InMode Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 6, 2024

There are 18 speakers on the call.

Operator

Welcome to BioNTech's First Quarter 2024 Earnings Call. I would like to hand the call over to Doctor. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Speaker 1

Thank you. Good morning and good afternoon. Thank you for joining Viantic's Q1 2024 Earnings Call. As a reminder, the slides we will be using on 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.

Speaker 1

Additional information about these statements and other risks are described in our filings with the U. S. 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 this conference call. We undertake no obligation to update or revise any of these statements.

Speaker 1

On Slide 3, you can find the agenda for today's call. Today, I am joined by the following members of Viantic's management team: Ugur Zahan, Chief Executive Officer and Co Founder Elam 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 over to Ulf.

Speaker 2

Thank you, Victoria, A warm welcome to all those joining us today. We believe that we are entering a transformational period for BioNTech. We have founded BioNTech with the vision to discover and develop scientific grade proof that harness the immune system to fight diseases and bring new medicines to patients. In the years following our establishment, we developed various therapeutic platforms, demonstrate the safety and clinical effectiveness of various drug candidates in early clinical trials. The period from now to 2030 is about progressing this candidate into late stage development and registration of the trials to become a multiproduct company with the 1st product to be delivered by our late stage oncology pipeline.

Speaker 2

We are continuing to execute this vision and our strategic priorities with this intense focus. In the Q1, we progressed our late stage oncology pipeline on multiple fronts. We dosed the 1st patient in the pivotal Phase III clinical trial evaluating our HER2 ADC, BNT-three twenty three in HR positive HER2 low metastatic breast cancer. At the AACR Annual Meeting, we presented 3 year follow-up data from a clinical trial evaluating our indirect mRNA cancer vaccine, or the G and C Wilmer RAN in pancreatic cancer. This data showed encouraging molecular survival in certain patients with immunogenic response to the vaccine, demonstrating the promise of our vaccine platform to induce persisting de novo neuroendocrine specific T cell responses that correlate with improvements in survival.

Speaker 2

We have also taken significant steps for our 1st launches in oncology. Anna Marie Hanekamp, an accomplished leader with a remarkable track record, is joining our team in July to drive and execute our global commercialization strategy. We appointed a General Manager in the U. S, who has commenced building out our commercial operations in the U. S, and we appointed further expertise in our global commercial team.

Speaker 2

For our COVID-nineteen vaccine franchise, we initiated preparations to be on track to introduce a new variant adapted COVID-nineteen vaccine for the upcoming season. We have received preliminary strain selection recommendations from the World Health Organization and European Medicines Agency and plan to submit for regulatory approval later this month. Today, SM and I will focus on our oncology strategy, while Jens and Ryan will provide updates on our financial and corporate progress. Slide 6. Our oncology portfolio strategy is driven by understanding the key challenges in cancer.

Speaker 2

Cancer is genetically diverse and heterogeneous disease driven by the substantial acquisition of mutations. One consequence of this is that many treatments have an initial effect, but are not associated with long term remission or cure. Our aim is to provide solutions across the continuum of cancer disease and establish new treatment paradigms. We believe our cancer vaccine candidates are particularly suited for early intervention, while thoughtfully designed combination treatments are intended for advanced and high volume tumors. We want to bring our therapies to as many patients as possible, and we want to use the potential power of our platforms alone and in combination.

Speaker 2

Slide 8. Our therapeutic strategy brings together synergistic mechanisms of action across 3 key categories. The first are novel immune modulators or IO, which are designed to engage the immune system, overcome cancer mediated immunosuppression and amplify immune responses. 2nd, targeted therapies which include CAR T cell therapies and anti polyprachonipids that can dramatically reduce the tumor burden. The 3rd category are mRNA vaccines, which are the centerpiece of our oncology strategy.

Speaker 2

Our mRNA cancer vaccines are designed to target multiple cancer antigens in parallel and can be individualized for each patient. BioNTech was built from the very beginning as a technology agnostic company. We do not limit ourselves to any one technology. We are interested in addressing unmet medical needs with the best possible solutions. Having a diversity of assets in our pipeline, we are positioned to pursue combination approaches that are proprietary and unique.

Speaker 2

This strategic advantage allow us to evaluate the activity of each individual compound and enables us to determine those patient population for which monotherapy or synergistic combinations are best suited. The potential for synergy in this combination is significant, enabling us to design treatment regimens that could lead to improved patient outcomes and broaden the scope of therapeutic options. We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the long term survival rates for patients. Slide 9. To reiterate, we are entering a transformative period for BioNTech, specifically in the development of our oncology pipeline and the formation of our oncology business, which will continue to evolve over the next few years.

Speaker 2

In 2024, we are aiming to increase the number of potential pivotal trials across our lead programs to 10 or more by year end. These trials will focus on areas of unmet medical need, clinical indications in which we may achieve an expeditious path to market And thereafter the first approval in the initial indication, there's a high potential for expanding the market opportunity to additional indications. Starting in 2025 and continuing into the following years, we expect to enter a period which was pivotal data that if positive could support regulatory submissions for marketing authorization across our pipeline. We have begun building a fully integrated oncology organization to support our transition into a global multiproduct company. This process will be accelerated this year as we bring our new Chief Commercial Officer on board.

