Puma Biotechnology Inc (PBYI) 2025 Q3 法說會逐字稿

Good afternoon. My name is Julian and I'll be your conference call operator for today. (Operator Instructions) As a reminder, this call is being recorded.

午安.我叫朱利安，今天我將擔任你們的電話會議接線生。（操作員說明）提醒您，本次通話正在錄音。

I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. Thank you. You may begin.

現在我謹將電話會議交給 Puma Biotechnology 的投資人關係資深總監 Mariann Ohanesian。謝謝。你可以開始了。

Thank you, Julian. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the third quarter of 2025. Joining me on the call today are Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales.

謝謝你，朱利安。下午好，歡迎參加彪馬公司2025年第三季獲利業績電話會議。今天與我一起參加電話會議的有：財務長 Maximo Nougues；行銷資深副總裁 Heather Blaber；以及銷售資深副總裁 Roger Storms。

After the close today, Puma issued a news release detailing earnings results for third-quarter 2025. That news release, the slides that Roger will refer to, and a webcast of this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

今天收盤後，彪馬發布新聞稿，詳細介紹了 2025 年第三季的獲利情況。新聞稿、羅傑將要提到的幻燈片以及本次電話會議的網路直播均可透過我們網站 pumabiotechnology.com 的首頁和投資者關係頁面存取。網路直播和簡報將在我們的網站上存檔，並可在接下來的 90 天內重播。

Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2024.

今天的電話會議將包含有關彪馬未來預期、計劃和前景的聲明，這些聲明構成聯邦證券法意義上的前瞻性聲明。此類聲明存在風險和不確定性，實際事件和結果可能與這些前瞻性聲明中表達的內容有所不同。有關這些風險和不確定性的全面討論，請參閱我們不時向美國證券交易委員會提交的定期報告和當前報告，包括截至 2024 年 12 月 31 日止年度的 10-K 表格年度報告。

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, November 6, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

請注意，不要過度依賴這些前瞻性聲明，這些聲明僅代表截至本次電話會議之日（2025 年 11 月 6 日）的觀點。除法律要求外，彪馬不承擔任何義務修改或更新任何前瞻性聲明以反映本次電話會議日期之後的事件或情況。

During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our third quarter 2025 earnings release. for reconciliation of our GAAP to non-GAAP results.

在今天的電話會議中，我們可能會提到一些非GAAP財務指標，這些指標涉及對我們GAAP數據的調整。我們認為這些非GAAP指標可以作為我們GAAP財務指標的補充，但不能取代GAAP財務指標，對投資人來說可能很有用。請參閱我們2025年第三季財報，以了解我們GAAP與非GAAP業績的調節情形。

I will now turn the call over to Ellen.

現在我將把電話轉給艾倫。

Thank you Mary Ann and thank you all for joining our call today. Today, Puma reported total revenue for the third quarter of 2025 of $54.5 million. Total revenue includes product revenue net which consists entirely of near link sales as well as royalties from our sublicensees.

謝謝瑪麗安，也謝謝大家今天參加我們的電話會議。今天，彪馬公佈了2025年第三季的總收入為5,450萬美元。總收入包括產品淨收入（完全由近距離銷售構成）以及來自我們分授權人的特許權使用費。

Product revenue net was $51.9 million in the third quarter of 2025. an increase from $49.2 million reported in Q2 2025, and a decrease from $56.1 million reported in Q3 2024. As a reminder to investors, Puma reported NERLYNX sales includes both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-US partners.

2025 年第三季產品淨收入為 5,190 萬美元，較 2025 年第二季報告的 4,920 萬美元有所增加，但較 2024 年第三季報告的 5,610 萬美元有所減少。提醒投資者，彪馬報告稱，NERLYNX 的銷售額包括 NERLYNX 在美國的淨銷售額以及向彪馬在美國以外的合作夥伴供應 NERLYNX 的產品收入。

Please note that in Q3 2024, we reported product supply revenue to our international partners of about $7.4 million versus $0.1 million in Q3 2025. Therefore, US net sales of NERLYNX in Q3 2025 were $51.8 million versus $48.8 million in Q3 2024.

請注意，2024 年第三季度，我們向國際合作夥伴報告的產品供應收入約為 740 萬美元，而 2025 年第三季僅為 10 萬美元。因此，NERLYNX 在 2025 年第三季的美國淨銷售額為 5,180 萬美元，而 2024 年第三季為 4,880 萬美元。

Product revenue for the third quarter of 2025 was impacted by approximately $3.1 million of inventory billed at our specialty pharmacies and specialty distributors. Royalty revenue was $2.6 million in the third quarter of 2025, compared to $3.2 million in Q2 2025, and $24.4 million in Q3 2024.

2025 年第三季的產品收入受到約 310 萬美元的庫存帳單的影響，這些庫存帳單來自我們的專科藥房和專科分銷商。2025 年第三季特許權使用費收入為 260 萬美元，而 2025 年第二季為 320 萬美元，2024 年第三季為 2,440 萬美元。

Q3 2024 royalty revenue included sales to China by our offshore partner, Pierre Fabre. We reported 2,949 bottles of NERLYNX sold in the third quarter of 2025, an increase of 341 from the 2,608 bottles sold in Q2 2025. In Q3 2025, we estimate that inventory increased by 172 bottles. In Q3 2025, new prescriptions were down approximately 3% compared to Q2 2025, and total prescriptions were down approximately 1% compared to Q2 2025. Roger will provide further details in his comments and slides.

