Puma Biotechnology Inc (PBYI) 2026 Q2 法說會逐字稿

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

下午好。我叫 Daryl，今天將擔任各位的電話會議接線員。(接線員說明) 提醒各位，本次通話將被錄音。

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

現在我想將電話會議交給 Puma Biotechnology 投資人關係資深總監 Mariann Ohanesian。您可以開始您的會議。

Thank you, Daryl. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the second quarter of 2026. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President, and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for the second quarter of 2026. 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.

謝謝你，Daryl。下午好，歡迎參加 Puma 的電話會議，討論我們 2026 年第二季的財報結果。今天與我一同參與通話的有：Puma Biotechnology 執行長、總裁暨董事會主席 Alan Auerbach；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。在今天收盤後，Puma 已發布新聞稿，詳述 2026 年第二季的財報結果。該新聞稿、Roger 將引用的投影片，以及本次通話的網路直播，可透過我們網站 pumabiotechnology.com 的首頁與投資人專區取得。網路直播與簡報投影片將在我們網站上存檔，並於未來 90 天內提供重播。

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, 2025. 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, August 6th, 2026. 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.

今天的電話會議將包含關於 Puma 未來預期、計畫與展望的陳述，依聯邦證券法之目的，構成前瞻性陳述。此類陳述受風險與不確定性影響，實際事件與結果可能與這些前瞻性陳述所表達者不同。如需完整了解這些風險與不確定性，請查閱我們不時向美國證券交易委員會（SEC）提交的定期與即時報告，包括截至 2025 年 12 月 31 日止年度的 Form 10-K 年度報告。敬請注意勿過度依賴這些前瞻性陳述；其僅反映本次即時電話會議日期（2026 年 8 月 6 日）當日之情況。除法律要求外，Puma 不承擔在本次電話會議日期之後，因事件或情況變化而修訂或更新任何前瞻性陳述之義務。

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 second quarter 2026 earnings release for a reconciliation of our GAAP to non-GAAP results.

在今天的通話中，我們可能會提及某些非 GAAP 財務衡量指標，這些指標涉及對我們 GAAP 數據的調整。我們認為，這些非 GAAP 指標可作為對我們 GAAP 財務衡量指標的補充，對投資人可能有用，但不能取代 GAAP 財務衡量指標。請參閱我們 2026 年第二季財報新聞稿，以取得 GAAP 與非 GAAP 結果之調節表。

I will now turn the call over to Alan.

現在我將把電話交給 Alan。

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2026 of $56.5 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sub-licensees. Product revenue net was $53.6 million in the second quarter of 2026, an increase from $42 million reported in Q1 of 2026 and $49.2 million reported in Q2 of 2025. As a reminder to investors, Puma's reported NERLYNX sales includes both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-US partners. Product revenue for the second quarter of 2026 included approximately $1.3 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the second quarter of 2026, compared to $2.8 million in Q1 2026 and $3.2 million in Q2 of 2025.

謝謝你，Mariann，也謝謝各位今天加入我們的通話。今天，Puma 公布 2026 年第二季總營收為 5,650 萬美元。總營收包含產品淨營收（完全由 NERLYNX 銷售構成），以及來自我們次授權合作夥伴的權利金收入。2026 年第二季產品淨營收為 5,360 萬美元，高於 2026 年第一季的 4,200 萬美元，以及 2025 年第二季的 4,920 萬美元。提醒投資人，Puma 所揭露的 NERLYNX 銷售同時包含 NERLYNX 在美國的淨銷售額，以及向 Puma 美國以外合作夥伴供應 NERLYNX 產品所產生的供貨收入。2026 年第二季的產品營收包含約 130 萬美元，係來自我們專科藥局與專科經銷商的庫存回落（inventory drawdown）。2026 年第二季權利金收入為 290 萬美元，相較於 2026 年第一季的 280 萬美元，以及 2025 年第二季的 320 萬美元。

We reported 2,929 bottles of NERLYNX sold in the second quarter of 2026, compared to 2,328 bottles sold in Q1 '26. In Q2 2026, we estimate that inventory decreased by 57 bottles. In Q2 2026, new prescriptions were down approximately 6% compared to Q1 2026, and total prescriptions were up approximately 7% compared to Q1 2026. Roger will provide further details in his comments and slides.

我們在 2026 年第二季售出 2,929 瓶 NERLYNX，相較於 2026 年第一季售出 2,328 瓶。在 2026 年第二季，我們估計庫存減少 57 瓶。在 2026 年第二季，新處方量較 2026 年第一季約下降 6%，而總處方量較 2026 年第一季約上升 7%。Roger 將在其評論與投影片中提供更多細節。

I will now provide updates from Puma's ongoing Phase 2 trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as ALISCA-Lung1 and ALISCA-Breast1. Heather Blaber and Roger Storms will add additional color on NERLYNX's commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the second quarter of 2026.

