G1 Therapeutics Inc (GTHX) 2023 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to the G1 Therapeutics third-quarter 2023 financial results call. (Operator Instructions)

美好的一天，感謝您的支持。歡迎參加 G1 Therapeutics 2023 年第三季財務業績電話會議。 （操作員說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Will Roberts, Vice President of Communications. Please go ahead.

請注意，今天的會議正在錄製中。現在，我想將會議交給今天的第一位發言者，傳播副總裁威爾羅伯茨 (Will Roberts)。請繼續。

Thank you, Teresa. Good morning, everyone, and welcome to the G1 conference call to discuss our third-quarter 2023 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our website, g1therapeutics.com.

謝謝你，特蕾莎。大家早上好，歡迎參加 G1 電話會議，討論我們的 2023 年第三季財務業績和業務更新。有關這些財務表現的新聞稿於今天早上發布，可以在我們網站 g1therapeutics.com 的新聞部分找到。

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

在今天早上的電話會議上，團隊將討論2023 年第三季的業務概覽，包括我們的臨床專案的最新情況以及我們與COSELA 在此期間的商業進展，COSELA 已獲得批准並可商業化，以降低化療引起的癌症發生率在治療廣泛期小細胞肺癌的含鉑/依托泊苷方案或含拓撲替康方案之前給藥時，患者、成年患者的骨髓抑制。

A Q&A session will follow the prepared comments. 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 judgment as of today and may involve risk and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on these 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, November 1, 2023.

在準備好的評論之後將進行問答環節。在我們開始之前，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。此類陳述代表了截至今天的管理層判斷，可能涉及風險和不確定性，可能導致實際結果發生變化。與這些陳述中明示或暗示的內容有重大差異。有關這些風險和不確定性的更多信息，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 或我們的公司網站上獲取。任何前瞻性陳述均代表我們截至今天（2023 年 11 月 1 日）的觀點。

Joining me on the call 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.

與我一起參加電話會議的是我們的執行長 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. Good morning, everyone, and thank you for joining us on the call today. I'm glad to have the opportunity to discuss our project's progress during the third quarter. We've experienced two quarters of selling into a strong headwind of a national platinum-based chemotherapy shortage. The shortage has been significant and prolonged as you've likely read. The good news is that it appears to be waning, and the FDA report suggests resolution by the end of this year. Yet despite the chemotherapy shortages, COSELA has grown quarter over quarter on a volume basis, although due to wholesaler purchasing patterns, [ex-factory] sales were slightly down in the third quarter.

謝謝，威爾。大家早安，感謝您今天加入我們的電話會議。我很高興有機會討論我們專案在第三季的進展。我們經歷了兩個季度的銷售，因為全國鉑類化療藥物短缺的強勁逆風。正如您可能已經讀到的那樣，短缺現象嚴重且持續時間較長。好消息是這種情況似乎正在減弱，FDA 報告建議在今年底前解決。然而，儘管化療藥物短缺，COSELA 的銷量仍逐季增長，儘管由於批發商的採購模式，第三季[出廠]銷售額略有下降。

As you saw in this morning's press release, because of the ongoing platinum shortage, we have decreased our COSELA net sales guidance for 2023 to $44 million to $47 million. While we are disappointed in the impact of the shortage, we remain confident in the opportunity for significant growth as reflected by a record month of sales in October. Andrew will provide additional color on our commercial results momentarily.

正如您在今天早上的新聞稿中看到的，由於鉑金持續短缺，我們已將 2023 年 COSELA 淨銷售額指導值下調至 4,400 萬美元至 4,700 萬美元。儘管我們對短缺的影響感到失望，但我們仍然對大幅成長的機會充滿信心，正如 10 月創紀錄的銷售量所反映的那樣。安德魯將立即為我們的商業成果提供更多的資訊。

Beyond that continued therapeutic innovation for people diagnosed with triple-negative breast cancer is paramount. And as we approach the overall survival readouts from our ongoing trials in TNBC, there is palpable excitement among clinicians regarding the potential for trilaciclib to improve survival and a significant opportunity for G1. Most importantly, all eyes are on the interim overall survival analysis for PRESERVE 2, our pivotal trial of trilaciclib in TNBC.

除此之外，對於被診斷為三陰性乳癌的患者來說，持續的治療創新至關重要。當我們接近正在進行的 TNBC 試驗的總體生存率讀數時，臨床醫生對 trilaciclib 提高生存率的潛力和 G1 的重大機會感到興奮。最重要的是，所有人的目光都集中在 PRESERVE 2 的中期總體生存分析上，這是我們在 TNBC 中使用 trilaciclib 的關鍵試驗。

If the results of the interim analysis in the first quarter of next year are positive, we will work closely with the FDA to expand the indication of COSELA. We look forward to these results and the opportunity for G1 to further establish our position as an innovation leader in this setting.