2024 年第三季特許權使用費收入包括我們海外合作夥伴 Pierre Fabre 對中國的銷售額。據報道，2025 年第三季 NERLYNX 的銷量為 2,949 瓶，比 2025 年第二季的銷量 2,608 瓶增加了 341 瓶。我們預計到 2025 年第三季度，庫存將增加 172 瓶。2025 年第三季度，新處方數量比 2025 年第二季度下降了約 3%，總處方數量比 2025 年第二季度下降了約 1%。羅傑將在他的評論和幻燈片中提供更多細節。

I will now provide a clinical review of the quarter, then Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities. Maximo will get us some follow up with highlights of the key components of our financial statements for the third quarter of 2025.

接下來我將對本季進行臨床回顧，然後 Heather Blaber 和 Roger Storms 將對 NERLYNX 的商業活動進行補充說明。Maximo 將為我們帶來一些後續訊息，重點介紹我們 2025 年第三季財務報表的關鍵組成部分。

As investors are aware, Puma currently has two ongoing Phase 2 trials of our investigational drug, alisertib, ALISCA-Breast1, which is a Phase 2 trial of alisertib in combination with endocrine treatment in patients with HER2-negative hormone receptor positive breast cancer, and ALISCA-Lung1, Phase 2 trial looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.

如投資人所知，Puma 目前正在進行兩項二期臨床試驗，研究藥物 alisertib：ALISCA-Breast1，這是一項二期臨床試驗，研究 alisertib 與內分泌治療聯合用於 HER2 陰性激素受體陽性乳腺癌患者的療效；ALISCA-Lung1，這是一項二期臨床試驗，研究 alisertib 單肺癌藥治療對小細胞的治療。

As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatments, which consists of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative, hormone receptor-positive metastatic breast cancer. Patients must be chemotherapy naive, have been previously treated with a CDK46 inhibitor, and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

提醒一下，ALISCA-Breast1 試驗研究了 alisertib 與內分泌治療（包括阿那曲唑、依西美坦、來曲唑、氟維司群或他莫昔芬）聯合用於 HER2 陰性、荷爾蒙受體陽性轉移性乳癌患者的療效。患者必須未接受過化療，之前接受過 CDK46 抑制劑治療，並且在復發或轉移性疾病的情況下至少接受過兩線內分泌治療，才有資格參加試驗。

Patients are being dosed with alisertib given at either 30 milligrams, 40 milligrams, or 50 milligrams twice daily BID on days 1 to 3, 8 to 10, and 15 to 17 in a 28-day cycle in combination with the endocrine therapy and the investigative choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial. The primary efficacy endpoints include objective response rate, duration of response, disease control rate, and progression for your survival.

患者接受的 alisertib 劑量為 30 毫克、40 毫克或 50 毫克，每日兩次（BID），分別在第 1 至 3 天、第 8 至 10 天和第 15 至 17 天服用，在一個 28 天的周期內，與內分泌治療和研究選擇聯合使用。患者之前不得接受過轉移性疾病的內分泌治療，而該治療將在試驗中與 alisertib 合併使用。主要療效終點包括客觀緩解率、緩解持續時間、疾病控制率和存活進展。

As a secondary objective, accompaniment will be evaluating each of these efficacy biomarkers within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy and has been seen in pre-clinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. The company will then look to focus the future clinical adult mental health service in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive metastatic breast cancer with these biomarkers.

作為次要目標，還將評估生物標記亞組中的每種療效生物標記物，以確定是否有任何生物標記亞組與更好的療效相關，並且已在其他癌症（包括乳腺癌和小細胞肺癌）的臨床前和臨床研究中觀察到。然後，該公司將著眼於未來，將這些生物標記與內分泌療法結合，為 HER2 陰性、荷爾蒙受體陽性的轉移性乳癌患者提供臨床成人心理健康服務。

The trial was initiated in late November 2024. There are currently 34 sites in the US and 18 sites in Europe that have been activated for the trial and the trial is rolling ahead of expectations. There are currently 98 patients enrolled in the trial and 14 additional patients in screening.

審判於2024年11月下旬開始。目前，美國已有 34 個試驗點，歐洲已有 18 個試驗點啟動試驗，試驗進展超出預期。目前已有 98 名患者入組試驗，另有 14 名患者正在接受篩檢。

Due to the faster than expected enrollment in the trial, the former interim analysis was triggered sooner than expected, we anticipate that the formal interim analysis will be completed in the first half of 2026 and look forward to sharing this with investors at that time.

由於試驗入組速度超出預期，先前的期中分析提前啟動，我們預計正式的期中分析將於 2026 年上半年完成，並期待屆時與投資者分享分析結果。

With respect to the ALISCA-Lung1, the ALISCA-Lung is a Phase 2 study of our investigational drug alisertib to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer and to specifically look at the efficacy of the drug in patients with biomarkers where the aurora kinase pathway plays a role.

關於 ALISCA-Lung1，ALISCA-Lung 是我們正在研究的藥物 alisertib 的 2 期研究，旨在研究 alisertib 單藥治療小細胞肺癌患者的療效，並特別關注該藥物在具有極光激酶通路發揮作用的生物標誌物的患者的療效。

The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel plus alisertib versus Paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020.

目標是將 ALISCA-Lung1 研究中這些生物標記亞群的療效與 2020 年發表在《胸科腫瘤學雜誌》上的紫杉醇加 alisertib 與紫杉醇加安慰劑隨機試驗中生物標誌物亞組的療效進行關聯。

In that randomized trial, a progression fee survival benefit and overall survival benefits were seen in patients with biomarkers which correlate with the aurora kinase pathway. If the efficacy and biomarker data are comparable from the two studies, the company would look to engage the FDA to discuss the regulatory path further.

