ADC Therapeutics SA (ADCT) 2025 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q4 2025 earnings conference Call. (Operator Instructions)

各位女士、先生，早安，歡迎參加 ADC Therapeutics 2025 年第四季財報電話會議。(接線員指示)

I will now turn the call over to Nicole Riley, Head of Investor Relations and Corporate Communications for ADC Therapeutics. Nicole, please go ahead.

現在我將把電話交給 ADC Therapeutics 投資人關係與企業傳播主管 Nicole Riley。Nicole，請開始。

Thank you, operator. Today, we issued a press release announcing our fourth-quarter and full-year 2025 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 fourth-quarter and full-year 2025 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 2025 年第四季與全年財務結果及業務最新進展。該新聞稿以及我們在今日簡報中將使用的投影片，可於 ADC Therapeutics 官網「投資人」專區取得。今天與會者包括我們的執行長 Ameet Mallik，他將說明營運表現與近期業務重點；接著由我們的財務長 Pepe Carmona 回顧 2025 年第四季與全年財務結果。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構成《1995 年美國私人證券訴訟改革法》安全港條款所定義的前瞻性陳述。這些前瞻性陳述受若干已知與未知的風險與不確定性影響；實際結果、表現與成就可能存在重大差異。相關風險已在隨附的投影片簡報以及公司向美國證券交易委員會（SEC）提交的文件中加以識別與說明，包括 10-K、10-Q 與 8-K 表格。ADC Therapeutics 僅就今日日期提供本資訊，除法律要求外，對於因新資訊、未來事件或情況而需更新本次電話會議所含任何前瞻性陳述，公司不承擔任何義務。公司提醒投資人勿過度依賴這些前瞻性陳述。

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 fourth-quarter, full-year 2025 earnings release for information and reconciliations of historical non-GAAP measures to the comparable GAAP financial measures.

今日簡報亦包含非 GAAP 財務報告。這些非 GAAP 指標應與依 GAAP 編製的資訊一併考量，不應單獨使用，亦不應作為其替代。請參閱公司 2025 年第四季與全年財報新聞稿，以取得歷史非 GAAP 指標與可比 GAAP 財務指標之資訊與調節表。

I will now turn the call over to our CEO, Ameet Mallik. Ameet.

現在我將把電話交給我們的執行長 Ameet Mallik。Ameet。

Thanks, Nicole, and hello, everyone. Thank you for joining us on today's call. We are pleased to share an update on our achievements in 2025 and our excitement for the future. Before I get into the details, I'd like to take a moment to reflect on the progress we've made over the past few years and why we believe this positions us strongly for the future. We have implemented a strategic plan to focus on ZYNLONTA with optimized life cycle management.

謝謝你，Nicole，各位大家好。感謝各位參加今天的電話會議。我們很高興向各位更新我們在 2025 年的成果，以及我們對未來的期待。在進入細節之前，我想先花一點時間回顧過去幾年我們取得的進展，以及為何我們相信這使我們在未來具備強勁的定位。我們已實施一項策略計畫，聚焦於 ZYNLONTA，並以最佳化的產品生命週期管理推進。

This includes advancing LOTIS-5 as well as initiating the bispecific combination study, LOTIS-7 and IITs in indolent lymphomas. By focusing the company, we reduced our operating cost structure by approximately 50%. At the same time, we refined our go-to-market model, which resulted in strengthened KOL advocacy, and a sustained market position in the third-line plus DLBCL setting despite the entry of the bispecific class. Central to these achievements, we upgraded leadership and talent across the organization which resulted in improved execution.

這包括推進 LOTIS-5，以及啟動雙特異性組合研究 LOTIS-7，並在惰性淋巴瘤領域開展研究者發起試驗（IIT）。透過聚焦公司，我們將營運成本結構降低約 50%。同時，我們也精進上市推廣（go-to-market）模式，強化關鍵意見領袖（KOL）的支持，並在第三線以上 DLBCL 治療情境中，即使雙特異性類別進入市場，仍維持穩固的市場地位。在這些成果的核心，我們在全組織升級了領導力與人才，進而提升執行力。

Lastly, we strengthened our balance sheet through equity and BD and improved our strategic flexibility with an amended HCR agreement. Having set the strategic course for our company, we see three horizons for potential value creation. These are centered around final data disclosures, approval and compendia inclusion and ultimately delivering growth.

最後，我們透過股權融資與商務開發（BD）強化資產負債表，並藉由修訂後的 HCR 協議提升策略彈性。在為公司設定策略方向後，我們看到三個可能創造價值的發展階段。其重點分別在於最終數據揭露、取得核准與納入藥典（compendia），並最終實現成長。

As we advance across these horizons, our vision is to first establish ZYNLONTA as a backbone therapy with a differentiated clinical profile across combinations in second-line plus DLBCL. Second, provide significant patient benefit in indolent lymphoma, including follicular lymphoma and marginal zone lymphoma. And third, achieve potential annual US peak revenue opportunity of $600 million to $1 billion, assuming compendia inclusion and regulatory approval with a highly leveraged cost structure providing us with broader opportunities to invest in complementary hematology assets. 2025 was a year of substantial progress for our company.

隨著我們在這些階段持續推進，我們的願景是：第一，在第二線以上 DLBCL 的各種聯合治療中，先將 ZYNLONTA 建立為具差異化臨床特徵的基石療法。第二，為惰性淋巴瘤（包括濾泡性淋巴瘤與邊緣區淋巴瘤）帶來顯著的病人效益。第三，在假設納入藥典並取得法規核准的前提下，達成美國年峰值營收約 6 億至 10 億美元的潛在機會；同時以高度槓桿化的成本結構，為我們提供更廣泛的機會投資於互補性的血液腫瘤資產。2025 年是公司取得重大進展的一年。

We further derisked our portfolio with multiple exciting milestones achieved for key ZYNLONTA trials in both second-line plus DLBCL and through the indolent lymphoma IITs. We undertook a strategic reprioritization to focus resources on ZYNLONTA expansion opportunities, positioning the company for long-term growth with significantly reduced operating expenses, and we significantly strengthened our balance sheet, providing us with the ability to deliver against our objectives. Among our accomplishments 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.

