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Operator
Operator
Good afternoon. My name is Darryl, and I will be your conference call operator today. (Operator Instructions) As a reminder, this call is being recorded.
午安.我叫 Darryl,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 call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.
現在,我想將電話會議轉給 Puma Biotechnology IR 高級總監 Mariann Ohanesian。您可以開始您的會議了。
Mariann Ohanesian - Investor Relations
Mariann Ohanesian - Investor Relations
Thank you, Darryl. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the fourth quarter of 2024. 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; and Jeff Ludwig, Chief Commercial Officer.
謝謝你,達裡爾。下午好,歡迎參加 Puma 電話會議,討論我們 2024 年第四季的獲利結果。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;以及首席商務官 Jeff Ludwig。
After the closing statement issued a news release detailing earnings results for the fourth quarter of 2024. That news release, slides that Jeff will refer to, and a webcast of accessible 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.
收盤聲明後發布了一份新聞稿,詳細介紹了 2024 年第四季的獲利結果。新聞稿、Jeff 將參考的幻燈片、以及我們網站 pumabiotechnology.com 上可存取和投資者部分的網路廣播。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. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time. Including our annual report on Form 10-K for the year ended December 31, 2024.
今天的電話會議將包括有關 Puma 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。要全面討論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和當前報告。包括我們截至 2024 年 12 月 31 日的 10-K 表年度報告。
You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date of this live conference call, February 27, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call except as required by law.
請注意不要過度依賴這些前瞻性陳述,這些陳述僅代表截至本次電話會議日期(2025 年 2 月 27 日)的觀點。除法律要求外,彪馬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 fourth-quarter 2024 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 GAAP 指標可能對投資者有用,可以作為我們 GAAP 財務指標的補充,但不能取代。請參閱我們的 2024 年第四季財報報告,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。
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Thank you, Mariann, and thank you all for joining our call today.
謝謝你,瑪麗安,也謝謝大家今天參加我們的電話會議。
Today, Puma reported total revenue for the fourth quarter of 2024 of $59.1 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sublicensees.
今天,彪馬公佈2024年第四季總營收為5,910萬美元。總收入包括產品淨收入(完全由 NERLYNX 銷售額以及來自我們的再授權商的特許權使用費組成)。
Product revenue net was $54.4 million in the fourth quarter of 2024, which declined from $56.1 million reported in Q3 2024 and increased from the $53.2 million reported in Q4 2023. Product revenue for the fourth quarter of 2024 was impacted by approximately $3.7 million of inventory increase at our specialty pharmacies and distributors.
2024 年第四季產品收入淨額為 5,440 萬美元,低於 2024 年第三季報告的 5,610 萬美元,高於 2023 年第四季報告的 5,320 萬美元。2024 年第四季的產品收入受到我們專業藥局和經銷商的庫存增加約 370 萬美元的影響。
Royalty revenue was $4.7 million in the fourth quarter of 2024 compared to $24.4 million in Q3 2024 and $19.0 million in Q4 2023. Royalty revenue in the third quarter of 2024 and fourth quarter of 2023 included the sales to China by our partner, Pierre Fabre, as we noted in our calls for those quarters.
2024 年第四季的特許權使用費收入為 470 萬美元,而 2024 年第三季為 2,440 萬美元,2023 年第四季為 1,900 萬美元。正如我們在這些季度的電話會議上所指出的,2024 年第三季和 2023 年第四季的特許權使用費收入包括我們的合作夥伴皮爾法伯 (Pierre Fabre) 對中國的銷售。
We reported 2,964 bottles of NERLYNX sold in the fourth quarter of 2024, an increase of 241 from the 2,723 bottles sold in Q3 2024. In Q4 2024, we estimate that inventory increased by about 205 bottles. In Q4 2024, new prescriptions, NRx, were down approximately 7% compared to Q3 2024, and total prescriptions, treatment, were up approximately 4% compared to Q3 2024.
我們報告稱,2024 年第四季售出 2,964 瓶 NERLYNX,比 2024 年第三季售出的 2,723 瓶增加了 241 瓶。2024 年第四季度,我們估計庫存增加了約 205 瓶。2024 年第四季度,新處方 (NRx) 與 2024 年第三季度相比下降約 7%,總處方 (治療) 與 2024 年第三季度相比增長約 4%。
Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter, and then Jeff Ludwig will add additional color on NERLYNX commercial activities, and Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2024.
傑夫將在他的評論和幻燈片中提供更多細節。我現在將對本季度進行臨床回顧,然後 Jeff Ludwig 將對 NERLYNX 商業活動進行更多介紹,然後 Maximo Nougues 將重點介紹我們 2024 年第四季度財務報表的關鍵部分。
There is currently an ongoing Phase I trial that is sponsored by the National Cancer Institute to evaluate the combination of neratinib and trastuzumab deruxtecan, otherwise known as Enhertu, in patients with metastatic solid tumors. The Phase I trial includes patients with metastatic solid tumors harboring HER2 overexpression, IHC3+, HERB2 amplifications or activating HER2 mutations. The primary objectives are to assess safety and tolerability of the combination, and the secondary objectives include evaluating pharmacokinetics, preliminary efficacy, and potential biomarkers of response. We anticipate that interim data from this trial will be presented in the first half of 2025.
