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Operator
Operator
Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q1 2026 earnings conference call. (Operator Instructions) This call is being recorded on Monday, May 4, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.
各位女士、先生,早安,歡迎參加 ADC Therapeutics 2026 年第一季財報電話會議。(接線員指示)本通話於 2026 年 5 月 4 日(星期一)錄音。現在我想把會議交給投資人關係與企業傳播主管 Nicole Riley。請開始。
Nicole Riley - Investor Relations
Nicole Riley - Investor Relations
Thank you, operator. Today, we issued a press release announcing our first quarter 2026 financial results and business updates. This release and the slides we will use in today's presentation are available on the Investors Section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance and recent business highlights, followed by our Chief Financial Officer, Pepe Carmona, who will review our first quarter 2026 financial results. We will then open the call to questions.
謝謝,接線員。今天,我們發布新聞稿,公布 2026 年第一季財務結果與業務更新。該新聞稿以及我們在今日簡報中使用的投影片,可於 ADC Therapeutics 官網的投資人專區取得。今天與會者包括我們的執行長 Ameet Mallik,他將說明我們的營運表現與近期業務重點,接著由我們的財務長 Pepe Carmona 回顧 2026 年第一季財務結果。之後我們將開放提問。
Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance and achievements could differ materially. They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q and 8-K. ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events or circumstances, except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements.
在開始之前,我想提醒各位聽眾,本次電話會議中的部分陳述將包含前瞻性陳述,其定義依據為 1995 年《美國私人證券訴訟改革法》之安全港條款。這些前瞻性陳述受到若干已知與未知風險及不確定性影響,實際結果、表現與成就可能出現重大差異。相關風險已於隨附的投影片簡報以及公司向美國證券交易委員會(SEC)提交的文件中加以辨識與說明,包括 Form 10-K、10-Q 與 8-K。ADC Therapeutics 僅以今日日期提供本資訊,除法律要求外,對於因新資訊、未來事件或情勢而需更新本次電話會議所含任何前瞻性陳述,不承擔任何義務。公司提醒投資人勿對這些前瞻性陳述過度依賴。
Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the company's first quarter 2026 earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures.
今日簡報亦包含非 GAAP 財務報導。這些非 GAAP 指標應與依 GAAP 編製之資訊一併考量,而不應單獨使用,亦不應作為 GAAP 資訊之替代。請參閱公司 2026 年第一季財報新聞稿,以取得歷史非 GAAP 指標與可比較 GAAP 財務指標之相關資訊與調節表。
I will now turn the call over to our CEO, Ameet Mallik.
現在我把電話交給我們的執行長 Ameet Mallik。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
Thank you, Nicole. We continue to make good progress in the first quarter of 2026 as we advance towards multiple important milestones for ZYNLONTA over the remainder of the year, beginning with the expected LOTIS-5 top line readout in the second quarter. From a commercial perspective, we continue to focus on execution and delivering on our commercial strategy, maintaining ZYNLONTA as a differentiated treatment option for third line plus DLBCL patients.
謝謝你,Nicole。2026 年第一季我們持續取得良好進展,並在今年剩餘期間推進 ZYNLONTA 多項重要里程碑,首先是預期於第二季公布 LOTIS-5 的主要(top line)結果。就商業面而言,我們持續聚焦於落實執行並交付我們的商業策略,維持 ZYNLONTA 作為第三線以上 DLBCL 病患具差異化的治療選項。
First quarter net product revenues were $20.0 million as compared to the prior year's first quarter net product revenues of $17.4 million. The increase was driven primarily by normal quarter-to-quarter variability in customer ordering with underlying demand broadly stable.
第一季產品淨營收為 2,000 萬美元,相較於去年第一季產品淨營收 1,740 萬美元。增加主要來自客戶訂貨在各季之間的正常波動,而基礎需求整體上大致穩定。
Looking toward the second line plus setting where we believe the largest growth opportunity lies. For LOTIS-5, our Phase III confirmatory trial of ZYNLONTA plus rituximab, we expect to share top line data before the end of June, potentially bringing us another step closer to providing this combination to significantly more patients. While this timeline is rapidly approaching, I do want to highlight that we are currently still blinded to the data.
