BioNTech SE ($BNTX)

Welcome to BioNTech's First Quarter 2026 Earnings Call. I will now hand the call over to Doug Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech's First Quarter 2026 Earnings Call. As a reminder, the slides we will use during this call and the corresponding press release can be found in the Investors section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On Slide 3, you can find the agenda for today's call. I'm joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and Co-Founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. Also available for the Q&A portion of today's call is Annemarie Hanekamp, our Chief Commercial Officer. With this, I'll hand the call over to Ugur.

Thank you, Doug, and everyone, welcome to everyone joining us today. As BioNTech has grown, our vision has remained confident translating signs into survivor. Cancer is a complex systems disease with heterogeneity across patients and variability within individual tumor. The future of cancer treatment will therefore center around rationally designed therapeutic combination, telling potent and precise mechanisms of action that create biological synergies. To address this, BioNTech has built a diversified toolkit of modalities comprising immunomodulators, ADCs and mRNA cancer immunotherapy. We believe that combination approaches will be key to elevate patient outcomes meaningfully across solid tumors. To execute against that vision in 2026, we have 3 priorities: first, accelerate the late-stage development of our oncology assets. Key late-stage data readouts are anticipated from our first day of oncology programs this year. Second, big momentum in combination therapy. In 2026, we are expanding our novel-novel combination strategy centered around Pumitamig as potential next-generation IO backbone. This includes the first expected readouts of combination tiles with our ADCs as well as with other next-generation therapies including the recently announced partnership with [indiscernible] to combine Pumitamig with quick standing. Third, shift from a platform-centric to tumor center clinical development approach around high incident cancers such as lung cancer, breast cancer and other tumor types. The foundation of this matrix approach is our combination strategy, which allows us to address several lines of treatment with different asset combinations. In March, we announced plans to pursue next-generation mRNA innovations in a new independent company, founded and led by SM and I, with BioNTech and our new company focusing on their respective strategic priorities, we aim to maximize value for patients and shareholders. Selling at [indiscernible] is ongoing, and we expect to share details of an agreement later this year. BioNTech is well positioned for this next phase. With a growing late-stage pipeline, strong partnerships and financial strength, we are on track to become a diversified multiproduct oncology company by 2030. We are targeting more than 17 late-stage and pivotal [indiscernible] to 2030, spanning multiple tumor types and different lines of treatment. We end up the remainder of this year's momentum solid execution and which set of catalyst opportunities ahead. With this, I will hand over to Ozlem for an update on our oncology execution.