目前正在進行一項由美國國家癌症研究所贊助的 I 期試驗,旨在評估 neratinib 和 trastuzumab deruxtecan(也稱為 Enhertu)聯合治療轉移性實體瘤患者的效果。I 期試驗包括患有 HER2 過度表現、IHC3+、HERB2 擴增或活化 HER2 突變的轉移性實體腫瘤患者。主要目標是評估組合的安全性和耐受性,次要目標包括評估藥物動力學、初步療效和反應的潛在生物標記。我們預計該試驗的中期數據將於 2025 年上半年公佈。
In addition, Puma currently has two ongoing Phase II trials of our investigational drug, alisertib. The first is the ALISCA-Breast1, which is a Phase II of alisertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer. And the second is the ALISCA-Lung1 trial, which is a Phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment.
此外,Puma 目前正對我們研究藥物 alisertib 進行兩項 II 期試驗。第一個是ALISCA-Breast1,這是alisertib與內分泌治療聯合用於未接受化療的HER2陰性、荷爾蒙受體陽性轉移性乳癌患者的II期臨床試驗。第二項是 ALISCA-Lung1 試驗,這是一項 II 期研究,旨在研究 alisertib 單藥治療小細胞肺癌患者的療效。提醒一下,ALISCA-Breast1 試驗研究了 alisertib 與內分泌治療的聯合作用。
The endocrine treatment consists of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer. Patients must have received previous treatment with a CDK4/6 inhibitor and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.
對於未接受化療的 HER2 陰性、荷爾蒙受體陽性轉移性乳癌患者,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。患者必須接受過 CDK4/6 抑制劑治療,並在復發或轉移的情況下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 at either 30 milligrams, 40 milligrams or 50 milligrams twice daily 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 that will be given in combination with alisertib in the trial. The primary efficacy endpoints include overall response rate, duration of response, disease control rate and progression-free survival.
患者在 28 天的週期內,分別在第 1 至 3 天、第 8 至 10 天和第 15 至 17 天每天兩次接受 30 毫克、40 毫克或 50 毫克的 alisertib 治療,並結合研究者選擇的內分泌療法。患者之前不得接受過在試驗中與 alisertib 合併進行的內分泌治療。主要療效終點包括總體反應率、反應持續時間、疾病控制率和無惡化存活期。
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 preclinical and clinical studies in other cancers including breast cancer and small cell lung cancer.
作為次要目標,該公司將評估生物標記亞組中的每個功效終點,以確定任何生物標記亞群是否與更好的功效相關,如乳腺癌和小細胞肺癌等其他癌症的臨床前和臨床研究中所見。
The company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive breast cancer in patients with these biomarkers. The trial was initiated in late November 2024. There are currently 22 sites that have been activated for the trial, and the trial is enrolling ahead of expectations. There are currently 14 patients enrolled in the trial with four additional patients in screening.
該公司將致力於未來臨床開發,將 alisertib 與內分泌療法聯合用於治療具有這些生物標記的 HER2 陰性、荷爾蒙受體陽性乳癌患者。該試驗於2024年11月下旬開始。目前已有 22 個站點啟動試驗,試驗的報名人數超出預期。目前共有 14 名患者參加試驗,另有 4 名患者正在接受篩選。
We look to have interim data from this trial later in 2025. With respect to ALISCA-Lung1, 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.
我們希望在 2025 年稍後獲得該試驗的中期數據。關於 ALISCA-Lung1,正如上次電話會議中所討論的那樣,該公司認為,迄今為止從 ALISCA-Lung1 試驗中獲得的數據初步表明,在具有極光激酶通路發揮作用的生物標誌物的患者中,其活性可能會更好。
The company recently met with members of the steering committee for the trial, and the committee recommended expanding enrollment in the trial to patients that have been treated with additional lines of prior treatment as the current protocol limits enrollment in the trial to patients with up to two prior lines of therapy. The biomarkers that correlate with aurora kinase activity tend to be acquired as a mechanism of resistance to treatment. So by opening up the protocol to patients with additional lines of treatment, we will allow for enrichment of these biomarkers.
該公司最近會見了該試驗的指導委員會成員,委員會建議將試驗的招募範圍擴大到已接受過其他療法治療的患者,因為目前的方案限制試驗的招募範圍為最多接受過兩種療法治療的患者。與極光激酶活性相關的生物標記物往往被視為一種抵抗治療的機制。因此,透過向接受其他治療方法的患者開放該方案,我們將能夠豐富這些生物標記。
The company is in the process of amending the protocol to allow for this. The company looks to have additional interim data from this trial later in 2025. As mentioned on prior 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 our existing R&D, regulatory, and commercial infrastructure. The company will keep investors updated on this as it progresses.
該公司正在修改協議以實現這一目標。該公司希望在 2025 年稍後獲得該試驗的更多中期數據。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 繼續評估幾種藥物,以便可能獲得許可,這將使公司實現多元化,並利用我們現有的研發、監管和商業基礎設施。公司將向投資者通報最新進展。
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),以回顧我們本季的商業表現。
Jeff Ludwig - Chief Commercial Officer
Jeff Ludwig - Chief Commercial Officer
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.
謝謝,艾倫。非常感謝,也感謝大家參加我們的第四季財報電話會議。在進入商業評論之前,我想提醒一下,我將做出前瞻性的陳述。
The HER2-positive breast cancer landscape is evolving, but there is no question that a significant unmet need remains. The Puma commercial team is committed to increasing the utilization of NERLYNX with a focus on patients that are deemed to have a higher risk of reoccurrence.
