Q1 2025 BioNTech SE Earnings Call
Welcome to BioNTech's first quarter, 2025 earnings call. I would like to hand the call over to Michael Horowicz, director and rest of relations. Please go ahead.
Thank you.
Good morning and good afternoon. Thank you for joining BioNTech's first quarter 2025 earnings call. As a reminder, the slides we will be using during this call, and the corresponding press release we should this morning, can be found in the investor relations 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 of the US Securities and Exchange Commission
For looking statements on this call are subject to significant risks and uncertainties, and seek only as of the date of this conference call. We undertake no obligation to update or revise any of these statements.
Speaker Change: On slide three, you can find the agenda for today's call. Today, I am joined by the calling members of BioNTech's management team.
Speaker Change: Ugur Sahin, Chief Executive Officer and Co-Founder, Ozlem Tureci, Chief Medical Officer and Co-Founder, Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand a call over to Ugur. [inaudible]
Ugur Sahin: Thank you, Michael. A warm welcome to all those joining us today. As BioNTech has grown and evolved significantly over the years, our vision has remained unchanged.
to translate science into survival by building an immunotherapy powerhouse. [inaudible]
Ugur Sahin: and becoming a fully integrated BioNTech company with multiple approved products. In today's call, we will provide updates on peer achievement from this broader related power strategy course.
Ugur Sahin: In oncology, we presented new clinical data for two panchuma-priority programs, our bi-specific immunomodulator BN-527, and our mRNA cancer immunotherapies at recent medical meetings.
Ugur Sahin: for BioNTech Freezo 7, our bi-specific anti-PDR1, anti-VGF, anti-body, who presented new six-two data in small cell lung cancer, at the European lung cancer congress.
The preliminary overall survival data in the first hands setting. [inaudible]
Ugur Sahin: At AECR, we reported the first data from our phase 1 trial, evaluating B&T-327 in combination with our top two target in ADC-B&T-325.
Ugur Sahin: Signalling that this combination appears to have a manageable safety profile and may have synergistic clinical efficacy. This data sprang in our conviction in BN27 as the next generation I owe that bill. The next generation I owe that bill is the next generation I owe that bill.
Ugur Sahin: We will continue to drive its clinical development, with the aim to establish a new standard of care for cancer patients.
Ugur Sahin: Who Akarn is treated with a poor checkpoint inhibitor and for some that Akarn is not. For our Americans immunotherapies, we reported data from ongoing phase 1 trial. [inaudible]
Ugur Sahin: Avaliating BNT 116, our off-the-shelf six rack, mRNA immunotherapy candidate in combination with the middle map in PDL-1 positive frair patient with non-sons of lung cancer.
Ugur Sahin: The data indicate that our off-the-shelf mRNA immunotherapy may be synergistic with chestfront inhibition. Likewise, we are progressing our individualized mRNA cancer immunotherapy, oxygen saving my run, in randomized phase two trials.
Ugur Sahin: Early in 2025, the public to minus goods, is carving our insight from two sales one price? [inaudible]
Ugur Sahin: which demonstrate the polyspecific induction of long-term, near-engine specific T-cell responses, and strongly support the anticipated mode of action of our individualized mRNA therapy approach in multiple cancer indications.
Ugur Sahin: We are also advancing towards commercialization in oncology with the first BLA submission for B&T323. I will have two ADC plans by the end of 2025 pending regulatory feedback.
Ugur Sahin: regarding our COVID-19 vaccine franchise, initiated preparations to be on track to roll out a variant adapted COVID-19 vaccine for the upcoming seasons.
Ugur Sahin: During the quarter, we closed the BioFields acquisition and now hold global control over BNT-317. We were able to achieve all this while maintaining a strong financial position.
Ugur Sahin: Leveraging our COVID-19 vaccine business and our strong financial position, we are significantly investing in the clinical development of our priority on college programs across key tumor
Ugur Sahin: Before I continue with our strategy in oncology, I would like to provide an update regarding our management board.
Today, we announce our new Chief Financial Officer, [inaudible]
Speaker Change: We will welcome Ramon Zapata and July 1st, 2025. Ramon is an economic leader with deep finance experience who will be taking over from Jens at an exciting phase.
Speaker Change: He rejoined BioNTech from Novartis, Global Biomedical Research Organization, where he has been serving as CEO of Austin, 2022.
Speaker Change: He will introduce himself in the next analyst and investor called in August . With this and as previously shared, our current CFO Jens Holstein will retire at the end of his term at the end of June as Pant.
Speaker Change: D.A. Yanks, thank you for your excellent financial leadership and your significant contributions to BioNTech's successful trajectory. We wish you a continued success and fulfillment in the next chapter of your journey. Thank you very much.
Now coming back to our oncology strategy. [inaudible]
Speaker Change: One of our first convictions for cancer immunotherapy is that we believe.
Speaker Change: that future cancer treatment and particularly the desire to increase cure rates in human cancers will be driven by combination therapy exploiting compound classes as potentially synergistic mode of actions.
