BioNTech Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 5, 2024

There are 18 speakers on the call.

Operator

Welcome to BioNTech's Second Quarter 2020 4 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 BioNTech's Q2 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.

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 the 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 BioNTech's management team: Ugur Zahain, Chief Executive Officer and Co Founder Ozlem Tureci, Chief Medical Officer and Co Founder Jens Holstein, Chief Financial Officer and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand over to Uwe.

Speaker 2

Thank you, Victoria. A warm welcome to all those joining us today. I will start with an overview of the quarter's highlights with a focus on Combinati and our late stage oncology portfolio. Preston will talk about some of our recent oncology pipeline advancement in more detail. Jens and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the year.

Speaker 2

Slide 5. The Q2 of 2024 was marked by a significant execution across our oncology pipeline and our leading COVID-nineteen franchise. Our progress in the quarter will set up for an impactful end of 2024 as we continue to progress towards our long term vision. I would like to highlight achievements in 3 areas. 1st, with regard to our COVID-nineteen vaccine leadership.

Speaker 2

On the back of the 1st regional approvals, we have initiated the launch of our new variant adapted vaccine and expect additional approvals in the coming weeks months. 2nd, in oncology, we shared numerous updates at major medical meetings that highlighted our clinical execution and pipeline progress and provided data on several of our assets across modalities. Usdin will discuss some of these updates in more detail, but I would like to highlight 2 of those specifically. Last week, we announced that our off the shelf zigzak mRNA cancer vaccine for melanoma, BNT-one hundred and eleven met the primary endpoint in the ongoing randomized Phase II trial, evaluating BNT-one hundred and eleven in combination with cemiplimab in patients with Stage 3 and Stage 4 plutaneous 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 mRNA vaccine technology, which is a key pillar of our oncology strategy.

Speaker 2

We have exciting news also with regard to another key pillar of our oncology strategy, mainly the development of novel IO ADC combination. This quarter, we started the search of several proprietary trials for our combination therapy strategy. The trial evaluates the combination of our anti PD L1 VGF bispecific antibody BNT-three twenty seven and our top 2 ADC BNT-three twenty five. We look forward to the initiating additional trials evaluating novel IO ADC combinations over the next 12 months. The 3rd area in which we made progress is our mission towards the creation of sustainable and resilient M2M vaccine ecosystem in Africa by expanding our partnership with JP.

Speaker 2

JP is committed up to US145 $1,000,000 to support us to establish mRNA vaccines clinical and commercial scale manufacturing capabilities at our facility in Kigali, Rwanda. These capabilities will contribute to better prepare for potential future epidemic and pandemic press in Africa in alignment with our corporate purpose of ensuring equitable access to our medicines. Slide 6, starting with our COVID-nineteen franchise. The continued circulation of SARS CoV-two will leads to the ongoing evolution and emergence of novel variants of the virus, which we continue to monitor and evaluate for the immune evasive potential and neovolence. In September 2022, the HBB lineage gradually emerged, dominated globally throughout 2023 with multiple subclinages and was successfully addressed by XBB1 fast growing adapted COVID-nineteen vaccine, including our own.

Speaker 2

This year, JN1 limits, including KP2 became the predominant variant globally, leading to the current surge in infections in many regions in the northern hemisphere. Shown on the right graph, we revert effectiveness data demonstrate that the antigenic shift and the distance of GAN-one lineages from XBB15 has impacted the vaccine effectiveness of the XBB15 adapted vaccine against the now prevalent JN1 lineages. Slide 7. Based on this and additional data, regulatory and public health authorities consequently advise vaccine manufacturers to revise the formulation for their authorized COVID-nineteen vaccines. The WHO and the EMA recommended the use JN1 lineage antigen in a monovalent COVID-nineteen vaccine for the season 2024 2025.

Speaker 2

And 70 days later, we were able to submit our application to the European regulator. Based on this recommendation and the contract and EMA approval on July 3, we have begun rolling out our updated Cominati JNVAC1 vaccine in Europe. In the United States, the FDA further recommended the use of KP2 as the preferred JN1 lineage antigen for the 2024, 2020 5 COVID-nineteen mRNA vaccine on June 13. Less than 2 weeks later, we initiated our rolling submission with the U. S.