HER2 陽性乳癌的前景正在發生變化,但毫無疑問,仍然存在大量未滿足的需求。Puma 商業團隊致力於提高 NERLYNX 的使用率,並專注於那些被認為復發風險較高的患者。
Our teams are working very hard to increase our engagement with clinicians through both personal and non-personal promotion with a heavy emphasis on increasing engagement when treatment decisions are being made. Q4 call activity decreased quarter over quarter as expected, given vacations and holidays, but did increase about 7% year over year.
我們的團隊正在努力透過個人和非個人推廣來增加與臨床醫生的互動,並專注於在做出治療決策時增加參與度。由於假期原因,第四季度的通話活動如預期般環比下降,但年增了約 7%。
We are working with new partners, new data, and new approaches to not only continue to increase our share of voice, but also to improve the impact of those engagements. We are also exploring opportunities to better support patients who are on NERLYNX with the goal of appropriately maximizing persistence and compliance. All of us remain focused and are committed to becoming more efficient and effective with our resources and are committed to balancing the short-term and long-term goals of Puma and its shareholders.
我們正在與新的合作夥伴、新的數據和新的方法合作,不僅繼續增加我們的聲音份額,而且還提高這些活動的影響力。我們也正在探索更好地支持使用 NERLYNX 的患者的機會,以適當地最大限度地提高持久性和依從性。我們所有人都將保持專注,致力於更有效率、更有效地利用我們的資源,並致力於平衡彪馬及其股東的短期和長期目標。
Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance. Once I have finished, I'll turn the call over to Maximo for a more detailed review of our financial results.
現在讓我轉到一些商業幻燈片,我將在其中提供有關性能的一些其他細節。當我完成後,我將把電話轉給馬克西莫,以便更詳細地審查我們的財務結果。
On slide 3, we have an overview of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. We added BioCare to our SD distribution network in Q4 of 2024. BioCare is the exclusive distribution partner to the newest community oncology-focused GPO.
在投影片 3 中,我們概述了我們的分銷模式,該模式分為專業藥房管道和專業分銷商或辦公室內配藥管道。我們於 2024 年第四季將 BioCare 添加到我們的 SD 分銷網絡中。BioCare 是最新社區腫瘤學 GPO 的獨家經銷合作夥伴。
A significant portion of our business is driven by community oncologists, so it made good sense to expand our network to further support these providers. In regards to the overall distribution of our business, in Q4, about 75% of our business was purchased through the SP channel and the remaining 25% was purchased through the SD channel. This is similar to what we reported during our Q3 earnings call.
我們的業務很大一部分是由社區腫瘤學家推動的,因此擴大我們的網絡以進一步支持這些提供者是很有意義的。從我們業務的整體分佈來看,第四季大概有75%的業務是透過SP管道購買的,剩下的25%是透過SD管道購買的。這與我們在第三季財報電話會議上報告的情況類似。
Now turning to slide 4. NERLYNX net revenue in Q4 of 2024 was $54.4 million, which represents a decline of $1.7 million from the $56.1 million we reported in Q3 of 2024 and a $1.2 million increase from the $51.6 million we reported in Q4 of 2023.
現在翻到幻燈片 4。NERLYNX 2024 年第四季的淨收入為 5,440 萬美元,比我們報告的 2024 年第三季的 5,610 萬美元下降 170 萬美元,比我們報告的 2023 年第四季的 5,160 萬美元增加 120 萬美元。
The significant changes in quarterly net revenue was driven primarily by four factors: number one, inventory changes; two, higher US ex-factory sales; three, a decrease in product supply revenue to our global partners; and four, a higher gross to net adjustment. I will provide some more details around product supply, revenue and inventory changes, and Maximo will provide some additional specifics during his update.
季度淨收入的顯著變化主要由四個因素推動:第一,庫存變化;二、美國出廠銷售額增加;三、對全球合作夥伴的產品供應收入減少;四是總淨調整幅度加大。我將提供有關產品供應、收入和庫存變化的更多細節,Maximo 將在他的更新中提供一些額外的細節。
In Q4 of 2024, we recorded product supply revenue of $800,000 versus $7.4 million in Q3 of 2024 and $5.3 million in Q4 of 2023. In Q4 of 2024, we estimate that inventory increased by about $3.7 million. As a comparator, we estimate that inventory increased by about $600,000 in Q3 of 2024 and increased by about $2.1 million in Q4 of 2023.
2024 年第四季度,我們的產品供應收入為 80 萬美元,而 2024 年第三季度為 740 萬美元,2023 年第四季為 530 萬美元。2024 年第四季度,我們估計庫存增加了約 370 萬美元。作為比較,我們估計庫存在 2024 年第三季增加了約 60 萬美元,在 2023 年第四季增加了約 210 萬美元。
Slide 5 shows Q4 of 2024 ex-factory bottle sales and also provides both a year over year and a quarter-over-quarter comparison. In Q4 of 2024, NERLYNX ex-factory bottle sales were 2,964, which represents an approximate 9% increase quarter over quarter and a 3% increase year over year.
幻燈片 5 展示了 2024 年第四季的出廠瓶裝銷量,並提供了同比和環比的比較。2024 年第四季,NERLYNX 出廠瓶裝銷量為 2,964 瓶,較上季成長約 9%,較去年同期成長 3%。
Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. We estimate that inventory increased by 205 bottles in Q4 of 2024. And as a comparator, we estimate that inventory increased by 37 bottles in Q3 of 2024 and increased by 127 bottles in Q4 of 2023.
