Puma Biotechnology Inc (PBYI) 2025 Q1 法說會逐字稿

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

午安.我叫雪莉，今天我將擔任您的電話會議接線生。（操作員指示）提醒一下，此通話正在被錄音。

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

現在，我想將會議交給 Puma Biotechnology 投資者關係高級總監 Mariann Ohanesian。謝謝。您可以開始您的會議了。

Thank you, Sherry. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the first quarter of 2025. 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; Jeff Ludwig, Chief Commercial Officer; Heather Blaber, Vice President of Marketing; and [Roger] Storms, Vice President of Sales (corrected by company after the call).

謝謝你，雪莉。下午好，歡迎參加 Puma 電話會議，討論我們 2025 年第一季的獲利結果。今天與我一起參加電話會議的還有 Puma Biotechnology 執行長、總裁兼董事會主席 Alan Auerbach； Maximo Nougues，財務長；傑夫·路德維希 (Jeff Ludwig)，首席商務官； Heather Blaber，行銷副總裁；以及銷售副總裁[Roger] Storms（通話後公司予以糾正）。

After the close today, Puma issued a news release detailing earnings results for first-quarter 2025. That news release, the slides that Jeff 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，彪馬發布了一份新聞稿，詳細介紹了 2025 年第一季的獲利結果。新聞稿、Jeff 將參考的幻燈片以及本次電話會議的網路直播可透過我們網站 pumabiotechnology.com 的主頁和投資者部分存取。網路廣播和簡報投影片將存檔在我們的網站上，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.

今天的電話會議將包括有關彪馬未來預期、計劃和前景的聲明，這些聲明構成聯邦證券法所指的前瞻性聲明。此類聲明受風險和不確定性的影響，實際事件和結果可能與這些前瞻性聲明中表達的不同。

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 period ended December 31, 2024. 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, May 8, 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.

要全面了解這些風險和不確定性，請查看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 日的 10-K 表年度報告。請注意不要過度依賴這些前瞻性陳述，這些陳述僅代表截至本次現場電話會議召開之日（2025 年 5 月 8 日）的觀點。除非法律要求，否則彪馬不承擔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的義務。

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 first-quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results.

在今天的電話會議中，我們可能會參考某些涉及對我們的 GAAP 數據進行調整的非 GAAP 財務指標。我們認為，這些非公認會計準則指標可能對投資人有用，可以作為我們公認會計準則財務指標的補充，但不能取代。請參閱我們的 2025 年第一季財報報告，以了解我們的 GAAP 與非 GAAP 結果的對照組。

I will now turn the call over to Alan.

現在我將電話轉給艾倫。

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of 2025 of $46.0 million. Total revenue includes products revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $43.1 million in the first quarter of 2025, a decline from the $54.4 million reported in Q4 2024 and an increase from the $40.3 million reported in Q1 of 2024. Product revenue for the first quarter of 2025 was impacted by approximately $4.7 million of inventory decrease at our specialty pharmacies and specialty distributors.

謝謝你，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 2025 年第一季總收入為 4,600 萬美元。總收入包括產品淨收入，其中完全由 NERLYNX 銷售額以及來自我們的分授權人的特許權使用費組成。2025 年第一季產品淨收入為 4,310 萬美元，低於 2024 年第四季的 5,440 萬美元，高於 2024 年第一季的 4,030 萬美元。2025 年第一季的產品收入受到我們專業藥局和專業經銷商庫存減少約 470 萬美元的影響。

Royalty revenue was $2.9 million in the first quarter of 2025 compared to $4.7 million in Q4 2024 and $3.5 million in Q1 2024. We reported 2,338 bottles of NERLYNX sold in the first quarter of 2025, a decrease of 626 from the 2,964 bottles sold in Q4 2024. In Q1 '25, we estimate that inventory decreased by 251 bottles.

2025 年第一季特許權使用費收入為 290 萬美元，而 2024 年第四季為 470 萬美元，2024 年第一季為 350 萬美元。我們報告稱，2025 年第一季售出了 2,338 瓶 NERLYNX，比 2024 年第四季售出的 2,964 瓶減少了 626 瓶。2025 年第一季度，我們估計庫存減少了 251 瓶。

In Q1 2025, new prescriptions, or NRx, were up approximately 6% compared to Q4 2024. And total prescriptions were down approximately 9% compared to Q4 2024. Jeff will provide further details in his comments and slides.

2025 年第一季度，新處方或 NRx 與 2024 年第四季相比成長了約 6%。與 2024 年第四季相比，總處方量下降了約 9%。傑夫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 Jeff Ludwig, as well as 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 first quarter of 2025.

我現在將對本季度進行臨床回顧，然後 Jeff Ludwig 以及 Heather Blaber 和 Roger Storms 將對 NERLYNX 的商業活動進行更多介紹。Maximo Nougues 將重點介紹我們 2025 年第一季財務報表的主要部分。

At the recent American Association for Cancer Research or AACR Annual Meeting, interim data from an ongoing Phase I trial, which is NCT-05372 that is sponsored by the National Cancer Institute, evaluating the combination of neratinib and fam-trastuzumab deruxtecan or Enhertu, in patients with metastatic solid tumors was presented. The Phase I data includes patients with metastatic solid tumors harboring HER2 overexpression, IHC3+, HERB2 amplifications or activating HER2 mutations.

在最近舉行的美國癌症研究協會 (AACR) 年會上，展示了正在進行的 I 期試驗的中期數據，該試驗由美國國家癌症研究所贊助，名為 NCT-05372，評估了 neratinib 和 fam-trastuzumab deruxtecan 或 Enhertu 聯合治療轉移性實體瘤患者的效果。I 期資料包括患有 HER2 過度表現、IHC3+、HERB2 擴增或活化 HER2 突變的轉移性實體瘤患者。

In the poster presentation, 20 patients received study treatment. Dose level 1 had seven patients; dose level 2 had four patients; dose level 3 had nine patients. The most common treatment-emergent adverse events of any grade included nausea N=15 or 75%, diarrhea N=15 or 75%, fatigue N=13 or 65%, and hypokalemia N=11 or 55%. Grade 3 treatment-emergent adverse events that incurred in more than two patients included anemia N=6 or 30%, diarrhea N=4 or 20%, and hypokalemia N=3 or 15%.