展望第二線以上的治療情境,我們認為最大的成長機會就在此。就 LOTIS-5 而言,這是我們針對 ZYNLONTA 合併利妥昔單抗(rituximab)的第三期確認性試驗,我們預期在 6 月底前分享主要數據,可能讓我們更接近把此合併療法提供給更多病患。雖然時程已迫在眉睫,但我也要強調,我們目前仍對數據維持盲態。
Turning to LOTIS-7. We expect to complete enrollment of approximately 100 patients at the selected dose level of ZYNLONTA plus (inaudible) in the second quarter with full data anticipated by year-end. In indolent lymphomas, we continue to anticipate data publication between the end of 2026 and mid-2027 from the multicenter investigator-initiated trials ZYNLONTA in combination with rituximab to treat relapsed or refractory follicular lymphoma and of ZYNLONTA as a monotherapy to treat relapsed or refractory marginal zone lymphoma.
接著談 LOTIS-7。我們預期在第二季完成於所選劑量層級之 ZYNLONTA 加上(聽不清)約 100 名病患的收案,並預計於年底前取得完整數據。在惰性淋巴瘤方面,我們仍預期在 2026 年底至 2027 年年中之間,發表多中心、研究者發起試驗的數據:包括 ZYNLONTA 合併利妥昔單抗(rituximab)治療復發或難治性濾泡性淋巴瘤,以及 ZYNLONTA 單藥治療復發或難治性邊緣區淋巴瘤。
We continue to pay close attention in the quarter to managing our cost base and optimizing our balance sheet. On a non-GAAP basis, we've reduced our total operating expenses by 13% versus Q1 2025 and we ended the first quarter of 2026 with a healthy cash balance of $231 million. This maintains our expected cash runway at least into 2028, enabling us to deliver against our strategy. We are building off the well-established role of ZYNLONTA as a single-agent therapy in third line plus DLBCL where ZYNLONTA has a profile of rapid, deep and durable efficacy, as well as manageable safety with simple and convenient administration.
本季我們持續密切關注成本基礎管理並優化資產負債表。以非 GAAP 基礎計算,我們的總營運費用較 2025 年第一季降低 13%,且 2026 年第一季末我們的現金餘額維持健康水準,為 2.31 億美元。這使我們預期的現金可支撐期至少延伸至 2028 年,讓我們得以落實策略。我們正以 ZYNLONTA 在第三線以上 DLBCL 單藥治療中已建立的角色為基礎持續發展;ZYNLONTA 具備快速、深度且持久的療效特徵,同時安全性可管理,且給藥方式簡單便利。
We believe the relative stability we've seen in net product revenues over multiple quarters demonstrates that ZYNLONTA has a clear place in this market. This is just a starting point as we believe in the potential for ZYNLONTA to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. The data we've seen across these settings so far have been consistently encouraging with the potential to be highly differentiating.
我們認為,過去多個季度產品淨營收的相對穩定,顯示 ZYNLONTA 在此市場中具有明確定位。這只是起點;我們相信,透過將 DLBCL 的使用擴展至更早線別治療,以及拓展至惰性淋巴瘤,ZYNLONTA 有潛力觸及顯著更多病患。迄今我們在這些情境中看到的數據一貫令人鼓舞,且有望具高度差異化。
Through expansion into these settings in DLBCL and into indolent lymphomas, we are confident that ZYNLONTA has the potential to reach peak annual revenues of $600 million to $1 billion in the US, assuming both compendia listing and regulatory approval. The upcoming LOTIS-5 trial readout, if positive, we'll begin to unlock the value of our life cycle management efforts for ZYNLONTA. Taken together with the upcoming data expected from LOTIS-7 and the (inaudible) lymphoma studies, we expect to accelerate our revenue growth trajectory starting in 2027.
透過在 DLBCL 與惰性淋巴瘤中的適應症擴展,我們有信心 ZYNLONTA 在美國的年度峰值營收可達 6 億至 10 億美元,前提是同時取得處方集(compendia)收錄與監管核准。即將公布的 LOTIS-5 試驗結果若為正面,我們將開始釋放 ZYNLONTA 生命週期管理工作的價值。再加上預期將自 LOTIS-7 與(聽不清)淋巴瘤研究取得的即將到來數據,我們預期自 2027 年起加速營收成長軌跡。
Now I would like to turn the call over to Pepe Carmona, our CFO, who will discuss financial results for the first quarter.