接下來我將提供 Puma 目前進行中的 alisertib 第二期臨床試驗進度更新，適應症為小細胞肺癌與 HER2 陰性、ER 陽性乳癌，亦稱為 ALISCA-Lung1 與 ALISCA-Breast1。Heather Blaber 與 Roger Storms 將補充說明 NERLYNX 的商業活動。之後 Maximo Nougues 將就我們 2026 年第二季財務報表的關鍵組成項目進行重點說明。

As investors are aware, Puma 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 therapy in patients with HER2-negative hormone receptor-positive recurrent or metastatic breast cancer, and ALISCA-Lung1, a Phase 2 study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.

投資人皆知，Puma 針對我們的研發中藥物 alisertib 目前有兩項進行中的第二期臨床試驗。ALISCA-Breast1 為第二期試驗，評估 alisertib 與內分泌治療合併用於 HER2 陰性、荷爾蒙受體陽性之復發或轉移性乳癌患者；ALISCA-Lung1 則為第二期研究，評估 alisertib 單藥治療用於小細胞肺癌患者的療效。

As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative hormone receptor-positive recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting, have had previous treatment with a CDK4/6 inhibitor, and have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

提醒各位，ALISCA-Breast1 試驗研究 alisertib 與內分泌治療合併使用；內分泌治療可為 anastrozole、exemestane、letrozole、fulvestrant 或 tamoxifen 之一，用於 HER2 陰性、荷爾蒙受體陽性之復發或轉移性乳癌患者。患者需符合以下條件方可入組：在復發或轉移性情境下未接受過化學治療、曾接受 CDK4/6 抑制劑治療，且在復發或轉移性情境下至少接受過兩線內分泌治療。

Patients were initially 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, on a 28-day cycle in combination with endocrine therapy of the investigator's 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. Interim data from this trial was presented on the company's first quarter conference call. As discussed during that presentation, the company believes that the data obtained to date from ALISCA-Breast1 is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role.

起初，患者接受 alisertib 給藥，劑量為每日兩次（BID）30 毫克、40 毫克或 50 毫克，於第 1 至 3 天、第 8 至 10 天及第 15 至 17 天給藥；每 28 天為一個週期，並合併研究者選擇的內分泌治療。患者在試驗中與 alisertib 合併給予的內分泌治療，於轉移性情境下不得曾接受過該內分泌治療。本試驗的期中數據已於公司第一季電話會議中發表。如同在該次發表中所討論，公司認為截至目前從 ALISCA-Breast1 所取得的數據，初步顯示在 Aurora kinase（極光激酶）途徑扮演角色之生物標記相關患者中，可能具有較佳的活性。

Based on the feedback that we have received from breast cancer key opinion leaders on this interim data, the trial has been amended such that now we are only continuing enrollment in the 40-milligram and 50-milligram dose groups. That amendment to the protocol has been submitted to the FDA and the EU authorities and is being submitted to the IRBs as well. We are hoping to begin enrollment under that amended protocol in Q3. We will also be updating interim data from the ALISCA-Breast1 trial, including longer-term patient follow-up in the fourth quarter of this year.

根據我們從乳癌領域關鍵意見領袖（KOL）對該期中數據所收到的回饋，試驗已修訂，目前僅持續在 40 毫克與 50 毫克劑量組招募。該試驗方案修訂已提交 FDA 與歐盟主管機關，並也正在提交給 IRB。我們希望能在第三季依修訂後的方案開始招募。我們也將在今年第四季更新 ALISCA-Breast1 試驗的期中數據，包括更長期的患者追蹤結果。

With respect to the ALISCA-Lung1 study, as investors are aware, Puma has an ongoing Phase 2 trial of our investigational drug, alisertib, to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer. Interim data from this trial was presented on the company's first quarter earnings call. As discussed during that presentation, the company believes that the data obtained to date from ALISCA-Lung1 is providing a preliminary indication of potentially better activity in patients with the biomarkers where the Aurora kinase pathway is playing a role.

關於 ALISCA-Lung1 研究，投資人皆知，Puma 目前正進行一項針對研發中藥物 alisertib 的第二期臨床試驗，以評估 alisertib 單藥治療在小細胞肺癌患者中的療效。本試驗的期中數據已於公司第一季財報電話會議中發表。如同在該次發表中所討論，公司認為截至目前從 ALISCA-Lung1 所取得的數據，初步顯示在 Aurora kinase（極光激酶）途徑扮演角色之生物標記相關患者中，可能具有較佳的活性。

As was also discussed on that call, the company previously amended the trial to increase the dose from 50 milligrams BID to 60 milligrams BID. Dosing in the trial was further increased to 70 milligrams BID, and the company is currently enrolling patients at the 70-milligram BID level. There are currently 92 patients in the trial, with 36 of the patients enrolled at the 60-milligram BID dose and four patients enrolled at the 70-milligram dose.

