter and April was our highest demand month ever.

    2026 年第一季,公司錄得產品淨銷售額 1,510 萬美元,較 2025 年第一季的 880 萬美元增加,年增約 73%。第一季展現了持續將 PEDMARK 交付給病患的動能;自新的商業領導團隊接手以來,產品淨銷售額已連續第六季成長。我們在 3 月季度看到創紀錄的新病患註冊數,而 4 月則是我們史上需求最高的月份。

  • On the OpEx side, which we define as R&D and SG&A, excluding stock-based compensation, it was approximately $14 million for the quarter, with a year-over-year increase of approximately $6 million. The increase was on the SG&A with expanded marketing investment and increased commercial headcount supporting PEDMARK growth. Important to note, we expect approximately $50 million in cash OpEx in 2026, with over 60% of those expenses expected in the first half of 2026.

    在營運費用(OpEx)方面,我們定義為研發(R&D)與銷售、一般及行政(SG&A),不含以股票為基礎的薪酬,本季約為 1,400 萬美元,年增約 600 萬美元。增加主要來自 SG&A,原因是擴大行銷投資以及增加商業人力以支持 PEDMARK 成長。需要特別指出的是,我們預期 2026 年現金 OpEx 約為 5,000 萬美元,其中超過 60% 的費用預計發生在 2026 年上半年。

  • Cash and cash equivalents were $40.1 million as of March 31, 2026. For the quarter, there was an increase of $3.3 million in cash and cash equivalents. The net increase in cash consisted of $2.3 million in operating cash flow and approximately $1 million in proceeds from option exercises. With regard to anticipated milestone payments from our partner, Norgine, we do not anticipate receiving the German milestone payment. We look forward to Norgine's expansion efforts in 2026 as they launch in multiple markets and the potential for the next milestone achievement by the end of 2026.

    截至 2026 年 3 月 31 日,現金及約當現金為 4,010 萬美元。本季現金及約當現金增加 330 萬美元。現金淨增加主要由 230 萬美元的營運現金流,以及約 100 萬美元的選擇權行使所得構成。關於我們合作夥伴 Norgine 預期的里程碑款項,我們預期不會收到德國的里程碑付款。我們期待 Norgine 在 2026 年於多個市場啟動上市所帶來的擴張努力,並期待在 2026 年底前達成下一個里程碑的可能性。

  • Importantly, we generated positive cash flow in the first quarter of 2026. As we grow the business, we anticipate select quarterly swings in the cash position based on collection cycles with customers and as such, expect the second quarter ending cash to be lower than the first quarter. However, we expect the third quarter cash to be positive and to grow the cash the remainder of the year in the second half of 2026.

    重要的是,我們在 2026 年第一季產生了正向現金流。隨著業務成長,我們預期現金部位在個別季度可能會因客戶收款週期而出現波動,因此預期第二季期末現金將低於第一季。然而,我們預期第三季現金將轉為正向,並在 2026 年下半年於全年剩餘期間持續增加現金。

  • We have tremendous leverage in the business with a predominantly fixed cost base. And as our revenue growth continues, we anticipate operating income to grow meaningfully in the quarters to come. Lastly, as stated in our press release, we anticipate that our cash, cash equivalents and investment securities as of March 31, 2026, combined with projected revenues from PEDMARK will be sufficient to fund our business based on our current operating plan.

    我們的業務具備顯著的營運槓桿,因為成本結構以固定成本為主。隨著營收持續成長,我們預期未來幾季的營業利益將顯著提升。最後,如同我們在新聞稿中所述,我們預期截至 2026 年 3 月 31 日的現金、約當現金與投資證券,加上 PEDMARK 的預估收入,將足以依據我們目前的營運計畫為業務提供資金。

  • Operator, with that, we are now ready to open the call for questions.

    主持人,接下來我們準備開放提問。

  • Operator

    Operator

  • (Operator Instructions) Madison El-Saadi, B. Riley Securities.

    (接線員指示)B. Riley Securities 的 Madison El-Saadi。

  • Madison El-Saadi - Analyst

    Madison El-Saadi - Analyst

  • Congrats on the quarter. It seems you gave some additional color this quarter on KPIs and performance. Maybe just help us break down really what drove the upside here, if this was predominantly new account adds in 1Q, if it was deepening utilization of your base accounts or maybe just productivity from sales force expansion that weren't fully onboarded as of March? And then afterwards, a follow-up.