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。我們估計 2024 年第四季庫存增加了 205 瓶。作為比較,我們估計 2024 年第三季庫存增加了 37 瓶,2023 年第四季庫存增加了 127 瓶。
Let me just take a moment to provide additional metrics and insights into our fourth quarter performance. As a reminder, we historically have seen enrollments and new patient starts soften in the fourth quarter as physicians and/or patients choose to initiate their therapy after the holidays to avoid the potential side effects of NERLYNX, which typically occur in the first month or so. Q4 of 2024 followed that historical pattern.
請允許我花一點時間來提供有關我們第四季業績的更多指標和見解。提醒一下,從歷史上看,第四季度的入學人數和新患者人數有所下降,因為醫生和/或患者選擇在假期後開始治療,以避免 NERLYNX 的潛在副作用(通常發生在第一個月左右)。2024 年第四季遵循了這一歷史模式。
In Q4, we saw enrollments decline 7% quarter over quarter and about 10% year over year. New patient starts, or NRx, decreased 7% quarter over quarter, but increased 10% year over year.
第四季度,我們發現入學人數較上季下降 7%,年減約 10%。新患者開始數量(NRx)比上一季下降了 7%,但比去年同期增加了 10%。
Turning to total prescriptions, or TRx. We saw TRx grow 4% quarter over quarter and also grew 3% year-over-year.
轉向總處方,或 TRx。我們看到 TRx 季度環比成長 4%,年增 3%。
Finally, let me give you some more insights and specifics around demand. In Q4, we saw demand grow approximately 3% quarter over quarter. It also grew numerically higher but was essentially flat as a percentage year over year, specifically Q4 of 2024 versus Q4 of 2023.
最後,讓我給你一些關於需求的更多見解和細節。在第四季度,我們發現需求較上季成長約 3%。從數值上看,它也實現了較高的成長,但與去年同期相比,百分比基本上持平,特別是 2024 年第四季與 2023 年第四季相比。
Moving to slide 6. Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q4, approximately 74% of patients started NERLYNX at a reduced dose. This is similar to the 76% we reported in Q4 of 2023, but higher than what we have reported in the last several quarters.
移至幻燈片 6。幻燈片 6 重點介紹了自 NERLYNX 推出以來每季採用的劑量遞增情況。在第四季度,約 74% 的患者開始以降低劑量使用 NERLYNX。這與我們在 2023 年第四季報告的 76% 相似,但高於我們過去幾季報告的水平。
Continued messaging and adoption of dose escalation is an important part of our commercial strategy. As a reminder, the control trial showed a significant reduction in grade 3 diarrhea and improved persistence and compliance when patients were started at a lower dose. We track multiple cohorts of patients and continue to see improved compliance when patients are started at a lower dose. The commercial team continues to explore additional opportunities to better support patients throughout their entire NERLYNX therapy.
持續傳達訊息和採用劑量遞增是我們商業策略的重要組成部分。需要提醒的是,對照試驗表明,當患者開始採用較低劑量時,3 級腹瀉顯著減少,且持續性和依從性得到改善。我們追蹤了多組患者,並發現當患者從較低劑量開始服藥時,依從性有所提高。商業團隊將繼續探索更多機會,以便在整個 NERLYNX 治療過程中為患者提供更好的支持。
Slide 7 highlights the strategic collaborations we have formed across the globe. In Q4, NERLYNX received regulatory approval in the extended adjuvant setting in Turkey and also received regulatory approval for both extended adjuvant and metastatic breast cancer in Thailand. We are also pleased to announce that NERLYNX was commercially launched in the extended adjuvant setting in both Turkey and Saudi Arabia.
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。在第四季度,NERLYNX 獲得了土耳其延長輔助治療的監管批准,也獲得了泰國延長輔助治療和轉移性乳癌的監管批准。我們也很高興地宣布,NERLYNX 已在土耳其和沙烏地阿拉伯的擴展輔助治療環境中進行商業上市。
We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward. I'd like to wrap up by thanking my Puma colleagues for their passion and commitment to helping patients and their families battling breast cancers. We know all too well the devastating effects this disease can have, and we're committed to finding ways to increase our support of these patients throughout their journey.
我們非常感謝全球合作夥伴所做的出色工作,並期待支持他們在未來繼續取得成功。最後,我要感謝彪馬的同事們,感謝他們為幫助乳癌患者及其家人所付出的熱情和奉獻。我們非常清楚這種疾病可能帶來的毀滅性影響,我們致力於尋找方法來增加對這些患者整個治療過程中的支持。
I'll now turn the call over to Maximo for a review of our financial results. Maximo?
現在我將把電話轉給 Maximo 來審查我們的財務結果。馬克西莫?
Maximo Nougues - Chief Financial Officer
Maximo Nougues - Chief Financial Officer
Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2024. Please note that I will make comparisons to Q3 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 2024 10-K, which will be filed today and includes our consolidated financial statements.
謝謝,傑夫。我將先簡要總結我們 2024 年第四季的財務表現。請注意,我將與 2024 年第三季進行比較,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 2024 10-K 文件,其中包含我們的合併財務報表。
For the fourth quarter of 2024, we recorded net income based on GAAP of $19.3 million or $0.39 per share. This compares to net income in Q3 2024 of $20.3 million or $0.41 per share. In the fourth quarter of 2024, we released a portion of our valuation allowance, resulting in a non-cash deferred tax income 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 quarter.