Thank you, Ugur, I'm glad to be speaking with everyone today. BioNTech's clinical development strategy seeks to address the full continuum of cancer. From resected high-risk tumors in the early setting to advanced and metastatic disease as well as treatment resistant and refractory cancers. We have defined a set of key tumor focus areas with high incidence and high unmet need, including lung cancer, breast cancer and others. Across these 2 more focus areas, our goal is to leverage novel combinations to maximize the potential of our pipeline and to elevate solid tumor treatment outcomes. As such, we are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the first quarter of 2026, we continue to make progress here, and I look forward to speaking to some of these updates today. I'll begin with lung cancer, which is our most advanced example of our disease area focused approach. Our lung cancer strategy is built as a matrix across firstly, disease stages and settings from resectable tumors to unresectable Stage III disease for metastatic first-line and later lines of therapy. Second, clinical and molecular subgroups including patients with and without actionable alterations and with different PD-L1 expression levels. And third, treatment backbones and combinations with pumitemic at the core. This quarter, we continued to add to the body of evidence for our lung cancer approach, including the presentation of new data at the European noncancer Congress. Starting with Bumitamic, our PD-L1bGFA bispecific antibody and the IO backbone of our combination-based development strategy. In March, we presented Phase Ib/IIa data at the LCC. This trial evaluated Pometamic as a monotherapy in patients with previously untreated advanced non-small cell lung cancer, enrolling both squamous and non-squamous histologies. The results are encouraging in an overall patient population with PD-L1 expression of at least 1%. We observed a confirmed objective response rate of 46%, a median progression-free survival of 13.6 months and the median overall survival of 27 months. The disease control rate was 96%. Two features of these data deserve particular emphasis. First, the activity observed across PD-L1 subgroups is noteworthy and second, the particularly strong response rate of 71% in PD-L1 high squamous disease. The tolerability profile was manageable with a low rate of treatment discontinuation. These data support the ongoing global Phase III program for Pumitamig in lung cancer. The RecetaLANg-02 trial is currently recruiting in its Phase III portion comparing to metamec chemotherapy to pembrolizumab plus chemotherapy in first-line non-small cell lung cancer. Phase II data from this trial are expected to be presented at ASCO 2026. As Ugur mentioned in his opening remarks, another component of our lung strategy is our recently announced collaboration with [ Bringelly ]. The study combines DLL3 targeting T cell engager or [indiscernible] with Pumitamig. The clinical trial aims to develop a novel treatment regimen that delivers more sustained tumor control in extensive stage small cell lung cancer, one of the most aggressive and underserved forms of cancer. Small cell lung cancer progresses rapidly metastasizes early and almost always recurs within a year after initial treatment. While the addition of immune checkpoint inhibitors to chemotherapy has led to improved survival outcomes for patients with extensive stage disease. Most patients progress within months after treatment and the prognosis remains poor. The collaboration combines 2 complementary immunoerapeutic mechanisms to explore a potential new path to enhance and sustain antitumor immunity. [indiscernible] T cells to cure DLL3 expressing tumor cells while pumitamic aims to restore TC's ability to recognize and destroy tumor cells while cutting off the blood and oxygen supply that feeds the tumor with the intention of preventing it from growing and proliferating. As you can see on our lung cancer slide, we are deploying multiple modalities, next-generation immune modulators, ADCs and mRNA immunotherapy. Gotistobart is a critical component of that picture. Gotistobart is our selective Treg modulator targeting CTLA-4 developed in collaboration with our partner, OncoSpand it is designed to precisely address the patient population that sits beyond Pumitamig's current focus, namely patients with metastatic squamous non-small cell lung cancer whose disease has progressed following platinum-based chemotherapy and PD-1 PD-L1 inhibitor treatment. This is a setting with very few effective options and poor prognosis. Gotistobart's differentiated mechanism, selective regulatory T cell depletion in the tumor microenvironment is designed to reengage the immune system even after prior checkpoint inhibitor