如同在那次電話會議中也曾討論過的，公司先前已修訂該試驗，將劑量由每日兩次（BID）50 毫克提高至每日兩次 60 毫克。該試驗的給藥劑量進一步提高至每日兩次 70 毫克，而公司目前正在以每日兩次 70 毫克的劑量水平招募患者。目前該試驗共有 92 名患者，其中 36 名患者以每日兩次 60 毫克劑量入組，另有 4 名患者以 70 毫克劑量入組。

As was also mentioned on the recent earnings call, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, ALISCA-Lung2, where the drug will be given in combination with paclitaxel, similar to the Phase 2 randomized trial that was previously published in the Journal of Thoracic Oncology. The company anticipates that enrollment in the ALISCA-Lung2 trial will start in Q3, and the company will provide investors with further information on this trial in the future. The company anticipates that it will have additional interim data from ALISCA-Lung1 and the initial data from ALISCA-Lung2 in 2027.

如同在近期財報電話會議中也提到的，Puma 亦計畫在小細胞肺癌啟動第二項 alisertib 試驗 ALISCA-Lung2，該藥物將與紫杉醇（paclitaxel）合併給藥，類似於先前發表於《Journal of Thoracic Oncology》的第二期隨機試驗。公司預期 ALISCA-Lung2 試驗將於第三季（Q3）開始招募，並將於未來向投資人提供更多關於此試驗的資訊。公司預期將於 2027 年取得 ALISCA-Lung1 的更多期中數據，以及 ALISCA-Lung2 的初步數據。

As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial stage and development stage drugs to potentially in-license or acquire 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.

如同在先前的財報電話會議中提及並回應投資人提問，Puma 持續評估多項商業化階段與研發階段的藥物，可能透過引進授權（in-license）或收購，以使公司業務多元化，並運用 Puma 既有的研發、法規與商業化基礎設施。公司將在進展過程中持續向投資人更新相關資訊。

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.

接下來我將把電話會議交給 Heather Blaber，請她更新我們的行銷推動計畫。之後 Roger Storms 將接續回顧本季的商業表現。

Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX, as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with healthcare professionals through both personal and non-personal promotion. Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression.

謝謝你，Alan。感謝有機會分享我們行銷策略的更多洞見。行銷團隊專注於持續提升對 NERLYNX 臨床數據的認知，同時強化在完成輔助治療後，HER2 陽性早期乳癌仍存在的未被滿足醫療需求。我們持續投資市場研究，以協助我們了解並驗證透過面對面與非面對面推廣，向醫療專業人員傳達我們數據的最有效方式。我們的策略聚焦於提升我們在 HER2 陽性乳癌之雙適應症的認知度。我們相信 NERLYNX 在早期治療中可透過降低復發風險發揮重要作用，並在轉移性治療情境中協助防止疾病進展。

Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post adjuvant treatment, but we continue to adopt new prescribers year-over-year who recognize the unmet need in HER2-positive early-stage breast cancer and how NERLYNX may help their patients reduce their risk of recurrence. In summary, we are excited and committed to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer in both the early and metastatic settings.

不僅是已有 NERLYNX 使用經驗的醫師持續辨識出在完成輔助治療後可從額外治療中受益的合適患者，我們也持續逐年增加新的處方醫師；這些醫師認知到 HER2 陽性早期乳癌的未被滿足需求，以及 NERLYNX 可能如何協助其患者降低復發風險。總結而言，我們對於與更多腫瘤科醫師互動並投入支持其在早期與轉移性治療情境中診斷為 HER2 陽性乳癌的患者，感到振奮且承諾不變。

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

接下來我將把電話會議交給 Roger Storms，請他概述第二季的商業表現。

Thank you, Heather, and thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on increasing the use of NERLYNX with a main focus on patients at higher risk of recurrence. They're 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.

謝謝你，Heather，也感謝各位參加我們第二季財報電話會議。在我進入商業回顧之前，先提醒一下，我將會做出前瞻性陳述。銷售團隊仍專注於提升 NERLYNX 的使用，主要聚焦於復發風險較高的患者。他們也致力於透過非面對面推廣活動強化臨床教育與互動，同時運用患者資源以支持患者在 NERLYNX 治療期間的持續用藥與依從性。

Let me now transition to some of the commercial slides, where I'll provide some additional specifics around performance. 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. Regarding the overall distribution of our business, in Q2 2026, about 61% of our business was purchased through the SP channel, and the remaining 39% was purchased through the SD channel. We continue to see stronger growth in the SD channel, driven by two main factors: increased sales in the group purchasing organizations, or GPO segment, and increasing 340B purchasing.