現在我想把電話交給我們的財務長 Pepe Carmona,他將說明第一季的財務結果。
Jose Carmona - Chief Financial Officer
Jose Carmona - Chief Financial Officer
Thank you, Ameet. On the financial front, ZYNLONTA net product revenues in the first quarter of 2026 were $20 million as compared to $17.4 million in the same quarter in 2025. Licensing revenues and royalties were lower this year due to $5 million milestone we received from our partner in the prior year period. Cost of sales increased by $1.6 million to $3.6 million for the three months ended March 31, 2026. This increase reflects a shift in the allocation of certain personnel costs due to a change in focus from research and development activities to commercial manufacturing activities.
謝謝你,Ameet。在財務方面,2026 年第一季 ZYNLONTA 產品淨營收為 2,000 萬美元,相較於 2025 年同季的 1,740 萬美元。今年授權收入與權利金較低,原因是我們在去年同期自合作夥伴收到 500 萬美元的里程碑款。銷貨成本在截至 2026 年 3 月 31 日的三個月期間增加 160 萬美元至 360 萬美元。此增加反映因工作重點由研發活動轉向商業製造活動,而導致部分人員成本分攤方式的變動。
Total operating expenses were $46.1 million for the first quarter. On a non-GAAP basis, total adjusted operating expenses were $42.9 million for the quarter. Total adjusted operating expenses were down by 13% over the prior year period, primarily driven by lower R&D expenses. As Ameet noted, when managing our costs carefully, and we remain disciplined in our capital allocation towards potential value creation while driving efficiency.
第一季的營運費用總額為 4,610 萬美元。以非 GAAP 基礎計算,本季調整後營運費用總額為 4,290 萬美元。調整後營運費用總額較去年同期下降 13%,主要由於研發費用降低所致。如 Ameet 所提到的,我們在審慎管理成本的同時,仍在資本配置上保持紀律,將資源投入於具潛在價值創造的機會並推動效率提升。
On a GAAP basis, we reported a net loss of $33 million for the first quarter of 2026 or $0.21 per basic and diluted share as compared to a net loss of $38.6 million or $0.36 per basic and diluted share for the same period in 2025. On a non-GAAP basis, the adjusted net loss was $19.7 million for the first quarter of 2026, as compared to a net loss of $24 million for the same period in 2025. The lower net loss on both GAAP and non-GAAP basis was primarily due to reduced R&D expenses.
以 GAAP 基礎計算,我們在 2026 年第一季報告淨損 3,300 萬美元,或每股基本及稀釋淨損 0.21 美元;相較之下,2025 年同期淨損為 3,860 萬美元,或每股基本及稀釋淨損 0.36 美元。以非 GAAP 基礎計算,2026 年第一季調整後淨損為 1,970 萬美元,相較 2025 年同期淨損 2,400 萬美元。無論在 GAAP 或非 GAAP 基礎下,淨損下降主要是由於研發費用減少。
The year-over-year reductions on a per share basis were additionally impacted by the higher number of weighted average shares outstanding. You can find the reconciliation of GAAP to non-GAAP measures for the first quarter in the compounding financial tables of the press release issued earlier today and in the appendix of this presentation.
以每股計算的年對年降幅亦受到加權平均流通在外股數較高的影響。您可在今日稍早發布之新聞稿所附的彙總財務表,以及本簡報附錄中,找到第一季 GAAP 與非 GAAP 指標之調節表。
At the end of the first quarter, we had cash and cash equivalents of $231 million as compared to $261.3 million as of December 31, 2025. This provides us with an expected cash runway at least into 2028.
截至第一季末,我們持有的現金及約當現金為 2.31 億美元,相較於 2025 年 12 月 31 日的 2.613 億美元。這使我們預期的現金可支撐期至少可延續至 2028 年。
Turning to upcoming milestones. We expect to have multiple data catalysts during the remainder of 2026 across the ZYNLONTA program. First, we expect to share the top line data for LOTIS-5 before the end of June with publication of full results anticipated by the year-end. As Ameet noted, we're currently blinded to the data.
