ADCセラピューティクス（ADCT）2026年第2四半期決算説明会：LOTIS-5に関するFDAの懸念、現金2億1,910万ドル

主要なポイント

• 2026年第2四半期のZYNLONTAの製品売上高（純額）は1,860万ドルとなり、2025年第2四半期の1,810万ドルから増加しました。経営陣は、販売量はここ最近の四半期と同水準を維持したと述べています。
• 第III相LOTIS-5試験は主要評価項目である無増悪生存期間を達成したものの、FDA（米国食品医薬品局）はベネフィット・リスク評価および臨床的ベネフィットの検証について重大な懸念を表明しました。ADC Therapeuticsは追加データ、リスク管理措置、および添付文書（適応症等）の変更可能性について検討を行っています。
• LOTIS-7試験では、ZYNLONTAとグロフィタマブの併用療法における体重1kgあたり150マイクログラム投与群で100名の患者登録を完了しました。同社は米国血液学会（ASH）にデータを提出しており、2026年にブレークスルーセラピー（画期的治療薬）指定を申請する計画です。
• 第2四半期のGAAPベースの純損失は、前年同期の5,660万ドルから1,660万ドルへと縮小しました。調整後純損失は、主に営業費用の減少により、前年同期の2,870万ドルから1,630万ドルへと減少しました。
• 四半期末時点の現金および現金同等物は総額2億1,910万ドルとなりました。経営陣は、現金創出期間（キャッシュランウェイ）が少なくとも2028年まで拡大すると見込んでいます。
• 戦略的組織再編により従業員を約17%削減し、年間約1,000万ドルのコスト削減効果が見込まれています。

主要財務データ

2026年上半期の製品売上原価は600万ドルとなり、前年同期の290万ドルから増加しました。

事業および営業業績

ZYNLONTAは、三次治療以降のびまん性大細胞型B細胞リンパ腫（DLBCL）に対する単剤療法としての位置付けを維持しています。2021年にFDAから迅速承認を取得して以来、米国で約5,000名の患者の治療に使用されてきました。

経営陣は、LOTIS-5の開示情報が、現在承認されている環境における患者数や医師の処方行動に影響を与えていないと述べました。また、事前sBLA協議におけるFDAからのフィードバックは、ZYNLONTA単体療法ではなく、ZYNLONTAとリツキシマブの併用療法に特有のものであると補足しました。

LOTIS-7試験では、二次治療以降のDLBCLを対象にZYNLONTAとグロフィタマブの併用療法を評価しています。選択された用量での患者登録は100名に達しました。ADC Therapeuticsによると、ASHへの提出データには登録患者の大多数のデータが含まれており、有効性および安全性の結果は引き続き非常に期待できる内容であるとしています。同社は第III相試験のデザインについても検討を進めています。

低悪性度リンパ腫に関しては、改訂されたマージナルゾーンリンパ腫（MZL）データがASHに提出されました。ADC TherapeuticsはMZLを対象としたブレークスルーセラピー指定の申請を目指しています。濾胞性リンパ腫の最新データは2027年第2四半期に発表される見込みです。

業績予想（ガイダンス）

経営陣は、6月に実施した組織再編により年間約1,000万ドルのコスト削減が実現すると見込んでいます。四半期末時点の現金残高2億1,910万ドルと合わせ、同社はキャッシュランウェイが少なくとも2028年まで延長すると予想しています。

ADC Therapeuticsは、2026年にZYNLONTAとグロフィタマブの併用療法に関するブレークスルーセラピー指定の申請を予定しています。LOTIS-5、LOTIS-7、およびMZLに関する論文発表やコンペンディア（適応医薬品集）への掲載申請は、計画されているデータ発表後に順次行われる予定であり、早ければ2027年からコンペンディアへの収載が開始される可能性があります。

経営陣は、臨床、規制、およびコンペンディア収載の進展次第で、2027年からZYNLONTAの成長機会が拡大すると見込んでいると述べました。

リスクと注視すべきポイント

最大の規制上の不確実性は、LOTIS-5の今後の進展経路です。本試験は主要評価項目を達成したものの、FDAはベネフィット・リスク評価および臨床的ベネフィットの検証に対して強い懸念を示しました。ADC Therapeuticsは、追加データ、リスク管理オプション、あるいは添付文書の変更によってそれらの懸念に対処できるかどうかを検討しています。

