Deciphera Pharmaceuticals Inc (DCPH) 2022 Q4 法說會逐字稿

Good morning, everyone, and welcome to Deciphera Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

大家早上好，歡迎來到 Deciphera Pharmaceuticals 第四季度和 2022 年全年財務業績電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Jen Larson, Senior Vice President of Finance and Investor Relations. Please go ahead.

我現在想把會議交給今天的發言人，財務和投資者關係高級副總裁 Jen Larson。請繼續。

Thank you, operator. Welcome, and thank you for joining us today to discuss Deciphera's fourth quarter and full year 2022 financial results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. With me this morning to discuss the financial results and provide general corporate update are Steve Hoerter, President and Chief Executive Officer; Dan Martin, Chief Commercial Officer; Matt Sherman, Chief Medical Officer; Margarida Duarte, Head of International; and Tucker Kelly, Chief Financial Officer.

謝謝你，運營商。歡迎並感謝您今天加入我們討論 Deciphera 的第四季度和 2022 年全年財務業績。我是財務和投資者關係高級副總裁 Jen Larson。今天早上與我討論財務業績並提供一般公司更新的是總裁兼首席執行官 Steve Hoerter；丹·馬丁，首席商務官；首席醫療官馬特·謝爾曼 (Matt Sherman)； Margarida Duarte，國際部主管；和首席財務官 Tucker Kelly。

Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this conference call include our expectations for our preclinical and clinical programs, our commercialization of Pima and 2023 guidance.

在我們開始之前，我想提醒您，我們在本次電話會議上所做的任何非歷史事實的陳述都是前瞻性陳述，反映了管理層根據《私人證券訴訟改革法》的安全港條款做出的當前信念和期望1995 年。在本次電話會議中做出的前瞻性陳述的例子包括我們對臨床前和臨床項目的預期、我們的 Pima 商業化和 2023 年指南。

Forward-looking statements made on this call involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent annual report on Form 10-K as well as our other SEC filings. We assume no obligation to update or revise any forward-looking statements. Following this call, a replay will be available on the company's website, www.deciphera.com.

在本次電話會議上做出的前瞻性陳述涉及重大風險和不確定性，可能導致實際結果與前瞻性陳述明示或暗示的結果存在重大差異，我們無法向您保證我們的預期將會實現。此類風險和不確定性包括我們最近的 10-K 表格年度報告以及我們向美國證券交易委員會提交的其他文件中規定的風險和不確定性。我們不承擔更新或修改任何前瞻性陳述的義務。電話會議結束後，公司網站 www.deciphera.com 將提供重播。

With that, I will now turn the call over to Steve Hoerter, President and Chief Executive Officer of Deciphera. Steve?

有了這個，我現在將把電話轉給 Deciphera 的總裁兼首席執行官史蒂夫赫特。史蒂夫？

Thank you, and good morning, everyone. Thank you for joining us today as we provide an update from the fourth quarter and full year 2022, review our financial results and provide additional context on our strategic outlook and planned corporate milestones for 2023.

謝謝大家，早上好。感謝您今天加入我們，因為我們提供了 2022 年第四季度和全年的最新情況，審查了我們的財務業績，並提供了有關我們戰略前景和 2023 年計劃公司里程碑的更多背景信息。

2022 was a year of exceptional execution for Deciphera. Global QINLOCK product revenue grew 44% compared to 2021, driven by very strong performance in the U.S. as well as launches outside of the U.S. QINLOCK is now approved for fourth-line gastrointestinal thermal tumor, or GIST, in 12 jurisdictions around the world.

2022 年是 Deciphera 表現出色的一年。與 2021 年相比，全球 QINLOCK 產品收入增長了 44%，這得益於美國非常強勁的表現以及美國以外地區的推出。QINLOCK 現已在全球 12 個司法管轄區獲准用於四線胃腸道熱腫瘤（ GIST ）。

Last month, we outlined our key strategic priorities for the year, which will enable Deciphera to continue its evolution towards being a fully integrated company with multiple approved medicines and capabilities ranging from international commercialization to early-stage discovery, all powered by our proprietary switch control kinase inhibitor platform. These priorities include expanding the market potential for QINLOCK into earlier lines of GIST by initiating the INSIGHT pivotal Phase III study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18 in the second half of 2023. If successful, we believe the INSIGHT study has the potential to change practice in second-line kit driven GIST and to double the U.S. revenues for QINLOCK.

上個月，我們概述了今年的關鍵戰略重點，這將使 Deciphera 能夠繼續發展成為一家完全整合的公司，擁有多種批准的藥物和從國際商業化到早期發現的能力，所有這些都由我們專有的開關控制提供支持激酶抑製劑平台。這些優先事項包括通過在 2023 年下半年在 KIT 外顯子11和17/18突變的二線 GIST 患者中啟動 QINLOCK 與舒尼替尼的 INSIGHT 關鍵 III 期研究，將 QINLOCK 的市場潛力擴大到早期的 GIST 系列。成功後，我們相信 INSIGHT 研究有可能改變二線試劑盒驅動 GIST 的實踐，並使 QINLOCK 在美國的收入翻一番。

We were very pleased that the circulating tumor DNA or ctDNA data from our Phase III INTRIGUE study of QINLOCK in second-line GIST was selected for presentation at the ASCO plenary series session a few weeks ago. Matt Sherman, our Chief Medical Officer, will review the data later in the call and outline our plans for the new Phase III INSIGHT study.

我們非常高興地看到，來自我們 QINLOCK 在二線 GIST 中的 III 期 INTRIGUE 研究的循環腫瘤 DNA 或 ctDNA 數據被選中在幾週前的 ASCO 全會系列會議上展示。我們的首席醫療官馬特·謝爾曼 (Matt Sherman) 將在稍後的電話會議中審查數據，並概述我們新的 III 期 INSIGHT 研究的計劃。

As we begin enrollment in the new Phase III INSIGHT study for QINLOCK, we also expect to read out another pivotal trial, the Phase III MOTION study of vimseltinib, our highly selective switch control kinase inhibitor of CSF1 receptor in patients with tenosynovial giant cell tumor, or TGCT, in the fourth quarter of this year. We have been very pleased with the pace of enrollment and are excited to announce today that we now expect to complete enrollment in the MOTION study in the first quarter and report top line data in Q4 of this year.

當我們開始註冊 QINLOCK 的新 III 期 INSIGHT 研究時，我們還期望讀出另一項關鍵試驗，即 vimseltinib 的 III 期 MOTION 研究，我們的 CSF1 受體高選擇性開關控制激酶抑製劑用於腱鞘鉅細胞瘤患者，或 TGCT，在今年第四季度。我們對入組速度感到非常滿意，今天很高興地宣布，我們現在預計將在第一季度完成 MOTION 研究的入組，並在今年第四季度報告收入數據。

For DCC-3116, our first-in-class inhibitor of the ULK1/2 kinases designed to inhibit autophagy, we expect to present updated data from the single-agent dose escalation portion of the Phase I/II study and initial combination data in the second half of 2023.

對於 DCC-3116，我們設計用於抑制自噬的一流 ULK1/2 激酶抑製劑，我們希望提供來自 I/II 期研究的單藥劑量遞增部分的更新數據和2023 年下半年。

Finally, we were very pleased to announce a clinical trial collaboration and supply agreement with Pfizer for a new combination dose escalation study of DCC-3116 and encorafenib and cetuximab in colorectal cancer that we plan to initiate in the second half of this year. We look forward to presenting the preclinical data supporting this new combination cohort in the first half of this year, along with additional new preclinical data for DCC-3116.

最後，我們非常高興地宣布與輝瑞公司就 DCC-3116 與 encorafenib 和西妥昔單抗聯合治療結直腸癌的新聯合劑量遞增研究達成臨床試驗合作和供應協議，我們計劃於今年下半年啟動該研究。我們期待在今年上半年展示支持這一新組合隊列的臨床前數據，以及 DCC-3116 的其他新臨床前數據。

We continue to complement these commercial and clinical stage advancements with investment in our research pipeline. Our discovery platform continues to drive new growth opportunities with potential first-in-class or best-in-class precision oncology agents, including DCC-3084, our newly nominated pan-RAF clinical development candidate for which we expect to present preclinical data in the first half of this year and to file an investigational new drug application in the second half of the year. DCC-3084 was discovered using the same proprietary switch control kinase inhibitor platform that has brought us QINLOCK, vimseltinib and 3116, and we look forward to quickly advancing this program to the clinic.

我們繼續通過投資我們的研究管道來補充這些商業和臨床階段的進步。我們的發現平台繼續通過潛在的一流或一流的精準腫瘤藥物推動新的增長機會，包括 DCC-3084，我們新提名的泛 RAF 臨床開發候選藥物，我們希望在今年上半年，下半年提交新藥研究申請。 DCC-3084 是使用相同的專有開關控制激酶抑製劑平台發現的，該平台為我們帶來了 QINLOCK、vimseltinib 和 3116，我們期待著將該項目迅速推進到臨床。

In addition, we plan to debut a new development candidate from our proprietary discovery engine in the coming months as well as preclinical data from other research programs our team has been working on. Matt Sherman, our Chief Medical Officer, will provide more detail about upcoming milestones for our pipeline programs on today's call. Dan Martin, our Chief Commercial Officer, will then share insights on the U.S. commercial performance for the quarter and Margarida Duarte, our Head of International, will provide an update on QINLOCK's ongoing fourth line launch in Europe, which has sustained its strong momentum throughout 2022. We'll end with Tucker Kelly, our Chief Financial Officer. We will review highlights from the fourth quarter and full year 2022 financial results and the recent highly successful follow-on equity offering that will allow us to continue to execute on our goals.