exposure. In January, Gotistobart received orphan drug designation from the FDA for squamous non-small cell lung cancer, building on its existing fast track designation. In March at the ECC, we presented updated data from the nonpivotal dose confirmation stage of Preserve-003, our global Phase III trial. The data are very encouraging. The 12-month PFS rate of 25% for Gotistobart versus zero for docetaxel is a signal of durable disease control. Gotistobart reduced the risk of death in this IO pretreated patient population by 54% compared to docetaxel with a hazard ratio of 0.46. The median OS in the Gotistobart arm has not yet been reached compared to approximately 10 months with docetaxel. At 12 months, 63% of patients treated with Gotistobart were alive versus 30% in the docetaxel arm. The safety profile was consistent with the previously established profile for Gotistobart with no new signals of concern. These encouraging data are derived from a small patient population and require further validation. Based on current event accrual projections, we expect interim data from the pivotal stage of Preserve-003 later this year. This program reinforces the breadth and depth of what we are building in Lung cancer. I'll now turn to gynecologic cancers, another of our tumor focus areas and 1 where we have a late-stage asset, trastuzumab Permian Tian, our HER2-targeted ADC developed in collaboration with our partner, [indiscernible] Updated TPAM data were presented at the Society of Gynecological Oncology Annual Meeting in April, and patients refer to expressing previously treated advanced or metastatic endometrial cancer, including patients who had received prior immunotherapy, TPAM demonstrated a confirmed objective response rate of 49%, with a median duration of response of 9.9 months and a disease control rate of 79%. Responses were observed across all HER2 expression levels, IHC1+, 2 plus and also [indiscernible]. The safety profile was manageable and consistent with what has been previously reported for ADCs and HER2 targeted agents in this setting. The confirmatory FRNC-01 Phase III trial continues to enroll. In addition to our studies of PAM in endometrial cancer, the ADC is also being evaluated in the Phase III clinical trial in HR-positive, HER2 low metastatic breast cancer the Dynasty BREAST 02 trial. The Phase III interim analysis for this trial is expected later this year based on current event accrual projections. Moving now to our portfolio of innovative mRNA cancer immunotherapies, which aim to activate and educate the immune system with precision. Our personalized approach includes autogenevumiran, which is partnered with Roche Genentech. In 2025 and early this year, we published data from multiple trials that support our focus on the adjuvant setting where tumor burden and heterogeneity is lowest. The biology and our clinical experience point to greatest relevance in earlier disease settings where lower tumor burden allows for immune system to consolidate control. Updated long-term follow-up data from the PDAC Phase I trial were presented at the AACR Annual Meeting this year among the 8 patients who mounted an immune response to the immunotherapy, 7 remained live for up to 6 years after surgery and demonstrated persistent cytotoxic cancer killing lymphocytes. In contrast of the 8 patients who did not exhibit an immune response, only 2 were still live was a median overall survival of 3.4 years. In adjuvant, CTDNA positive, Stage 2 high risk or Stage 3 colorectal cancer. We have a Phase II trial evaluating autogenerumiran monotherapy against watchful waiting. The final analysis with disease-free survival as primary endpoint is event-driven and according to projections to be expected in 2027. For fixed rack in first-line HPV16-positive PD-L1 high HNSCC. We have a Phase II/III trial in combination with pembrolizumab. Recruitment is ongoing in the Phase III interim analysis is expected in 2026. In Q1, we generated additional data and evidence to support lung and gynecological cancer 2 of our tumor disease focus areas, in particular. Looking ahead for catalyst calendar for the remainder of the year remains rich. In our late-stage programs, we anticipate 5 more readouts in parallel, early data from our pometamicplusADC combination trials will begin to inform the design of our first pivotal combination trials, a milestone that marks the next chapter of our novel strategy. We are in the midst of a sustained evidence led data generation phase [indiscernible] is designed to advance our pipeline, derisk our programs and bring us closer to our goal of delivering meaningful new treatment options for patients with cancer. With that, I will now turn the presentation over to our CFO, Ramon Zapata, for the financial update.

