$BNTX BioNTech Q2 2024 Earnings Conference Call

thank you for joining biontech 2 quarter 2024 earnings call as a reminder the slides we will be using during this call and the corresponding press release we issued 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 with the US Securities and Exchange Commission forward looking statements in this call are subject to significant risks and uncertainties and speak only as of the date of the conference call we undertake no obligation to update or revise any of these statements on slide three you can find the agenda for today's call today I am joined by the following members of bionex management team uger zahin chief executive officer and co-founder elim TTI chief medical officer and co-founder hin Chief Financial Officer and Ryan Richardson Chief strategy officer with this I would like to hand over to thank you Victoria a warm welcome to all those joining us today I will start with an overview of the quarter's highlight with a focus on communality and our late stage on colip portfolio first then to talk about some of our recent oncol pipeline Advan ment in more detail yance and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the Year Slide Five the second quarter of 2024 was marked by a significant execution across our oncology Pipeline and our leading covid-19 franchise our progress in the quarter will set up for an impactful end of 2024 as you continue to progress towards our long-term Vision I would like to highlight achievements in three areas first with regard to our co9 vaccine leadership on the back of the first Regional approvals we have initiated the launch of our new variant adapted vaccine and expect additional approvals in the coming weeks and months second in oncology we shared numerious updates at Major Medical meetings that h highlighted our clinical executions and pipeline progress and provided data on several of our assets across modalities as will discuss some of these updates in more detail but I would like to highlight two of those specifically last week we announced that our of the Sher pix M cancer vacine for melanoma BNT 111 met the primary Endo in the ongoing randomized phase two trial evaluating b11 in combination with Sim up impatients with stage three and stage four panus melanoma this preliminary result is a significant milestone for our company and underscores our belief in the transformative potential of this new class of medicine and of our mine technology which is a key pillar of our oncology strategy we have exciting news also with regard to another key pillar of our oncology strategy namely the development of no IO ADC combination this quarter we started the first of several Preparatory trials for our combination therapy strategy the trial evaluates a combination of our anti pd1 vgs by specific antibody BNT 327 and our top two ADC BNT 325 we look forward to the initiating additional cards evaluting Noel IO ADC combination over the next 12 months the third area in which we made progress is our mission towards the creation of sustainable and resilient endtoend vacine ecosystem in Africa by expanding our partnership with CP KP is committed up to$ 145 million Us doll to support us to establish M vacine clinical and Commercial scale manufacturing capabilities at our facility in Kigali Rwanda these capabilities will contribute to better prare for potential future epidemic and pandemic threats in Africa in alignment with our corporate purpose of ensuring Equitable access to our medicine start six starting with our covid-19 frenchise The Continuous circulation of sasov tool leads to the ongoing Evolution and emergence of Noel variants of the virus which we continue to monitor and evaluate forther immune evasive potential and vience in September 2022 the xcb lineage gradually emerged dominated globally throughout 2023 with multiple sub lineages and was successfully addressed by xbb vanar adapted covid-19 vaccin including our own this year JN R lineage including kp2 became the predominant variant globally leading to the current spge in infections in many regions in the northern hemisphere shown on the right graph real Effectiveness data demonstrate that the antigenic shift and the distance of G1 lineages from xbb 15 has impacted the vaccine effectiveness of the xbb 15 adapted vaccine against the now prevalent j& V lineages slide seven based on this and additional data Regulatory and public health authorities consequently advise vaccine manufacturers to revise the formulation for their authorized covid-19 vaccines the wh and the EMA recommended the use of jn1 lineage antigen in a monov covid-19 vaccine for the season 2024 2025 and 17 days later we were able to submit our application to the European regulator based on this recommendation and the consequent EMA approval on July 3rd we have begun rolling out our updated communality JN one vaccine in Europe in the United States the FDA further recommended the use of kp2 as the preferred J One lineage antigen for the 2024 20205 covid-19 M vaccines on June 13 less than two weeks later we initiated our voting submission with the usfda we and our partner f are working hard to enable early availability of variant adaptive vaccines for people around the world with the aim of reducing or preventing severe disease hospitalization and covid-19 related deaths we expect the FDA approval of our kp2 adaptive vaccine by mid-september and we aim to deliver the first vaccine doses to the people in the United States shortly there after slide eight the the other area I'm highly excited about is the progress on our oncology pipeline before I hand over to eartham to Deep dive into the recent achievements let me remind you of our overarching oncology strategy M cancer imun therapies were our starting points when we founded bonch and they Remain the center piece ever since we have been pursuing a technology agnostic approach by not limiting ourselves to any one technology over the past two years we added platforms to complement the Mr centerpiece today we have an oncology toolkit featuring multiple modalities including targeted therapies such as ABCs and immun modulators iOS that open up new combination opportunities through fistic mechanisms of action having this diverse of aets in our pipeline enable us to pursue combination approaches that are poly and unique this strategic Advantage allows us to evaluate the activity of each individual compound and to determine those patient populations for which monotherapy or xisc combinations are best suited we believe that our strategy has the potential to address fundamental challenges of cancer and to D meaningful Improvement in a long-term survival race for patients and as you will hear from us the last quarter has been about executing towards this Vision before I hand over I would like to thank you all for your ongoing support as we enter this to the exciting period for Bion Tech and our progress towards our founding Vision thank you thank you ug glad to speaking with everyone today our m PL formology clinical pipeline is continuing to grow and to progress and it is a rich source for the rationally planned novel novel