G1 Therapeutics Inc (GTHX) 2023 Q4 法說會逐字稿

Good day, and thank you for standing by, and welcome to the G1 Therapeutics fourth quarter 2023 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的耐心等待，歡迎參加 G1 Therapeutics 2023 年第四季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your first speaker today Will Roberts, Corporate Communications. Please go ahead.

現在我想將會議交給今天的第一位發言人威爾·羅伯茨（Will Roberts），企業傳播部。請繼續。

Thank you, Rivka, and good morning, everyone, and welcome to the G1 conference call to discuss our fourth quarter and full year 2023 financial results and business update. Press release on these financial results was issued this morning and can be found in the news section of our corporate website, g1therapeutics.com.

謝謝 Rivka，大家早上好，歡迎參加 G1 電話會議，討論我們的第四季度和 2023 年全年財務業績和業務更新。有關這些財務表現的新聞稿已於今天上午發布，可在我們公司網站 g1therapeutics.com 的新聞部分找到。

On this morning's call, the team will provide a business overview of the 2023 fourth quarter and full year, including an update on our clinical programs and our commercial progress in that period with COSELA, which approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum etoposide containing regimen or topotecan containing regimen for extensive-stage small cell lung cancer. A Q&A session will follow the prepared remarks.

在今天早上的電話會議上，該團隊將提供2023 年第四季度和全年的業務概覽，包括我們的臨床項目的最新情況以及我們與COSELA 的商業進展，COSELA 已獲得批准並投入商業使用，以降低化療的發生率 -當在含有鉑依托泊苷的方案或含有拓撲替康的方案治療廣泛期小細胞肺癌之前給藥時，會引起成年患者的骨髓抑制。準備好的發言之後將進行問答環節。

Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.

在開始之前，我想提醒您，今天的網路廣播包含 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。此類聲明代表管理階層截至目前的判斷，可能涉及風險和不確定性，可能導致實際結果與這些聲明中明示或暗示的結果有重大差異。

More information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, February 28, 2024.

有關此類風險和不確定性的詳細資訊。請參閱我們向美國證券交易委員會提交的文件，這些文件可從 SEC 或我們公司網站上取得。任何前瞻性陳述均代表我們截至今天（2024 年 2 月 28 日）的觀點。

Joining me on the call today are Jack Bailey, our Chief Executive Officer; Andrew Perry, our Chief Commercial Officer; Raj Malik, our Chief Medical Officer; and John Umstead, our Chief Financial Officer.

今天和我一起參加電話會議的是我們的執行長傑克貝利 (Jack Bailey)；安德魯·佩里，我們的首席商務官； Raj Malik，我們的首席醫療官；以及我們的財務長約翰·烏姆斯特德 (John Umstead)。

With that, I'll turn the call over to Jack.

這樣，我就把電話轉給傑克。

Thanks, Will, and good morning, everyone, and thank you for joining us on the call today.

謝謝威爾，大家早安，謝謝您今天加入我們的電話會議。

From a commercial perspective, as you'll hear from John and Andrew, we experienced strong solid growth in the fourth quarter of 2023, including revenue and vial volume growth of 29% and 19%, respectively, thanks to this progress from that, which we expect in 2024, we have provided full year 2024 net product sales guidance of between $60 million and $70 million.

從商業角度來看，正如您將從約翰和安德魯那裡聽到的那樣，我們在2023 年第四季度實現了強勁穩健的增長，包括收入和小瓶銷量分別增長29% 和19%，這要歸功於這項進展，我們預計到 2024 年，我們提供的 2024 年全年淨產品銷售指引將在 6,000 萬美元至 7,000 萬美元之間。

That said, as we discuss the milestones we have achieved during the fourth quarter, it's essential. We continue to look forward to and prepare for the opportunities ahead, namely that of category leadership in triple-negative breast cancer if we are successful in our clinical programs.

也就是說，當我們討論第四季取得的里程碑時，這一點至關重要。我們將繼續期待並為未來的機會做好準備，即如果我們的臨床計畫取得成功，我們將成為三陰性乳癌領域的領導者。

First, as you'll hear from Raj, the final results from our ongoing Phase 3 PRESERVE 2 trial of trilaciclib in the metastatic setting are expected in the third quarter of this year. Given our statistical boundaries, our trial is successful in generating results. Similar to that of our Phase 2 trial, it would be among the most important data generated in the first-line metastatic setting in both PD-L1 positive and negative tumors to date.

首先，正如您將從 Raj 那裡聽到的，我們正在進行的 trilaciclib 在轉移性環境中的 3 期 PRESERVE 2 試驗的最終結果預計將於今年第三季度公佈。鑑於我們的統計界限，我們的試驗成功地產生了結果。與我們的 2 期試驗類似，這將是迄今為止在 PD-L1 陽性和陰性腫瘤的一線轉移環境中產生的最重要的數據之一。

Beyond that, the use of antibody drug conjugates or ADCs is appropriately becoming common place in the second-line and later TNBC treatment settings in addition to other tumor types. We have shown promising benefits thus far in our ongoing Phase 2 trial for trilaciclib that is combined with a TROP2 ADC, including improvements in tolerability and more recently in initial overall survival.