Speaker 2

Ultimately, we are building our organization to support multiple oncology launches beginning in 2026. With that, I would like to thank you all for your ongoing support. I will now turn the call over to Esme.

Speaker 3

Thank you, Ugur. Glad to be speaking with everyone today. As Ugur highlighted, we will focus in the next few years on increasing the number of potentially pivotal clinical trials to fuel our transition towards becoming a multiproduct company by 2,030. In oncology, we have already started to execute against this goal. This is why you can see that the late stage part of our pipeline on this slide is enriched and populated with multiple trials that feature our priority assets such as our mRNA vaccines and also our and also our most advanced ADCs and IOs, including those which we consider as attractive backbones of unique combination treatments.

Speaker 3

To highlight recent additions to our pipeline, one is a Phase III trial in collaboration with Duality Bio evaluating BNT-three twenty three in patients with hormone receptor positive and HER2 low metastatic breast cancer that has progressed on hormone therapy and or cycling dependent kinase for 6 blockers. With BNT-three twenty three, we are also planning to start a confirmatory Phase III trial this year in patients with metastatic endometrial cancer that will complement our ongoing single arm trial in this indication. In our early stage pipeline, we have started a Phase III trial in collaboration with Genmab evaluating BNT-three fourteen, a bispecific antibody product candidate with ADCOM dependent for 1BB agonistic activity in multiple solid tumors. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approvals in the next 18 months. Before highlighting some of the programs and platforms that we consider priority assets to contribute to clinical progress, let me say a couple of words to execution.

Speaker 3

The coming years will be about late stage clinical trial execution. Enrolling the patients to participate in clinical trials requires deep coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global trial execution approach. As we and our partners have increased the number of ongoing late stage trials, we have also drastically increased the number of patients that participate in trials, generating data for our fully owned and partnered product Comparing the average quarterly number of patients enrolled across the last few years here on this slide, On quarterly average in 2022 through the Q1 of 2024, we have increased the number of patients enrolled by over 400%. On the back of the significant increase in enrollment and thus progress in clinical trial execution, we expect our clinical development pipeline to generate the corresponding increase in the number of data sets in the coming years. Our ultimate goal at BioNTech is to bring our data scientific breakthroughs to patients in need.

Speaker 3

Moving to our priority assets, let me start with BNT-three twenty seven or PMH 002, a bispecific antibody consisting of an anti VEGF A Fc silenced IgG fused to a humanized anti PD L1 BHH binder being developed in collaboration with our partner, Biophias. BNT327 combines 2 validated mechanisms of action. VGFA binding inhibits the VGFA, VGFR access, blocks tumor angiogenesis, which leads to reduced tumor cell proliferation and survival. The GFA inhibition also contacts formation of the immune suppressive tumor microenvironment as does the PD L1 arm of this bispecific antibody by reverting PD L1PD1 excess mediated T cell exhaustion. The PD L1 arm also anchors this antibody to the tumor bed for efficient and localized scavenging of the EGFA, which may contribute to mitigate of tumor on target side effects.

Speaker 3

Data from ongoing Phase III clinical trials across several indications in over 600 patients executed by our partner, BioPhias, have shown a favorable safety profile. Our partner, BioPhears, presented selected examples of this compound's performance in 2023, showing strong single compound activity and high response rates in combination with chemotherapy in triple negative breast cancer and small cell lung cancer. In first line TNBC, in combination with nab paclitaxel, almost 80% objective response rate, as shown on this slide. At ASCO now, there will be more data disclosures in cervical, in ovarian cancer and in non small cell lung cancer. An investigational new drug application has been accepted by the FDA for further studies in the United States, and we plan to start global trials in several indications this year.

Speaker 3

One area that we see increased development activity in the coming years will be our mRNA cancer vaccine candidates. MRNA cancer vaccines are a centerpiece of our pipeline and are pivotal to our goal of developing breakthroughs for cancer patients. The aim is to develop this technology as monotherapy in combination with standard of care and in combination with candidates from our proprietary pipeline. Our 6 vaccines use sets of multiple antigens shared by patients across 1 tumor type. Inest, our individualized vaccine program, partnered with Genentech, identifies neoantigens derived from cancer mutations that are unique to an individual's tumor.

Speaker 3

While INIS and FICC VAC target different types of cancer cell antigens, they are based on the same mRNA and delivery technology, namely our UroDIN mRNAlipopax platform. Its distinct mechanism of action is that the delivered antigen is presented by professional antigen presenting cells in lymphoid compartments body wide in close proximity to T cells to be induced and that it comes with intrinsic adjuvanticity. These features by design promote the induction of high end of magnitude T cell immune responses that we have been detecting in all our clinical trials across tumor types and for various types of targeted cancer cell antigens as shown on the right hand side of this slide. On the next slide, you can see exemplary data from different trials in different treatment settings and tumor types in which we are evaluating our neoantigen based individualized cancer our neoantigen based individualized cancer vaccines, including several years of follow-up. Our mRNA based neoantigen vaccine has demonstrated the ability to induce the neoantigen specific, functional, polyspecific and persistent T cell responses at substantial magnitude in high proportions of treated patients.