Speaker Change: Driven by our vision, we want to address the full continuum of campus across different states.
Speaker Change: from Resacted Cancer, which are in the atrium stage and have a high risk for relapse.
Tourist stage metastatic cancer. [inaudible]
Speaker Change: as well as the late stage cancers, which are refractory to different types of treatment.
Speaker Change: We have built a pipeline with compounds from different rock classes that are well suited to achieve this, following for novel novel combinations of immunomodulators with targeted therapies and mRNA cancer immunotherapies.
Speaker Change: With a clear focus, we will continue to invest in our technologies and drug candidates that have the potential to improve outcomes for patients across wide range of tumultives.
Speaker Change: and our bi-specific anti-PDF-1 anti-VG-S anti-body P-257 have disruptive potential in our aligned to the out-of-the-follow mission.
Speaker Change: It's successfully developed and approved. We believe these programs could establish a new standard of care and enhance patients outcome in multiple cancer indications globally. We are significantly investing in the clinical development of these programs. [inaudible]
Speaker Change: A course, various Gensertaps, building up commercial sanctions for the future commercialization in key markets and enhancing manufacturing capabilities to support both clinical price and commercial supply.
Speaker Change: I will turn the call over to ask them to provide more details on select clinical programs.
Thank you, Ugur, glad to be speaking with everyone today.
Ozlem Tureci: Our first oncology programs are moving towards commercial stage. We continue to advance toward our first BLA submission in oncology with BND323 in her two expressing...
Fecundine Indomitro Cancer.
Longside, Pianti Free 23,
Ozlem Tureci: and our mRNA cancer immunotherapies. The NT-327 is a key programme in our development pipeline with first global pediatric clinical trials in triple negative breast cancer, small cell and non-small cell lung cancer.
Beyenti327.
by co-localizing the blockade of PDL1 and VGFA.
Ozlem Tureci: Signaling to the tumour, is being developed with the aim to deliver superior anti tumour immunomodulatory and anti-angiogenic effects.
Ozlem Tureci: compared to individual targeting of PDL 190 EGFA, and with the potential to minimize its worst events associated with systemic NIVGFA therapy.
Ozlem Tureci: We now have data from over 1,000 patients across indications which further strengthens our conviction in this asset.
Ozlem Tureci: with the anti-PDL1 and anti-VGA mechanisms being validated across numerous tumour types and in some cases in combination we have a clear roadmap for development.
Ozlem Tureci: The first way to focus on small cell and on small cell lung cancer, NTNBC, is key indications to establish PNT327, combined, the standard of care chemotherapy, with first-proofers.
Ozlem Tureci: then for the first line settings of these indications. We have made continuous progress over the past months in researching these clear indications.
Ozlem Tureci: Our second wave of development with B&T327 reflects that IOPUS ADC combos are an emerging treatment paradigm in oncology.
Ozlem Tureci: The last wave aims at further broadening our global clinical development program with BNT327 through additional and other combinations across Tumortat.
Ozlem Tureci: As mentioned, triple negative breast cancer is a priority indication for BNT327 based on the unmet need we see for patients and based on the clinical profile observed to date.
Ozlem Tureci: that 40 NBC patients face poor prognosis with a five-year survive rate around 10 percent. [inaudible]
Ozlem Tureci: Covered BV patients, depending on their PDI-1 status, either treated with checkpoint inhibitor in combination with chemotherapy, or with chemotherapy alone.
Ozlem Tureci: BDL1 positive stations have a median overall survival of 23 months, while BDL1 negative stations have a median overall survival of 15.2 months as observed in the keynote 355 study.
Ozlem Tureci: Data from a study in first-time metastatic trip to negative breast cancer. [inaudible]
Stortford, B&T, free 27. 7.
Speaker Change: In combination with chemotherapy, hasn't encouraging the eye objective response rate of 73.8% irrespective of PDI-1 status.
Speaker Change: We also observed in the trial encouraging landmark overall survival rates such as 69.7% at 18 months for BNG327 in this setting, suggesting that effective control of disease
and Frantzade into improved overall survival.
Speaker Change: In addition to the encouraging efficacy data, the manageable safety profile was observed, with no new safety sickness beyond those typically described for standard of care chemotherapy for anti-PD1-PDI-1 and anti-VGF-A-1-Feropiece.
Speaker Change: Based on this data, we believe that the NT-327 has the potential to become a first-line treatment option for triple negative breast cancer patients, including those not currently treated by existing IO therapies. We also plan to start a phase three trial later this year in the first-line set. [inaudible]
Speaker Change: Singh. Moving to extensive stage, small cell lung cancer, an immunologically cold tumor for which I am at need remains. With current standard of care treatment, the durability of responses is quite short, and 5-year survival rate is only 3%.
Speaker Change: Today, these patients are treated with a combination of Arte Solizumab and Kimu therapy and experience a median overall survival of 12.3 months as observed in the Empower 133 clinical trial.
Speaker Change: Based on our emerging data, we believe that BND327 has the potential to improve clinical outcomes for patients with small cell lung cancer.