接下來談談即將到來的里程碑。我們預期在 2026 年剩餘期間,於 ZYNLONTA 計畫上將有多項數據催化劑。首先,我們預期在 6 月底前分享 LOTIS-5 的主要(top line)數據,並預計於年底前發表完整結果。如 Ameet 所提到的,我們目前仍對數據保持盲態(blinded)。
And to the top line data has been presented, will remain in a blackout period, which means we may need to cancel our participation in any conferences as well as meetings with investors and analysts. Assuming the results are positive, we plan to submit a supplemental biologics license application to the FDA by year-end, with (inaudible) publication and compendia inclusion in the first half of 2027 and confirmatory approval to follow thereafter.
在主要(top line)數據公布之前,我們將處於資訊封鎖期(blackout period),這表示我們可能需要取消參與任何會議,以及與投資人與分析師的會面。若結果為正向,我們計畫於年底前向 FDA 提交補充生物製劑許可申請(sBLA),並於 2027 年上半年完成(聽不清)發表與納入彙編(compendia inclusion),其後再取得確認性核准。
With LOTIS-7, we are on track to complete enrollment in the second quarter. We plan to share the next update with full data at a medical meeting by the end of 2026. In addition, assuming positive results, we plan to pursue competing inclusion as well as assess our regulatory strategy.
就 LOTIS-7 而言,我們正按計畫於第二季完成收案。我們計畫在 2026 年底前於醫學會議上分享下一次更新並提供完整數據。此外,若結果為正向,我們計畫推動納入彙編(compendia inclusion),並評估我們的法規策略。
With (inaudible), we expect the lead investigator to share additional data at medical conferences between the end of 2026 and mid-2027 and we plan to assess regulatory and competing strategies once sufficient data are available. I will now turn the call back over to Ameet.
就(聽不清)而言,我們預期主要研究者將於 2026 年底至 2027 年年中間的醫學會議上分享更多數據;待取得足夠數據後,我們將評估法規與彙編策略。我現在把電話交回給 Ameet。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
Thank you, Pepe. To close, I am pleased with our start to 2026. We have achieved solid commercial performance while maintaining our strict capital discipline as we look forward to multiple anticipated value-creating catalysts, beginning with the expected LOTIS-5 readout. We are excited about delivering on our strategy and confident we can drive significant potential long-term growth starting in 2027. We can now open the line for questions.
謝謝你,Pepe。最後,我對我們 2026 年的開局感到滿意。我們在維持嚴格資本紀律的同時,達成穩健的商業表現,並期待多項可望創造價值的催化劑,其中首個為預期的 LOTIS-5 讀出。我們對落實策略感到振奮,並有信心自 2027 年起推動顯著的長期成長潛力。現在我們可以開放提問。
Operator
Operator
(Operator Instructions) Maury Raycroft, Jefferies.
(接線員指示)Jefferies 的 Maury Raycroft。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Good morning. Congrats on the progress. Thanks for taking my question. You mentioned on the call that you remain blinded to the data. Can you clarify if the database is locked at this point and when you reach the 262 events? And from a process standpoint, can you say what's happening currently? And what are the drivers that will allow you to unblind the data?
早安。恭喜進展,也謝謝讓我提問。您在電話會議中提到目前仍對數據保持盲態。能否釐清目前資料庫是否已鎖定(database locked),以及何時會達到 262 個事件(events)?從流程角度來看,您能說明目前正在進行哪些工作嗎?以及哪些因素會讓你們得以解除盲態(unblind)並查看數據?
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
Thanks for the question. So what I can tell you is we're on track to be able to read the data. So the -- we're completely binded to the data side. I don't know any information yet. But as soon as the database (inaudible) and we do the statistical analysis, we'll then be able to disclose top line data. So we're not at that point yet. On track to basically to share the data this quarter.
謝謝你的問題。我能告訴你的是,我們正按計畫推進,將能夠讀出數據。所以——我們在數據方面是完全盲態。我目前還不知道任何資訊。但一旦資料庫(聽不清)並完成統計分析,我們就能揭露主要(top line)數據。所以我們還沒到那一步。不過進度符合預期,基本上會在本季分享數據。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Got it. Okay. And for when you reach the 262 events, is there anything more on that you're saying? From a timing perspective?
了解。好的。那關於達到 262 個事件的時間點,你還能補充什麼嗎?就時程而言?
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
We're not commenting on exactly where we're hitting the events. But what I can tell you is we're on track to hit the -- to basically to get to the top line results this quarter in the second quarter.