除此之外，除了其他腫瘤類型外，抗體藥物偶聯物或 ADC 的使用在二線和後來的 TNBC 治療環境中也逐漸變得普遍。迄今為止，我們正在進行的 trilaciclib 與 TROP2 ADC 聯合的 2 期試驗已經顯示出有希望的益處，包括耐受性的改善以及最近的初始總生存期的改善。

We expect updated results from that trial midyear. With these and other recent results, we believe that continued clinical success in these trials could position G1 for category leadership across the spectrum of TNBC in addition to our work in extensive-stage small cell lung cancer.

我們預計年中該試驗的最新結果。憑藉這些和其他最近的結果，我們相信，除了我們在廣泛期小細胞肺癌方面的工作外，這些試驗的持續臨床成功可以使 G1 在 TNBC 領域處於領先地位。

On today's call, Andrew will cover our recent commercial results. Raj, will provide an update on our clinical pipeline, including our progress toward final results with our Phase 3 PRESERVE 2 trial. John, will then discuss financial results for the quarter as well as our 2024 guidance. Finally, I'll be back with some concluding comments.

在今天的電話會議上，安德魯將介紹我們最近的商業表現。Raj 將提供我們臨床管道的最新信息，包括我們的 3 期 PRESERVE 2 試驗最終結果的進展。John 隨後將討論本季的財務表現以及我們 2024 年的指引。最後，我會帶著一些結論性意見回來。

With that, I'll turn the call over to Andrew.

這樣，我會將電話轉給安德魯。

Thank you, Jack. I'm glad to be with you today, to provide an update on our Q4 2023 sales performance and the significant progress we've made in our commercial execution over recent months, having navigated a period of slower growth during the national platinum chemotherapy shortage last year.

謝謝你，傑克。我很高興今天能與您在一起，介紹我們2023 年第四季度的銷售業績以及近幾個月來我們在商業執行方面取得的重大進展，我們在去年全國鉑類化療藥物短缺期間經歷了一段增長放緩的時期年。

Our goal in Q4 was to restore the momentum we have built early in the year, but have been interrupted by supply disruptions of carboplatin and test plots. And during Q2, Q2 and Q3, we were able to achieve this goal and to continue to demonstrate a broader platform of deeply adopting customer organizations.

我們第四季的目標是恢復年初建立的勢頭，但由於卡鉑和試驗區的供應中斷而中斷。在第二季、第二季和第三季期間，我們能夠實現這一目標，並繼續展示深度採用客戶組織的更廣泛平台。

Getting the sales results, we ended the quarter with 19% overall, while volume growth compared with Q3 2023, all three of our sales regions generated double digit volume growth in the fourth quarter, focusing on the top 100 customer organizations, which represent around half the volume opportunity in the market.

從銷售結果來看，我們本季的整體銷量成長了19%，而與2023 年第三季相比，我們的所有三個銷售區域在第四季度都實現了兩位數的銷售成長，重點關注前100 名客戶組織，約佔一半市場上的成交量機會。

Our growth was higher at 24% in the segment, and we added two new top 100 customers during Q4, meaning 75 of the top 100 about, of course, our launch today. The quarter, our efforts to grow and top 100s were supported by our new strategic accounts team for reflects with our latest real-world evidence data and our focus on creating systematic growth in our largest customers.

我們在該領域的成長率更高，達到 24%，我們在第四季度新增了 2 個前 100 名客戶，這意味著前 100 名客戶中的 75 家與我們今天的推出有關。本季度，我們的成長和前 100 名的努力得到了我們新的策略客戶團隊的支持，這反映了我們最新的現實世界證據數據以及我們對在我們最大的客戶中創造系統性成長的關注。

And as a result, top 100 customers composed 58% of our total volume in the quarter. Community clinics and hospitals grew over 20% during Q4 and represented just over 80% of sales with the remainder being in academic centers. Our fastest-growing segment during the quarter was in customers covered by volume-based contract agreements.

因此，前 100 名客戶佔本季總交易量的 58%。第四季度，社區診所和醫院成長了 20% 以上，佔銷售額的 80% 以上，其餘則位於學術中心。本季我們成長最快的部分是基於數量的合約協議所涵蓋的客戶。

Contracted customers grew 28% during the quarter and made up around a third of our overall volume. We continue to see a broader base of adoption with 55 new accounts and almost 30 customers ordering 100 or more vials in Q4. Our estimate, of COSELA patient share continues to grow.

本季簽約客戶成長了 28%，約占我們總客戶量的三分之一。我們繼續看到更廣泛的採用基礎，第 4 季有 55 個新帳戶和近 30 位客戶訂購了 100 瓶或更多。我們估計 COSELA 患者比例持續成長。

And although claims data for Q4 are not fully available, we estimate patient share of over 13% in the first line market, demonstrating that there remains significant opportunity for growth. 97% of our volume in the quarter was in commercial supply for 3% provided through our patient assistance program. Our paramix remains stable with the majority covered by Medicare and third-party payer reimbursement has remained strong.