Speaker Change: At the European Lancaster Congress, we disclosed interim data from our phase two clinical trials evaluating BNT327 in combination with team of European as a first line treatment for patients with extensive stage nor the Lancaster. Dr. Prasimov, Dr. Prasimov, Dr. Prasimov, Dr. Prasimov
Speaker Change: 0.4% and median progression free survival of 6.9 months. The ELCC data also included for the first time median overall survival data with a median overall survival of 16.8 months. [inaudible]
Speaker Change: In addition, a manager of a safety profile was observed with known new safety signals beyond those typically described for chemotherapy agents and anti-PDI-1 and anti-V Jeff Moon of
Speaker Change: Avis data us to immature, we are encouraged by the findings.
Speaker Change: These data support our decision to evaluate B&T-327 in combination with chemotherapy in the ongoing global randomized phase-free clinical trial Rosetta-Zang-O-1.
Speaker Change: We view Nonsmos alone cancer as one of our priority indications as it's one of the most prevalent cancer globally. Over 80% of patients are diagnosed at late stages.
Speaker Change: Long-term outcomes depend on PDL1 status and astrology, but overall remain poor-disfied improvements in care by checkpoint inhibitors.
Speaker Change: At the ESCO Annual Meeting last year, we presented data from the Phase I trial, evaluating BNT-327 as a month of European first-time treatment in metastepic PDI-1 positive non-smoselang cancer.
Speaker Change: BNK327 Monoferep treatment resulted in an overall response rate of 47 percent, the DCR of 100 percent, and the MPSS of 13.6 months.
In summary, BNT327 indicated that encouraging anti-Juma activity
Speaker Change: and Management Safety and Dispatient Population. Safety events were consistent with those described for NTAP-DL-1 and NTAP-VGF MonofEuropean.
Speaker Change: These data support our decision to start our Global Phase III trial in Nonsmossel Lang Cancer, which is named Rosetta Lang 02.
Speaker Change: Rosetta Lank O2 is designed to evaluate the potential of BNT327. The BNT327 is designed to evaluate the potential of BNT327.
Speaker Change: Those in combination with chemotherapy to improve on survival outcomes when compared to standard of care, Pembrolyzumab in combination with chemotherapy as a first-line therapy for non-smart cell lung cancer patients, without actionable genomic alterations.
Speaker Change: This trial is enrolling both non-squamous and squamous histologies in two separately powered substudies, and each substudy will enrol patients across all PDL-1 status.
Speaker Change: The study includes a phase two part with 40 patients seeking to establish the dose for the phase three randomized part in 942 patients. The cope primary endpoints up progression free survivors and overall survivors. [inaudible]
Speaker Change: Today we are enrolling patients in the face to part and expect of progress to the face
Speaker Change: We will present the complete trial design for our tour ongoing BNG327 Global Phase 3 studies.
Rosetta Lang O1 and Rosetta Lang O2, which are evaluating.
Speaker Change: BNT327, Doast in combination with chemotherapy, in first-line small cell, and non-small cell lung cancer, at the ESCO and UN meeting at the end of this month.
Speaker Change: We plan to have a significant presence at the ESCO and your meeting, including five clinical data updates across our oncology pipeline.
but also our Anti-CTLA-4, BNT316, our B7H3-targeting ADC, BNT324.
and BNK142, our clothing, Sixth T-cell, Engager, Rydo Knot. [inaudible]
Speaker Change: We look forward to this and other conferences this year, during which we plan to share more data updates across our investigational oncology pipeline as we continue our progress toward becoming a multi-product oncology company.
Speaker Change: To conclude, as I highlighted at the beginning of my section, we remain strongly convinced that our combination-based pipeline offers this potential to positively impact the future outcomes for patients in key indications such as in breast and lung cancers. Thank you very much.
Speaker Change: With that, I will now pass the presentation to our CFO Jens Holstein.
Jens Holstein: Thank you, Aslam, and a warm welcome to everyone who has doubts in today's call.
Jens Holstein: Let me begin my section with our Q1 2025 funders' results. Thank you very much.
Jens Holstein: In the first quarter of 2025, we reported total revenues of approximately 183 million euros driven mostly by the sale of our COVID-19 vaccines compared with 188 million euros for the first quarter of 2024.
Jens Holstein: This revenue figure is consistent with our expectations and reflects the seasonality that we expect in an endemic COVID-19 environment. Research and development expenses reached 526 million euros for the first quarter of 2025 compared to 508 million euros for the comparative prior year period.
Jens Holstein: The increase was mainly driven by progressing late-stage clinical studies for pipeline candidates including BNT-327 in our ADC portfolio.
Jens Holstein: SGNA expenses amounted to approximately 121 million euros in the first quote of 2025 compared to 133 million in the comparative prior year period.
Jens Holstein: The decrease was primarily driven by reduction in external services.
Jens Holstein: For the first quarter of 2025, we reported a net loss of 460 million euros compared to a net loss of 315 million euros for the competitive prior year period.