    恭喜本季表現。看起來你們本季對 KPI 與績效提供了更多補充說明。能否協助我們拆解一下,這次優於預期主要是由哪些因素驅動:是第一季新增帳戶為主、既有帳戶使用量加深,或是銷售團隊擴編帶來的生產力提升(截至 3 月尚未完全到位)?之後我還有一個追問。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Sure. This is Jeff. Thanks for the question. I appreciate it. And I'll let Terry comment on it a little bit. We talked about execution early on when I even first got here 1.5 years or so ago and going on. And we're starting to see it now. And one of the things that we saw with Project Ignite was the ability for us to be able to not only expand our reach but expand our frequency. And that's what we're seeing and one of the reasons why you're seeing such significant uptake, especially in a month like April.

    當然。我是 Jeff。謝謝你的問題,我很感謝。我也會請 Terry 補充一些。我在大約 1.5 年前剛加入時就一直在談執行力,而我們現在開始看到成果。其中一件我們在 Project Ignite 看到的,是我們不僅能擴大觸及,也能提高拜訪頻次。這正是我們目前所看到的,也是你會看到如此顯著採用提升的原因之一,尤其是在像 4 月這樣的月份。

  • So we can go into a little bit more detail. Fennec HEARS is something that drives a lot of the growth here. And we see demand all throughout Q1 growing through Fennec HEARS. So that's also exciting for us. But I'll let Terry comment a little bit more on some of the growth.

    我們可以再多談一些細節。Fennec HEARS 是推動這裡許多成長的因素之一。我們看到整個第一季透過 Fennec HEARS 的需求持續成長,這也讓我們很振奮。不過我先請 Terry 再補充一些成長面的觀察。

  • Terry Evans - Chief Commercial Officer

    Terry Evans - Chief Commercial Officer

  • Yes, for sure. Thank you for the question. What we're seeing is new starts in Q2 is balanced really between both academic and community. In that balanced approach, utilizing the additional folks that we have, our increased reach and frequency that Jeff mentioned, we're seeing that really present itself in academic and large community small community practices. We're seeing a nice growth in both AYA and pediatrics. So yes, we're encouraged by the balance of the year.

    是的,當然。謝謝你的提問。我們看到第二季的新啟動(new starts)在學術機構與社區端之間相當均衡。在這種均衡策略下,運用我們新增的人力,以及 Jeff 提到的觸及與頻次提升,我們看到這點在學術中心以及大型社區、小型社區診所都很明顯。我們也看到 AYA 與兒科兩端都有不錯的成長。所以,是的,我們對今年接下來的表現感到鼓舞。

  • Madison El-Saadi - Analyst

    Madison El-Saadi - Analyst

  • Yes, please. So it seems like you've had multiple inbound interests regarding these ISTs. I'm just wondering why you guys decided to go with the ISTs and the tumor types you did. And if we focus just on, say, the AYA adult testicular, what can this practically mean for the company? Is it more of a means of entrenching PEDMARK, increasing awareness? Or is it more in the context of TAM expansion? And I'm just curious if you can comment if you've seen any revenue come out of these IST institutions. It seems that would be a really tremendous kind of leading indicator of kind of the awareness gap.

    好的,謝謝。看起來你們收到多方對這些 IST 的主動興趣。我想了解你們為什麼決定採用 IST,以及選擇目前這些腫瘤類型的原因。如果只聚焦在例如 AYA 成人睪丸癌,這在實務上對公司可能意味著什麼?比較像是鞏固 PEDMARK、提升認知度的方式?還是更偏向擴大 TAM(總可服務市場)的脈絡?另外也想請教,你們是否已經看到這些 IST 機構帶來任何收入?這看起來會是衡量認知落差的一個非常重要的領先指標。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Yes. Great question, again, and I'll touch on it first, and then I'll kick it over to Pierre, who's sitting here with us today. ISTs are something that are important for a couple of reasons. Number one is it establishes our position in the space. So one of the pushback you'll get from AYA physicians that talk is, let me see the data. Let me see some of the data that was generated in this population.

    是的,再次是個很好的問題。我先回應一下,然後再交給今天也在現場的 Pierre。IST 之所以重要,有幾個原因。第一,它能建立我們在這個領域的定位。因為你會從 AYA 醫師那裡聽到的反對意見之一是:讓我看看數據,讓我看看在這個族群產生的一些數據。

  • As you know, the trials that got PEDMARK approved were trials that were done with the Children's Oncology Group or in the pediatric space. So that's one of the reasons why we're excited about the testicular data that we're generating through the -- as well as some of the adult data down the road that are going to come from these.

    如你所知,使 PEDMARK 獲准的試驗,是由兒童腫瘤學組織(Children's Oncology Group)或在兒科領域完成的試驗。因此,這也是我們對透過這些(研究)所產生的睪丸癌數據感到興奮的原因之一——以及未來一路上也將從這些研究中產生的一些成人數據。

  • The second part is as you -- and I'll let Pierre talk a little bit more on how this happens inside the institutions, but we -- not only the physicians who are participating in these studies are using the product, but also physicians that are surrounding those physicians. And so we're seeing that expansion throughout the institution. And Pierre, maybe you can comment a little bit on that.