此外，我們計劃在未來幾個月內推出來自我們專有發現引擎的新開發候選藥物，以及來自我們團隊一直致力於的其他研究項目的臨床前數據。我們的首席醫療官 Matt Sherman 將在今天的電話會議上提供更多關於我們管道項目即將到來的里程碑的詳細信息。然後，我們的首席商務官 Dan Martin 將分享對本季度美國商業業績的見解，我們的國際主管 Margarida Duarte 將提供 QINLOCK 在歐洲持續推出的第四條線的最新情況，該線在整個 2022 年保持強勁勢頭. 我們將以我們的首席財務官塔克·凱利 (Tucker Kelly) 結束。我們將回顧第四季度和 2022 年全年財務業績的亮點，以及最近非常成功的後續股權發行，這將使我們能夠繼續實現我們的目標。

First, I'll turn the call over to Matt Sherman to provide an update on our R&D efforts. Matt?

首先，我會將電話轉給 Matt Sherman，以提供我們研發工作的最新情況。馬特？

Thanks, Steve. We are thrilled with the progress we have made across our clinical and preclinical pipeline in 2022 and already in the first few weeks of this year. As Steve mentioned, it was our privilege to present additional ctDNA data from the INTRIGUE Phase III study at QINLOCK at the ASCO preliminary session last month, which we believe represents a potential practice-changing event in the treatment of second line KIT-driven GIST. The results strongly support our planned insight study and the potential to expand QINLOCK's label which, if approved, will allow physicians for the first time to optimize treatment for patients in the second-line setting based on the mutational profile to improve outcomes over the current standard of care.

謝謝，史蒂夫。我們對 2022 年以及今年頭幾週在臨床和臨床前管道中取得的進展感到興奮。正如 Steve 所提到的，我們有幸在上個月的 ASCO 初步會議上展示來自 QINLOCK 的 INTRIGUE III 期研究的額外 ctDNA 數據，我們認為這代表了治療二線 KIT 驅動的 GIST 的潛在實踐改變事件。結果強烈支持我們計劃的洞察力研究和擴大 QINLOCK 標籤的潛力，如果獲得批准，這將允許醫生首次根據突變特徵優化二線環境中患者的治療，以改善當前標準的結果照顧。

In the ctDNA analysis for patients with KIT exon 11 and 17/18 mutations, QINLOCK show the striking benefit compared to Sezannib across all efficacy measures, beginning with a 44% confirmed objective response rate with all patients on QINLOCK achieving either a partial response or stable disease. In contrast, there were no objective responses in the sunitinib arm.

在對 KIT 外顯子 11 和 17/18 突變患者的 ctDNA 分析中，與 Sezannib 相比，QINLOCK 在所有療效指標上都顯示出顯著優勢，首先確認的客觀緩解率為 44%，所有接受 QINLOCK 治療的患者均達到部分緩解或穩定疾病。相比之下，舒尼替尼組沒有客觀反應。

Similarly, QINLOCK demonstrated the greatly improved PFS with a median of 14.2 months compared to only 1.5 months for sunitinib. In fact, half of the patients receiving sunitinib had progressed or died by their first restaging scan at 6 weeks. This resulted in a hazard ratio of 0.22, meaning that treatment with QINLOCK resulted in a 78% reduction in the risk of disease progression or death.

同樣，QINLOCK 顯示 PFS 大大改善，中位 PFS 為 14.2 個月，而舒尼替尼僅為 1.5 個月。事實上，接受舒尼替尼治療的患者中有一半在 6 週時的第一次重新分期掃描時出現進展或死亡。這導致風險比為 0.22，這意味著使用 QINLOCK 治療可使疾病進展或死亡的風險降低 78%。

We also saw a strong trend for overall survival in favor of QINLOCK in the subgroup of patients. The OS results are based on an updated data cut as of September 2022 and show that the QINLOCK arm still had not reached the median while patients randomized to sunitinib had an overall survival of 17.5 months. This resulted in a hazard ratio of 0.34 or a 66% reduction in the risk of death and the landmark analysis shows that the number of patients alive at 30 months on QINLOCK was estimated to be nearly twice that of patients randomized to sunitinib. QINLOCK was generally well tolerated and the subgroups safety and tolerability profile was consistent with the primary analysis of the INTRIGUE study.

我們還看到在患者亞組中有利於 QINLOCK 的總體生存趨勢。 OS 結果基於截至 2022 年 9 月的更新數據，顯示 QINLOCK 組仍未達到中值，而隨機分配給舒尼替尼的患者的總生存期為 17.5 個月。這導致風險比為 0.34，即死亡風險降低了 66%，里程碑式的分析表明，在 30 個月時接受 QINLOCK 治療的患者數量估計幾乎是隨機接受舒尼替尼治療的患者數量的兩倍。 QINLOCK 總體耐受性良好，亞組安全性和耐受性概況與 INTRIGUE 研究的主要分析一致。

For patients with mutations in KIT exon 11 and 17/18, fewer patients in the QINLOCK arm experienced Grade 3, 4 treatment-emergent adverse events compared to sunitinib. Based on the intrigue ctDNA data and regulatory input, we plan to initiate INSIGHT a new pivotal Phase III study of QINLOCK versus sunitinib in this group of second-line GIST patients. If positive, we believe the results of the INSIGHT study will support an expanded label for QINLOCK in select second-line GIST patients and transform how physicians treat these patients.

對於 KIT 外顯子 11 和 17/18 突變的患者，與舒尼替尼相比，QINLOCK 組中出現 3 級、4 級治療緊急不良事件的患者較少。基於有趣的 ctDNA 數據和監管輸入，我們計劃啟動 INSIGHT 一項新的關鍵 III 期研究，在這組二線 GIST 患者中比較 QINLOCK 與舒尼替尼。如果結果是肯定的，我們相信 INSIGHT 研究的結果將支持 QINLOCK 在特定二線 GIST 患者中的擴展標籤，並改變醫生治療這些患者的方式。

Moving from 1 pivotal Phase III program to another, I now want to talk about vimseltinib which we believe will become the second approved product from our proprietary switch control kinase inhibitor platform. We are strongly encouraged by the compelling clinical data we have generated to date supporting the potential of vimseltinib to be the standard of care treatment for patients with TGCT non-amenable to surgery.

從一個關鍵的 III 期項目轉到另一個項目，我現在想談談 vimseltinib，我們相信它將成為我們專有的開關控制激酶抑製劑平台的第二個獲批產品。我們對迄今為止產生的令人信服的臨床數據感到非常鼓舞，這些數據支持 vimseltinib 有可能成為不適合手術的 TGCT 患者的標準治療。

We began enrolling patients in the Phase III MOTION study in early 2022, and I'm very pleased to announce today that we now anticipate completing enrollment this quarter, enabling us to read out the top line results in the fourth quarter of this year. We also expect to present updated data from the Phase I/II study of vimseltinib in the second half of this year that will focus on longer-term safety and efficacy and provide additional support for the clinical and commercial opportunity for vimseltinib.

我們於 2022 年初開始在 III 期 MOTION 研究中招募患者，今天我很高興地宣布，我們現在預計將在本季度完成招募，使我們能夠在今年第四季度公佈最重要的結果。我們還希望在今年下半年提供來自 vimseltinib 的 I/II 期研究的更新數據，這些數據將側重於長期安全性和有效性，並為 vimseltinib 的臨床和商業機會提供額外的支持。

Turning now to DCC-3116. We were excited to announce our first clinical trial collaboration and supply agreement for the program a few weeks ago. Under the agreement, Pfizer will supply encorafenib at no cost as part of a new dose escalation combination evaluating 3116 with encorafenib and cetuximab in patients with colorectal cancer.

現在轉向 DCC-3116。幾週前，我們很高興地宣布了我們針對該項目的第一份臨床試驗合作和供應協議。根據協議，輝瑞將免費提供 encorafenib 作為新劑量遞增組合的一部分，該組合評估 3116 與 encorafenib 和西妥昔單抗在結直腸癌患者中的療效。

Additionally, we plan to present updated data from the single-agent dose escalation cohorts and initial data from the combination dose escalation cohorts of the Phase I/II study and initiate one or more expansion cohorts in the second half of this year in combination with the MEK inhibitors, trametinib or binimetinib or the KRAS G12C inhibitor. So that wraps it.

此外，我們計劃提供 I / II 期研究的單藥劑量遞增隊列的更新數據和聯合劑量遞增隊列的初始數據，並在今年下半年啟動一個或多個擴展隊列，結合MEK 抑製劑、trametinib 或 binimetinib 或 KRAS G12C 抑製劑。這樣就可以了。

We remain optimistic about the potential for DCC-3116 to broadly impact the treatment of cancer as a first-in-class autophagy inhibitor based on the strong preclinical in vitro and in vivo data we have generated showing additive or synergistic activity in combination with multiple agents targeting the RTK, RAS and MAP kinase pathways.

我們對 DCC-3116 作為一流的自噬抑製劑廣泛影響癌症治療的潛力持樂觀態度，因為我們生成的強大的臨床前體外和體內數據顯示與多種藥物聯合使用具有累加或協同活性靶向 RTK、RAS 和 MAP 激酶通路。

Finally, the next program slated into the clinic is DCC-3084, our pan-RAF inhibitor, for which we expect to submit an IND in the second half of this year. We plan on presenting in vitro and in vivo data in the coming months, demonstrating its preclinical profile as a potent and selective inhibitor of BRAF CRAF kinases with optimized pharmaceutical properties for potential development in both single agent and combination opportunities as well as data from additional undisclosed research programs and look forward to the expected nominations of our newest development candidate.