在該隨機試驗中，與極光激酶路徑相關的生物標記的患者觀察到了疾病進展生存獲益和總生存獲益。如果兩項研究的療效和生物標記數據具有可比性，該公司將尋求與美國食品藥物管理局 (FDA) 接洽，進一步討論監管途徑。

As discussed in the recent earnings call, the company believes the data obtained to date from the ALISCA-Lung1 is providing a preliminary indication potentially better activity in patients with biomarkers where the aurora kinase plays a role. The most recent analysis of the PK data from the ALISCA-Lung1 suggests that we're seeing lower PK of alisertib in the ALISCA-Lung1 study compared to the previous Phase 2 of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology. The company has amended the protocol for the trial to increase the dose of al-Ascertib from 50 milligrams BID to 60 milligrams BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase 2.

正如在最近的財報電話會議上所討論的那樣，該公司認為，迄今為止從 ALISCA-Lung1 獲得的數據初步表明，在極光激酶發揮作用的生物標誌物患者中，該藥物可能具有更好的活性。ALISCA-Lung1 的最新 PK 數據分析表明，與先前發表在《柳葉刀腫瘤學》上的 alisertib 單藥治療小細胞肺癌患者的 2 期研究相比，ALISCA-Lung1 研究中 alisertib 的 PK 值較低。該公司已修改試驗方案，將 al-Ascertib 的劑量從 50 毫克每日兩次增加到 60 毫克每日兩次，該公司認為這將使藥物的藥物動力學更接近先前 2 期試驗中觀察到的水平。

The company is currently enrolling patients at the 60 milligram dose -- 60 milligram BID dose. There are currently 61 patients in the trial with nine of these patients enrolled at the 60 milligram BID dose, an additional two patients in screening. Assuming the safety at the 60 milligram dose is acceptable, the company plans to meet with the FDA in order to amend the protocol to continue to dose escalate to 70 milligrams. The company looks to have additional interim data from this trial in the first half of 2026.

該公司目前正在招募患者接受 60 毫克劑量（每日兩次，每次 60 毫克）的治療。目前該試驗共有 61 名患者，其中 9 名患者接受了 60 毫克每日兩次的劑量，另有 2 名患者正在接受篩選。假設 60 毫克劑量的安全性可以接受，該公司計劃與 FDA 會面，以便修改方案，繼續將劑量增加到 70 毫克。該公司預計將於 2026 年上半年獲得該試驗的更多中期數據。

As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-license require that would allow the company to diversify itself and leverage Puma's existing R&D regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses.

正如先前在財報電話會議上以及對投資者提問的回應中所提到的，Puma 繼續評估幾種藥物，可能需要引進許可，這將使公司能夠實現多元化，並利用 Puma 現有的研發監管和商業基礎設施。本公司將隨時向投資者通報進度。

I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.

現在我將把電話轉給 Heather Blaber，請她介紹我們行銷計畫的最新進展。Roger Storms 將隨後對我們本季的商業業績進行回顧。

Thank you, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on creating awareness of both clinical messaging for NERLYNX as well as recently published data that demonstrate the continued need to reduce the risk of recurrence and HER2-positive early breast cancer. after treatment with adjuvant therapy.

謝謝你，艾倫。我很榮幸有機會與大家分享一些關於我們行銷策略的額外見解。行銷團隊致力於提高人們對 NERLYNX 臨床資訊的認知，以及對近期發表的數據的認知，這些數據表明，在接受輔助治療後，仍需繼續降低復發風險和 HER2 陽性早期乳癌的風險。

We continue to invest in market research to help us better understand risk factors that put a patient at high risk of recurrence in HER2-positive early stage breast cancer, as well as garner insights on the NERLYNX clinical data in this patient population.

我們繼續投資市場研究，以幫助我們更好地了解導致 HER2 陽性早期乳癌患者復發風險高的風險因素，並深入了解 NERLYNX 在該患者群體中的臨床數據。

Together with our marketing initiatives, our strategy is focused on increasing awareness of our broad indication of patients that are appropriate for treatment with NERLYNX. We have adjusted our strategy based on our learnings and revised both personal and non-personal messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence still remains high and where we believe NERLYNX can play an important role in helping to reduce the risk of recurrence in patients with early stage HER2-positive breast cancer.

結合我們的行銷舉措，我們的策略重點是提高人們對 NERLYNX 適用廣泛的患者的認識。我們根據所學到的經驗調整了策略，並修改了個人和非個人信息，目的是讓醫生接觸到更多復發風險仍然很高的患者，我們相信 NERLYNX 可以在幫助降低早期 HER2 陽性乳腺癌患者的復發風險方面發揮重要作用。

In addition to revising our messaging, we have a new resource to support patients throughout their recommended course of NERLYNX therapy. This educational resource is provided to patients on a monthly basis with the goal of improving patient adherence as they receive their refills. Lastly, year to date, we have reached 99.7% of oncologists through non-personal promotion and continue to expand our share of voice working closely with the sales team to increase engagement with healthcare providers.

除了修改我們的宣傳訊息外，我們還新增了資源，旨在為患者在整個 NERLYNX 療程中提供支援。此教育資源每月提供給患者，目的是提高患者在領取續藥時的依從性。最後，今年迄今為止，我們已透過非人員推廣方式涵蓋了 99.7% 的腫瘤科醫生，並將繼續與銷售團隊緊密合作，擴大我們的市場份額，以提高與醫療保健提供者的互動。

In summary, we are excited about our new marketing strategy and messaging. which we believe will continue to help educate and engage oncologists on the unmet need for those diagnosed with HER2-positive early breast cancer.