Jens Holstein: Our basic and diluted loss per share for the first quarter of 2025 was 1 euro and 73 euro cents compared to a basic and diluted loss per share of 1 euro and 31 euro cents in a comparative prior to period.
Jens Holstein: As indicated in our full year earnings call in March, 2025 will be a year of transition for BioNTech with the aim of becoming a multi-product oncology company.
Jens Holstein: We will continue to invest with discipline in our long-term growth strategy, namely by enmancing B&T327 and our mRNA cancer immunotherapies.
Jens Holstein: We believe that these two programs have disruptive and humor potential. We ended the quarter in a strong financial position with 15.9 billion euros in total cash plus security investment.
Jens Holstein: Among other things, the reduction compared to the year end figure is due to the payment of approximately $800 million US dollars as part of the buyer's views acquisition.
It also
Jens Holstein: Reflects the payment made in connection with the settlement of the contractual dispute with NIH of about $792 million US dollars.
Jens Holstein: We expect an additional payment of $400 million dollars associated with the settlement with the University of Pennsylvania to be reflected in our second quarter 2025 financial position.
Jens Holstein: With respect to both these settlements, we expect to be reimbursed partially by our partner Pfizer during 2025 and 2026.
Jens Holstein: Building on our strong caste position and track record of financial discipline, we will continue to invest in our pan tumour oncology programs, which we believe position us well to achieve sustainable growth.
Jens Holstein: Turning to the next slide, we're confirming the company's financial guidance for the 2025 financial year with revenue expected to be in the range of 1.7 to 2.2 billion euros.
Jens Holstein: R&D expenses expected to be in the range of 2.6 to 2.8 billion Euros, SGNA expenses expected to be in the range of 650 to 750 million Euros, and capital expenditures expected to be in the range of 250 to 350 million Euros.
Jens Holstein: Our revenue guidance assumes relatively stable vaccination rates, pricing and market share as compared to 2024. We anticipated revenue-facing similar to last year with the last three to four months of the year driving the full year revenue figure.
Jens Holstein: Please note that potential changes in law or government policy, including tariffs in public health policy.
Jens Holstein: and evolving public sentiment around vaccines and mRNA technology worldwide could further negatively
Jens Holstein: While it is premature to commence specifically on the potential impact of terrorists on the pharmaceutical industry at the stage, we're actively monitoring the situation and I'm valuating potential risk mitigation strategies.
Jens Holstein: In addition, we estimate some inventory rounddowns and other charges in the range of roughly 15% of BioNTech's share of growth profit from COVID-19 vaccine sales in the Pfizer territory.
Jens Holstein: We also expect revenues related to our service businesses as well as revenues from the German pandemic preparedness agreement to contribute to our overall group revenues. We continue to diligently invest in our long-term growth strategy.
Womentaining Financial Discipline. [inaudible]
Jens Holstein: We remain focused on achieving long-term sustainable growth and generating value for patients and shelters.
Today I will close my section on a personal note.
Speaker Change: As Ugur mentioned, I will retire for my executive role at BioNTech at the end of June , and will focus on non-executive board roles in future.
Speaker Change: As this is my last earnings call as CFO of BioNTech, I would like to take this opportunity to thank the investor and analyst community for their trust.
Speaker Change: I also thank my colleagues on the supervisor and management board as well as my teams for the dedication and collaboration during this remarkable growth journey.
Speaker Change: It has been a privilege to be part of the development of BioNTech into one of the largest global biotechnology companies.
Thank you.
I'm confident that BioNTech is well positioned for continued success.
Speaker Change: And with that, I would like to turn the call over to our Chief Strategy Officer Ryan Richardson for our strategic outlook and concluding remarks. Thank you. Thank you, Jens.
Ryan Richardson: I will close our prepared remarks with a brief summary of our 2025 strategic priorities.
Ryan Richardson: We are continuing to focus on executing against two pen tumor product opportunities, BMT-327 and our mRNA Cancer Immunotherapies, Dixthak and Ninest.
Ryan Richardson: Both of these programs are currently in multiple, ongoing phase two and three trials, reflecting our strategy to bring novel combinations to patients. We expect to generate additional meaningful data for these programs throughout this year. [inaudible]
Ryan Richardson: We are also continuing to build out our commercial capabilities and oncology to support our goal of becoming a fully integrated biopharmaceutical company.
Ryan Richardson: These include a U.S. General Manager and broader global commercial leadership team, with the goal of commercial readiness to support our transition to the commercial stage in oncology, starting with the potential launch of BNT323 as early as 2026, if approved.
Ryan Richardson: In infectious diseases, we will continue to invest to maintain our advisor's global leadership position in the COVID-19 vaccine market, while advancing next-generation and combination vaccines in the clinic.
Ryan Richardson: We expect to provide multiple updates from our early stage infectious disease pipeline this year.
Ryan Richardson: In closing, I would like to highlight on the next slide important investor events we will be holding this year.