combinations that we consider a key pillar of our strategy as you can see two of our modalities namely mRNA and immunomodulator iOS are dominantly represented in our Pipeline and particularly so in the advanced clinical stages today I want to focus on priority assets Within These modalities which have our special attention our mRNA vaccines and one of our IO compounds BNT 327 before I cover these assets let me just mention that a rich clinical Pipeline and ambitious plans require execution capability which we are continuously building as you can see on the slide we are accelerating the pace of pipeline wide patient approval compared to last quarter compared to 2022 we and our network of partners are now recruiting six times as many patients per quarter to support enrollment into the clinical trials you saw on the previous slide this increase is a testament of our drive towards more and larger mid to late stage trials as part of our ambition to achieve multiple product launches in oncology by the year 2030 it also underlines the success of our partnership strategy which not only gives us acccess to compounds that complement our own pipeline but enables us to leverage additional clinical trial execution capacity and knowhow and Geographic reach now to a centerpiece of our oncology portfolio our mRNA cancer vaccine platforms inest and fix vac which differ in the type of tumor antigen they target Inus targets NE antigens derived from somatic mutations in cancer cells that are unique to an individual's tumor inest vaccines are manufactured on demand and personalized to each individual patient fixc vaccines Target multiple non-mutated antigens shared by a majority of patients with a given tumor type and are off the shelf the computational approaches to discover and select these two different types of Target endogens are one of our core competencies inist and six both use the same technology namely our proprietory mRNA lpx platform today we have ongoing trials in multiple disease settings and indications across both vaccine platforms we have reported translational and clinical data over the last couple of years and future data updates from multiple trials shown on this slide are planned aggregate data that we have reported in the past across inest and fixc trials indicate that urine mRNA lpx based vaccines have a manageable and largely mild safety profile as single agent in combination with anti pd1 pd1 compounds and in combination with chemotherapy our data also indicates that our urin mRNA apx based vaccines are proficient in inducing and expanding High magnitude functional and long lift t- cell responses in the majority of patients which is a prerequisite for clinical activity furthermore our data from small sample siiz patient cohorts indicates clinical activity alone and in combination with anti pd1 pdl1 treatment several of the now ongoing trials that's shown on the slide aim to answer the material question of whether or mRNA vaccines are superior to the respective standard of care in our fixc program here on the right I would like to highlight fre vaccine candidates currently being evaluated in multiple trials in both the metastatic and adant settings first BNT 113 being well under way in first line hpv1 16 positive pdl1 positive head neck scam cell carcinoma in a potentially registrational phase two randomized trial second BNT 116 being investigated in two trials a single agent and in various combinations in different nonmoral lung cancer patient populations and treatment lines and last but not least the nt11 being investigated in anti pd1 relapsed or refractory melanoma about which I would like to talk a bit more the 2111 is a urin mRNA lpx based vaccine that encodes four melanoma Associated antigens that collectively cover more than 90% of melanoma patients and are highly immunogenic in the randomized freearm phase 2 clinical trial conducted in collaboration with our partner regeneron we are evaluating V t111 in combination with regeneron's anti pd1 compound simap and we measure activity of b111 alone or Sim up alone in a total of 184 enrolled patients with pdl1 refractory unresectable stage three or stage 4 melanoma as Ugo noted earlier we very recently announced that the trial met its primary endpoint achieving a statistically significant Improvement of overall response rate in the bn11 sly up combination arm as compared to a historical control of anti pd1 monotherapy in relapsed refractory patients the historic control was based on multiple late stage clinical trials that established the expected objective response rate for monotherapy checkpoint Inhibitors in this setting for this patient population while the data are further maturing we do see a trend towards impr moved overall Survivor the bn11 trial is based on the earlier lipo Merit phase one2 trial in patients with Advanced melanoma who had exhausted treatment options the trial established the dose and provided initial safety efficacy and immunogenicity data on dn11 as single agent and with checkpoint Inhibitors approved in this patient population in that proof of concept study we observed that treatment with bn11 alone or in combination with anti pd1 could induce Strong high magnitude TSA responses against at least one targeted tumor Associated antigen in all analyzed patients most of which were not detectable prior to using the vaccine as shown here objective responses by bn11 were durable with some patients followed up for several years the safety profile was generally mild and in line with expectations for those patients who were co- treated with checkpoint Inhibitors the results we are seeing in the phase 2 b& 1101 study are consistent with these prior results we plan to present the full data from the primary analysis at the medical conference in 2025 and are entering into discussions with regulatory author ities regarding our data and the clinical path forward for this program cutaneous melanoma carries a high and continuously increasing incidence and mortality burden the introduction of checkpoint inhibitor directed therapies was a breakthrough for patients that led to significant improvements in survival nonetheless in advanced disease stages only a third of patients achieve a long-term response and long-term survival after failure of checkpoint Inhibitors there is no established standard of care with only limited and shortlived responses to salvage therapy while a new adoptive s theapy has recently become available for this patient population we do not expect that all patients will be eligible leaving a significant unmet medical need unaddressed in this context our bn11 maybe of Interest to potentially help treat this High medical need population moreover the bn11 data is a proof of concept in three dimensions firstly a proof of concept for our decad long improved mRNA cancer vaccine technology that uses urin mRNA chemistry a non-coding backbone that is engineered for optimal translational performance and our proprietory lipoplex form ation for systemic delivery second this is a proof of concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication specific sixc program candidates and