Puma Biotechnology Inc (PBYI) 2023 Q4 法說會逐字稿

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

午安.我叫艾莉西亞，今天我將擔任您的電話會議接線生。（操作員說明）謹此提醒，此通話正在錄音。我現在想將電話會議轉給 Puma Biotechnology 的 IR 高級總監 Mariann Ohanesian。您可以開始您的會議了。

Thank you, Alicia. Good afternoon and welcome to Puma's conference call to discuss our financial results for the fourth quarter of 2023. 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.

謝謝你，艾莉西亞。下午好，歡迎參加 Puma 電話會議，討論我們 2023 年第四季的財務表現。今天和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，Jeff Ludwig，財務長。

After market close today, Puma issued a news release detailing fourth-quarter and full-year 2023 financial results. 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 @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，Puma 發布了一份新聞稿，詳細介紹了 2023 年第四季和全年財務業績。新聞稿、傑夫將參考的幻燈片以及本次電話會議的網路廣播均可透過我們網站 @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 the company's future expectations, plans and prospects that constitutes forward-looking statements for purposes of federal securities law. 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公司未來預期、計劃和前景的聲明，這些聲明構成聯邦證券法規定的前瞻性聲明。此類陳述存在風險和不確定性，實際事件和結果可能與這些前瞻性陳述中表達的有所不同。

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 year ended December 31, 2023. 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, February 29, 2024. The company 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.

如需對這些風險和不確定性進行全面討論，請查看我們不時向 SEC 提交的定期報告和當前報告，包括我們截至 2023 年 12 月 31 日的年度 10-K 表格年度報告。請您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之日（2024 年 2 月 29 日）的情況。除非法律要求，否則本公司不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後發生的事件或情況的義務。

During today's call, we may also 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 fourth-quarter 2023 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

在今天的電話會議中，我們也可能會提及某些涉及對我們的 GAAP 數據進行調整的非 GAAP 財務指標。我們相信，這些非公認會計原則指標可能對投資者有用，作為我們公認會計原則財務指標的補充，但不能替代。請參閱我們的 2023 年第四季新聞稿，以了解我們的 GAAP 與非 GAAP 業績的調整表。我現在將把電話轉給艾倫。

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the fourth quarter of $72.2 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sublicenses. Product revenue net was $53.2 million in the fourth quarter of 2023, which was an increase from the Q3 2023 and slightly below $53.7 million reported in Q4 2022.

謝謝瑪麗安，也謝謝大家今天加入我們的電話會議。今天，Puma 報告第四季總收入為 7,220 萬美元。總收入包括產品淨收入，其中完全包括 NERLYNX 銷售額以及我們的分授權的特許權使用費。2023 年第四季的產品淨收入為 5,320 萬美元，較 2023 年第三季有所成長，略低於 2022 年第四季的 5,370 萬美元。

Product revenue for the fourth quarter of 2023 was impacted by approximately $2.1 million of inventory increase at our specialty pharmacies and specialty distributors. Royalty revenue was $19 million in the fourth quarter of 2023 compared to $4.5 million in Q3 of 2023 and $12 million in Q4 of 2022. We reported 2,881 bottles of NERLYNX sold in the fourth quarter of 2023, essentially unchanged from the 2,874 bottles sold in Q3 of 2023.

2023 年第四季的產品收入受到我們的專業藥局和專業經銷商約 210 萬美元庫存增加的影響。2023 年第四季的特許權使用費收入為 1,900 萬美元，而 2023 年第三季為 450 萬美元，2022 年第四季為 1,200 萬美元。我們報告稱，2023 年第四季 NERLYNX 銷量為 2,881 瓶，與 2023 年第三季銷量 2,874 瓶基本持平。

In Q4 of '23, we estimate that inventory increased by about 127 bottles. In Q4 2023, new prescriptions or NRx were down approximately 9% compared to Q3 2023; and total prescriptions, TRx, were down approximately 7% compared to Q3 '23. Jeff will provide further details in his comments and slides.

23 年第四季度，我們估計庫存增加約 127 瓶。2023 年第四季度，新處方或 NRx 與 2023 年第三季相比下降了約 9%；與 23 年第三季相比，總處方量 TRx 下降了約 7%。傑夫將在他的評論和幻燈片中提供更多詳細資訊。

NERLYNX sales were negatively impacted by the decline in enrollments that we mentioned in our third quarter earnings call, a lower than anticipated rate of conversion from enrollment to commercial new patient starts and a higher than expected gross to net. Jeff and Maximo will discuss these topics further in their comments. We have continued to reduce our internal expenses to account for these factors as we recognize our fiscal responsibility to the shareholders and continue to be net income positive in 2024.

我們在第三季財報電話會議中提到的註冊人數下降、從註冊到商業新患者啟動的轉換率低於預期以及毛淨值高於預期，對 NERLYNX 的銷售產生了負面影響。Jeff 和 Maximo 將在他們的評論中進一步討論這些主題。我們認識到我們對股東的財務責任，並在 2024 年繼續實現正淨利潤，因此我們繼續減少內部支出，以應對這些因素。

I will now provide a clinical review of the quarter. Then Jeff Ludwig will add additional color on NERLYNX commercial activities and natural gas will follow with highlights of the key components of our financial statements for the fourth quarter of 2023.

我現在將提供本季度的臨床回顧。然後 Jeff Ludwig 將為 NERLYNX 商業活動添加更多色彩，隨後天然氣將重點介紹我們 2023 年第四季度財務報表的關鍵組成部分。

In February, we are pleased to announce that we initiated the alisertib in cancer or ALISCA-Lung 1 trial, a Phase 2 clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. This trial was previously referred to as Study PUMA-ALI-4201. The trial will enroll up to 60 patients with extensive-stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy.