2024 年第四季度,我們根據 GAAP 記錄的淨收入為 1,930 萬美元,即每股 0.39 美元。相比之下,2024 年第三季的淨收入為 2,030 萬美元或每股 0.41 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稅務收入收益。設立估價準備金是為了抵銷我們的遞延稅務資產,這主要與我們的歷史損失有關。這大大增加了我們本季的淨收入。
On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $21.1 million or $0.43 per basic and diluted share for the fourth quarter of 2024.
根據非 GAAP 基礎,經調整以消除股票薪酬費用的影響,我們報告 2024 年第四季的淨收入為 2,110 萬美元,即每股基本和稀釋後 0.43 美元。
Gross revenue from NERLYNX sales was $66.5 million in Q4 2024 and $67.7 million in Q3 2024. As Alan mentioned, net product revenue from NERLYNX sales was $54.4 million, down slightly from the $56.1 million reported in Q3 2024.
NERLYNX 銷售總收入在 2024 年第四季為 6,650 萬美元,在 2024 年第三季為 6,770 萬美元。正如艾倫所提到的,NERLYNX 銷售的淨產品收入為 5,440 萬美元,略低於 2024 年第三季報告的 5,610 萬美元。
The lower net revenue was driven by two factors: lower product sales to our global partners as we recorded only $0.8 million in Q4 versus $7.4 million in Q3, and higher gross to net expenses. These were partially offset by higher US demand and inventory build.
淨收入下降有兩個原因:我們在第四季度對全球合作夥伴的產品銷售額下降(僅為 80 萬美元,而第三季為 740 萬美元),以及毛支出與淨支出相比有所上升。這些被美國需求的增加和庫存的增加部分抵消。
Inventory increase by our distributors was approximately $3.7 million in Q4 versus an increase of approximately $0.6 million in Q3 2024. Royalty revenue totaled $4.7 million in the fourth quarter of 2024 compared to $24.4 million in Q3 2024, which included NERLYNX sales to China by our licensing partner, Pierre Fabre. Our gross to net adjustment in Q4 2024 was about 18.2% compared to the 17.1% gross to net adjustment reported in Q3 2024.
我們的經銷商的庫存在第四季度增加了約 370 萬美元,而 2024 年第三季增加了約 60 萬美元。2024 年第四季的特許權使用費收入總計 470 萬美元,而 2024 年第三季為 2,440 萬美元,其中包括我們的許可合作夥伴 Pierre Fabre 向中國銷售 NERLYNX。我們的 2024 年第四季總淨調整額約為 18.2%,而 2024 年第三季報告的總淨調整額為 17.1%。
Cost of sales for Q4 2024 declined to $13.9 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2024 was $29.1 million, reflecting the sales of NERLYNX to China. Going forward, we will continue to recognize amortization of milestones to the licensor, about $2.4 million per quarter, as cost of sales.
2024 年第四季的銷售成本下降至 1,390 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 年第三季的銷售成本為 2,910 萬美元,反映了 NERLYNX 對中國的銷售。展望未來,我們將繼續將里程碑攤銷確認為授權人的銷售成本,每季約 240 萬美元。
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%. 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.
對於 2025 財年,Puma 預計 NERLYNX 產品的淨收入將在 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。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 萬至 2400 萬美元之間,低於 2024 年的水平,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 progress.
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,我們尚未預測淨收入估算中是否會釋放任何額外的稅務資產評估準備金,但我們會持續對此進行評估。我們將繼續向投資者通報此事的進展。
We anticipate that for Q1 2025, NERLYNX product revenue net will be in the range of $41 million to $43 million. Also, we expect Q1 royalty revenues will be in the range of $1.5 million to $2.5 million and no license revenue. We further estimate that the gross to net adjustment in Q1 2025 will be approximately 22.5% to 23.5%. Puma anticipates a Q1 net loss between $2 million and breakeven.
我們預計,2025 年第一季度,NERLYNX 產品淨收入將在 4,100 萬美元至 4,300 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 150 萬美元至 250 萬美元之間,沒有授權收入。我們進一步估計,2025 年第一季的毛利率與淨利率調整幅度將約為 22.5% 至 23.5%。Puma 預計第一季淨虧損在 200 萬美元至損益平衡之間。
As investors are aware, Q1 usually represents the lowest net product revenue of the four quarters due to the burn-off of the inventory build from Q4. SG&A expenses were $16.6 million in the fourth quarter of 2024 compared to $16.8 million for the third quarter of 2024. SG&A expenses included non-cash charges for stock-based compensation of $1.3 million for Q4 and $1.5 million for Q3 2024.
投資者都知道,由於第四季度庫存的消耗,第一季的淨產品收入通常是四個季度中最低的。2024 年第四季的銷售、一般及行政費用為 1,660 萬美元,而 2024 年第三季的銷售、一般及行政費用為 1,680 萬美元。銷售、一般及行政開支包括 2024 年第四季的 130 萬美元和第三季的 150 萬美元的股票薪酬非現金費用。
Research and development expenses were $15.2 million in the fourth quarter of 2024, an increase from $12.5 million in the third quarter of 2024. R&D expenses included non-cash charges for stock-based compensation of $0.5 million in the fourth quarter of 2024 and $0.6 million in the third quarter of 2024. On the expense side, Puma anticipates flat to a 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.