儘管第四季度的索賠數據尚未完全獲得，但我們估計一線市場的患者份額超過 13%，這表明仍然存在巨大的成長機會。本季我們 97% 的銷售來自商業供應，其中 3% 透過我們的患者援助計畫提供。我們的 paramix 保持穩定，大部分由醫療保險覆蓋，第三方付款人報銷仍然強勁。

Moving into Q1 2024, we have embedded our new strategic accounts capabilities. We continue to pursue new contract customer opportunities, and we've already seen our highest month ever for both volume and ex-factory sales in January, giving us confidence of continued growth going forward.

進入 2024 年第一季度，我們嵌入了新的策略客戶功能。我們繼續尋求新的合約客戶機會，一月份的銷售和出廠銷售都創下了有史以來最高的月份，這讓我們對未來的持續成長充滿信心。

I'll now pass the call over to Raj.

我現在將把電話轉給 Raj。

Thanks, Andrew, and good morning, everyone. I'll start with a reminder of recent progress that our Phase 3 PRESERVE 2 trial in metastatic triple-negative breast cancer. Earlier this month, we announced that the independent data monitoring committee for the trial reviewed data from the interim analysis of overall survival and recommended that the trial continue to the final analysis, which will be conducted on the intent to treat or ITT population.

謝謝安德魯，大家早安。我首先要提醒大家我們在轉移性三陰性乳癌中的 3 期 PRESERVE 2 試驗的最新進展。本月早些時候，我們宣布該試驗的獨立數據監測委員會審查了總體生存期中期分析的數據，並建議該試驗繼續進行最終分析，該分析將針對意圖治療或 ITT 族群進行。

Importantly, the DMC did not express any concerns with the trial. And as a reminder, G1 remains blinded to all data. We continue to be confident in the ability of trilaciclib to achieve a positive outcome for a variety of reasons. First, there is a greater likelihood of achieving a positive outcome at a final analysis and an interim because there are larger number of events and a higher alpha allocation at the final analysis.

重要的是，DMC 沒有對審判表示任何擔憂。提醒一下，G1 對所有數據仍然視而不見。出於多種原因，我們仍然對 trilaciclib 取得積極成果的能力充滿信心。首先，在最終分析和中期分析中獲得積極結果的可能性更大，因為最終分析中的事件數量更多且阿爾法分配更高。

This results in the ability to detect a larger critical hazard ratio at the final analysis compared to the interim, we discussed on the last call that the critical hazard ratio was 0.61 at the interim, and the final analysis will be able to pick up a larger hazard ratio of 0.67.

與中期相比，這導致最終分析時能夠檢測到更大的臨界風險比，我們在上次通話中討論了中期的臨界風險比為 0.61，最終分析將能夠檢測到更大的臨界風險比。風險比為0.67。

And of course, second, the strength of the data that precedes which this trial provides additional confidence we frequently describe the Phase 2 trial in which we saw statistically significant improvements in median overall survival in patients receiving trilaciclib prior to gemcitabine carboplatin compared to those receiving chemotherapy alone.

當然，其次，該試驗之前的數據強度提供了額外的信心，我們經常描述2 期試驗，在該試驗中，我們發現與接受化療的患者相比，在吉西他濱卡鉑之前接受trilaciclib 的患者中位總存活期有統計學意義的改善獨自的。

Importantly, the capital [Meier] survival curves of trial participants receiving trilaciclib plus gemcitabine carboplatin continue to separate over time compared to participants receiving placebo prior to their chemotherapy, particularly for patients with PD-L1 negative tumors for curve separation didn't occur until approximately 15 months.

重要的是，與化療前接受安慰劑的受試者相比，接受trilaciclib 加吉西他濱卡鉑的試驗參與者的資本[Meier] 生存曲線隨著時間的推移繼續分離，特別是對於PD-L1 陰性腫瘤患者，曲線分離直到大約15個月。

This is particularly relevant as the enrollment period for PRESERVE 2 from June 2021, until October 2022, and the interim analysis in February 2024, was conducted approximately 15 months after the last patient was enrolled.

這尤其重要，因為 PRESERVE 2 的入組期為 2021 年 6 月至 2022 年 10 月，並且 2024 年 2 月的中期分析是在最後一名患者入組後約 15 個月進行的。

Therefore, the additional months of follow-up between the interim and final analyses could be important for the curve to continue to meaningfully separate. Equally compelling were the results that we presented in December last year at the San Antonio Breast Cancer Symposium regarding subsequent anti-cancer therapy used for lung patients that participated in the Phase 2 TNBC trial.

因此，中期分析和最終分析之間額外幾個月的追蹤對於曲線繼續​​有意義地分離可能很重要。同樣令人信服的是我們去年 12 月在聖安東尼奧乳癌研討會上提出的關於參與 2 期 TNBC 試驗的肺部患者的後續抗癌治療的結果。

Participants who received trilaciclib with gemcitabine carboplatin and then received subsequent anti-cancer therapy after trilaciclib discontinuation exhibited cynically meaningful improvements in overall survival. With medians of 32.7 months versus 12.8 months.

