ADC Therapeutics (ADCT) - Teleconferência de Resultados do 2º Trimestre de 2026: Preocupações da FDA com o LOTIS-5, US$ 219,1 Milhões em Caixa

Principais Destaques

• A receita líquida de produtos do ZYNLONTA foi de US$ 18,6 milhões no 2º trimestre de 2026, em comparação com US$ 18,1 milhões no 2º trimestre de 2025. A administração afirmou que o volume de vendas permaneceu consistente com o dos trimestres recentes.
• O ensaio de Fase III LOTIS-5 atingiu seu endpoint primário de sobrevida livre de progressão, mas a FDA levantou preocupações substanciais sobre a relação benefício-risco e a verificação do benefício clínico. A ADC Therapeutics está avaliando dados adicionais, medidas de gestão de risco e potenciais modificações na bula.
• O LOTIS-7 concluiu o recrutamento de 100 pacientes na dose de 150 microgramas por kg de ZYNLONTA mais glofitamabe. A empresa submeteu os dados à ASH e planeja solicitar a designação de terapia inovadora em 2026.
• O prejuízo líquido GAAP do 2º trimestre diminuiu para US$ 16,6 milhões, ante US$ 56,6 milhões no mesmo período do ano anterior. O prejuízo líquido ajustado caiu para US$ 16,3 milhões, frente a US$ 28,7 milhões, principalmente devido a despesas operacionais menores.
• O caixa e equivalentes de caixa somaram US$ 219,1 milhões no final do trimestre. A administração espera que a autonomia de caixa se estenda pelo menos até 2028.
• Uma reorganização estratégica reduziu o quadro de funcionários em aproximadamente 17% e deve gerar cerca de US$ 10 milhões em economia de custos anualizada.

Principais Dados Financeiros

Nos primeiros seis meses de 2026, o custo das vendas de produtos foi de US$ 6,0 milhões, em comparação com US$ 2,9 milhões no período correspondente de 2025.

Desempenho Comercial e Operacional

O ZYNLONTA permaneceu posicionado como um tratamento em monoterapia para linfoma difuso de grandes células B de terceira linha e posteriores. Desde que recebeu a aprovação acelerada da FDA em 2021, a terapia foi usada para tratar aproximadamente 5.000 pacientes nos Estados Unidos.

A administração informou que a divulgação do LOTIS-5 não afetou o volume de pacientes nem o comportamento de prescrição médica no cenário atualmente aprovado. A empresa também declarou que o feedback da FDA na reunião pré-sBLA se referia especificamente ao regime de ZYNLONTA mais rituximabe, e não à monoterapia com ZYNLONTA.

O LOTIS-7 está avaliando o ZYNLONTA com glofitamabe em LDGCB de segunda linha e posteriores. O recrutamento atingiu 100 pacientes na dose selecionada. A ADC Therapeutics afirmou que a submissão à ASH continha dados da vasta maioria dos pacientes inscritos e continuou caracterizando os achados de eficácia e segurança como convincentes. A empresa também está avaliando o desenho de um ensaio de Fase III.

Para linfomas indolentes, dados atualizados sobre o linfoma de zona marginal foram submetidos à ASH. A ADC Therapeutics espera solicitar a designação de terapia inovadora para LZM. Dados atualizados sobre o linfoma folicular são previstos para o 2º trimestre de 2027.

Orientação da Administração

A administração espera que a reorganização de junho proporcione cerca de US$ 10 milhões em economia anualizada. Combinada com o saldo de caixa de US$ 219,1 milhões ao final do trimestre, a empresa prevê que sua autonomia de caixa se estenda pelo menos até 2028.

A ADC Therapeutics planeja solicitar a designação de terapia inovadora para a combinação ZYNLONTA-glofitamabe em 2026. Espera-se que a publicação e potenciais submissões aos compêndios para LOTIS-5, LOTIS-7 e LZM ocorram após as apresentações de dados planejadas, com potencial inclusão nos compêndios a partir de 2027.

A administração afirmou prever oportunidades de crescimento para o ZYNLONTA a partir de 2027, sujeito a avanços clínicos, regulatórios e de compêndios.

Riscos e Pontos de Atenção

A principal incerteza regulatória é o caminho a ser seguido pelo LOTIS-5. Embora o estudo tenha atingido seu endpoint primário, a FDA expressou preocupações substanciais em relação à relação benefício-risco e à verificação do benefício clínico. A ADC Therapeutics está avaliando se dados adicionais, opções de gestão de risco ou alterações na bula poderiam sanar essas preocupações.

A administração afirmou que as infecções de Grau 5 observadas no LOTIS-5 foram essencialmente bacterianas. Ao contrário do LOTIS-5, o protocolo do LOTIS-7 recomenda profilaxia e vacinações abrangendo infecções virais, fúngicas e bacterianas, incluindo PJP e herpes-vírus. A empresa acredita que essas diferenças de protocolo poderiam contribuir para resultados de segurança distintos, mas os resultados finais do LOTIS-7 permanecem sujeitos a apresentação e revisão regulatória.

O cronograma, o desenho e o custo de um potencial ensaio de Fase III do LOTIS-7 ainda não foram determinados. A empresa planeja reunir opiniões da comunidade médica e discutir possíveis desenhos com a FDA.

Destaques das Perguntas e Respostas dos Analistas

• Aprovação acelerada atual: A administração disse que a discussão com a FDA focou apenas no LOTIS-5 e no regime de ZYNLONTA mais rituximabe. A empresa permanece confiante de que a monoterapia com ZYNLONTA manterá sua aprovação acelerada enquanto trabalha para obter a aprovação total por meio do LOTIS-5 ou de outro estudo.
• Opções regulatórias do LOTIS-5: A ADC Therapeutics está revisando o feedback da FDA e considerando dados adicionais, medidas de gestão de risco e modificações em uma potencial bula.
• Desenvolvimento do LOTIS-7: A administração disse que o resumo da ASH reflete dados da maioria dos 100 pacientes inscritos. A empresa planeja solicitar a designação de terapia inovadora e discutir opções de desenho para a Fase III com a FDA.
• Leitura de segurança: A administração não espera que o sinal de infecção de Grau 5 do LOTIS-5 afete a inclusão do LOTIS-7 nos compêndios, citando diferenças nos regimes de tratamento e nos protocolos de profilaxia.
• Impacto comercial: A empresa informou que não houve alteração no volume do ZYNLONTA após a divulgação do LOTIS-5 e espera que a demanda por monoterapia em LDGCB de terceira linha e posteriores permaneça estável.

Transcrição Completa da Teleconferência de Resultados

Transcrição completa da teleconferência de resultados

Comentários da administração

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.

Perguntas e respostas

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.