Speaker 3

Frequently against tumor antigens that were overlooked by the patient's immune system, so called de novo immune responses. We have shown that our vaccine induced T cells persist over years and build immunological memory. In the two papers quoted on this slide, we have shown that vaccination with neoantigen encoding mRNA is associated with reduction of recurrences in patients. The favored setting for developing our individualized vaccines are patients that have minimal residual disease or require adjuvant treatment to reduce the probability of recurrence. Today, we have INS and FICC FACT trials in multiple disease settings and indications and data releases from several of the trials shown on this slide upland.

Speaker 3

In our fixed fact program, we are evaluating 4 vaccine candidates, which each target tumor associated antigens specific to melanoma, HPV-sixteen positive head and neck cancer, prostate cancer and non small lung cancer, as monotherapy and in several combinations. We shared early data for all FICC candidates in the past years and plan to present additional data this and next year. Further, we plan to start an additional trial with Inest in the adjuvant setting with our collaborator Genentech. I would like to highlight 3 of these programs that are on our priority list. 2 programs using our individualized vaccine and cancer types that have a low tumor mutational burden and are resistant to immune therapy, namely colorectal cancer and PDAC and our NSCLC FICC program.

Speaker 3

Starting with CRC with colorectal cancer. The majority of patients with early stage localized and resectable CRC undergo surgery followed by adjuvant chemotherapy. Standard of care in Stage II high risk and Stage III disease after adjuvant treatment is watchful waiting. 20% to 35% of patients experience recurrences of their disease. CtDNA is a marker for minimal residual disease and identifies patients with high risk of such recurrence.

Speaker 3

We are running a Phase II trial with our individualized vaccine in Stage II high risk and Stage III resected CRC patients that are ctDNA positive After adjuvant chemotherapy patients are randomized to either receive autogen, sevomeran or individualized vaccine or observation. We expect the first readout of this trial in the second half of twenty twenty five. Secondly, a randomized Phase II clinical trial evaluating our individualized vaccine in combination with the anti PDL-one agent atezolizumab followed by standard of care chemotherapy in patients with resected pancreatic cancer, PDAC, compared to chemotherapy alone was started in collaboration with Genentech in 2023 and is recruiting patients. PDAC is a high medical need, tumor expected to become the 2nd leading cause in cancer related death. Up to 85% of patients with localized pancreatic cancer that undergo surgical resection and adjuvant chemotherapy do experience recurrence of disease.

Speaker 3

This trial was initiated based on data from an investigator initiated trial that were published last year and updated at AACR a few weeks ago. That Phase I trial showed that with our individualized vaccine combined with adesolizumab and standard of care adjuvant chemotherapy, half of the 16 treated patients develop high magnitude vaccine induced immune responses and that these patients have a much lower risk of tumor recurrence at 1.5 years of median follow-up and continue to do so after a 3 year follow-up period. Moving to our off the shelf tumor associated antigen based mRNA cancer vaccine candidate BNT116. BNT116 is an RNA lipo plex cancer vaccine candidate comprising 6 mRNA, MAGE A3, Clodin6, KTL C1, PRAME, MAGE A 4, MAGE C1. We have selected these tumor associated antigens by an in silico approach developed for design of 6 vaccines for different tumor types.

Speaker 3

And based on low or lack of expression in toxicity relevant organs, expression in a substantial fraction of lung tumors of various histologies, immunogenicity and tumor biological growth. About 85% of expressed at least 1 of the 6 selected tumor associated antigens and more than 60% expressed at least 2 of them. BNT116 is currently being evaluated with our partner Regeneron in 2 clinical trials that cover various non small cell lung cancer patients' operation. 1 is the Phase I trial investigating BNT-one hundred and sixteen in adjuvant first line and second line blood settings and various treatment regimens as listed on the left side of this slide. We plan to introduce novel unique combination cohorts into this multi cohort Phase 1 trial.

Speaker 3

The second trial is a randomized Phase 2 evaluating BND116 in combination with cemiplimab in first line treatment of patients with PD L1 high expressing non small cell lung cancer shown on the right side of the slide. At AACR, we presented preliminary results from Cohort 3 of a leukamaret 1 Phase 1 trial evaluating BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non small cell lung cancer that progressed on PD-onePD L1 inhibitor and pisetinib based chemotherapy. Combination treatment with BNT116 and docetaxel was active with an overall response rate of 30%, a disease control rate of 85%, medium progression free survival of 4.4 months. Comparable to other 6FAC candidates, BNT116 presents a manageable safety profile alone and in combination. We expect further data from these cohorts in the next 12 months, and that will inform further development of PNT-one hundred and sixteen in lung cancer.