Thank you, Ozlem, and a warm welcome to everyone joining us. Today, I will cover 3 topics. To begin, our first quarter 2026 financial results. Second, our reaffirmed full year 2026 financial guidance; and third, an update on our capital allocation strategy, where I will speak to our planned share buyback program and our manufacturing footprint consolidation initiative. Note that all figures will be in euros unless otherwise stated. Our first quarter performance is in line with our expectations and reflects the seasonal demand pattern we expect across quarters for COVID-19 vaccines. Revenues for the first quarter of 2026 were $118 million. This compares to $183 million in the same period last year. The decrease was primarily driven by lower demand from our COVID-19 but since as expected. R&D expenses were $557 million compared to $526 million in the prior year period. The increase was driven by higher spending on our immuno-oncology and ADC programs in particular, to Pumitamig and Gotistobart as well as R&D costs from BioNTech China, previously named by [indiscernible] and [indiscernible] which were acquired in 2025. These increases were partly offset by lower expenses from our COVID-19 vaccine collaboration with Pfizer. On an adjusted basis, R&D expenses were $527 million, excluding an impairment charge for an intangible asset. SG&A expenses were $151 million compared to $121 million in the prior year period. The increase was mainly driven by our ongoing commercial buildup and the post-acquisition inclusion of operations from BioNTech China and [indiscernible] Adjusted SG&A expenses were identical to the results under IFRS accounting standards. We ended the first quarter with $16.8 billion in cash. Cash equivalents and security investments. Our strong financial position continues to support sustained investment across our pipeline, late-stage oncology programs and our preparations for commercialization. Turning to the next slide. We are reaffirming our previously disclosed full year 2026 financial guidance. All guidance is provided on an adjusted non-IFRS basis. We expect total revenues for 2026 in the range of $2 billion to $2.3 billion. As stated at the beginning of the year, we anticipate lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the United States and European markets. The U.S. market continues to be competitive and dynamic. In Europe, we expect lower revenues as we defend our market share and begin managing the transition away from multiyear contracts. In Germany, specifically, we recognize direct sales of our COVID-19 vaccines as revenue. Hence, the anticipated declines in our sales of COVID-19 vaccines in the country will have a direct impact to our top line, whereas revenues outside of Germany only affect our top line as part of the 50% gross profit split with our partner, Pfizer. Revenues from our collaboration with EMS from the Badami preparedness contract with the German government and from our services businesses are expected to remain stable. On revenue cadence, we anticipate COVID-19 vaccine revenue pacing to be similar to last year's, with the last 4 months of the year, driving the majority of the full year revenue figure. The BMS collaboration payment of $613 million is expected to be recognized in the third quarter of 2026. We expect adjusted R&D expenses in the range of $2.2 billion to $2.5 billion. Investments will be concentrated on our priority late-stage programs. We will continue applying disciplined portfolio prioritization across all development stages. We expect adjusted SG&A expenses in the range of $700 million to $800 million reflecting our continued commercial build-out in oncology. Turning to capital allocation. Let me highlight 3 key components of our approach to create long-term shareholder value. The first component is focused R&D investments to maximize the potential of our pipeline. We actively manage our portfolio, focusing our resources and programs that have the greatest potential to elevate patient outcomes. This means increasing investment into our late-stage priority products, namely Pumitamig, our ADC assets mRNA immunotherapies and the respective combinations while reducing spend outside of those areas. The second component see us mobilizing our strong balance sheet as a statement of confidence in the business. We plan to initiate a share repurchase program of American depositary shares of up to USD 1 billion over the coming 12 months. Let me walk you through some principles that guided this decision. One is opportunistic flexibility. This program gives us the ability to deploy capital during times when our share price may be disconnected from intrinsic company value. Another principle is that our pipeline remains the primary driver of value. The buyback is supportive of the share price. But it is not determinative. The real value creation story at BioNTech remains the clinical execution of our oncology pipeline. Also, disciplined capital management. This program implements our R&D investment. We retain full optionality to advance our pipeline, execute partnerships and corporate development opportunities. Our balance sheet with $16.8 billion in cash, cash equivalents and security investments gives capacity to do all of this simultaneously. In short, the share repurchase program reflects confidence in our science. Capital management discipline and a commitment to delivering long-term value for our shareholders. The third key component of our capital allocation strategy relates to the optimization of operational efficiency and commitment to sustainable value creation at sites. This will affect just over 1,800 positions. For each of these manufacturing sites, we are exploring divestment options through the end of 2026. This includes a partial or total sale. We expect cost savings to ramp up over time. Once the measures are fully implemented, we expect approximately $500 million in recurring annual savings in alignment with our capital allocation approach, these savings are intended to further support the advancement of our oncology pipeline towards commercialization. This is a decision we have taken after careful assessment. Our commercial and R&D drug supply will be covered by our broader manufacturing network. Supply of our COVID-19 vaccine will be fully handled by our partner Pfizer via their established manufacturing capacity beginning at the end of 2026. These plans underline our commitment to continuously steel our capacities in support of our strategy to become a multiproduct company by 2030. As we look across these 3 icons on the slide, we are energized by the progress we have made to date and the path ahead. We are making progress towards our strategy -- we are progressing key programs into pivotal stage, leveraging our partnership with BMS and our fortified balance sheet to fund our pipeline. From 2026 through 2029, we will drive execution at scale and speed, advancing combination therapy studies, accelerating pivotal trial execution, building tumor indication specific portfolios and executing our first oncology launches. By 2030, our goal is to be a diversified multiproduct global biopharmaceutical company, addressing the high unmet medical needs of cancer patients worldwide. BioNTech's robust financial position empowers us to pursue that goal. We remain fully committed to translating our science into survival for patients. With that, I will hand back to the operator to open the call for questions. Thank you.