在海報展示中，20名患者接受了研究治療。劑量等級 1 有 7 名患者；劑量等級 2 有 4 名患者；劑量等級 3 有 9 名患者。任何程度最常見的治療出現的不良事件包括噁心 N=15 或 75%、腹瀉 N=15 或 75%、疲勞 N=13 或 65% 和低血鉀 N=11 或 55%。兩名以上患者發生的 3 級治療中出現的不良事件包括貧血 N=6 或 30%、腹瀉 N=4 或 20% 和低血鉀 N=3 或 15%。

The only Grade 4 treatment-related adverse event was neutropenia that incurred one patient, which was 5%, 1 DLT, which was acute kidney injury was observed at dose level 1. No DLTs were observed at dose level 2 and 1 DLT was observed, which was, fatigue leading to early discontinuation at dose level 3. Three patients developed Grade 1 pneumonitis or interstitial lung disease, ILD, two patients at dose level 1 and one at dose level 3. The proportion of reported treatment-emergent adverse events was lower at higher doses. Of the 15 response evaluable patients by RECIST, four patients had a partial response, including patients with gastroesophageal, which was N=2.

唯一 4 級治療相關不良事件是嗜中性白血球減少症，發生率為 5%，1 DLT，即在劑量水準 1 下觀察到的急性腎損傷。在劑量水平 2 下未觀察到 DLT，而在劑量水平 3 下觀察到 1 個 DLT，即疲勞導致提前停藥。三名患者出現了 1 級肺炎或間質性肺病 (ILD)，其中兩名患者為劑量水平 1，一名患者為劑量水平 3。劑量越高，報告的治療中出現的不良事件比例越低。在 15 名根據 RECIST 可評估療效的患者中，有 4 名患者達到部分療效，其中包括胃食道癌的患者，佔 N=2。

And it was one HER2-positive IHC3+ and one HER2 mutated. Pancreatic, which was one patient who was an IHC3+, and ovarian, which was one patient who was also a 3+, and the ovarian was a confirmed response.

其中一個為 HER2 陽性 IHC3+，另一個為 HER2 突變。一名患者為胰臟癌，其 IHC 為 3+；一名患者為卵巢癌，其 IHC 也為 3+，且卵巢癌已被確認反應。

Most notably, three of five patients with advanced pancreatic cancer were observed to have tumor regression; one PR for 13 cycles, which is ongoing; and two with stable disease, consisting of one patient with a 29.4% tumor regression for nine cycles and one patient with a 13.3% regression for eight cycles.

最值得注意的是，五名晚期胰腺癌患者中有三名出現腫瘤消退；一項 PR 持續 13 個週期，目前正在進行中；兩名患者病情穩定，其中一名患者在 9 個週期內腫瘤消退率為 29.4％，另一名患者在 8 個週期內腫瘤消退率為 13.3％。

Dose level 3, which consisted of trastuzumab deruxtecan at 5.4 mgs per kg, and neratinib at 120 mgs in week one, 160 in week 2 and 240 in week 3 and onward, was selected as the recommended Phase II dose. Part two of the study, which consists of a pharmacodynamic evaluation of trastuzumab deruxtecan with neratinib in 12 patients opened to enrollment in March of 2025.

劑量等級 3 被選為建議的 II 期劑量，包括每公斤 5.4 毫克的曲妥珠單抗德魯替康和第一周 120 毫克、第二週 160 毫克、第三週及以後 240 毫克的來那替尼。研究的第二部分包括對 12 名患者進行曲妥珠單抗德魯替康與來那替尼的藥效動力學評估，於 2025 年 3 月開始招募。

Patients with advanced solid tumor and HER2 amplification or overexpression or HER2 mutation will be enrolled. We look forward to updated data from this trial to be presented likely in 2026.

將招募患有晚期實體瘤且 HER2 擴增或過度表現或 HER2 突變的患者。我們期待在 2026 年公佈該試驗的最新數據。

In addition, Puma currently has two ongoing Phase II studies of our investigational drug, alisertib, the ALISCA-Breast1 trial, which is a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative hormone receptor positive, metastatic breast cancer, and ALISCA-Lung1, which is a Phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.

此外，Puma 目前正在進行兩項針對其研究藥物 alisertib 的 II 期研究：ALISCA-Breast1 試驗，該試驗是針對 HER2 陰性激素受體陽性轉移性乳腺癌患者進行 alisertib 聯合內分泌治療的 II 期試驗；以及 ALISCA-Lung1，該試驗是一項 II 期研究，旨在探討 alisertib 單藥治療小細胞的療效。

As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment, which consists of 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 CDK4/6 inhibitors, 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 與內分泌治療的聯合作用，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，用於治療 HER2 陰性激素受體陽性轉移性乳腺癌患者。患者必須未接受化療，之前曾接受過 CDK4/6 抑制劑治療，並且在復發或轉移性環境中接受過至少兩種內分泌治療才有資格參加試驗。

Patients are being dosed with alisertib given at either 30 mgs, 40 mgs or 50 mgs twice daily BID, on days 1 to 3, 8 to 10, and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that is being given in combination with alisertib in the trial.

患者將接受 30 毫克、40 毫克或 50 毫克的 alisertib 治療，每日兩次，在 28 天的一個週期內，第 1 至 3 天、第 8 至 10 天和第 15 至 17 天服用，並結合研究者選擇的內分泌療法。患者之前不得接受過與試驗中的 alisertib 合併進行的轉移性內分泌治療。

Primary efficacy endpoints will include objective response rate, duration of response, disease control rate, and progression-free survival. As a secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in the preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of alisertib in combination with endocrine for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.

主要療效終點包括客觀緩解率、緩解持續時間、疾病控制率和無惡化存活期。作為次要目標，該公司將評估生物標記亞組中的每個療效終點，以確定任何生物標記亞群是否與更好的療效相關，正如在其他癌症（包括乳腺癌和小細胞肺癌）的臨床前和臨床研究中所看到的那樣。該公司將著眼於未來臨床開發，專注於針對具有這些生物標記的 HER2 陰性荷爾蒙受體陽性乳癌患者進行合併內分泌治療。

The trial was initiated in late November 2024. There are currently 26 sites in the US and 12 sites in Europe that have been activated for the trial. And the trial is enrolling ahead of expectations. There are currently 28 patients enrolled in the trial, one expected to be enrolled this week and six additional patients in screening. We are looking to have interim data from this trial later in 2025.