Speaker 3

The ESCO annual meeting is right around the corner. At ESCO, we and our partners will present new clinical data for several of our programs, data that is of relevance for making informed decisions about the direction of those projects development. Firstly, we and Genmab plan to present data for BNT311 from our Phase II in post IO non small cell lung cancer patients. BNT311 is a bispecific antibody candidate combining PD L1 checkpoint inhibition with 4 1BB co stimulatory activation. 2nd, as already mentioned, monotherapy data from Phase II trials are planned to be presented for VNT-three twenty seven, the biospecific anti VEGFA, anti PD L1 antibody we are developing in collaboration with Biophheres.

Speaker 3

3rd, we and our partner Medialing plan to present 1st in human data for our RAV3 targeting ADC. Then we will also present epidemiologic data, including postoperative ctDNA prevalence and prognostic value from non interventional observational study in patients with resected high risk stage 2, stage 3 colorectal cancer that supports and informs the development of our individualized vaccine in this patient population. And lastly, for BNT-two eleven, our CAR T cell product candidate, we plan to initiate a potentially registrational trial in patients with germ cell tumors. At ASCO, we will present real world evidence of overall survival and treatment patterns of this patient population in the U. S.

Speaker 3

That will inform the trial design for our Phase II trial. With that, I will now pass the presentation to our CFO, Jens Holstein.

Speaker 4

Thank you, Aslem, and a warm welcome to everyone who has dialed in today's call. Let me begin my section with some key financial figures for Q1 2024. In the Q1 of 2024, we reported total revenues of approximately €188,000,000 driven mostly by commercial revenues from the sales of our COVID-nineteen vaccine. This revenue figure is consistent with our internal expectations for the period and reflects the seasonality that we expect in an endemic environment for our COVID-nineteen vaccines. Our group revenues will continue to be driven largely by the uptake of our COVID-nineteen vaccines until oncology revenues will be recognized.

Speaker 4

We expect to recognize approximately 90% of our full year revenues in the last month of 2024, mostly in Q4. In terms of our operational spending, we are also in line with our internal plans and ended the Q1 with a loss before tax of €332,000,000 We maintained our strong financial position with €16,900,000,000 in total cash plus security investments at the end of the quarter. As mentioned by my colleagues before, we started the year making real progress across our oncology pipeline. We dosed the 1st patient in our 2nd pivotal Phase III trial and are on track to start multiple additional potentially registrational trials this year. Our focus remains on our late stage clinical trials and to invest in our mRNA platform approaches that represent the core capability of BioNTech and differentiates us from others in the industry.

Speaker 4

Also continue to invest in our leading and profitable COVID-nineteen vaccine business. Alongside our partner Pfizer, we're working on variant adapted COVID-nineteen vaccines for the upcoming vaccination season. We also continue to invest in our leading and profitable COVID-nineteen vaccine business. Alongside our partner, Pfizer, we are working on variant adapted COVID-nineteen vaccines for the upcoming vaccination season. We are also investing in a COVID-nineteen flu combination vaccine candidate, which we expect to potentially drive additional demand if approved.

Speaker 4

Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well positioned to achieve future sustainable growth. I'll now be going into a little more detail on our financial results for the Q1 of 2024. As noted earlier, our total revenues reported for the Q1 of 2024 reached €188,000,000 compared with approximately €1,300,000,000 for the Q1 of 2023. Moving to cost of sales. These amounted to €59,100,000 for the Q1 of 2024 compared to €96,000,000 for the comparative prior year period.

Speaker 4

Research and development expenses reached €508,000,000 for the Q1 of 2024 compared to €334,000,000 for the comparative prior year period. The increase was mainly due to progressing clinical studies for our oncology pipeline and related personnel expenses to manage those. Sales and marketing expenses of €16,000,000 incurred in the Q1 of 2024 compared to €12,000,000 in the comparative prior year period. General and administrative expenses amounted to €117,000,000 for the Q1 of 2024 compared to €112,000,000 for the comparative prior year period. The increase in SG and A was mainly due to increased expenses for IT services as well as an increase in headcount to support the scaling of our business.

Speaker 4

Income taxes were realized with an amount of €16,700,000 for the Q1 of 2024 compared to €205,500,000 of tax expenses for the comparative prior year period. The derived effective income tax rate for the Q1 of 2024 was approximately 5%, applicable on the negative income. For the Q1 of 2024, we reported a net loss of €315,000,000 compared to a net profit of approximately €502,000,000 for the comparative prior year period. Our loss per share for the Q1 of 2024 amounted to €1.31 compared to a diluted profit per share of €2.05 for the comparative prior year period. As indicated earlier this year, 2024 is a year for our company beyond which we will continue to invest in our long term growth strategy.

Speaker 4

We aim to have potentially 10 plus pivotal trials running by year end 2024, which we believe will change the picture of the company going forward. Besides having a strong franchise infectious diseases, we aim to have multiple oncology products reaching the market by 2026 onwards. Turning to the next slide, I would like to emphasize that we are reiterating the company's financial guidance for the 2024 financial year. As mentioned previously, we expect to recognize approximately 90% of our full year revenues in the last months of 2024, mostly in Q4. Additionally, we also reiterate our R and D and SG and A guidance from our year end call with €2,400,000,000 to €2,600,000,000 for R and D and €700,000,000 to €800,000,000 for SG and A expenses.