總而言之，我們對新的行銷策略和訊息傳遞方式感到興奮，我們相信這將繼續幫助腫瘤科醫生了解並關注HER2陽性早期乳癌患者未被滿足的需求。

I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the third quarter.

現在我將把電話交給羅傑·斯托姆斯，讓他概述第三季的商業表現。

Thank you, Heather, and thanks to everyone for joining our third quarter earnings call.

謝謝Heather，也謝謝各位參加我們第三季財報電話會議。

Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on expanding overall HCP reach and frequency with a strong emphasis on driving engagement at key treatment decision points.

在進行商業評論之前，提醒大家一下，我將發表一些前瞻性聲明。銷售團隊仍專注於擴大整體 HCP 覆蓋率和接觸頻率，並專注於在關鍵治療決策點推動互動。

In Q3 2025, call activity increased 22% year over year and increased 17% quarter over quarter. This is a direct result of continued emphasis put on execution excellence and increased accountability with the existing sales team. I expect call activity to continue to improve as we fill vacancies. Commercial team continues to prioritize increasing use of NERLYNX with the main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts, as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.

2025 年第三季度，電話活動年增 22%，較上季成長 17%。這是持續重視卓越執行力和提高現有銷售團隊責任感的直接結果。隨著職缺的填補，我預期電話諮詢量將持續改善。商業團隊繼續優先考慮增加 NERLYNX 的使用，主要關注復發風險較高的患者。他們也致力於透過非個人化的宣傳活動來加強臨床教育和參與，並利用患者資源來支持患者在 NERLYNX 治療期間的堅持和依從性。

Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance.

現在讓我過渡到一些商業方面的幻燈片，我將在其中提供有關性能的一些額外細節。

Slide 3 is an illustration of our distribution model. which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. In regards to overall distribution of our business, in Q3 2025, about 65% of our business was purchased through the SD channel and the remaining 35% was purchased through the SD channel. We are seeing some stronger growth in the SD channel driven by two main factors.

投影片 3 展示了我們的分銷模式，該模式分為專科藥房通路和專科分銷商或診所內配藥管道。就我們業務的整體分佈而言，在 2025 年第三季度，我們約 65% 的業務是透過 SD 管道購買的，其餘 35% 的業務是透過 SD 管道購買的。我們看到，受兩個主要因素驅動，SD頻道呈現更強勁的成長動能。

One, increased sales in the group purchasing organization segment and two, increased 340B purchasing.

第一，集團採購組織部門的銷售額增加；第二，340B採購量增加。

Turning to slide 4, narrowing to net product revenue in Q3 2025 was $51.9 million, which represents an increase of $2.7 million from the $49.2 million we reported in Q2 2025 and a decrease of $4.2 million from the $56.1 million we reported in Q3 of 2024.

翻到第 4 張投影片，2025 年第三季淨產品收入為 5,190 萬美元，比 2025 年第二季報告的 4,920 萬美元增加了 270 萬美元，比 2024 年第三季報告的 5,610 萬美元減少了 420 萬美元。

As a reminder to investors, Puma's reported narrow link sales includes both US sales of NERLYNX and product supply revenues of narrow links to Puma's XUX partners. Please note that in Q3, 2024, we reported product supply revenue to our international partners of about $7.4 million versus the $0.1 million in Q3 of 2025. Therefore, US net sales of narrow links in Q3, 2025 were $51.8 million. versus the $48.8 million in Q3 of 2024. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update. In Q3 of 2025, we estimate that inventory increased by about $3.1 million. As a comparator, we estimate that inventory decreased by about $1.3 million in Q2 of 2025 and increased by about $0.7 million in Q3 of 2024.

提醒投資者，Puma 報告的窄鏈銷售額包括 NERLYNX 在美國的銷售額以及向 Puma 的 XUX 合作夥伴供應窄鏈產品的收入。請注意，2024 年第三季度，我們向國際合作夥伴報告的產品供應收入約為 740 萬美元，而 2025 年第三季僅為 10 萬美元。因此，2025 年第三季美國窄鏈產品的淨銷售額為 5,180 萬美元，而 2024 年第三季為 4,880 萬美元。我將提供有關庫存變化的更多詳細信息，Maximo 將在更新中提供有關毛支出和淨支出的一些具體細節。我們預計，2025 年第三季庫存將增加約 310 萬美元。作為對比，我們估計 2025 年第二季庫存減少了約 130 萬美元，2024 年第三季庫存增加了約 70 萬美元。

Slide 5 shows Q3 2025 X factory bottle sales and also provides both the year over year and the quarter over quarter comparison. In Q3 2025, NERLYNX factory bottle sales were 2,949, which represents an approximate 13% increase quarter over quarter, and an 8% increase year over year. Inventory declined for the first two quarters but increased in Q3 of 2025.

幻燈片 5 顯示了 2025 年第三季 X 工廠瓶裝銷量，並提供了同比和環比比較。2025 年第三季度，NERLYNX 工廠瓶銷量為 2,949 瓶，較上季成長約 13%，較去年同期成長約 8%。2025 年前兩季庫存下降，但第三季庫存增加。

Similar to the prior slide, let me specifically call the inventory changes from a bottle perspective. In Q3 2025, we estimate that inventory increased by 172 bottles. As a comparator, we estimate that inventory decreased by 85 bottles in Q2 of 2025 and increased by 39 bottles in Q3 of 2024.