経営陣によると、LOTIS-5で観察されたグレード5の感染症は主に細菌性のものでした。LOTIS-5とは異なり、LOTIS-7の治験プロトコルでは、ニューモシスチス肺炎（PJP）やヘルペスウイルスを含むウイルス、真菌、細菌感染を網羅する予防投与とワクチン接種が推奨されています。同社は、これらのプロトコルの違いが異なる安全性結果をもたらす可能性があると考えていますが、LOTIS-7の最終結果は今後の発表および規制当局の審査に委ねられています。

可能性のあるLOTIS-7第III相試験の時期、デザイン、および費用はまだ決定されていません。同社は医療コミュニティからの意見を収集し、可能なデザインについてFDAと協議する予定です。

アナリストQ&Aの主なポイント

• 現在の迅速承認：経営陣は、FDAとの協議がLOTIS-5およびZYNLONTAとリツキシマブの併用療法のみに焦点を当てていたと説明しました。同社は、LOTIS-5または他の試験を通じて正式承認を目指す間、ZYNLONTA単剤療法が迅速承認を維持できることに引き続き確信を持っています。
• LOTIS-5の規制上の選択肢：ADC TherapeuticsはFDAのフィードバックを検討しており、追加データ、リスク管理措置、および添付文書案の変更を考慮しています。
• LOTIS-7の開発：経営陣は、ASHの抄録が登録された100名の患者の大多数からのデータを反映していると述べました。同社はブレークスルー指定を申請し、第III相試験のデザイン案についてFDAと協議する計画です。
• 安全性への影響（リードスルー）：経営陣は、治療法や予防プロトコルの違いを挙げ、LOTIS-5のグレード5感染シグナルがLOTIS-7のコンペンディア収載に影響を与えるとは予想していません。
• 商業的影響：同社はLOTIS-5の公表後もZYNLONTAの販売量に変化はないと報告しており、三次治療以降のDLBCLにおける単剤療法の需要は引き続き安定していると見込んでいます。

決算説明会（トランスクリプト）全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 Earnings Conference Call. [Operator Instructions] This call is being recorded on Thursday, August 13, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

Nicole Riley

Thank you, operator. Today, we issued a press release announcing our second quarter 2026 financial results and business update. 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 Medical Officer, Mohamed Zaki, who will provide clinical and regulatory updates; and lastly, our Chief Financial Officer, Pepe Carmona, who will review our second quarter 2026 financial results. We will then open the call to questions.

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 U.S. 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.

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 second quarter 2026 earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures.

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

Ameet Mallik

Thank you, Nicole. We are pleased to share that ZYNLONTA's commercial performance in the second quarter of 2026 continued to be broadly in line with recent quarters. We remain confident in the role ZYNLONTA will continue to play as a differentiated single-agent treatment option for third-line plus DLBCL patients.

Turning to our pipeline progress. As previously disclosed, we announced top line results for LOTIS-5 in June. Based on this data, we held a pre-sBLA meeting with the FDA. And following the meeting, we are assessing the best regulatory path forward. Mohamed will share more details regarding the FDA feedback and our regulatory strategy.

Further to this, the full LOTIS-5 data have now been submitted for presentation at ASH, and we are preparing to submit for publication with compendia submission to follow.

For LOTIS-7, we were pleased to complete enrollment of 100 patients at the selected dose level of ZYNLONTA plus glofitamab as shared in June and have submitted an abstract to ASH for presentation of the data, which we continue to believe demonstrate the most compelling combination data generated to date in second-line plus DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures.

With these data, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line position in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL. Beyond this, we are preparing to submit for publication of the LOTIS-7 data with compendia submission to follow. Simultaneously, we are exploring the potential regulatory pathway for this combination and expect to submit for breakthrough designation this year.

With respect to the multicenter investigator-initiated trials of ZYNLONTA in indolent lymphomas, updated marginal zone lymphoma data was submitted to ASH with publication and compendia submission to follow. Presentation of updated follicular lymphoma data is anticipated in the second quarter of 2027 with publication and compendia submission to follow. We also intend to assess potential regulatory pathways for these indolent lymphomas and expect to submit for breakthrough designation for MZL.

Moving now to corporate updates. We announced a strategic reorganization in June. As part of this, we implemented a reduction in our workforce of approximately 17% as well as additional operational efficiencies, resulting in cost savings of approximately $10 million on an annualized basis. As shared at that time, with these changes, we are resourced to deliver on our key clinical, regulatory and manufacturing activities while maintaining the full externally facing footprint to support the continued commercialization of ZYNLONTA in the third-line plus DLBCL setting.