Speaker 4

Those expenses are expected to gradually increase quarter by quarter until year end. With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategy outlook and concluding NuMex.

Speaker 5

Thank you, Jens. We are working with Pfizer to be ready to launch our variant adapted COVID-nineteen vaccine in the second half of the year upon regulatory approval. Consistent with the WHO's recommendation, we expect that the updated vaccine will encode the JN-one variant and will be monovalent. As of April 2024, over 90% of SARS CoV-two genetic sequences in publicly available databases were derived from the JN1 variant. In 2023, we received strain inclusion recommendations from the WHO and other advisory committees in May June and were granted approval in late August September.

Speaker 5

This year, the timelines for strain selection and those anticipated for approval are expected to come earlier. The WHO and EMA have already received strain recommendations and expect additional regulatory updates in mid May. We expect approval in the EU and FDA could come in late July August respectively. If this occurs, it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the variant adapted COVID-nineteen vaccine in over 80 geographies worldwide.

Speaker 5

While most regions outside the U. S. Will continue to be served by government contracts, we do expect some new private markets in regions like the UK to open in 2024. This could enable individuals who may not qualify under existing immunization recommendations to access updated COVID-nineteen vaccines should they choose to do so. Turning to the next slide, our aim is to create value for patients and shareholders by delivering sustained long term growth and our strategy is to continue to invest in our technology platforms and diverse pipeline.

Speaker 5

We believe each of the drug classes we are investing in contain product candidates that aim to address major unmet needs and could unlock significant commercial potential. We are entering a catalyst rich period over the next 12 months to 24 months with data updates expected from 1 or more product candidates across each of these classes. We look forward to disclosing additional pivotal trials and more details on our go to market strategy for selected programs in the months ahead. To conclude on the next slide, our aim is to transform medicine through successive waves of innovation. We remain focused on our near term goal to have 10 plus potentially registrational trials initiated by year end 2024 and to continue to ramp up our commercial readiness activities.

Speaker 5

Over the midterm, we aim to enter the commercial stage in oncology by 2026 with our first product candidates while advancing our pipeline of late stage and novel combination therapies. Longer term, we aim to broaden our portfolio of approved products and transform BioNTech into a diversified multiproduct immunotherapy company that is in a position to redefine medicine. We are truly excited by the potential our technologies and pipeline holds to make a difference for patients around the world. Before opening the floor for questions, I would like to highlight on the next slide important investor events we will be holding this year. Our Annual General Meeting will take place on May 17th and our inaugural artificial intelligence and machine learning event will take place on October 1.

Speaker 5

Our May 2024 Innovation Series event is planned for November 14th. We will share further details on these events in due course. With that, I would like to open the call up for questions.

Operator

Thank you. And your first question comes from the line of Tazeen Ahmad from Bank of America. Please go ahead.

Speaker 6

Hi, good morning. Thanks for taking my question. For the data that you're going to be presenting at the upcoming ASCO conference as it relates to the Genmab compound. Can you just remind us how many patients worth of data to expect? And once that data is presented, can you talk to us about the next steps in the development plan for that program?

Speaker 6

Thanks. So

Speaker 3

So that will be I cannot tell you the specific number from the top of my head, but this will be around 100 patients, so a substantial number of patients.

Speaker 6

And also what level of detail should we expect to see?

Speaker 3

So you will see safety data, the activity data, which we have until then and ORR data.

Speaker 6

Okay. And what is the plan moving forward with this program?

Speaker 3

We are in the planning phase with our partner GenNet, so that we cannot disclose any specifics at this time, but you will hear more about this program sometime later this year.

Speaker 6

Okay. Thank

Operator

you. Thank you. Question comes from the line of Dana Graybosch from Leerink Partners. Please go ahead.

Speaker 3

Hi, thank you for the question.

Speaker 7

I have another one on ASCO. So I wonder if you could talk more about the data we should expect from PMA0002 at ASCO? And also if you could talk about how this molecule compares to the competitor from Akhisko Summit, which also is a bispecific of VEGF, but targeting PD-one rather than your PD L1. How much read through positively can we take from the AKISO data to yours and from yours to the AKISO data for the overall approach? Thank you.

Speaker 2

Hi, Diana.

Speaker 3

So we have at the moment

Speaker 2

the clinical trial running in multiple indications, including also indications for single arm and combination. What we are going to update is on ASCO is on the cervical cancer and platinum resistant ovarian cancer and non small cell lung cancer trial. And you will see response data and safety data in this cohort. Just to remind you, we have presented already response data on the combination in triple negative breast cancer and small cell lung cancer, which are very encouraging, shown also responses in the PD L1 or cold tumors, PD L1 negative or cold tumors. And we expect to present similar data now for non small cell lung cancer.

Speaker 2

Of course, we do not have direct comparison comparative data with AKISO, but I think the data that we are seeing goes into the same direction that this bispecific and that means direct targeting of the PD L1 access plus VGF access is appears to be associated with a better response rate as well as a better safety profile as compared to MDVGF treatment. So we are very excited about using these compounds as combination approach for chemo therapies and in the upcoming future for our ADCs.