接下來我將轉到一些商業簡報頁面，並提供關於表現的更多具體細節。第 3 張投影片說明我們的配送模式，分為專科藥局（specialty pharmacy，SP）通路，以及專科經銷商或院內配藥（in-office dispensing）通路（SD）。就我們業務的整體配送而言，於 2026 年第二季（Q2 2026），約 61% 的業務透過 SP 通路採購，其餘 39% 透過 SD 通路採購。我們持續看到 SD 通路有較強勁的成長，主要由兩項因素驅動：團體採購組織（group purchasing organizations，GPO）區隔的銷售增加，以及 340B 採購增加。

Turning to slide 4, NERLYNX net product revenue in Q2 2026 was $53.6 million, an increase from the $42 million we reported in Q1 2026, and the $49.2 million we reported in Q2 of 2025. As a reminder to investors, Puma's reported NERLYNX sales include both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-US partners. Please note that in Q2 2026, we reported minimal product supply revenue to our international partners versus about $100,000 in Q1 2026. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update.

轉到第 4 張投影片，2026 年第二季 NERLYNX 淨產品營收為 5,360 萬美元，較我們在 2026 年第一季（Q1 2026）報告的 4,200 萬美元增加，也高於我們在 2025 年第二季（Q2 2025）報告的 4,920 萬美元。提醒投資人，Puma 所報告的 NERLYNX 銷售包含 NERLYNX 在美國的淨銷售額，以及向 Puma 的美國以外合作夥伴供應 NERLYNX 產品所產生的供貨收入。請注意，在 2026 年第二季，我們向國際合作夥伴報告的產品供貨收入極少，相較之下 2026 年第一季約為 10 萬美元。我將提供更多關於庫存變動的細節，而 Maximo 也將在他的更新中提供更多關於毛利到淨額（gross-to-net）費用的具體資訊。

In Q2 2026, we estimate that inventory decreased by about $1 million. As a comparator, we estimate that inventory decreased by about $7.9 million in Q1 of 2026. Slide five shows Q2 2026 ex-factory bottle sales, and also provides both a year-over-year and a quarter-over-quarter comparison. As a reminder, ex-factory bottles include sales to our SP and SD channels. In Q2 2026, NERLYNX ex-factory bottle sales were 2,929, which represents an approximate 26% increase quarter-over-quarter and 12% increase year-over-year. Let me specifically call out the inventory changes from a bottle perspective. In Q2 2026, we estimate that inventory decreased by 57 bottles. As a comparator, we estimate that inventory decreased by 439 bottles in Q1 of 2026, and decreased by 85 bottles in Q2 of 2025. Slide six highlights our commercial demand for the quarter.

在 2026 年第二季，我們估計庫存約減少 100 萬美元。作為比較，我們估計 2026 年第一季庫存約減少 790 萬美元。第 5 張投影片顯示 2026 年第二季出廠（ex-factory）瓶數銷售，並提供年對年與季對季的比較。提醒一下，出廠瓶數包含對我們 SP 與 SD 通路的銷售。在 2026 年第二季，NERLYNX 出廠瓶數銷售為 2,929 瓶，約較前一季增加 26%，較去年同期增加 12%。我特別說明一下以瓶數角度觀察的庫存變動。在 2026 年第二季，我們估計庫存減少 57 瓶。作為比較，我們估計 2026 年第一季庫存減少 439 瓶，且 2025 年第二季庫存減少 85 瓶。第 6 張投影片重點呈現本季的商業需求。

In Q2 2026, US demand was 2,986 bottles, which represents an approximate 8% increase quarter-over-quarter and 11% increase year-over-year. As mentioned earlier, we have seen stronger growth in the SD channel, where we saw demand grow by about 12% quarter-over-quarter and 32% year-over-year. The year-over-year and quarter-over-quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. Our Q2 2026 call activity increased 18% year-over-year and 2% quarter-over-quarter. Total prescriptions, or TRxs, increased by 7% quarter-over-quarter and 3% year-over-year. Enrollments in the quarter grew 1% quarter-over-quarter and 12% year-over-year. Commercial new patient starts in the quarter declined 6% quarter-over-quarter and grew 8% year-over-year.

在 2026 年第二季，美國需求為 2,986 瓶，約較前一季增加 8%，較去年同期增加 11%。如先前所述，我們在 SD 通路看到較強勁的成長，該通路需求約季增 12%、年增 32%。年對年與季對季的成長，直接源自於我們持續強調卓越執行力以及提升前線責任制。我們 2026 年第二季的拜訪／聯繫活動量（call activity）年增 18%、季增 2%。總處方量（total prescriptions，TRxs）季增 7%、年增 3%。本季入組（enrollments）季增 1%、年增 12%。本季商業新患者起始治療（new patient starts）季減 6%、年增 8%。

Continued messaging and adoption of dose escalation remains an important commercial priority, and 73% of patients started NERLYNX at a reduced dose. We believe dose escalation, coupled with patient education resources, will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide seven highlights the strategic collaborations we formed across the globe. Most recently, in Q1 2026, NERLYNX was launched in Thailand, also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.