今年 2 月，我們很高興地宣布啟動了 alisertib 癌症試驗或 ALISCA-Lung 1 試驗，這是一項 alisertib 單藥治療廣泛期小細胞肺癌患者的 2 期臨床試驗。該試驗之前稱為研究 PUMA-ALI-4201。該試驗將招募多達 60 名廣泛期小細胞肺癌患者，這些患者在一線鉑類化療和免疫治療後病情進展。

Patients must provide tissue-based biopsies so that biomarkers can be analysed. Alisertib will be dosed at 50 milligrams BID on days one to seven of every 21 day cycles. So our plan is to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy.

患者必須提供基於組織的活檢，以便分析生物標記。Alisertib 將在每 21 天週期的第一至第七天以 50 毫克 BID 給藥。因此，我們的計劃是進行初步中期分析，以評估生物標記以及療效評估。

As we discussed in our last earnings call, the goal of this Phase 2 study will be to confirm the efficacy of alisertib monotherapy in patients with small cell lung cancer with biomarkers where the aurora kinase pathway plays a role. The goal would be to correlate the efficacy of these biomarker subgroups in the ALISCA-Lung 1 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 previously published in the Journal of Thoracic Oncology in 2020.

正如我們在上次財報電話會議中討論的那樣，這項 2 期研究的目標是確認 alisertib 單藥療法對具有極光激酶通路發揮作用的生物標誌物的小細胞肺癌患者的療效。目標是將ALISCA-Lung 1 研究中這些生物標記亞組的功效與先前在紫杉醇加alisertib 與紫杉醇加安慰劑的隨機試驗中觀察到的生物標誌物亞組的功效相關聯，該隨機試驗先前發表在《Journal of Medicine》上。2020 年胸部腫瘤學。

If the efficacy and biomarker data are comparable from the two studies, the company believed it would represent a potential accelerated approval strategy and would engage FDA to discuss this further. We currently have four sites open for enrollment and expect to have 10 to 15 sites open within the next 30 to 60 days. We anticipate that we will be able to share interim data from this trial with investors in the second half of 2024.

如果兩項研究的功效和生物標記數據具有可比性，該公司相信這將代表一種潛在的加速批准策略，並將與 FDA 進一步討論這一問題。目前，我們有 4 個站點可供註冊，預計未來 30 至 60 天內將有 10 至 15 個站點開放。我們預計我們將能夠在 2024 年下半年與投資者分享該試驗的中期數據。

We also anticipate the initiation of ALISCA-Breast1, a Phase 2 trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive breast cancer in Q4 of 2024. We additionally anticipate two clinical data presentations on alisertib in the first half of 2024.

我們也預計將於 2024 年第四季啟動 ALISCA-Breast1，這是一項將 alisertib 與內分泌治療聯合治療初治 HER2 陰性、荷爾蒙受體陽性乳癌患者的 2 期試驗。我們也預計 2024 年上半年將發布兩項關於 alisertib 的臨床數據。

Investors will remember that the Phase 2 trial referred to as TBCRC-041, which was a Phase 2 trial of alisertib monotherapy versus alisertib plus endocrine therapy in patients with HER2-negative, hormone receptor-positive metastatic breast cancer was published in JAMA Oncology in 2023. As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of alisertib in patients with HER2 negative hormone receptor-positive metastatic breast cancer correlates with any biomarkers. We anticipate that the biomarker data from this trial will be presented in the first half of 2024.

投資人會記得，名為TBCRC-041 的2 期試驗於2023 年在《JAMA Oncology》雜誌上發表，該試驗是對HER2 陰性、激素受體陽性轉移性乳癌患者進行alisertib 單藥治療與alisertib 加內分泌治療的2 期試驗。作為該試驗的一部分，對生物標記進行了分析，以確定 alisertib 對 HER2 陰性激素受體陽性轉移性乳癌患者的療效是否與任何生物標記相關。我們預計該試驗的生物標記數據將於 2024 年上半年公佈。

In addition, there's an ongoing investigator-sponsored trial of alisertib given in combination with osimertinib in patients with metastatic EGFR-mutant non-small cell lung cancer. More specifically patients with metastatic EGFR-mutant non-small cell lung cancer are treated with osimertinib, and then at the time of progression, alisertib is added to osimertinib in order to see if alisertib can overcome osimertinib resistance.

此外，一項由研究者資助的試驗正在進行中，將 alisertib 與奧西替尼聯合用於治療轉移性 EGFR 突變非小細胞肺癌患者。更具體地說，患有轉移性EGFR 突變非小細胞肺癌的患者接受奧希替尼治療，然後在病情進展時，將阿利替尼添加到奧希替尼中，以觀察阿利替尼是否可以克服奧希替尼抗藥性。

Interim data on this trial as previously presented at ASCO, prior to Puma licensing the drug. We anticipate that updated data from this trial will be presented in the first half of 2024. Most notably, a recent biomarker analysis from this trial has demonstrated a subgroup of patients with a biomarker with aurora kinase pathway plays a role or alisertib appears to have much greater efficacy when added to osimertinib at the time of progression on osimertinib. This biomarker occurs in about half of the patients in the trial, which is consistent with the published literature on this biomarker in this patient population.