Finally, we ended the second quarter of 2026 with a healthy cash balance of $219.1 million, maintaining our expected cash runway at least into 2028 and enabling us to deliver against our strategy.

Now I'd like to take a moment to remind everyone of our strategy to grow ZYNLONTA. Currently, ZYNLONTA plays a clear role in the third-line plus DLBCL setting. As monotherapy, ZYNLONTA has a well-established profile of rapid, deep and durable efficacy as well as manageable safety with simple and convenient administration. Since FDA accelerated approval in 2021, ZYNLONTA monotherapy has been used in treating approximately 5,000 patients in the U.S. We believe this is just a starting point as we see the potential for ZYNLONTA to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas.

Now I would like to turn the call over to Mohamed, our CMO, to share more on our pipeline.

Mohamed Zaki

Thank you, Ameet. I would now like to share more on our LOTIS-5 and LOTIS-7 studies as we continue to work towards expansion of ZYNLONTA in earlier lines of DLBCL. As a reminder, LOTIS-5 is our Phase III confirmatory study of ZYNLONTA in combination with rituximab versus R-GemOx in patients with second-line DLBCL, which recently read out and met the primary endpoint of progression-free survival.

As noted, we held a meeting with the FDA in early August to present and discuss the totality of the LOTIS-5 data, along with the potential regulatory pathway. During this meeting, the FDA noted substantial concerns regarding the benefit risk or verification of clinical benefit observed in the LOTIS-5 trial. As such, the company is now assessing the regulatory path forward. We plan to provide an update on regulatory strategy and timing in the future. Beyond this, the data has been submitted to ASH. We are simultaneously pursuing publication for LOTIS-5 and potential compendia inclusion starting in 2027.

Turning now to LOTIS-7, our Phase Ib trial combining ZYNLONTA with the highly effective bispecific glofitamab in second-line plus DLBCL patients. We recently announced completion of enrollment of 100 patients at the 150 micrograms per kg dose. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis, including vaccinations for viral, fungal and bacterial infections, including PJP and herpes virus, which was not part of the LOTIS-5 protocol.

Here, we continue to be encouraged by the promising LOTIS-7 data shared to date, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be the best-in-class combination. The data on a larger number of patients with longer follow-up has been submitted to ASH for presentation. This data supports the company's belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in second-line DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures.

Separately, we are preparing for submission of the full LOTIS-7 data for publication and following that, plan to submit to compendia for potential inclusion starting in 2027. In addition, based on this potentially practice-changing LOTIS-7 data, the company plans to submit for breakthrough designation this year and is assessing a Phase III trial for the combination of ZYNLONTA plus glofitamab.

Moving forward, we plan to work closely with the FDA to determine the best path forward to achieve the full approval and advance ZYNLONTA combinations into earlier lines of therapy in DLBCL. In the meantime, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies within its currently approved third-line plus DLBCL setting.

With that, I would like to turn the call over to Pepe Carmona, our CFO.

Jose Carmona

Thank you, Mohamed. On the financial front, ZYNLONTA net product revenues in the second quarter of 2026 were $18.6 million as compared to $18.1 million in the same quarter in 2025. Cost of product sales was $2.3 million and $6 million for the second quarter and 6 months ended June 30, 2026, as compared to $0.8 million and $2.9 million for the same period in 2025. The increases compared to prior year are primarily driven by a change in focus of personnel from research and development clinical supply activities to commercial manufacturing activities.

Total operating expenses were $44.7 million for the second quarter. On a non-GAAP basis, total adjusted operating expenses were $37.2 million for the quarter and were down by 22% over the prior year, primarily driven by lower R&D expenses. As Ameet noted, we expect to save an additional $10 million on an annual basis as a result of the strategic reorganization we announced in June.

On a GAAP basis, we reported a net loss of $16.6 million for the second quarter of 2026 as compared to a net loss of $56.6 million for the same period in 2025. The second quarter of 2026 included a onetime expense related to the strategic reorganization, while the year-ago quarter included restructuring, impairment and related costs from the June 2025 strategic reprioritization and restructuring plan.