    第二部分如同你所說——我會讓 Pierre 再多談一點這在機構內部是如何發生的——但我們看到的不只是參與這些研究的醫師在使用產品,連同圍繞在這些醫師周邊的其他醫師也在使用。因此,我們看到在整個機構內的擴散。而 Pierre,也許你可以就此稍微評論一下。

  • Pierre Sayad - Chief Medical Officer

    Pierre Sayad - Chief Medical Officer

  • Sure, Jeff. Thanks for the question. So yes, as the medical team has the conversations around our two Phase III clinical trials, as Jeff alluded, those were obviously in the pediatric setting, there's a very natural conversation that happens with our physicians where they say, okay, now that I'm really understanding how cisplatin is causing this damage in the cochlea and how PEDMARK can potentially prevent that, they're coming to us with these new and very creative ISTs to test this out in AYA and adult patients.

    當然,Jeff。謝謝你的問題。是的,當醫療團隊就我們兩項第三期臨床試驗進行討論時,如 Jeff 所提到的,那些試驗顯然是在兒科情境中進行,於是我們與醫師之間會自然產生一段對話:他們會說,好,現在我真正理解順鉑(cisplatin)如何在耳蝸造成這種損傷,以及 PEDMARK 如何可能預防它,他們就會帶著這些新的、非常有創意的研究者發起試驗(IST)來找我們,想在 AYA 與成人病患中測試。

  • So we're -- as you know, from previous press releases, at least on the three ISTs that have already been announced, these are across tumor types, AYA setting, adult setting, localized tumors, metastatic tumors and all these ideas are coming directly from the KOLs. So we're very excited about all this interest.

    所以我們——如你所知,從先前的新聞稿來看,至少已公告的三項 IST,涵蓋不同腫瘤類型、AYA 情境、成人情境、局部腫瘤、轉移性腫瘤,而所有這些想法都直接來自關鍵意見領袖(KOL)。因此,我們對這些高度興趣感到非常振奮。

  • I think your second question maybe was what do we do with this data? As you can imagine, as the data matures and our data set expands, we're certainly thinking about potential regulatory conversations, NCCN guideline submissions, so on and so forth. And I think the third point, just to cover what Jeff said, we absolutely see this very interesting trend of once an IST is activated in a given academic institution, there's so much training, so much conversation that needs to happen that now you have the pharmacists, the nurses, other oncologists all really on board with PEDMARK. So we begin to see a little bit of an uptick in commercial use in those institutions.

    我想你的第二個問題可能是:我們如何運用這些數據?如你所能想像,隨著數據逐漸成熟、我們的資料集擴大,我們當然在思考潛在的法規端對話、NCCN 指南提交等等。第三點,為了呼應 Jeff 所說,我們確實看到一個非常有趣的趨勢:一旦某個 IST 在特定學術機構啟動,就需要大量訓練與大量溝通,於是藥師、護理師、其他腫瘤科醫師都會真正支持 PEDMARK。因此,我們開始看到這些機構的商業使用量出現一些上升。

  • Operator

    Operator

  • Chase Knickerbocker, Craig-Hallum.

    Chase Knickerbocker,Craig-Hallum。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Congrats on the nice quarter here. Could you maybe just share what percentage of your volume or just some kind of underlying demand metric was driven by the new rep hires over the last couple of quarters? And then how is that productivity trending in Q2? Really just trying to get to the extent of kind of what -- to what magnitude those new hires are playing a role in this sequential growth and then when they can be fully productive.

    恭喜這一季表現不錯。你們能否分享一下,你們的用量中有多少比例——或任何可反映底層需求的指標——是由過去幾季新聘的業務代表所帶動?另外,這些生產力在第二季的趨勢如何?我主要是想了解:這些新聘人員在這次連續成長中扮演的角色有多大、到什麼程度,以及他們何時能完全發揮產能。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Yes. I'll give this over to Terry, but Chase, thanks for the question. It's a good one. And we -- the things we're seeing early on April is new patients or I mean, coming from new territories, which is exciting. So we see a healthy mix, both coming from new and existing prescribers. And I'm commenting now on the April numbers that we're seeing.