Speaker 2

FDA. We and our partner Pfizer 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-nineteen related deaths. We expect the FDA approval of our KP2 adapted vaccine by mid September, and we aim to deliver the first vaccine doses to the people in the United States shortly thereafter. Slide 8. The other area I'm highly excited about is the progress on our oncology pipeline.

Speaker 2

Before I hand over to Ersteem to deep dive into the recent achievements, let me remind you of our overarching oncology strategy. MRNA cancer immunotherapy were our starting point when we founded BioNTech, and they remain the centerpiece. Ever since, we have been pursuing a technology agnostic approach by not limiting ourselves to any one technology. Over the past 2 years, we added platforms to complement the mRNA centerpiece. Today, we have an oncology toolkit featuring multiple modalities, including targeted therapies such as ABCs and immunomodulators, IOs, that open up new combination opportunities to the logistics mechanisms of action.

Speaker 2

Having this diversity of assets in our pipeline enable us to pursue combination approaches that are proprietary and unique. This strategic advantage allows us to evaluate the activity of each individual compound and to determine those patient population for which monotherapy or synergistic combinations are best suited. We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvement in a long term survival rate 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 truly exciting period for BioNTech and our progress towards our founding vision.

Speaker 2

Thank you.

Speaker 3

Thank you, Ugo. Glad to speaking with everyone today. Our multi platform immunology clinical pipeline is continuing to grow and to progress, and it is a rich source for a rationally planned novel novel combinations that we consider a key pillar of our strategy. As you can see, 2 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.

Speaker 3

Our mRNA vaccines and one of our IO compounds, BNT-three twenty seven. 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 accrual compared to last quarter. Compared to 2022, we and our network of partners are now recruiting 6 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 2,030.

Speaker 3

It also underlines the success of our partnership strategy, which not only gives us access to compounds that complement our own pipeline, but enables us to leverage additional clinical trial execution capacity and know how and geographic reach. Now to a centerpiece of our oncology portfolio, our mRNA cancer vaccine platforms, Inez and fixed VAC, which differ in the type of tumor antigen they target. Inez targets neuro antigens derived from somatic mutations in cancer cells that are unique to an individual's tumor. Inez vaccines are manufactured on demand and personalized to each individual patient. FICC vaccines target multiple non mutated antigens shared by a majority of patients with a given tumor type and are off the shelf.

Speaker 3

The computational approaches to discover and select these 2 different types of target antigens are one of our core competencies. Inez and Sigveq both use the same technology, namely our proprietary mRNA LPX platform. Today, we have ongoing trials in multiple disease settings and indications across both vaccine platforms. We have reported translation and clinical data over the last couple of years and future data updates from multiple trials shown on the slide are planned. Aggregate data that we have reported in the past across INS and Zixact trials indicate that uridine mRNA LPX based vaccines have a manageable and largely mild safety profile as single agent in combination with anti PD-onePD L1 compounds and in combination with chemotherapy.

Speaker 3

Our data also indicates that our uridine mRNA LPX based vaccines are proficient in inducing and expanding high magnitude functional and long lived T cell responses in the majority of patients, which is a prerequisite for clinical activity. Furthermore, our data from small sample size patient cohorts indicates clinical activity alone and in combination with anti PD-onePD L1 treatment. Several of now ongoing trials shown on this slide aim to answer the material question of whether our mRNA vaccines are superior to the respective standard of care. In our fixed set program here on the right, I would like to highlight 3 vaccine candidates currently being evaluated in multiple trials in both the metastatic and adjuvant settings. First, BNT-one hundred and thirteen being well underway in first line HPV16 positive PD L1 positive head, neck squamous cell carcinoma in a potentially registrational Phase II randomized trial.