On a non-GAAP basis, the adjusted net loss was $16.3 million for the second quarter of 2026 as compared to a net loss of $28.7 million for the same period in 2025. The lower net loss on a non-GAAP basis was primarily due to lower operating expenses. The year-over-year changes 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 second quarter in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of the second quarter, we had cash and cash equivalents of $219.1 million as compared to $231 million as of March 31, 2026, a change primarily driven by cash used in operations. This provides us with an expected cash runway at least into 2028.

With that, I will turn the call back over to Ameet. Ameet?

Ameet Mallik

Thank you, Pepe. To close, we are pleased by the commercial performance and the role that ZYNLONTA monotherapy continues to play in third-line plus DLBCL. We look forward to presentation of data from LOTIS-5, LOTIS-7 and MZL before year-end with publication and potential compendia inclusion to follow. Following the FDA pre-sBLA meeting, we are assessing regulatory approaches to determine the best path forward for the LOTIS-5 trial.

At the same time, we believe we have an opportunity for ZYNLONTA plus glofitamab to take a leading second-line position in DLBCL as a potential best-in-class bispecific combination and are actively assessing the potential regulatory path forward. Together, we anticipate we can grow ZYNLONTA beginning in 2027 as we work to make a meaningful difference in the lives of many more patients with B-cell malignancies.

We can now open the line for questions. Operator?

Operator

[Operator Instructions] Your first question comes from Eric Schmidt with Cantor.

質疑応答

Eric Schmidt

Appreciate all the updates. Maybe just on the status of the current accelerated approval for ZYNLONTA, given the questions around risk benefit from LOTIS-5. Was there any FDA discussion of maintaining that accelerated approval status?

Ameet Mallik

Yes, great question. So first of all, all the discussions with the FDA were related only to the trial. All their comments were specific to the combination of ZYNLONTA plus rituximab on the trial. So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market. We'll continue to have accelerated approval. And we're committed to working with the FDA to make sure that we can satisfy the full approval either through LOTIS-5 or through another study.

Eric Schmidt

And then on LOTIS-7 and your characterization of the most recent efficacy data that you guys have seen is compelling and consistent in safety. Have you essentially now seen the final ASH presentation? And do your comments pertain to that? In other words, do you know exactly what you'll present? And is it consistent with that statement?

Ameet Mallik

Yes. So we've already submitted the abstract for ASH, which contains obviously the vast majority of the 100 patients that we enrolled. So the belief that I'm sharing with you about the fact that we think we have very compelling efficacy and safety data is reflective of that ASH abstract. We obviously, for disclosure reasons, you can imagine we don't want to share all the details, but we do believe that we have very compelling data, both from an efficacy and a safety standpoint within the LOTIS-7 data that was submitted to ASH.

Eric Schmidt

And one more question, if I may, with regard to exploring a Phase III pathway for the combination in LOTIS-7. Is that something you're exploring with Roche or by yourselves?

Ameet Mallik

I don't want to comment on that. Obviously, we have a great partnership with Roche, and they've given us great feedback throughout. But what I would say is we've had lots of discussions, but also lots of thought, as you can imagine, even independent of the feedback from the FDA about a potential Phase III design because we know that this data is so compelling that there could be significant upside for the asset by potentially pursuing a Phase III trial. So it's something we've been thinking about for a long time. The team has already been preparing on different design options, and we do plan to file for breakthrough designation this year and to discuss with the FDA potential designs.

Operator

Your next question comes from Michael Schmidt with Guggenheim Securities.

Unknown Analyst

This is Sarah on for Michael. Just wanted to follow on quickly on the Phase III plans, whether you could give any color on sort of time line for that now that it appears to be sort of more of the future-looking focus. And then additionally, I had a sort of a question on the LOTIS-5 data. So I know you've mentioned the 105-day period for monitoring adverse events after treatment. I was wondering if you could comment on the timing of the deaths.

Ameet Mallik

So first of all, I just want to emphasize we have a positive study for LOTIS-5. So we still are assessing possibilities to identify the best regulatory approach for LOTIS-5. I mean specifically, we're considering whether additional data risk management options or modifications to the potential label can address the FDA concern. So we are doing that.

In parallel, given that we have, we think, potentially practice-changing data on hand with the LOTIS-7, we're also in parallel going to file for breakthrough designation and explore a Phase III approach there. So it's too premature at this point, as you can imagine, while we're still gathering input from the medical community and obviously have to talk with the FDA on the final design to talk about timing and costs. But I just want to reemphasize that those 2 things are going in parallel.