lastly it's a proof of concept for our strategy to to combine synergistic modalities in this case b111 with an established immune checkpoint inhibitor treatment all three of these also applies to bnt1 122 our individualized mRNA cancer immuno therapy based on our inest platform and the same delivery technology we consider individualized cancer vaccines as a medical breakthrough in addressing the high unmet medical need of rejectable cancers and in atrovent or minimal residual disease treatment settings here I want to highlight ongoing randomized Phase 2 trials with our individualized vaccine in pancreatic ductal adenocarcinoma and in caal cancer the fiveyear survival rate in pancreatic ductal adenocarcinoma after reection alone is 10% and up to 75% of patients with pancreatic ductal carcinoma relapse even though they appear tumor free within 5 years after aten treatment as for highrisk stage two or stage three choral cancer about 35% of patients relapse within five years after reection and uen therapy as discussed in the last earning called we demonstrated that our individualized vaccine used in patients with atran pancreatic cancer can induce the noo t- cell responses that are specific to the individual mutant tumor neoantigens and that the risk of recurrence of cancer for patients with vaccine induced immune responses was reduced even after a three-year followup period at the recent esoi conference we disclosed findings from the biomarker substudy of our ongoing Phase 2 Inus trial BNT 1221 involving patients with stage two high risk or stage three coloror cancer who remains ctdna positive following the surgical exision of their localized cancer upon completion of standard of care atent chemo therapy these patients received bn22 our individualized vaccine in contrast to the conventional weight and watch approach in the subset of 12 patients who were accessible for immunogenicity analysis a high magnitude denovo Tia response against at least one vaccine encoded neoantigen was observed in all patients these TSA responses were Amplified with successive vaccination Cycles notably in several patients the tel responses were sustained even after 2 years of follow all 12 patients involved in the immunogenicity analysis remain disease free at the time of data cut off enrollment for the main part of the corcor cancer study is underway to establish the safety and efficacy of bn22 in patients with ctdna positive stage 2 stage three coloral cancer as opposed to the standard weight and watch strategy we anticipate presenting the results from this randomized Phase 2 study by late 2025 or early 26 as multiple Phase 2 trials are ongoing and our clinical data on mRNA immunotherapies continues to mature we are scaling up our manufacturing capabilities and capacities for bu mRNA drug supply for off share fix vaccines and also for our individualized vaccine programs to build out our manufacturing capacity for personalized mRNA we are currently building a pilot facility in mines Germany to support our ongoing late stage trials and potentially in the future commercialization we also continue to leverage in studies our wholly owned AI subsidiary company to work with our teams in improving both the up and downstream processes in personalized mRNA manufacturing from our mRNA cancer vaccines I'm now moving to our immunomodulatory IO compounds specifically BNT 327 which we consider as a key immunomodulatory concept and compelling backbone for novel combinations the n327 combines two validated mechanisms of action V GFA binding inhibits the vegfa vegfr exis blocks tum enog Genesis which leads to reduced tumor cell proliferation and survival the egfa inhibition also counter formation of the immunosuppressive tumor micro environment as does the pdl1 arm offers by specific antibody by reverting pdl1 pd1 excess mediated t- cell exhaustion the pdl1 arm also anchors this by specific antibody to the tumored for efficient and localized Scavenging of V egfa which may contribute to mitigate of tumor on target side effects given that both the anti vefa and the anti pd1 mechanisms are validated across many tumor types and in some cases as a combination we have a clear road map ahead of us where to develop BN 327 Beyond these initial indications in which we may combine with standard of care chemotherapy we tend to evaluate novel BNT 327 combinations the first of which were started recently these novel BNT 327 combinations may open up new areas of activity for our anv GFA and anti pdl1 molecules we and our partner bopus have treated over 600 patients across a wide range of clinical indications with BNT 327 either as monotherapy or in combination with various standard of care protocols this extensive data collection effort provides a solid foundation for making informed data driven decisions on potential indications and patient cohorts for future registration studies notably the data demonstrate robust single agent activity of BNT 327 in previously untreated Advanced nonm cell lung cancer and high response rates in combination with standard of chemotherapy in triple negative breast cancer and small cell lung cancer specifically in first line triple negative breast cancer we observed an objective response rate approaching 80% with durable responses then combined with NP pet AEL the safety profile in these indications was generally well managed and in line with Adverse Events observed with other therapies targeting pd1 and appears to be more favorable than those seen with anv GFA agents these data have driven our strategic decision to initiate registration trials in small cell lung cancer non-s small cell lung cancer and in triple negative breast cancer this year and next year in small cell lung cancer therapeutic options for the treatment of metastatic disease remain limited with few Innovative approaches Beyond Frontline anti pd1 checkpoint Inhibitors which only achieve response rates of around 20% tnb patients particularly those with pd1 negative tumors have few treatment options as they are not eligible for current anti- pd1 Therapies in metastatic nonm lung cancer while anti pd1 Inhibitors have significantly changed the treatment landscape nearly half of these patients still do not respond to Frontline therapy in combination with chemotherapy we will soon start two Global phase two dose optimization studies to enable selection of a registrational dose for Global registrational trials in these particular indications at Esco we presented updated preliminary efficacy and safety data from an ongoing phase one two study in cohorts of advanced cervical cancer Platinum resistant relapsed ovarian cancer and advanced relapsed nonm cell lung cancer we will be presenting signal finding data from additional tumor indication at upcoming conferences this will add to our extensive database and is the basis of our plans for further development in key indications most importantly as Ugo also noted it is a strategic goal for us to explore BNT 327 as part of novel novel combinations in particular with our ADC assets and mRNA therapies we have started to implement ment this strategy by investigating BNT 327 in combination