該試驗於2024年11月下旬啟動。目前美國已有 26 個站點、歐洲已有 12 個站點啟動試驗。且該試驗的招募進度超出了預期。目前共有 28 名患者參加試驗，預計本週將有一名患者參加，另有 6 名患者正在接受篩選。我們希望在 2025 年稍後獲得該試驗的中期數據。

With respect to the ALISCA-Lung study, as discussed on the last conference call, the company believes that the data obtained to date from the ALISCA-Lung1 trial is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role.

關於 ALISCA-Lung 研究，正如上次電話會議所討論的那樣，該公司認為，迄今為止從 ALISCA-Lung1 試驗中獲得的數據初步表明，在 Aurora 激酶通路發揮作用的生物標誌物患者中，其活性可能會更好。

The most recent analysis of the pharmacokinetic data from the ALISCA-Lung1 trial suggests that we are seeing a lower PK of alisertib in the ALISCA-Lung trial compared to the previous Phase II study of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology. The company is in the process of amending the protocol to increase the dose of alisertib from 50 migs to 60 migs, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase II trial. The company looks to have additional interim data from this trial later in 2025.

對 ALISCA-Lung1 試驗藥物動力學數據的最新分析表明，與先前在《柳葉刀腫瘤學》上發表的針對小細胞肺癌患者進行 alisertib 單藥治療的 II 期研究相比，我們在 ALISCA-Lung 試驗中看到的 alisertib 的 PK 較低。該公司正在修改方案，將 alisertib 的劑量從 50 微克增加到 60 微克，該公司認為此舉將使該藥物的 PK 值提高到更接近先前 II 期試驗的水平。該公司希望在 2025 年稍後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 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.

正如在先前的收益電話會議和回答投資者問題時所提到的，Puma 正在繼續評估幾種可能獲得許可或收購的藥物。這將使公司實現多元化，並利用 Puma 現有的研發、監管和商業基礎設施。公司將向投資者通報此事的進展。

I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the quarter.

現在，我將把電話轉給彪馬商務長傑夫路德維希 (Jeff Ludwig)，讓他回顧一下我們本季的商業表現。

Thanks, Alan. Appreciate it, and thanks to everyone for joining our first-quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements.

謝謝，艾倫。非常感謝，也感謝大家參加我們的第一季財報電話會議。在進入商業評論之前，我只想提醒一下，我將做出前瞻性的陳述。

The commercial team remains focused on expanding the utilization of NERLYNX with a primary emphasis on patients who are at increased risk of reoccurrence. The marketing team has recently revised the core sales aligned with this strategy.

商業團隊仍致力於擴大 NERLYNX 的使用率，主要關注復發風險較高的患者。行銷團隊最近修改了與該策略一致的核心銷售。

In addition, the team has continued their emphasis on improving clinical education and engagement through nonpersonal promotion and developed a new patient resource brochure designed to improve persistence and compliance throughout a patient's NERLYNX therapy. The sales team is working very hard on expanding overall HCP reach and frequency with an emphasis on increasing engagement when treatment decisions are being made.

此外，團隊繼續強調透過非個人推廣來改善臨床教育和參與度，並開發了新的患者資源手冊，旨在提高患者在整個 NERLYNX 治療過程中的堅持性和依從性。銷售團隊正在努力擴大 HCP 的整體覆蓋率和頻率，重點是在製定治療決策時提高參與度。

In Q1 of 2025, call activity was flat year over year and down about 2% quarter over quarter, driven by an increased number of vacancies. We expect that trend to improve as these vacancies are filled. Heather Blaber, our VP of Marketing; and Roger Storms, our VP of Sales, have joined us during this call and will add some additional details in a few moments.

2025 年第一季度，由於空房數量增加，呼叫活動較去年同期持平，季減約 2%。我們預計，隨著這些空缺職位得到填補，這一趨勢將會改善。Heather Blaber，我們的行銷副總裁；和我們的銷售副總裁 Roger Storms 也參加了此次電話會議，稍後將補充一些詳細資訊。

Let me now transition to some of the commercial slides where I will 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.

現在讓我轉到一些商業幻燈片，我將在其中提供一些有關性能的額外細節。投影片 3 說明了我們的分銷模式，該模式分為專業藥房通路和專業經銷商或辦公室配藥通路。

In regards to the overall distribution of our business, in Q1 of '25, about 67% of our business was purchased through the SP channel and the remaining 33% was purchased through the SD channel. We are seeing some stronger growth in the SD channel driven by two main factors: number one, increased sales in the GPO segment; and two, some increasing 340B purchasing.

就我們業務的整體分佈而言，在 2025 年第一季度，大約 67% 的業務是透過 SP 管道購買的，其餘 33% 是透過 SD 管道購買的。我們看到 SD 通路出現了更強勁的成長，主要由兩個因素推動：第一，GPO 部門的銷售額成長；二是加大340B採購力道。

Turning to slide 4. NERLYNX net revenue in Q1 of 2025 was $43.1 million, which represents a decline of about $11.3 million from the $54.4 million we reported in Q4 of 2024 and an increase of $2.8 million from the $40.3 million we reported in Q1 of 2024. The significant change in quarterly revenue was driven largely by anticipated seasonal inventory changes and higher gross to net expenses in the prior quarter. I will provide some more details around inventory changes. And Maximo will provide some additional specifics around gross to net expenses during his update.

翻到幻燈片 4。NERLYNX 2025 年第一季的淨收入為 4,310 萬美元，比 2024 年第四季報告的 5,440 萬美元下降約 1,130 萬美元，比 2024 年第一季報告的 4,030 萬美元增加 280 萬美元。季度收入的顯著變化主要是由於預期的季節性庫存變化以及上一季總支出與淨支出的增加。我將提供有關庫存變化的更多詳細資訊。馬克西莫將在更新中提供有關總支出與淨支出的一些額外細節。

In Q1 of 2025, we estimate that inventory decreased by about $4.7 million. As a comparator, we estimate that inventory increased by about $3.7 million in Q4 of '24 and decreased by about $2 million in Q1 of '24.