Speaker 3

2nd, BNT-one hundred and sixteen being investigated in 2 trials as single agent and in various combinations in different non small cell lung cancer patient populations and treatment lines. And last but not least, BNT-one hundred and eleven being investigated in anti PD-one relapsed or refractory melanoma, about which I would like to talk a bit more. BNT-one hundred and eleven is a uridine mRNA LPX based vaccine that encodes 4 melanoma associated antigens that collectively cover more than 90% of melanoma patients and are highly immunogenic. In the randomized pre arm Phase 2 clinical trial conducted in collaboration with our partner, Regeneron, we are evaluating BNT-one hundred and eleven in combination with Regeneron's anti PD-one compounds, cemiplimab, and we measure activity of BNT-one hundred and eleven alone or cemiplimab alone in a total of 184 enrolled patients with PD L1 refractory unresectable Stage III or Stage IV melanoma. As Ugur noted earlier, we very recently announced that the trial met its primary endpoint, achieving a statistically significant improvement of overall response rate in the BNT-one hundred and eleven cineplumab combination arm as compared to historical control of anti PD-one monotherapy in relapsed refractory patients.

Speaker 3

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 improved overall survival. The BNT11 1 trial is based on the early alipomeric Phase III 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 BNT-one hundred and eleven as single agent and with checkpoint inhibitors approved in this patient population. In that proof of concept study, we observed that treatment with BNT-one hundred and eleven alone or in combination with anti PD-one could induce strong high magnitude T cell responses against at least 1 targeted tumor associated antigen in all analyzed patients, most of which were not detectable prior to using the vaccine.

Speaker 3

As shown here, objective responses by BMD-one hundred and eleven 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 II BNT1101 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 authorities regarding our data and the clinical path forward for this program. Cutaneous melanoma carries a high and continuously increasing incidence and mortality burden.

Speaker 3

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 short lived responses to salvage therapy. While a new adoptive cell therapy 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 BNT-one hundred and eleven may be of interest to potentially help treat the Thai medical need population.

Speaker 3

Moreover, the BNT-one hundred and eleven data is a proof of concept in 3 dimensions. Firstly, a proof of concept for our decathlon improved mRNA cancer vaccine technology that uses uridine mRNA chemistry, a non coding backbone that is engineered for optimal translational performance and our proprietary LipoPlex formulation for systemic delivery. 2nd, this is a proof of concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication specific 6 sec program candidates. And lastly, it's a proof of concept for our strategy to combine synergistic modalities, in this case, BNT-one hundred and eleven, with an established immune checkpoint inhibitor treatment. All free offers also applies to BNT122, our individualized mRNA cancer immunoTRP based on our INET platform and the same delivery technology.

Speaker 3

We consider individualized cancer vaccines as a medical breakthrough in addressing the high unmet medical need of resectable cancers and in adjuvant or minimal residual disease treatment settings. Here, I want to highlight ongoing randomized Phase II trials with our individualized vaccine in pancreatic ductal adenocarcinoma and in colorectal cancer. The 5 year survival rate in pancreatic ductal adenocarcinoma after a resection alone is 10%, and up to 75% of patients with pancreatic ductal carcinoma relapse even though they appear tumor free within 5 years after adjuvant treatment. As for high risk Stage II or Stage III colorectal cancer, about 35% of patients relapse within 5 years after resection and adjuvant therapy. As discussed in the last earnings call, we demonstrated that our individualized vaccine used in patients with atrial pancreatic cancer can induce de novo 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 3 year follow-up period.

Speaker 3

At the recent ESMO GI Conference, we disclosed findings from the biomarker sub study of our ongoing Phase II INS trial, BNT12201, involving patients with Stage II high risk of Stage III colorectal cancer who remain ctDNA positive following the surgical accession of the localized cancer. Upon completion of standard of care adjuvant chemotherapy, these patients received BNT122, our individualized vaccine, in contrast to the conventional wait and watch approach. In the subset of 12 patients who were assessable for immunogenicity analysis, a high magnitude de novo T cell response against at least one vaccine encoded neoantigen was observed in all patients. These T cell responses were amplified with successive vaccination cycles. Notably, in several patients, the T cell responses were sustained even after 2 years of follow-up.