with our toop 2 ADC BNT 325 further combinations will be announced in the coming months we are very excited to advance these combination trials with our partners on my final slide now I would like to provide an outlook on upcoming Congress presentations in September with updates on some of our priority assets at annual esmo Congress in Barcelona here we will present an update on our two trials evaluating bn13 six the first update will include patients with anal head and neck cervical and other HPV 16 driven carcinomas and will report mainly safety and immunogenicity findings from the phase one two trial the second update from a safety run in cohort of our ongoing Phase 2 trial evaluating BN 113 do in combination with pitum up versus pmup alone will include patients with hpv6 positive head next grous cell carcinoma this update will focus on the safety immunogenicity and preliminary activity findings of the Court we will also present the updated results on vn327 in patients with tmbc with egfr mutated nons small cell lung cancer and with kidney cancer together with our partner bopus these updates will contain either initial or follow up data on safety and efficacy of b327 as a monotherapy and as a combination with different chemotherapeutic regins and finally we will be presenting updated results from our ongoing phase one trial evaluating safety and efficacy of our claudin six car T cell in combination with Claud in six encoding mRNA vaccine in patients with relapsed refractory claudin six solid humors this data will be a followup from what was presented at last year's esmo Congress and will include updated safety and efficacy data as well as data on K self assistant we will share additional details on these and further Congress Publications in the near future with that I will now pass the presentation to our CFO Yen hin thank you Aslam and a warm welcome to everyone who has doubt in today's call let me start by reviewing our financial results for the three months ended June 30th 20124 our total revenues reported for the second quarter of 2024 reached approximately 129 million EUR compared with approximately 168 million EUR for the second quarter of 202 three our second quarter revenues reflect the current demand of a seasonal emic covid-19 vaccine market and I expect it to be the low point in this year's covid-19 vaccine uptake parts of our total revenues are derived from a pandemic preparedness agreement with the German government which is expected to run until early 2027 moving to cost of sales cost of sales amounted to approximately 60 million EUR for the second quarter of 2024 compared to approximately €63 million EUR for the comparative prear period research and development expenses were approximately 585 million EUR for the second quarter of 2024 compared to approximately 373 million EUR for the comparative prior year period of the total R&D spend in the second quarter we invested approximately 90% in our non-co business mainly by initiating larger clinical studies for our late stage oncology candidates and by investing in additional Personnel in our R&D departments to run those clinical trials sales General and administrative expenses amounted to approximately €84 million EUR in the second quarter of 2024 compared to about 138 million euros in a comparative prior year period the increase in sgna was mainly due to the increased expenses for our it environment as well as an increase in headcount to support the scaling of our business regarding the company's other operating results during the second quarter of 2024 this amounted to approximately 267 million EUR in negative operating result compared to about 57 million EUR in negative operating result for the comparative PRI year period this change was primarily due to the recording of a provision related to a contractual dispute income taxes were acced with an amount of 2 million EUR of tax expenses for the second quarter of 2024 compared to approximately 200 22 million EUR of realized tax income for the comparative prior year period the effective income tax rate for the first half of 2024 was approximately 1.3% for the second quarter of 2024 we reported a net loss of approximately 88 million EUR compared to a net loss of about €90 million EUR for the comparative prior period our loss per share for the second quarter of 2024 amounted to €3 36 compared to to a loss per share of €79 cents for the comparative prior year period as of June 30th 2024 our cash and cash equivalent and security Investments reached approximately 18.5 billion EUR our strong balance sheet provides us with a strategic flexibility to invest in our long-term growth strategy as part of that strategy we will continue to invest in the development of our individualized Therapies in the build out of the manufacturing capacities and capabilities to to support additional late stage TRS and commercialization to create long-term value we aim to advance our clinical programs quickly yet coste efficiently towards potential registration turning to the next slide today we are reiterating the company's Financial guidance for The Current financial year consistent with the expectations of approval of our variant adapted cid9 vaccine in the United States in mid-september we expect to recognize the vast majority of or full year revenues mostly in Q4 independent of the timing of the revenue generation and as communicated earlier in the year we expect to report a loss for the 2024 Financial year while we continue to invest in our proprietary assets and Technologies as such we also reiterate our R&D and sgna Guidance with 2.4 to 2.6 billion EUR for R&D in 700 to800 million EUR for sna expenses those expenses are expected to increase in the second half compared to the first half of 2024 please note that this guidance does not include any m&a transactions payment for collaboration agreements or licensing deals not yet disclosed nor any potential payments resulting from the outcomes of ongoing and or future legal disputes or related activities such as judgments or settlements which may have a material effect on our results of operations and or cash flows in summary our Focus so far has been on executing the company strategy highlighted about the progress in all part one we've Advanced and started new potentially registrational trials and have shared encouraging data that demonstrates the potential of our pipeline our focus in oncology remains on investing in our Innovative Technologies that we believe can make a difference while progressing our late stage programs towards potential Market authorizations supported by our strong cash position and demonstrative Financial discipline we will continue to invest in our Pipeline and focus on generating value patients and our shels with that I would like to turn the call over to our chief strategy officer Ryan Richardson for an update on our strategic Outlook and concluding remarks thank you thank you yens our efforts over the last few months have put us in a strong position to execute our covid-19 vaccine launches this fall season in June the European medicines agency recommended marketing authorization for our