[Operator Instructions] Our first question comes from the line of Dain a Graybosch from Leerink Partners.

We're excited to see the initial data from Rosetta Long 02 at ASCO. And I wonder although I have a question more about the statistical design of that study. We've all noticed and I think you shared in the last earnings call that you changed the primary end point from a dual PFS OS to a single PFS primary. And I wonder if you could talk more about why you made that change, including any conversations you had with BMS and with FDA.

First question from Daina about [indiscernible] which is coming at ASCO and a question about the rationale behind the endpoint change, which we announced, I believe, about 2 months ago.

Yes, I can take that, Doug. Daina, thank you for the question. We have made this change because PFS is a well-accepted endpoint in non-small cell lung cancer and is very large, and we expect the largest and earliest benefit a signal in this endpoint and wanted to make sure that we allocate the full alpha on this endpoint and have a statistically robust read out. This does not mean that we need let overall neglect overall survival. Overall survival is in fact, a key secondary endpoint and will also be assessed. And as you know, this is a well-trodden regulatory path in particular, for non-small cell lung cancer, which has also been extensively used by Kate Roder.

We'll now move on to our next question. Our next question comes from the line of Jessica Fye from JPMorgan.

Thinking ahead to [indiscernible] the HR-positive HER2 trial for TPAM, on what metric or endpoint do you expect the data to best underscore differentiation from HER2.

Okay. Question from Jeff at JPM on essentially how we see differentiation of TPAM versus in HER2.

So you asked for the endpoint metrics. The primary endpoint is objective response rate in connection with duration of response. And we have provided the data from the largest recurrent endometrial cancer population at SGO, which you might have seen where we demonstrate the objective response rate and duration of response together with a manageable safety profile. The differentiation is that we have now a data set, which shows that our ADC has also a clinically meaningful benefit in the lower HER2 population and the 1-plus and 2-plus population, which is a differentiator.

I was asking for Dynasty Breast 02, the HER2-low trial, where we have benchmark data from in HER2?

So this is -- yes, just to uses a pile of Tamesimotherapy. There's not a direct comparison of HER2. Of course, there are data where you can benchmark the results of this part which no. We have to see the readout and ensure, first of all, that there's a positive study and then whether we can make a cost comparisons to other [indiscernible]

And I'll add this is [indiscernible] Chief Commercial Officer for Biotech. We've always signaled that TPAM is an important asset for BioNTech also predominantly as a strategic asset not just for building out our commercial engine, which will be the first time for buying tech in the oncology space, but also as a combination partner. So towers point, we will wait for the data readout the physicians we spoke to always signal that they like to have more than one option. So we do see a meaningful place for [indiscernible] in the West center space as well. But again, a strategic asset that we predominantly also focus on in combination.

We'll now move on to our next question. And our next question comes from the line of Tazeen Ahmad from Bank of America.

For the upcoming data that you're expecting to show at ASCO for Punis chemo in the frontline non-small cell setting. How can we best frame expectations? What would be good data there?

Okay. Thank you. So -- that question was on our upcoming data that we are presenting at ASCO PMI frontline non-small cell lung cancer, what are our expectations in terms of that data set. Ozlem, would you like to take that?

Yes, I can take that. So this -- the data we present at ASCO is stronger Phase II heart of this trial. And what we will show is efficacy profile and the safety profile of 2 different doses of Tomita in the combination with chemo in this patient population. And that data might have to inform about what to expect then from the ongoing pivotal Phase III part of the trial.

Our next question comes from the line of Akash Tewari from Jefferies.

This is Manoj on for Akash. Just 1 from my end. Given the recent disclosures around the PFS interim from the HARMONY 3 global trial, do you think any changes in FX size assumptions or design changes needed to be considered for the Ocotlan trials? -- and also the Optoplan of trial showed interim overall arable hazard ratio around 0.6. So do you still think the chemo combos are the optimal approach -- market entry approach in the city?

Okay. Thank you, Manoj. So I caught that first question is on Harmony if that checks our perspective on the space? And second question, it was a little tricky to hear that all your within about best option for chemo combinations. Could you just clarify the question?

Yes. So [indiscernible] option from the fact TMDslike hazard ratio of 0.6 overall as a ratio point -- so just wondering like whether chemo combos are still the option or like going for the ADC combos will be the most optimal option to enter the market first?

Okay. Great. So also, should we pass over to you for the HARMONY-03 data? And then Ugur, if you could offer some context on the second question, please.