持續傳達並推動劑量遞增（dose escalation）的採用仍是重要的商業優先事項，且有 73% 的患者以較低起始劑量開始使用 NERLYNX。我們相信劑量遞增搭配患者教育資源，將能在整個 NERLYNX 治療期間為患者提供更佳支持，並最終協助其降低復發風險。第 7 張投影片重點呈現我們在全球建立的策略合作。最近在 2026 年第一季，NERLYNX 已於泰國上市，同樣用於延伸輔助治療（extended adjuvant）情境。我們非常感謝全球合作夥伴所做的出色工作，並期待在未來持續支持他們的成功。

I will close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating, and while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together.

最後，我要向整個 Puma 團隊致上我誠摯的感謝，感謝他們堅定不移地致力於支持受乳癌影響的病患與家庭。這種疾病確實極具破壞性；儘管我們已取得有意義的進展，但我們知道前方仍有重要工作要做，而且我們攜手合作還能完成更多。

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

接下來我將把電話會議交給 Maximo，請他回顧我們的財務結果。

Thanks, Roger. I will begin with a brief summary of our financial results for the second quarter of 2026. Please note that I will make comparisons to Q1 2026, 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 second quarter 2026 10-Q, which will be filed today and includes our consolidated financial statements. For the second quarter of 2026, we reported net income based on GAAP of $8.2 million, or $0.16 per diluted share. This compares to a net loss in Q1 2026 of $3.8 million or $0.07 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $10.1 million, or $0.20 per basic share and $0.19 per diluted share for the second quarter of 2026.

謝謝你，Roger。我先簡要總結我們 2026 年第二季的財務結果。請注意，我將與 2026 年第一季（Q1 2026）進行比較；我們認為，對於一家商業化公司而言，這比年對年比較更能反映我們的進展。如需更多資訊，我建議各位參閱我們 2026 年第二季的 10-Q（將於今日提交），其中包含我們的合併財務報表。2026 年第二季，我們依 GAAP 基礎報告的淨利為 820 萬美元，或稀釋後每股 0.16 美元。相較之下，2026 年第一季的淨損為 380 萬美元，或每股 0.07 美元。以非 GAAP 基礎（調整以剔除以股份為基礎之薪酬費用的影響）計算，我們 2026 年第二季的淨利為 1,010 萬美元，或基本每股 0.20 美元、稀釋後每股 0.19 美元。

Gross revenue from NERLYNX sales was $74.3 million in Q2 2026 and $57.5 million in Q1 2026. As Alan mentioned, net product revenue from NERLYNX sales was $53.6 million, an increase from the $42 million reported in Q1 2026 and the $49.2 million reported in Q2 2025. As a reminder to investors, Puma reported NERLYNX sales include both US net sales of NERLYNX and product supply revenue of NERLYNX to Puma ex-US partners.

2026 年第二季 NERLYNX 銷售的總營收為 7,430 萬美元，2026 年第一季為 5,750 萬美元。如 Alan 所提及，NERLYNX 銷售的淨產品營收為 5,360 萬美元，高於 2026 年第一季報告的 4,200 萬美元，也高於 2025 年第二季報告的 4,920 萬美元。提醒投資人，Puma 所報告的 NERLYNX 銷售包含美國 NERLYNX 的淨銷售額，以及向 Puma 美國以外合作夥伴供應 NERLYNX 產品所產生的產品供應營收。

Please note that in Q2 2026, we reported product supply revenue to our international partners of around $23,000. Therefore, US net sales of NERLYNX in Q2 2026 were $53.6 million, versus $41.9 million in Q1 2026. The increase in net product revenue in Q2 2026 versus Q1 2026 was driven by higher demand, inventory decrease in Q2 of about $1.3 million, versus inventory decrease of $7.9 million in Q1 2026, offset by a higher gross-to-net in Q2.

請注意，在 2026 年第二季，我們向國際合作夥伴報告的產品供應營收約為 2.3 萬美元。因此，2026 年第二季美國 NERLYNX 淨銷售額為 5,360 萬美元，而 2026 年第一季為 4,190 萬美元。2026 年第二季相較 2026 年第一季淨產品營收的增加，主要由較高需求所帶動；第二季庫存減少約 130 萬美元（相較之下，2026 年第一季庫存減少 790 萬美元），但部分被第二季較高的 gross-to-net（總額到淨額）所抵銷。

Royalty revenue totaled $2.9 million in the second quarter of 2026, compared to $2.9 million in Q1 2026. Our gross-to-net adjustment in Q2 2026 was about 27.9%, and 27% in Q1 2026. The high gross-to-net adjustment was driven by higher Medicaid share. Cost of sales for Q2 2026 was $12.5 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales from Q1 2026 was $10.4 million. Going forward, we will continue to recognize amortization of milestones to the license, or about $2.4 million per quarter as cost of sales. For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $205 million-$209 million, higher than our prior guidance of $202 million to $206 million. We also anticipate that our gross-to-net adjustment for the full year 2026 will be between 26.5% and 27.5%.