2025 年第一季度，我們估計庫存減少了約 470 萬美元。作為比較，我們估計 2024 年第四季庫存增加了約 370 萬美元，而 2024 年第一季庫存減少了約 200 萬美元。

On slide 5, slide 5 shows Q1 2025 ex-factory bottle sales and also provides a year-over-year and a quarter-over-quarter comparison. In Q1 of 2025, NERLYNX ex-factory bottle sales were 2,338, which represents an approximate 21% decrease quarter-over-quarter and a 3% decrease year over year. It is typical for us to see inventory increase in Q4 and then subsequently decline in Q1. Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective.

在第 5 張投影片上，投影片 5 顯示了 2025 年第一季的出廠瓶裝銷量，並提供了同比和環比的比較。2025年第一季，NERLYNX出廠瓶裝銷售量為2,338瓶，較上季下降約21%，較去年同期下降3%。我們通常會看到庫存在第四季度增加，然後在第一季下降。與之前的投影片類似，讓我從瓶子的角度具體講一下庫存變化。

In Q1 of 2025, we estimate that inventory decreased by 251 bottles. As a comparator, we estimate that inventory increased by 204 bottles in Q4 of '24 and decreased by 120 bottles in Q1 of 2024. Let me take a moment to provide some additional metrics regarding our first quarter performance and then I'll turn the call over to Heather and Roger to share their insights into sales and marketing.

2025年第一季度，我們估計庫存減少了251瓶。作為比較，我們估計 2024 年第四季庫存增加了 204 瓶，2024 年第一季庫存減少了 120 瓶。請容許我花點時間提供一些關於我們第一季業績的額外指標，然後我會將電話轉給 Heather 和 Roger，讓他們分享他們對銷售和行銷的見解。

In Q1, we saw enrollments increased about 6% quarter over quarter, but declined about 8% year over year. We have seen some continued enrollment softness in April, which we are monitoring very closely.

第一季度，我們發現入學人數較上季增加約 6%，但年減約 8%。我們發現四月入學人數持續疲軟，我們正在密切關注這一情況。

New patient starts, or NRx, followed a similar pattern, growing about 6% quarter over quarter, but declining about 7% year over year.

新患者開始就診數量（NRx）也遵循類似的模式，季增約 6%，但年減約 7%。

Turning to total prescriptions or TRx. We saw a TRx decline of about 9% quarter over quarter and a decline of about 3% year over year.

轉向總處方或 TRx。我們發現 TRx 環比下降約 9%，年減約 3%。

Finally, let me share some specifics around demand. In Q1, we saw demand declined about 6% quarter over quarter, but increased about 2% year over year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD demand grow about 4% quarter over quarter and about 14% year over year.

最後，讓我分享一些有關需求的具體情況。第一季度，我們發現需求較上季下降約 6%，但年增約 2%。如前所述，我們看到 SD 通路的需求成長更加強勁，其中 SD 需求較上季成長約 4%，較去年同期成長約 14%。

Let me now turn the call over to Heather and Roger for some additional insights. Why don't we start with Heather Blaber, our VP of Marketing? Heather, the floor is yours.

現在，讓我將電話轉給 Heather 和 Roger，以徵求一些額外的見解。我們為什麼不從行銷副總裁 Heather Blaber 開始呢？希瑟，現在請你發言。

Thanks, Jeff. I appreciate the opportunity to be on this call and share some more insights into the marketing strategy and execution. As Jeff mentioned earlier, the marketing team is focused on increasing the utilization of NERLYNX with a focus on patients who are at continued risk of recurrence.

謝謝，傑夫。我很感謝有機會參加這次電話會議並分享有關行銷策略和執行的更多見解。正如 Jeff 之前提到的，行銷團隊致力於提高 NERLYNX 的使用率，並專注於那些持續面臨復發風險的患者。

We recently conducted several focus groups with community oncologists to better understand patient risk factors that are most concerning to physicians and to garner feedback on some more recent publications regarding the overall risk of recurrence. We have utilized those insights to update and revised our core sales aid and messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence is high and where we believe that NERLYNX can play an important role in helping to reduce that risk.

我們最近與社區腫瘤學家進行了幾次焦點小組討論，以更好地了解醫生最關心的患者風險因素，並收集有關復發總體風險的一些最新出版物的反饋。我們利用這些見解來更新和修改我們的核心銷售輔助和資訊傳遞方式，目的是讓醫生參與更廣泛的患者群體，這些患者的復發風險很高，我們相信 NERLYNX 可以在幫助降低這種風險方面發揮重要作用。

In addition to revising the core sales aid and messaging, we have also recently rolled out a new patient education resource designed to better support our patients throughout their recommended course of NERLYNX therapy. This educational resource will be provided to patients on a monthly basis as they receive their refills.

除了修改核心銷售輔助和資訊傳遞之外，我們最近還推出了新的病患教育資源，旨在為我們的患者在建議的 NERLYNX 治療過程中提供更好的支援。當患者收到補充藥物時，我們將每月向他們提供此教育資源。

Lastly, I know Jeff mentioned our goal of expanding the overall share of voice. The marketing team works very closely with our field leadership team to increase the engagement with oncologists through our nonpersonal promotion, both branded and unbranded messaging.

最後，我知道傑夫提到了我們擴大整體話語權的目標。行銷團隊與我們的現場領導團隊密切合作，透過非個人推廣（包括品牌和非品牌訊息）增加與腫瘤學家的互動。

Our nonpersonal promotion efforts target a very broad group of oncologists. And we are continually evaluating new partners and new approaches that will enhance these efforts. I know our sales team is also heavily focused on increasing engagements with health care providers.

我們的非個人推廣活動針對的是廣泛的腫瘤學家群體。我們正在不斷評估新的合作夥伴和新方法，以加強這些努力。我知道我們的銷售團隊也非常注重增加與醫療保健提供者的合作。

So now I would like to take the opportunity to turn it over to our Vice President of Sales, Roger Storms, to provide some additional insights and perspective. Roger?