Operator

Thank you. Thank you. We will now go to the next question. And your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

Speaker 8

Hey, this is more high level. But in the past, I know the team has tried to position BioNTech as an earnings growth story. With that in mind, what is the best estimate for BioNTech returning to consistent profitability? Is this something that should occur once COVID flu enters the market? Or is this more tied to your oncology pipeline?

Speaker 8

And then separately, would you look to work with a large cap partner to launch your ADCs and broader oncology pipeline? Or would you look to build that commercial sales force internally? Thanks so much.

Speaker 5

Yes. Thanks, Akash, for the question. I'll start with maybe the second part of it. I think, strategic partnerships have been one of the hallmarks approach in oncology early on and also with COVID-nineteen. And I think we will continue to evaluate partnerships asset by asset to see if that could help us accelerate certain assets, broaden their reach geographically or even help us reach profitability sooner for specific assets where there might be a partner that brings infrastructure that's relevant.

Speaker 5

Generally speaking though, we do now we have a strong balance sheet. We do want to retain more of the economics as a general matter of strategy. So I think that those partnering decisions are going to really be made on an asset by asset basis, while at the same time we do commit to actually build a commercial presence in oncology in the major markets. And so that is going to be a priority over the next couple of years. I'll let Jens speak a little bit to the profitability point, but I'll just say high level at the outset that we do see, as you've alluded, that there's an opportunity here with the pipeline that we're building and advancing now into late stage studies to deliver long term sustained growth driven by successive product launches.

Speaker 5

We've indicated 2026 as a significant time point in those plans, but really the plans go beyond that. And that's why we put out the target of having 10 approvals in oncology by 2,030, highlighting that we do think that that revenue growth can come from indication approvals and multiple products. And so that our priority is to get on that long term growth trajectory. And of course, being profitable is important. But the focus right now is really getting on that growth trajectory.

Speaker 9

Yes. Thanks, Ryan. I think you made the most important statement already. So I mean, if you look into the revenue development going forward, of course, we see some potential upside when we have a COVID flu combination within the market. And how big that upside could be, we are not 100% clear yet.

Speaker 9

We haven't given any guidance for 25 in the ongoing years for that combination. We got to see how it evolves. In terms of our spend, I think we have shown that we control the cost as good as we can, as sensible as it is. We want to create value in investing in our oncology portfolio. And to lift it, I think Ryan made the statement already, we are looking, of course, to have some partners here and there regionally to lift the value going forward.

Speaker 9

But we are very optimistic in terms of the growth that

Speaker 4

we have in front of us as a company. Yes. And I think so

Speaker 5

what you're hearing from us Akash is, in the very short term, we do think that the COVID combination vaccine with flu is successful. The profitability is going to be dependent in part on COVID vaccination rates. And that's one of the near term drivers that has the potential to bring those rates up.

Operator

Thank you. We will now go to your next question. And your next question comes from the line of Jessica Fye from JPMorgan. Please go ahead.

Speaker 7

Hey there. Thanks for taking my questions. Coming back to BNT-three eleven and the ASCO update, which regimen would you focus us on? And what element of the profile do you expect to best showcase the product's efficacy? And related to that, what's the right benchmark to compare that efficacy metric to?

Speaker 7

Thank you.

Speaker 3

So the regimen we will be a combination of BNT311 with pembrolizumab in second line on small cell lung cancers and the post CPI population to which you would then need to compare this regimen.

Speaker 7

Okay. Maybe I'll just throw in one more. Can you recap a hypothetical list of what the 10 potentially registrational trials running by year end might be? I imagine you contemplated a few scenarios here, but maybe you could throw out an example or 2.

Speaker 3

COVID-nineteen, trials we are trying to activate or you want examples. Is this the question? So we have several of them activated. One example is the BNT-three sixteen trial, our cooperation with ONC4 and entire CTLA-four, which is in non small cell lung cancer in PD-one, PD L1 experience in Phase III. Another trial, which is potentially registrational is our breast cancer trial in HER2 low breast cancer with BNT-three twenty three.

Speaker 3

Also Phase 3, which has started early this year. Then in this priority asset list, we have trials with autogensevomeran, the individualized vaccine we are co developing with Genentech Roche. One example is our colorectal cancer trial, which will read out in around 2026. Another example is our adjuvant pancreatic cancer trial. Additionally, we will activate trials with BNT-three twenty seven, so the PD L1 BGS compound we have talked about earlier.

Speaker 3

So these are several of the examples of potentially registrational trials we would like to activate by end of this year. One very exciting one, I should also list here, which is our trial with our CAR T cell, Clodine 6 CAR T cell in testicular cancer.

Operator

Thank you. We will now go to the next question. And your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

Speaker 8

Hi, great. This is Brendan on for Yaron. Thanks for taking the question. Just a quick one from us actually on the infectious disease pipeline. It looks like we're going to have a Phase 1 update from the shingles vaccine sometime this year.