接受 trilaciclib 合併吉西他濱卡鉑治療並在停用 trilaciclib 後接受後續抗癌治療的參與者在總體生存率方面表現出顯著的改善。中位數為 32.7 個月 vs 12.8 個月。

These results were statistically significant with a p-value of 0.001. Further median overall survival for patients who received trilaciclib was 14 months from the time they started their first subsequent therapy compared to 5.8 months for patients who did not receive trilaciclib.

這些結果具有統計顯著性，p 值為 0.001。接受 trilaciclib 治療的患者自開始首次後續治療後的中位總存活期為 14 個月，而未接受 trilaciclib 治療的患者為 5.8 個月。

And the p-value for this analysis was also 0.001. These results show that trilaciclib can provide benefits during the administration with chemotherapy in the short term and additional benefits after trilaciclib discontinuation by improving long-term immune surveillance.

此分析的 p 值也是 0.001。這些結果表明，trilaciclib 可以在短期化療期間提供益處，並透過改善長期免疫監視在停用 trilaciclib 後提供額外益處。

Given that pembrolizumab achieved a hazard ratio of 0.89 in the ITT population in the keynote 355 trial achieving our boundary hazard ratio of 0.67 would mark the biggest improvement in overall survival seen in first-line metastatic triple-negative breast cancer to date. We look forward to the final results, which are estimated to be in the third quarter of this year.

鑑於在主題355 試驗中，派姆單抗在ITT 族群中實現了0.89 的風險比，達到0.67 的邊界風險比將標誌著迄今為止在一線轉移性三陰性乳癌中觀察到的總體生存率的最大改善。我們期待最終結果，預計今年第三季公佈。

Regarding our Phase 2 trial of trilaciclib in combination with the TROP2 ADC sacituzumab govitecan. In January, we described promising initial efficacy results, including meaningful improvements in median overall survival among patients receiving trilaciclib compared to historical results for the ADC alone, we expect to provide updated overall survival results mid-year.

關於 trilaciclib 與 TROP2 ADC sacituzumab govitecan 組合的 2 期試驗。一月份，我們描述了有希望的初步療效結果，包括與單獨使用ADC 的歷史結果相比，接受trilaciclib 的患者中位總生存期的有意義的改善，我們預計在年中提供更新的總生存期結果。

Assuming the updated results remain strong, we anticipate continued partnership interest in developing trilaciclib with TROP2 ADCs that are in various stages of clinical development in TNBC and beyond. Additional clinical trials are ongoing, along with tracking real world data to evaluate whether trilaciclib may also improves survival in extensive stage small cell lung cancer.

假設更新的結果仍然強勁，我們預計將繼續與 TROP2 ADC 合作開發 trilaciclib，這些 ADC 處於 TNBC 及其他臨床開發的不同階段。其他臨床試驗正在進行中，同時追蹤真實世界數據，以評估 trilaciclib 是否也能提高廣泛期小細胞肺癌的存活率。

The potential overall survival benefit is demonstrated with supplement. The already known trilaciclib benefits of model protection and reductions in hospitalizations and associated costs. These ongoing survival studies and analyses and small cell lung cancer include post-marketing study of trilaciclib party topotecan in approximately 300 patients.

潛在的整體生存益處透過補充劑得到證明。已知的 trilaciclib 具有模型保護和減少住院及相關費用的優點。這些正在進行的小細胞肺癌存活研究和分析包括在約 300 名患者中進行的 trilaciclib party 拓撲替康的上市後研究。

The real-world evidence we continue to generate the most recent of which was presented in October at the ASCO quality care symposium and a Phase 2 investigator initiated trial at UNC line burger from combination of lurbinectedin which according to the study, investigator continues to look promising from the perspective of both model protection and tumor responses.

我們繼續產生的真實世界證據，其中最新的證據於10 月在ASCO 品質護理研討會上提出，並且2 期研究人員在UNC line Burger 啟動了lurbinectedin 組合的試驗，根據該研究，研究人員仍然看起來很有希望從模型保護和腫瘤反應的角度來看。

However, a neutral of legal focus for the next six months remain on advancing the science in triple-negative breast cancer as we deliver the TMBC ADC Phase 2 results midyear and the Phase 3 final results in the third quarter.

然而，隨著我們在年中發布 TMBC ADC 2 期結果並在第三季發布 3 期最終結果，未來六個月的法律重點仍然是推動三陰性乳癌的科學發展。

With that, I'll turn the call over to John for the financial results.

這樣，我會將電話轉給約翰，詢問財務結果。

Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the fourth quarter and full year 2023 are available in this morning's press release and will be in the 10-K, which we expect to file after market close.

謝謝拉吉，大家早安。正如 Will 所提到的，第四季度和 2023 年全年的完整財務業績可在今天上午的新聞稿中獲取，並將包含在 10-K 中，我們預計將在收盤後提交。

Net sales of solid grew 29% in the fourth quarter of 2023 to $13.9 million compared to 19% quarterly vial volume growth. This disparity is largely related to the timing of the sales. As mentioned on our November call, we recognize revenue upon delivery to distributors. We experienced an increase in patient vial demand towards the end of the third quarter of 2023, which was recognized as revenue in the fourth quarter.