Yes, sure. So the recent disclosure of Harmony free data is about interim analysis of PFS, which is which was a late edit early look into PFS. But we don't know much about the metrics behind that. So we cannot comment extensively. However, Summit management has signaled that quote, they have deliberately used in minimal alpha to set the bar high, which is a very valid approach at that in this case. However, it also means that statistically this interim analysis is uninformative on the hazard ratio. So we have to wait for the next analysis, which will be later this year.

Yes. And so in short, we are -- this does not change anything for our overall strategy. We would like to remind everyone that our overall strategy has several days of development. The first day of development is Kometani such Simon. But we have already started more than a year ago, with first combinations, ADC combination. And at the moment, we have more than 10 clinical case ongoing to assess the combination of Puritane our ADC to our 4 to 5, 3 to 6. And we were in part on the studies end of -- in the second half of 2026. And this study is, of course, provide our differentiation that actually what comes next as the second phase, which will be a combination of comatoselected ADCs in different type of indications.

We'll now move on to our next question. Our next question comes from the line of David Day from UBS.

I just wanted to come back to the LOI, where you changed the primary endpoint from dual PFS OS to PFS primary endpoint. How do you think this will help with regulatory pathway? Does that mean that you're able to actually get approved just on PFS with accelerated approval and then full approval on the OS, just also thinking litter around how should we think about Redapt using PFS as a primary endpoint.

Okay. Great. Thank you, David. So Alan, maybe if I pass to you. So it was a question -- a follow-on question on Resetting on the endpoint changing from dual to primary on the rationale for that, specifically what it helps us to do with the development.

Yes. So first of all, this position was discussed with our partner, BMS and also with regulators -- and the point is, in fact, that PFS is the earliest potential readout. We know that this type of next-gen -- is that PFS is the earliest and also the largest endpoint to cover the mechanism of action of this next-gen IOs. And with having PFS as only primary endpoint, we can put the entire alpha on this PFS and ensure that it has the highest speed out power -- so this is the rationale behind that. Again, still overall survival is a key secondary endpoint. And having it as a secondary end point allows us to get a clean path to approval with even a delay or soft OS.

Our next question comes from the line of Asad Haider from Goldman Sachs.

The updates on the trial progress. Maybe just shifting gears quickly for Ramon on capital allocation. just given the substantial cash balance, it would be helpful to hear your updated thoughts on deployment and what the considerations were that went into the $1 billion share program you repurchase program you announced this morning. And then just on the revenue guidance reaffirmation despite the seasonally lower Govin 1Q that you're calling out, just talk us through how you're thinking about the revenue progression through the rest of the year.

Okay. Great. Thank you so -- thank you, Asad. I appreciate the questions. So first, talking about our capital allocation. I think our capital allocation strategy remains the same. We acknowledge that we are in an investment phase that we are building biotech into a commercial stage multi proto-oncogy company by 2030. And the good thing is that the strength of our balance sheet allows us to invest in the pipeline, continue to build our commercial capabilities and preserve flexibility for target opportunities in the M&A or the BD space. And additionally, now it's also allows us to return capital to shareholders. So the repurchasing program is not at the expense of our innovation efforts on pipeline, but it's more to be seen as an element of our overall capital allocation strategy. And then if I move to the revenue guidance and the dynamics of the COVID vaccine revenues. So I would say that our current guidance already assume assumes lower pro basin revenues versus last year. And as you rightly point out, so the regulatory and the recommendation landscape remains dynamic. And as you can expect, we are monitoring these developments very closely. Now based on the information available today and including the expected seasonal profile of comminate revenues, we are reaffirming our 2020 revenue guidance.

Our next question comes from the line of Terence Flynn from Morgan Stanley.

Just two for me. I was wondering if there's any update on the CEO search? And if you can provide a time line for when that might be finalized? And then also with respect to your TPAM FDA discussions, similar type question, just any update there and expected time line for visibility.

Thank you for the question. On the succession process. So this is being led by the Supervisory Board, so I cannot comment on specific timing or process details. What I can tell you is that both Ugur and Ozlem, together with the full management board and the overall organization, we remain committed to delivering our 2026 priorities. Our operating focus and strategy has not changed. And we will over the market as appropriate when we have more information on that.

