ADC Therapeutics (ADCT) Q2 2026 Earnings Call: FDA-Bedenken zu LOTIS-5, 219,1 Mio. USD liquide Mittel

Wichtigste Erkenntnisse

• Der Nettoprodukterlös von ZYNLONTA lag im 2. Quartal 2026 bei 18,6 Mio. US-Dollar, verglichen mit 18,1 Mio. US-Dollar im 2. Quartal 2025. Das Management erklärte, das Absatzvolumen sei im Vergleich zu den vergangenen Quartalen stabil geblieben.
• Die Phase-III-Studie LOTIS-5 erreichte ihren primären Endpunkt des progressionsfreien Überlebens, jedoch äußerte die FDA erhebliche Bedenken hinsichtlich des Nutzen-Risiko-Verhältnisses und der Bestätigung des klinischen Nutzens. ADC Therapeutics wertet derzeit zusätzliche Daten, Risikomanagement-Maßnahmen und potenzielle Anpassungen der Fachinformation aus.
• In der Studie LOTIS-7 wurde die Rekrutierung von 100 Patienten für die Dosis von 150 Mikrogramm pro kg ZYNLONTA plus Glofitamab abgeschlossen. Das Unternehmen hat Daten bei der ASH eingereicht und plant, 2026 den Status einer Breakthrough-Therapie zu beantragen.
• Der GAAP-Nettoverlust verringerte sich im 2. Quartal von 56,6 Mio. US-Dollar im Vorjahr auf 16,6 Mio. US-Dollar. Der bereinigte Nettoverlust sank im Wesentlichen aufgrund geringerer Betriebsausgaben von 28,7 Mio. US-Dollar auf 16,3 Mio. US-Dollar.
• Die flüssigen Mittel beliefen sich zum Quartalsende auf 219,1 Mio. US-Dollar. Das Management geht davon aus, dass die Liquiditätsreichweite mindestens bis ins Jahr 2028 reicht.
• Eine strategische Reorganisation reduzierte die Belegschaft um etwa 17 % und soll voraussichtlich zu jährlichen Kosteneinsparungen von rund 10 Mio. US-Dollar führen.

Wichtigste Finanzdaten

In den ersten sechs Monaten des Jahres 2026 beliefen sich die Herstellungskosten der verkauften Produkte auf 6,0 Mio. US-Dollar, verglichen mit 2,9 Mio. US-Dollar im entsprechenden Vorjahreszeitraum 2025.

Geschäfts- und operative Entwicklung

ZYNLONTA blieb als Monotherapie für das diffuse großzellige B-Zell-Lymphom ab der Drittlinie positioniert. Seit Erhalt der beschleunigten FDA-Zulassung im Jahr 2021 wurde die Therapie bei etwa 5.000 Patienten in den USA angewendet.

Das Management erklärte, dass die Bekanntgabe zu LOTIS-5 weder das Patientenvolumen noch das Verschreibungsverhalten der Ärzte im derzeit zugelassenen Anwendungsbereich beeinflusst habe. Das Unternehmen stellte zudem klar, dass sich das Feedback der FDA bei dem Pre-sBLA-Treffen speziell auf das Regimen aus ZYNLONTA plus Rituximab bezog und nicht auf die ZYNLONTA-Monotherapie.

LOTIS-7 untersucht ZYNLONTA in Kombination mit Glofitamab bei DLBCL ab der Zweitlinie. Die Patientenzahl erreichte 100 Patienten bei der ausgewählten Dosis. ADC Therapeutics gab an, dass die ASH-Einreichung Daten des Großteils der eingeschlossenen Patienten enthielt, und beschrieb die Ergebnisse zu Wirksamkeit und Sicherheit weiterhin als überzeugend. Das Unternehmen prüft zudem das Design einer Phase-III-Studie.

Für indolente Lymphome wurden aktualisierte Daten zum Marginalzonenlymphom bei der ASH eingereicht. ADC Therapeutics geht davon aus, den Status einer Breakthrough-Therapie für MZL zu beantragen. Aktualisierte Daten zum follikulären Lymphom werden für das 2. Quartal 2027 erwartet.