2023 年第四季固體淨銷售額成長 29%，達到 1,390 萬美元，而季度小瓶銷量成長 19%。這種差異很大程度上與銷售時間有關。正如我們在 11 月的電話會議中所提到的，我們在向分銷商交付時確認收入。到 2023 年第三季末，我們的患者藥瓶需求增加，這在第四季度被確認為收入。

In addition to that, which we recognized due to strong quarter over quarter growth, our total revenue for the fourth quarter of 2023 grew 45% over the fourth quarter of 2022 to $14.9 million, comprised of the $13.9 million I just described in net COSELA revenue and $1 million in license revenue.

除此之外，我們認識到由於季度環比強勁增長，我們2023 年第四季的總收入比2022 年第四季增長了45%，達到1,490 萬美元，其中包括我剛才在COSELA 淨收入中描述的1,390 萬美元以及 100 萬美元的許可收入。

This compares favorably to the $10.3 million in total revenue, including $8.9 million in product revenue in the fourth quarter of 2022. Total revenues for the full year 2023 or $82.5 million, including to sell a net revenue of $46.3 million and license revenue of $36.2 million. For the full year 2022, total revenues were $51.3 million, including net product revenue of $31.3 million.

相較之下，2022 年第四季的總收入為 1,030 萬美元，其中包括 890 萬美元的產品收入。2023 年全年總收入為 8,250 萬美元，其中銷售淨收入為 4,630 萬美元，許可收入為 3,620 萬美元。2022 年全年總收入為 5,130 萬美元，其中產品淨收入為 3,130 萬美元。

Cost of goods sold for the fourth quarter of 2023 was $1.3 million compared to $1 million for the same period in 2022. Cost of goods sold for the full year 2023 was $7.2 million compared to $3.7 million for the prior year.

2023 年第四季的銷售成本為 130 萬美元，而 2022 年同期為 100 萬美元。2023 年全年銷售成本為 720 萬美元，而前一年為 370 萬美元。

As we guided in November, our operating expenses of $122 million in 2023 or 35% lower than the $187.5 million in OpEx in 2022. Research and development expenses for the fourth quarter of 2023 were $7.4 million compared to $16.6 million for the same period in 2022. The decrease was primarily due to lower clinical program costs.

正如我們 11 月的指引，我們 2023 年的營運支出為 1.22 億美元，比 2022 年的營運支出 1.875 億美元低 35%。2023 年第四季的研發費用為 740 萬美元，而 2022 年同期為 1,660 萬美元。減少的主要原因是臨床項目成本降低。

R&D expenses for the full year 2023 were $43.7 million compared to $83.3 million for 2022. Our selling, general and administrative expenses for the fourth quarter of 2023 were $15.2 million compared to $23.6 million for the fourth quarter of 2022.

2023 年全年研發費用為 4,370 萬美元，而 2022 年為 8,330 萬美元。2023 年第四季我們的銷售、一般和管理費用為 1,520 萬美元，而 2022 年第四季為 2,360 萬美元。

The decrease in SG&A expenses was primarily due to decreases in personnel costs and medical affairs and further optimization of our commercialization activities. SG&A expenses for the full year 2023 were $71.1 million compared to $100.4 million for the prior year.

SG&A 費用的減少主要是由於人員成本和醫療事務的減少以及我們商業化活動的進一步優化。2023 年全年的 SG&A 費用為 7,110 萬美元，而前一年為 1.004 億美元。

Regarding our cash position, we ended the fourth quarter with cash, cash equivalents and marketable securities of $82.2 million compared to $145.1 million as of December 31, 2022. Finally, regarding revenue and cash runway guidance for the full year 2024, as Jack mentioned, we expect net to seller revenue to be between $60 million and $70 million for 2024.

關於我們的現金狀況，第四季末我們的現金、現金等價物和有價證券為 8,220 萬美元，截至 2022 年 12 月 31 日為 1.451 億美元。最後，關於 2024 年全年的收入和現金跑道指導，正如 Jack 所提到的，我們預計 2024 年賣家淨收入將在 6,000 萬美元至 7,000 萬美元之間。

There's no change to our 2024 gross-to-net expense percentage estimates. We expect the 2024 year end cash, cash equivalents and marketable securities balance of between $50 million to $60 million. Additionally, we will continue to look for ways to optimize our cost structure in the near term with targeted headcount reductions outside of the commercial organization and identifying other potential efficiency improvements where appropriate. And based on the foregoing, we expect that our cash runway will take us into 2025.

我們對 2024 年總費用與淨費用百分比的預測沒有改變。我們預計 2024 年底現金、現金等價物和有價證券餘額將在 5,000 萬美元至 6,000 萬美元之間。此外，我們將繼續尋找短期內優化成本結構的方法，有針對性地減少商業組織以外的人員數量，並在適當的情況下確定其他潛在的效率改進。基於上述情況，我們預計我們的現金跑道將帶我們進入 2025 年。

With that, I'll turn the call back over to Jack for some closing comments. Jack?

這樣，我會將電話轉回給傑克，以徵求一些結束語。傑克？

Thank you, John, Raj, Andrew, and Will. Also want to recognize the cancer community. We are thankful for the opportunity to be part of your journey. We are encouraged by the feedback we receive daily from physicians who rely and co-sell to reduce the chemotherapy related myelosuppressive side effects and their patients with extensive stage small cell lung cancer and by the demand trajectory in Q4 2023 and the beginning of Q1 2024.