Speaker 3

All 12 patients involved in the immunogenicity analysis remained disease 3 at the time of data cutoff. Enrollment for the main part of the colorectal cancer study is underway to establish the safety and efficacy of BNT122 in patients with ttDNA positive Stage II, Stage III colorectal cancer as opposed to the standard wait and watch strategy. We anticipate presenting the results from this randomized Phase II study by late 2025 or early 2026. As multiple Phase II trials are ongoing and our clinical data on mRNA immunotherapies continues to mature, we are scaling up our manufacturing capabilities and capacities for bulk mRNA drug supply for off the shelf fixed 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 Mainz, Germany to support our ongoing late stage trials and potentially in the future commercialization.

Speaker 3

We also continue to leverage InStudy, 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-three twenty seven, which we consider as a key immunomodulatory concept and compelling backbone for novel combination. BNT-three twenty seven combines 2 validated mechanisms of action: VGSA binding inhibits the VEGFA with VEGFR access, blocks tumor angiogenesis,

Speaker 4

which leads

Speaker 3

to reduced tumor cell proliferation and survival. VEGF A inhibition also counteracts formation of the immunosuppressive tumor microenvironment as does the PD L1 arm of a bispecific antibody by reverting PD L1PD1 access mediated T cell exhaustion. The PD L1 arm also anchors this bispecific antibody to the tumor bed for efficient and localized scavenging of the EGFA, which may contribute to mitigate off tumor on target side effects. Given that both the NTBE GFA and the anti PD-one mechanisms are validated across many tumor types and in some cases as a combination, we have a clear roadmap ahead of us where to develop BNT-three twenty seven. Beyond these initial indications in which we may combine with standard of care chemotherapy, we plan to evaluate novel BNT-three twenty seven combinations, the first of which were started recently.

Speaker 3

These novel BNT-three twenty seven combinations may open up new areas of activity for our anti VEGF A and anti PD L1 molecule. We and our partner, BioPhiose, have treated over 600 patients across the wide range of clinical indications with BNT-three twenty seven, 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 demonstrates robust single agent activity of BNT-three twenty seven in previously untreated advanced non small cell lung cancer and high response rates in combination with standard of chemotherapy and 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 paxlitaxel.

Speaker 3

The safety profile in these indications was generally well managed and in line with adverse events observed with other therapies targeting PD L1 and appears to be more favorable than those seen with anti V GFA agents. These data have driven our strategic decision to initiate registration trials in small cell lung cancer, non 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 PD-one checkpoint inhibitors, which only achieve response rates of around 20%. TNBC patients, particularly those with PD L1 negative tumors, have few treatment options as they are not eligible for current anti PD-one therapy. In metastatic non small cell lung cancer, while anti PD-one inhibitors have significantly changed the treatment landscape, nearly half of these patients still do not respond to frontline therapy in combination with chemotherapy.

Speaker 3

We will soon start 2 global Phase II dose optimization studies to enable selection of a registrational dose for global registrational trials in these particular indications. At ASCO, we presented updated preliminary efficacy and safety data from an ongoing Phase III study in cohorts of advanced cervical cancer, platinum resistant relapsed ovarian cancer and advanced relapsed non small cell lung cancer. We will be presenting signal finding data from additional tumor indications at upcoming conferences. This will add to our extensive database and is the basis of our plans for further development in key indication. Most importantly, as Ugo also noted, it is a strategic goal for us to explore BNT-three twenty seven as part of novel combination, in particular with our ADC assets and mRNA therapies.

Speaker 3

We have started to implement this strategy by investigating BNT327 in combination with our top 2 ADC, BNT325. 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 CYVA Annual ESMO Congress in Barcelona, here we will present an update on our two trials evaluating BNT-one hundred and thirteen, 6FAC.

Speaker 3

The first update will include patients with anal, head and neck, cervical and other HPV 16 granular carcinomas and we report mainly safety and immunogenicity findings from the Phase III trial. The second update from a safety run-in cohort of our ongoing Phase II trial evaluating BNT-one hundred and thirteen dosing combination with pembrolizumab versus pembrolizumab alone will include patients with HBV16 positive head and neck squamous cell carcinoma. This update will focus on the safety immunogenicity and preliminary activity findings of the cohort. We will also present the updated results on BNT-three twenty seven in patients with TNBC with EGFR mutated non small cell lung cancer and with kidney cancer, together with our partner BioPhields. These updates will contain either initial or follow-up data on safety and efficacy of BNT-three twenty seven at the monotherapy and as a combination with different chemotherapeutic regimens.