在 Puma 許可該藥物之前，先前在 ASCO 上公佈了該試驗的中期數據。我們預計該試驗的更新數據將於 2024 年上半年公佈。最值得注意的是，該試驗最近的一項生物標記分析表明，具有極光激酶通路生物標誌物的患者亞組發揮了作用，或者在奧希替尼進展時添加到奧希替尼時，阿利替尼似乎具有更大的療效。此生物標記出現在試驗中約一半的患者中，這與該患者群體中該生物標記的已發表文獻一致。

Based on this biomarker data, the trial is being amended to limit enrollment in the trial to only continue enrolling patients who have this biomarker. We believe that this might represent a another potential indication for alisertib, and we look forward to discussing this data with investors once it has been presented publicly.

根據該生物標記數據，該試驗正在進行修改，以限制試驗的招募對象，僅繼續招募具有該生物標記的患者。我們認為，這可能代表了 alisertib 的另一個潛在跡象，我們期待在公開發布後與投資者討論該數據。

As mentioned on previous earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-license 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. 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.

正如先前的財報電話會議和回答投資者問題時提到的，Puma 繼續評估幾種可能獲得許可的藥物，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。隨著進展，該公司將向投資者通報最新情況。我現在將把電話轉給彪馬商務長傑夫路德維希（Jeff Ludwig），以回顧我們本季的商業表現。

Hey, thanks, Alan. Appreciate it, and thanks to everyone for joining our fourth-quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward looking statements. Let me again start with a high-level overview of our commercial strategy, and then I will go into more details as we discuss specific slides.

嘿，謝謝，艾倫。對此表示讚賞，並感謝大家參加我們的第四季財報電話會議。在進行商業評論之前，請注意我將做出前瞻性陳述。讓我再次從我們的商業策略的高層次概述開始，然後在我們討論具體投影片時我將詳細介紹。

From a commercial strategy perspective, we believe that NERLYNX can benefit patients in the metastatic setting, but we remain heavily focused on early-stage breast cancer. We do not have direct competition in the extended adjuvant setting and believe that there remains significant unmet need, especially for patients who were deemed to be at higher risk or reoccurrence. We want to see NERLYNX play a larger role in helping patients reduce the risk of reoccurrence and avoid metastatic disease.

從商業策略的角度來看，我們相信 NERLYNX 可以使轉移性患者受益，但我們仍然專注於早期乳癌。我們在擴展輔助治療方面沒有直接競爭，並且認為仍然存在大量未滿足的需求，特別是對於那些被認為具有較高風險或復發的患者。我們希望看到 NERLYNX 在幫助患者降低復發風險和避免轉移性疾病方面發揮更大作用。

We believe NERLYNX continues to be promotionally sensitive. Our sales and marketing teams are working hard to expand their reach and frequency, both with personal and nonpersonal promotion. HCP calls in the fourth quarter increased about 12% year over year with about 80% of those calls being live interactions. In addition to pure call activity, we are using internal and external data to try and improve our abilities to engage with clinicians at the right time, given the various treatment decisions and duration of therapies.

我們相信 NERLYNX 仍然具有促銷敏感性。我們的銷售和行銷團隊正在努力透過個人和非個人促銷來擴大其影響範圍和頻率。第四季 HCP 通話量年增約 12%，其中約 80% 是即時互動。除了純粹的呼叫活動之外，考慮到各種治療決策和治療持續時間，我們還使用內部和外部數據來嘗試提高我們在正確的時間與臨床醫生接觸的能力。

Finally, as a commercial organization, we remain committed to being more efficient and effective with our resources. We will continue to adapt to the changes in the business and the needs of the broader Puma organization. Let me now transition to some of the commercial slides where I will provide some additional specifics around performance. Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results.

最後，作為一個商業組織，我們仍然致力於提高我們的資源的效率和效力。我們將繼續適應業務的變化和更廣泛的 Puma 組織的需求。現在讓我過渡到一些商業幻燈片，我將在其中提供一些有關性能的其他細節。完成後，我會將電話轉給 Maximo，以便對我們的財務表現進行更詳細的審查。

Turning to slide 3. Slide 3 provides an overview of our distribution model. Now this model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and a specialty distributor channel. We do see quarterly fluctuations, but the majority of our business continues to flow through the specialty pharmacy channel.

轉到投影片 3。幻燈片 3 概述了我們的分發模型。現在這種模式沒有改變，仍然分為兩個不同的通路：專業藥局通路和專業經銷商通路。我們確實看到季度波動，但我們的大部分業務繼續透過專業藥局管道流動。

In Q4, about 74% of our business went through the specialty pharmacy channel and our remaining 26% went through the specialty distributor channel. As a comparison, this compares to the 80% specialty pharmacy channel and 20% specialty distributor channel that we reported in Q3 of '23.

第四季度，我們約 74% 的業務透過專業藥局管道，其餘 26% 透過專業經銷商通路。作為比較，這與我們在 23 年第三季報告的 80% 專業藥局通路和 20% 專業經銷商通路進行了比較。

Turning to slide 4, NERLYNX net revenue in Q4 2023 was $53.2 million, which is a $1.6 million increase from the $51.6 million we reported in Q3 of '23 and about a $500,000 reduction from the $53.7 million we reported in Q4 of 2022. Inventory changes will impact these comparisons, so let me provide some additional information here. In Q4 2023, we estimated that inventory increased by about $2.1 million. As a comparison, we estimate that inventory increased by about $600,000 in Q3 of '23 and increased by about $2.6 million in Q4 of 2022.