最後，下一個進入臨床的項目是我們的泛 RAF 抑製劑 DCC-3084，我們預計將在今年下半年提交 IND。我們計劃在未來幾個月提供體外和體內數據，證明其作為 BRAF CRAF 激酶的有效和選擇性抑製劑的臨床前特徵，具有優化的藥物特性，可在單藥和組合機會方面進行潛在開發，以及來自其他未公開的數據研究計劃，並期待我們最新開發候選人的預期提名。

I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to provide an update on the U.S. commercial efforts. Dan?

我現在將電話轉給我們的首席商務官丹·馬丁，以提供有關美國商業努力的最新情況。擔？

Thanks, Matt. In 2022, we continue to execute on our commercial goals for QINLOCK in the U.S., further reinforcing its status as the clear standard of care in fourth-line GIST, irrespective of mutational profile while continuing to expand our prescriber footprint. U.S. net product revenue was $25.6 million in Q4. And for the full year 2022, QINLOCK sales grew to $97.2 million, representing an increase of about 20% over 2021. Approximately half of this growth came from increased demand volume with the remainder coming from net price growth and a lower percentage of patients receiving free drug under our patient assistance program or PAP. The higher demand volumes seen in 2022 was driven principally by an increasing our duration of therapy as the real-world persistency curve continues to mature and more fully reflects the impact of patients who receive prolonged clinical benefit from QINLOCK. Specifically, we estimate that the average duration of therapy in 2022 grew to approximately 7 months. We expect the average duration of therapy to continue to increase gradually over time and could ultimately reach as high as 8 to 8.5 months.

謝謝，馬特。 2022 年，我們將繼續在美國執行 QINLOCK 的商業目標，進一步鞏固其作為四線 GIST 明確治療標準的地位，無論突變情況如何，同時繼續擴大我們的處方足跡。第四季度美國產品淨收入為 2560 萬美元。 2022 年全年，QINLOCK 銷售額增長至 9720 萬美元，比 2021 年增長約 20%。這一增長中約有一半來自需求量的增加，其餘來自淨價增長和接受免費治療的患者比例較低我們的患者援助計劃或 PAP 下的藥物。 2022年的需求量增加主要是由於我們的治療持續時間增加，因為現實世界的持久性曲線繼續成熟並更充分地反映了從 QINLOCK 獲得長期臨床益處的患者的影響。具體而言，我們估計 2022 年的平均治療持續時間將增長至約 7 個月。我們預計平均治療持續時間將隨著時間的推移逐漸增加，最終可能高達 8 至 8.5 個月。

As expected, the percentage of patients receiving free drug under our PAP program increased in the fourth quarter versus the prior quarter. Consistent with what we saw in Q4 of 2021, the PAP percentage was slightly above the high end of our estimated annual range of 20% to 30%. This PAP seasonality is common and is driven by patient affordability challenges that tend to increase as the year progresses due to the Medicare Part D drug benefit design.

正如預期的那樣，第四季度根據我們的 PAP 計劃接受免費藥物的患者比例比上一季度有所增加。與我們在 2021 年第四季度看到的情況一致，PAP 百分比略高於我們估計的年度範圍 20% 至 30% 的上限。這種 PAP 季節性很常見，並且受患者負擔能力挑戰的驅動，由於 Medicare D 部分藥物福利設計，這些挑戰往往會隨著時間的推移而增加。

The development and approval of QINLOCK for fourth-line GIST addressed a major unmet medical need and fundamentally change the treatment paradigm in advanced GIST. Based on the compelling data from the ctDNA analysis of INTRIGUE, we are eager to start the INSIGHT study, and we believe if approved for this new indication, QINLOCK has the potential to advance the GIST treatment paradigm yet again, this time in the second-line setting based on mutational profile. We believe that if we are successful in expanding the label with a second-line KIT exon 11 and 17/18 indication, that it would double the QINLOCK peak revenue potential to $350 million to $400 million in the U.S. alone.

QINLOCK 用於四線 GIST 的開發和批准解決了一個主要未滿足的醫療需求，並從根本上改變了晚期 GIST 的治療模式。基於 INTRIGUE ctDNA 分析的令人信服的數據，我們渴望啟動 INSIGHT 研究，我們相信，如果批准用於這一新適應症，QINLOCK 有可能再次推進 GIST 治療範式，這一次是在第二次-基於突變譜的線設置。我們相信，如果我們成功地擴大具有二線 KIT 外顯子 11 和 17/18 適應症的標籤，它將使 QINLOCK 的峰值收入潛力翻一番，僅在美國就達到 3.5 億至 4 億美元。

Turning to Vimseltinib. With the readout of the Phase III MOTION study fast approaching, the commercial team continues to prepare for a potential approval and launch. We remain highly encouraged by the market opportunity in TGCT where we have estimated a total addressable market of $850 million in the U.S. With a potentially best-in-class product profile, we believe vimseltinib is uniquely positioned to address the high unmet medical need within TGCT. And given the approximately 90% overlap among GIST and TGCT prescribers, we believe vimseltinib will be an excellent addition to our commercial business and that QINLOCK and vimseltinib together have the potential to generate in excess of $1 billion in global peak revenue.

轉向 Vimseltinib。隨著 III 期 MOTION 研究的讀數快速臨近，商業團隊繼續為潛在的批准和啟動做準備。我們仍然對 TGCT 的市場機會感到高度鼓舞，我們估計美國的潛在市場總額為 8.5 億美元。憑藉潛在的一流產品概況，我們相信 vimseltinib 具有獨特的優勢，可以解決 TGCT 內未滿足的高醫療需求.鑑於 GIST 和 TGCT 處方者之間約有 90% 的重疊，我們相信 vimseltinib 將成為我們商業業務的極好補充，並且 QINLOCK 和 vimseltinib 共同有可能產生超過 10 億美元的全球峰值收入。

I will now turn the call over to Margarida Duarte, our Head of International, to discuss the progress of our QINLOCK launch in Europe. Margarida?

我現在將電話轉給我們的國際主管 Margarida Duarte，討論我們在歐洲推出 QINLOCK 的進展情況。瑪格麗達？

Thanks, Dan. We are very proud of the strength and sustained momentum of QINLOCK's European market entry. 2022 was a key year that saw very successful execution in 2 critical markets, our launch in Germany and the post-approval paid access program in France. It was also a year in which we made significant progress towards market access in other major European markets with the submission of the reimbursement application to Knife for access for accessing inconels and to IFraccess in Italy and the initiation of the market access process in Spain.

謝謝，丹。我們為 QINLOCK 進入歐洲市場的實力和持續勢頭感到非常自豪。 2022 年是關鍵的一年，我們在 2 個關鍵市場的執行非常成功，即我們在德國的推出和在法國的批准後付費訪問計劃。也是在這一年，我們在其他主要歐洲市場的市場准入方面取得了重大進展，向 Knife 提交了獲取鉻鎳鐵合金的報銷申請，並向意大利的 IFraccess 提交了報銷申請，並啟動了西班牙的市場准入流程。

For the full year 2022, international net product sales were $28.3 million, up significantly from $5.9 million in 2021. These strong results reflect QINLOCK's best-in-class clinical profile in flanges and a significant unmet need. And I'm very proud of the team's superb execution of our launch strategy that enables such exceptional performance.

2022 年全年，國際產品淨銷售額為 2830 萬美元，遠高於 2021 年的 590 萬美元。這些強勁的業績反映了 QINLOCK 在法蘭領域的一流臨床表現和未滿足的重大需求。我為團隊出色地執行我們的發布策略而獲得如此出色的表現感到非常自豪。

Our fourth quarter international net product revenue of $7.3 million was driven primarily by continued growth in demand in Germany and in France. However, net product revenue for the fourth quarter did include a onetime reserve for QINLOCK's product sales in Germany, it was change in German law effective as of November 2022, shortening the free pricing period retroactively to 6 months from 12 months.

我們第四季度的國際產品淨收入為 730 萬美元，主要受德國和法國需求持續增長的推動。然而，第四季度的淨產品收入確實包括了 QINLOCK 在德國的產品銷售的一次性儲備金，這是自 2022 年 11 月起生效的德國法律變更，將免費定價期從 12 個月追溯縮短至 6 個月。

In Germany, our team is in the last stages of the price negotiations. And although we are not yet in a position to disclose the details, we remain confident that our final negotiated price will reflect the high value that QINLOCK brings to patients and payers in Germany. We also continue to advance our access discussions with NICE as well as with the authorities in Italy and Spain and look forward to sharing updates on future calls.

在德國，我們的團隊正處於價格談判的最後階段。儘管我們還不能透露細節，但我們仍然相信，我們的最終協商價格將反映 QINLOCK 為德國患者和付款人帶來的高價值。我們還將繼續推進與 NICE 以及意大利和西班牙當局的准入討論，並期待在未來的電話會議上分享最新情況。

Turning to Rest of the World. We were pleased to see that the national reimbursements were leased released by China's National Healthcare Security Administration was recently updated to include QINLOCK, which will provide access to QINLOCK for many more patients in China for our partner, Zai Lab. In 2022, we recognized $8.5 million in collaboration revenue under our agreement with Zai and look forward to their continued strong commercial execution in Greater China.

轉向世界其他地方。我們很高興地看到，中國國家醫療保障局發布的國家報銷租賃最近更新為包括 QINLOCK，這將為我們的合作夥伴 Zai Lab 在中國更多患者提供 QINLOCK 的訪問。 2022 年，我們根據與再鼎醫藥的協議確認了 850 萬美元的合作收入，並期待他們在大中華區繼續保持強勁的商業執行力。

In addition, we are excited to announce that we recently received approvals for QINLOCK in New Zealand, Israel and Macau, increasing the number of jurisdictions around the world to 12, in which QINLOCK is approved for 4 launches.