jn1 adopted covid-19 vaccine followed by European commission approval on July 3D we started Distributing vaccine doses to EU member states shortly thereafter we expect the earlier launch of our updated covid-19 vaccine in Europe relative to last year will allow vaccination campaigns this year to be more closely aligned with seasonal influenza vaccination campaigns in the United States the FDA has recommended the use of kp2 as the preferred strain for the 2425 season we and our partner fiser have initiated a rolling submission with the FDA for our kp2 adapted covid-19 vaccine and expect to be in a position to begin vaccine distribution in the US following regulatory approval with first shipments expected in September covid-19 vaccine demand continues to be globally distributed we and our partner fiser are preparing to launch our variant adopted covid-19 vaccine in over 40 countries and regions worldwide we expect approximately two-thirds of demand potential to reside outside the United States while some regions outside the US continue to be served by government contracts we anticipate several newly established private markets to open up in regions like the UK and Japan this could enable broader access to covid-19 vaccines for individuals who may not qualify under local immunization recommendations which tend to focus on the higher risk population segments in addition we have increased our supply of pre-filled syringes but we'll continue to offer a mix of pre-filled syringes single dose vials and multi-dose vials across Ross regions we believe the comady franchise is well positioned to maintain its leading position globally in the continued fight against covid-19 moving to oncology on the next slide we will continue to invest in our mRNA cancer vaccine platforms based on our belief that personalized mRNA cancer vaccines have potential to establish a new paradigm in cancer treatment these vaccines employ cuttingedge mRNA technology which aims to address the root cause of cancer genomic mutations or neoantigens that are largely specific to each individual's tumor neoantigen selection for each patient is today driven by AI algorithms and a fully in silico process we believe this is fundamentally distinct from other pharmaceutical products and that it will allow for iterative improvement over time powered by data Assets in addition to their ability to be combined with other therapies with complimentary mechanisms of action we believe these therapies have potential to extend beyond the product life cycle of a traditional off-the-shelf pharmaceutical product the next slide highlights the key pipeline Milestones to focus on as we look ahead to 24 and 25 we are entering a catalyst Rich period over the next 18 months with data updates and Regulatory submissions expected from multiple product candidates this includes but is not limited to phase three covid flu combination vaccine Topline data expected this year and data expected in 202 from both our mRNA cancer vaccine platforms ffac and inest we also expect data updates for BNT 327 our anti- pdl1 VF bpacific antibody and BNT 323 are her2 ADC in a variety of solid tumor indications finally we plan to initiate multiple combination trials and solid tumor indications over the next 12 months consistent with our strategy to develop novel combinations which leverage complimentary mechanisms of action turning to the next slide we continue to focus on our late stage oncology portfolio in line with our near-term goal to have 10 potentially registrational trials active by the end of the year while still in the early stages we are making progress in attracting talented professionals to join our commercial organization to support our first wave of anticipated oncology product launches we believe that focusing execution on our diverse late stage pipeline will bring significant potential for Mid and long-term value creation on the next slide I would like to remind everyone that we plan to hold our first artificial intelligence Innovation series event via webcast on October 1st followed by our annual Innovation series event on November 14th further details will be released soon we welcome you to join these events for a deeper look at the exciting developments taking place at Bion Tech with that I would like to open the floor for questions thank you to ask a question please press start 1 one on your telephone and wait for your name to be announced to withow your question please press star one and one again we kindly ask participants to limit themselves to one question per person we will now take the first question from the line of dinina Crush from leing Partners please go ahead hi uh thank you guys and thanks for the question uh this is one is on the LA early as 2026 I wonder if you could talk about what specific programs and settings trials you think are most likely to be able to launch in 2026 and if that's dependent on accelerated approval uh what gives you confidence in accelerated approvals uh by that date uh I guess I'm specifically referencing whether any of those are your face to vaccine trials thank you yeah thank you Dana um I I'll start um briefly and and my colleagues can jump in so I think for 2026 um we have a couple of different programs that potentially could launch in that time frame um and the first of which is B&T 323 or her 28c and we've highlighted the potential for we think for an accelerated approval in second and third line into mutal cancer um so that would be one one asset that where we're expecting data next year and if that timeline is confirmed with further FDA discussions we think that that could be a a 26 launch opportunity in addition we've highlighted the potential for an accelerated pathway with our um bmt1 122 inest in adant colar rectal cancer think we still have further discussions to to take place with the FDA um but based on on the the current study design and the pace of enrollment we do think that there's the potential if the data is strong also for data uh to be for a submission um and uh and potentially a launch in that sort of time frame most likely towards the end of the year or early 27 but it could it could fall in 26 thank you we will now take the next question from the line of yaron wber from TD Cohen please go ahead yeah hi thanks for for taking my question maybe just a quick question I know you probably can't say a lot but um BMT 1111 fix V when you're looking at historical controls and and you're looking at sort of the overall survival uh sort of trend can you give us a sense what which historical control do you think are most appropriate just to kind of help gauge uh what the the effect could be thank you oh yes you you know this is a very dire uh indication CPI refractory resistant melanoma and uh the controls uh against which uh we compare our anti pd1 pdl1 treatments which have been tested in this indication uh are chemotherapies which have been tested in this indication and as compared to those we see a clinically meaningful benefit uh with regard to objective response rate uh there is a trend uh for overall Sur rival but it is too early to be more specific about PFS and Os now the