我們在第二線以上 DLBCL 的多項關鍵 ZYNLONTA 試驗，以及惰性淋巴瘤 IIT 中達成多個令人振奮的里程碑，進一步降低了產品組合風險。我們進行策略性重新排序，將資源聚焦於 ZYNLONTA 的適應症擴展機會；在大幅降低營運費用的同時，為公司長期成長奠定定位，並顯著強化資產負債表，使我們具備達成目標的能力。在商業面成果方面，我們持續聚焦於執行並落實商業策略，維持 ZYNLONTA 作為第三線以上 DLBCL 病人的差異化治療選擇。

Building off an unusually low Q3. Performance was strong in Q4 with net product revenues of $22.3 million, primarily driven by variability in customer ordering patterns, as well as activation of some new accounts. Sales for the year were $73.6 million and remained roughly stable in line with our expectations in the third-line plus setting. Looking toward the second-line plus setting, where we believe the real growth opportunity lies, with LOTIS-5, we expect to share top-line data in the second quarter of 2026, potentially bringing us another step closer to providing this combination treatment to significantly more patients. With LOTIS-7, we expanded target enrollment to approximately 100 patients at the selected dose level and shared updated safety and efficacy data on 49 efficacy evaluable patients in December, which we believe continues to support the potential for this regimen to be a best-in-class combination in a highly competitive market.

在第三季異常偏低的基期之上。第四季表現強勁，產品淨營收為 2,230 萬美元，主要受客戶下單模式的波動所驅動，並且也有部分新客戶帳戶啟用。全年銷售額為 7,360 萬美元，與我們對第三線以上治療情境的預期一致，整體大致維持穩定。展望第二線以上治療情境（我們認為真正的成長機會所在），就 LOTIS-5 而言，我們預期將於 2026 年第二季分享主要（top-line）數據，這可能使我們更接近將此聯合治療提供給更多病人。就 LOTIS-7 而言，我們在所選劑量水準將目標入組人數擴大至約 100 名病人，並於 12 月分享了 49 名具療效可評估病人的更新安全性與療效數據；我們認為這些結果持續支持該方案在高度競爭市場中成為同類最佳（best-in-class）聯合治療的潛力。

Indolent lymphoma's promising Phase 2 data was also shared in 2025 from the multicenter investigator-initiated trials of 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 with presentations at the International Conference on malignant lymphoma and the international workshop on non-Hodgkin lymphoma. We anticipate publication of data across these IITs between the end of 2026 and mid-2027.

惰性淋巴瘤方面的具前景第二期數據亦於 2025 年分享，來自多中心研究者發起試驗（IIT）：包括 ZYNLONTA 與利妥昔單抗（rituximab）聯合用於治療復發或難治性濾泡性淋巴瘤，以及 ZYNLONTA 單藥用於治療復發或難治性邊緣區淋巴瘤；並於國際惡性淋巴瘤會議（International Conference on Malignant Lymphoma）及非霍奇金淋巴瘤國際研討會（International Workshop on Non-Hodgkin Lymphoma）進行發表。我們預期將於 2026 年底至 2027 年年中之間，陸續發表這些 IIT 的數據。

Most recently, we were pleased to have entered into an amendment to our royalty purchase agreement with HealthCare Royalty. This update to the terms of our agreement is a reflection of ACR's conviction and the long-term value of ZYNLONTA, and we believe these new terms give us greater strategic flexibility. Finally, from a corporate perspective, through strict capital management in 2025, including a strategic reprioritization and multiple financings, we ended the year with a cash balance of $261 million with an expected cash runway at least into 2028.

最近，我們很高興已與 HealthCare Royalty 就我們的權利金購買協議簽訂修訂案。本次對協議條款的更新，反映了 ACR 的信念以及 ZYNLONTA 的長期價值；我們相信這些新條款讓我們擁有更大的策略彈性。最後，從公司層面來看，透過 2025 年嚴格的資本管理（包括策略性重新排序以及多次融資），我們在年底的現金餘額為 2.61 億美元，預期現金可支撐營運至少至 2028 年。

With this significant progress, we are confident in our path ahead as we work to make an impact for more patients moving forward. As a single-agent therapy and third-line plus DLBCL, ZYNLONTA has a profile of rapid, deep and durable efficacy as well as manageable safety with simple and convenient administration. Beyond our current indication, we believe in the potential 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 has been consistently encouraging with the potential to be highly differentiated. We continue to believe that through expansion into these settings, ZYNLONTA has the potential to reach peak annual revenues of $600 million to $1 billion in the US.

在取得這些重大進展後，我們對未來的道路充滿信心，並將持續努力為更多患者帶來影響。作為單藥治療且用於三線及以上 DLBCL，ZYNLONTA 具備快速、深度且持久的療效特徵，同時安全性可控，且給藥方式簡單便利。除目前適應症外，我們相信透過將使用擴展至 DLBCL 的更早治療線別以及惰性淋巴瘤，可觸及顯著更多患者。迄今我們在這些情境中看到的數據一貫令人鼓舞，且有望具備高度差異化。我們仍然相信，透過擴展至這些情境，ZYNLONTA 在美國的年度峰值營收有潛力達到 6 億至 10 億美元。

Our current indication, as I noted earlier, has shown relative stability in net revenues over multiple quarters demonstrating ZYNLONTA has a clear place in the market as a monotherapy. We believe LOTIS-5 has the potential to lift peak annual revenue for ZYNLONTA to $200 million to $300 million as we expand into the second-line setting. Not only would this double the addressable patient population, but with an improved clinical profile versus our current indication of the monotherapy, we expect to gain share in the second line offsetting and improved duration of therapy. With LOTIS-7, we estimate we can expand the total opportunity for ZYNLONTA in DLBCL to $500 million to $800 million in peak annual revenue with both regulatory approval and compendia listing. If the data continues to be compelling, we believe ZYNLONTA plus glofitamab has the potential to transform the future of lymphoma treatment paradigm by becoming the preferred bispecific combination in the second-line plus DLBCL setting.