此外，我們很高興地宣布，我們最近在新西蘭、以色列和澳門獲得了 QINLOCK 的批准，使全球司法管轄區的數量增加到 12 個，其中 QINLOCK 獲批 4 次上市。

I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review the fourth quarter and full year financial results and recent financing. Tucker?

我現在將電話轉給我們的首席財務官塔克凱利，以審查第四季度和全年的財務業績以及最近的融資。塔克？

Thanks, Margarida. Total revenue for the fourth quarter was $36.3 million, which included $32.9 million in net product revenue at QINLOCK and $3.4 million in collaboration revenue. For the full year, total revenue grew 39% to $134 million, including net product sales of $125.5 million and collaboration revenue of $8.5 million. Cost of sales in the fourth quarter was $3.2 million, including $0.7 million in cost of net product revenue and $2.5 million in cost of collaboration revenue. For the full year, cost of sales was $8.8 million, including $2.7 million in cost of net product revenue and $6.1 million in cost of collaboration revenue.

謝謝，瑪格麗達。第四季度總收入為 3630 萬美元，其中包括 QINLOCK 的 3290 萬美元淨產品收入和 340 萬美元的協作收入。全年總收入增長 39% 至 1.34 億美元，其中產品淨銷售額為 1.255 億美元，協作收入為 850 萬美元。第四季度的銷售成本為 320 萬美元，其中包括 70 萬美元的淨產品收入成本和 250 萬美元的協作收入成本。全年，銷售成本為 880 萬美元，其中包括 270 萬美元的淨產品收入成本和 610 萬美元的合作收入成本。

In 2021, total cost of sales was $2.9 million, of which $1.6 million was cost of collaboration revenue and $1.3 million was cost of net product revenue. In the third quarter of 2022, we completed the sale of 0 cost inventories that had been expensed as R&D prior to FDA approval in 2020. In Q4, total operating expenses were $83.5 million, compared to operating expenses of $112.6 million in the same period in 2021.

2021 年，總銷售成本為 290 萬美元，其中 160 萬美元為協作收入成本，130 萬美元為淨產品收入成本。 2022 年第三季度，我們完成了在 2020 年 FDA 批准之前作為研發支出的零成本庫存的銷售。第四季度，總運營費用為 8350 萬美元，而同期運營費用為 1.126 億美元2021.

For the full year 2022, total operating expenses were $316.8 million, a decrease of approximately 20% compared to operating expenses of $396.2 million in 2021. Research and Development expenses in the fourth quarter of 2022 were $48.1 million compared to $74.9 million for the same period in 2021. In 2022, R&D expenses were $187.8 million compared to $257 million in 2021.

2022 年全年總運營費用為 3.168 億美元，比 2021 年的運營費用 3.962 億美元減少約 20%。2022 年第四季度的研發費用為 4810 萬美元，同期為 7490 萬美元2021 年。2022 年研發費用為 1.878 億美元，而 2021 年為 2.57 億美元。

Selling, general and administrative expansion expenses in the fourth quarter were $32.2 million compared to $37.2 million in Q4 of '21. For the full year, SG&A was $120.2 million compared to $136.3 million in 2021. We ended the year with cash, cash equivalents and marketable securities of approximately $339 million. In January of this year, we raised an additional $134.7 million in net proceeds through a very successful public offering that further strengthened our financial position and extended our cash runway into 2026. The strong support we received from both existing and new investors in the offering will allow us to increase shareholder value as we strive to become the company with multiple approved products.

第四季度的銷售、一般和行政擴張費用為 3220 萬美元，而 2021 年第四季度為 3720 萬美元。全年，SG&A 為 1.202 億美元，而 2021 年為 1.363 億美元。年底，我們的現金、現金等價物和有價證券約為 3.39 億美元。今年 1 月，我們通過一次非常成功的公開募股額外籌集了 1.347 億美元的淨收益，進一步加強了我們的財務狀況，並將我們的現金跑道延長至 2026 年。我們在此次募股中獲得的現有和新投資者的大力支持將使我們能夠增加股東價值，因為我們努力成為擁有多種批准產品的公司。

With that, I'll now turn the call back over to Steve.

有了這個，我現在將把電話轉回給史蒂夫。

Thank you, Tucker. The outstanding progress we've made at Deciphera over the past year, along with our planned 2023 milestones puts us firmly on the path to becoming a company with multiple approved products around the world. As we near enrollment completion and prepare to announce top line results from our Phase III MOTION study, we look forward to also initiating our Phase III INSIGHT study later this year. We are proud to leverage our proprietary switch control kinase inhibitor platform and deep pipeline to make a difference for people living with cancer.

謝謝你，塔克。過去一年我們在 Deciphera 取得的顯著進步，以及我們計劃的 2023 年里程碑，使我們堅定地走上了成為一家在全球擁有多種獲批產品的公司的道路。在我們即將完成註冊並準備公佈 III 期 MOTION 研究的主要結果時，我們期待著在今年晚些時候啟動我們的 III 期 INSIGHT 研究。我們很自豪能夠利用我們專有的開關控制激酶抑製劑平台和深度管道為癌症患者帶來改變。

With that, operator, I would like to now open the call for Q&A.

有了這個，接線員，我現在想打開問答電話。

(Operator Instructions) Our first question comes from Daniel Wolle with JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的 Daniel Wolle。

Just a couple of questions. First, for INSIGHT, with the idea of combining QINLOCK with considered for the pivotal trial? Second, you're able to refine the timeline for enrollment completion for MOTION from first half 23 to 1Q '23? What can you attribute this acceleration to? And then for DCC-3116, while results from the dose escalation combination study are not expected until second half. What should investors expect with initial data? And specifically, should there be an expectation for antitumor activity?

只是幾個問題。首先，對於INSIGHT，有結合QINLOCK的想法，考慮進行關鍵性的試驗？其次，您是否能夠將 MOTION 的註冊完成時間表從 23 年上半年改進到 23 年第一季度？您可以將這種加速歸因於什麼？然後是 DCC-3116，而劑量遞增組合研究的結果預計要到下半年才會出現。投資者應該對初始數據有何期待？具體來說，是否應該對抗腫瘤活性有預期？

Daniel, thanks for joining, and thanks for the 3 questions. So let me take those in order. First, you broke up on the first part of your question with respect to INSIGHT, I believe it was related to a combination. Can you just repeat that for me? Operator go ahead.

丹尼爾，感謝您的加入，並感謝您提出 3 個問題。所以讓我整理一下。首先，你在關於 INSIGHT 的問題的第一部分分手了，我相信這與組合有關。你能為我重複一遍嗎？接線員繼續。

Sure. I guess the question was, was the idea of combining QINLOCK with considered as 1 arm of the pivotal study?

當然。我想問題是，結合 QINLOCK 的想法是否被視為關鍵研究的一個分支？

I see. Okay. Thanks for that question. So I'll take the question on, INSIGHT and on MOTION, then ask Matt just to speak to 3116 and expectations here in the second half for the combination dose escalation data. So first, Daniel, with respect to INSIGHT, the data that we presented at the ASCO plenary series session just last month and we, of course, disclosed at the beginning of the year, we view as being very, very clear, very compelling in terms of the activity of QINLOCK in this group of patients relative to Sutent. So no, as a result, we did not consider adding a third arm to the study looking at a combination because we don't believe that a combination with Sutent in particular, would add any additional activity in the selected group of patients.

我懂了。好的。謝謝你的問題。因此，我將提出問題，INSIGHT 和 MOTION，然後請 Matt 僅與 3116 交談，並在下半年對組合劑量遞增數據的期望進行討論。首先，Daniel，關於 INSIGHT，我們在上個月的 ASCO 系列全體會議上展示的數據，當然，我們在年初披露了這些數據，我們認為這些數據非常、非常清晰、非常有說服力QINLOCK 在本組患者中的活性相對於 Sutent 而言。因此，不，因此，我們沒有考慮在研究中增加第三個手臂來觀察組合，因為我們不相信特別是與 Sutent 的組合會在選定的患者組中增加任何額外的活動。

With respect to MOTION, we were very pleased as we announced today that we'll be reaching full enrollment in the MOTION study in quarter 1 instead of quarter, the first half of this year. Still reporting out in quarter 4 of this year. And the enrollment in the study, as we've been telegraphing over the course of the last 6 to 9 months, we've been really pleased with the pace of enrollment how enthusiastic investigators and patients are to enroll in the study. And it's really that enthusiasm and the pace of enrollment that allowed us to enroll the study faster than we previously anticipated and is going to allow us to get to full enrollment here in this first quarter. So we look forward to reporting out the study in quarter 4 of this year. Matt, do you want to speak to the 3116 question?

關於 MOTION，我們非常高興，因為我們今天宣布，我們將在第一季度而不是今年上半年的季度完成 MOTION 研究的全面註冊。仍在今年第 4 季度報告。正如我們在過去 6 到 9 個月的過程中一直在通知的那樣，這項研究的招募情況讓我們對招募的速度感到非常滿意，研究人員和患者對這項研究的熱情是多麼高。正是這種熱情和招生速度使我們能夠比我們之前預期的更快地參加這項研究，並且將使我們能夠在第一季度在這裡實現全面招生。因此，我們期待在今年第 4 季度報告這項研究。馬特，你想談談 3116 問題嗎？

Daniel, it's Matt. So yes, in regards to the 3116 program, as you know, ESMO last year, we were able to present the monotherapy dose escalation data, we're very pleased with the results showing that we had good dose-proportional PK, that we had a very good safety profile. And also we're able to inhibit the target of autophagy in patients treated with 3116. So-- as we announced earlier as well, taking that forward in the combination escalation cohorts with 2 MEK inhibitors, binimetinib and trametinib as well as the KRAS G12C inhibitor to the rasib. So as we've announced, we'll expect to have an update on the combination cohorts in the second half of this year, our expectation there will be to continue to show the PK as well as the safety profile of the drug.