與上一張投影片類似，讓我具體從瓶子的角度來談談庫存變化。我們預計到 2025 年第三季度，庫存將增加 172 瓶。作為對比，我們估計 2025 年第二季庫存減少了 85 瓶，2024 年第三季庫存增加了 39 瓶。

Let me take a moment to provide some additional metrics regarding our second quarter performance. In Q3, we saw enrollments increase by about 6% quarter over quarter and decline about 6% year over year. New patient starts, or NRx, follow a similar pattern, increasing 3% quarter over quarter and declining about 1% year over year.

請容許我花一點時間提供一些關於我們第二季業績的其他指標。第三季度，入學人數較上季成長約 6%，年減約 6%。新患者開藥量（NRx）也呈現類似的趨勢，每季增加 3%，每年下降約 1%。

Turning to total prescriptions, or TRx, we saw TRx decline about 1% quarter over quarter and decline about 4% year over year.

從處方總量（TRx）來看，我們發現 TRx 環比下降約 1%，比去年同期下降約 4%。

Finally, let me share some specifics around demand. In Q3 2025, we saw demand increase by about 3% quarter over quarter and about 3% year over year. As mentioned earlier, we have seen stronger demand growth in the SD channel where we saw SD demand grow by about 11% quarter over quarter and about 25% year over year. Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch.

最後，我想分享一些關於需求的具體細節。2025 年第三季度，我們看到需求較上季成長約 3%，年增約 3%。如前所述，我們看到 SD 通路的需求成長更為強勁，SD 需求較上季成長約 11%，較去年同期成長約 25%。幻燈片 6 重點介紹了自 NERLYNX 上市以來每季劑量遞增的採用情況。

In Q3 2025, approximately 77% of patients started NERLYNX at a reduced dose. This is higher compared to the 71% we reported in Q2 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who are started on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation coupled with the new patient education resources will give patients better support throughout their NERLYNX therapy, and ultimately, help them reduce their risk of recurrence.

2025 年第三季度，約 77% 的患者開始服用 NERLYNX，但劑量降低。這比我們在 2025 年第二季報告的 71% 要高。持續宣傳和推廣劑量遞增策略仍然是一項重要的商業優先事項。以劑量遞增方式開始使用 NERLYNX 的患者俱有較好的堅持性和遵從性。我們相信，劑量遞增加上新的病患教育資源將為患者在整個 NERLYNX 治療過程中提供更好的支持，最終幫助他們降低復發風險。

Slide 7 highlights the strategic collaborations we formed across the globe. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.

第 7 張投影片重點介紹了我們在全球範圍內建立的策略合作夥伴關係。我們非常感謝世界各地合作夥伴所做的出色工作，並期待支持他們繼續取得成功。

Let me close by expressing my heartfelt gratitude to the entire Puma team for their unwavering passion and dedication to supporting patients and families affected by breast cancer. This disease can be devastating. and we recognize there is still more work to do and more that can be done.

最後，我要向整個彪馬團隊表達我由衷的感謝，感謝他們始終如一的熱情和奉獻精神，支持受乳癌影響的患者及其家人。這種疾病可能造成毀滅性的後果。我們也意識到，還有更多的工作要做，還有很多事情要做。

I will now turn the call over to Maximo for a review of our financial results.

現在我將把電話轉交給 Maximo，請他介紹我們的財務表現。

Thanks, Roger. I will begin with a brief summary of our financial results for the third quarter of 2025. Please note that I will make comparisons to Q2 2025, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our third quarter 2025 -- thank you, which will be filed today and includes our consolidated financial statements.

謝謝，羅傑。我將首先簡要概述我們2025年第三季的財務表現。請注意，我將與 2025 年第二季進行比較，我們認為這比同比比較更能反映我們作為一家商業公司的進展。如需了解更多信息，我建議您參閱我們今天提交的 2025 年第三季報告——謝謝，報告中包含我們的合併財務報表。

For the third quarter of 2025, we reported net income benchmark gap of $8.8 million or $0.18 per basic share and $0.17 per diluted share. This compares to net income in Q2 2025 of $5.9 million or $0.12 per share.

2025 年第三季度，我們報告淨收入基準缺口為 880 萬美元，即每股基本收益 0.18 美元，每股稀釋收益 0.17 美元。相比之下，2025 年第二季淨收入為 590 萬美元，即每股 0.12 美元。

On non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $10.5 million or $0.21 per basic and diluted share for the third quarter of 2025.

根據非GAAP準則（已調整以消除股票選擇權費用的影響），我們報告2025年第三季淨收入為1050萬美元，即每股基本和攤薄收益0.21美元。

Gross revenue from net link sales was $70 million in Q3 2025 and $62.1 million in Q2 2025. As I mentioned it, net product revenue from net link sales was $51.9 million, an increase from the $49.2 million reported in Q2 2025, and a decrease versus the $56.1 million reported in Q3 2024.

2025 年第三季淨連結銷售總收入為 7,000 萬美元，2025 年第二季淨連結銷售總收入為 6,210 萬美元。正如我之前提到的，淨連結銷售的淨產品收入為 5,190 萬美元，比 2025 年第二季報告的 4,920 萬美元有所增加，但比 2024 年第三季報告的 5,610 萬美元有所減少。

So reminder to investors, Puma reported NERLYNX sales include both US net sales of NERLYNX and product supply revenue of NERLYNX to Puma's ex-UX partners.