如我先前所提，我們目前的適應症在多個季度的淨營收表現相對穩定，顯示 ZYNLONTA 作為單藥治療在市場上具有明確定位。我們相信，隨著我們擴展至二線治療情境，LOTIS-5 有潛力將 ZYNLONTA 的年度峰值營收提升至 2 億至 3 億美元。這不僅會使可觸及的患者族群倍增，而且相較於目前單藥適應症的臨床特徵有所改善，我們預期可在二線取得市占，以抵銷並改善治療持續時間。透過 LOTIS-7，我們估計在取得法規核准與收載於藥典（compendia）後，可將 ZYNLONTA 在 DLBCL 的整體機會擴大至年度峰值營收 5 億至 8 億美元。若數據持續具說服力，我們相信 ZYNLONTA 加上 glofitamab 有潛力透過成為二線及以上 DLBCL 情境中首選的雙特異性組合，改變淋巴瘤治療典範的未來。

On top of this, we see additional potential for ZYNLONTA in relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. If the encouraging initial data in the Phase 2 IITs are maintained in larger patient numbers, we believe these indolent lymphomas could provide additional peak annual revenue for ZYNLONTA of $100 million to $200 million with both regulatory approval and compendia listing, primarily driven by MZL. Let's drill down a little more into the specifics of the DLBCL treatment landscape to explain why we believe ZYNLONTA has the opportunity to play a significant role. In both the second and third-line plus setting, there are two main segments. The first segment includes complex therapies, which require unique infrastructure and expertise to handle logistical requirements and patient management.

此外，我們也看到 ZYNLONTA 在復發或難治性邊緣區淋巴瘤（MZL）以及復發或難治性濾泡性淋巴瘤方面的額外潛力。若第二期研究者發起試驗（IITs）的初步鼓舞數據能在更大患者數中維持，我們相信在取得法規核准與收載於藥典（compendia）後，這些惰性淋巴瘤可為 ZYNLONTA 帶來額外的年度峰值營收 1 億至 2 億美元，主要由 MZL 驅動。接下來我們更深入說明 DLBCL 的治療版圖細節，以解釋為何我們認為 ZYNLONTA 有機會扮演重要角色。在二線以及三線及以上情境中，主要可分為兩個區隔。第一個區隔包含複雜療法，這些療法需要獨特的基礎設施與專業能力，以處理物流需求與患者管理。

These are primarily confined to the academic centers and more sophisticated community centers and include therapies like CAR-T, transplant and biospecifics. The second segment comprises more broadly accessible therapies which all physicians can administer in the outpatient setting and include ADCs, monoclonal antibodies and chemotherapy. The launch of bispecifics is monotherapy in the third-line plus study has resulted in an evolution of the treatment landscape, where we estimate there is currently a 60-40 split between complex and broadly accessible segments. In the second-line setting where bispecifics have not yet been approved or added last year to NCCN guidelines for use in combination, we expect that they will continue to gain share and grow the use of complex therapies. Through LOTIS-5 and 7, we believe ZYNLONTA combinations have the potential to raise the borrowing efficacy in second-line plus DLBCL in their respective treatment segments, establishing ZYNLONTA as a backbone therapy with a differentiated clinical profile across combinations and offering complementary approaches to addressing unmet needs.

這些療法主要侷限於學術中心與較先進的社區中心，包括 CAR-T、移植以及雙特異性抗體等療法。第二個區隔由更廣泛可及的療法構成，所有醫師都可在門診環境施作，包括 ADC、單株抗體與化學治療。雙特異性抗體以單藥形式在三線及以上研究中的上市，促使治療版圖演進；我們估計目前複雜療法與廣泛可及療法之間約為 60/40 的分布。在二線情境中，由於雙特異性抗體尚未獲核准，或尚未於去年被納入 NCCN 指引以供合併使用，我們預期其仍將持續提升市占並擴大複雜療法的使用。透過 LOTIS-5 與 LOTIS-7，我們相信 ZYNLONTA 的合併療法有潛力在各自的治療區隔中提升二線及以上 DLBCL 的療效門檻，將 ZYNLONTA 建立為具差異化臨床特徵的骨幹療法，並透過不同組合提供互補方式以滿足未被滿足的需求。

In LOTIS-5, our Phase 3 confirmatory study, we are combining ZYNLONTA with the most widely used agent rituximab in patients with second-line plus DLBCL. As a reminder, initial data from the safety lead-in portion showed an overall response rate of 80% and a complete response rate of 50% with no new safety signals demonstrating that this combination has the potential to provide competitive second-line plus efficacy with a favorable safety profile, allowing broad accessibility.

在我們的第三期確認性研究 LOTIS-5 中，我們將 ZYNLONTA 與二線及以上 DLBCL 患者中使用最廣泛的藥物利妥昔單抗（rituximab）合併。提醒一下，安全性導入部分的初步數據顯示總反應率為 80%，完全反應率為 50%，且未出現新的安全性訊號，顯示此組合有潛力在具良好安全性特徵的前提下，提供具競爭力的二線及以上療效，並可廣泛可及。

In LOTIS-7, our Phase Ib trial, we are combining ZYNLONTA with a highly effective bispecific, glofitamab in second-line plus patients. In December, we reported updated data from the trial, which demonstrated a 90% best overall response rate and a 78% complete response rate across 49 efficacy evaluable patients with a minimum of 6-month follow-up. Not only did this support a clinically meaningful benefit for patients, but the data also showed the combination continues to generally be well tolerated with a manageable safety profile.