Okay. Great. Thank you, Ramon. So now on TPAM, maybe if we pass to Osman, first of all, and then Marie, you could add some color as possible.

And this time it's about endometrial that study, right? Sorry for missing that for the other questions. So this cancer Phase II cohort is fully enrolled, and we have presented data, the confirmatory Phase III trial, the FERC continues to enroll, and we are in discussion with the FDA. We haven't changed our plans to submit Yes. And I would add to that what I stated before, TTM continues to be an important asset for us to lay our groundwork for commercial stage biopharmaco company and we continue to see the started launch as a very strategic opportunity to build our commercial infrastructure and prepare for potential future launches where, as you know, especially in the United States, time to peak for oncology assets go around time lines of potentially 9 months. So we don't have time to learn on the fly sort of saying, especially if we look at the potential for mid where we also partner with Bristol-Myers Squibb on the commercialization. This together would set us up nicely for success even though currently, we're not experienced in oncology launches as of yet.

Our next question comes from the line of Evan Seigerman from BMO Capital Markets.

We're looking forward to the data at ASCO. I want to follow up on Terence's question. As you think about the management change. Can you talk to the profile of a new executive team that you might want to bring in? Is it still R&D focused? Are we going to shift more towards commercial as you transform the company.

Thank you, Evan. Again, sorry if I am not going to be able to give too many specifics and details because the management board is not running this process. It's our Supervisory Board. Now having said that, our Chairman Helene has shared some characteristics last quarter when we disclosed the change in the management board. But I think it's -- so what we are looking is for skills and capabilities in late-stage development as well as commercialization -- production and commercialization and scale of pharmaceutical products. So I think I would be close to what Heather would be commenting on that.

Our next question comes from the line of Cory Kasimov from Evercore.

Do have 1 question. Let me ask if a competitor bisect data shows like an OS , how does that change the bar for percent of Lent, ike what is strong and just a West trend here beenough? Or does that just the antibias second, I'll clearly [indiscernible]

Sorry, the audio was not so clear on that. Would you mind clarifying? Were you talking about Pfizer's data or a different data set?

I would say ask historic data in the PD-1 BGS space here that does show like a clear OS benefit? How does that change or raise the bar for your studies?

Okay. Yes, understood. We get back now. So I'll pass over to [indiscernible] Can you it's about how many fixed did I a. On is positive is a how this would change our view.

Okay. So we are also excited to see the data. Remind you that this is a China study, which means that the comparator is titles past chemo, not embolus chemo. So it would not have a direct full for our [indiscernible] study.

We'll now move on to our next question. Our next question comes from the line of Mohit Bansal from Wells Fargo.

Given the Harmony 3 versus how many 6, and we don't know the data in alpha spend on FEI, but there has been some -- there are some questions around the translatability of China data to the global data. So I'm not asking you to comment on HR, but would love to understand when you are seeing your own China data versus global data, what gives you confidence that you would be able to replicate what you saw in China into a global trial.

So generally speaking, there are data sets. For example, Punit, small cell lung cancer, Puma TNBC data IVO second-line EGFR-mutated non-small cell lung cancer data, which are reproductions of previous China data on a global level. So we continue to be very positive about the regional report usability of this data. Having said that, with regard to the molecules to the molecule class, there seems to be reusability of data. However, there could be still setting specific frictions on data reproducibility in populations or indications in which there are major differences between global and regional population. For example, small cell lung cancer or non-small cell lung cancer, we are in China of smoking rates -- smokers rates are different to global. And that means we have to continue to monitor and follow the data and we'll see from the data, which comes out whether such setting specific frictions on reproducibility will show up.

Our next question comes from the line of Yaron Wage from TD Securities.

This is Jen on for Yaron. So to make the tire catalyst rich here with 5 more late-stage pipeline data readouts across Godin, BMC, et cetera. side a company premedicine ASCO, how should we think about the order and timing for the rest of these CLA stage readouts? And then secondly, on Kanuma. Beyond our 3 lead indications, obviously, 1 other Phase III trials during this year. How are you doing Bristol evaluating where Communic has the most potential.