Speaker 8

But wanted to also see where you're at with enrollment and potential timing to data for maybe malaria, HSV and TB programs and kind of if there's any notable updates on how you're prioritizing this part of the pipeline. Thanks very much.

Speaker 2

Yes. We would we will provide data updates actually on the HSV-two trial, on the TB trial, on the malaria trial, which created safety and immunogenicity data in a Phase I and are proceeding now into Phase II settings. And the data will come at various events until end of this year.

Operator

Thank you. We will now go to the next question. And your next question comes from the line of Etzer Dorot from BMO Capital Markets. Please go ahead.

Speaker 10

Great. Thanks for taking the question. Just another bigger picture strategy question around oncology. It looks like the early combination approaches rely on external assets, moving those into proof of concept studies and when we could start maybe assets, moving those into proof of concept studies and when we could start maybe seeing some of

Speaker 4

those sort of emerge? Thank you.

Speaker 2

Yes, excellent question. This is actually one of the strengths that we would like now to activate. So the first type of combination trials with internal assets is including 6 CAR T cell therapy with RNA vaccine. We have recently reported data shown in data synergy between the 2 of the combination increasing the persistence of T cells. We will see start end of this year, the first combination price of our ADC compounds with our IO portfolio.

Speaker 2

And actually, 2020 5 will be an intense year, where we will do multiple combination price dedicated to contribution of components price and safety assessment to bring us into the position to go into 1st registrational price in our combos in the second half of twenty twenty five.

Operator

Great. Thank you. Thank you. We'll now go to the next question. And your next question comes from the line of Terence Flynn from Morgan Stanley.

Operator

Please go ahead.

Speaker 11

Great. Thanks for taking the question. For BNT122, it sounds like it was on your list of registrational trials. So just wondering for the data next year from that Phase 2 CRC trial, what you'd need to show on an efficacy basis to consider filing for an accelerated approval? And then again, I noticed you had an ASCO presentation on some epidemiologic data here.

Speaker 11

Again, just what are you expecting to show there at ASCO or what would be the key learnings? Thank you.

Speaker 2

Yes. So this study is a sufficiently powered Phase 2 study. It is in our patient population of colorectal cancer patients who are ctDNA positive. Multiple epidemiological studies have shown that this patient population have a very poor prognosis. Actually, and PFS in this patient population after surgery is around 12 months.

Speaker 2

After chemotherapy is around 7 months. So this is actually a metastatic early metastatic patient population. And the clinical trial compares a standard of care, which is adjuvant chemotherapy in this patient population versus standard of care followed by the personalized vaccine. The clinical trial endpoint is disease free survival. And we expect and the endpoint analysis for this trial in the second half of twenty twenty five, yes.

Speaker 2

The trial is enrolling as expected at the moment. And of course, this is all what we can say, everything else will depend on the totality of the data.

Speaker 5

Do you want to say a few words about the epidemiological study at ASCO?

Speaker 3

Yes, I can do that. So what we will present at ASCO is an epidemiological study. So it's not a treatment study and we have conducted this epidemiological study in order to better understand the prognosis of those patient populations we have in our ongoing clinical trial with BNT122, in particular also of subpopulations which are ctDNA positive because that further informs our ongoing clinical trial. In addition, this epidemiological trial is a prescreening trial to identify patients to recruit into our investigational trial. So you will get, in particular, epidemiological data of ctDNA positivity rates in high risk populations in colorectal cancer and disease free survivors, which are seen in these subpopulation.

Operator

Thank you. Your next question comes from the line of Ellie Merle from UBS. Please go ahead. Hello, Ellie, is your phone on mute? Ellie, is your phone on mute?

Operator

And your next question comes from the line of Phil McGann from Canaccord. Please go ahead.

Speaker 12

Hi and thank you. So as a technology agnostic oncology company who has not yet gotten into radiotherapy, do you see the excitement recently in that field as warranted? And if so, could we expect, BeyondTech to potentially get some stake in a radiotherapy combination or technology by partnership or just bringing it internally? It seems like lot of the deal sizes recently could be in the range that BeyondTech could look at. Thank you.

Speaker 2

Yes. So indeed, indeed, value immunotherapy is reaching our maturity. This is one of the aspects that we are following. We are currently not looking for opportunities for in licensing, but some of the research that we are doing internally could go into that direction. We could talk about this end of this year when we have first validation data.

Operator

Thank you. Thank you. We will now go to the next question. And your next question comes from the line of Hartaj Singh from Oppenheimer. Please go ahead.

Speaker 13

Great. Thank you. Thank you for the question. I just want to ask a question on the slide where you've listed the average quarterly patient enrollments. Over the last couple of years, we've seen actually real difficulty with companies in oncology just because of the vast number of trials going on in oncology and IO recruiting patients.

Speaker 13

And you've seen a really nice acceleration from 2022 to 2023 and the Q1 of 2024. So can you just put some color behind that or meat on the bone of what exactly are you doing? Is it just the ability to the trials getting IRB approved more trials actually moving head to late stage, maybe spending more patients on recruiting trials at site? I'd love to hear that. And then how does this change your thinking on potential readouts?