Speaker 3

And finally, we will be presenting updated results from our ongoing Phase I trial evaluating safety and efficacy of our CLARITY6 CAR T cells in combination with Claudine 6 encoding mRNA vaccine in patients with relapsedrefractory Claudine 6 solid tumors. These data will be a follow-up from what was presented at last year's ESMO Congress and will include updated safety and efficacy data as well as data on CAR T cells assistance. 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, Jens Holzschein.

Speaker 5

Thank you, Aslem, and a warm welcome to everyone who has dialed in today's call. Let me start by reviewing our financial results for the 3 months ended June 30, 2024. Our total revenues reported for the Q2 of 2024 reached approximately €129,000,000 compared with approximately €168,000,000 for the Q2 of 2023. Our Q2 revenues reflect the current demand of a seasonal pandemic COVID-nineteen vaccine market, and I expect it to be the low point in this year's COVID-nineteen vaccine uptake. Parts of our total revenues are derived from the pandemic preparedness agreement with the German government, which is expected to run until early 2027.

Speaker 5

Moving to cost of sales. Cost of sales amounted to approximately €60,000,000 for the Q2 of 2024 compared to approximately €163,000,000 for the comparative prior year period. Research and development expenses were approximately €585,000,000 for the Q2 of 2024, compared to approximately €373,000,000 for the comparative prior year period. Of the total R and D spend in the 2nd quarter, we invested approximately 90% in our non COVID business, mainly by initiating larger clinical studies for our late stage oncology candidates and by investing in additional personnel in our R and D departments to run those clinical trials. Sales, general and administrative expenses amounted to approximately €184,000,000 in the Q2 of 2024 compared to about €138,000,000 in the comparative prior year period.

Speaker 5

The increase in SG and A 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 Q2 of 2024, this amounted to approximately €267,000,000 in negative operating result compared to about €57,000,000 in negative operating result for the comparative prior year period. This change was primarily due to the recording of a provision related to a contractual dispute. Income taxes were accrued with an amount of €2,000,000 of tax expenses for the Q2 of 2024 compared to approximately €222,000,000 of realized tax income for the comparative prior year period. The effective income tax rate for the first half of twenty twenty four was approximately 1.3%.

Speaker 5

For the Q2 of 2024, we reported a net loss of approximately €808,000,000 compared to a net loss of about €190,000,000 for the comparative prior year period. Our loss per share for the Q2 of 2024 amounted to €3.36 compared to a loss per share of €0.79 for the comparative prior year period. As of June 30, 2024, our cash and cash equivalents and security investments reached approximately €18,500,000,000 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 and the build out of the manufacturing capacities and capabilities to support additional late stage trials in commercialization. To create long term value, we aim to advance our clinical programs quickly, yet cost efficiently towards potential registration.

Speaker 5

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 COVID-nineteen vaccine in the United States in mid September, we expect to recognize the vast majority of our 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 will also reiterate our R and D and SG and A guidance with €2,400,000,000 to €2,600,000,000 for R and D €700,000,000 to €800,000,000 for SG and A expenses.

Speaker 5

Those expenses are expected to increase in the second half compared to the first half of twenty twenty four. Please note that this guidance does not include any M and 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 judgment 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's strategy, highlighted by the progress in our pipeline. 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.

Speaker 5

Supported by our strong cash position and demonstrated financial discipline, we will continue to invest in our pipeline and focus on generating value for patients and our shareholders. 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.

Speaker 6

Thank you, Jens. Our efforts over the last few months have put us in a strong position to execute our COVID-nineteen vaccine launches this fall season. In June, the European Medicines Agency recommended marketing authorization for our JN1 adopted COVID-nineteen vaccine, followed by European Commission approval on July 3. We started distributing vaccine doses to EU member states shortly thereafter. We expect that the earlier launch of our updated COVID-nineteen vaccine in Europe relative to last year will allow vaccination campaigns this year to be more closely aligned with seasonal influenza vaccination campaigns.