謝謝約翰、拉傑、安德魯和威爾。也想認識癌症界。我們非常感謝有機會成為您旅程的一部分。我們每天從依靠和共同銷售來減少化療相關骨髓抑制副作用的醫生及其患有廣泛期小細胞肺癌的患者那裡收到的反饋以及2023 年第四季度和2024 年第一季初的需求軌跡感到鼓舞。

And while we have a strong commercial team driving co-selling penetration and demand and a clear path to profitability in this first indication. Our focus is also on generating the clinical results required for TNBC category leadership. To that end you've heard today, we have important updated survival results from our Phase 2 study in combination with the TROP2 ADC expected midyear and final results from our ongoing Phase 3 trial in first-line metastatic triple-negative cancer are expected in the third quarter of 2024.

儘管我們擁有強大的商業團隊，可推動共同銷售滲透率和需求，並在第一個跡像中提供清晰的獲利路徑。我們的重點還在於產生 TNBC 類別領導所需的臨床結果。為此，您今天聽說了，我們的2 期研究與TROP2 ADC 相結合的重要更新生存結果預計將於年中公佈，而我們正在進行的一線轉移性三陰性癌症3 期試驗的最終結果預計將於 2019 年取得。2024 年第三季。

Thank you for your time this morning. We will speak again in this format on the first quarter of 2024 call in May and see many of you at the spring investor meetings.

感謝您今天早上抽出時間。我們將在 5 月的 2024 年第一季電話會議上再次以這種形式發言，並在春季投資者會議上見到你們中的許多人。

With that, I'll turn it over to Q&A. Operator, would you please remind our listeners how to ask a questions.

接下來，我將把它轉為問答。接線員，請您提醒我們的聽眾如何提問。

(Operator Instructions)

（操作員說明）

Joseph Thome, TD Cowen.

約瑟夫·托姆，TD·考恩。

Good morning. Thank you for taking my question. Maybe just just overall, I mean, initially the front-line TNBC data were delayed from sort of your very initial expectations, which I guess kind of suggests that the event rate is maybe occurring a little bit slower than initially anticipated. And hopefully some of that is due to the addition of COSELA. But what do you think about the comparator arm? I guess, is there anything over the past several years in particular that would have no extended overall survival for the comparator.

早安.感謝您回答我的問題。也許只是總體而言，我的意思是，最初前線 TNBC 數據比您最初的預期有所延遲，我想這表明事件發生率可能比最初預期的要慢。希望其中一部分是由於 COSELA 的加入。但您對比較器臂有何看法？我想，在過去的幾年裡，是否有任何事情不會延長比較者的整體生存期。

And what is sort of a good comparator for what the that Army should do is 355 the best obviously based on your Phase 2 data, but that includes a few patients in later lines.

根據您的第 2 階段數據，陸軍應該做的事情的一個很好的比較器是 355，顯然是最好的，但這包括後來的一些患者。

And then second, on the commercial side that 13% penetration in frontline seems really strong. I guess how high do you think penetration can go in the frontline? And are these the same or these accounts that have the most experience with because that letter they start later line and go forward or kind of who's using it in the frontline? Thank you.

其次，在商業方面，前線 13% 的滲透率似乎確實很高。我猜你認為前線的滲透率能達到多高？這些是相同的帳戶還是那些擁有最多經驗的帳戶，因為他們從後面開始並繼續使用該字母，或者是誰在前線使用它？謝謝。

Thanks, Joe. What we have Raj take the first one, and then we'll have Andrew answer the second. Raj?

謝謝，喬。我們請 Raj 回答第一個，然後我們請 Andrew 回答第二個。拉傑？

Yeah, hey, Joe. Yeah, I mean, in terms of comparator, we still think that the keynote 355 gem carbo arm is a reasonable one because there aren't really any other data beyond that. I mean, it's the most contemporary data we have I mean, in terms of on things that could potentially be confounding. The one change of course, even since then is likely greater ADC used, particularly in later lines of therapy.

是的，嘿，喬。是的，我的意思是，就比較器而言，我們仍然認為 keynote 355 gem carbo 臂是合理的，因為除此之外沒有任何其他數據。我的意思是，就可能令人困惑的事情而言，這是我們擁有的最新數據。當然，從那時起，唯一的變化可能是使用更多的 ADC，特別是在後來的治療中。

But in a blinded trial, we would expect that would be relatively balanced between the two arms. And so we would expect that trial are based on the prior data in terms of benefiting patients, even with subsequent therapies will continue to show benefit when added to for rather than ADCs given after trial.

但在盲法試驗中，我們預期兩組之間會相對平衡。因此，我們預計該試驗是基於先前的數據，使患者受益，即使後續療法在添加到 ADC 中而不是在試驗後給予 ADC 時仍將繼續顯示出益處。

Interesting. Thank you.