Ryan Richardson: Our annual general meeting will take place on May 16th. We also plan to hold our innovation series event in the fall and we'll share more details later in the year. With that, we would like to open the floor for questions.
Speaker Change: Thank you. Task a question, you will need to press star one and one on your telephone and wait for your name to be announced. Please make sure you ask your question loudly and clearly into your microphone and please limit yourself to one question only.
Ryan Richardson: To withdraw your question, please press star 1 and 1 again.
who will now go to your first question?
Speaker Change: And your first question, consumer line of Tazeen Ahmad from Bank of America, please go ahead.
Kazim Ahmed: Hello, good morning. Thank you for taking my question. As you prepare for your first launch for endometrial cancer, can you talk to us about how you think?
Kazim Ahmed: that particular adjustable population is. And then related to that, can you remind us where manufacturing of 327 is expected to take place, and if you expect any impact from those
Speaker Change: Yeah, thank you, Tazeen. So, we estimate that the second line market in the mutual cancer is about 10,000 patients in the US and Europe .
Speaker Change: So it is a sizable potential market opportunity in regards to manufacturing. So we've licensed this program, and we're going to introduce you to the three of you now from duality biologics. Manufacturing is currently action.
Speaker Change: Currently supplied China, and we are in the process of diversifying our supply base and our plans over the next couple of years are to establish multiple supply and I know it's including outside of China but for the time being we're reliant on a China-based CDMO.
Thank you.
Speaker Change: Brooks, I'll just say that, you know, maybe yes, you can say a few things about Terence for our broader business, but we don't anticipate at the current time significant impact financial impact. Thank you very much.
Speaker Change: from the tariffs that have been announced. Obviously we're continuing to track policies and responses to the U.S. policy in that regard.
Thank you.
Speaker Change: We will now take the next question and your next question comes the line of Akash Tewari from Jeffries, please go ahead.
Akash Tiwari: You know, Vegif by specific change standard of care in chemo combo, or you really actually needed a novel ADC along with the by specific to beat Pembro chemo. And then kind of as an add on how do you expect the safety profile of 327 to evolve in chemo combo versus some of the early data you seen with the trope to ADC thanks.
Yeah, thanks Akash, so I think you're asking. Thank you.
Akash Tiwari: Yeah, just to clarify the question. So you're asking in five years, how do we see the NSCLC market evolving? Do we see this?
We'll go with that.
Akash Tiwari: I think that was the question. Akash, we think that actually both will be the case. On the one hand, we, as you know, are developing our bi-specific pre-27 in combination with chemotherapy to replace first-generation CPIs and non-smart cell lung cancer. However, we expect that the clinical benefit [inaudible]
Threshold, to be reached, will be moving over time, and therefore also ADCs in combination.
Akash Tiwari: and with our Vice-Pacifics, all with such PD-1, PD-I-1, BGS, Vice-Pacifics, we also have a role.
Akash Tiwari: That's the reason why we are following both strings of development in a sort of sequential manner.
Akash Tiwari: and the Free Guard. And the Free Guard to the ADC that you know, we have several ADCs that and principle can be combined in the non-sponsor lung and syndication, including our top two ADC BC7H3 as well as our Free ADC BNC326.
Thank you.
Speaker Change: Your next question comes from the line of Daina Graybosch from Layering Partners, please go ahead.
Speaker Change: Hi, CDC's ASF is going to have a vote in June on the recommendation of COVID Boosters and my interpretation of their pre-meeting was there is a likelihood that they narrow the U.S. recommendations to a risk-based.
Speaker Change: And I wonder if you could talk about that meeting, what you anticipate the vote will be, and if they do narrow it, how that might impact your COVID-19 vaccine trails in the US. Thank you.
Yeah, thanks for the question, Dana. And indeed, we...
Speaker Change: of the world, not just in the United States, but also in other regions. And we are expecting actually the first wave of decisions regarding strain selection and policy for COVID.
Speaker Change: So the COVID season in 2025, take place actually in the next couple of weeks in May already in some regions.
Speaker Change: and we're going to be tracking that very closely, so I think we'll have...
Speaker Change: within the next four to six weeks we already have some additional clarity in terms of the picture. I think in regards to the U.S. policy specifically.
Speaker Change: It's already been the case that the majority of vaccinations in the United States have gotten to the older 65-plus population, along with the immunocompromised, which together account for about 20% of the U.S. populations, about 18% of the less population is 65-plus and there's a couple more percent.
that take into account the immunocompromised, so that's it. [inaudible]
Speaker Change: And that's already been the majority of vaccinations in the US for the last couple of years. So while of course we're going to we're going to track the outcome of the meeting that you mentioned, we think that the markets already oriented in that direction. And so you know our our base scenario here is that we think that. [inaudible]
Speaker Change: The vaccination rates in the U.S. around 20% that we've seen over the last couple of years is still our sort of base scenario going into the end of this year.
Speaker Change: And in addition, maybe Daina, to just that, we've seen such a development and other jurisdictions before as well. So it's nothing new. What we experienced is, of course, you know, the recommendation goals for the whole of the population goes for the new suppressor population. This is the recommendation.