轉向投影片4，NERLYNX 2023 年第四季的淨收入為5,320 萬美元，比我們在2023 年第三季報告的5,160 萬美元增加了160 萬美元，比我們在2022 年第四季報告的5,370 萬美元減少了約50 萬美元。庫存變化會影響這些比較，所以讓我在這裡提供一些額外的資訊。2023 年第四季度，我們估計庫存增加約 210 萬美元。作為比較，我們估計 23 年第三季庫存增加約 60 萬美元，2022 年第四季庫存增加約 260 萬美元。

Turning to Slide 5. Slide 5 shows Q4 2023 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. In Q4 of 2023, NERLYNX's ex-factory bottle sales were 2,881, which represents a slight increase of about 0.2% quarter over quarter and a 13% decline year over year.

轉到投影片 5。幻燈片 5 顯示了 2023 年第四季度出廠瓶銷量，並提供了同比和環比比較。2023年Q4，NERLYNX出廠瓶銷售量為2,881瓶，較上季小幅成長約0.2%，較去年同期下降13%。

Let me again provide more specifics around the inventory impact, which is also included at the bottom of this slide. We estimate that inventory increased by about 127 bottles in the fourth quarter of 2023. As a comparison, we estimate that inventory increased by about 164 bottles in Q4 of 2022 and increased by about 32 bottles in Q3 of 2023.

讓我再次提供有關庫存影響的更多細節，這也包含在本投影片的底部。我們預計 2023 年第四季庫存將增加約 127 瓶。作為比較，我們估計2022年第四季庫存增加約164瓶，2023年第三季庫存增加約32瓶。

Now, let me share some additional metrics and insights into our fourth quarter performance. In Q4, we saw new patient starts or NRx declined about 9% quarter over quarter and about 25% year over year. In terms of total prescriptions or TRx, we saw about 7% quarter over quarter decline and about 17% decline year over year.

現在，讓我分享一些有關我們第四季度業績的其他指標和見解。在第四季度，我們看到新患者數量或 NRx 環比下降約 9%，年減約 25%。就總處方量或 TRx 而言，我們看到環比下降約 7%，年減約 17%。

Our SD business did grow 10% quarter over quarter and about 4% year over year. As a reminder, we do not pick up NRx or TRx data in the SD channel. Overall, demand decreased 3.1% quarter over quarter and about 12.8% year over year.

我們的 SD 業務較上季成長了 10%，年成長了 4% 左右。提醒一下，我們不會在 SD 頻道中擷取 NRx 或 TRx 資料。整體而言，需求季減 3.1%，年減約 12.8%。

As Alan mentioned, Q4 performance was negatively impacted by several factors. First, let me talk about enrollments. Enrollments are a very important leading indicator as they convert into new patient starts, new patient starts turning into refills, which influence performance in subsequent quarters.

正如艾倫所提到的，第四季的業績受到多種因素的負面影響。首先，我來說一下招生。註冊人數是一個非常重要的領先指標，因為它們會轉化為新患者的開始，新患者開始轉化為補充，這會影響隨後幾季的表現。

Q4 performance was negatively impacted by the decline in enrollments we saw in Q3 and discussed during the Q3 earnings call. Soft Q3 enrollments had a negative impact on fourth quarter new patient starts, TRx, and overall demand. As I mentioned during the third quarter earnings call, we did see the enrollment trend improve as the third quarter progressed.

我們在第三季看到並在第三季財報電話會議上討論過的入學人數下降對第四季的業績產生了負面影響。第三季的入院人數疲軟對第四季的新病患開工率、TRx 和整體需求產生了負面影響。正如我在第三季財報電話會議上提到的，隨著第三季的進展，我們確實看到入學趨勢有所改善。

Early in the fourth quarter, we increased the amount of HCP nonpersonal promotion. As we have discussed with investors in prior earnings calls, we typically see a decline in enrollments in the fourth quarter as patients delay starting therapy until after the holidays.

第四季初，我們增加了 HCP 非個人晉升的數量。正如我們在先前的財報電話會議中與投資者討論的那樣，我們通常會看到第四季度的入組人數下降，因為患者將開始治療推遲到假期之後。

In Q4, we were pleased to see enrollments continue to improve from Q3, and we saw Q4 enrollments grow 12% sequentially. This is the first time we have seen this growth Q4 over Q3. We are hopeful that this increase in nonpersonal promotion was contributor to this enrollment growth; however, we are waiting on additional data before making that conclusion.

在第四季度，我們很高興看到入學人數較第三季度繼續提高，並且第四季度的入學人數環比增長了 12%。這是我們第一次看到第四季比第三季出現這種成長。我們希望非個人晉升的增加能促進入學人數的成長；然而，在做出這一結論之前，我們正在等待更多數據。

The second factor that negatively impacted our Q4 performance was the conversion rate from enrollments to commercial new patient starts. In Q4, we saw a decrease in a percent of patients converting from enrollments to new patient starts with the majority of that being driven by an increase in PAP or free goods. We do see quarterly fluctuations in these conversion rates, but in Q4 we had this metric move in a negative direction.

對我們第四季業績產生負面影響的第二個因素是從入組到商業新病患啟動的轉換率。在第四季度，我們發現從入組患者轉為新患者的患者比例有所下降，其中大部分是由於 PAP 或免費商品的增加。我們確實看到這些轉換率出現季度波動，但在第四季度，我們的這項指標朝負方向移動。

Turning to slide 6. Slide 6 highlights the adoption of dose escalation since launch. We continue to believe that monitoring the adoption of dose escalation is an important metric for NERLYNX. Patients that started a reduced dose will experience significantly lower Grade 3 diarrhea and are likely to have a lower rate of discontinuation.