    是的。我先把這題交給 Terry,不過 Chase,謝謝你的問題,問得很好。我們——在四月初期看到的情況是有新病患,或者說,來自新區域的病患,這很令人振奮。因此我們看到一個健康的組合,既有來自新開發的處方醫師,也有來自既有處方醫師。我現在評論的是我們在四月看到的數字。

  • These are established accounts, but which are becoming more comfortable with PEDMARK, but also we're seeing execution in accounts in new accounts and which is really exciting in places where we've never seen patients before. And we knew that once we expanded our reach and we expanded the frequency of this -- of the PEDMARK message, we were going to see continued adoption through these. Terry, maybe you can comment a little bit.

    這些是既有帳戶,但他們對 PEDMARK 越來越熟悉;同時我們也看到在新帳戶的執行落地,這非常令人興奮,因為在一些我們以前從未見過病患的地方開始出現病患。我們早就知道,一旦我們擴大覆蓋範圍、提高 PEDMARK 訊息傳遞的頻率,就會透過這些帶來持續採用。Terry,也許你可以補充一下。

  • Terry Evans - Chief Commercial Officer

    Terry Evans - Chief Commercial Officer

  • Yes. A couple of things. Jeff is exactly right. There's a significant number of our new territories that had prescriptions or patients that have come through between the time that our national meeting occurred through the end of April. To part of the point that you made, Chase, we actually began the hiring -- we began the decision of Project Ignite in Q4, and that kind of happened all the way through Q1. We trained everybody the first week of March, ended at our national meeting.

    好的。有幾點。Jeff 說得完全正確。在我們全國會議舉行之後到四月底之間,我們有相當多的新區域已經出現處方或病患。回到你提到的部分,Chase,我們其實在第四季就開始招聘——我們在第四季做出 Project Ignite 的決策,並一路延續到第一季。我們在三月第一週完成所有人的訓練,並在全國會議時告一段落。

  • The effectiveness of the salespeople, the new salespeople really began, call it, on March 9. So as you know, and through years of experience, there's a ramp period of productivity for our sales team. We've talked about kind of the second half as we get these folks up and running and more productive. But early signs are good.

    新業務人員的成效真正開始發揮,大概是在 3 月 9 日左右。如你所知,也基於多年經驗,我們的銷售團隊會有一段生產力爬坡期。我們談過,隨著這些同仁在下半年逐步上手並更具生產力。但早期跡象是正面的。

  • There's a good balance between new accounts and existing accounts and growing patients and prescriptions inside of both of those. So we're encouraged that the fact that with the strengthened commercial footprint, we're going to drive reach and frequency, and we're excited that we've been able to deliver six consecutive quarters of strong performance.

    新帳戶與既有帳戶之間有良好的平衡,兩者內部的病患數與處方量都在成長。因此我們受到鼓舞:隨著商業覆蓋版圖的強化,我們將提升觸及率與頻率;同時我們也很高興能交出連續六個季度的強勁表現。

  • Chase Knickerbocker - Analyst

    Chase Knickerbocker - Analyst

  • Helpful. And maybe just a couple of smaller kind of details. Can you just speak to the kind of stability of the pediatric revenue? Just trying to get a sense for kind of underlying sequential AYA growth? And then can you just remind us what percentage of your business at this point, either from a demand or revenue perspective is flowing through Fennec HEARS?

    很有幫助。再問兩個比較小的細節:你能否談談兒科營收的穩定性?我想藉此了解 AYA 連續成長的底層動能。另外,也請提醒我們,目前你們的業務中,無論以需求或營收角度來看,有多少比例是透過 Fennec HEARS 流轉?

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Yes. I'll take a couple of the beginning points of this, then I'll give it over to Terry. But Chase, we see -- we're excited about the business and how it's growing. And so the Fennec HEARS right now, what we're seeing is in April alone, about 50% of our business and demand is going through Fennec HEARS. That's increasing every day. It increases as we get better implementation. It increases as physicians want to add more patients to this. And so we're continuing to see that.

    好的。我先回答前面幾點,然後再交給 Terry。Chase,我們看到——我們對業務及其成長方式感到振奮。至於 Fennec HEARS,目前我們看到僅在四月,就大約有 50% 的業務與需求是透過 Fennec HEARS 進行。這個比例每天都在提高。隨著我們的導入執行更到位會提高;隨著醫師希望把更多病患納入也會提高。因此我們持續看到這個趨勢。

  • Our pediatric business is growing. It's growing not at the pace, of course, of AYA, and we've said that before in the past. But pediatric business grows because we're getting now into institutions and places where we didn't have the ability to get to in the past with our pediatric business as well.