Speaker Change: and there will be a chunk of people that will, and that's difficult to predict, a chunk of people that will get vaccinations nonetheless independent of the recommendation on the age, that's the experience that we had in the past to great extent, so we gotta, it has to be seen how the implications will...
will look like. [inaudible]
Speaker Change: Good. Good. I have a negative implication, but it's very difficult to protect this.
Thank you for your time.
Thank you.
Speaker Change: Your next question comes from the line of Cory Kasimov from Everkall. Please go ahead.
Corey Kazimoff: Hey, good morning, guys. Thank you for taking my questions and I end congratulations on your retirement.
Corey Kazimoff: So, I want to recognize it's difficult to comment on programs and another company, but I'd be interested in your perspective on a case of preliminary overall survival data that recently came out. I mean, is this something that's in line with your expectations and maybe more specifically is related to? [inaudible]
Corey Kazimoff: 2-3-2-7. Does it have any impact at all in how you think about designing your own trials in not small cell lung cancer? Thank you.
Speaker Change: Yes, thank you, Cory, for the question. You know, we are also strong believers of the VGF PD-1 PD-01 by a specific concept. Therefore, we find the data which has been reported from Harmony to very encouraging. The PSS, which was the primary endpoint, is, as I speak for itself, the OS print, which...
Speaker Change: is based on a premature analysis of an immature information fraction with a very low alpha, also business encouraging. It has not direct impact on our program, Rosetta Lang, O2 is in a different population, and it's in combination with chemo theorists.
Speaker Change: Therapy, however, as I said, seeing that the concept as such is producing and encouraging data and clinical benefit is also very positive for us.
Thank you.
Thank you.
Unknown Speaker
Speaker Change: Your next question comes from a line of Terence Flynn from Morgan Stanley . Please go ahead.
Terrence Flynn: Great. Thanks for taking the question. Two part for me on 327. Thanks for the details on the Rosetta Long-02 study. I was just wondering if you could elaborate in terms of the doses that are being studied exactly in the Phase II portion, and when we might see some of the Phase II data, and then can you disclose the powering of the Phase III portion of that trial? Thank you. Thank you.
Terrence Flynn: We cannot comment at this point on the doses we are exploring. You might get more information on that later this year when we will present the trial design on conferences. The second question was
Can you repeat the second question?
Terrence Flynn: The timing of the data for Phase Two and the powering of the Phase Reportion. [inaudible]
Terrence Flynn: Yeah, so the data for Phase 2, we will see some data this year, beginning of next year. And the powering for the Phase 3 portion is to accommodate, to accommodate a core primary PFS OS. [inaudible]
Thank you.
Thank you.
Speaker Change: Your next question comes from the line of Jessica Faye from J.B. Morgan, please go ahead.
Jessica Faye: Hey guys, good morning. Thanks for taking my question. Ryan, I think earlier in the call you mentioned minimal impact from current tariffs, but can you speak to how the potential implementation of future bioforma tariffs in the US might impact?
Speaker Change: is commercially for the US market made in the U.S.
Speaker Change: and second, can you just recap what you guys see as the key similarities, or maybe, you know, more importantly, the key areas of differentiation of your development plans for 327 relative to the I'm an SMS development program. Thank you. Thank you.
Speaker Change: Yes, sure. Thanks, Jessica. So, on the tariff point, my reference to a limited year-term financial impact was related mainly to the fact that we've got one commercial state product in community currently where we have production infrastructure and capability through our partnership with Pfizer on both sides of the globe.
Atlantic, so we got...
Jens Holstein: We have the ability to produce that vaccine in the United States. We also have the ability to produce it in Europe . And we have sufficient capacity to manage that accordingly. I don't know, Jens, would you add anything? No, it just, you know, they're existing tariffs already for China, you know, 20% at this point in time. We have the ability to produce that vaccine in the United States.
Jens Holstein: that we've got to cover and the financial implications so far have been really minor for us going forward. That brings lies a little bit difficult in terms of predictions. Of course, how that will evolve over time and some miracles.
Jens Holstein: Will be challenged and costs could go up for clinical trials and for research work, but overall at this point in time, we would estimate that it's not being...
Jens Holstein: Really critical for us, we can't talk for anyone else, of course. I mean, you've seen a lot of statements from other companies in terms of the terrorists. We got to wait for things that are evolving over time and how severe financial implications can look like.
Speaker Change: and with regard to your second question, Jessica, on BN2327 development strategy.
Jens Holstein: I would just note that our strategy is based on a couple of key pillars, the first of which is to establish B&T 327 as an approved therapy and a number of solid tumor indications.
Jens Holstein: We've announced publicly three of those indications, a couple of those where we think were positioned, if we can execute well to be potentially first to market,
Jens Holstein: Those first wave of trials are with chemotherapy backbones. We think that's the fastest path to market. But the broader and longer-term strategy is to combine E&T327 with other agents, including ADCs, and there we think we have a differentiated strategy. [inaudible]
Jens Holstein: by virtue of our broad pipeline and the ADC's and other therapies that we have in house that could be combined with it.