所以現在我想藉此機會將話題交給我們的銷售副總裁 Roger Storms，以提供一些額外的見解和觀點。羅傑？

Thanks, Heather. I also appreciate the opportunity to participate on the call and share my perspective. I joined Puma in December of last year, so I'm still relatively new. But I'm very excited to be here and passionate about finding ways to better support HER2-positive breast cancer patients. My focus is on executional excellence and expanding overall share of voice.

謝謝，希瑟。我也很感謝有機會參加這次電話會議並分享我的觀點。我是去年 12 月加入 Puma 的，所以我還比較新。但我很高興來到這裡，並熱衷於尋找更好地支持 HER2 陽性乳癌患者的方法。我關注的是卓越的執行力和擴大整體的話語權。

As previously mentioned, our Q1 call activity was flat year over year and down about 2% quarter over quarter, driven by a higher vacancy rate. My expectation is that we will see an increase in our overall reach and frequency driven by a reduction in these vacancies as well as better overall execution.

如前所述，由於空置率上升，我們第一季的通話活動與去年同期持平，與上一季相比下降約 2%。我的期望是，隨著這些空缺職位的減少以及整體執行情況的改善，我們的整體覆蓋率和頻率將會增加。

I'm happy to say that we've made good progress on our openings and have brought in strong talent with both breast cancer experience and established relationships with key customers. In regards to executional excellence, we are focused on helping our sales reps get in front of more customers with the goal of increasing engagement when clinical decisions are being made.

我很高興地說，我們的開業工作取得了良好的進展，並引進了具有乳癌經驗並與主要客戶建立了關係的優秀人才。在執行卓越方面，我們專注於幫助我們的銷售代表接觸更多客戶，以期在製定臨床決策時提高參與度。

We're utilizing claims data, nonpersonal promotion feedback, and piloting predictive analytics to help our teams prioritize their time and maximize their impact. Early feedback on the new marketing core sales aid has been positive and allows my team to discuss a broad group of patients, which is aligned with our goal of increasing the utilization of NERLYNX.

我們正在利用索賠數據、非個人促銷反饋和試點預測分析來幫助我們的團隊安排時間並最大限度地發揮他們的影響力。對新行銷核心銷售援助的早期回饋是正面的，並使我的團隊能夠討論廣泛的患者群體，這與我們提高 NERLYNX 利用率的目標一致。

Thanks, Roger, and thanks, Heather, for providing additional specifics and insights. Let me wrap up with just a few more slides, then I'll turn the call over to Maximo for a more detailed financial review.

謝謝羅傑和希瑟提供更多細節和見解。讓我再用幾張投影片來總結一下，然後我會將電話轉給 Maximo 進行更詳細的財務審查。

Turning to slide 6. Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q1, approximately 72% of patients started NERLYNX at a reduced dose. This is similar to the 74% we reported in Q4 of 2024. 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 resource Heather discussed, will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of reoccurrence.

翻到幻燈片 6。幻燈片 6 重點介紹了自 NERLYNX 推出以來每季劑量遞增的採用情況。在第一季，約有 72% 的患者開始以降低的劑量服用 NERLYNX。這與我們在 2024 年第四季報告的 74% 相似。持續傳遞訊息和採用劑量遞增仍然是重要的商業優先事項。以劑量遞增開始使用 NERLYNX 的患者俱有更好的持久性和依從性。我們相信劑量遞增，加上 Heather 討論的新的病人教育資源，將為患者在整個 NERLYNX 治療過程中提供更好的支持，並最終幫助他們降低復發風險。

Slide 7 highlights the strategic collaborations we have formed across the globe. In Q1 of 2025, NERLYNX was launched in Libya in the extended adjuvant setting. And we signed a distribution agreement with Er-Kim for select countries in Eastern Europe and Central Asia. We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward.

投影片 7 重點介紹了我們在全球範圍內建立的策略合作關係。2025 年第一季度，NERLYNX 在利比亞以延長輔助治療的形式推出。我們也與 Er-Kim 簽署了針對東歐和中亞部分國家的分銷協議。我們非常感謝全球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 wrap up by thanking the entire Puma team once again for their continued passion and commitment for helping patients and their families battling breast cancer. This disease can have devastating effects. And we know more can be done and more needs to be done.

最後，我要再次感謝整個 Puma 團隊，感謝他們持續的熱情和承諾，幫助乳癌患者及其家人。這種疾病可能會造成毀滅性的影響。我們知道還可以做更多，也需要做更多。

I'll now turn the call over to Maximo for a review of our full financial results. Maximo?

現在我將把電話轉給 Maximo，以審查我們的全部財務結果。馬克西莫？

Thanks, Jeff. I will begin with a brief summary of our financial results for the first quarter of 2025. Please note that I will make comparisons to Q4 2024, 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 first-quarter 2025 10-Q, which will be filed today and includes our consolidated financial statements.

謝謝，傑夫。我將首先簡要概述我們 2025 年第一季的財務表現。請注意，我將與 2024 年第四季進行比較，我們認為，與同比比較相比，這更能表明我們作為一家商業公司的進步。欲了解更多信息，我建議您參考我們今天將提交的 2025 年第一季度 10-Q 報告，其中包含我們的合併財務報表。

For the first quarter of 2025, we reported net income based on GAAP of $3 million or $0.06 per share. This compares to net income in Q4 2024 of $19.3 million or $0.39 per share. In the fourth quarter of 2024, we released a portion of our valuation allowance, resulting in a noncash deferred income tax benefit of $7.1 million. The valuation allowance was established to offset our deferred tax assets, which are primarily related to our historical losses. This significantly increased our net income for the fourth quarter.

2025 年第一季度，我們報告的基於 GAAP 的淨收入為 300 萬美元或每股 0.06 美元。相比之下，2024 年第四季的淨收入為 1,930 萬美元，即每股 0.39 美元。2024 年第四季度，我們釋放了部分估值準備金，產生了 710 萬美元的非現金遞延所得稅收益。設立估價準備金是為了抵銷我們的遞延稅務資產，這些資產主要與我們的歷史損失有關。這大大增加了我們第四季的淨收入。

On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $5 million or $0.10 per basic and diluted share for the first quarter of 2025.