我們不會評論事件達成的確切進度。但我能告訴你的是,我們正按計畫推進——基本上會在第二季、本季取得主要(top line)結果。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Okay. Understood. Maybe one other quick question. Just following the site level interventions you implemented to address the early dropout in censoring, do you have any perspective potentially from the IDMC to provide any indication that sensoring rates improved after those changes? I guess any -- any more color on that could be helpful.
好的,明白。也許再一個快速問題。針對你們在站點層級所採取的介入措施,以解決早期退出造成的設限(censoring)問題,在實施這些變更後,你們是否可能從 IDMC 那邊得到任何觀點或指標,顯示設限率有所改善?我想任何——任何更進一步的說明都會有幫助。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
I can't comment further. What I can tell you is the last IDMC look, which is from a safety standpoint, was last fall. And again, that recommendation wants to proceed as is there have been any other looks from the IDMC at the data.
我無法進一步評論。我能告訴你的是,上一次 IDMC 的檢視(從安全性角度)是在去年秋天。再次強調,當時的建議是按原計畫繼續進行,且 IDMC 並未對數據進行任何其他檢視。
Operator
Operator
Michael Schmidt, Guggenheim.
Guggenheim 的 Michael Schmidt。
Michael Schmidt - Analyst
Michael Schmidt - Analyst
Good morning. Thanks for taking my question. I have a couple. Maybe first commercially. The $20 million in 1Q, it's about 15% growth annually. I know you mentioned ordering pattern, but it just seems more growth than we've seen in recent quarters. And just curious if there's anything else going on in terms of driving more volume perhaps in the approved indication in the market?
早安。謝謝讓我提問。我有幾個問題。先從商業面來看,第一季 2,000 萬美元的表現,年增約 15%。我知道你提到訂貨模式,但看起來成長幅度比我們近幾季看到的更高。想請教是否還有其他因素在推動,例如在已核准適應症的市場中帶來更多用量?
And then the other question I just had on LOTIS-5, so great to hear that the data is still on track for this quarter. Could you just comment on how much of the result, you'll be able to disclose in the top line announcement? Will you be able to share things like median PFS or perhaps asset ratios, et cetera, in the top line release? Thanks so much,
另外一個問題是關於 LOTIS-5,很高興聽到數據仍按計畫在本季公布。你能否談談在主要(top line)公告中,你們能揭露多少結果?例如在主要新聞稿中,是否能分享像是 PFS 中位數或可能的風險比(hazard ratios)等資訊?非常感謝。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
Thanks, Michael. So first, on sales, as you recall, Q3 was quite low and the Q4 was quite strong. So we had $15.8 million, the $22.3 million, now we're at $20 million. I think it's too soon to call a change in trend to as right now. But I think what we're seeing is definitely very good execution. We're happy that we've been able to maintain our share despite a very competitive environment. And there is quarter-to-quarter vary. As we saw in the Q3 was one of the lowest quarters in the Q4 is one of the higher quarters in the last couple of years.
謝謝你,Michael。首先談銷售,如你所記得,第三季相當低,而第四季相當強勁。我們分別是 1,580 萬美元、2,230 萬美元,而現在是 2,000 萬美元。我認為現在就斷言趨勢改變還太早。但我想我們看到的是確實非常好的執行力。我們很高興在競爭非常激烈的環境下仍能維持市占。而且季度之間會有波動。正如我們看到的,第三季是近幾年較低的季度之一,而第四季則是近幾年較高的季度之一。
But I think after two quarters in that $20-plus million range, it's encouraging, but too soon to call the trend. So I think if this continues, that may cause it to sort of change where we think the range is going to be. But I think at this point, just given the variable that we've seen in the last couple of years, I think -- we think it's -- we're still in the range of normal demand within the content of custom order variability.
但我認為,在連續兩個季度都落在2,000萬美元以上的區間之後,這是令人鼓舞的,但現在就斷言這是一個趨勢仍為時過早。因此我認為,如果這種情況持續下去,可能會促使我們調整對於該區間走向的判斷。但就目前而言,鑑於過去幾年我們看到的波動性,我認為——我們認為——在客製化訂單波動性的背景下,需求仍處於正常需求範圍內。
With regards to LOTIS-5, we plan to share all the relevant information on the primary endpoints, of course, like (inaudible), hazard ratio, any information that we have on key secondary endpoints, as well as top-line safety data. So we do want to make sure that the disclosure is clear with the information that we have and well understood what the result is. At the same time, a lot of sub-analyses and other things that are typically less relevant for a top-on result, but critical for, let's say, a medical conference or publication. Those would be details that would come later in the year.