因此提醒投資者，彪馬報告稱，NERLYNX 的銷售額包括 NERLYNX 在美國的淨銷售額以及向彪馬前用戶體驗合作夥伴提供的 NERLYNX 產品供應收入。

Please note that in Q3 2024, we reported product supply revenue to our international partners. [$0.1 million] in Q3 2025. Therefore, US net sales of NERLYNX in Q3 2025 were $51.8 million versus $48.8 million in Q3 2024. The increase in Q3 2025 net revenue versus Q2 2025 was driven primarily by an increase in NERLYNX bottles sold in the US, inventory built of $3.1 million, offset by a high gross to net expense.

請注意，我們在 2024 年第三季向國際合作夥伴報告了產品供應收入。 2025 年第三季報告的收入為 10 萬美元。因此，NERLYNX 在 2025 年第三季的美國淨銷售額為 5,180 萬美元，而 2024 年第三季為 4,880 萬美元。2025 年第三季淨收入較 2025 年第二季有所成長，主要原因是美國 NERLYNX 瓶裝產品銷售增加，庫存增加 310 萬美元，但被較高的毛利淨利抵銷。

Inventory bill by our distributors was approximately $3.1 million in Q3 versus drawdown of approximately $1.3 million in Q2 2025. Royalty of revenue totaled $2.6 million in the third quarter of 2025 compared to $3.2 million in Q2 2025.

2025 年第三季度，我們經銷商的庫存支出約為 310 萬美元，而 2025 年第二季的支出約為 130 萬美元。2025 年第三季特許權使用費收入總計 260 萬美元，而 2025 年第二季為 320 萬美元。

Our gross to net adjustment in Q3 2025 was about 25.9% and 20.8% in Q2 2025. The increase on gross to net was driven mostly by a higher than expected Medicaid rebate driven by the Inflation Reduction Act implemented in Q4 of 2022 and higher Medicaid share.

2025 年第三季毛利與淨利的調整幅度約為 25.9%，2025 年第二季約 20.8%。毛利與淨利潤之比的成長主要是由於 2022 年第四季實施的《通貨膨脹削減法案》帶來的醫療補助退款高於預期，以及醫療補助份額增加所致。

Cost of sales for Q3 2025 was $12.2 million and includes $2.4 million for the amortization of intangible assets related to our Neratinib license. Cost of sales for Q2 2025 was $12.3 million.

2025 年第三季的銷售成本為 1,220 萬美元，其中包括與我們的 Neratinib 授權相關的無形資產攤銷 240 萬美元。2025 年第二季的銷售成本為 1,230 萬美元。

Going forward, we will continue to recognize amortization of the milestones to the license store about $2.4 million per quarter as cost of sales.

展望未來，我們將繼續把授權商店里程碑的攤銷額每季確認為約 240 萬美元，作為銷售成本。

For fiscal year 2025, Puma anticipates that net net earnings product revenue will be in the range of $198 million to $200 million, higher than our prior guidance. We also anticipate that our gross net adjustment for the full year 2025 will be between 23% and 23.5%. In addition, for fiscal year 2025, We anticipate receiving royalties from our partners around the world in the range of $22 million to $23 million, lower than 2024, due to the fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025.

Puma 預計 2025 財年淨利產品收入將在 1.98 億美元至 2 億美元之間，高於我們先前的預期。我們也預計，2025 年全年毛淨調整率將在 23% 至 23.5% 之間。此外，由於我們的合作夥伴在 2025 年前幾季進行監管過渡，預計對中國的出貨量會減少，因此我們預計 2025 財年將從世界各地的合作夥伴處收到 2,200 萬美元至 2,300 萬美元的特許權使用費，低於 2024 年的水準。

We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $27 million to $29 million. The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustment will be required or, if so, the potential timing or size of such an adjustment. We will continue to keep investors updated on this as it progresses.

我們預計2025年不會有任何授權收入。我們也預計全年淨收入將在 2,700 萬美元至 2,900 萬美元之間。目前的指導意見並未在我們的淨收入預測中納入任何可能釋放的額外稅務資產估值準備金。作為持續稅務估值分析的一部分，該公司正在審查其遞延所得稅資產，但尚未確定是否需要進行任何調整，如果需要調整，則尚未確定此類調整的潛在時間或規模。我們將持續向投資者通報最新進展。

At this time, we do not believe the tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product costs or results of operations. However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid- to high single digit percentage of our cost of goods sold.

目前，我們認為美國已徵收或擬徵收的關稅，特別是對其他國家徵收的關稅，不會對我們的產品成本或經營業績產生實質影響。然而，美國和其他國家的貿易政策變化迅速，難以預測。作為參考，我們的產品製造成本佔銷售成本的個位數百分比處於中等至較高水準。

We anticipate that for Q4 2025, NERLYNX product revenue net will be in the range of $54 million to $56 million. Please note that Q4 net product revenue guidance includes almost $4.5 million of product sales to one of our global partners, as well as US net revenue, which we expect to be in the range of $50 million to $52 million.

我們預計，2025 年第四季度，NERLYNX 產品淨收入將在 5,400 萬美元至 5,600 萬美元之間。請注意，第四季度淨產品收入預期包括向我們的全球合作夥伴銷售的近 450 萬美元產品，以及美國淨收入，我們預計該收入將在 5,000 萬美元至 5,200 萬美元之間。

The sales to our global partners will also contribute to the large royalty revenue we expect in Q4. We expect Q4 royalty revenue will be in the range of $13 million to $14 million and no license revenue. We further estimate that the gross-to-net adjustment in Q4 2025 will be approximately 24% to 25%. Puma anticipates Q4 net income between $9 million and $11 million.