丹尼爾，我是馬特。所以是的，關於 3116 計劃，正如你所知，去年 ESMO，我們能夠提供單藥治療劑量遞增數據，我們對顯示我們有良好劑量比例 PK 的結果感到非常滿意，我們有一個非常好的安全配置文件。而且我們還能夠抑制接受 3116 治療的患者的自噬目標。所以——正如我們早些時候宣布的那樣，在與 2 種 MEK 抑製劑、binimetinib 和 trametinib 以及 KRAS G12C 的組合升級隊列中推進這一目標rasib 的抑製劑。因此，正如我們已經宣布的那樣，我們預計將在今年下半年對聯合隊列進行更新，我們預計將繼續展示 PK 以及藥物的安全性。

And in terms of efficacy, certainly, it is designed as dose escalation in small cohorts of patients but of course, if there's a signal of efficacy, we'd be very pleased to have that information for updating in the second half later this year.

就療效而言，當然，它被設計為小群患者的劑量遞增，但當然，如果有療效信號，我們將非常高興在今年下半年更新該信息。

Okay. Got it. One last question. With multiple KRAS inhibitors in development actually and on the market as you continue development of Node2016, is there an opportunity for you to select the best fit partner as you advance into late-stage development?

好的。知道了。最後一個問題。隨著您繼續開發 Node2016，實際開發和市場上有多種 KRAS 抑製劑，您是否有機會在進入後期開發時選擇最合適的合作夥伴？

Yes. Thanks for the question, Daniel, with respect to KRAS G12C inhibitors. And you're right, there are a variety of agents now, 2 approved in the U.S. And what we're -- as we've reported previously, the effect that we see with 3116 addressing autophagy is an escape when used in combination with the KRAS G12C inhibitor is not specific to an individual KRAS G12C inhibitor. It's certainly a class effect. It's a mechanistic effect that we see. So we've seen that and reported that preclinically, both with sotorasib, but also with at adagrasib. So there would be an opportunity going forward for us to consider additional KRAS G12C combinations as we think about the ideal partner for a potential 3116 KRAS G12C inhibitor combination.

是的。感謝 Daniel 提出有關 KRAS G12C 抑製劑的問題。你是對的，現在有多種藥物，其中 2 種在美國獲得批准。正如我們之前報導的那樣，我們看到的 3116 解決自噬的效果是與KRAS G12C 抑製劑對單個 KRAS G12C 抑製劑沒有特異性。這當然是一種階級效應。這是我們看到的一種機械效應。所以我們已經看到並在臨床前報告了這一點，既有 sotorasib，也有 atagrasib。因此，在我們考慮潛在的 3116 KRAS G12C 抑製劑組合的理想合作夥伴時，我們將有機會考慮其他 KRAS G12C 組合。

Please stand by for our next question. Our next question comes from Michael Schmidt with Guggenheim.

請等待我們的下一個問題。我們的下一個問題來自古根海姆的邁克爾施密特。

This is Paul on for Michael. One from us on recruitment for the INSIGHT study. So your analysis sort of suggests that only a portion of gestation have detectable mutations through ctDNA -- and there is some discussion at the ASCO plenary about just as a relatively low ctDNA shedding cancer. So I just wanted to get your expectations on the speed of recruitment of patients for this target mutation population? And INSIGHT, once that study to later this year and whether you anticipate any sort of challenges in that aspect? And then secondly, on 3116, maybe just provide some color on what drove your decision to combine with encorafenib and cetuximab and where you see that potential for the combination in colorectal cancer?

這是保羅替邁克爾。我們為 INSIGHT 研究招募了一位。因此，您的分析有點表明只有一部分妊娠具有可通過 ctDNA 檢測到的突變——並且在 ASCO 全體會議上有一些討論是關於相對較低的 ctDNA 脫落癌症。所以我只是想了解一下您對這個目標突變人群的患者招募速度的期望？ INSIGHT，一旦研究到今年晚些時候，您是否預計在這方面會遇到任何挑戰？其次，在 3116 上，也許只是提供一些顏色，說明是什麼促使您決定與 encorafenib 和西妥昔單抗聯合使用，以及您在哪裡看到結直腸癌聯合治療的潛力？

Paul, it's Steve. So I'll take the INSIGHT question that you posed and then ask Matt to speak to the 3116, encorafenib and cetuximab combination. So first, with respect to INSIGHT and enrollment in that study, we've now demonstrated very clearly the capability to enroll these large randomized studies in GIST globally. So we have a clear capability in terms of getting these studies up and running and enrolling them rapidly.

保羅，是史蒂夫。所以我會接受你提出的 INSIGHT 問題，然後請 Matt 談談 3116、encorafenib 和西妥昔單抗的組合。因此，首先，關於 INSIGHT 和參與該研究，我們現在已經非常清楚地證明了在全球範圍內將這些大型隨機研究納入 GIST 的能力。因此，我們有能力啟動和運行這些研究並迅速招募他們。

With respect to patients with the specific mutation that we'll be looking for patients who don't shed ctDNA. This is a very similar fraction in GIST versus other solid tumors. So we don't see that as being a differentiating factor and with a simple blood-based diagnostic with a rapid turnaround time of 5 to 10 days, we don't see that as being a barrier at all. In fact, we see it as being an advantage to enrolling in the study.

對於具有特定突變的患者，我們將尋找不脫落 ctDNA 的患者。這是 GIST 與其他實體瘤中非常相似的分數。因此，我們不認為這是一個差異化因素，並且使用簡單的基於血液的診斷和 5 到 10 天的快速周轉時間，我們根本不認為這是一個障礙。事實上，我們認為這是參加研究的優勢。

And then lastly, I would just offer that what we continue to hear from investigators and from thought leaders is a considerable amount of enthusiasm given the data that's now been reported at ASCO for the potential of QINLOCK in the selected group of patients, and I think that's going to serve as a real tailwind in terms of not only getting sites up and running, but also getting patients enrolled on study. Matt?

最後，我只想說，我們繼續從研究人員和思想領袖那裡聽到的是，考慮到 ASCO 現在報告的關於 QINLOCK 在選定患者組中的潛力的數據，我認為這是相當大的熱情這將成為一個真正的順風，不僅可以讓網站啟動和運行，還可以讓患者參與研究。馬特？

Paul, it's Matt. So yes, in regards to our plan to initiate a cohort of 3116 in combination with encorafenib and cetuximab, we're obviously very excited overall with the preclinical data we've generated to date showing that we can inhibit multiple nodes along the RTK, RAS and MAP kinase pathway in combination 3116 and show an additive or even synergistic combination effect on tumor killing. So as we've initiated a number of these combination cohorts now looking at the unmet medical need in treating advanced-stage colorectal cancer. And while cetuximab and encorafenib have activities demonstrated in the BEACON study a number of years ago. That was somewhat limited activity with an objective response rate, approximately 20% and the PFS of about 4 months. So they're showing a lot of headroom for improvement in treating patients. And recognizing this might be a huge opportunity for 3116 and colorectal cancer.

保羅，是馬特。所以是的，關於我們啟動 3116 隊列聯合 encorafenib 和西妥昔單抗的計劃，我們顯然對我們迄今為止生成的臨床前數據總體上非常興奮，這些數據表明我們可以抑制 RTK、RAS 沿線的多個節點和 MAP 激酶途徑結合 3116 並顯示出對腫瘤殺傷的加和甚至協同組合作用。因此，由於我們已經啟動了一些這樣的組合隊列，現在正在研究治療晚期結直腸癌的未滿足的醫療需求。雖然西妥昔單抗和 encorafenib 的活性在多年前的 BEACON 研究中得到證實。這在某種程度上是有限的活動，客觀反應率約為 20%，PFS 約為 4 個月。因此，他們在治療患者方面顯示出很大的改進空間。認識到這可能是 3116 和結直腸癌的巨大機遇。

Please stand by for our next question. Our next question comes from Tyler Van Buren with Cowen.

請等待我們的下一個問題。我們的下一個問題來自 Tyler Van Buren 和 Cowen。

I had a couple for you. The first is can you help us understand what the magnitude of the onetime reserve for QINLOCK sales in Germany was and elaborate more on your expectations for the cadence of ex U.S. sales throughout the year? And the second is for vim and TGCT, you've presented an extensive claims analysis, but what other data points give you confidence in this market, given that patients are so diffused throughout the country and not necessarily concentrated in Centers of Excellence?

我有一對給你。首先是您能否幫助我們了解 QINLOCK 在德國的一次性銷售儲備量是多少，並詳細說明您對全年除美國銷售節奏的預期？第二個是針對 vim 和 TGCT，您已經提供了廣泛的索賠分析，但是考慮到患者在全國如此分散並且不一定集中在卓越中心，還有哪些其他數據點讓您對這個市場充滿信心？

Tyler, thanks for the set of questions. I'll ask Tucker to comment first on the reserve in Germany. Margarida, perhaps you can then comment on what you see as the cadence in terms of the commercial business across Europe. And then, Dan, why don't you take the final question with respect to Vimseltinib claims analysis and the confidence we have and the size of the opportunity. Tucker?

泰勒，謝謝你提出的一系列問題。我會請塔克首先對德國的保護區發表評論。瑪格麗達，也許你可以評論一下你所看到的整個歐洲商業業務的節奏。然後，Dan，你為什麼不回答關於 Vimseltinib 索賠分析的最後一個問題以及我們擁有的信心和機會的大小。塔克？

Sure, Tyler. So we haven't quantified the amount of the reserve in Germany that we took in the fourth quarter. But just to remind folks, what happened is that the German authorities in November changed the law. It used to be that you had a 12-month period of free pricing and that got shortened to 6 months effective retroactively based on the law change in November. So in the fourth quarter, we took a reserve based on the net sales that we had booked at our free pricing price in the third quarter. And then in the fourth quarter, the sales in Germany were booked at an estimate because we're still not at our final price in Germany, but an estimate of where we think we may end up with the German authorities on pricing. So we haven't quantified it, but it certainly was a larger number in the quarter that we wanted to make sure people understood that as they looked at the quarter-over-quarter change in international product sales.