Prognose des Managements

Das Management erwartet, dass die Reorganisation im Juni zu jährlichen Einsparungen von rund 10 Mio. US-Dollar führen wird. Zusammen mit den flüssigen Mitteln von 219,1 Mio. US-Dollar zum Quartalsende geht das Unternehmen davon aus, dass die Liquiditätsreichweite mindestens bis ins Jahr 2028 reicht.

ADC Therapeutics plant, im Jahr 2026 einen Antrag auf den Status einer Breakthrough-Therapie für die Kombination aus ZYNLONTA und Glofitamab einzureichen. Veröffentlichungen und potenzielle Anträge auf Aufnahme in medizinische Kompendien für LOTIS-5, LOTIS-7 und MZL sollen im Anschluss an die geplanten Datenpräsentationen folgen, wobei eine Aufnahme in Kompendien frühestens 2027 beginnen könnte.

Das Management gab an, ab 2027 Wachstumschancen für ZYNLONTA zu erwarten, vorbehaltlich klinischer, regulatorischer und kompendieller Fortschritte.

Risiken und wichtige Beobachtungspunkte

Die wesentliche regulatorische Unsicherheit liegt im weiteren Vorgehen bei LOTIS-5. Obwohl die Studie ihren primären Endpunkt erreichte, äußerte die FDA erhebliche Bedenken hinsichtlich des Nutzen-Risiko-Verhältnisses und der Bestätigung des klinischen Nutzens. ADC Therapeutics prüft, ob zusätzliche Daten, Optionen für das Risikomanagement oder Änderungen der Fachinformation diese Bedenken ausräumen können.

Das Management erklärte, dass die in LOTIS-5 beobachteten Infektionen vom Grad 5 überwiegend bakterieller Natur waren. Im Gegensatz zu LOTIS-5 empfiehlt das Protokoll von LOTIS-7 eine Prophylaxe und Impfungen gegen virale, pilzbedingte und bakterielle Infektionen, einschließlich PJP und Herpesviren. Das Unternehmen geht davon aus, dass diese Protokollunterschiede zu unterschiedlichen Sicherheitsergebnissen beitragen könnten; die endgültigen LOTIS-7-Ergebnisse stehen jedoch noch unter dem Vorbehalt der Präsentation und der regulatorischen Überprüfung.

Zeitplan, Design und Kosten einer potenziellen Phase-III-Studie für LOTIS-7 stehen noch nicht fest. Das Unternehmen plant, Rückmeldungen aus der Fachwelt einzuholen und mögliche Designs mit der FDA zu besprechen.

Highlights der Fragerunde mit Analysten

• Aktuelle beschleunigte Zulassung: Das Management erklärte, dass sich die Diskussionen mit der FDA ausschließlich auf LOTIS-5 und das ZYNLONTA-plus-Rituximab-Regimen konzentrierten. Das Unternehmen bleibt zuversichtlich, dass die ZYNLONTA-Monotherapie ihre beschleunigte Zulassung behält, während an der vollständigen Zulassung über LOTIS-5 oder eine andere Studie gearbeitet wird.
• Regulatorische Optionen für LOTIS-5: ADC Therapeutics prüft das Feedback der FDA und zieht zusätzliche Daten, Risikomanagement-Maßnahmen und Anpassungen einer potenziellen Fachinformation in Betracht.
• Entwicklung von LOTIS-7: Das Management gab an, dass das ASH-Abstract Daten des Großteils der 100 eingeschlossenen Patienten widerspiegelt. Das Unternehmen plant, den Status einer Breakthrough-Therapie zu beantragen und Optionen für das Phase-III-Design mit der FDA zu erörtern.
• Übertragbarkeit der Sicherheitsdaten: Das Management erwartet nicht, dass das Signal zu Infektionen vom Grad 5 bei LOTIS-5 die Aufnahme von LOTIS-7 in Kompendien beeinflussen wird, und begründete dies mit Unterschieden bei Behandlungsregimen und Prophylaxe-Protokollen.
• Kommerzielle Auswirkungen: Das Unternehmen berichtete nach der Veröffentlichung zu LOTIS-5 von keinen Veränderungen beim ZYNLONTA-Volumen und erwartet eine stabile Nachfrage nach der Monotherapie bei DLBCL ab der Drittlinie.

Vollständiges Transkript der Telefonkonferenz

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

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.

Fragen und Antworten

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.