如果明年第一季的中期分析結果是正面的，我們將與 FDA 密切合作，擴大 COSELA 的適應症。我們期待這些成果，也期待 G1 有機會進一步確立我們作為這領域創新領導者的地位。

We will discuss each of these topics in order. Andrew will cover our recent commercial results, Raj will provide an update on our clinical pipeline, including an update on the phase -- on the TNBC Phase 3 trial. John will then provide the financial results for the quarter and remind you of our revenue, expense, and cash expectations. Finally, I'll be back for some concluding comments.

我們將按順序討論每個主題。 Andrew 將報告我們最近的商業結果，Raj 將提供我們臨床管道的最新信息，包括 TNBC 第 3 期試驗的階段更新。然後約翰將提供本季的財務業績，並提醒您我們的收入、費用和現金預期。最後，我會回來發表一些結論性意見。

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 third-quarter 2023 sales performance and the progress we've made in our commercial execution over recent months, despite facing some continuation of the external challenges we described last quarter.

謝謝你，傑克。我很高興今天能與大家一起介紹我們 2023 年第三季的銷售業績以及近幾個月來我們在商業執行方面取得的進展，儘管我們仍面臨著上季度描述的一些外部挑戰。

Our goal in Q3 was to continue to expand our quarter-over-quarter growth by broadening our platform of deeply adopting customer organizations. The strategy helps to secure growth even when we face external challenges such as the platinum chemotherapy shortage, which we described in our Q2 call. I'll discuss some of the factors underlying our Q3 performance to date.

我們第三季的目標是透過擴大我們深度採用客戶組織的平台來繼續擴大我們的季度環比成長。即使我們面臨外部挑戰，例如我們在第二季電話會議中描述的鉑類化療藥物短缺，該策略也有助於確保成長。我將討論迄今為止第三季業績的一些因素。

And beginning with sales results, we ended the quarter with 3% final volume growth compared with Q2. As discussed in our Q2 call, we entered the quarter with the continued impact of well-publicized national shortages of both carboplatin and cisplatin. In fact, a recent survey conducted by the National Comprehensive Cancer Network showed that as of the first week of October, 72% of centers surveyed experienced a shortage of carboplatin and 59% were still seeing a shortage of cisplatin.

從銷售業績開始，本季末我們的最終銷量較第二季成長了 3%。正如我們在第二季電話會議中所討論的，我們在進入本季時受到了廣為人知的卡鉑和順鉑全國短缺的持續影響。事實上，全國綜合癌症網絡最近進行的一項調查顯示，截至 10 月第一周，72% 的受訪中心出現卡鉑短缺，59% 的中心仍出現順鉑短缺。

Customers are managing through it and have dealt with the shortage by substituting chemotherapies, swapping out cisplatin for carboplatin or reducing cycles and doses. We have seen these items stabilized somewhat during Q3 and in some cases return to more normal levels. And while it may impact the fourth quarter to some extent as well, FDA report suggests that it should fully resolved by the end of the year. In terms of the effect in our COSELA business, this may have impacted the number of continuing patients from second quarter on new patients in the beginning of third quarter. From a volume growth perspective, the impact was similar in size to that in the second quarter.

客戶正在克服這一困難，並透過替代化療、以卡鉑取代順鉑或減少週期和劑量來解決短缺問題。我們看到這些項目在第三季度有所穩定，在某些情況下恢復到更正常的水平。雖然這也可能在一定程度上影響第四季度，但 FDA 報告表明，這個問題應該會在年底前完全解決。就我們 COSELA 業務的影響而言，這可能會影響第二季度的持續患者數量和第三季初的新患者數量。從銷售成長的角度來看，影響程度與第二季相似。

We showed similar growth this quarter across both top 100 and non-top 100 customers with 56% of our volume and top 100 organizations. Community clinics and hospitals represented 80% of sales and academic centers represented 20% with the community segment growing a little faster this quarter.

本季我們在前 100 名和非前 100 名客戶中都顯示出類似的成長，占我們數量的 56% 和前 100 名組織。社區診所和醫院佔銷售額的 80%，學術中心佔 20%，本季社區部分的成長速度稍快一些。

We saw a number of indicators that our COSELA business continues to build a stronger base of deep adoption during the quarter, 58 of the top 100 organizations order during the quarter compared to 56 in Q2, and we saw a similar number of customers purchasing more than 100 vials during the quarter. We brought onboard 56 new accounts. And since the end of the quarter, we have also added one new top 100 organizations, meaning 74 of the top 100 have ordered COSELA launched today.