2024 年第四季的研發費用為 1,520 萬美元,高於 2024 年第三季的 1,250 萬美元。研發費用包括 2024 年第四季 50 萬美元和 2024 年第三季 60 萬美元的股票薪酬非現金費用。在費用方面,Puma 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、一般及行政開支將年減 5% 至 10%,研發支出將年增 10% 至 15%。
In the fourth quarter of 2024, Puma reported cash burn of approximately $4.3 million. This compares to cash burn of approximately $0.1 million in Q3 2024. Please note that during Q4, we made our term 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 $67 million.
2024 年第四季度,Puma 報告現金消耗約 430 萬美元。相比之下,2024 年第三季的現金消耗約為 10 萬美元。請注意,在第四季度,我們支付了與 Athyrium 相關的 1,110 萬美元定期貸款。結果,我們的未償還本金債務總額減少至約 6,700 萬美元。
At December 31, 2024, we had approximately $101 million in cash, cash equivalents, and marketable securities versus about $96 million at year-end in 2023. Our accounts receivables balance was $32 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are about 48 days. We estimate that as of December 31, 2024, our distribution network maintained approximately four weeks of inventory.
截至 2024 年 12 月 31 日,我們擁有約 1.01 億美元的現金、現金等價物和有價證券,而 2023 年底約為 9,600 萬美元。我們的應收帳款餘額為3,200萬美元。我們的應收帳款期限在 10 至 68 天之間,而我們的銷售未收款天數約為 48 天。我們估計,截至 2024 年 12 月 31 日,我們的分銷網絡維持約四週的庫存。
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,並控制我們的費用。
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
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 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 few years.
謝謝,馬克西莫。Puma 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 財年的正淨收入源自於公司過去幾年的財務紀律。
The expense reductions that we have performed and continue to perform are also a major contributor to the positive net income that the company achieved in Q4 2024 and that the company is guiding to for full year 2025. The company remains committed to continuing to achieve this positive net income, and we'll continue to reduce expenses if needed to achieve this.
我們已經執行並繼續執行的費用削減也是該公司在 2024 年第四季度實現正淨收入以及公司預計的 2025 年全年淨收入的主要貢獻者。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。
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, and we will continue to strive to achieve that goal.
我們期待未來向投資者通報這一情況。對於乳癌、肺癌和其他實體腫瘤患者來說,仍然存在著巨大的未滿足的治療需求。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,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。我們現在將發言權交還給接線員進行問答。操作員?
Operator
Operator
(Operator Instructions) Ed White, HC Wainwright.
(操作員指令) Ed White、HC Wainwright。
Edward White - Analyst
Edward White - Analyst
Alan, just wanted to ask a question on the Phase I NCI data with Enhertu. You had said that you could see interim data in the first half of 2025. Do you expect this to be presented at a medical conference, perhaps ASCO? Or is this something that you'd release perhaps in a press release?
艾倫,我只是想問一個關於 Enhertu 第一階段 NCI 數據的問題。您曾說過,您可以在 2025 年上半年看到中期數據。您是否希望在醫學會議上(例如 ASCO)展示這項成果?或者這是您可能會在新聞稿中發布的內容?
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Ed, thanks for the question. It has been submitted to -- I apologize for my memory loss here. It was either AACR or ASCO. So one of those two. That's where I would expect it to be presented.
艾德,謝謝你的提問。已提交至——我為我的記憶喪失在這裡道歉。它要么是 AACR,要么是 ASCO。所以是那兩個中的一個。我期望它能在那裡被呈現。
Edward White - Analyst
Edward White - Analyst
Okay. Great. And Jeff, you mentioned that you're trying to maximize persistence and compliance. Can you give us some statistics on what persistence and compliance is right now, how you're thinking about it? And what are the steps that you're taking?
好的。偉大的。傑夫,你提到你正在努力最大限度地提高持久性和合規性。您能否向我們提供一些關於當前持久性和合規性的統計數據,以及您對此有何看法?您採取了哪些措施?
Jeff Ludwig - Chief Commercial Officer
Jeff Ludwig - Chief Commercial Officer
Yes, Ed, appreciate it. Obviously, a couple of things we're trying to do. One, from a clinical perspective, we are educating customers using clinical data that shows the benefits of patients finishing therapy or staying on therapy greater than 11 months. And we have very good clinical data from the ExteNET study showing the benefits of that. We are working now to achieve that and extend that length of therapy.
是的,埃德,非常感謝。顯然,我們正在嘗試做幾件事。首先,從臨床角度來看,我們正在使用臨床數據來教育客戶,這些數據顯示了患者完成治療或繼續治療超過 11 個月的好處。我們從 ExteNET 研究獲得了非常好的臨床數據,證明了這樣做的好處。我們正在努力實現這一目標並延長治療時間。
We are working very closely with our SP partners, all of our sales reps. Also, we have reports looking at delayed refills, pending refills. So we're trying to educate and engage with customers throughout their entire journey to give them the best chance and the best support to stay on therapy throughout the recommended likely 12 months.
我們與我們的 SP 合作夥伴以及所有銷售代表密切合作。此外,我們還有關於延遲補充和待補充的報告。因此,我們試圖在整個治療過程中對客戶進行教育和與客戶互動,為他們提供最好的機會和最好的支持,讓他們在建議的 12 個月內繼續接受治療。
Our marketing team's also creating an additional piece that really does a nice job of highlighting all the benefits and support that we can offer a patient throughout their journey, and that will be shipped with all refills coming here very quickly here in 2025. \
我們的行銷團隊還創建了一個附加部分,它很好地強調了我們在整個旅程中為患者提供的所有好處和支持,並且將於 2025 年與所有補充裝一起快速發貨。\
From a data perspective, Ed, you've asked me this question. Let me give you some more color here. As I look at dose escalation, again, being another part of increasing that persistence and compliance, as I look at the most recent cohorts of data that we've talked about previously, we continue to follow multiple cohorts of data.