在我們的 Ib 期試驗 LOTIS-7 中，我們將 ZYNLONTA 與一種高效的雙特異性抗體 glofitamab 合併，用於二線及以上患者。在 12 月，我們公布了該試驗的更新數據：在 49 名可評估療效且至少追蹤 6 個月的患者中，最佳總反應率為 90%，完全反應率為 78%。這不僅支持對患者具有臨床上有意義的效益，數據亦顯示該組合整體而言仍具良好耐受性，且安全性特徵可控。

Taken together, we are encouraged by the expanding data set, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be a best-in-class combination in a highly competitive market. When you look at the CR rates across these two treatment segments, we believe the emerging clinical profile of ZYNLONTA plus glofitamab in LOTIS-7 positions us well among complex therapies. And at the same time, the clinical profile of ZYNLONTA plus rituximab in LOTIS-5 has the potential to differentiate us among broad-based sensible therapies. Together, we believe these combinations have the potential to double the addressable patient population as we move into second-line and increase the duration of therapy moving, on average, from three cycles to five to six cycles. We have established a place for ZYNLONTA monotherapy today in later lines because it works quickly.

綜合而言，我們對不斷擴增的數據集感到鼓舞；我們相信這些數據顯示 ZYNLONTA 加上 glofitamab 有潛力在高度競爭的市場中成為同類最佳（best-in-class）的組合。當你觀察這兩個治療區隔的完全反應（CR）率時，我們相信 LOTIS-7 中 ZYNLONTA 加上 glofitamab 所呈現的新興臨床特徵，使我們在複雜療法中具備良好定位。同時，LOTIS-5 中 ZYNLONTA 加上利妥昔單抗（rituximab）的臨床特徵，也有潛力使我們在廣泛可及的療法中脫穎而出。我們相信，這些組合合計有潛力在我們進入二線後，使可觸及的患者族群倍增，並將治療持續時間平均由三個療程提高至五到六個療程。我們已在較後線別中為 ZYNLONTA 單藥治療建立了定位，因為它起效迅速。

CRs, when achieved, are durable, and it has manageable safety and a convenient dosing schedule. As compared to our current indication as a monotherapy, we believe an improved CR rate in a broader patient population with LOTIS-5 will makes ZYNLONTA more relevant among both academic and community treaters, especially for patients who cannot access, are not suitable for or progress on a CAR-T or bispecific based therapy. When you take into account the fact that there are approximately 12,000 patients in the second line, in addition to the approximately 6,000 in our currently addressable third-line plus patient population and the average number of cycles in ZYNLONTA will increase from approximately 3 to 5. We believe that once in the second-line setting, we will be positioned to reach more patients with additional cycles and we'll capture share accordingly. In the second line setting, every 10 points of share translates to approximately $200 million in revenue and every 10 points of share in the third-line plus setting to approximately $100 million based on the expected longer duration of therapy for this combination.

一旦達成完全反應（CR），其持久性良好，且安全性可控並具便利的給藥時程。相較於我們目前的單藥適應症，我們相信 LOTIS-5 在更廣泛患者族群中帶來更高的 CR 率，將使 ZYNLONTA 在學術與社區治療者之間更具相關性，特別是對於無法取得、不適合，或在 CAR-T 或雙特異性療法上出現疾病進展的患者。若將二線約 12,000 名患者、加上我們目前可觸及的三線及以上約 6,000 名患者族群，以及 ZYNLONTA 的平均療程數將由約 3 個增加至 5 個一併考量。我們相信，一旦進入二線情境，我們將能以更多療程觸及更多患者，並相應取得市占。在二線情境中，每增加 10 個百分點的市占約可轉化為 2 億美元營收；而在三線及以上情境中，每增加 10 個百分點的市占約可轉化為 1 億美元營收，係基於此組合預期更長的治療持續時間。

We have already achieved an approximately 10% share in the third-line plus setting as a monotherapy with a CR rate lower than that of competitive combination-based therapies. Therefore, if we maintain a 10% share we have today in the third-line plus setting, achieving only 5% to 10% share in the second-line setting, would translate to roughly $200 million to $300 million in peak sales opportunity for the ZYNLONTA plus rituximab combination alone. Taken together with the DLBCL bispecific combination and indolent lymphoma opportunities, we believe we could deliver on our vision of a combined potential peak annual revenue of $600 million to $1 billion in the US assuming compendia listings and regulatory approvals.

我們在第三線以上治療情境中，作為單藥治療已經取得約10%的市占率，且其CR率低於具競爭力的聯合療法。因此，若我們在第三線以上治療情境維持目前10%的市占率，並在第二線治療情境僅取得5%至10%的市占率，則僅就ZYNLONTA加上利妥昔單抗（rituximab）之組合而言，峰值銷售機會約可達2億至3億美元。綜合DLBCL雙特異性抗體組合以及惰性淋巴瘤的機會，我們相信在假設獲得指南/彙編（compendia）收錄與監管核准的情況下，我們可實現我們的願景：在美國達成合計潛在峰值年營收6億至10億美元。

Now, I will turn the call over to Pepe Carmona, our CFO, who will discuss financial results for the fourth quarter. Pepe.

現在，我將把電話會議交給我們的財務長Pepe Carmona，他將說明第四季的財務結果。Pepe。

Thank you, Ameet. On the financial front, ZYNLONTA net product revenues in the fourth quarter of 2025 were $22.3 million as compared to $16.4 million in the same quarter in 2024. On a full-year basis, net product revenues were $73.6 million versus $69.3 million in 2024 with an underlying volume broadly flat. Total operating expenses were $41 million and $202.9 million for the fourth quarter and full year ended December 31, 2025, respectively. On a non-GAAP basis, total adjusted operating expenses were $39.4 million and $181.3 million for the quarter and full year ended December 31, 2025, respectively.

謝謝你，Ameet。在財務方面，ZYNLONTA於2025年第四季的產品淨營收為2,230萬美元，相較於2024年同季的1,640萬美元。以全年計，產品淨營收為7,360萬美元，對比2024年的6,930萬美元，而基礎銷量大致持平。截至2025年12月31日止，第四季與全年總營業費用分別為4,100萬美元與2億零290萬美元。以非GAAP口徑計，截至2025年12月31日止，第四季與全年調整後總營業費用分別為3,940萬美元與1億8,130萬美元。

Total adjusted operating expenses were down over prior year by 15% and 6%, respectively. The reduction in total adjusted operating expenses for the fourth quarter was primarily driven by lower R&D expenses. The decrease in total adjusted operating expenses for the full year was across all major lines of the income statement. We continue to be disciplined in our market allocation towards potential value creation while driving efficiencies across the portfolio. On a GAAP basis, we reported a net loss of $6.4 million for the fourth quarter of 2025 or $0.04 per basic and diluted share as compared to a net loss of $30.7 million or $0.29 per basic and diluted share for the same period in 2024.