我們看到多項指標表明我們的COSELA 業務在本季度繼續建立更強大的深度採用基礎，排名前100 的組織中有58 個在本季度訂購了產品，而第二季度為56 個，並且我們看到類似數量的客戶購買了超過本季 100 瓶。我們新增了 56 個帳戶。自本季末以來，我們還增加了一個新的 100 強組織，這意味著前 100 強中有 74 家訂購了今天推出的 COSELA。

During the quarter, we added two new community contract customers and we estimate roughly 30% of our business as customers who have a volume agreement. Our estimate of COSELA patient share continues to grow, and although claims data for Q3 are not fully available, we estimate patient share of approximately 11% in the first-line market, which demonstrates ample opportunity for future growth.

本季度，我們增加了兩個新的社區合約客戶，我們估計大約 30% 的業務是簽訂大量協議的客戶。我們對 COSELA 患者份額的估計持續增長，儘管第三季度的理賠數據尚未完全獲得，但我們估計一線市場的患者份額約為 11%，這表明未來有充足的成長機會。

98% of our volume in the quarter was in commercial supply with 2% provided through our patient assistance program. Our payer mix remained stable with the majority covered by Medicare and third-party payer reimbursement has remained strong.

本季我們 98% 的銷售來自商業供應，其中 2% 透過我們的患者援助計畫提供。我們的付款人結構保持穩定，大多數人都享有醫療保險，第三方付款人報銷仍然強勁。

Moving into Q4 2023, we're encouraged to see a healthy start for the quarter with continued strong demand in October, which was a record month for sales. As always, we will continue to evolve as necessary to achieve our ambitions for COSELA.

進入 2023 年第四季度，我們很高興看到該季度的良好開局，10 月份的需求持續強勁，這是銷售創紀錄的月份。一如既往，我們將繼續根據需要不斷發展，以實現 COSELA 的目標。

I'll now turn the call over to Raj for a pipeline update.

我現在將把電話轉給 Raj 以獲取管道更新。

Thanks, Andrew, and good morning, everyone. Today, I will review our clinical work starting with expected timelines for overall survival results from each of our ongoing trials. First, as Jack said, all eyes are on the interim overall survival analysis for PRESERVE 2, our pivotal trial of trilaciclib in triple-negative breast cancer. This trial largely replicates the design of our Phase 2 trial that showed a statistically significant overall survival advantage in both arms for participants receiving trilaciclib prior to standard of care compared to standard of care alone.

謝謝安德魯，大家早安。今天，我將回顧我們的臨床工作，從我們正在進行的每項試驗的整體存活結果的預期時間表開始。首先，正如 Jack 所說，所有人的目光都集中在 PRESERVE 2 的中期總體生存分析上，這是我們在三陰性乳癌中進行 trilaciclib 的關鍵試驗。該試驗在很大程度上複製了我們2 期試驗的設計，該試驗顯示，與僅接受標準護理相比，在標準護理之前接受trilaciclib 的參與者在雙臂中具有統計學上顯著的總體生存優勢。

The interim overall survival analysis is event driven. And based on the current rate of event accumulation, we remain confident that the analysis will take place in the first quarter of 2024. If the trial meets the interim analysis stopping rule, it will be unblinded and G1 will report the topline results. If the trial does not meet the interim analysis stopping rule, it will continue to the final analysis expected later in 2024.

中期總體存活分析是事件驅動的。根據目前的事件累積速度，我們仍然有信心分析將在 2024 年第一季進行。如果試驗符合臨時分析停止規則，它將是非盲的，G1 將報告頂線結果。如果試驗不符合中期分析停止規則，則將繼續進行預計於 2024 年稍後進行的最終分析。

Regarding the stopping criteria with respect to the hazard ratio, recall that in group two of the Phase 2 study, where patients receive trilaciclib on the day of chemotherapy, the hazard ratio was 0.31. Based on the size of this study, we'll be able to pick up a larger hazard ratio of approximately 0.61 at the interim. So the hazard ratio can be up to approximately two times larger than what we saw in group two of the Phase 2 study, and we would still have a positive outcome.

關於風險比的停止標準，請回想一下，在 2 期研究的第二組中，患者在化療當天接受 trilaciclib，風險比為 0.31。根據這項研究的規模，我們將能夠在此期間獲得約 0.61 的更大風險比。因此，風險比可能比我們在第二階段研究的第二組中看到的大約高出兩倍，但我們仍然會得到積極的結果。

The mechanism of action of trilaciclib impacts longer-term endpoints like overall survival to a greater extent than shorter-term end points. Preserving bone marrow and immune system function, in addition to enhancing antitumor immunity, should allow patients to benefit while receiving trilaciclib and also while receiving subsequent anti-cancer therapies following trilaciclib.

trilaciclib 的作用機轉對長期終點（如總存活期）的影響比短期終點更大。除了增強抗腫瘤免疫力之外，保留骨髓和免疫系統功能應該使患者在接受 trilaciclib 治療以及在 trilaciclib 之後接受後續抗癌治療時受益。

To that end, we have performed new post-hoc analyses on our Phase 2 TNBC trial evaluating survival outcomes for patients who did or did not receive subsequent therapies after study treatment, and the results are compelling. We have submitted the results to a medical meeting and look forward to discussing that once they are presented in December.