根據非公認會計準則 (non-GAAP)，經調整以消除股票薪酬費用的影響，我們報告 2025 年第一季的淨收入為 500 萬美元，即每股基本收益和稀釋收益 0.10 美元。

Gross revenue from NERLYNX sales was $54.4 million in Q1 2025 and $66.5 million in Q4 2024. As Alan mentioned it, net product revenue from NERLYNX sales was $43.1 million, a decrease from the $54.4 million reported in Q4 2024. The lower net revenue was driven mostly by seasonality of inventory fluctuation and higher gross to net expenses than prior quarter.

2025 年第一季，NERLYNX 銷售總收入為 5,440 萬美元，2024 年第四季為 6,650 萬美元。正如艾倫所提到的，NERLYNX 銷售的淨產品收入為 4,310 萬美元，低於 2024 年第四季報告的 5,440 萬美元。淨收入下降主要是由於庫存波動的季節性以及總淨支出高於上一季所致。

Inventory drawdown by our distributors was approximately $4.7 million in Q1 versus an increase of approximately $3.7 million in Q4 2024. Royalty revenue totaled $2.9 million in the first quarter of 2025 compared to $4.7 million in Q4 2024.

我們的經銷商的庫存減少量在第一季約為 470 萬美元，而 2024 年第四季則增加了約 370 萬美元。2025 年第一季特許權使用費收入總計 290 萬美元，而 2024 年第四季為 470 萬美元。

Our gross to net adjustment in Q1 2025 was about 20.8% compared to the 18.2% gross to net adjustment reported in Q4 2024. Cost of sales for Q1 2025 declined to $10.6 million and includes $2.4 million for amortization of intangible assets related to our neratinib license. Cost of sales for Q4 2024 was $13.9 million. Going forward, we will continue to recognize amortization of our milestones to the license source about $2.4 million per quarter as cost of sales.

2025 年第一季我們的總淨調整額約為 20.8%，而 2024 年第四季報告的總淨調整額為 18.2%。2025 年第一季的銷售成本下降至 1,060 萬美元，其中包括 240 萬美元與我們的 neratinib 許可相關的無形資產攤銷。2024 年第四季的銷售成本為 1,390 萬美元。展望未來，我們將繼續將里程碑攤銷至授權來源，每季約 240 萬美元作為銷售成本。

For fiscal year 2025, Puma anticipates that net NERLYNX product revenue will be in the range of $192 million to $198 million. We also anticipate that our gross to net adjustment for the full year 2025 will be between 20.5% and 21.5%.

對於 2025 財年，Puma 預計 NERLYNX 產品淨收入將介於 1.92 億美元至 1.98 億美元之間。我們也預計，2025 年全年的總淨調整額將在 20.5% 至 21.5% 之間。

In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 million to $24 million, lower than 2024 due to fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025. We don't expect license revenue in 2025.

此外，在 2025 財年，我們預計從世界各地的合作夥伴處獲得的特許權使用費將在 2000 萬美元至 2400 萬美元之間，低於 2024 年，原因是由於我們的合作夥伴在 2025 年前幾個季度經歷監管過渡，預計對中國的出貨量將減少。我們預計 2025 年不會有授權收入。

We also expect that net income for the full year will be in the range of $23 million to $28 million. We are not forecasting any potential release of any additional tax asset valuation allowance in our net income estimate at this time. However, this will be evaluated on an ongoing basis. We will continue to keep investors updated on this as it progresses.

我們也預計全年淨收入將在 2,300 萬美元至 2,800 萬美元之間。目前，我們並未預測在淨收入估算中會釋放任何額外的稅務資產估值準備金。然而，我們將持續對此進行評估。我們將繼續向投資者通報此事的進展。

At this time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shifting 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 total cost of goods sold.

目前，我們認為美國徵收或提議徵收的關稅，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重大影響。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，我們的製造產品成本占我們總銷售成本的中高個位數百分比。

We anticipate that for Q2 2025, NERLYNX product revenue net will be in the range of $48 million to $50 million. Also, we expect Q2 royalty revenue 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 Q2 2025 will be approximately 20% to 21.5%. Puma anticipates Q2 net income between $4 million and $6 million. SG&A expenses were $17.6 million in the first quarter of 2025 compared to $16.6 million in the fourth quarter of 2024.

我們預計，2025 年第二季度，NERLYNX 產品淨收入將在 4,800 萬美元至 5,000 萬美元之間。此外，我們預計第二季特許權使用費收入將在 200 萬至 300 萬美元之間，沒有授權收入。我們進一步估計，2025 年第二季的總額與淨額調整幅度將約為 20% 至 21.5%。Puma 預計第二季淨收入將在 400 萬至 600 萬美元之間。2025 年第一季的銷售、一般及行政費用為 1,760 萬美元，而 2024 年第四季為 1,660 萬美元。

SG&A expenses included noncash charges for stock-based compensation of $1.2 million for Q1 and $1.3 million for Q4 2024. Research and development expenses were $13.8 million in the first quarter of 2025, a decrease from $15.2 million in the fourth quarter of 2024. R&D expenses included noncash charges for stock-based compensation of $0.8 million in the first quarter of 2025 compared to $0.5 million in the fourth quarter of 2024.

銷售、一般及行政費用包括 2024 年第一季 120 萬美元及第四季 130 萬美元的股票薪酬非現金費用。2025 年第一季研發費用為 1,380 萬美元，低於 2024 年第四季的 1,520 萬美元。研發費用包括 2025 年第一季 80 萬美元的股票薪酬非現金費用，而 2024 年第四季為 50 萬美元。

On the expense side, Puma anticipates flat to slightly lower total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG&A expenses to decrease by 5% to 10% and R&D expenses to increase by 10% to 15% year over year. In the first quarter of 2025, Puma reported cash burn of approximately $7.8 million. This compares to cash earned of approximately $4.3 million in Q4 2024.

在費用方面，彪馬預計 2025 年的總營運費用將與 2024 年持平或略有下降。更具體地說，我們預計銷售、一般及行政費用將年減 5% 至 10%，研發費用將年增 10% 至 15%。2025 年第一季度，彪馬報告現金消耗約 780 萬美元。相比之下，2024 年第四季的現金收入約為 430 萬美元。

Please note that during Q1, we made our fourth principal loan payment of $11.1 million related to our obligation with Athyrium. As a result of this, our total outstanding principal debt balance decreased to approximately $56 million.