data will mature and at the time when we present uh the data uh next year we will be able to be more specific thank you we will now take the next question from the line of tesin aat from Bank of America Securities please go ahead hi good morning uh thanks for taking my question uh regarding the upcoming phase three Co covid flu combo data later this year can you frame for us what would be good data and um how would you think that would impact the demand for the regular covid vaccine going forward and then also related to that how long before you think that this product the combo products would be able to launch thanks hi is ug yeah thanks for for your question so we are we are expecting expecting that U time frame time frame the safety immunogenicity data and efficacy data uh end of this year and uh and based on the results we have to see uh whether the data uh qualify for submission and potential potential approval uh for the season 2025 2026 what would you consider good data thougher to be an improvement over the regular public vaccine can you repeat your question I didn't get that what would you consider to be good data relative to the to the covid only vaccine in order to yeah I think I think I think the data data is is very clear there uh it's is an efficacy Tri yeah it's um it's about comparability with with the covid-19 uh plus plus efficacy efficacy in the in the BL and um and uh and additional immunogenicity data data supporting the mode of action of the vaccine thank you we will now take the next question from the line of eter Dar from Capital markets please go ahead hi um thanks for taking a question just wondering sort of in the wake of theab update and your maintenance of R&D guidance is there a specific internal oncology program that potentially benefits here in other words you know maybe potential of acceleration of Investments or broadening out of of of the the program just so curious your thoughts around around who maybe what programs may may benefit from this internally yeah yeah thank you for that question um I mean ultimately this does come down to portfolio strategy as you I think your question alludes to and the fact is that we have multiple programs that we think could have potential in nons small cell lung cancer um we've already started a phase three for B 2316 we've just brought out data at ASCO for b327 um which all be at early we think is quite promising and we also have a fixb program that's also in Inc so we've got already critical mass in our portfolio in the non-s small cell lung cancer indication and we we are planning a a multi-pronged uh strategy uh to execute against so while we found the data encouraging for a Cuma map um we decided to prioritize other programs frankly over this in the next phase I think the important takeaway here though of course is that as genmab now takes this program forward into phase three we will we will still retain a a economic stake in the program and and a stake in the success the future success of the program um but we won't fund phase three and we think that that's the right balance given the the many shots on goal and exciting data that we're seeing from the portfolio all right thank you thank you we will now take the next question from the line of eang Leu from HSBC Bank PLC please go ahead uh hello thank you for taking my question uh I've got a question on margin progression uh so just how should we think about as your you know as your oncology pipeline progresses and also in the meantime you've scaling out manufacturing and potentially investment in R&D and then sgna how should we think about that margin progression and especially as as as you're launching your oncology products in the future thanks yeah yeah we couldn't hear you very well there but just want to make sure we get the question right so your your question is about how do we see margin progression over the next couple of years specifically as it relates to oncology is that right uh uh yes because yeah I think I think the the long is predominantly we see sort of in in in oncology space and yeah just the question on margin progression thank you maybe I'll start um it's awfully difficult actually to understand you yeah you're fading away somewhat but um I mean you've seen that of course the margin that we have um with our in our partnership with fiser is extremely good I mean we're close to 100% proven the gr margin share structure that we have with fiser so that's that's out outstanding and certainly not normal in terms of oncology going forward you know we would expect that we see similar sort of margins um as you see um in uh you know with other companies I think in in looking forward in terms of uh iniz medicine I think we got to wait uh a little bit on how we can when we can make some statements in terms of the margin but we're working very hard can assure you we're working very hard to bring the costs down for IND life medicine candidates yeah yeah and I would just I would just add one point to that so in addition to what Yin just said about oncology I think it you know we're still expecting of course that our covid business is going to still be in for the next couple of years still a a a driver of our overall margins and I think there we've got as we pointed out in the past a very attractive economic model these are the our partner fizer that we think will allow us to keep our overall uh operating profile quite attractive right thank you thank you we will now take the next question from the of man erat from Jeff please go ahead hi uh this is actually Akash um so you recently topl lined data from your 111 trial in cutaneous uh melanoma our analysis suggests the combo arm would have uh a 24% Delta versus roughly the 11% historical control rate for AP pd1 is that the ballpark way to think about the O Delta in this study and what would you have to see on PFS and Os to justify moving this forward into a phase three and maybe just stepping back what is this trial teach the biontech team about the ideal place for cancer vaccines I feel like one of the lessons from your early minus data was that cancer vaccines were perhaps not well suited for patients with metastatic late stage disease and yet these patients were pd1 refractory so you know how should we interpret that thank you okay thank thank you it's a great question so the the the personized cancer vaccines um have a manifacturing turnaround time in the range of six 6 to 8 weeks and therefore in the static setting and this type of vaccines vaccines are are difficult uh to to provide a clinical benefit since uh since this patients rapidly progress so the statement of uh um refers to the personalized vacines with regard to fixb we have seen that fixb has two activities is on the one side the direct activity due to the adance function we are seeing a type one inter response yeah and has seen now in a number of indications not only in melanoma but also also in lung cancer uh objective responses in patients with Advanced cancers and we expect and that a combination particularly with a with um with a treatment that is able to control the disease for a certain time and and we are