為此，我們對 2 期 TNBC 試驗進行了新的事後分析，評估在研究治療後接受或未接受後續治療的患者的生存結果，結果令人信服。我們已將結果提交給醫學會議，並期待在 12 月提交結果後進行討論。

Second, we expect to provide the initial overall survival results from our Phase 2 trial with the antibody-drug conjugate sacituzumab govitecan in the first quarter of 2024. Thus far, we have shown convincing data that trilaciclib can improve the tolerability of sacituzumab. When administered prior to the ADC, trilaciclib reduced the rates of multiple adverse events by over 50% compared to the single-agent ADC, including neutropenia, anemia, and diarrhea.

其次，我們預計在2024 年第一季提供抗體藥物偶聯物sacituzumab govitecan 的2 期試驗的初步總體生存結果。到目前為止，我們已經顯示了令人信服的數據，證明trilaciclib 可以提高sacituzumab 的耐受性。與單藥 ADC 相比，在 ADC 之前給藥時，trilaciclib 可使多種不良事件的發生率降低 50% 以上，包括嗜中性白血球減少症、貧血和腹瀉。

In addition to the benefit on tolerability, we believe that combining trilaciclib and sacituzumab could also enhance survival, and in doing so provide a path for meaningful improvements in outcomes for people living with triple-negative breast cancer.

除了耐受性方面的益處外，我們相信將 trilaciclib 和 sacituzumab 聯合使用還可以提高生存率，從而為三陰性乳癌患者的預後提供有意義的改善。

And third regarding the bladder cancer Phase 2 trial, we announced this morning that we are concluding the trial following the next protocol defined analysis of survival later this quarter, allowing us to focus our resources on our core areas of TNBC and ADC combinations. We will report the results from this Phase 2 trial in bladder cancer at a future medical meeting.

第三，關於膀胱癌2 期試驗，我們今天早上宣布，我們將在本季度晚些時候進行下一個協議定義的生存分析後結束試驗，這使我們能夠將資源集中在TNBC 和ADC 組合的核心領域。我們將在未來的醫學會議上報告膀胱癌 2 期試驗的結果。

This is a signal-finding study designed to assess the potential additive contribution of trilaciclib to anticancer therapy, including combination with immune checkpoint inhibitor of avelumab alone without chemotherapy in the maintenance phase of the study. Approximately 30 patients in each arm entered maintenance. To date, although no meaningful benefit was observed with the overall study, we have observed an overall survival trend in favor of the trilaciclib plus avelumab arm in the maintenance phase, suggesting a potential additive benefit when used in combination with a checkpoint inhibitor consistent with the immune-based mechanism of action of trilaciclib. These data will be instructive for future studies in our core areas of focus.

這是一項訊號發現研究，旨在評估 trilaciclib 對抗癌治療的潛在附加貢獻，包括在研究的維持階段與單獨的免疫檢查點抑制劑 avelumab 聯合使用，無需化療。每組約有 30 名患者進入維持治療。迄今為止，雖然整個研究沒有觀察到有意義的益處，但我們觀察到在維持階段有利於trilaciclib 加avelumab 組的總體生存趨勢，這表明與與檢查點抑製劑一致的檢查點抑製劑聯合使用時具有潛在的附加益處。trilaciclib 基於免疫的作用機制。這些數據將對我們核心重點領域的未來研究具有指導意義。

Changing topics to trilaciclib in our first approved indication. Recently presented new real-world data show for the first time that trilaciclib may improve survival in patients with extensive-stage small cell lung cancer. First, our partner, Simcere presented new data at the ESMO Conference from part two of the randomized placebo-controlled Phase 3 study called TRACES where trilaciclib or placebo were combined with chemotherapy in patients with extensive-stage small cell lung cancer.

在我們第一個批准的適應症中將主題更改為 trilaciclib。最近公佈的新的真實世界數據首次顯示 trilaciclib 可以改善廣泛期小細胞肺癌患者的生存率。首先，我們的合作夥伴先聲藥業在 ESMO 會議上展示了名為 TRACES 的隨機安慰劑對照 3 期研究第二部分的新數據，其中 trilaciclib 或安慰劑與化療聯合治療廣泛期小細胞肺癌患者。

After a median follow-up of 14.1 months, the median overall survival was 12 months in the trilaciclib group and 8.8 months in the placebo group with a hazard ratio of 0.69. Although this was not statistically significant due to the size of the trial, the hazard ratio in all subgroups favored the trilaciclib group.