向我們的全球合作夥伴的銷售也將有助於我們預計在第四季度獲得豐厚的特許權使用費收入。我們預計第四季度特許權使用費收入將在 1300 萬美元至 1400 萬美元之間，沒有許可收入。我們進一步估計，2025 年第四季毛利與淨利之間的調整幅度約為 24% 至 25%。Puma預計第四季淨利潤在900萬美元至1100萬美元之間。

SG&A expenses were $16.8 million in the third quarter of 2025 compared to $18 million in the second quarter. SG&A expenses included non-cash charges for stock-based compensation of $1.1 million for Q3 and $1 million for Q2 2025.

2025 年第三季銷售、一般及行政費用為 1,680 萬美元，而第二季為 1,800 萬美元。銷售、一般及行政費用包括 2025 年第三季 110 萬美元及 2025 年第二季 100 萬美元的非現金股票選擇權費用。

Research and development expenses were $15.9 million in the third quarter of 2025 and $15.5 million in the second quarter. R&D expenses included non-cash charges for stock-based compensation of $0.6 million in the third quarter of 2025 unchanged from the second quarter.

2025 年第三季研發費用為 1,590 萬美元，第二季為 1,550 萬美元。2025 年第三季研發費用包括 0.6 百萬美元的非現金股票選擇權費用，與第二季持平。

On the expense side, Puma anticipates flat to slightly higher total operating expenses in 2025. compares to 2024. More specifically, we anticipate SG&A expenses to decrease by 7% to 10% and R &D expenses to increase by 20% to 25% year over year. The higher increase in R&D is driven by faster enrollments in our clinical trials than previously expected.

在支出方面，彪馬預計 2025 年的總營運支出將與 2024 年持平或略有上升。更具體地說，我們預計銷售、一般及行政費用將年減 7% 至 10%，研發費用將年增 20% 至 25%。研發投入的大幅成長是由於臨床試驗的入組速度比預期更快。

In the third quarter of 2025, Puma reported cash burn of approximately $1.6 million. This compares to cash earned of approximately $2.9 million in Q2. Please note that during Q3, we made our sixth quarterly principal loan payment of $11.1 million related to our obligation with Ethereum. As a result of this, our total outstanding principal debt balance decreased to approximately $33 million.

2025 年第三季度，彪馬報告現金消耗約 160 萬美元。相比之下，第二季獲得的現金約為 290 萬美元。請注意，在第三季度，我們支付了與我們對以太坊的債務相關的第六筆季度本金貸款，金額為 1,110 萬美元。因此，我們的未償還本金債務總額減少至約 3,300 萬美元。

On September 30, 2025, We had approximately 94 million in cash, cash equivalents, and marketable securities. This was about $101 million at year end 2024. Our accounts receivables balance was $33.6 million. Her accounts receivable terms ranged between 10 and 68 days. Where our day sales are standing are about 50 days.

截至 2025 年 9 月 30 日，我們擁有約 9,400 萬美元的現金、現金等價物及有價證券。到 2024 年底，這個數字約為 1.01 億美元。我們的應收帳款餘額為 3,360 萬美元。她的應收帳款期限在 10 到 68 天之間。我們目前的每日銷售額約為 50 天。

We estimate that as of September 30, 2025, Our distribution network maintain approximately 3.5 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib, and controlling our expenses.

我們估計，截至 2025 年 9 月 30 日，我們的分銷網絡大約能維持 3.5 週的庫存。整體而言，我們將繼續投入財務資源，專注於 NERLYNX 的商業化、alisertib 的開發以及控制支出。

Thanks, Maximo. On past earnings calls, we have stressed that Puma's senior management, in cooperation with the board of directors, continues to remain focused on near-link sales trends in 2025 and beyond, and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income. We believe that this focus has contributed to our commercial execution in a positive way.

謝謝，馬克西莫。在先前的財報電話會議上，我們強調，彪馬的高階管理層與董事會合作，將繼續專注於 2025 年及以後的近距離銷售趨勢，並認識到其對股東的財政責任，即繼續保持正的淨收入。我們相信，這種專注對我們的商業表現產生了正面的影響。

As according to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018. We are pleased to report this demand-driven growth in NERLYNX sales for the first nine months of 2025.

根據我們目前的預測，2025 年將標誌著自 2018 年以來美國對 NERLYNX 的需求首次實現年增。我們很高興地宣布，在 2025 年前九個月，NERLYNX 的銷售額實現了由市場需求驅動的成長。

In addition, we believe that the positive net income that the company achieved in Q325 and that the company is guiding to for the full year 2025 has resulted from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future.

此外，我們認為，公司在 2025 年第三季實現的淨利潤為正，且公司預計 2025 年全年也將實現淨利潤為正，這得益於公司過去幾年持續的財務紀律。公司仍致力於繼續實現正淨利潤，並將繼續在必要時削減開支以實現這一目標。我們期待未來向投資者報告這方面的進展。

There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors. We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation.

對於正在與乳癌、肺癌和其他實體腫瘤作鬥爭的患者而言，仍然存在著巨大的未滿足需求。我們彪馬致力於尋找更有效的途徑來幫助這些患者度過他們的治療之旅，並將繼續努力實現這一目標。今天的報告到此結束。

We will now turn the floor back to the operator for Q&A. Operator.

現在我們將把問答環節交還給操作員。操作員。

(Operator Instructions) Marc Frahm, TD Cowen.