Speaker 6

In the United States, the FDA has recommended the use of KP2 as the preferred strain for the 20 four-twenty five season. We and our partner Pfizer have initiated a rolling submission with the FDA for our KP2 adapted COVID-nineteen vaccine and expect to be in a position to begin vaccine distribution in the U. S. Following regulatory approval with first shipments expected in September. COVID-nineteen vaccine demand continues to be globally distributed.

Speaker 6

We and our partner Pfizer are preparing to launch our variant adapted COVID-nineteen vaccine in over 40 countries and regions worldwide. We expect approximately 2 thirds of demand potential to reside outside the United States. While some regions outside the U. S. Continue to be served by government contracts, we anticipate several newly established private markets to open up in regions like the U.

Speaker 6

K. And Japan. This could enable broader access to COVID-nineteen 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 prefilled syringes, but we'll continue to offer a mix of prefilled syringes, single dose vials and multi dose vials across regions. We believe the Comirnaty franchise is well positioned to maintain its leading position globally in the continued fight against COVID-nineteen.

Speaker 6

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 cutting edge mRNA technology, which aims to address the root cause of cancer, genomic mutations or neoantigens that are largely specific to each individual's tumor. Neoantigens 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.

Speaker 6

In addition to their ability to be combined with other therapies with complementary mechanisms of action, we believe these therapies have potential to extend beyond the product lifecycle of a traditional off the shelf pharmaceutical product. The next slide highlights the key pipeline milestones to focus on as we look ahead to 2024 2025. 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 3 COVID flu combination vaccine top line data expected this year and data expected in 2025 from both our mRNA cancer vaccine platforms, FixVac and Inest. We also expect data updates for BNT327, our anti PD L1 VEGF bispecific antibody and BNT-three twenty three, our HER2 ADC in a variety of solid tumor indications.

Speaker 6

Finally, we plan to initiate multiple combination trials in solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations, which leverage complementary 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.

Speaker 6

On the next slide, I would like to remind everyone that we plan to hold our 1st artificial intelligence innovation Series event via webcast on October 1, followed by our Annual Innovation Series event on November 14. Further details will be released soon. We welcome you to join these events for a deeper look at the exciting developments taking place at BioNTech. With that, I would like to open the floor for questions.

Operator

Thank from the line of Daina Kraybusch from Leerink Partners. Please go ahead.

Speaker 7

Hi. Thank you guys and thanks for the question.

Speaker 1

This is one is on the early as 2026. I'm wondering if

Speaker 7

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, what gives you confidence in accelerated approvals by that date? I guess I'm specifically referencing whether any of those are your Phase 2 vaccine trials? Thank you.

Speaker 8

Yes. Thank you, Dana. I'll start briefly and my colleagues can jump in. So I think for 2026, we have a couple of different programs that potentially could launch in that timeframe. And the first of which is BNT-three twenty three or HER2 ADC.

Speaker 8

And we've highlighted the potential for we think for an accelerated approval in second and third line endometrial cancer. So that would be one asset where we're expecting data next year. And if that timeline is confirmed with further FDA discussions, we think that that could be a 26 launch opportunity. In addition, we've highlighted potential for an accelerated pathway with our BMT-one hundred and twenty two INEST in adjuvant colorectal cancer. We still have further discussions to take place with the FDA, but based on the current study design and the pace of enrollment, we do think that there's the potential if the data strong also for data to be for submission and potentially a launch in that sort of timeframe, most likely towards the end of the year or early 20 27, but it could fall in 2026.

Operator

Thank you. We will now take the next question from the line of Yaron Werber from TD Cowen. Please go ahead.

Speaker 9

Maybe just a quick question, I know you probably can't say a lot, but BNP-one hundred and eleven fix back, when you're looking at historical controls and you're looking at sort of the overall survival sort of trend, can you give us a sense what which historical control do you think

Speaker 6

are most appropriate just to kind of help gauge what the efficacy could be? Thank you.