2026 年第二季權利金營收合計 290 萬美元，與 2026 年第一季的 290 萬美元相當。我們 2026 年第二季的 gross-to-net 調整約為 27.9%，2026 年第一季為 27%。gross-to-net 調整偏高主要是由於 Medicaid 佔比提高所致。2026 年第二季銷貨成本為 1,250 萬美元，其中包含與我們 neratinib 授權相關之無形資產攤銷 240 萬美元。2026 年第一季銷貨成本為 1,040 萬美元。展望未來，我們將持續把授權里程碑的攤銷（每季約 240 萬美元）認列為銷貨成本。就 2026 會計年度而言，Puma 預期 NERLYNX 淨產品營收將落在 2.05 億至 2.09 億美元區間，高於先前指引的 2.02 億至 2.06 億美元。我們也預期 2026 全年 gross-to-net 調整將介於 26.5% 至 27.5%。

In addition, for fiscal year 2026, we anticipate receiving royalties from our partners around the world in the range of $19 million to $22 million, slightly lower than our prior guidance of $20 million to $23 million. Under our sub-license agreement covering China, the royalty rate payable to us is subject to reduction when the market share of generic versions of NERLYNX in China reaches a specific threshold. We are unable to predict with certainty when this threshold will be reached. However, we believe it is possible that the threshold could be reached, triggering the royalty rate reduction in late 2026 or in 2027. We don't expect any license revenue in 2026. We also expect that net income for the full year will be in the range of $17 million to $20 million, also higher than our prior guidance of $16 million to $19 million.

此外，就 2026 會計年度而言，我們預期自全球合作夥伴取得的權利金將落在 1,900 萬至 2,200 萬美元區間，略低於先前指引的 2,000 萬至 2,300 萬美元。依我們涵蓋中國的再授權（sub-license）協議，當 NERLYNX 在中國的學名藥版本市占率達到特定門檻時，支付給我們的權利金比率將會下調。我們無法確定預測該門檻何時會被達到。然而，我們認為該門檻有可能在 2026 年底或 2027 年達到，進而觸發權利金比率下調。我們預期 2026 年不會有任何授權收入。我們也預期全年淨利將落在 1,700 萬至 2,000 萬美元區間，同樣高於先前指引的 1,600 萬至 1,900 萬美元。

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. At this time, we do not believe that the tariffs imposed or proposed to be imposed by the US, particularly with other countries, will have a material impact on our product costs or results of operations. However, shift in trade policies in the US and other countries have been rapidly evolving and are difficult to predict.

目前的指引並未在我們的淨利估計中納入任何可能額外釋出之遞延所得稅資產估值備抵（valuation allowance）。公司正將遞延所得稅資產納入其持續進行的稅務估值分析中，尚未決定是否需要任何調整；若需要，也尚未確定該調整的可能時點或規模。我們將在進展過程中持續向投資人更新。目前我們不認為美國已實施或擬實施的關稅（尤其是與其他國家之間）會對我們的產品成本或營運結果造成重大影響。然而，美國及其他國家的貿易政策變化正快速演進，且難以預測。

As a point of reference, our manufacturing product cost accounts for a mid to high single-digit percentage of our total cost of goods sold. We anticipate that for Q3 2026, NERLYNX product revenue net will be in the range of $54 million to $56 million. We expect Q3 royalty revenues will be in the range of $2 million to $3 million, and no license revenue. We further estimate that the gross-to-net adjustment in Q3 2026 will be approximately 26% to 27%. Puma anticipates a Q3 net income between $2 million and $2.5 million. SG&A expenses were $17.5 million in the second quarter of 2026 compared to $18.4 million in the first quarter of 2026. SG&A expenses include non-cash charges for stock-based compensation of $1.2 million for Q2 2026 and $1.1 million for Q1 2026.

作為參考，我們的製造產品成本約占銷貨成本總額的中至高個位數百分比。我們預期 2026 年第三季（Q3 2026）NERLYNX 淨產品營收將落在 5,400 萬至 5,600 萬美元區間。我們預期第三季權利金營收將落在 200 萬至 300 萬美元區間，且不會有授權收入。我們進一步估計 2026 年第三季 gross-to-net 調整約為 26% 至 27%。Puma 預期第三季淨利介於 200 萬至 250 萬美元。2026 年第二季的銷售、一般及行政（SG&A）費用為 1,750 萬美元，2026 年第一季為 1,840 萬美元。SG&A 費用包含以股份為基礎之薪酬的非現金費用：2026 年第二季為 120 萬美元，2026 年第一季為 110 萬美元。

Research and development expenses were $18.9 million in the second quarter of 2026 and $19.8 million in Q1 2026. R&D expenses included non-cash charges for stock-based compensation of $0.8 million in Q2 2026 and $0.8 million in Q1 2026. On the net expense side, Puma anticipates higher total operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 1% to 2% and R&D expenses to increase by 34% to 37% year-over-year. The higher increase in R&D is driven by the progress of our clinical trials. In the second quarter of 2026, Puma reported cash burn of approximately $9.7 million. This compares to cash earn of approximately $4 million in Q1. Please note that during Q2 2026, we made our final quarterly principal loan payment of $11.1 million related to our obligation with Athyrium. As a result, Puma now is debt-free.