當然，泰勒。所以我們還沒有量化我們在第四季度獲得的德國儲備量。但提醒人們，發生的事情是德國當局在 11 月修改了法律。過去，您有 12 個月的免費定價期，但根據 11 月的法律變更，追溯有效期縮短為 6 個月。因此，在第四季度，我們根據第三季度以免費定價預訂的淨銷售額提取了儲備金。然後在第四季度，德國的銷售額是按估計值計算的，因為我們仍然不是我們在德國的最終價格，而是我們認為我們最終可能會在德國當局定價的地方的估計值。所以我們還沒有量化它，但它肯定是本季度的一個更大的數字，我們希望確保人們在查看國際產品銷售的季度環比變化時理解這一點。

Okay. I will take the second one. Thanks, Tyler, for the question. So I would say that the cadence for the rest of the year in Europe will come from 2 key strategic drivers: the first one is to continue to successfully drive price and reimbursement in the countries where we don't have yet access so that we can launch in new markets in the future; And the second one, I would say, is to continue to successfully execute on our launch strategy and continue to raise awareness to drive demand and to expand the prescriber base. And I would also offer to and say that I'm extremely pleased with the success that we are seeing so far and with the strong demand that we continue to see.

好的。我會拿第二個。謝謝，泰勒，提出這個問題。所以我想說歐洲今年剩餘時間的節奏將來自兩個關鍵的戰略驅動因素：第一個是繼續在我們還沒有進入的國家成功地推動價格和報銷，這樣我們就可以將來在新市場推出；第二個，我想說的是，繼續成功執行我們的發布戰略，並繼續提高意識以推動需求並擴大處方者基礎。我還想說，我對我們迄今為止所取得的成功以及我們將繼續看到的強烈需求感到非常高興。

And Tyler, this is Dan Martin. I'll take your question on what gives us confidence in the TGCT market. I think what gives us confidence of several factors. First, you mentioned claims analysis that we've presented on. That was just a component of our overall analysis of the opportunity. We actually conducted a couple of different methodologies, all of which gave very similar answers. We conducted a more typical sort of literature-based Epi build up and totally separately, we conducted the claims analysis, and both resulted in a really similar findings in terms of the overall patient journey for TGCT as well as the size of the addressable opportunity.

泰勒，這是丹·馬丁。我會回答你的問題，是什麼讓我們對 TGCT 市場充滿信心。我認為是什麼讓我們有信心的幾個因素。首先，您提到了我們已經介紹過的理賠分析。這只是我們對機會的整體分析的一個組成部分。我們實際上採用了幾種不同的方法，所有這些方法都給出了非常相似的答案。我們進行了一種更典型的基於文獻的 Epi 構建，並且完全分開，我們進行了索賠分析，並且在 TGCT 的整體患者旅程以及可尋址機會的規模方面都得出了非常相似的發現。

We -- as it relates to the claims data, the 1,300 to 1,400 patients that we have noted as being the incident Rx treated patients in the U.S. in this data set. We've always viewed that as really a floor of the opportunity and one that gives us confidence because this is an analysis that doesn't provide indicators of patients. It actually sees the patients. And so we can see these patients being treated in the data, which gives us great confidence.

我們——因為它與索賠數據有關，我們在這個數據集中註意到 1,300 到 1,400 名患者是美國接受 Rx 治療的事件患者。我們一直認為這是真正的機會底線，也是給我們信心的底線，因為這是一項不提供患者指標的分析。它實際上看到了病人。因此我們可以在數據中看到這些患者正在接受治療，這給了我們很大的信心。

Lastly, I would just note that one of the things that we get asked is our view of sort of products used in the space and market share, and we've presented the findings from the claims database there as well, showing that only about 15% of the patients received pexidartinib in this data set. And that enables us to sort of triangulate or cross walk back to the opportunity that we've laid out. So across multiple different views of the market. We land in very similar places, which gives us great confidence that the opportunity is there.

最後，我只想指出，我們被問到的其中一件事是我們對空間和市場份額中使用的產品類型的看法，我們也在那裡展示了索賠數據庫的調查結果，表明只有大約 15在此數據集中，接受 pexidartinib 治療的患者百分比。這使我們能夠進行某種三角測量或穿越回到我們已經佈局的機會。因此，跨越多個不同的市場觀點。我們降落在非常相似的地方，這讓我們非常有信心機會就在那裡。

Lastly, I'll just note that diffuse markets with patients being spread between both academic and community settings as a bit of a specialty of ours. We've developed real capability and being successful in that space because that's very much the description of GIST. GIST is very similar in that way. And frankly, one more point is that we know that the overlap between GIST and TGCT is really high. So for all these reasons, we have great confidence that the market is there and that we're uniquely positioned to be successful.

最後，我要指出的是，患者分散在學術和社區環境之間的市場是我們的一個專長。我們已經開發了真正的能力並在該領域取得了成功，因為這非常符合 GIST 的描述。 GIST 在這方面非常相似。坦率地說，還有一點是我們知道 GIST 和 TGCT 之間的重疊非常高。因此，出於所有這些原因，我們非常有信心市場就在那裡，而且我們處於成功的獨特位置。

Please stand by for our next question. Our next question comes from Eun Yang with Jefferies.

請等待我們的下一個問題。我們的下一個問題來自 Jefferies 的 Eun Yang。

I have actually a few questions. First, you mentioned that in 2022, the treatment duration for QINLOCK was 7 months and expect that to increase to 8.5 months. What's driving the increase in the treatment of duration? And do you expect to achieve 8 to 8.5 months of this year? Second question is on the NCCN guidelines. I don't know, it's something -- I understand it is something that we cannot predict. But you have submitted your data for second-line INTRIGUE data. But in light of this double group analysis in exon 11 and 17/18 patient population, do you expect NCC -- NCCN decision could be on the subgroup?

我實際上有幾個問題。首先，您提到2022年QINLOCK的療程為7個月，預計會增加到8.5個月。是什麼推動了治療持續時間的增加？你預計今年能達到8到8.5個月嗎？第二個問題是關於 NCCN 指南。我不知道，這是一些事情——我知道這是我們無法預測的事情。但是你已經提交了你的二線INTRIGUE數據的數據。但鑑於外顯子 11 和 17/18 患者群體的這種雙組分析，您是否認為 NCC - NCCN 決定可能針對亞組？

So I'll take the second question. First with respect to NCCN, and then I'll ask Dan to cover off on the treatment duration for QINLOCK that we see in the real-world experience in the U.S. market. So first for NCCN, you're exactly right, Eun. It's not something that we can predict in terms of whether the NCCN is going to update the guidelines when that might occur or what might be reflected in the guideline update. We were excited to present the data from the subgroup as part of the ASCO plenary series session just last month, very compelling data in this group of patients with QINLOCK. So we're excited about that. I think the field is very excited about it as you will have seen from the presentation and the discussion at the ASCO session at the end of January. And so we await, as you do any potential updates to the guidelines, difficult for us to predict in what shape or form or timing that might be in. So we'll stay tuned for that and see if there are any updates. Dan?

那麼我來回答第二個問題。首先是關於 NCCN，然後我會請 Dan 談談我們在美國市場的真實經驗中看到的 QINLOCK 的治療持續時間。所以首先對於 NCCN，你是完全正確的，Eun。我們無法預測 NCCN 是否會在可能發生更新指南或指南更新中可能反映的內容方面進行預測。作為上個月 ASCO 全會系列會議的一部分，我們很高興地展示了該亞組的數據，這些 QINLOCK 患者組的數據非常引人注目。所以我們對此感到興奮。我認為該領域對此非常興奮，正如您從 1 月底 ASCO 會議上的介紹和討論中看到的那樣。因此，當您對指南進行任何潛在的更新時，我們都在等待，我們很難預測可能的形狀、形式或時間。因此我們將繼續關注，看看是否有任何更新。擔？

Yes. Thanks, Eun, for the question regarding average duration of therapy. It's a really important dynamic that was key in driving the really solid growth that we saw year-over-year. As I noted in my remarks -- prepared remarks, we demonstrated about 20% growth year-over-year with $97 million in the U.S. in 2022. And that was driven by a number of factors, but importantly, by volume growth and the volume growth was driven principally by this increasing average duration of therapy that we see. And the driver for that is really just a maturing of the real-world persistency curve or said another way, maturing of the real world sort of prevalent treated pool that now more fully reflects patients who have had extended and prolonged benefit from QINLOCK, which just pulls the average duration of therapy up now beyond the median PFS that we saw in the INVICTUS study. And that's really important because we expect that to continue to be a gradual growth driver over time. We had noted -- we expect that could potentially reach 8 to 8.5 months. And there's a number of proof points for that which I could certainly go into, but we feel confident that ultimately 8 to 8.5 months average duration of therapy is very achievable.