關於LOTIS-5,我們計畫分享所有與主要終點相關的資訊,當然包括(聽不清)、風險比(hazard ratio),以及我們掌握的任何關於關鍵次要終點的資訊,同時也會提供頂線(top-line)安全性資料。因此,我們確實希望確保揭露內容清楚、以我們所掌握的資訊為基礎,並讓結果能被充分理解。同時,許多次群分析與其他通常對頂線結果較不相關、但對例如醫學會議或論文發表至關重要的內容,這些細節會在今年稍晚提供。
Operator
Operator
Eric Schmidt, Cantor.
Eric Schmidt,Cantor。
Eric Schmidt - Analyst
Eric Schmidt - Analyst
Thanks for a very efficient call. A couple of questions for me also on LOTIS-5. First, with regard to procedures, do I take that base comments to mean that you're now entering the quiet period? Is that starting after today?
感謝這場非常高效率的電話會議。我也有幾個關於LOTIS-5的問題。首先,關於程序方面,我是否可以把你剛才的基本說法理解為你們現在要進入靜默期(quiet period)?是從今天之後開始嗎?
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
We started actually a quiet period, and we have to do earnings, of course, but we haven't been engaging with analyst -- investors since April 1 for the whole quarter until we disclose the data.
我們其實已經開始靜默期了,當然我們仍需進行財報發布,但自4月1日起,整個季度直到我們揭露數據之前,我們都沒有與分析師——投資人進行互動。
Eric Schmidt - Analyst
Eric Schmidt - Analyst
Thank you. And then, Ameet, on the information that you'll be able to disclose with regard to the top line data for LOTIS-5 this quarter. Will we get some thoughts on how survival is trending? I know the trial's primary endpoint is PFS and you're well powered there. But wondering if you'll be able to provide color on OS trends. And then if you know at this point, how many OS events or how mature the OS data might be at the time of the PFS top line look? Thanks.
謝謝。接著,Ameet,關於你們本季能就LOTIS-5頂線數據揭露的資訊。我們會聽到一些對存活(survival)趨勢的看法嗎?我知道試驗的主要終點是PFS,而且你們在那方面的統計力很充足。但我想了解你們是否能提供OS趨勢的補充說明。另外,如果你目前知道的話,在PFS頂線讀出時,OS事件大概有多少,或OS數據成熟度可能到什麼程度?謝謝。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
So in addition to TFS, which obviously will be mature, we will give the gaps that we have on overall survival. So whether it's mature or it's a trend, we will provide the information that we have on overall survival as well as the other key secondary endpoints as well in response rate, duration of response. So we plan to share all the information we have.
因此,除了TFS(顯然會是成熟的)之外,我們也會提供我們掌握的整體存活(overall survival)資訊。所以不論它是成熟數據或只是趨勢,我們都會就整體存活以及其他關鍵次要終點(包括反應率、反應持續時間)提供我們所掌握的資訊。因此我們計畫分享我們擁有的所有資訊。
I can't comment right now on how many events we have with regards to (inaudible) survival. But what I can tell you is it will be -- with whatever restoration we have, we will make a part of the disclosure.
我目前無法評論關於(聽不清)存活的事件數有多少。但我可以告訴你的是——無論我們有什麼樣的(聽不清),我們都會把它納入揭露內容的一部分。
Eric Schmidt - Analyst
Eric Schmidt - Analyst
And then maybe just one modeling it for Pepe. The change that we saw from personnel from R&D into cost of goods. Is that an ongoing transition? Are we expecting COGS to be inflated in subsequent quarters as well?
然後也許再問一個建模問題給Pepe。我們看到人員成本從研發轉到銷貨成本(COGS)。這是一個持續性的轉移嗎?我們是否預期後續季度的COGS也會同樣被墊高?
Jose Carmona - Chief Financial Officer
Jose Carmona - Chief Financial Officer
It is going to continue throughout all quarters from now on. So it's a reallocation of those expenses into cost of goods, and we capitalize on time inventory, but the cost of goods are going to increase because of this fixed cost and now it's getting allocated.