調整後總營業費用相較前一年分別下降15%與6%。第四季調整後總營業費用的下降主要由較低的研發費用所帶動。全年調整後總營業費用的下降則遍及損益表的所有主要項目。我們持續在市場資源配置上保持紀律，聚焦於潛在價值創造，同時推動整體產品組合的效率提升。以GAAP口徑計，我們2025年第四季淨損為640萬美元，或每股基本及稀釋淨損0.04美元；相較之下，2024年同期間淨損為3,070萬美元，或每股基本及稀釋淨損0.29美元。

Net loss for the full year ended December 31, 2025 was $142.6 million or a net loss of $1.12 per basic and diluted share as compared to a net loss of $157.8 million or a net loss of $1.62 per basic and diluted share for the full year ended December 31, 2024. The lower net loss over both periods was primarily due to a higher cumulative catch-up adjustment gain associated with our deferred royalty obligation and reduced R&D expenses partially offset by a restructuring impairment and related costs incurred in connection with the strategic realization and restructuring plan. You can find the reconciliation of GAAP to non-GAAP measures for the fourth quarter and year-to-date in the compounding financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of the quarter, we had cash and cash equivalents of $261.3 million compared to $250.9 million as of December 31, 2024. We significantly strengthened our balance sheet in 2025 by entering into a $100 million PIPE financing in June 2025 and a $60 million PIPE financing in October 2025, providing an expected cash runway at least into 2028.

截至2025年12月31日止全年淨損為1億4,260萬美元，或每股基本及稀釋淨損1.12美元；相較之下，截至2024年12月31日止全年淨損為1億5,780萬美元，或每股基本及稀釋淨損1.62美元。兩個期間淨損下降主要由與我們遞延權利金義務相關的累計追溯調整收益（cumulative catch-up adjustment gain）增加，以及研發費用降低所致；但部分被與策略執行與重組計畫相關的重組減損及相關成本所抵銷。您可在今日稍早發布之新聞稿的彙總財務表，以及本簡報附錄中，找到第四季與年初至今GAAP與非GAAP衡量指標的調節表。截至本季末，我們持有的現金及約當現金為2億6,130萬美元，較2024年12月31日的2億5,090萬美元增加。我們於2025年顯著強化資產負債表：在2025年6月完成1億美元PIPE融資，並於2025年10月完成6,000萬美元PIPE融資，使預期現金跑道至少可延伸至2028年。

We expect to have multiple data catalysts in 2026 across the ZYNLONTA program. For LOTIS-5, we expect to provide top-line data in the second quarter of 2026. We expect to publish full results by the year-end. Assuming the results are positive, we will file a supplemental biologic license application submission to the FDA with potential publication and compendia inclusion in the first half of 2027 and confirmatory approval to follow in mid-2027. With LOTIS-7, we plan to share the next update with full data at a medical meeting and through publication by the end of 2026.

我們預期在2026年，ZYNLONTA計畫將出現多項數據催化劑。就LOTIS-5而言，我們預期於2026年第二季提供主要（top-line）數據。我們預期在年底前發表完整結果。若結果為正向，我們將向FDA提交補充生物製劑許可申請（sBLA），並有望於2027年上半年發表並納入指南/彙編（compendia），隨後於2027年年中取得確認性核准。就LOTIS-7而言，我們計畫在2026年底前於醫學會議分享下一次更新的完整數據，並透過論文發表。

In addition, assuming positive results, we plan to pursue competing inclusion as well as assess a regulatory strategy. Within indolent lymphomas, we expect additional data to be shared at medical conferences by the lead investigators between the end of 2026 and mid-2027 and we plan to assess regulatory and competitive strategies while sufficient data are available. I will now turn the call back over to Ameet.

此外，若結果為正向，我們計畫推動指南/彙編（compendia）收錄，並評估監管策略。在惰性淋巴瘤方面，我們預期由主要研究者於2026年底至2027年年中期間，在醫學會議上分享更多數據；在具備足夠數據的情況下，我們也計畫評估監管與競爭策略。我現在把電話會議交回給Ameet。

Thank you, Pepe. To close, we achieved meaningful progress across our ZYNLONTA clinical program in DLBCL and through investigator-initiated trials in indolent lymphomas this past year. And we believe we have laid the foundation for multiple anticipated value-created catalysts ahead, as Pepe just highlighted. With our strengthened cash runway, we are confident we will drive significant potential long-term growth beginning in 2027. We can now open the line for questions. Operator.

謝謝你，Pepe。總結來說，過去一年我們在DLBCL的ZYNLONTA臨床計畫，以及在惰性淋巴瘤的研究者發起試驗方面，都取得了具意義的進展。而且我們相信，正如Pepe剛才所強調的，我們已為未來多項預期的價值創造催化劑奠定基礎。在我們強化的現金跑道支持下，我們有信心自2027年起推動顯著的潛在長期成長。現在我們可以開放提問。接線員。

(Operator Instructions) Maury Raycroft, Jefferies.

（接線員指示）Jefferies的Maury Raycroft。

Congrats on the priors. I'm going to ask one on LOTIS-5. At a high level, how are PFS events tracking relative to the 262 events required to trigger the top-line analysis? Is there any chance the readout could get bumped into third quarter? And then wondering if you can clarify what will be included in the top line and whether CR durability could be included in that update, or is that more likely to be reserved for a later medical conference?