是的。謝謝，Eun，關於平均治療持續時間的問題。這是一個非常重要的動力，是推動我們看到的同比真正穩健增長的關鍵。正如我在準備好的發言中指出的那樣，我們在 2022 年在美國實現了 9700 萬美元的同比增長約 20%。這是由許多因素推動的，但重要的是，銷量增長和銷量增長主要是由我們看到的這種增加的平均治療持續時間推動的。其驅動因素實際上只是現實世界持久性曲線的成熟，或者換句話說，現實世界中流行的治療池的成熟，現在更充分地反映了已經從 QINLOCK 中長期獲益的患者，這只是現在將平均治療持續時間拉高到超過我們在 INVICTUS 研究中看到的中位 PFS。這真的很重要，因為我們預計隨著時間的推移，這將繼續成為一個漸進的增長動力。我們已經註意到 - 我們預計可能會達到 8 到 8.5 個月。並且有許多我當然可以進入的證據點，但我們相信最終 8 到 8.5 個月的平均治療持續時間是非常可以實現的。

However, we have noted that, that's a gradual phenomenon. That's a gradual trend that we will expect to see develop over time. So it's hard to predict exactly what timetable that will develop in, but that's why we underscored and we see that as a peak average duration of therapy. And we don't expect that to be something that changes dramatically quarter-to-quarter. So likely something that we will share additional color on sort of as warranted over time.

但是，我們注意到，這是一個漸進的現象。這是一個漸進的趨勢，我們預計會隨著時間的推移而發展。因此，很難準確預測將在什麼時間表中發展，但這就是我們強調的原因，我們將其視為治療的平均峰值持續時間。而且我們不希望這會在每個季度之間發生巨大變化。隨著時間的推移，我們很可能會在某種程度上分享額外的顏色。

Can I ask you some follow-up questions?

我可以問你一些後續問題嗎？

Please do, Eun. Go ahead.

請做，恩。前進。

Yes. So a question on the INSIGHT trial. So based on the severe analysis that you've done from the INTRIGUE, it looks like you may need to screen about 400 to 500 patients. So question number 1 is, how long do you think it would take to enroll about 54 patients? And secondly, in the currently practice, is this a mutational analysis at imatinib done recently?

是的。所以有一個關於 INSIGHT 試驗的問題。因此，根據您從 INTRIGUE 所做的嚴格分析，看起來您可能需要篩查大約 400 到 500 名患者。所以第一個問題是，您認為招募大約 54 名患者需要多長時間？其次，在目前的實踐中，這是最近對伊馬替尼進行的突變分析嗎？

Yes, Eun, thanks for the 2 questions. Good questions. So I'll take both of those. So first, with respect to the INSIGHT study, you're right, our sites will need to screen patients for eligibility for enrollment in the study. We -- from our experience with INTRIGUE, which we ran as a large global study multiple sites. We have the capability, of course, and have demonstrated the capability to run these large studies to open multiple sites and to find patients for enrollment. At the site level, of course, we know that physicians will be using an easy liquid diagnostic or a liquid biopsy where they simply draw blood and there's a 5- to 10-day turnaround time to identify patients. And furthermore, sites will know generally the primary mutation status for their patients already from their time of diagnosis. So we would expect that physicians would really be interested in looking at their primary exon 11 patients, of course, and understanding what their secondary mutation profile is as they consider them for enrollment in the study. So we have a lot of confidence based on our demonstrated capabilities in this area of running these sorts of studies and we're looking forward to getting INSIGHT up and running at the end of this year.

是的，Eun，謝謝你提出的兩個問題。好問題。所以我會接受這兩個。所以首先，關於 INSIGHT 研究，你是對的，我們的網站需要篩選患者是否有資格參加該研究。我們——根據我們對 INTRIGUE 的經驗，我們將其作為一個大型全球研究多個站點運行。當然，我們有能力，並且已經證明有能力進行這些大型研究，以開設多個站點並尋找患者進行登記。當然，在站點級別，我們知道醫生將使用簡單的液體診斷或液體活檢，他們只需抽血，並有 5 到 10 天的周轉時間來識別患者。此外，網站通常會從診斷時就知道患者的主要突變狀態。因此，我們預計醫生會真正有興趣查看他們的主要外顯子 11 患者，當然，並在他們考慮將他們納入研究時了解他們的二次突變概況是什麼。因此，基於我們在這一領域開展此類研究所展示的能力，我們充滿信心，我們期待著在今年年底啟動並運行 INSIGHT。

Now with respect to practice within the U.S. or globally even, there isn't a need -- hasn't been a need up until now for physicians to consider looking at the emergence of secondary mutations post-imatinib treatment. But what we know from other analogs, whether it's looking at lung cancer or other solid tumors is that these sorts of liquid biopsies, these blood-based diagnostics see very good adoption. As I noted, these are easy to run. It's simply a tube of blood that's sent off to a lab with a 5- to 10-day turnaround time. So we don't expect, especially given the nature of the data that we've now presented with QINLOCK in this group of patients, we don't expect adoption of a diagnostic to be a barrier to use at all. In fact, we think there will be a considerable amount of enthusiasm among physicians and patients to understand what their secondary mutation status is. So they'll know whether QINLOCK could be an option for them in the second-line setting.

現在，就美國乃至全球的實踐而言，沒有必要——直到現在還沒有必要讓醫生考慮研究伊馬替尼治療後二次突變的出現。但我們從其他類似物中了解到，無論是研究肺癌還是其他實體瘤，這些液體活檢，這些基於血液的診斷都得到了很好的採用。正如我所指出的，這些很容易運行。它只是將一管血液送到實驗室，周轉時間為 5 到 10 天。所以我們不期望，特別是考慮到我們現在在這組患者中使用 QINLOCK 提供的數據的性質，我們不期望採用診斷成為使用的障礙。事實上，我們認為醫生和患者會有相當大的熱情來了解他們的二次突變狀態是什麼。所以他們會知道 QINLOCK 是否可以成為他們在二線設置中的一個選項。

Please stand by for our next question. Our next question comes from Chris Raymond with Piper Sandler.

請等待我們的下一個問題。我們的下一個問題來自 Chris Raymond 和 Piper Sandler。

This is Nicole Gabreski on for Chris. Maybe just 2 from us. One, just in terms of using ctDNA as a potential companion diagnostic for patient identification. I guess can you talk about how that would be integrated if the subset analysis data is included early in NCCN guidelines? Maybe versus if you get regulatory approval in the second line KIT exon 11 and 17/18 setting? Are there any differences just in the setup? I guess we're trying to understand if it's important to have a cleared or approved companion diagnostic in the setting.

這是克里斯的妮可加布雷斯基。也許只有我們兩個。第一，就使用 ctDNA 作為患者識別的潛在伴隨診斷而言。我想您能談談如果子集分析數據儘早包含在 NCCN 指南中將如何整合嗎？也許與如果您在二線 KIT 外顯子 11 和 17/18 設置中獲得監管批准相比？只是設置有什麼不同嗎？我想我們正在嘗試了解在設置中進行清除或批准的伴隨診斷是否重要。

And then maybe second, just around vimseltinib. Going back to your ESMO presentation last year, I know that you guys were highlighting that responses deepen over time, but ORR at the 25 week time point, for Vimseltinib to match the pexidartinib label. And we understand that the CT profile will be the key differentiator, allowing patients to stay on therapy longer. But I guess -- how will that be effectively captured within the Phase II MOTION study? And how does that translate into a potential label?

然後可能是第二個，就在 vimseltinib 附近。回到你們去年的 ESMO 演講，我知道你們都在強調反應會隨著時間的推移而加深，但 Vimseltinib 在 25 週時間點的 ORR 與 pexidartinib 標籤相匹配。我們知道 CT 輪廓將是關鍵的區別因素，可以讓患者接受更長時間的治療。但我想——這將如何在 II 期 MOTION 研究中有效地體現出來？這如何轉化為潛在的標籤？

Good question, Nicole. Thanks for those. So let me take first the ctDNA question, and then I'll ask Matt just to comment on the MOTION study and the data we presented last year at ESMO and touched on the data we're collecting as part of MOTION that would then inform a label and the profile of the drug in a commercial setting upon a potential approval. But first, for the ctDNA data in GIST today, and I think your question Nicole was in the present-day environment, even absent a regulatory approval for QINLOCK in this patient population what could physicians do in practice. We know that, of course, these sorts of blood-based panels are already available, so from companies like Foundation Medicine, Garden Health and the like. And so physicians today, if they were so inclined, it could draw a tube of blood and send it off to a foundation or to Garden for analysis. And these panels today will pick up the secondary mutations seen in just patients and report back on that. So physicians, if they so chose to do so, they could run that analysis and then make treatment decisions, which would be off-label today. So this isn't something that we can or would promote to, but physicians could then make treatment decisions and they would have to work with the patient's insurance provider to obtain coverage for that off-label use. But I guess my point is just that these diagnostics are available today for physicians who are interested in understanding the secondary mutation status for their patients. Matt, do you want to comment then on vimseltinib and MOTION?

問得好，妮可。感謝那些。所以讓我先回答 ctDNA 問題，然後我會請 Matt 就 MOTION 研究和我們去年在 ESMO 上展示的數據發表評論，並談到我們作為 MOTION 的一部分收集的數據，這些數據將告知潛在批准後在商業環境中的標籤和藥物概況。但首先，對於今天 GIST 中的 ctDNA 數據，我認為你的問題 Nicole 在當今環境中，即使沒有對 QINLOCK 在這個患者群體中的監管批准，醫生在實踐中可以做什麼。我們知道，當然，這些基於血液的面板已經可用，因此來自 Foundation Medicine、Garden Health 等公司。所以今天的醫生，如果他們願意的話，它可以抽取一管血液並將其送到基金會或花園進行分析。今天，這些小組將檢測僅在患者身上發現的繼發性突變，並就此進行報告。所以醫生，如果他們選擇這樣做，他們可以運行該分析，然後做出治療決定，這在今天是標籤外的。所以這不是我們可以或不會推廣的東西，但醫生可以做出治療決定，他們必須與患者的保險提供者合作以獲得標籤外使用的保險。但我想我的意思是，今天這些診斷可用於有興趣了解患者二次突變狀態的醫生。 Matt，你想對 vimseltinib 和 MOTION 發表評論嗎？

Yes. So yes, as you note, for the 25-week endpoint in the TGCT study, we had a 38% response rate, which was similar to what was reported for the Vimseltinib study in their label. But also as we also know, these patients continue on therapy for longer than 6 months and can have a response beyond that. And we reported for the Phase 1 dissolution cohorts who were on study the longest of 69% overall response rate in the TGCT patients in the Phase I/II study. And in terms of a label, it's also -- it's also noted that enlivens label, or pace documents label based on the 11 study also shows their overall response rate in the open-label portion of the study. And that's 61% in the current label for pexidartinib. So we could expect that our label for consults that may contain the longer-term follow-up and a higher overall response rate.