    我們的兒科業務也在成長。當然,它的成長速度不如 AYA——我們過去也說過。但兒科業務之所以成長,是因為我們現在能進入一些機構與地點,而過去在兒科業務上我們沒有能力觸及。

  • So when a pharmacist, for example, becomes comfortable in an academic institution with the product, for example, in the AYA space, we're seeing now uptake in the pediatric space as well because of the ability to be comfortable with the product. Whether we get in there through AYA or pediatric for me, it doesn't really matter. It's the opportunity to be able to access these patients.

    因此,舉例來說,當某位藥師在一個學術機構中對產品感到熟悉——例如是在 AYA 領域——我們也會看到兒科領域的採用提升,因為大家對產品更有信心。對我而言,我們是透過 AYA 或兒科切入其實不重要;重要的是能夠接觸到這些病患的機會。

  • Terry Evans - Chief Commercial Officer

    Terry Evans - Chief Commercial Officer

  • Yes. Jeff, I agree. Chase, we're growing in both pediatrics and AYA. Fennec HEARS, as Jeff mentioned, is roughly about 50%. It's important to note that even though we grow pediatrics and we're growing the AYA, PEDMARK is weight-based. And just -- and AYA represents 20-plus 1,000 patients with a high survival rate that take high dose cisplatin. So the AYA would be expected to outpace pediatrics even though the pediatric space is growing. So in both of those things, I think we're taking a balanced approach, which, again, kind of leads us to six quarters of strong growth.

    是的,Jeff,我同意。Chase,我們在兒科與 AYA 兩邊都在成長。Fennec HEARS 如 Jeff 所提,大約是 50%。需要注意的是,即使我們在兒科成長、也在 AYA 成長,PEDMARK 是按體重計量的。而且——AYA 代表超過 2 萬名、存活率高、接受高劑量順鉑的病患。因此,即便兒科領域也在成長,AYA 預期會跑得比兒科更快。綜合這兩點,我認為我們採取的是一個平衡的做法,而這也再次帶來連續六個季度的強勁成長。

  • Operator

    Operator

  • David Amsellem, Piper Sandler & Company.

    David Amsellem,Piper Sandler & Company。

  • David Amsellem - Senior Research Analyst

    David Amsellem - Senior Research Analyst

  • This is Alex von Riesemann on for David. My first question is just how are you thinking about life cycle management for PEDMARK? And then secondly, what is your appetite for acquiring another asset?

    我是代替 David 的 Alex von Riesemann。我的第一個問題是,你們如何思考 PEDMARK 的產品生命週期管理?第二,你們對收購另一項資產的意願如何?

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Yes, it's a great question. And I'll touch on it on the life cycle, and I can turn to Pierre on this, but you're starting to see a little bit of that life cycle management come into play with the ISTs. We talk about three kind of groups of patients for our business. It's the pediatric and we talk about AYA, but there's also adult. When you think of where cisplatin is given, it's given across not only these three areas, but it's also given to both localized and metastatic.

    是的,這是個很好的問題。我先談生命週期部分,之後也可以請 Pierre 補充。不過你已經開始看到,透過 IST,生命週期管理正在逐步發揮作用。我們談到業務的三類病患族群:兒科、AYA,另外還有成人。當你想到順鉑的使用場景,它不僅涵蓋這三個領域,也同時用於局部與轉移性疾病。

  • And so now you're starting to see us start to grow the opportunity to develop data and expand it from a life cycle management standpoint into these other types of populations, the metastatic population, for example, can this product be given there and be effective in these patients in the adult patients, in the head and neck space. So you're starting to see all of this. And we have got more opportunities to be able to do that in other areas. Maybe, Pierre, you can touch on those.

    因此,你現在開始看到我們從生命週期管理的角度,擴大機會去建立數據並延伸到其他族群——例如轉移性族群:這個產品能否在那裡使用並對這些病患有效;在成人病患、頭頸癌領域也是如此。你開始看到這一切。我們也有更多機會在其他領域推進。Pierre,也許你可以談談那些。

  • Pierre Sayad - Chief Medical Officer

    Pierre Sayad - Chief Medical Officer

  • Sure. That's exactly right, Jeff. So as these -- as I touched upon earlier, the ISTs are beginning to mature and we're seeing the data come through. So that obviously is going to open doors into metastatic indications. We've had a tremendous interest from multiple academic institutions putting forth very creative new ISTs in the head and neck space.

    當然。Jeff,你說得完全正確。隨著這些——如我先前提到——IST 開始成熟、我們看到數據逐步產出,這顯然會為轉移性適應症打開大門。我們也看到多家學術機構對頭頸癌領域提出非常有創意的新 IST,興趣非常高。

  • So as I mentioned and alluded to before, we have our sights set on possible NCCN designation criteria for head and neck and cervical is also a very robust area in terms of interest. So as the data matures, that will define our strategy to expand, whether it's with regulatory meaningfulness or NCCN guidelines.