And then with regards to the 105-day safety window in terms of capturing AEs post the last dose, that's the same, by the way, in LOTIS-7 as well. And one thing I want to emphasize is that as Mohamed mentioned on the call, there was a big difference between LOTIS-5 and LOTIS-7, particularly with regards to the prophylactic measures taken. So in LOTIS-7, consistent with a lot of the other -- with the other glofitamab trials that have been run, LOTIS-7 recommends prophylaxis, including vaccinations for viral, fungal and bacterial infections. That was not part of the LOTIS-5 protocol. So while the time period that we're capturing AEs is very similar, there was a pretty big difference in terms of prophylaxis in the protocol between 5 and 7.

Operator

Your next question comes from Maury Raycroft with Jefferies LLC.

Unknown Analyst

This is James on for Maury. Can you provide more detail on the type of Grade 5 infections that were observed in LOTIS-5 and whether those events would have been expected to be mitigated by the prophylactic and vaccination strategies now incorporated in LOTIS-7? Did other infections occur that aren't addressed by those vaccines? And I have a follow-up after that.

Ameet Mallik

Yes. So the primary type of infections were bacterial, which is why we think that prophylaxis could play a role.

Unknown Analyst

Got it. And how do you think about the potential read-through from LOTIS-5 Grade 5 signal to potential NCCN compendia inclusion and adoption of the ZYNLONTA glofitamab combination within the academic community? Could LOTIS-5 impact the NCCN language? And could there be any safety monitoring requirements?

Ameet Mallik

Yes. I don't think there will be any read-through in terms of LOTIS-7 compendia inclusion. Two very different studies, 2 different regimens. As I mentioned, the protocol is different, which we think can help to contribute to some of the safety differences. Just as a reminder, obviously, I can't speak to the data that we have on hand, but I can speak to the prior disclosure that we had. We had a very low percent of Grade 5 events, approximately 4% if you look at our last disclosure we had in December on the 49 patients that we reported. So I do think there's a difference and we don't think there would be a read-through to LOTIS-7 or to any potential NCCN or compendia inclusion.

Operator

We now have a question from Leonid Timashev with RBC Capital Markets.

Unknown Analyst

Josh on for Leo here. I was wondering whether or not the FDA in their feedback in response to the Phase III, did they provide any kind of indication of what an effective path forward might look like and what strategies you guys are thinking about at the time being?

Ameet Mallik

Yes. And I think typical in what you have in the pre-sBLA meeting, we share the data results and you're aligning on the package for an sBLA submission. During that, as it is typical with any other pre-sBLA meeting, they share concerns that they have with the data. And so right now, we're basically going through the feedback and assessing whether additional data risk management options or modification to the potential label can help to address those FDA concerns. And that's the basis of which we're evaluating our path forward for LOTIS-5.

Operator

[Operator Instructions] Your next question comes from Rob Burns with H.C. Wainwright.

Unknown Analyst

This is Ahmed on for Rob. I was just wondering if you saw Q2 product revenue increase versus Q2 '25. And I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-5 disclosure? And then for my second question, I was wondering if in your conversations with the FDA, did they focus on the PFS in patients 75 or older, and if that would influence eligibility criteria or future label?

Ameet Mallik

Yes. So with regard to sales, we haven't seen any impact. If you look at the volume in Q2, very consistent with prior quarters. So -- and we don't think that there will be. If you look overall over the past several quarters, the commercial performance of the monotherapy in the third-line plus setting has been relatively consistent. And that's because ZYNLONTA has an established place in the third-line plus setting, and we don't expect any impact on monotherapy sales.

And then remind me again, I'm sorry, your second question.

Unknown Analyst

No problem. I was wondering if...

Ameet Mallik

Oh, just about patients 75 or older, right?

Unknown Analyst

Yes.

Ameet Mallik

Yes. We don't think it will have any impact on other studies. I think obviously, older patients specifically with infection, we think that the prophylaxis can play a role. And that's also why the protocol, again, I want to stress the LOTIS-7 versus LOTIS-5 are quite different. So I think each study is on its own. I don't think that there's a read-through from this. We certainly learned a lot from LOTIS-5, and we're happy with the differences in the protocol, of course, that we're seeing in LOTIS-7. So we don't see any read-through from LOTIS-5 to either the current indication or other potential combinations.

Operator

There are no further questions at this time. So I will now turn the call over to Ameet Mallik for closing remarks. Please continue.

Ameet Mallik

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

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.