是的。所以是的，正如您所注意到的，對於 TGCT 研究的 25 週終點，我們的反應率為 38%，這與標籤中 Vimseltinib 研究的報告相似。但我們也知道，這些患者繼續接受治療超過 6 個月，並且可以有超過 6 個月的反應。我們報告了在 I/II 期研究中 TGCT 患者中最長的 69% 總體反應率的 1 期溶出隊列。就標籤而言，它也是——還注意到基於 11 項研究的活躍標籤或速度文件標籤也顯示了他們在研究的開放標籤部分中的總體響應率。在當前的 pexidartinib 標籤中，這是 61%。因此，我們可以預期我們的諮詢標籤可能包含更長期的跟進和更高的總體響應率。

Please stand by for our next question. Our next question comes from Brad Canino with Stifel.

請等待我們的下一個問題。我們的下一個問題來自 Stifel 的 Brad Canino。

Steve, maybe a follow-up on your previous comments. I guess I want to -- based on the KOL and physician feedback to the subgroup analysis, do you expect a material enough proportion of practices to adopt a second-line ctDNA guided treatment paradigm in the next 3 years to impact QINLOCK sales? And then a second question, with the top line readout for themselves in inflated for 4Q. When you think about the degree of data that you would include in the package to the FDA is successful, can you add any comments about how long you expect it to take to reach an NDA filing?

史蒂夫，也許是對你之前評論的跟進。我想我想——根據 KOL 和醫生對亞組分析的反饋，您是否期望在未來 3 年內有足夠多的實踐採用二線 ctDNA 指導治療範式來影響 QINLOCK 的銷售？然後是第二個問題，第 4 季度他們自己的頂線讀數被誇大了。當您考慮到提交給 FDA 的數據包中所包含的數據的成功程度時，您能否添加任何關於您預計需要多長時間才能完成 NDA 備案的評論？

Yes. Thanks, Brad. Two good questions. So with respect to expectations around taking the data that we presented at ASCO and that being translated or changing practice today, it's an uncertainty. So of course, we can't promote to that use. We don't have extensive market research that tells us whether physicians will adopt the use of the drug on an off-label basis. What we've seen so far in our experience is that use has been -- for QINLOCK has been generally within our approved label. So we'll continue to monitor and understand how physicians they choose to change practice, how that practice changes over time. But we don't have any information at the moment with respect to what changes might occur. Clearly, having a label in the second-line setting in this patient population is what will ultimately allow us to drive share and drive utilization and that is one of the reasons that we decided to conduct the INSIGHT study and seek a label in the second-line is to be able to promote to that use upon approval.

是的。謝謝，布拉德。兩個好問題。因此，關於我們在 ASCO 上展示的數據以及今天被翻譯或改變實踐的期望，這是一個不確定性。所以當然，我們不能推廣到那個用途。我們沒有廣泛的市場研究來告訴我們醫生是否會在標籤外使用該藥物。到目前為止，根據我們的經驗，我們所看到的是使用情況——因為 QINLOCK 通常在我們批准的標籤範圍內。因此，我們將繼續監測和了解他們如何選擇改變實踐的醫生，以及這種實踐如何隨著時間的推移而變化。但是我們目前沒有關於可能發生什麼變化的任何信息。顯然，在該患者群體的二線環境中使用標籤最終將使我們能夠推動份額和利用率，這也是我們決定進行 INSIGHT 研究並在第二線尋求標籤的原因之一-線是能夠在批准後推廣到該用途。

Your second question, I think, Brad, was related to vimseltinib and our announcement this morning that we expect to complete enrollment in the first quarter of this year and read out the study in Q4. And your question was around the timing for a potential NDA. So it's really premature for us to share our thoughts around what the timing could be for an NDA post top line readout. What I can say is that our team has demonstrated with -- certainly with QINLOCK and our fourth line label, our ability to quickly move from top line data readout to get a filing in. This will be no different. And when we have a readout of the study of the top line results, I'm sure we'll be in a position at that time to offer some additional color around what the timing could be for a potential filing in the U.S. and filings outside of the U.S.

Brad，我認為你的第二個問題與 vimseltinib 和我們今天早上宣布我們預計將在今年第一季度完成入組並在第四季度宣讀研究有關。你的問題是關於潛在保密協議的時間安排。因此，我們現在就 NDA 後頂線讀數的時機分享我們的想法還為時過早。我可以說的是，我們的團隊已經證明——當然是通過 QINLOCK 和我們的第四行標籤，我們能夠快速從頂行數據讀取轉移到歸檔。這不會有什麼不同。當我們讀出對最高線結果的研究時，我相信那時我們將能夠提供一些額外的顏色，說明在美國和國外提交的潛在申請的時間可能是什麼美國的

(Operator Instructions) Please stand by for our next question. At this time, please stand by for our next question. Our next question comes from Peter Lawson with Barclays.

（操作員說明）請等待我們的下一個問題。這個時候，請等候我們的下一個問題。我們的下一個問題來自巴克萊銀行的彼得勞森。

Just on NCCN guidelines. Are you looking to gain guideline inclusion for exon 11 17/18?

就在 NCCN 指南上。您是否希望獲得外顯子 11 17/18 的指南收錄？

Yes. Thanks for the question, Peter, with respect to NCCN. So we're going to continue to monitor what NCCN decides to do with respect to any guideline update, and that will guide our decision about any future submissions of data. So that's the approach that we plan on taking with respect to NCCN going forward.

是的。彼得，謝謝你提出關於 NCCN 的問題。因此，我們將繼續監測 NCCN 對任何指南更新的決定，這將指導我們對未來提交數據的決定。這就是我們計劃在未來對 NCCN 採取的方法。

Got you. I mean just the exon 11 17/18 data plus various other mutations that make the NCCN guideline changes the second-line will come as difficult then to make that judgment call?

明白了我的意思是僅外顯子 11 17/18 數據加上使 NCCN 指南發生變化的各種其他突變，二線會變得難以做出判斷嗎？

Yes. I think what we've learned Peter from the analysis is that there's a level of complexity and nuance I think, to the data. I mean, certainly, the 11 17/18 population, the result is very clear in terms of QINLOCK -- the benefit of QINLOCK versus sunitinib. And we have this group of patients in whom ctDNA is not detectable where we see on the forest plot, the hazard ratio for PFS is virtually in the center of that forest plot. So I think it's unclear at the moment what NCCN might choose to do. We know that physicians generally are interested in having more options available to treat their patients. And we don't think that this situation with just is any different. So we would expect that, that will be of interest to physicians on the panel as they think about providing options to patients going forward.

是的。我認為我們從分析中了解到彼得，我認為數據存在一定程度的複雜性和細微差別。我的意思是，當然，11 17/18 人口，就 QINLOCK 而言，結果非常清楚——QINLOCK 與舒尼替尼相比的好處。我們有這組患者，在我們在森林圖上看到的地方無法檢測到 ctDNA，PFS 的風險比實際上位於該森林圖的中心。所以我認為目前還不清楚 NCCN 可能會選擇做什麼。我們知道，醫生通常希望有更多的選擇來治療他們的病人。而且我們認為這種情況與 just 沒有任何不同。因此，我們預計專家小組的醫生會對此感興趣，因為他們正在考慮為未來的患者提供選擇。

Got you. And then just on China, just the kind of the size of the opportunity, how we should think about pricing and kind of how you think it could help revenues over the next couple of years, whether it's '23 or '24?

明白了然後就中國而言，機會的大小，我們應該如何考慮定價以及您認為它如何在未來幾年內幫助增加收入，無論是'23 還是'24？

Sure. Margarida, would you like to address the China opportunity and sizes closures?

當然。 Margarida，你想談談中國的機會和規模關閉嗎？

Absolutely. Thank you. Thanks for the question, Peter. So we view this listing very positively as it will increase affordability and access for Chinese patients moving forward. So we do expect this to be a key contributor of volume growth over time how quickly that happens, we do not have a lot of details yet. But all in all, we view this extremely positively.

絕對地。謝謝。謝謝你的問題，彼得。因此，我們非常積極地看待這次上市，因為它將提高中國患者未來的負擔能力和可及性。因此，我們確實希望隨著時間的推移，這將成為銷量增長的關鍵因素，這種情況發生的速度有多快，我們還沒有很多細節。但總而言之，我們對此持非常積極的態度。

I show no further questions at this time. I would now like to turn the conference back to Steve Hoerter for closing remarks.

我現在沒有進一步的問題。我現在想把會議轉回 Steve Hoerter 作閉幕詞。

Great. Thank you, Michelle. Thanks to all of you for joining us on today's call. Thank you for your continued support of the work that we're doing here at the Deciphera. We look forward to keeping you updated on our progress for the balance of this year, and hope you have a great rest of your day.

偉大的。謝謝你，米歇爾。感謝大家參加今天的電話會議。感謝您一直以來對我們在 Deciphera 所做的工作的支持。我們期待著讓您了解我們今年餘下時間的最新進展，並希望您度過愉快的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。