particularly interested here in our ADC M vaccine combinations you will see a number of ties coming up in 2025 for this uh would be an exciting opportunity for our fix up approach and maybe for the for the other part I give to as yes uh your question regarding bn11 was about uh the clinical benefit which we would like to see as compared to standard uh standard of care uh I I cannot preempt our disclosures which will uh come uh uh when we have mature mature data um but what I can uh say is uh as you know uh standard of care objective response rates for this patient population is around 10 perish uh so uh what we would like to see is something well buffet and uh this is also what uh our data shows us we also want to see duration uh of response and also uh this uh looks clinically meaningful in the current data set which we have and then it's obviously also about safety uh and what we see is that b11 as a fixb based on RNA lipoplex technology is um has a a very manageable safety profile and in combination with s map we don't see anything which is surprising so there is no additive toxicity also um uh which for us means that uh the clinical profile looks very Pro promising for this patient population thank you we will now take the next question from the line of Jessica five from JP Morgan Chase please go ahead hey guys good morning thanks for taking my question it looks like the beyondtech uh Topline guidance reflects a different expectation for 2024 commity sales than what fiser guidance would imply what gives you confidence in achieving this result and to the extent that part of the Delta is driven by German pandemic preparedness contract uh which I believe Falls outside the collaboration can you quantify what that is contributing to the guidance thank you yeah let me let me start and maybe Ryan want to jump in so um I think we are we are very much aligned with fer in terms of our commun expectations um um you know we we should um keep in mind that fisa has reiterated its guidance you know we did the same today you should be aware that uh and take into account that we have a contract together with the European Union um we have F in the UK so I think for Europe this gives us some comfort in terms of how the full year should look like of course there's always some insecurity in that respect but you know in in that in in that sense you know we feel we feel good about it and in terms of um the pandemic preparedness contract um you know we have confidentiality with the German government so we're a bit Limited in in really stating here some numbers but um you know you should expect that there is a significant amount of money um being part of what we have reported in the first half so we have reported outside of communa if you look into the documents 120 million so a big chunk of that in the in the first half comes from that pandemic preparedness contract thank you thank you we will now take the next question from the line of Cory casimo from evercore isi please go ahead I thanks for taking the question so regarding the upcoming data at esmo for B&T 327 in egfr mutated um non-s small cell lung cancer there's obviously been a lot of attention um of late on the competitive pd1 VF B specific that's out there so I'm curious like kind of based on what you know about that compound and the data presented to date how similar or different do you expect your approach to be and how confident are you in having competitive data in this population thank you yeah thank you for the question I can uh keep it short I think the data that we are going to present will be competitive and um and uh and as you know um the asset that BNT 327 is now now a molecule that that is currently in evaluation multiple indications uh at Bion Tech and our collaboration partner bius and we will see additional studies to be announced end of this year beginning next year okay thank you thank you we will now take the next question from the line of creas shibutani from Goldman Sachs please go ahead yes thank you if I could just follow up on the BNT 327 noting from slide 10 it appears from uh the change in your pipeline plans uh are some additional trials there which seem to signal that biontech is quite enthusiastic in that regard um I think it would be helpful the investor Community was certainly attentive during ASCO to understand how your approach May differ from that of a competitor sum Therapeutics and in particular can I ask you are you looking to do any head-to-head trials uh involving Kuda um how are you thinking about sort of clinical development strategy that we can understand to be differentiated thank you um uh thank you for this question Chris uh we can not comment on the strategy of of uh of others but what we can say is that uh we think that b327 and this concept is highly compelling and qualifies as a IO uh backbone for uh various combinations and um our approach here uh to be is to be uh bro with regard to the indications which we will pursue also in potentially registrational trials uh we are well uh poised for that because our partner biop uh has already uh brought a multi-indication program ongoing with uh a number of uh signal seeking uh cohorts in various indications with in with various standard of care regiment so that we have a wealth of data already and uh can uh pick the indications and expand that as they uh mature and uh another uh dimension of diversification is that we see b327 as a backbone for uh many of our uh pipeline assets um uh holy owned ones but also those we have partnered uh because it has such a um a permissive synergistic uh um uh prone mode of action yeah yeah and regarding pble um uh so we are seeing of course um data from now a number of indications coming in uh and and continue to mature yeah and we have uh we have seen uh for data for which for example historical uh Benchmark data are available for for example in triple negative breast cancer and uh and the extent of clinical benefit that we are observing BMT 327 is uh is is is really encouraging yeah and and for any indication in which pble is approved as a backbone yeah our plan would be of course of course uh to compare ficacy of B3 to7 plus X against against the against the counterpart standard of care and if it's p we would compare against T thank you thank you we will now take the next question from the line of Terren fleing from Morgan Stanley please go ahead hi thanks for taking out questions this is Chris an for Terence we have a two-part question on bn22 incorrecto cancer you guide the data by the end of 2025 or early 2026 but is there a potential for an interim analysis that would allow you to to look at the data earlier and then second what would you and your partner Ro need to see in this trial in order to advance it into phase three thank you yeah we have we have um we have hinted to to a potential analysis in in end of 2025 as you know the study study is uh end point is disease free survival uh in this indication and the the general General um principle uh that we expect from individ cancer vaccines is is that uh metastatic tumor cells which are which are present after surgery could be removed by