轉到投影片 6。投影片 6 重點介紹了自上市以來劑量遞增的採用情況。我們仍然相信，監測劑量遞增的採用是 NERLYNX 的一個重要指標。開始減少劑量的患者的 3 級腹瀉發生率將顯著降低，停藥率也可能較低。

In Q4, approximately 76% of patients who received commercial drug started NERLYNX on a lower daily dose. We have seen a fairly steady increase in the adoption of dose escalation over the last several years, and I am pleased with the feedback that we receive from customers.

在第四季度，大約 76% 接受商業藥物的患者以較低的每日劑量開始 NERLYNX。在過去的幾年裡，我們看到劑量遞增的採用相當穩定地增加，我對我們從客戶那裡收到的回饋感到滿意。

Slide 7 highlights the collaborations we have formed across the globe. I have highlighted in red a number of updates since our Q3 earnings call. We are pleased to announce that in late Q3, NERLYNX received regulatory approval in Mexico in the metastatic setting and also received regulatory approval in the United Arab Emirates in the extended adjuvant setting.

投影片 7 重點介紹了我們在全球範圍內形成的合作。自從第三季財報電話會議以來，我用紅色突出顯示了一些更新。我們很高興地宣布，在第三季末，NERLYNX 在轉移性治療中獲得了墨西哥監管機構的批准，在阿拉伯聯合大公國的擴展輔助治療中也獲得了監管機構的批准。

In addition, in Q1, NERLYNX recently received regulatory approval in Syria in the extended adjuvant setting and was officially launched in Morocco, also in the extended adjuvant setting. We truly appreciate all the efforts put forth by our partners to make NERLYNX available to more patients around the world.

此外，在第一季度，NERLYNX 最近在敘利亞獲得了監管部門的批准，用於延長佐劑設置，並在摩洛哥正式推出，同樣用於延長佐劑設置。我們衷心感謝我們的合作夥伴為使 NERLYNX 為世界各地更多患者提供服務所付出的所有努力。

I'd like to wrap up by thanking my colleagues at Puma for their passion and dedication to making an impact on the lives of patients and their families battling cancer. This team is committed to finding ways to be more efficient and effective and adapting to the changing needs of the business. I will now turn the call over to Maximo for a review of our full financial results. Maximo?

最後，我要感謝彪馬的同事們的熱情和奉獻精神，為與癌症奮鬥的患者及其家人的生活帶來影響。該團隊致力於尋找更有效率、更有效的方法，並適應不斷變化的業務需求。我現在將把電話轉給馬克西莫，以審查我們的全部財務表現。馬克西莫？

Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2023. Please note that I will make comparisons to Q3 2023, 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 2023 10-K, which will be filed today and includes our consolidated financial statements.

謝謝，傑夫。我將首先簡要概述 2023 年第四季的財務表現。請注意，我將與 2023 年第三季進行比較，我們認為這比同比比較更能表明我們作為一家商業公司的進展。如需了解更多信息，我建議您參閱我們將於今天提交的 2023 年 10-K，其中包括我們的合併財務報表。

In the fourth quarter of 2023, we reported net income based on GAAP of $12.3 million or $0.26 per share. This compares to net income in Q3 2023 of $5.8 million or $0.12 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $14.8 million or $0.31 per share for the fourth quarter of 2023.

2023 年第四季度，我們公佈的基於 GAAP 的淨利潤為 1,230 萬美元，即每股 0.26 美元。相比之下，2023 年第三季的淨利潤為 580 萬美元，即每股 0.12 美元。根據非公認會計準則（為消除股票薪酬費用的影響而進行調整），我們報告 2023 年第四季淨利潤為 1,480 萬美元，即每股 0.31 美元。

Gross revenue from NERLYNX sales was $64.9 million in Q4 2023 and $60.4 million in Q3 2023. As Alan mentioned it, net product revenue from NERLYNX sales was $53.2 million, an increase from $51.6 million reported in Q3 2023. Q4 net sales were impacted by lower volumes in Q3 as well as a higher gross-to-net in Q4.

2023 年第四季 NERLYNX 銷售總收入為 6,490 萬美元，2023 年第三季為 6,040 萬美元。正如 Alan 所提到的，NERLYNX 銷售的產品淨收入為 5,320 萬美元，比 2023 年第三季報告的 5,160 萬美元有所增加。第四季的淨銷售額受到第三季銷量下降以及第四季毛淨額較高的影響。

Inventory build up by our distributors was approximately $2.1 million in Q4, which was lower than expected versus approximately $0.6 million buildup in Q3 2023. Royalty revenue totaled at $19 million in the fourth quarter of 2023 compared to $4.5 million in Q3 2023. Higher royalties versus Q3 reflect the timing of shipments to our partner in China as we noted last quarter.

我們的經銷商在第四季的庫存累積約為 210 萬美元，低於預期，而 2023 年第三季的庫存累積約為 60 萬美元。2023 年第四季的特許權使用費收入總計 1,900 萬美元，而 2023 年第三季為 450 萬美元。正如我們上季度指出的那樣，與第三季度相比較高的特許權使用費反映了向中國合作夥伴發貨的時間。

Our gross-to-net adjustment in Q4 2023 was about 18.1% compared to the 14.6% gross-to-net adjustment recorded in Q3 2023. Higher Medicaid routes share, particularly from patients in Puerto Rico and higher government charge-backs were the main drivers of the increase versus Q3 2023.

我們 2023 年第四季的毛淨值調整約為 18.1%，而 2023 年第三季的毛淨值調整為 14.6%。與 2023 年第三季相比，醫療補助路線份額增加（尤其是來自波多黎各患者的醫療補助路線份額）和政府退款增加是這一增長的主要驅動因素。

Cost of sales for Q4 2023 was $24.3 million, including $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2023 was $13.3 million. Going forward, we will continue to recognize amortization of milestones to the licensor of about $2.4 million per quarter as cost of sales.