這將會從現在起在所有季度持續下去。因此這是把那些費用重新分配到銷貨成本中;我們會在庫存期間將其資本化,但由於這些固定成本現在被分攤,銷貨成本將會因此上升。
Operator
Operator
(Operator Instructions). Sudan Loganathan, Stephens.
(接線員指示)。Sudan Loganathan,Stephens。
Sudan Loganathan - Equity Analyst
Sudan Loganathan - Equity Analyst
Good morning. Thanks for taking my question. My first one, I wanted to ask what -- what you believe the immediate impacts post the LOTIS-5 top line results in the second quarter could be -- for instance, if it is positive, good PFS readout, how this may change of ZYNLONTA is prescribed reviewed in the second half of this year, even prior to complete listing? And then secondly, I just wanted to ask, even push over to the IITs, how does that add some incremental value over the next year or two?
早安。謝謝讓我提問。第一個問題,我想問你們認為在第二季LOTIS-5頂線結果公布後,可能會有哪些立即影響——例如,如果結果是正面的、PFS讀出良好,這可能會如何改變今年下半年ZYNLONTA的處方/使用情況,即使在完整收錄(listing)之前?第二個問題,我也想問,延伸到IIT(研究者發起試驗),它在未來一到兩年如何帶來一些增量價值?
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
So once we get to the top line readout assuming it's positive, we then would work to kind of go down too fast. One is to prepare the sBLA submission that typically four to five months, we expect to have that certainly before the end of this year. And then that could lead to our approval thereafter next year.
因此,一旦我們拿到頂線讀出,假設是正面的,我們接下來會著手推進兩件事。第一是準備sBLA遞交,通常需要四到五個月,我們預期肯定能在今年年底前完成。之後可能在明年帶來核准。
And then in addition, we plan to submit to a medical congress and publication by the end of this year. To share the full details as a result, that would be the basis that we would submit to Compendia. So we expect that we could get companion inclusion sometime in the first part of next year and then an approval sometime thereafter in 2027. So we don't expect any revenue impact this year. We expect this year to be largely in line with what the previous years are and only see revenue trajectory increase next year as we'll only start promoting the product once we have a formal approval sometime around the middle of next year.
此外,我們也計畫在今年年底前向醫學年會投稿並進行論文發表,分享完整細節;這將成為我們提交至Compendia的基礎。因此我們預期可在明年上半年某個時間點取得Compendia收錄,之後在2027年某個時間點取得核准。因此我們不預期今年會有任何營收影響。我們預期今年大致會與前幾年一致,只有到明年才會看到營收軌跡上升,因為我們只會在大約明年年中某個時間點取得正式核准後才開始推廣該產品。
And your second question was around the IIT, correct?
你的第二個問題是關於IIT,對嗎?
Sudan Loganathan - Equity Analyst
Sudan Loganathan - Equity Analyst
Yes. Yes.
是的。是。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
Okay. So with the IITs, we have both marginal and (inaudible). Both of those -- let's call it the data on the full study will be disclosed sometime between the end of this year and the middle of next year. We expect publications to happen around that same time and then to be submitted for company inclusion after that. In addition, we're evaluating the regulatory approach for (inaudible), but we would take it in a smash we move toward in parallel.
好的。關於IIT,我們同時有marginal以及(聽不清)。這兩項——就整體研究的數據而言——將會在今年年底到明年年中之間某個時間點揭露。我們預期論文發表也會在差不多的時間進行,之後再提交以爭取Compendia收錄。此外,我們也正在評估(聽不清)的法規路徑,但我們會以並行方式推進,朝著同時進展的方向前進。
Operator
Operator
There are no further questions at this time. I will now turn the call over to Ameet Mallik for closing remarks.
目前沒有其他問題。我現在把電話交回給Ameet Mallik做結語。
Ameet Mallik - Chief Executive Officer, Director
Ameet Mallik - Chief Executive Officer, Director
Thank you all for joining the call today and for your continued support. We look forward to keeping you updated on our progress and look forward to speaking to you. Operator, you may now end the call. Thank you.
感謝各位今天參加電話會議並持續支持。我們期待持續向各位更新我們的進展,也期待再與各位交流。接線員,您現在可以結束會議。謝謝。
Operator
Operator
Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
各位女士、先生,今天的電話會議到此結束。感謝各位參與,並請各位掛斷電話線路。