2026 年第二季研發（R&D）費用為 1,890 萬美元，2026 年第一季為 1,980 萬美元。研發費用包含以股份為基礎之薪酬的非現金費用：2026 年第二季為 80 萬美元，2026 年第一季亦為 80 萬美元。就淨費用面而言，Puma 預期 2026 年的總營運費用將高於 2025 年。更具體而言，我們預期 SG&A 費用年增 1% 至 2%，研發費用年增 34% 至 37%。研發費用較高的增幅主要由臨床試驗進展所驅動。2026 年第二季，Puma 報告的現金消耗（cash burn）約為 970 萬美元。相較之下，第一季約為現金增加（cash earn）400 萬美元。請注意，在 2026 年第二季，我們已就與 Athyrium 相關之義務支付了最後一筆每季貸款本金 1,110 萬美元。因此，Puma 現在已無負債。

On June 30th, 2026, we had approximately $93.9 million in cash equivalents, and marketable securities versus $97.5 million at year-end 2025. Our accounts receivable balance was $34.1 million. Our account receivable terms range between 10 and 68 days, while our day sales outstandings are about 44 days. We estimate that as of June 30th, 2026, our distribution network maintained approximately three 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.

截至2026年6月30日，我們持有約9,390萬美元的現金及約當現金與有價證券，相較於2025年年底的9,750萬美元。我們的應收帳款餘額為3,410萬美元。我們的應收帳款付款條件介於10至68天，而我們的應收帳款週轉天數（DSO）約為44天。我們估計截至2026年6月30日，我們的經銷網路維持約三週的庫存。整體而言，我們持續運用財務資源，聚焦於NERLYNX的商業化、alisertib的開發，以及費用控管。

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 NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain a positive net income. We believe that this focus has contributed to our commercial execution thus far in 2026. According to our current projections, 2026 will mark the second year-over-year demand increase for NERLYNX in the United States, and the first time in the history of the launch of NERLYNX in the United States that we have seen two positive consecutive year-over-year increases in demand.

謝謝你，Maximo。在過去的財報電話會議中，我們一直強調Puma的高階管理團隊在董事會的合作下，持續專注於NERLYNX的銷售趨勢，並認知到對股東負有財務責任，必須持續維持正的淨利。我們相信，這樣的專注已促成我們在2026年迄今的商業執行成果。根據我們目前的預測，2026年將是NERLYNX在美國需求連續第二年年增，也是NERLYNX在美國上市以來首次出現連續兩年需求年增為正的情況。

We are pleased to report this demand-driven increase in NERLYNX sales in the second quarter of 2026, and we believe that the positive net income that the company is guiding to for full-year 2026 has resulted from both this increased demand as well as 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. 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 at helping these patients during their journey. We will continue to strive to achieve that goal. This concludes today's presentation.

我們很高興報告，2026年第二季NERLYNX銷售出現由需求帶動的成長；我們也相信，公司對2026年全年所提供的正淨利指引，來自於需求增加以及過去幾年全公司持續的財務紀律。公司仍致力於持續達成正淨利，並將在必要時持續降低費用以達成此目標。我們期待未來向投資人更新相關進展。對於與乳癌、肺癌及其他實體腫瘤奮戰的患者而言，仍存在顯著未被滿足的醫療需求。我們Puma致力且充滿熱忱，尋找更有效的方法在患者的治療旅程中提供協助。我們將持續努力達成該目標。以上為今天的簡報內容。

We'll now turn the floor back to the operator for Q&A. Operator?

接下來我們把時間交還給主持人進行問答。主持人？

(Operator Instructions) Marc Frahm, TD Cowen.

（主持人指示）Marc Frahm，TD Cowen。

Hey, thanks, and congrats on the strong quarter and recent commercial performance. Maybe looking a little further beyond the formal guidance, you have a couple trials ongoing and another one going to start up. Can you speak to, Alan, what the R&D spend trajectory looks like maybe beyond just Q3 and more into as we look into 2027 as some of those trials are a little more fully up and running?