2023 年第四季的銷售成本為 2,430 萬美元，其中包括與我們的 neratinib 許可相關的無形資產攤銷 240 萬美元。2023 年第三季的銷售成本為 1,330 萬美元。展望未來，我們將繼續將許可方每季約 240 萬美元的里程碑攤銷確認為銷售成本。

For fiscal year 2024, Puma anticipates that NERLYNX product revenue will be in the range of $183 million to $190 million. We also anticipate that our gross to net adjustment for the full year 2024 will be between 21.5% and 22.5%, driven by the Inflation Reduction Act and higher expected Medicaid rebates.

2024財年，Puma預計NERLYNX產品營收將介於1.83億美元至1.9億美元之間。我們也預計，在《通貨膨脹削減法案》和預期較高的醫療補助回扣的推動下，2024 年全年的毛淨調整將在 21.5% 至 22.5% 之間。

In addition, for fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of $30 million to $33 million. We expect license revenue in 2024 in the range of $1 million to $2 million. We also expect the net income for the full year will be in the range of $12 million to $15 million.

此外，在 2024 財年，我們預計將從世界各地的合作夥伴處獲得 3,000 萬至 3,300 萬美元的特許權使用費。我們預計 2024 年的授權收入將在 100 萬美元至 200 萬美元之間。我們也預計全年淨利潤將在 1200 萬美元至 1500 萬美元之間。

We anticipate that for Q1 2024, NERLYNX product revenue net will be in the range of $38 million to $40 million. Also, we expect Q1 royalty revenues will be in the range of $2.5 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q1 2024 will be approximately 23% to 24%.

我們預計 2024 年第一季，NERLYNX 產品淨收入將介於 3,800 萬美元至 4,000 萬美元之間。此外，我們預計第一季的特許權使用費收入將在 250 萬美元至 300 萬美元之間，並且沒有許可收入。我們進一步估計 2024 年第一季的毛淨調整約為 23% 至 24%。

We must anticipate a Q1 net loss of between $10 million and $12 million. Puma anticipates a Q1 net loss between $10 million and $12 million. As investors are aware, Q1 usually represent the lowest net product revenue on the fourth quarter due to the burn-off from inventory build from Q4.

我們必須預期第一季的淨虧損將在 1,000 萬至 1,200 萬美元之間。Puma 預計第一季淨虧損在 1,000 萬美元至 1,200 萬美元之間。正如投資者所知，由於第四季度庫存增加的消耗，第一季通常代表第四季度最低的淨產品收入。

Also due to our litigation expense and a one-time alisertib expense, we expect higher expenses in Q1 than other quarters in 2024. Due to those items, we are forecasting a net loss in Q1, but anticipate that we will be net income positive for the remainder of 2024 as well as for the full year.

此外，由於我們的訴訟費用和一次性 alisertib 費用，我們預計 2024 年第一季的費用將高於其他季度。由於這些項目，我們預計第一季將出現淨虧損，但預計 2024 年剩餘時間以及全年淨利潤將為正值。

SG&A expenses were $20.2 million in the fourth quarter of 2023, compared to $22.8 million for the third quarter. SG&A expenses included noncash charges for stock-based compensation of $1.8 million for Q4 2023, unchanged from Q3 2023.

2023 年第四季的銷售管理及行政費用為 2,020 萬美元，而第三季為 2,280 萬美元。SG&A 費用包括 2023 年第四季股票薪酬非現金費用 180 萬美元，與 2023 年第三季持平。

Research and development expenses were $12.9 million in the fourth quarter of 2023 compared to $11.4 million for the third quarter. R&D expenses included non-cash charges for stock-based compensation of $0.8 million in the fourth quarter of 2023, unchanged from the third quarter.

2023 年第四季的研發費用為 1,290 萬美元，而第三季的研發費用為 1,140 萬美元。研發費用包括 2023 年第四季 80 萬美元的基於股票薪酬的非現金費用，與第三季持平。

On the expense side, Puma anticipates flat total operating expenses in 2024 compared to 2023. More specifically, we anticipate SG&A expenses to decrease by 8% to 12% and R&D expenses to increase 17% to 20% year over year. Due to our litigation expenses, we expect G&A expenses in Q1 and Q2 to be significantly higher than Q3 and Q4.

在費用方面，Puma 預計 2024 年的總營運費用將與 2023 年持平。更具體地說，我們預計 SG&A 費用將年減 8% 至 12%，研發費用將年增 17% 至 20%。由於我們的訴訟費用，我們預計第一季和第二季的一般管理費用將顯著高於第三季和第四季。

In the fourth quarter of 2023, Puma reported cash earn of approximately $10.4 million. This compares to cash earn of approximately $10.6 million in Q3 2023. For a full year, Puma reported cash earn of approximately $14.4 million.

2023 年第四季度，Puma 報告現金收入約 1,040 萬美元。相比之下，2023 年第三季的現金收入約為 1,060 萬美元。Puma 全年現金收入約 1,440 萬美元。

2023, we made a $12.5 million payment for a sales milestone from Pfizer and an $8 million settlement payment as well. At December 31, 2023, we had approximately $96 million cash, cash equivalents, and marketable securities versus $81 million a year earlier. Our accounts receivables balance was $47.8 million.