恭喜先前的成果。我想問一個關於LOTIS-5的問題。整體而言，PFS事件的累積進度相對於觸發主要分析所需的262個事件，目前追蹤情況如何？是否有任何可能使讀出時間延後到第三季？另外也想請你釐清，主要（top-line）更新會包含哪些內容；CR的持久性是否可能納入該次更新，或更可能保留到之後的醫學會議再公布？

Yes. Thanks so much for the question. So we are confident in the Q2 timing of the top line readout. So we expect to be able to hit the events in time, and we will be able to share top-line data in Q2. We're very confident in that.

是的。非常感謝你的提問。我們對於第二季主要數據讀出的時程很有信心。我們預期能及時達到所需事件數，並能在第二季分享主要數據。我們對此非常有信心。

In terms of what we expect to share, we're going to share the primary endpoint, which is PFS for the trial. That's what the study is powered to show. In addition, we're going to share all the secondary endpoints that are mature as of the time of the top-line data as well as key safety tables. So we want to make sure that we're as transparent as possible with the market without compromising obviously, publication that we expect to happen by the end of the year.

就我們預期分享的內容而言，我們將分享主要終點，也就是該試驗的PFS。這也是本研究設計用來證明的重點。此外，我們也會分享截至主要數據時點已成熟的所有次要終點，以及關鍵安全性表格。因此，我們希望在不影響我們預期於年底發表的論文之前提下，盡可能對市場保持透明。

Michael Schmidt, Guggenheim.

Michael Schmidt，Guggenheim。

Another one on LOTIS-5. And so just thinking about your market projections in second-line DLBCL. I think you spoke about an incremental $200 million to $300 million opportunity, assuming maintaining sort of a 10% share in that setting. And I was just wondering if that is perhaps too conservative. I'm just curious how you think about the market, especially now that we've seen Monjuvi perhaps moving into first-line, we see some of the bispecific antibody data reading out, perhaps below expectations. And so I'm just curious if there's upside perhaps to your LOTIS-5 opportunity assessment? And then I had a follow-up question.

再一個關於 LOTIS-5 的問題。我在想你們對二線 DLBCL 市場的預測。我記得你提到在該治療線別、假設維持約 10% 市占率的情況下，增量機會約為 2 億至 3 億美元。我想問這是否可能過於保守。我很好奇你們如何看待市場，尤其是現在我們看到 Monjuvi 可能進入一線，同時也看到一些雙特異性抗體數據讀出，可能低於預期。所以我想了解，你們對 LOTIS-5 機會評估是否可能有上行空間？然後我還有一個追問。

Yes. I mean, I think based on the profile we saw in the safety run and if the final results look similar, obviously very highly confident that we can play a meaningful role in second-line plus DLBCL with this combination. To your point, we've already achieved an approximately 10% share in the third-line plus setting as a monotherapy. And I would say it has some attributes that physicians really like the fact that it works very quickly, very durable CRs, manageable safety profile, convenient dosing. One of the drawbacks right now is we have a less than competitive CR rate because we're competing against combination.

是的。我的意思是，基於我們在安全性導入期看到的特徵，如果最終結果看起來相似，我們顯然非常有信心，這個組合療法能在二線及以上 DLBCL 中扮演重要角色。如你所說，我們作為單藥在三線及以上治療中已經達到約 10% 的市占率。我會說它有一些醫師非常喜歡的特點：起效非常快、CR（完全緩解）非常持久、安全性可控、給藥便利。目前的一個缺點是，我們的 CR 率不如競品有競爭力，因為我們是在與聯合療法競爭。

So of course, now with the combination, we expect to have competitive and potentially been differentiating CR rates with a positive Phase 3 study. So we do feel confident we should be able to maintain that share in the 10% range in the third-line plus setting. And if we're able to maintain that same 10% in second- line, that would translate to $300 million. The exact, I would say, peak sales opportunity, we're going to know when we know the clinical profile because we think we can achieve this even with a competitive profile relative to other competitors. If we have a more differentiated profile, potentially we could do more.

因此，當然，現在有了聯合療法，我們預期在一項陽性的三期研究支持下，CR 率將具備競爭力，甚至可能形成差異化。所以我們確實有信心，在三線及以上治療中能維持約 10% 左右的市占率。如果我們能在二線也維持同樣的 10%，那就對應約 3 億美元。至於確切的峰值銷售機會，我會說要等我們掌握臨床特徵後才會更清楚，因為我們認為即使相對其他競爭者僅具備具競爭力的特徵，我們也能達成這點。如果我們有更具差異化的特徵，可能就能做得更多。

But we'll revisit the peak sales opportunity once we know the final clinical profile of the combination.

但我們會在知道該組合療法的最終臨床特徵後，再重新檢視峰值銷售機會。

Yes. That makes sense. And then just another question on LOTIS-5. So just curious whether you've allowed crossover in this study? Especially as it pertains to getting an early look at overall survival, whether that's something that could perhaps be achieved?

是的。這很合理。那再問一個關於 LOTIS-5 的問題。想請教這項研究是否允許交叉治療（crossover）？特別是就提早觀察整體存活期（OS）而言，是否有可能做到？

And then the other question related to that, I had is how are you thinking about potential use of bispecific antibodies post-progression perhaps impacting OS. Obviously, that could happen in either arms of the study. But I'm just curious, in general, perhaps how meaningful or how important you think OS could be as a differentiator in the setting, which obviously was not achieved by some of the other programs in second-line.

另外一個相關問題是，你們如何看待疾病進展後使用雙特異性抗體，可能對 OS 造成影響。顯然，這可能在研究的任一組別都會發生。但我想了解的是，整體而言，你們認為在這個治療情境中，OS 作為差異化指標會有多重要或多有意義；而這點顯然在其他一些二線方案中並未達成。

Yes. So we obviously don't know whether and how the subsequent therapies are between the different arms. So that's -- whether there were CAR-T bispecifics, as you said, or any other therapies, we're not obviously certain, we're completely blinded in terms of the study. Obviously, subsequent therapies can affect overall survival. I think the way we look at this is if we have a positive PFS without any detrimental effect to overall survival and overall a positive benefit risk profile, we think that we'll have a very good submission for the FDA.