請注意，在第一季度，我們支付了第四筆本金貸款 1,110 萬美元，與我們與 Athyrium 的義務有關。因此，我們的未償還本金債務總額減少至約 5,600 萬美元。

At March 31, 2025, we had approximately $93 million in cash, cash equivalents, and marketable securities versus about $101 million at year-end in 2024. Our accounts receivable balance was $24.2 million. Our accounts receivables terms range between 10 and 68 days, while our days sales outstanding are about 50 days. We estimate that as of March 31, 2025, our distribution network maintained approximately three weeks of inventory.

截至 2025 年 3 月 31 日，我們擁有約 9,300 萬美元的現金、現金等價物和有價證券，而 2024 年底約為 1.01 億美元。我們的應收帳款餘額為 2,420 萬美元。我們的應收帳款期限為 10 至 68 天，而我們的未收帳款天數約為 50 天。我們估計，截至 2025 年 3 月 31 日，我們的分銷網絡維持約三週的庫存。

Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib, and controlling our expenses.

整體而言，我們將繼續部署財務資源，專注於 NERLYNX 的商業化、alisertib 的開發以及控制我們的開支。

Thanks, Maximo. Puma's senior management, in cooperation with the Board of Directors, continues to remain focused on NERLYNX sales trends in 2025 and beyond and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income. We believe that the positive net income that was seen in fiscal years 2023 and 2024 resulted from the financial discipline across the company over the last three years.

謝謝，馬克西莫。Puma 的高階管理層與董事會合作，繼續關注 2025 年及以後的 NERLYNX 銷售趨勢，並認識到其對股東的財務責任，繼續保持正淨收入。我們認為，2023 財年和 2024 財年的正淨收入得益於公司過去三年的財務紀律。

The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company achieved in Q1 2025 and the company is guiding to for full year 2025. The company remains committed to continuing to achieve this positive net income, and we will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future.

我們先前已實施並將繼續實施的費用削減也是公司在 2025 年第一季實現正淨收入以及公司預計 2025 年全年實現正淨收入的重要因素。公司仍然致力於繼續實現這一正淨收入，如果需要的話，我們將繼續削減開支以實現這一目標。我們期待將來向投資者通報這一情況。

There continues to remain a significant unmet medical 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. And we will continue to strive to achieve that goal.

對於與乳癌、肺癌和其他實體腫瘤作鬥爭的患者來說，仍然存在著巨大的未滿足的醫療需求。我們 Puma 致力於並熱衷於尋找更有效的方法來幫助這些患者度過難關。我們將繼續努力實現這一目標。

This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

今天的演講到此結束。我們現在將把時間交還給接線員進行問答。操作員？

(Operator Instructions) Divya Rao, Cowen and Company.

（操作員指示）Divya Rao，Cowen and Company。

This is Divya on for Marc. I just had two questions on alisertib. One, I guess, could you talk about where the alisertib IP is held? Is it in Ireland? Is it in the US? And then also manufacturing? The comments that you made, was that just related to NERLYNX manufacturing? Or is that similar for alisertib as well?

這是 Divya 為 Marc 主持的。我剛剛對 alisertib 有兩個疑問。首先，您能談談 alisertib IP 在哪裡嗎？在愛爾蘭嗎？是在美國嗎？然後還有製造業？您發表的評論僅與 NERLYNX 製造有關嗎？或者這對 alisertib 來說也是類似的嗎？

And then I have a second question.

我還有第二個問題。

Hi, Divya, thank you for the question. So in terms of the IP, we actually have a license to the IP from Takeda. I need to get back to you on where it is physically located. The origin of alisertib is that it was originally developed by Millennium, which is here in the United States. I'm assuming that's where it is, but I don't have that information in front of me. So let me get back to you on that. It's a great question. I just don't have the information in front of me.

你好，Divya，謝謝你的提問。因此，就智慧財產權而言，我們實際上擁有武田的智慧財產權許可。我需要告訴你它的具體位置。alisertib 的由來是，它最初是由美國的 Millennium 公司開發的。我假設它就在那裡，但我面前沒有這方面的資訊。那麼就讓我回覆你這個問題。這是一個很好的問題。我面前只是沒有這些資訊。

Now, on the manufacturing, I believe it is mostly done in the US, if I'm remembering this correctly, currently. Now obviously, we're not at commercial scale. And we obviously will take into account tariffs and future tariffs and things like that in the future. But I believe right now, my remembrance of this is that we're doing it all in the US.

現在，就製造而言，如果我沒記錯的話，我相信目前大部分都是在美國完成的。顯然，我們還沒有達到商業規模。我們顯然會考慮關稅以及未來的關稅等問題。但我相信現在，我記得我們在美國做這一切。

Okay, that's helpful. Thank you.

好的，這很有幫助。謝謝。

Do you have another question on the IP? I kind of cut you off there. I apologize.

您對 IP 還有其他問題嗎？我打斷了你的話。我很抱歉。

No. No worries. I think you answered it. Thank you.

不。不用擔心。我想你回答了。謝謝。

Thank you.

謝謝。

Gena Wang, Barclays.

巴克萊銀行的 Gena Wang。

Hi. This is Hang Hu on behalf of Gena Wang from Barclays, we have a few questions. For alisertib, lung cancer Phase II trial, you just mentioned the protocol amendment for dose increase. Could you confirm whether the interim data readout will still be later this year? And in addition to the PK data, how did the response data looks like based on the current dose?

你好。我是巴克萊銀行的王吉娜代表 Hang Hu，我們有幾個問題。對於 alisertib 肺癌 II 期試驗，您剛才提到了劑量增加的方案修改。您能否確認中期數據是否仍將在今年稍後公佈？除了 PK 數據之外，基於當前劑量的反應數據是什麼樣的？

Second question is for the NERLYNX Phase I data presented at AACR '25. So some tumor types like pancreatic cancer showed a better response than others. How would you select the tumor type moving forward? And what the magnitude of PFS improvement expected based on the response data?