2023 年，我們向輝瑞支付了 1,250 萬美元的銷售里程碑付款，並支付了 800 萬美元的和解金。截至 2023 年 12 月 31 日，我們擁有約 9,600 萬美元的現金、現金等價物和有價證券，而一年前為 8,100 萬美元。我們的應收帳款餘額為 4,780 萬美元。

Our accounts receivable terms range between 10 and 68 days, while our days sales outstanding to about 46 days. We estimate that as of December 31, 2023, our distribution network maintain 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.

我們的應收帳款期限為 10 至 68 天，而應收帳款天數約為 46 天。我們估計，截至 2023 年 12 月 31 日，我們的分銷網絡維持約三週的庫存。總體而言，我們繼續部署財務資源，專注於 NERLYNX 的商業化、alisertib 的開發以及控制我們的開支。

Thanks, Massimo. We are pleased to report positive net income for the fourth quarter of 2023 and for full year 2023. Puma's senior management in cooperation with the Board of Directors continues to remain focused in nearing sales trends in 2024 and beyond and recognizes this fiscal responsibility to shareholders to continue to maintain positive net income.

謝謝，馬西莫。我們很高興地報告 2023 年第四季和 2023 年全年實現正淨利。Puma 的高階管理層與董事會合作，繼續關注 2024 年及以後的銷售趨勢，並認識到股東的財務責任，以繼續保持正的淨利潤。

In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operational cash flows. We believe that the positive net income reported in the fourth quarter and for the full year 2023 reflects these expense reduction.

2021年第四季度，我們實施了費用削減，目的是減少開支，以實現營運現金流最大化。我們認為，第四季和 2023 年全年報告的正淨利潤反映了這些費用的減少。

Expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company is guiding to for full year 2024. 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.

我們先前實施並持續實施的費用削減也是公司 2024 年全年實現正淨利潤的主要貢獻者。該公司仍然致力於繼續實現這一正淨利潤，並將在需要時繼續減少開支以實現這一目標。我們期待未來向投資者通報最新情況。

It 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 and 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，它仍然是一個未被滿足的重大需求。Puma 致力於並熱衷於尋找更有效的方法並在患者的治療過程中為他們提供幫助，我們將繼續努力實現這一目標。

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

今天的演講到此結束。我們現在將把電話轉回給接線員進行問答。操作員？

(Operator Instructions) Divya Rao, TD Cowen.

（操作員說明）Divya Rao，TD Cowen。

Hi, guys. Congrats on the quarter. This is Divya on for Marc. So I had a few questions on the Phase 2 trial in small cell lung cancer. One would be, in terms of the second half days disclosure, should we expect it to be at a medical meeting or do you think it could be a press release?

嗨，大家好。恭喜本季。這是 Divya 替 Marc 發言。我對小細胞肺癌的第二期試驗有一些疑問。其中一個問題是，就下半年的揭露而言，我們是否應該期望它在醫療會議上進行，或者您認為它可能是新聞稿？

And then my second question is, I know you mentioned that the biomarker data was going to be one of the metrics that you use from the interim analysis to determine whether you move forward talking with the FDA. Is the Alisertib combo trial with paclitaxel also the best bar to look at when you're looking at efficacy and you feel like you want to see both the biomarker and the efficacy data kind of line up with that trial before moving forward with the FDA on a future discussion? Thanks.

然後我的第二個問題是，我知道你提到生物標記數據將成為你從中期分析中使用的指標之一，以確定你是否繼續與 FDA 對話。當您考慮療效並且希望在向 FDA 提出申請之前看到生物標記和療效數據與該試驗一致時，Alisertib 與紫杉醇的組合試驗是否也是最好的選擇？未來的討論？謝謝。

Yeah. So Divya, thank you for your question. In terms of the disclosure, I would imagine it would be something more direct to investors, not at a medical meeting because just to present at a medical meeting, you have to submit lab abstract and there's a lead time there. And I'm not sure how much data we would have to submit to at a medical meeting.

是的。Divya，謝謝你的提問。就披露而言，我認為這對投資者來說會更直接，而不是在醫學會議上，因為僅僅為了在醫學會議上發言，你就必須提交實驗室摘要，並且有一個準備時間。我不確定我們必須在醫學會議上提交多少數據。

So a medical meeting presentation, I would guess probably is more of a 2025 event, but presenting that in some way, shape, or form to investors, that would be the way we would do this; and obviously, in as much detail as we can.

因此，我認為醫學會議演示可能更像是 2025 年的活動，但以某種方式、形式或形式向投資者展示，這將是我們這樣做的方式；顯然，我們會盡可能詳細地說明。

As we mentioned, we're going to be greatly increasing the number of sites this month. And so we're anticipating we're going to have a good number of patients to talk about. In terms of your second question, so obviously, in small cell lung cancer, you have both the chemotherapy sensitive group and the chemotherapy refractory group or the resistant group. So it's two different totally homogeneous.

正如我們所提到的，本月我們將大幅增加網站數量。因此，我們預計將有大量患者可以討論。關於你的第二個問題，很明顯，在小細胞肺癌中，既有化療敏感組，也有化療難治組或抗藥性組。所以它是兩個不同的完全同質的。

I don't know that cross trial comparison is going to be -- compared to this trial, it gets a little tricky in terms of prior treatments and things like that. I think the clear signal we're looking for is both response rate and PFS. But to see something that's better in the group that has the biomarker, has been doesn't from the early, data because again, the thesis we have is that, alisertib is an aurora kinase inhibitor. So the biomarkers that are involved in the aurora kinase pathway is where we should see the best efficacy.