    因此,如我之前提到並暗示的,我們的目標是爭取頭頸癌可能的 NCCN 指定/納入標準;而子宮頸癌在興趣面也非常強勁。隨著數據成熟,將會界定我們的擴張策略——無論是走具法規意義的路徑,或是 NCCN 指南。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Yes. And as related to the second part of your question, looking at other products and bringing in other opportunities, we continue to be open to that. As you know now, we've expanded our commercial team significantly, we've expanded the organization and put resources in places now that you could start to expect a potential opportunity to be able to layer in some additional products, for example. So yes, we continue to be open to that, and that's something that we're looking at as well.

    是的。至於您問題的第二部分,關於檢視其他產品並引入其他機會,我們仍然對此持開放態度。如您所知,我們目前已大幅擴編商業團隊,也擴大了組織規模,並將資源配置到一些位置,讓您可以開始期待,例如有機會再疊加一些額外產品。因此,是的,我們仍然對此保持開放,這也是我們正在評估的方向。

  • Operator

    Operator

  • Ram Selvaraju, H.C. Wainwright.

    Ram Selvaraju,H.C. Wainwright。

  • Katherine Degen - Analyst

    Katherine Degen - Analyst

  • This is Katie on for Ram. I guess I'm wondering what is the typical profile of a high-volume prescriber for PEDMARK at this point? Are those high-volume prescribers predominantly NCI cancer centers? Are they more community oncologists? And how many of those physicians are there in the US.

    我是代替 Ram 的 Katie。我想請教,目前 PEDMARK 的高用量處方醫師典型輪廓是什麼?這些高用量處方醫師主要是 NCI 癌症中心嗎?還是更多是社區腫瘤科醫師?以及在美國大約有多少位這樣的醫師?

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • We talked about -- Terry mentioned -- that's a good question. I appreciate it. Terry mentioned that we're targeting about 5,400 folks with our new team expanded up from just a little bit over 1,000. So -- and those breakout, typically, we see the concentration of our uptake in both academic and community settings. So our strategy, as we get into this is designed to engage both academic centers and also community practices, and we're seeing a really good balance between both. Maybe, Terry, you can comment on that.

    我們談到過——Terry 提到——這是個好問題,我很感謝。Terry 提到,我們透過新擴編的團隊,目標鎖定約 5,400 位對象,從原本略高於 1,000 位擴大而來。所以——而在這些細分中,我們通常看到採用(uptake)的集中度同時出現在學術與社區場域。因此,我們在推進這項策略時,設計上就是要同時與學術中心以及社區診所互動,而我們也看到兩者之間非常好的平衡。或許 Terry,你可以補充一下。

  • Terry Evans - Chief Commercial Officer

    Terry Evans - Chief Commercial Officer

  • No, I think you're exactly right. With our greater reach and frequency, we're seeing new starts from academic and community settings. It's one of the important things that I may or may not have said, which is PEDMARK is a long -- it's a long play sometimes where -- it takes medical. It takes sales, it takes market access. It takes patient support services, lots of these cross-functional teams to kind of pull it through. So the need in academic is slightly different than the need in community. And I've mentioned this before, we're taking a nice balanced approach and activating both sides of them. So thank you.

    不,我認為你說得完全正確。隨著我們覆蓋範圍與拜訪頻率提升,我們看到來自學術與社區場域的新起始用藥(new starts)。我可能有或沒有提到的一個重點是,PEDMARK 有時是一個長期戰——有時需要醫療端、銷售端、市場准入、病患支持服務,以及許多這類跨職能團隊共同推動,才能把它真正落地。因此,學術端的需求與社區端的需求略有不同。我之前也提過,我們採取了良好的平衡策略,同時啟動兩端的動能。謝謝。

  • Katherine Degen - Analyst

    Katherine Degen - Analyst

  • Excellent. If I could sneak in one more question. Do you guys have an idea of how many additional investigator-initiated trials you're going to have starting this year? And could any of those outcomes give you evidence to label expansion?

    很好。如果我可以再偷偷問一個問題:你們是否知道今年將啟動多少項由研究者發起的試驗(investigator-initiated trials)?而其中任何結果是否可能為適應症標籤擴大提供證據?

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Sure. It's a good question. We get -- as soon as we put out your first press release, you start to see significant interest come in, right? Because we see that we have -- our doors are open for partnerships. So let me let Pierre comment on that a little bit. But again, the doors -- we -- there's a limit to how many we're going to do. I can tell you that. But there are some really interesting ones that we've been talking about. Pierre, maybe you can comment on that.