第二個問題是關於 AACR '25 上展示的 NERLYNX 第一階段資料。因此，某些類型的腫瘤（如胰腺癌）比其他類型的腫瘤表現出更好的反應。您將如何選擇未來的腫瘤類型？根據回應數據，預計 PFS 改善的幅度是多少？

And lastly, we would like to ask your view on the impact from the Medicare Part D redesign and also the new CBR director and the potential impact on the drug approval path.

最後，我們想問您對 Medicare Part D 重新設計以及新任 CBR 主任的影響以及對藥品審批途徑的潛在影響的看法。

Let me handle the first two. With regard to the small cell lung cancer, so we are amending the protocol to go from 50 to 60 milligrams. In the prior monotherapy trials of alisertib, if I remember correctly, they went up as high as 100 milligrams. So I think we're assuming we're going to be okay to go up to 60. I don't have the data in front of me in terms of what we would expect in terms -- obviously, we haven't dosed the patients at that level yet.

讓我來處理前兩個。對於小細胞肺癌，我們正在修改方案，從 50 毫克增加到 60 毫克。如果我沒記錯的話，在先前的 alisertib 單藥治療試驗中，劑量高達 100 毫克。所以我認為我們假設我們可以上升到 60。就我們預期而言，我面前還沒有數據——顯然，我們還沒有給患者註射那種劑量。

So I don't have the data in front of me in terms of what we'd expect in terms of changes in response rates and things like that. In terms of the biomarkers, again, I don't have the data in front of me. We did definitely see better activity in the patients where the Aurora kinase pathway played a role. We would expect we would probably see something similar to that at the higher doses as well. We still are planning to have data later this year. Obviously, the quicker we can get the amendment done and enroll patients, the more patients at 60 milligrams we could have. So I can't really speculate on that right now.

因此，我面前沒有關於我們預期的回應率變化和諸如此類的事情的數據。就生物標誌物而言，我面前還沒有數據。我們確實看到 Aurora 激酶路徑發揮作用的患者表現出更好的活性。我們預計在更高劑量下也可能會看到類似的結果。我們仍計劃在今年稍後獲取數據。顯然，我們越快完成修訂並招募患者，我們就能擁有越多的 60 毫克劑量患者。所以我現在還無法對此做出推測。

With regard to the NERLYNX Phase I, you are correct that we did tend to see more activity in the combination of neratinib within HER2. The reason for that is mechanistically based, which is, that neratinib being an irreversible HER2 inhibitor, it internalizes the HER2 receptor. So because of that, if you have an ADC, the perception is what you're doing is you're bringing more of the ADC into the cell that may be why we are seeing in tumor types where you historically have not seen much activity with in HER2 like pancreatic.

關於 NERLYNX 第一階段，您說得對，我們確實傾向於看到 HER2 內 neratinib 的組合具有更多的活性。原因在於機制，奈拉替尼是一種不可逆的 HER2 抑制劑，它可以內化 HER2 受體。因此，如果您有 ADC，那麼人們會認為您正在做的就是將更多的 ADC 帶入細胞，這可能是為什麼我們在歷史上沒有在 HER2 中看到太多活性的腫瘤類型（如胰腺癌）中看到這種現象。

We're seeing the better activity with the combination. Not clear what we would expect. I think we need more data to be able to say what we expect in terms of ORR, PFS, et cetera. But there's no question. We are extremely encouraged by it.

我們看到這種組合的效果更好。不清楚我們期望什麼。我認為我們需要更多數據才能說出我們對 ​​ORR、PFS 等方面的期望。但毫無疑問。我們對此感到非常鼓舞。

My understanding is that they've had quite a lot of interest in enrollment since we've opened the new cohorts. So I think we'll probably have some more data on that to talk about later this year. And I think my understanding is they're looking to present it publicly at a scientific conference probably in the first half of '26 is my recollection. In terms of your commentary on the FDA, that's CBER, we go through CDER. So not a whole lot we can really add in value.

據我了解，自從我們開設新班以來，他們對招生表現出了濃厚的興趣。所以我認為我們可能會在今年稍後討論更多有關這方面的數據。我的理解是，他們希望在科學會議上公開展示它，我記得大概是在 26 年上半年。就您對 FDA 的評論而言，那是 CBER，我們透過 CDER。因此，我們真正能夠增加的價值並不多。

And if you repeat your question on the Medicare, please?

請您再重複一下有關醫療保險的問題，好嗎？

Yes. So your view on the impact from Medicare Part D redesign in 2026 to '27.

是的。那麼，您對 2026 年至 2027 年 Medicare Part D 重新設計的影響有何看法？

So in terms of -- you're talking about the Medicare redesign, it was part of the IRA. Is that what you're asking about?

所以就您所談論的醫療保險重新設計而言，它是愛爾蘭共和軍的一部分。這就是你要問的嗎？

Yes.

是的。

Yeah. So great question. So we've been paying attention to that. What we've seen from the IRA portion is that co-pay for patients have actually declined somewhat in '25, and we expect them to decline in '26 as well. So we've actually seen an increase in the percent of our business going through Medicare and a subsequent slight decrease in that going to free goods. So it's actually been helpful to us. And it's made it slightly more affordable for patients to get on and stay on NERLYNX.

是的。這個問題問得真好。所以我們一直在關注這一點。我們從 IRA 部分看到，患者的共同支付費用在 25 年實際上有所下降，我們預計 26 年也會下降。因此，我們實際上看到透過醫療保險的業務比例增加，而免費商品的比例則略有下降。所以它實際上對我們有幫助。這也讓患者服用並繼續使用 NERLYNX 的費用稍微便宜一些。

Does that answer your question?

這回答了你的問題嗎？

Thank you.

謝謝。

This concludes our question-and-answer session. I would like to turn the conference call back over to Mariann for closing remarks.

我們的問答環節到此結束。我想將電話會議交還給瑪麗安，請她做最後發言。

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.

感謝大家今天的參與。提醒一下，今天稍後開始您可以透過 pumabiotechnology.com 上的網路直播重播來存取本次電話會議。祝您晚上愉快。

Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program. Everybody, have a great day. You may now disconnect.

女士們、先生們，感謝你們參加今天的電話會議。我們的節目到此結束。祝大家有個愉快的一天。您現在可以斷開連線。