嗨，謝謝，也恭喜本季表現強勁以及近期商業表現。或許把視角稍微放到正式指引之外，你們有幾項試驗正在進行，另有一項即將啟動。Alan，你能否談談研發費用的走勢，可能不僅是第三季，而是更往後、展望到2027年，當其中一些試驗更全面地運作起來時，研發支出會是什麼樣子？

In terms of the R&D in 2027, 2028, 2029, we've gotten this question from investors before, which is, let's say you want to do the Phase 3 trials of both alisertib in ER-positive breast cancer and in small cell lung cancer. Can you do that? The answer to that is, according to our current projections, yes. We probably have to stagger them, so start one before the other type of thing, it is completely achievable and that's what we're looking to do. We think that with the Thankfully, now we're a debt-free company. We're cash flow positive. Obviously thinking investing that in alisertib is a good thing with the shareholders. It's a very interesting drug.

就2027、2028、2029年的研發而言，我們之前也被投資人問過這個問題：假設你想針對alisertib在ER陽性乳癌以及小細胞肺癌兩個適應症都進行第三期試驗。你們做得到嗎？依我們目前的預測，答案是可以。我們可能需要錯開進行，也就是先啟動其中一項再啟動另一項；這完全可行，也是我們希望採取的做法。我們認為，值得慶幸的是，現在我們是一家無負債公司。我們的現金流為正。顯然，將其投資於alisertib，對股東而言是件好事。這是一款非常有意思的藥物。

We're very pleased with the data, and assuming the data continues to hold up, we're very eager to start the Phase 3 trials, and I think that we have the ability to do that, hopefully, knock on wood, next year. I think that's where we're heading. I think there's no reason we can't run both of them. Like I said, we are committed to maintaining positive net income. If we have to stagger the trials, we can stagger them.

我們對這些數據非常滿意；假設數據持續維持良好，我們非常渴望啟動第三期試驗，我認為我們有能力做到，並希望（但願如此）明年就能開始。我想這就是我們前進的方向。我認為沒有理由不能同時推進兩項試驗。如我所說，我們承諾維持正的淨利。如果必須錯開試驗，我們也可以錯開。

Okay, that's helpful. Also in your prepared remarks, you mentioned continuing to evaluate BD opportunities. Can you speak a little bit more as to what would be of interest? Should we look at alisertib as very much the model in terms of stage, or would you be willing to take on maybe either a little bit more of an upfront or maybe a little bit earlier stage projects?

好的，這很有幫助。另外在你們的事先準備講稿中，你提到會持續評估BD機會。你能否再多談一些你們會感興趣的方向？我們是否應把alisertib視為在階段上的主要範例，還是你們也願意承擔可能前期投入更高、或更早期階段的專案？

Yeah. From a BD perspective, we look at commercial assets, we look at development stage ones. On the commercial side, I think that we've shown a strong ability to obviously cut costs, generate cash from our commercial assets. If there's ones out there where we feel like we could fit it into the existing organization, continue to do that for shareholders, add on additional sales, build additional cash, I think that would be something very wise to do for the shareholders. On the development stage side, obviously there's a lot of drugs being developed right now in the oncology space. If there's something where we feel that it's a unique asset and something where we believe that we can contribute to shareholder value by bringing it in and developing it clinically, we're happy to look at that.

是的。從BD角度來看，我們會看商業化資產，也會看開發階段的資產。在商業化方面，我認為我們已展現出強大的能力，能夠明顯降低成本，並從我們的商業化資產中產生現金。如果市場上有一些資產，我們覺得可以納入現有組織架構中運作，持續為股東做到這點、增加額外銷售、累積更多現金，我認為這會是對股東非常明智的作法。在開發階段方面，顯然目前腫瘤領域有許多藥物正在開發。如果有某項資產我們認為具有獨特性，且我們相信透過引進並進行臨床開發能為股東創造價值，我們很樂意評估。

We're not technology agnostic, if you will, like we just only look at small molecules or something like that. We're happy to look at any other technologies. I guess the same thing would be true on the commercial side as well. Is it just something in breast or lung cancer? Again, happy to look at things that are outside of that if we feel that we can, number one, most importantly, help cancer patients. Number two, by helping cancer patients benefit the shareholders.

我們並非所謂的「技術不可知」，也就是不會只看小分子之類的單一技術。我們很樂意評估其他任何技術。我想在商業化方面也是同樣道理。是否只限於乳癌或肺癌領域？同樣地，如果我們認為能夠做到，第一、也是最重要的，幫助癌症患者，第二、透過幫助癌症患者而讓股東受益，我們也很樂意看乳癌與肺癌以外的機會。

Okay. That's helpful. Thank you.

好的。這很有幫助。謝謝。

Thank you. This concludes our question-and-answer session. I will now return the conference back to Mariann for closing remarks.

謝謝。問答環節到此結束。我現在把會議交還給Mariann作結語。

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

感謝各位今天加入我們。提醒各位，本次電話會議可於今日稍晚起透過pumabiotechnology.com的網路直播重播收聽。祝各位晚安。

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.

各位女士、先生，感謝參與今天的電話會議。本次會議到此結束。祝各位有美好的一天。您現在可以掛線。