    當然。這是個好問題。我們——一旦發布第一則新聞稿,就會開始看到大量的興趣湧入,對吧?因為大家看到我們——我們的大門對合作是敞開的。所以我先請 Pierre 對此稍作評論。不過再說一次,我們的大門——我們——能做的數量是有限的,我可以告訴你這點。但我們確實在討論一些非常有意思的項目。Pierre,也許你可以談談。

  • Pierre Sayad - Chief Medical Officer

    Pierre Sayad - Chief Medical Officer

  • Sure, sure. I'm smiling a little bit at the question. I mean the -- we're really excited, very encouraged. When you have the amount of interest that we've had from the top academic institutions for new IPs, it's always a great sign. In terms of how many are we expecting to see, I can't comment on that, but there will hopefully be more press releases here soon.

    當然,當然。我對這個問題有點想笑。我的意思是——我們真的很興奮,也非常受到鼓舞。當你看到頂尖學術機構對新的 IP(研究構想/計畫)表現出如此多的興趣時,這總是一個很好的訊號。至於我們預期會有多少項,我無法評論,但希望很快會有更多新聞稿發布。

  • I think the point, though, that I want to make is these are not -- I'll use the word haphazard. We have a very strong strategy as to which ones we're approving and which ones we are not. And so ultimately, there will be efforts to combine data, et cetera, do some pooled analyses with very specific purposes, again, as I mentioned, for regulatory enabling conversations.

    不過我想強調的一點是,這些並不是——我用「隨意」這個詞。我們對於核准哪些、不核准哪些,有非常強而有力的策略。因此,最終會有一些工作去整合數據等等,進行一些合併分析(pooled analyses),而且目的非常明確——如我所提,為了支持與監管機構的推進性對話。

  • Operator

    Operator

  • Sudan Loganathan, Stephens.

    Sudan Loganathan,Stephens。

  • Sudan Loganathan - Equity Analyst

    Sudan Loganathan - Equity Analyst

  • We appreciate the updates and the great progress. My first question, I wanted to ask what your internal pipeline looks like to target new patient populations also treated with platinum-based chemotherapies such as ovarian cancer, bladder cancer, colorectal cancer and even non-small cell or small cell lung cancers. I believe those areas will start getting into more into the AYA population. I'm curious to see what you view out of those maybe or others to be the next low-hanging fruit.

    感謝更新與很好的進展。我的第一個問題是,我想了解你們內部的產品/研發管線(pipeline)如何規劃,以鎖定同樣接受含鉑化療的新病患族群,例如卵巢癌、膀胱癌、大腸直腸癌,甚至非小細胞或小細胞肺癌。我相信這些領域會開始更多進入 AYA(青少年與年輕成人)族群。我很好奇,在這些或其他領域中,你們認為下一個「低垂的果實」會是哪些。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Sure. Thanks. It's a good question. We go where cisplatin is given, right? And we know that there's certain tumor types that are obviously a target for us in that space of where these patients receive therapy with cisplatin. I'll let Pierre comment on the potential new ones. But we see as an opportunity, obviously, testicular because cisplatin has done so -- it's the gold standard. It's something that there's a lot of cisplatin that's given and we see a big impact of CIO in that space.

    好的,謝謝。這是個好問題。我們會去到使用順鉑(cisplatin)的地方,對吧?而我們知道在病患接受順鉑治療的領域中,有一些腫瘤類型顯然是我們的目標。我先讓 Pierre 談談潛在的新領域。不過我們認為一個機會很明顯是睪丸癌,因為順鉑在那裡表現非常——它是黃金標準。那是一個順鉑使用量很大的領域,我們也看到在那個領域中,CIO(順鉑誘發性耳毒性)的影響很大。

  • But there are others that physicians have come to us throughout our time frame as we expand because they're using a lot of cisplatin in cervical and head and neck and other places. And so we see that expansion in places like that. But maybe, Pierre, you can talk about why we see that.

    但還有其他領域,隨著我們擴張,醫師在這段期間也陸續來找我們,因為他們在子宮頸癌、頭頸癌以及其他地方也大量使用順鉑。因此我們看到在這些地方也有擴展的空間。不過也許 Pierre,你可以談談我們為什麼會這麼看。

  • Pierre Sayad - Chief Medical Officer

    Pierre Sayad - Chief Medical Officer

  • Yes. So as we've covered before, there's a strong foothold, if you will, interest that has come through for head and neck testicular cervical. We are absolutely having a lot of conversations in those additional areas that you mentioned as well, bladder as well as lung. And I think it's basically what Jeff said, the mechanism by which cisplatin, a, combats the tumor, but then also defeats and kills these very sensitive cochlear hair cells is the same across all these tumors.