從數據的角度來看,艾德,你問了我這個問題。讓我在這裡給你更多顏色。當我再次觀察劑量遞增時,這是提高持久性和依從性的另一個部分,當我查看我們之前討論過的最新數據群時,我們繼續追蹤多組數據。
And whether I look at a three-month cohort that started a year ago, following that three-month cohort from a year ago until now, if I back up a little farther looking at a six-month cohort following that six-month group of patients out a year and even a nine-month, what we see every step of the way, we see now about a 5% to 10% more patients remaining on therapy if you start at a lower dose than if you started on full dose. So that is contributing to us extending that length of therapy a little bit and giving us some benefits on our forecast as well. Is that helpful?
無論是觀察一年前開始的三個月組,還是追蹤一年前至今的三個月組,如果我再往前追溯一點,觀察一年甚至九個月後追蹤的六個月組患者,我們看到每一步進展,如果以較低劑量開始,那麼現在繼續接受治療的患者比以全劑量開始的患者多出約 5% 至 10%。因此,這有助於我們稍微延長治療時間,也為我們的預測帶來一些好處。這樣有幫助嗎?
Edward White - Analyst
Edward White - Analyst
Yes, it is. And I just wanted to -- the revenue guidance for the year is sort of flattish. I guess, how are you thinking about price versus volume in that guidance?
是的。我只是想說——今年的營收預期有點持平。我想,您在該指導中是如何考慮價格與數量的?
Jeff Ludwig - Chief Commercial Officer
Jeff Ludwig - Chief Commercial Officer
So, Ed, a couple of things, as I think Maximo shared as well. There's a couple things going on there with guidance. One is we do see a decrease in product supply revenue in 2025 versus 2024. We did take price. That's already been announced.
所以,Ed,有幾件事,我認為 Maximo 也分享了。在指導下,那裡發生了幾件事。一是,我們確實看到 2025 年的產品供應收入相對於 2024 年有所下降。我們確實收取了價格。這已經宣布了。
We did take price in early Q1 of 2025. We announced that. That was a 7% price increase. As I think about just pure demand, last year, if you look at the demand that we reported, demand declined about 9% or 10% year over year. We are forecasting to a demand decline currently of about 2%.
我們確實在 2025 年第一季初確定了價格。我們宣布了這一消息。價格上漲了7%。當我想到純需求時,如果你看看去年我們報告的需求,需求比去年同期下降了約 9% 或 10%。我們預測目前需求將下降約 2%。
Now that's in our guidance. Obviously, it's my job to not let that happen and exceed that, but we're forecasting to a demand decline of about 2% year over year.
這就是我們的指導方針。顯然,我的工作就是不讓這種情況發生並超過這個數字,但我們預測需求將年減約 2%。
Edward White - Analyst
Edward White - Analyst
Okay, great. And my last question is just when thinking about the royalty stream from outside of the US, you had mentioned China would be down. Do we think about China being lumpy as we've seen in the past with just boluses of revenue and then nothing again in 2025?
好的,太好了。我的最後一個問題是,當想到美國以外的版稅流時,您提到中國會下降。我們是否認為中國的經濟會像我們過去看到的那樣不穩定,只有巨額的收入,然後在 2025 年再次失去收入?
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Yes, Ed. So you're correct. In all of our revenue streams that we get from royalties, we get paid basically as the drug is sold, so it's just a straight royalty. China's a little bit different because it's sold through a distribution network. So we basically sell it to our partner. And then once it's sold to them, they put it into the distribution network, so it's not as directly time-related demand-driven.
是的,埃德。所以你是對的。在我們從特許權使用費中獲得的所有收入來源中,我們基本上是在藥品售出時獲得報酬,因此這只是直接的特許權使用費。中國有點不同,因為它是透過分銷網絡銷售的。所以我們基本上將其賣給我們的合作夥伴。一旦賣給他們,他們就會將其放入分銷網絡,因此它不會直接受與時間相關的需求所驅動。
So we're in the -- as Maximo mentioned in his script, we're in the process of having the official registration authorization transferred from us to Pierre Fabre. So we kind of built up some inventory ahead of that. So I would expect the shipments to be a little bit lower in 2025, and that's one of the reasons you see the decline in royalties year over year. And to answer your question, yes, it would be kind of lumpy as well.
因此,正如馬克西莫在他的腳本中提到的那樣,我們正在將官方註冊授權從我們轉移到皮爾法伯。因此我們提前建立了一些庫存。因此我預計 2025 年的出貨量會略低一些,這也是特許權使用費逐年下降的原因之一。回答你的問題,是的,它也會有點凹凸不平。
Jeff Ludwig - Chief Commercial Officer
Jeff Ludwig - Chief Commercial Officer
And Al, let me just add one more piece as we look at China. The one thing I do want to comment, Alan's talking about the lumpiness. We do pay attention to in-market demand, and in-market demand continues to be on track with previous estimates and is still forecasted to grow as we previously saw. So we do not have a demand reduction in China.
艾爾,當我們討論中國問題時,讓我再補充一點。我確實想評論的一件事是艾倫談論的腫塊問題。我們確實關注市場需求,並且市場需求繼續與先前的估計保持一致,並且仍預計會像我們之前看到的那樣成長。因此,中國的需求並沒有減少。
Operator
Operator
Marc Frahm, TD Cowen.