是的。所以我們顯然不知道不同組別後續治療是否、以及如何有所差異。因此——不論是你提到的 CAR-T、雙特異性抗體或任何其他療法，我們當然無法確定；就研究而言我們是完全盲態的。顯然，後續治療可能影響整體存活期。我們的看法是：如果我們能在不對 OS 造成不利影響的情況下取得陽性的 PFS（無惡化存活期），且整體效益風險特徵為正向，我們認為將能向 FDA 提出非常有力的申報資料。

Eric Schmidt, Cantor.

Eric Schmidt，Cantor。

This is Alexa on for Eric. And congrats on a great year. So one question for me. So R&D spend was down about $10 million from the previous quarter. So do you expect what we're seeing in Q4 to be the current run rate going forward?

我是 Alexa，代 Eric 提問。恭喜你們今年表現很出色。我這邊有一個問題。研發（R&D）支出較前一季下降約 1,000 萬美元。你們是否預期我們在第四季看到的水準，將會是未來的目前執行速率（run rate）？

Thanks, Alexa. I appreciate the question. So Pepe I'll turn that question to you around R&D spend in Q4 and what we expect going forward.

謝謝你，Alexa。感謝這個問題。Pepe，我把這個關於第四季研發支出以及我們對未來預期的問題交給你。

Yes. Thanks for the question. So we expect that as we move to 2026 and 2027, R&D expenses should go down, assuming we maintain the current number of trials and the current pipeline that we have as the LOTIS-5 trial will continue to wind down and then LOTIS-7, we'll get to a peak, but then will go down. So R&D expenses are expected to fluctuate quarter-over-quarter, but in general, for '26 and '27 to be going down.

是的。謝謝你的問題。我們預期，隨著進入 2026 年與 2027 年，在我們維持目前試驗數量與現有研發管線的前提下，研發費用應會下降，因為 LOTIS-5 試驗將持續逐步收尾，而 LOTIS-7 會達到高峰後也會下降。因此研發費用預期會呈現逐季波動，但整體而言，2026 年與 2027 年會是下降趨勢。

Sudan Loganathan, Stephens.

Sudan Loganathan，Stephens。

The first one, given the amended health care royalty agreement, they expect the cash flow weigh into 2028. How should we think about the capital allocation priorities between commercial investment behind ZYNLONTA or advancing combination strategies and then the potential business development angle, especially considering the remaining deferred royalty and term loan obligations?

第一個問題，鑑於修訂後的醫療保健權利金協議，他們預期現金流的負擔會延續到 2028 年。我們應該如何看待資本配置的優先順序：是在 ZYNLONTA 的商業投資、推進聯合療法策略，以及潛在的業務開發方向之間如何取捨？特別是考量到剩餘的遞延權利金與定期貸款（term loan）義務。

Yes. I'll start off, and then Pepe, feel free to add. So I would say that right now, we feel pretty confident with our cash runway guidance that even with relatively stable revenues until we get to the new indications, which we expect to happen in 2027 with LOTIS-5 and as well as with the cost guidance that Pepe just mentioned, for all the activities that we have currently planned, our current LOTIS-5, our current LOTIS-7, our current IITs, all of our current ongoing activity as well as investing more prelaunch in both commercial and medical affairs activities. That's -- those are all the assumptions that we have in our current guidance. Obviously, if we were to do any additional life cycle management or new activities that would not be currently based within our cash runway guidance that we have right now.

是的。我先回答，然後 Pepe 也可以補充。我會說，目前我們對現金跑道（cash runway）指引相當有信心：即使在我們取得新適應症之前營收相對穩定——我們預期 LOTIS-5 會在 2027 年帶來新適應症——再加上 Pepe 剛提到的成本指引，對於我們目前規劃的所有活動，包括現行的 LOTIS-5、現行的 LOTIS-7、現行的 IIT（研究者發起試驗），以及所有正在進行的活動，同時也包含在商業與醫藥事務（medical affairs）方面增加更多上市前（prelaunch）投資。這些——都是我們目前指引中的假設。當然，如果我們要做任何額外的產品生命週期管理或新的活動，那就不在我們目前現金跑道指引所涵蓋的範圍內。

We think the ACR agreement provides strategic flexibility now because, obviously, by reducing the change in control payment just allows more strategic flexibility and optionality for the company going forward. And so we're really pleased by that. In exchange, of course, they continue the royalties, which given that our COGS is low to mid-single digit, when you add on the royalty agreement, the gross margin is still quite good for this product even when you add both of those things then. But Pepe is there anything else you would add to what I just said?

我們認為 ACR 協議現在提供了策略彈性，因為顯然，降低控制權變更（change in control）付款，使公司未來在策略上有更大的彈性與選擇性。因此我們對此非常滿意。作為交換，當然他們會持續收取權利金；考量到我們的銷貨成本（COGS）為低到中個位數百分比，即使再加上權利金協議，該產品的毛利率在把這兩項都納入後仍然相當不錯。不過 Pepe，你還有什麼要補充我剛才所說的嗎？

Yes. I think you gave all the details. It's -- at the end of the day, we are solely focused on driving ZYNLONTA growth, and that's by completing the LOTIS-5 and LOTIS-7 and indolent lymphoma trials. That capital has been allocated and is part of our cash runway as well as all the prelaunch activities and launch activities of ZYNLONTA in 2027 in the second-line setting. It does also cover some of those expenses related to a loan. So it's all included. We believe we have a really strong cash position right now to execute on our plan.

是的。我認為你已經提供了所有細節。歸根結底，我們唯一專注的就是推動 ZYNLONTA 的成長，而這將透過完成 LOTIS-5、LOTIS-7 以及惰性淋巴瘤試驗來達成。這筆資金已完成配置，並已納入我們的現金可支撐期（cash runway），同時也涵蓋 ZYNLONTA 在 2027 年於二線治療情境的所有上市前活動與上市活動。它也涵蓋了部分與貸款相關的費用。所以這些都已包含在內。我們相信目前我們的現金部位非常強勁，足以執行我們的計畫。

And if I could, just a second one real quick. I wanted to ask about if you can give any details on maybe your market strategy as you get some of these last final data readouts this year and looking -- going towards the regulatory -- compendia and regulatory inclusion pathway first half of next year. Could you give us any details on how your marketing strategy could change to get into the DLBCL space, the second-line space?