中位追蹤 14.1 個月後，trilaciclib 組的中位總存活期為 12 個月，安慰劑組為 8.8 個月，風險比為 0.69。儘管由於試驗規模的原因，這在統計上並不顯著，但所有亞組的風險比均有利於 trilaciclib 組。

In addition, we presented four posters at the ASCO Quality Care Symposium last weekend providing new real-world evidence that trilaciclib can substantially lower the impact of chemotherapy-induced myelosuppression on patients, hospitalizations, and health care resource utilization.

此外，我們上週末在 ASCO 品質護理研討會上展示了四張海報，提供了新的現實證據，證明 trilaciclib 可以顯著降低化療引起的骨髓抑制對患者、住院治療和醫療保健資源利用的影響。

Importantly, we also reported that based on claims data from Medicare and Inovalon, patients receiving trilaciclib at a higher survival at six months of 84% compared to 72% for the group that did not receive trilaciclib. The hazard ratio for the effect on survival was 0.63.

重要的是，我們還報告稱，根據 Medicare 和 Inovalon 的索賠數據，接受 trilaciclib 治療的患者六個月生存率較高，為 84%，而未接受 trilaciclib 治療的患者的生存率為 72%。對存活影響的風險比為 0.63。

Finally, I'll mention the important recent news that trilaciclib has been recommended as a myeloid supportive agent in the updated ASCO small-cell lung cancer guidelines for patients with untreated or previously treated small-cell lung cancer for undergoing treatment with chemotherapy or chemoimmunotherapy. These guidelines provide evidence-based recommendations to practicing clinicians on the management of such patients, which is vital to ensuring appropriate patient access and strong payer reimbursement.

最後，我要提一下最近的重要消息，在更新的ASCO 小細胞肺癌指南中，trilaciclib 已被推薦作為骨髓支持劑，用於未經治療或既往治療過的小細胞肺癌患者接受化療或化學免疫治療。這些指南為執業臨床醫生提供了有關此類患者管理的循證建議，這對於確保適當的患者獲取和強有力的付款人報銷至關重要。

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

我現在將把電話轉給約翰，讓他審查財務表現。約翰？

Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the third-quarter 2023 are available in this morning's press release and will be in the 10-Q, which we expect to file after market close. Our total revenue for the third quarter of 2023 was $12.3 million, comprised of net to seller revenue of $10.8 million and license revenue of $1.5 million.

謝謝拉吉，大家早安。正如威爾所提到的，2023 年第三季的完整財務業績可在今天上午的新聞稿中獲得，並將在第十季公佈，我們預計將在收盤後提交。我們 2023 年第三季的總收入為 1,230 萬美元，其中賣家淨收入為 1,080 萬美元，授權收入為 150 萬美元。

As mentioned by Jack, although there was a decrease in net revenue during the third quarter, our vial volume grew by 3% over the second quarter despite the continued impact of the platinum shortage. This disparity is related to the timing of the sales. Recall that we recognized revenue at the point of sale to our distributors.

正如 Jack 所提到的，儘管第三季的淨收入有所下降，但儘管受到鉑金短缺的持續影響，我們的小瓶銷量仍比第二季度增長了 3%。這種差異與銷售時間有關。回想一下，我們在向經銷商銷售時確認了收入。

We experienced an increase in patient vial demand towards the end of the quarter, but the impact of our sales to the distributor will be reflected in revenue in the fourth quarter, where we've seen our highest gross sales to date in October.

在本季度末，我們對患者藥瓶的需求有所增加，但我們對分銷商的銷售的影響將反映在第四季度的收入中，我們在10 月份看到了迄今為止的最高銷售額。

Regarding our lerociclib license agreement with EQRx. In August, we received formal notice of their intent to terminate the license agreement and to revert the product rights back to us as part of the proposed acquisition by Revolution Medicines. Both parties have signed the side letter agreement pursuant to which EQRx agreed to pay $1.6 million to us for the remainder of the costs to wind down the company-sponsored lerociclib study.

關於我們與 EQRx 的 lerociclib 許可協議。八月，我們收到正式通知，表示他們打算終止授權協議並將產品權利歸還給我們，作為 Revolution Medicines 擬議收購的一部分。雙方已簽署附函協議，根據該協議，EQRx 同意向我們支付 160 萬美元，作為結束公司贊助的 lerociclib 研究的剩餘費用。

The payment was received during the third quarter. No milestones have been achieved through September 30, 2023. And as a result of the termination, we will not receive any further milestone payments or future royalties from EQRx.

付款已於第三季收到。截至 2023 年 9 月 30 日，尚未實現任何里程碑。由於終止，我們將不會從 EQRx 收到任何進一步的里程碑付款或未來的特許權使用費。

Cost of goods sold for the three months ended September 30, 2023, was $3.1 million compared to $1.1 million for the same period in 2022. This difference was primarily driven by an increase in sales volume coupled with a onetime inventory reserve for potential product obsolescence.