馬克·弗拉姆(Marc Frahm),TD Cowen。
Marc Frahm - Analyst
Marc Frahm - Analyst
Maybe one on the commercial side. Just there's the second part of the IRA's Part D redesign and other kind of payment reforms this year. Just any impact you're seeing in the early returns here in the first couple of months of the year in terms of how the patients are experiencing reimbursement?
也許是一個商業方面的問題。今年,IRA 的 D 部分重新設計的第二部分以及其他類型的支付改革。就患者的報銷情況而言,您認為今年前幾個月的早期回報有什麼影響嗎?
Jeff Ludwig - Chief Commercial Officer
Jeff Ludwig - Chief Commercial Officer
Marc, we're not seeing an overall big impact. One is when you think about that reform, what I will tell you is our distribution of Medicare patients and the trends on Medicare patients have been fairly stable. Our length of therapy on Medicare is fairly consistent. So we're not seeing a significant change in trends that we have seen prior based on the IRA reform at this point in time.
馬克,我們並沒有看到整體的巨大影響。首先,當你考慮到那項改革時,我會告訴你我們的醫療保險患者的分佈和醫療保險患者的趨勢一直相當穩定。我們的醫療保險治療時間相當一致。因此,我們目前還沒有看到基於 IRA 改革的先前趨勢發生重大變化。
Marc Frahm - Analyst
Marc Frahm - Analyst
Okay. That's helpful. And then maybe just on the breast cancer trial for alisertib, just the interim data. Alan, can you kind of run through the expectations there for -- remind us just how much data you expect to be able to share at that interim?
好的。這很有幫助。然後可能只是關於 alisertib 乳癌試驗的中期數據。艾倫,您能否簡要介紹一下這方面的期望——提醒我們一下您預計在此期間能夠共享多少數據?
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Yes, Marc. I think we'll have a better idea of like number of patients and things like that probably in the next earnings call or so. But again, they're being randomized to one of three doses. So obviously, we would have probably some early response, early duration data. If you look at the most recent trial that was done, which is the TBCRC 041 trial, the median PFS there was like 5.5 months.
是的,馬克。我想我們可能會在下次財報電話會議左右對患者數量等情況有更好的了解。但同樣,他們會被隨機分配到三種劑量中的一種。因此顯然,我們可能會有一些早期反應和早期持續時間的數據。如果您查看最近進行的試驗,即 TBCRC 041 試驗,其中位 PFS 為 5.5 個月。
So assume for a patient that's coming on in March, if that's the PFS they see, we're not going to see that end for quite some time. So a lot of it would probably be ongoing data where it's kind of a plus next to the number. That would be something to anticipate.
因此,假設對於 3 月發病的患者,如果他們看到 PFS,那麼我們將在相當長的一段時間內看不到其結束。因此,很多數據可能都是持續數據,在數字旁邊加上一個加號。這是值得期待的事。
Operator
Operator
Gena Wang, Barclays.
巴克萊銀行的 Gena Wang。
Hang Hu - Analyst
Hang Hu - Analyst
This is Hang Hu on behalf of Gena Wang from Barclays. I just wanted to follow up with the HER2 cancer for the ALISCA Phase II trial. So I'm curious like what's your bar regarding the efficacy and the safety you want to hit in this trial?
我是巴克萊銀行 Gena Wang 的代表 Hang Hu。我只是想追蹤 ALISCA 第二階段試驗的 HER2 癌症情況。所以我很好奇,您對這次試驗的功效和安全性有什麼要求?
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Yes. Can you clarify which trial you're referring to? Are you referring to the breast or the lung?
是的。您能澄清一下您所指的是哪一項試驗嗎?您指的是乳房還是肺?
Hang Hu - Analyst
Hang Hu - Analyst
The breast.
乳房。
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Alan Auerbach - Chairman of the Board, President, Chief Executive Officer, Secretary
Yeah. So the best marker for expectations for the breast trial would probably be the TBCRC 041 trial. We're doing the same -- so the TBCRC 041 trial was 50 milligrams of alisertib given BID, same dosing schedule, 3 days a week for 3 weeks in a 28-day cycle. That would probably be the best bar.
是的。因此,乳癌試驗預期的最佳指標可能是 TBCRC 041 試驗。我們也正在做同樣的事情 — — TBCRC 041 試驗採用 50 毫克 alisertib,每日兩次,相同的給藥方案,每週 3 天,持續 3 週,為一個 28 天的週期。那可能是最好的酒吧。
Now again, we're going 30 milligrams, 40 milligrams, 50 milligrams. So there's a reason for doing that. We're trying to look for if there's a dose response to satisfy Project Optimus from the FDA. So that would probably be the bar I would look to as the comp.
現在我們再重複一遍,30毫克、40毫克、50毫克。所以這樣做是有理由的。我們正在嘗試尋找是否有劑量反應來滿足 FDA 的 Optimus 計畫要求。因此,這可能是我所期望的比較標準。
Operator
Operator
That concludes our question-and-answer session. I would now like to turn the conference back over to Mariann for closing remarks.
我們的問答環節到此結束。現在,我想將會議交還給瑪麗安,請她作結束語。
Mariann Ohanesian - Investor Relations
Mariann Ohanesian - Investor Relations
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 上的網路直播重播訪問本次電話會議。祝你晚上愉快。
Operator
Operator
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.
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。