Okay. Thank you for that. So I thought that, that is essentially around timing and cadence of our late-stage data readouts, I would imagine that in the coming year because that's what we've disclosed and then also how discussions are going with BMS in terms of which indications to prioritize. So Ozlem, should I pass it to you for this?

Yes, I can start with the second one from a scientific and clinical and medical point of view. I can say that BMS and we are very aligned in the understanding of the potential of Punita and that it is a very broad opportunity, and we are deciding on the sequence and on the specific indications together based on data and all the other dimensions, which are relevant for making strategic decisions for anetumab portfolio. With regards to data readouts, we will have a couple of data readouts on Pumitamig over the last -- over the next -- this year, 12 to 18 months. One of these readouts, for example, at ASCO, the Rosetta LAN GO-2 trial. Later this year, hightop readout from Phase I/II studies of combinations with our ADCs with Punita and additional readouts will follow in the next year. Yes. And I would just add on the BMS and medic strategy is that we have a very deep and strong governance ongoing with BMS at a different level. So from a scientific, from a clinical perspective. And also we're looking, of course, at where can we address unmet medical needs the most. And as you know, the oncology space is in constant evolution providing more options for patients and making sure that by the time our designs or trials read out, we're still relevant in what the current standard of practice clinical practices, and that is something where we can leverage both DMS and biotech capabilities as we're coming together to make those decisions. And sometimes, that also includes changing some of our initial thinking to maximize the opportunity for Pumitamig for both BioNTech and [indiscernible]

Our next question comes from the line of Jeff Meacham from Citigroup.

This is Jae on for Jeff. Maybe just following up on earlier questions on TPAM. Are there any outstanding data maturation requirements for TPAM that could push the time line beyond the current 2026 submission? And then earlier on the comments on TPAM having efficacy in low HER2 as well, is the strategy to pursue a broad pan-HER2 label?

Okay. Great. So we caught whether TPAM has any outstanding data request that could impact regulatory pathway. And then clarification on HER2 low and what our approach might be there. So also would you like to take the data question.

Yes. I can take both and the after we can also get for commercial input here. So no, we don't have outstanding data questions around TAM what we are currently monitoring is the enrollment of confirmatory trial to ensure a harmonized timing of BLA submission and the time lines for data to come out of this confirmatory trial. With regard to the populations, we are interested in a broad labor. We -- that's our goal, given that we have a large data set for all HER2 IHC levels, including the low expression on -- and I would add from a commercialization perspective, that -- I mentioned this before and talking to our customers or treating physicians that secondary option is always welcome. I think Part from our commercialization strategic launch and making sure that physicians start to get familiar with TFM itself as we're also moving forward with combination strategy it's going to be important for us to understand where we can leverage the strategic launch for TPAM specifically and then move through in commercialization.

Our next question comes from the line of Harry Gillis from Berenberg.

I have a follow-up on Catalyst timings. I was wondering based on the latest event accrual projections you have. Can you be any more specific on the timing of the Stage 2 portion of the gate Stobart reading. And then so on the [indiscernible] had a net trial, when we might expect those within 2026? And following on from that, for each of these if they were to be positive, should we just expect a press release at the time, stating that? Or would we expect any specific data? And then given got a [indiscernible] interim and I believe the fix back as well if these were to pass the interim readout, would we just nothing and then maybe get an update at the next quarterly results. So just exactly when we might expect those and how we should expect an uptick.

Thank you, Harry, for those questions. So we first question on Stage 2 GOT data. and then fix back head and neck and whether each would be likely to have interim data readouts or not. So Ugur, I'll pass over to you for this one.

Yes, yes. I think from the timing, nothing changed, we had guided to the second half of 2026 for [indiscernible] studies. We are on track on -- with regard to the enrollment of the -- in the study, and we are also on track with regard to the event count study, yes. This will be entering read out with -- in both studies, this is challenging hazard payback ratio. So it is a first income readout. If the internet out is positive, of course, we will document that if the study continues to go we will also inform the market that the [indiscernible] was performed and the study will continue to go on.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.