截至 2023 年 9 月 30 日的三個月銷售成本為 310 萬美元，而 2022 年同期為 110 萬美元。這一差異主要是由於銷售增加以及潛在產品過時的一次性庫存儲備造成的。

We mentioned on the call that we expected our 2023 operating expenses to be close to 30% lower than that of 2022. We have continued to recognize these savings. And as an update, we now expect our 2023 operating expenses to be at least 30% lower than that of the prior year.

我們在電話會議上提到，預計 2023 年的營運費用將比 2022 年降低近 30%。我們繼續認識到這些節省。作為更新，我們現在預計 2023 年的營運費用將比上一年降低至少 30%。

Our research and development expenses for the third quarter of 2023 were $8.8 million compared to $19.1 million for the third quarter 2022.

我們 2023 年第三季的研發費用為 880 萬美元，而 2022 年第三季為 1,910 萬美元。

Our selling, general, and administrative expenses for the third quarter of 2023 were $16.8 million compared to $24.4 million for the third quarter of 2022. This reduction is primarily related to decreases in expenses associated with commercialization activities, personnel costs, and medical affairs activities.

我們 2023 年第三季的銷售、一般和管理費用為 1,680 萬美元，而 2022 年第三季為 2,440 萬美元。這項減少主要與商業化活動、人員成本和醫療事務活動相關費用的減少有關。

Regarding our cash position, we ended the third quarter with cash, cash equivalents, and marketable securities of $94.4 million compared to $145.1 million as of December 31, 2022.

關於我們的現金狀況，第三季末我們的現金、現金等價物和有價證券為 9,440 萬美元，截至 2022 年 12 月 31 日為 1.451 億美元。

Finally, regarding revenue and cash runway guidance for 2023, as Jack mentioned, as a direct result of the impact of the ongoing platinum-based chemotherapy shortage extending from the second quarter through the third quarter of 2023, we have adjusted our net product revenue guidance for 2023 to a range between $44 million and $47 million. Based on the FDA's ongoing reporting, we continue to expect the shortage in this quarter.

最後，關於 2023 年的收入和現金跑道指導，正如 Jack 所提到的，作為從 2023 年第二季度到第三季度持續的鉑類化療短缺的影響的直接結果，我們調整了我們的淨產品收入指導2023 年的預算將在4,400 萬至4,700 萬美元之間。根據 FDA 的持續報告，我們仍然預計本季會出現短缺。

There is no change to our 2023 gross-to-net expense percentage estimates. We now anticipate a year-end cash, cash equivalents, and marketable securities balance in the range of $75 million to $80 million and based on the foregoing, we now believe that our cash runway currently takes us beyond the third quarter of 2024.

我們對 2023 年總費用與淨費用百分比的估計沒有變動。我們現在預計年終現金、現金等價物和有價證券餘額將在 7,500 萬美元至 8,000 萬美元之間，基於上述情況，我們現在相信我們的現金跑道目前可以帶我們到 2024 年第三季之後。

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. I also want to recognize the cancer community. We are thankful for the opportunity to be part of your recovery journey. We continue to be encouraged with the mounting real-world evidence confirming the benefit of COSELA to patients and hospitals and the support of organizations like ASCO through their recent small-cell lung cancer guideline update recommending COSELA use. And as you heard from Andrew, we remain confident in its potential in its initial indication of extensive stage small cell lung cancer as the leading indicators of growth showed continued progress.

謝謝約翰、拉傑、安德魯和威爾。我還想認識癌症界。我們很高興有機會參與您的康復之旅。我們繼續受到越來越多的現實世界證據證實 COSELA 對患者和醫院的益處以及 ASCO 等組織透過其最近的小細胞肺癌指南更新推薦使用 COSELA 的支持而感到鼓舞。正如您從安德魯那裡聽到的那樣，我們對其在廣泛期小細胞肺癌的初步適應症中的潛力仍然充滿信心，因為領先的增長指標顯示出持續的進展。

Importantly, we accomplished quarter-over-quarter volume growth in the face of the ongoing platinum chemotherapy shortage. And while we have a clear path to profitability with COSELA in its first indication, our focus is on driving therapeutic innovation in triple-negative breast cancer and building our position as a leader in this space.

重要的是，面對持續的鉑類化療短缺，我們實現了季度環比銷量成長。雖然我們在 COSELA 的第一個適應症中擁有明確的獲利途徑，但我們的重點是推動三陰性乳癌的治療創新，並建立我們在該領域的領導者地位。

We are executing on our clinical pipeline to help clarify the future potential for trilaciclib and in combination with anti-cancer drugs, including ADCs. Most importantly, the interim analysis of the Phase 3 TNBC trial planned for the first quarter of next year is positive, we intend to meet with the FDA to discuss filing an sNDA to expand the use of COSELA to this indication as quickly as possible.