Speaker 13

I mean, it's nice to see the improvement in enrollment, but how does that translate to when readouts could actually happen? Thank you.

Speaker 2

Yes. Let me take the first part of the question. So in the timeline of 2020 to 2022, 2023, of course, we dealt with early clinical trials, which are typically recruiting a lower number of patients defining based on those escalations in of cohort safety assessment, biomarker assessment and so on. And we are now reaching a phase where we have multiple trials in Phase II and first clinical trials in Phase III, which naturally allow us to enroll faster and ensure that we get the statistics. This is also the reason why we are now able to move multiple clinical trials into a registration trial end of this year.

Speaker 2

And for all of the registration trials, we will provide the time lines, then we expect the readout. As Ryan alluded, the first readout for our first potential registration trial is in endometrial cancer will be next year, second half of or mid next year with the opportunity to get an authorization end of next year. And we will have multiple interim readouts for to be presented at ASCO and ESMO and SITC this year on the currently running cohorts.

Speaker 3

If I just add to that, you have pointed out quite correctly that patient recruitment becomes more and more difficult. We are in the fortunate situation that we have a richness of different assets and thereby a design space to choose those assets and combination trials, which can give us several hits on our target to become a multiproduct oncology company by 2,030, but it was very clear to us from the very beginning that this also means that we have to improve our capability to execute to improve our capability to execute these clinical trials. So we have invested and this is what this bar chart shows. We have invested major efforts to mature our clinical development operations, organization and also to grow it. And we also have invested into models such as working with partners, with our partner companies to enroll into our joint trials and public private partnership, for example, the partnership we have with UK in which we are building a cancer vaccine launch and thereby mobilizing on a national level large numbers of clinical sites.

Speaker 3

And this is basically what these numbers reflect.

Operator

Thank you. We'll now take the next question. And your next question comes from the line of Ellie Merlo, UBS.

Speaker 14

Hey guys, can you hear me now?

Speaker 9

We can hear you.

Speaker 14

Okay, perfect. Great. Thank you. Just for your HER2 ADC, where you got breakthrough in endometrial cancer late last year. And I think you just mentioned you expect to have the pivotal data in the second half of next year, if I heard that correctly.

Speaker 14

Can you tell us a little bit more around the design of this pivotal study? And also how you're thinking about the opportunity for this asset in endometrial and where it would fit in the broader landscape there? Thanks.

Speaker 2

The time the Iranian pride is a single arm pride in this population. And it is the registration will be based on safety data and response data and durability of response data. And this will be combined with the confirmatory trial for which we still are in the planning phase and we will inform in around 3 to 4 months about the design of the confirmatory trial.

Operator

Thank you. Your next question comes from the line of Simon Baker from Red Bell Atlantic. Please go ahead.

Speaker 15

Thank you for taking my question. And it's on SG and A. Your guidance implies an increase between €160,000,000 to €160,000,000 this year. I would assume a large part of that is the global commercial footprint build out. I just wonder if you could give us an idea of how that phases over this year and also 2024 versus 25?

Speaker 15

Is most of the spend this year or is most of it in 2025? So my idea of the cadence of that build out would be great. Thanks so much.

Speaker 9

Yes. Thanks for the question. You should expect for 2024 that we have sliding through quarter by quarter in terms of S and M costs and the G and A costs there in 2024. And then for 2025, likely to have a further increase in the setup. Of course, you start to hire personnel for the commercialization, you'll see force only shortly before you launch and that will the timing of

Speaker 4

that will drive the spend in 25.

Speaker 5

Okay. Thanks so much.

Operator

Thank you. Your next question comes from the line of Yifeng Liu from HSBC. Please go ahead.

Speaker 16

Hello. Thanks for taking my question. Just one question on your HER2 ADC in breast cancer. How do you think about the biomarker infection there when you have like HER2 low and perhaps whether you think about HER2 ultra low as well in the design of your pivotal study? Thanks.

Speaker 2

Yes. This is a good question, indeed. Indeed, the question is about how to 1, how to low 1 plus, 2 plus or even ultra low or even negative. So we are considering all patient cohorts in our trial design and we'll make a decision on the patient population to be enrolled and the patient population to be analyzed later on in the for the upcoming trials. And we'll most likely report about the clinical trial design end of this year.

Speaker 8

Thanks.

Operator

Thank you. We will now take our final question for today. And your final question comes from the line of Susanne van Voorteuten from VLK. Please go ahead.

Speaker 17

Hi there. This is Suzanne from VLK. Thanks for taking my question, which relates to business development and M and A. Last year, you were fairly active on the deal making front. So we need to

Speaker 10

focus on what we expect

Speaker 17

going forward for this and next year. You have a lot of cash on hand, but also a lot of projects to run and many moving parts on the profitability side. So I was wondering if you're continuing to pursue similar deals and assets as previously or does your appetite change? Thank you.

Speaker 5

Yes. Thanks, Susan. I think our focus this year is more on clinical execution. That said, we will be opportunistic. And if we we're open to synergistic assets, but I think you can expect the general level of activity in terms of number of deals to be decreased this year.

Operator

Thank you. This concludes today's conference call. Thank you

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