uh by uh by um in inducing a t response uh the indication that we have chosen is a ctdna positive indication that means that means based on uh based on the on the on published data and they know that this patient population P patient population who are ctdna positive after surgery with a stage two stage three Coral cancer has have a PSS in the range of of um 10 to 12 months yeah and after chemotherapy and the PFS more is more around pH uh medium PFS is around more 6 to 8 months so that means at that time point we would expect that at least part of the data would be matured yeah H and then then then based on the on the on the results uh we uh we yeah it will depend how uh how how the results are and and uh whether additional studies would be required at that time point or whether the data would be sufficient to continue and request uh potential regulatory steps great thank you thank you we will now take the next question from the line of Simon Baker from redbor Atlantic please go ahead thank you for taking my question um it's a question on inest capacity I wonder if you can give us an idea of the capacity that M facility will give you in 2027 and also you mentioned the ability to reduce the um bottlenecks in vain to Vain time I I wonder if you could give us an idea of where they stand and where this currently go to and just related to this based on your comments um on 122 is it right to assume that um completion of that facility um is is rather one two2 approval is not contingent on a uh completion of that facility thanks so much yeah so uh at the moment we can't uh comment on the capacity of of the of the facility that is that is uh being built because because we are still in uh process further process improvements increasing the overall capacity uh so reliable numbers will be available end of 2025 yeah for the for the capacity but the uh U facility has been built um has been built with the idea that it could act yeah as a pilot facility uh if uh one of the uh personized vaccine products is approved at the time pump yeah so this is this is uh this is this is ongoing work and and parall parall for uh building this facility which is intended uh to act as a potential pilot facility we are expanding currently our clinical trial capacity yeah to ensure that that uh uh we we can start additional ties in 2025 and later on then I think there's a Simon you asked about bottlenecks in terms of VTO Vin time yes please um bottleneck yeah so so this is of course a complete new process manufacturing a vaccine in real time and you can imagine and that and that every step um must be must be uh validated so this is we are we have established personalized manufacturing um um of M vaccines for the first time in uh 2014 since then we have uh we have been two two additional Innovation Cycles uh we have recently implemented implemented a additional change in the manufacturing further reducing the turnaround plan um but still still um um U manufacturing release of such a vaccine comes with multiple release test for the individual batches yeah so so we are working on making the steps more robust reducing the cost and uh and this will become become uh become more or less also the value dri of of of um of um uh this approach uh being able to reduce the cost substantially and thereby allow allowing that this is an affordable approach all be available uh for a large population of patients thanks so much thank you we will now take the next question from the line of Elana Merl from UBS please go ahead hi guys thanks so much for taking the question um your slides mentioned starting the first novel combo trials in oncology this year I guess just a strategic question in terms of your oncology combination strategy given the breath of your portfolio I guess what are the programs that you are most excited about or prioritizing for combination thanks um we are uh thank you for the question adiana we are in principle very excited about the io ADC combination concept because we expect and also our pre-clinical data supports this that this is highly synergistic uh and as you pointed out we have started uh our first trial which is the first of the series you will see where we use the n327 as the io backbone uh which in this first trial is combined with our top two ADC from our partnership with uh dualy in multiple solid Cancers and and this will be extended to additional uh adcs from our pipeline to be combined with BNT 327 we are also very excited about um a combination which is ongoing for quite some time uh namely one of our priority assets BNT 211 which is our Claudine 6 car T Cell uh in combination with our vaccine which is designed in in this case in a way that it specifically um acts on the adoptively transferred car T cells and our data uh which uh shows um that uh the vaccine in in in fact uh adds to the persistence and duration uh of adoptive transferred car T cells uh is getting uh stronger and stronger with data maturing great thank you thank you we will now take the next question from the line of John Newman from kakore genuity please go ahead hi there thanks very much uh for taking my question you're obviously in the midst of very active development for BNT 327 I'm wondering specifically for the trials where you're combining with BNT 325 your Trope 28c do you see the potential down the road for Accelerated approval in some of those indications thank you thank you this is too early to say okay thanks thank you we will now take the next question from the line of Manos Master ruse from Dutch bank please go ahead hello thank you for taking my question on again on BNT 327 just wanting to understand how you thinking about the clinical trial design are you hoping or aiming to uh study mainly pd1 positive uh populations or are you can to keep that open and see what the data looks like after after the fact thank you yes see see this is a great question let let me share our view yeah uh so the introduction of of anti PD treat pd1 treatments uh led to to the division of of patient population population in pdl1 high pdl1 pd1 low and pdl1 negative population and the exciting observation that we that we made uh now now in two indications is that the combination of chemotherapy uh plus B3 to7 appears uh to to uh to be effective uh in a in a in a highly clinically meaningful manner also in the pdl1 negative population and this really provides the great opportunity yeah so so we believe that B3 to7 yeah is not only something which is which could could be better better than existing pd1 treatment but we see the chance that we overcome the the current current classification of the patients into pdl1 negative and pdl1 positive patient population this is exciting yeah and and by this of course of course the patient populations would dramatically increase and clinical Tri could be done in a much easier way and standard of care yeah uh could become become easier manageable uh based on on on uh on uh treatment uh combinations that are independent of pd1 stain yeah thank you this is all the time we have for questions today I would like to hand back over to the speakers yes thank you very much for joining us today