我們正在執行我們的臨床管道，以幫助闡明 trilaciclib 以及與包括 ADC 在內的抗癌藥物聯合使用的未來潛力。最重要的是，計劃於明年第一季度進行的 3 期 TNBC 試驗的中期分析結果是積極的，我們打算與 FDA 會面，討論提交 sNDA，以盡快將 COSELA 的使用範圍擴大到該適應症。

Thank you for your time this morning. We will speak again in this format on the fourth quarter 2023 earnings call, and we'll see you at the fall and winter investor and medical meetings.

感謝您今天早上抽出時間。我們將在 2023 年第四季財報電話會議上再次以這種形式發言，我們將在秋季和冬季投資者和醫療會議上與您見面。

With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask a question?

這樣，我將結束通話並將其轉入問答環節。接線生，您能提醒我們的聽眾如何提問嗎？

(Operator Instructions) Gil Blum, Needham & Co.

（操作員說明）Gil Blum, Needham & Co.

Hi. Good morning, everyone, and thanks for the updates. Maybe first one here on the upcoming interim for the TNBC study. Just help me understand, would there be sufficient data not just the stuff for efficacy, but also the stuff for futility?

你好。大家早安，感謝您的更新。也許第一個是即將到來的 TNBC 研究中期報告。請幫我理解，是否有足夠的數據，不僅有功效的數據，還有無用的數據？

Hey, Gil. This is Raj. Yes, I mean, we will -- it's really an efficacy interim analysis based on the O'Brien-Fleming boundary. But yes, if those futility that DMC certainly has that prerogative to stop the trial.

嘿，吉爾。這是拉吉。是的，我的意思是，我們會——這實際上是基於奧布萊恩-弗萊明邊界的功效中期分析。但是，是的，如果這些都是徒勞的話，DMC 當然有權利停止審判。

Maybe on the context around the ASCO guidelines, I'm not familiar with the NCCN guidelines, but maybe you can help us understand what that could mean for COSELA?

也許就 ASCO 指南的背景而言，我不熟悉 NCCN 指南，但也許您可以幫助我們了解這對 COSELA 意味著什麼？

Yes, thank you. These guidelines are obviously put together by well-respected clinicians, academic clinicians who are very influential in their own clinics and in their own right and with their own clinical trial experience. So we're very encouraged to see that additional support from us coming through. I think it cements our position as an emerging standard of care in extensive-stage small cell. So we were excited to see that result come through and it can only strengthen our promotional efforts on our support from payers for reimbursed.

是的，謝謝。這些指南顯然是由備受尊敬的臨床醫生、學術臨床醫生編寫的，他們在自己的診所中非常有影響力，並憑藉自己的權利和自己的臨床試驗經驗。因此，看到我們提供額外支持，我們感到非常鼓舞。我認為它鞏固了我們作為廣泛期小細胞新興護理標準的地位。因此，我們很高興看到這一結果的實現，它只會加強我們對付款人報銷支持的宣傳。

All right. And maybe a last one on the fund dynamics for the upcoming quarter. In small cell lung cancer, would patients avoid therapy during the holidays. Is this a thing or physicians will treat you immediately as you are received?

好的。也許是關於下一季基金動態的最後一篇。對於小細胞肺癌，患者會在假期中避免接受治療嗎？這是一件事情嗎？醫生會在收到您後立即對您進行治療嗎？

Yeah, so small cell is considered an emergency diagnosis. So when patients present and are diagnosed, they would be treated immediately per the recommendation of the physician.

是的，所以小細胞被認為是緊急診斷。因此，當患者出現並被診斷時，他們將立即按照醫生的建議進行治療。

Thanks for taking all of our questions.

感謝您回答我們所有的問題。

Dane Leone, RJF.

戴恩·萊昂內，RJF。

Hi. Thanks for taking the questions and congrats on the progress. The primary question that we've been receiving recently and this morning off of the results is whether your team feels there's overlap in some of the higher volume used centers of COSELA to where some of the newer small cell lung cancer studies are being run with specific reference, I think, to maybe tarlatamab studies within the DeLLphi program there. Is there any color you can provide of where you think some of the utilization might have dropped maybe beyond or utilization maybe inhibiting a bit of momentum or the ability to penetrate deeper at some of these academic centers? Or is the entire headwind more just driven by platinum-based shortage. Thank you.