（操作說明）Marc Frahm，TD Cowen。

So taking my question, maybe just looking forward to the breast cancer interim, just reminds what the kind of bar you're going to be kind of evaluating that with in terms of, know, willingness to continue to spend on that indication particularly like to your comments to kind of the prepared remarks of remaining committed to staying profitable.

所以，關於我的問題，也許只是展望一下乳癌的過渡期，這提醒我們，你將用什麼樣的標準來評估它，例如，是否願意繼續在這個適應症上投入資金，特別是像你之前提到的，致力於保持盈利的評論。

Yeah, thanks, Mark. So There's been two. This is going to be alisertib in combination with endocrine. You remember there was a previous trial, T[BCRC 41], of alisertib in combination with endocrine. And I think that's probably going to be the gauge we're looking for to compare to those numbers. Right now, as you know, the standard of care for HER2-postiive, HER2-negative breast cancer is first line, they get a CDK46 inhibitor.

是啊，謝謝你，馬克。所以，一共出現了兩次。這將是阿利塞替尼合併內分泌治療。你還記得之前有一項試驗，即 T[BCRC 41]，研究 alisertib 與內分泌治療的聯合應用。我認為這很可能就是我們要用來與這些數字進行比較的衡量標準。如您所知，目前對於 HER2 陽性、HER2 陰性乳癌的標準治療方案是第一線治療，即使用 CDK46 抑制劑。

Second line, depending on which mutation they have, they may get a targeted therapy or may get a different type of a combination therapy.

第二線治療，根據他們所攜帶的突變類型，他們可能會接受標靶治療，或接受不同類型的合併治療。

Third line is still kind of a white space, if you will. And that's where we're focusing is in that third line white space. So all these patients are kind of third line endocrine, if you will. So obviously, what we would look for in terms of continued spend would really be number one, how the efficacy compares to what we would typically expect to be standard of care in third line. But then also, assuming we're able to find a biomarker where it portends for or it predicts a better outcome to alisertib, that would obviously be quite compelling as well.

第三行還是有點像空白。而我們關注的重點就在於第三行的空白區域。所以，如果你願意的話，這些患者都算是第三線內分泌患者。因此，很顯然，就持續投入而言，我們真正要關注的第一點是療效與我們通常預期的三線標準療法相比如何。但是，假設我們能夠找到一種生物標誌物，它預示或預測了阿利塞替尼治療效果會更好，那顯然也是很有說服力的。

So we've gotten asked that question in the past, which is, you have both the breast and the lung. You want to remain profitable. As we've said in the past, and I will say again, we're happy to stagger the indications to control the burn so we can remain a profitable company.

過去我們常被問到這個問題，那就是，你既有乳房又有肺。你想保持獲利。正如我們過去所說，我還要再說一遍，我們樂於分階段推出這些藥物，以控製成本，從而保持公司的盈利能力。

Okay, that's helpful, but I guess, you the next steps could ultimately involve a larger pivotal program. Would that which I think would strain for any one of the indications might strain the ability to stay profitable. Would you be willing to go negative with the data, go back to a loss if the data supports it or does that require a partner?

好的，這很有幫助，但我想，下一步最終可能涉及一個更大的關鍵項目。我認為任何一項指標的波動都可能影響獲利能力。如果數據支持，你是否願意接受虧損，或者說，你是否願意接受虧損？還是說這需要合作夥伴？

Yeah, so a couple things to remember from that perspective, Marc. If you look at our guidance, for our full year in terms of net income, remember that includes us paying down our debt. The debt goes away mid next year, and we become a debt-free company.

是的，從這個角度來看，有幾件事需要記住，馬克。如果您查看我們對全年淨收入的預期，請記住，這包括我們償還債務。債務將於明年年中消除，我們將成為無債公司。

So you start to see cash flow generation occurring because of that. Now, in terms of the pivotal Phase 3 that you would need -- based on the other Phase 3s I've seen in this space, I'm not anticipating this to be like a thousand patient trial or something. So I think it would still be within a manageable number. And especially given that, you you're not going to hit all those expenses at once. You're going to see it spaced out over time.

因此，你會看到現金流開始產生。至於所需的關鍵性 3 期臨床試驗——根據我所看到的其他 3 期臨床試驗，我預計這不會像上千名患者的試驗那樣。所以我覺得應該還在可控範圍內。尤其考慮到這一點，你不可能一次性支付所有這些費用。你會看到它隨著時間的推移而逐漸出現。

I think it's still possible to be able to do, you a Pivotal Phase 3 just based on the cash flow from NERLYNX and remaining committed to being in that income.

我認為，僅憑 NERLYNX 的現金流並繼續致力於獲得該收入，仍然有可能開展關鍵的 3 期臨床試驗。

Okay, thanks, it's very helpful.

好的，謝謝，這很有幫助。

Thank you. With that, this does conclude today's question-and-answer session. I'd like to turn to conference to Max and Mariann for closing remarks.

謝謝。至此，今天的問答環節就結束了。我謹請Max和Mariann在會議結束時致閉幕詞。

Thank you for joining us today. As a reminder, this call may be accessed via replay at pumabiotechnology.com beginning later today. Have a good evening.

感謝您今天蒞臨。提醒各位，本次電話會議的錄音回放將於今日稍晚在 pumabiotechnology.com 網站上提供。祝你晚上愉快。

Thank you, ladies and gentlemen. Thank you for participating in today's conference call. This concludes our program. Everyone have a great day. You may now disconnect your lines.

謝謝各位女士、先生。感謝您參加今天的電話會議。我們的節目到此結束。祝大家今天過得愉快。現在您可以斷開線路了。