    是的。如同我們之前提到的,在頭頸癌、睪丸癌、子宮頸癌方面,已經形成了相當強的立足點(foothold)與興趣。我們也確實在您提到的其他領域進行大量對話,包括膀胱癌以及肺癌。我想基本上就像 Jeff 說的,順鉑一方面對抗腫瘤的機制,但同時也會損傷並殺死這些非常敏感的耳蝸毛細胞,而這個機制在所有這些腫瘤中都是相同的。

  • So wherever cisplatin goes, PEDMARK absolutely has a strong potential of helping those patients. So yes, you're absolutely right, right? It's head and neck, cervical, testicular, lung, bladder, and there's probably a few more that we could rattle off here. Those are all absolutely big targets for PEDMARK.

    因此,只要有順鉑的地方,PEDMARK 就非常有潛力幫助那些病患。所以是的,你完全正確,對吧?頭頸癌、子宮頸癌、睪丸癌、肺癌、膀胱癌,可能還有幾個我們在這裡也能一口氣列出來。這些都是 PEDMARK 的重要目標。

  • Sudan Loganathan - Equity Analyst

    Sudan Loganathan - Equity Analyst

  • Great. And secondly, if I can squeeze one more in. Could we give more details on how the PEDMARQSI launches are going? What are the primary sticking points? And when do you anticipate revenues from there maybe to start actually moving the needle for the business?

    很好。第二個問題,如果我可以再塞一個:能否提供更多關於 PEDMARQSI 上市進展的細節?主要卡點是什麼?以及你們預期那邊的營收何時可能開始對公司業務產生實質帶動?

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Yes. We're enthusiastic about what we're seeing with Norgine. It's -- this is the year we'll see significant growth in Norgine throughout their territories and we're starting to see, obviously, many countries. As Robert said, maybe you can comment a little bit on some of the growth that we're seeing through Fennec HEARS, I mean, through Norgine.

    是的。我們對於從 Norgine 那邊看到的情況感到振奮——今年我們將看到 Norgine 在其各個區域出現顯著成長,而且我們也開始看到,顯然,許多國家。如 Robert 所說,也許你可以稍微評論一下我們透過 Fennec HEARS——我是說,透過 Norgine——所看到的一些成長。

  • Robert Andrade - Chief Financial Officer

    Robert Andrade - Chief Financial Officer

  • Yes. PEDMARQSI for 2026 will be launched in multiple markets, almost double-digit type markets. So this is the year where the foundation gets laid. I think an important point there is not only our royalties, which start in the mid-teens as they grow those sales, but also the milestones. And if you think of the over $200 million in milestones, at least half of those are tied purely to achieving certain sales. So we look forward to giving you updates, but this -- 2026 is the year where we see the ramp starting.

    是的。PEDMARQSI 在 2026 年將於多個市場上市,幾乎是接近雙位數的市場數量。因此,今年是打下基礎的一年。我認為一個重要重點不僅是我們的權利金(royalties)——隨著他們銷售成長,權利金從十幾個百分點(mid-teens)起跳——還包括里程碑款(milestones)。如果你想想超過 2 億美元的里程碑款,至少有一半純粹是與達成特定銷售額掛鉤。因此我們期待向各位更新,但——2026 年是我們看到爬坡(ramp)開始的一年。

  • Sudan Loganathan - Equity Analyst

    Sudan Loganathan - Equity Analyst

  • And congrats. Great quarter.

    也恭喜你們,這是一個很棒的季度。

  • Operator

    Operator

  • I would now like to turn the call back to Jeff for closing remarks.

    我現在想把電話交回給 Jeff 作結語。

  • Jeffrey Hackman - Chief Executive Officer, Director

    Jeffrey Hackman - Chief Executive Officer, Director

  • Perfect. Well, thanks, and great questions, and I really appreciate everybody here attending today. So in closing, we believe our first quarter performance reflects meaningful momentum across the business and reinforces our confidence in 2026 as an important year for Fennec. With strong execution underway in Q2 and multiple catalysts ahead, we remain focused on delivering sustained value. So thank you all again for your continued interest and support. We appreciate it. Take care.

    很好。謝謝,也謝謝大家提出很棒的問題,我非常感謝今天在場的各位參與。最後總結,我們認為第一季的表現反映了公司各面向的實質動能,並強化我們對 2026 年將成為 Fennec 重要一年之信心。隨著第二季強力執行正在進行,且前方有多項催化劑,我們仍專注於交付可持續的價值。再次感謝各位持續的關注與支持。我們非常感激。保重。

  • Operator

    Operator

  • And this concludes today's conference. Thank you for your participation. You may now disconnect.

    今天的會議到此結束。感謝您的參與。您現在可以掛線。