如果可以的話，我再快速問第二個問題。我想請教，隨著今年將有一些最後的關鍵數據讀出，並且展望明年上半年朝向法規—彙編（compendia）與法規納入（regulatory inclusion）途徑推進，你們是否能提供一些市場策略方面的細節？你們的行銷策略可能會如何調整，以進入 DLBCL 領域、二線治療領域？

I mean the good thing is we have a very good footprint. So our field force already covers about 90% of the potential of DLBCL. We have a full MSL team as well. and a strong headquarter team. So we will make some incremental increases, both on the commercial and MSL footprint as well as some additional expenses in terms of A&P and other expenses from a headquarters basis.

我的意思是，好的一點在於我們已經有非常好的佈局。因此，我們的外勤團隊已涵蓋約 90% 的 DLBCL 潛在市場。我們也有完整的 MSL 團隊，以及強大的總部團隊。因此我們會做一些增量式的擴充，包括商業端與 MSL 佈局的增加，並且在總部層面也會增加一些 A&P（廣告與促銷）及其他費用。

But I would say incremental because we think we're already pretty well covered. Obviously, when you do a prelaunch and launch activities, and we can expand into a much bigger population, the second-line population, which we think also with a better profile than we have today. Those incremental investments are going to help us to make sure that we drive education around the product use, particularly with -- when we anticipate a LOTIS-5 approval sometime in the middle of next year. We think LOTIS-5 obviously, is also key because once we get to the top line readout next year, it really actually unlocks the total value of the life cycle management plan for ZYNLONTA because that is our full approval.

但我會說是增量式的，因為我們認為目前覆蓋已相當到位。顯然，當你進行上市前與上市活動，並且我們可以擴展到更大的族群—也就是二線治療族群，而我們認為其產品特性也會比目前更好。這些增量投資將幫助我們確保推動產品使用相關的教育，特別是—當我們預期 LOTIS-5 可能在明年年中某個時間獲得核准時。我們認為 LOTIS-5 顯然也很關鍵，因為一旦我們在明年取得主要結果（top line）讀出，它實際上就能解鎖 ZYNLONTA 全部生命週期管理計畫的總價值，因為那將是我們的完全核准（full approval）。

And we think that the total opportunity that we have for ZYNLONTA, not just with LOTIS-5, but assuming we can have regulatory approvals and compendia for the other indications, it could take the total peak revenue opportunity for ZYNLONTA to $600 million to $1 billion. So we think ZYNLONTA LOTIS-5 readout to Q2 is really a key unlocking event to start driving the value of the total asset potential.

我們認為 ZYNLONTA 的整體機會，不僅是 LOTIS-5；假設我們也能在其他適應症取得法規核准並納入彙編（compendia），ZYNLONTA 的總峰值營收機會可能達到 6 億至 10 億美元。因此我們認為，ZYNLONTA 的 LOTIS-5 在第二季的讀出確實是一個關鍵的解鎖事件，可開始推動整體資產潛力的價值。

Leonid Timashev, RBC Capital Markets.

Leonid Timashev，RBC Capital Markets。

I just wanted to ask on sort of the current commercial run rate for ZYNLONTA. I guess you've had a couple of stronger quarters. I guess at what point do you think that becomes a trend where you're actually seeing genuinely more enthusiasm and use from investigators in the current labeled indication, or is there still seasonality? And maybe what does that tell you about potential future launch of ZYNLONTA as you expand the indication?

我想問一下關於 ZYNLONTA 目前的商業化運行速率（commercial run rate）。我想你們有幾個季度表現較強。你們認為在什麼時點，這會成為一個趨勢，代表你們在目前核准標示的適應症中，確實看到研究者更高的熱情與使用？還是仍然存在季節性因素？另外，這對於你們在擴大適應症後、未來推出 ZYNLONTA 的潛在上市表現有何啟示？

Yes. I mean I think we're pleased that over the last couple of years, since bispecifics have launched, we've basically been able to maintain our share within a space that's gotten a lot more competitive. So I think we feel really good about that. If you look more broadly at 2025 versus 2024, volumes are roughly stable. There's some slight increase in sales mainly driven to slight increases in net price.

是的。我的意思是，我們很高興在過去幾年中，自從雙特異性抗體（bispecifics）上市以來，我們基本上仍能在競爭更激烈的市場中維持我們的市佔。所以我們對此感覺非常好。如果更廣泛地看 2025 年相較 2024 年，銷量大致持平。銷售額略有增加，主要是由淨價格的小幅上升所帶動。

So as you know, we don't provide any annual net revenue guidance, but we still -- we expect this year, sales again to remain broadly in line with what we've seen in the recent years. And the real inflection point will start when we get the approval for LOTIS-5 next year where we think we can really significantly increase the potential sales opportunity for ZYNLONTA.

因此如你所知，我們不提供任何年度淨營收指引，但我們仍然—我們預期今年的銷售將再次大致與近年所見的水準一致。而真正的拐點將在明年取得 LOTIS-5 核准後開始，屆時我們認為可以顯著提升 ZYNLONTA 的潛在銷售機會。

Thank you. As there are no further questions at this time, we may proceed with the conference.

謝謝。由於目前沒有進一步的問題，我們可以繼續進行會議。

Well, I want to thank you all for joining our call today and for your continued support. We look forward to keeping you updated on our progress. Operator, you may now end the call.

我想感謝各位今天加入我們的電話會議，並感謝你們持續的支持。我們期待持續向各位更新我們的進展。接線員，您現在可以結束通話。

Ladies and gentlemen, this does conclude your conference call for today. We thank you very much for your participation. You may now disconnect. Have a great day.

各位女士先生，今天的電話會議到此結束。非常感謝各位的參與。您現在可以掛線。祝您有美好的一天。