有趣的。謝謝。

Thankfully also and yes, thank you. The 13% and for flying. So obviously over 90% of our use is in that first-line setting on the we're talking about an overall market here, very accessible to co-sell, of which we estimate to over $700 million and potential gross revenue. So very, very significant market opportunity for us. We've seen that market share go up very consistently, even through that platinum shortage.

值得慶幸的是，是的，謝謝。13% 是為了飛行。顯然，我們 90% 以上的使用都是在一線環境中，我們在這裡談論的是整個市場，很容易聯合銷售，我們估計其中的潛在總收入超過 7 億美元。對我們來說非常非常重要的市場機會。我們看到，即使在鉑金短缺的情況下，市場份額仍然持續上升。

Our market share continues to grow. There were just fewer patients taking eligible chemotherapies which makes sense. And we're very ambitious for what we can continue to add and not market share going forward. And frankly, I won't be satisfied until every eligible patient. I've got to COSELA.

我們的市場佔有率持續成長。接受符合條件的化療的患者越來越少，這是有道理的。我們對能夠繼續增加的東西而不是未來的市場份額非常雄心勃勃。坦白說，直到每一位符合條件的患者都得到了治療，我才會感到滿意。我得去科塞拉。

Perfect. Thank you very much.

完美的。非常感謝。

Gil Blum, Needham Company.

吉爾布魯姆，李約瑟公司。

Good morning. And thanks for taking our questions. Just a clarifying question. Did the IDMC look at the interim data that the committee have a remnant discontinue the study for futility?

早安.感謝您回答我們的問題。只是一個澄清問題。IDMC 是否查看中期數據，認為委員會有剩餘內容因無效而終止研究？

Yeah. Hey, Gil. So the interim analysis of the efficacy, one only obviously, if they saw the data they could, of course, do additional analyses at their discretion but the only analysis that was sort of prespecified was one for efficacy.

是的。嘿，吉爾。因此，對功效的中期分析很明顯，如果他們看到數據，當然可以自行決定進行額外的分析，但唯一預先指定的分析是針對功效的分析。

Okay. And maybe looking towards mid '24 for the ADC result, just to set our expectations of what we could potentially see there? Thank you.

好的。也許期待 24 年中期的 ADC 結果，只是為了設定我們對在那裡可能看到的結果的期望？謝謝。

Yeah. So you know, obviously, what we are interested in seeing is we presented the early talk at the JPM. And so we'll be looking to see how the data February sorry, continue to track versus that. And if you recall, the 12 months, we had about a 20% improvement from clearly the rest of the curve could change, but we we're looking to see how much improved the survival is relative to historical data and then make decisions on further development likely in a partnership scenario.

是的。所以你知道，顯然我們有興趣看到的是我們在摩根大通的早期演講。因此，我們將關注 2 月的數據，抱歉，繼續追蹤該數據。如果您還記得，在這12 個月中，我們的改善程度約為20%，顯然曲線的其餘部分可能會發生變化，但我們希望了解相對於歷史數據，生存率改善了多少，然後做出進一步的決定合作關係中可能的發展。

Anupam Rama, JPMorgan.

阿努帕姆‧拉瑪，摩根大通。

Hi, guys. This is Priyanka on for Anupam, we just have a quick question. How much of the incremental headwind via the Platinum shortage is assumed in the 2024 guidance for COSELA? Thank you.

嗨，大家好。我是 Anupam 的 Priyanka，我們有一個簡單的問題。2024 年 COSELA 指南中假設了鉑金短缺帶來的增量阻力有多大？謝謝。

So Priyanka can you repeat the question, please?

Priyanka，你能重複這個問題嗎？

Yeah, sure. So how much of the incremental headwind via the Platinum shortage is assumed in the 2024 guidance for COSELA?

好，當然。那麼，2024 年 COSELA 指南中假設了鉑金短缺帶來的增量阻力有多大？

Yeah, we don't assume if you're inflating any carry forward, we don't assume any given the limited duration of therapy of these patients along with, unfortunately, the diagnosis to expiration and you tend to see with these this very aggressive cancer, we don't see that any of this sort of pushes patients into 2024.

是的，我們不假設你是否會誇大任何結轉，我們不假設任何給定這些患者的有限治療持續時間以及不幸的是，診斷到期，你往往會看到這些非常激進癌症方面，我們沒有看到任何此類因素會將患者推遲到2024 年。

What we are doing is currently certainly monitoring the FDA website and to make sure that it doesn't we don't see a repeat in '24 of what we saw in '23 and certainly at the clinic level, what we've heard from really late Q3 is that customers are not having issue being able to access any of the carbo versus platinum.

我們目前所做的當然是監控 FDA 網站，並確保我們不會在 24 年看到我們在 23 年看到的情況重複，當然在臨床層面，我們從那裡聽到的情況也不會重複。第三季度很晚的一點是，客戶在獲得碳和鉑時沒有遇到任何問題。

Understood. Thank you so much.

明白了。太感謝了。

Laura Prendergast, Raymond James.

勞拉·普倫德加斯特，雷蒙德·詹姆斯。

Hey guys. Thanks for taking the questions. I was going to be able to elaborate a bit on CDC midyear. This ADC combo data could still continue to look strong. What are the timing of when you expect to initiate a randomized trial and then additionally, on your cash runway, does that include baked in launch costs represented to us if the final analysis is successful and the Phase 3 for the ADC combination? Thanks.