我不知道交叉試驗比較會——與這次試驗相比，在先前的治療和類似的事情方面會變得有點棘手。我認為我們正在尋找的明確訊號是回應率和 PFS。但是，從早期數據來看，在具有生物標記的群體中看到更好的東西是不可能的，因為我們的論點是，alisertib 是一種極光激酶抑制劑。因此，參與極光激酶途徑的生物標記是我們應該看到最佳功效的地方。

That's really the signal we want to confirm. Because of different numbers and things like that, I'm not quite sure if we're going to want to do cross-trial comparisons quite yet. But in terms of the early data, that's really what we're going to be looking for is to see, is there a biomarker subgroup that selects for the patients who are most likely to benefit from the drug.

這確實是我們想要確認的訊號。由於不同的數字和類似的事情，我不太確定我們是否想要進行交叉試驗比較。但就早期數據而言，我們真正要尋找的是是否有一個生物標記亞群可以選擇最有可能從該藥物中受益的患者。

Got it. That's helpful. Thank you.

知道了。這很有幫助。謝謝。

Gena Wang.

王吉娜.

Hi, good afternoon. Thanks for taking your questions. This is Rashida on for Gena. I had a couple on alisertib, and Alan, you touched on this a little bit in the previous question. But I wanted to get some more color on what the efficacy bar would be for alisertib in the small cell trial?

嗨，下午好。感謝您提出問題。這是拉什達（Rashida）代表吉娜（Gena）發言。我在 alisertib 上有幾個，艾倫，你在上一個問題中談到了這一點。但我想進一步了解小細胞試驗中 alisertib 的功效欄是什麼？

And I understand you disclosed that you don't want to make cross-trial comparisons, but any color you can shed on how you're thinking about alisertib, especially in light of the DLL3 targeting agents that are in development, including Amgen's polatuzumab that has approval later this year, and Harpoon's TriTAC, that got taken over by Merck. They had shown some early results in Phase 1. So just keeping this in the background, I was curious if you could shed some color on how you're thinking about alisertib.

據我所知，您透露您不想進行跨試驗比較，但您可以透露您對 alisertib 的看法，特別是考慮到正在開發的 DLL3 標靶藥物，包括 Amgen 的 polatuzumab今年晚些時候獲得批准，Harpoon 的TriTAC已被默克公司收購。他們在第一階段展示了一些早期結果。因此，只是將其保留在背景中，我很好奇您是否可以透露一些您對 alisertib 的看法。

Yeah. So with reference to the deal of three drugs, trastuzumab was a third line drug. So challenging from that perspective, just try to compare second line third line. And also I would say that, while I recognize, response rate is the typical thing people like to do cross-trial comparisons on.

是的。因此，就三種藥物的交易而言，曲妥珠單抗是第三線藥物。從這個角度來看具有挑戰性，只需嘗試比較第二線和第三線。我還要說，雖然我認識到，反應率是人們喜歡進行跨試驗比較的典型因素。

As you're aware, you can't just get approval on response rate. You need actually show a magnitude of that benefit, so a PFS or survival benefit. So I think all of those are going to be important for us to look at. There is data on alisertib as a monotherapy that was published in Lancet Oncology previously. And off the top my head, remembering it was like a 20%-ish response rate and some around three month PFS in a non selected group.

如您所知，您不能僅根據回覆率獲得批准。您需要實際顯示該益處的大小，即 PFS 或生存益處。所以我認為所有這些對我們來說都很重要。先前曾在《刺胳針腫瘤學》上發表有關 alisertib 作為單一療法的數據。我突然想到，在非選定組中，反應率大約為 20%，無惡化存活期約為 3 個月。

So that would kind of be the only data we have for alisertib as a single agent if you will. But trying to compare it to other agents, especially just looking at response rates. In small cell lung cancer, unfortunately, you've seen lots of drugs that have got really high response rate, but they can't confirm the clinical benefits because of no increase in PFS or OS. So I think, again, it's going to be really a totality of data where we want to see a response rate improvement, a PFS improvement. And the PFS and the OS, obviously, are going to be the ones going to be more important to us.

因此，如果您願意的話，這將是我們作為單一代理擁有的 alisertib 的唯一數據。但嘗試將其與其他代理進行比較，尤其是僅查看回應率。不幸的是，在小細胞肺癌中，您已經看到許多藥物具有非常高的緩解率，但由於 PFS 或 OS 沒有增加，因此它們無法確認臨床益處。所以我再次認為，這將是一個真正的數據整體，我們希望看到回應率的提高、PFS 的提高。顯然，PFS 和作業系統對我們來說將更加重要。

Got it. Thank you. That's helpful. And then just a quick question again on alisertib. Have you disclosed what the exact royalty percentages you owe to Takeda if the product's approved commercialized?

知道了。謝謝。這很有幫助。然後再問一個關於 alisertib 的簡單問題。您是否曾揭露過，如果該產品獲準商業化，您應向武田支付的具體特許權使用費百分比為何？

I do not have that in front of me. In terms of our public disclosure. My recollection is we said something in the single digit range if I remember correctly.

我面前沒有那個。就我們的公開揭露而言。我的記憶是，如果我沒記錯的話，我們說了個位數範圍內的事。

That helpful. Got it. Thank you so much.

很有幫助。知道了。太感謝了。

Thank you. There are no further questions at this time. I would like to turn the conference back over to Mariann for closing comments.

謝謝。目前沒有其他問題。我想將會議轉回瑪麗安以徵求結束意見。

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.

感謝大家今天加入我們。提醒一下，從今天晚些時候開始，可以透過 pumabiotechnology.com 上的網路廣播重播來觀看此電話會議。祝你晚上愉快。

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

女士們、先生們，感謝你們參加今天的電話會議。我們的計劃到此結束。每個人都度過了美好的一天。您可以斷開連線。