你好。感謝您提出問題並祝賀取得的進展。我們最近和今天早上收到的主要問題是，你們的團隊是否認為 COSELA 的一些使用量較大的中心與正在進行的一些較新的小細胞肺癌研究有重疊我認為，也許可以參考DeLLphi 項目中的tarlatamab 研究。您是否可以提供任何顏色來說明您認為某些利用率可能已經下降或超出或利用率可能會抑制一些動力或在某些學術中心深入滲透的能力？或者說整個逆風更多是由鉑金短缺造成的。謝謝。

Yeah, thanks. I see the headwind is driven by the platinum-based shortage. We've yet to pick up any noticeable impact of any clinical trial programs on our demand, any segment of [customers].

是的，謝謝。我認為逆風是由鉑金短缺造成的。我們尚未發現任何臨床試驗計劃對我們的需求、[客戶]的任何部分產生任何明顯的影響。

Anupam Rama, JP Morgan.

阿努帕姆‧拉瑪，摩根大通。

Hey, guys. Thanks so much for taking the question. On your cash position of good till 3Q '24, does that assume that the interim OS on PRESERVE 2 hit? Or does it assume that you're going to go to the final analysis later in the year -- next year? Thanks so much.

大家好。非常感謝您提出問題。就您到 2024 年第 3 季為止的現金狀況而言，這是否假設 PRESERVE 2 上的臨時作業系統已上線？或者是否假設您將在今年稍後（明年）進行最終分析？非常感謝。

So we've provided guidance that we would get through past Q3, and that does not include any expectation from a TNBC readout.

因此，我們提供了過去第三季度的指導，這不包括 TNBC 讀數的任何預期。

Got it. Thanks so much for taking the question.

知道了。非常感謝您提出問題。

Troy Langford, TD Cowen.

特洛伊·蘭福德，TD·考恩。

Hi, thanks for taking our questions and congrats on all the progress on the quarter. I just have two quick questions. First, with respect to the Phase 2 TRODELVY combo [OS] result expected next quarter, how quickly do you all think you could initiate additional studies related to that combination should the data look positive?

您好，感謝您提出我們的問題，並祝賀本季取得的所有進展。我只有兩個簡單的問題。首先，關於預計下季度的 2 期 TRODELVY 組合 [OS] 結果，如果數據看起來積極，你們認為你們可以多快啟動與該組合相關的其他研究？

Maybe I can talk from a clinical data perspective and then Jack can talk about timing. So obviously, we're looking for the survival data which we expect the early data in 2024. So that in the first quarter, I should say, and that would really give us directionally whether this is something we would want to pursue and then I'll leave it to Jack for the time.

也許我可以從臨床數據的角度談談，然後傑克可以談談時機。顯然，我們正在尋找生存數據，我們預計會在 2024 年獲得早期數據。因此，我應該說，在第一季度，這確實會給我們一個方向，這是否是我們想要追求的目標，然後我暫時交給傑克吧。

Yeah, thanks, Troy. Yeah. I mean, it's going to obviously depend on the readout itself, but we will certainly look for different avenues if the data is compelling to be able to pursue that. So I would just say stay tuned and let's see what the data shows.

是的，謝謝，特洛伊。是的。我的意思是，這顯然取決於讀數本身，但如果數據令人信服，我們肯定會尋找不同的途徑。所以我想說，請繼續關注，讓我們看看數據顯示什麼。

Okay, great. Thanks for that color. And then just one other more, I guess logistical question. Can you all just provide any more color on the one-time inventory reserve for potential product obsolescence that you will refer to in the press release issued this morning? And apologies if you mentioned it in the prepared remarks and I missed it.

好的，太好了。謝謝那個顏色。然後還有一個問題，我猜是後勤問題。你們能否就潛在產品過時的一次性庫存儲備提供更多信息，你們將在今天早上發布的新聞稿中提到這一點？如果您在準備好的評論中提到了這一點而我錯過了，我深表歉意。

No, thanks, Troy. So what it is obviously we had mentioned lowering our guidance. We're taking a conservative approach in how we look at our inventory reserves. It's a one-time non-cash impact to the P&L. I mean, obviously something we'll continue to monitor, but we feel like it was a conservative approach for it at this point in the balance sheet.

不，謝謝，特洛伊。所以很明顯我們已經提到降低我們的指導。我們在看待庫存儲備方面採取保守的方法。這是對損益表的一次性非現金影響。我的意思是，顯然我們將繼續監控這一點，但我們認為在資產負債表的這一點上這是一種保守的方法。

Thank you for your questions. I am showing no further questions at this time. I would now like to turn it back to Jack Bailey for closing.

謝謝您的提問。我目前沒有提出任何進一步的問題。我現在想把它轉回傑克貝利以結束。

Thank you, operator. And as always, I look forward to keeping all of you updated on our progress. Thank you for joining us today. We'll be in touch. Thank you.

謝謝你，接線生。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。保持聯繫。謝謝。

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

感謝您參加今天的會議。這確實結束了程序，您現在可以斷開連接。