大家好。感謝您提出問題。年中我本來可以詳細闡述一下 CDC。該 ADC 組合數據仍可能持續強勁。您期望啟動隨機試驗的時間是什麼時候？此外，在您的現金跑道上，如果最終分析成功，這是否包括向我們展示的初始啟動成本以及 ADC 組合的第 3 階段？謝謝。

So I'll have John pick the last one and then we can flip over to Raj.

所以我會讓約翰選擇最後一項，然後我們可以轉向拉吉。

For the cash runway part unit from TMBC launch costs. We do have those inclusive of it. Obviously, with the delay to interim, those costs get pushed out, but we do have them baked in in our runway.

現金跑道部分單位的發射費用由 TMBC 承擔。我們確實有那些包含在內。顯然，隨著過渡期的推遲，這些成本被推遲了，但我們確實將它們納入了我們的跑道中。

You mentioned I believe in ADC Phase 3 randomized trial. We do not have that in there. I think as Raj mentioned, we want to see our midyear results and then hopefully have the ability to partner with a some type of collaboration potentially where we would look at a Phase 3 trial.

你提到我相信 ADC 3 期隨機試驗。我們那裡沒有那個。我認為正如 Raj 所提到的，我們希望看到年中結果，然後希望有能力與某種類型的合作夥伴合作，我們可能會考慮進行第三階段試驗。

Yeah. I mean, I was going to just I think, John covered it unless there are we have an additional question

是的。我的意思是，我只是想，約翰涵蓋了它，除非我們還有其他問題

And then that's all for me. Thank you.

這就是我的全部了。謝謝。

Thank you, Laura.

謝謝你，勞拉。

(Operator Instructions)

（操作員說明）

Edward White, H.C. Wainwright.

愛德華懷特，H.C.溫賴特。

Hey, guys. Thanks for taking our question. This is Steve on for Ed. First question, do you think the sales force is rightsized now? Or would you need additional investments and if so, how should we think about SG&A for next year or this year?

大家好。感謝您提出我們的問題。這是史蒂夫為艾德代言的。第一個問題，您認為現在銷售團隊規模是否合理？或者您需要額外的投資？如果需要，我們應該如何考慮明年或今年的銷售及管理費用？

Why don't we go first with Andrew on the sales force and then John can touch on the SG&A going this year.

我們為什麼不先和安德魯談談銷售隊伍，然後約翰可以談談今年的銷售、管理和管理費用。

Yeah. Thanks, Steve. We continue to make tweaks to our, I would say, our commercial footprint in the field. And one example is our new strategic accounts team that we deployed in Q4 and into Q1, and we've been delighted with the progress they've made so far.

是的。謝謝，史蒂夫。我想說，我們繼續調整我們在該領域的商業足跡。一個例子是我們在第四季和第一季部署的新策略客戶團隊，我們對他們迄今為止所取得的進展感到高興。

We think our commercial footprint in terms of sales professionals right now is about right. I think as we move forward into new market expansion into new indications, we would reevaluate, but I don't see it being like a real phase shift. I see it being an evolution of the team that we have.

我們認為目前我們在銷售專業人員方面的商業足跡大致正確。我認為，當我們進入新市場、新適應症的擴張時，我們會重新評估，但我認為這並不是真正的相變。我認為這是我們團隊的演變。

And from SG&A costs -- Steve, from an SG&A cost perspective, I think you'd asked about that. I mean we continue to invest in commercial, as we always have, as I mentioned earlier, you know, we do create and continue to see efficiencies in optimizing that cost structure of the commercial front, but we continue to invest in it.

從 SG&A 成本來看——史蒂夫，從 SG&A 成本的角度來看，我想你已經問過這個問題了。我的意思是，我們繼續投資商業，就像我之前提到的那樣，我們確實創造並繼續看到優化商業方面成本結構的效率，但我們繼續投資。

Okay, thanks. And then is there any update on Simcere in China?

好的謝謝。那麼先聲藥業在中國有什麼最新消息嗎？

No. I mean, they obviously are continuing to sell COSELA for the initial indication in small cell there also. And they're also running their own studies, and they've been a wonderful partner to us to continue to be to that to this day. So no other updates beyond that.

不。我的意思是，他們顯然還在繼續銷售 COSELA，以用於小型基地台的初步適應症。他們也在進行自己的研究，他們一直是我們出色的合作夥伴，直到今天仍然如此。所以除此之外沒有其他更新。

All right. Thank you.

好的。謝謝。

I am showing no further questions at this time. I would now like to turn it back to Jack Bailey, Chief Executive Officer for closing remarks.

我目前沒有提出任何進一步的問題。現在我想請執行長傑克貝利 (Jack Bailey) 致閉幕詞。

Thank you operator. As always, I look forward to keeping everyone updated on our progress going forward. Thank you for joining us today, and we'll be in touch. Thank you.

謝謝運營商。一如既往，我期待著向大家通報我們的最新進展。感謝您今天加入我們，我們將與您聯繫。謝謝。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了該程式。您現在可以斷開連線。