Thank you all. Thank you. Thank you.
Thank you.
Ryan Richardson: I don't have much choice at all to add, thank you, Ryan. I think that some rise was...
Someride is a lot of differentiation strategy.
Thank you.
Your next question?
Speaker Change: Come from the line of Evan Vigerman from BMO Capital Markets, please go ahead.
Speaker Change: Hi, all. Thank you so much for taking my question. I wanted to take a higher level question. You know, with varying views on mRNA technology, how are you thinking about the potential of your therapeutic testing franchise? You know, there's a lot of resistance building up in the United States. You still see this as a core component of your strategy. You're more focused on the bi-specific. Thank you so much. Thank you.
Unknown Speaker. Okay. Thank you. Thank you. Bye-bye.
Definitely, we have the other...
Crimes in our Amani Territory Dicks. [inaudible]
We have eluded today, we have...
Speaker Change: A two-pan tumour opportunities is beautifully to seven, which gives us the opportunity to develop the product as a potential newer IO backbone in multiple indications.
Speaker Change: and the same as two for the Pantuma potential for our therapeutic mRNA immunotherapies.
based on our neo-antigen as well as our TXVAC approach.
Speaker Change: We believe that this approach has a huge potential, particularly in the patient population with a higher risk of relapse.
Speaker Change: either in the achievements setting or in the minimum gradey-to-easy setting. But we also believe that the combination of both compounds, Beguiru 7, as well as our vaccine and monitor, a poetics vaccine, provide a huge opportunity.
Speaker Change: So the science is clearly stating that mRNA teleporities are going to be a disruptive platform of the future and we believe it's even more the time to invest into the technologies and further leverage our strengths here. [inaudible]
Thank you.
Speaker Change: Your next question comes from the line of Yaron Werber from TD Cowan, please go ahead.
Yaron Berber: Yeah, hi. Thanks for taking my question. I have a couple interrelated questions. The first one is...
Unknown Speaker
Speaker Change: You know, you've been very clear, and everything you said made a lot of sense on how you're going to develop 327, small cell, TNBC, non-small cell.
Speaker Change: What about second-line EGFR mutant? Any thoughts on that indication? Obviously we're waiting for the phase three from the competitor. And then secondly, can you just remind us for 3.23 for second-line endometrial? What data are we expecting this here in filing? For accelerated approval is going to be based on which end point specifically and if you can just the powering for that study. Thank you. Thank you.
Speaker Change: for Second Announcement of the Lancaster, I believe you refer to the EGF R Mutant Population, right?
Speaker Change: We have recently published data in the population including, including response and PFS data.
Speaker Change: based also with differentiation into patient populations with PDL-1 positive and PDL-1 negative populations, the data are very encouraging.
We will consider, consider, we are considering to combine both to, as we expect [inaudible]
Synergistic Activities here.
Speaker Change: and we also keep the option to be in deep into seven in the sub population of E.G.F.R. mutant tumors based on their PDR-1 for creativity.
Speaker Change: I think in regards to your second question, which I believe was what are the endpoints in the data package that we expect for B&T?
3-2-3, later, the Sherales, and do you want that? [inaudible]
Yes.
Speaker Change: single arm trial, which comes basically out of our basket trial across solid cancers, which we are conducting, have conducted together with dualities and the end point is objective response rate. We are in discussion with regulatory authorities.
Speaker Change: to better understand the expectations for a BLA and are progressing in these discussions.
Thank you for your attention.
Thank you.
Speaker Change: I might also add, I have to say that the population is across all her two positivity scores, so it's the broader second sign and no mutual cancer population.
Transcription by CastingWords
Thank you.
Speaker Change: Your next question comes from the line of Mo'Head, Banzal from Wells Fargo, Plank Goahead.
Mohit Bansal: Okay, thank you very much for taking my question and congrats on all the progress.
Mohit Bansal: I have two questions. So one is with Rosetta Langtou, could you give us some timelines then should we expect face to portion of the study to be over and you're moving forward into face three. And second one, I mean we get a lot of questions around the differences between
different by specific to your stomachs and muscles and the key... [inaudible]
Speaker Change: Key difference I see like one is that you are the only one using a PDL one.
Speaker Change: and you also have the very, very heavy chain, so VH, VH. So could you talk a little bit about these differences and how much could they matter in the real world, especially PDL1 given that the experience with PDL1 antibody bodies has not been that fruitful. Thank you.
Unknown Speaker
Speaker Change: Okay, so I think the first question was, when do we expect the phase two portion of the Rosetta Long trial to be complete?
Speaker Change: The phase two portion of Rosetta will be completed later this year or we will have data to inform, put it in this way to inform the phase three portion of the trial, defining the dose which will be then used in the phase three portion which we'll start this year. [inaudible]
Speaker Change: The other question I think was about the molecule differentiation between different bi-specific molecules with this mode of action. We cannot comment others molecules. Obviously, we have deliberately chosen when we were assessing different external opportunities of bi-specific molecules.
Speaker Change: Pact from PDL1 that it might be superior to PD1 in anchoring in particular in the two more micro-environland where we want to have the bi-specific that was one of the reasons and also the molecular format. Thank you very much.
Speaker Change: with full and IGG, VGF, anti-VGF portion, and VHH, PDA1 portion, was compelling to us because we think that we get the right pattern of cross-leagation in the tumor microns.
Environment.
Thank you.
Speaker Change: Your next question comes from the line of Jeff Meacham from Citigroup. Please go ahead.
Speaker Change: Hi guys, this is Nishan Gondon for Jeff and thanks for the question. So on 3 to 7, you also highlight potential to kind of combine with other modalities, including ADCs and cell therapies. So I wanted to ask, what are the key factors driving the selections of this? [inaudible]
Speaker Change: Special Combination, then what is the overall kind of rationale for this kind of combination? Thank you.
Speaker Change: Our portfolio, Entai and the content portfolio has three categories of products which are all suitable for its combination therapies.
Speaker Change: Professor of our I.O. Pipeline, so we have a multiple edition, by specifics, particularly also after acquisition of BioNTech. Thank you very much.
Speaker Change: in the pipeline, including, for example, TJPVIPG, Entipody, Batswethic Entipody and other Batswethic Entipody.
Speaker Change: So these are the river engage into clinical trials, we have in preclinical context.
Speaker Change: a mode of action synergy for this compound second class, which we find very exciting is our M.A. vaccines and M.A. immunotherapies.
and Improved OS.
but also have to completely eradicate residual tumor size, which...
which we made, we made after check-point blockade.
Speaker Change: We have been engaging into a number of breakthroughs and our first. [inaudible]
Speaker Change: Crackle Courts are going to start this year in later this year.
and we have recently demonstrated pre-clinical proof and concept. [inaudible]
Speaker Change: of Combination of Beauty with the Seven. That's our ADC, ADC, the portfolio.
Ritchie Provides,
and Opportunity to reduce tomorrow's garden, which is 80 feet. [inaudible]
to benefit from the immunogenic cell deaths mediated by ADCs.
Speaker Change: Superreo effect of the bi-specific combining VGF, AntivgF, and PDL, and our one activities.
Thank you.
Speaker Change: To our next question, from the line of Attika Gunavardiner from Turingist, please go ahead.
Speaker Change: Titus Karina for us, but thanks for seeing your question. I have the question on the initial ACHR data for BNT327, which was combined with Trump to ADC. There was notable rate of stromatitis.
and the Thomas Pytus raid in the Formination.
Speaker Change: He was very comparable to the tomatoes that is observed with...
Speaker Change: B&T325, our entire top 280 C alone, which is very encouraging that we don't see additional
Thank you.
Speaker Change: Your next question. Course on the line of Harry Gillis from Bamberg, please go ahead.
Harry Gilles: Higher, thank you very much for taking the questions. Could you please comment on the extent of global phase 2, BNT327 data you've seen internally that informs your decision for phase 3 entry in small cell, lung and TNBC?
Speaker Change: and then related to that, is Phase 3 entry in TMBC still contingent on any Phase 2 global data? And finally, when could we expect the Phase 2 global data for...
Speaker Change: for the NT327 in Small Cell, or TNBC this year, could we say that as more well-drawn? Thank you.
Yeah, yeah, as you might...
Speaker Change: We are doing now our clinical trials in this indication in a global, a global man in the US, in Europe , in the multiple centers in Turkey.
Speaker Change: and the recapitulating data identified, identified, identified or previously presented from China patients. We are very confident that this...
Speaker Change: Findings of the China Prize will be more or less fully recapitulated in the Global Times.
Thank you. Bye-bye.
Speaker Change: Thank you. We will now take our final question for today.
Speaker Change: And the final question comes from the line of John Newman from Cannicle Genuity. Please go ahead.
John Newman: Hi, thanks very much for taking my question. I'm just curious regarding the development of the COVID-19 vaccine. It's Pfizer. What are the happening thoughts on?
John Newman: Some of the recent comments coming out of FDA regarding the possibility of looking at randomized studies of a really strange update. It's morning if you think that's feasible or likely, if it were to move forward what your strategy might be.
Thank you for watching.
Speaker Change: Yeah, thanks, John . So, I think that I would note that the COVID-19 vaccine was first approved after a study of 43,000.
participants, very large, global study.
where we demonstrated efficacy. It's huge.
in the next study. And, um...
Speaker Change: You know, obviously we're continuing to track all policy potential policies out of the A.A. but...
Speaker Change: We don't expect that that talk is going to have an year-term impact on our COVID vaccine franchise given it's been approved for multiple years. Our expectation is that there's going to be multiple regions selecting strains for the fall of 25-26 season, and that's our focus at the moment. [inaudible]
Absolutely.
Speaker Change: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.