Speaker 3

Yes. This is a very dire indication, CPI refractory resistant melanoma and the controls against which we compare anti PD-onePD L1 treatments, which have been tested in this indication, are chemopuripies, which have been tested in this indication. And as compared to those, we see clinically meaningful benefit with regard to objective response rate, There is a trend for overall survival, 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 the data next year, we will be able to be more specific.

Operator

Thank you. We will now take the next question from the line of Tazeen Ahmad from Bank of America Securities. Please go ahead.

Speaker 7

Hi, good morning. Thanks for taking my question. Regarding the upcoming Phase 3 COVID flu combo data later this year, Can you frame for us what would be good data? And 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 product would be able to launch?

Speaker 7

Thanks.

Speaker 2

Hi, this is Ugo. Yes, thanks for your question. So we are expecting that time frame with safety immunogenicity data and efficacy data end of this year. And based on the results, we have to see whether the data qualify for submission and potential approval for the season 20252026.

Speaker 7

What would you consider good data that will occur to be an improvement over the regular COVID vaccine?

Speaker 2

Can you repeat your question? I didn't get that.

Speaker 7

What would you consider to be good data relative to the COVID only vaccine in order to adjust the I think the data is very

Speaker 2

clear. It an efficacy trial. It's about comparability with the COVID-nineteen plus efficacy in the through arm, okay, additional immunogenicity data supporting the mode of action of the vaccine.

Operator

Thank you. We will now take the next question from the line of Etzer Darrut from BMO Capital Markets. Please go ahead.

Speaker 10

Hi. Thanks for taking the question. Just wondering sort of in the wake of the axinolumab update and your maintenance of R and D guidance, is there a specific internal oncology program that potentially benefits here? In other words, maybe potential of acceleration of investments or broadening out of the program. Just so curious, your thoughts around who maybe what programs may benefit from this internally?

Speaker 8

Yes. Thank you for that question. Ultimately, this does come down to portfolio strategy, as you're I think your question alludes to. And the fact is that we have multiple programs that we think could have potential in non small cell lung cancer. We've already started a Phase 3 for BNT-three sixteen.

Speaker 8

We've just brought out data at ASCO for BNT-three twenty seven, which albeit early we do think is quite promising. And we also have a fixed back program that's also in SCLC. So we've got already critical mass in our portfolio in the non small cell lung cancer indication and we are planning a multipronged strategy to execute against. So while we found the data encouraging for ekazimlimab, 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 3, we will still retain a economic stake in the program and a stake in the success, the future success of the program, but we won't fund Phase 3.

Speaker 8

And we think that that's the right balance given the many shots on goal and exciting data that we're seeing from the portfolio.

Speaker 10

All right. Thank you.

Operator

Thank you. We will now take the next question from the line of Yifeng Liu from HSBC Bank Plc. Please go ahead.

Speaker 11

Hello. Thank you for taking my question. I've got a question on margin progression. So just how should we think about as your oncology pipeline progresses and also in the meantime you've scaling up manufacturing and potentially investing in R and D and then SG and A, how should we think about that margin progression and especially as you're launching your oncology for those in the future? Thanks.

Speaker 8

Yes. We couldn't hear you very well there, but just want to make sure we get the question right. So 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?

Speaker 11

Yes. Because I think the launch is predominantly we see sort of in oncology space and yes, just the question on margin progression.

Speaker 5

Thank you. Maybe I'll start. It's awfully difficult actually to understand you. You're fading away somewhat. But I mean you've seen that of course the margin that we have with our in our partnership with Pfizer is extremely good.

Speaker 5

I mean, we're close to 100% given the gross margin share structure that we have with Pfizer. So that's outstanding and certainly not normal. In terms of oncology, going forward, we would expect that we see similar sort of margins as you see in with other companies. I think in looking forward in terms of in realized medicine, I think we got to wait a little bit on how we can when we can make some statements in terms of the margin, but we're working very hard. I can assure you, we're working very hard to bring the costs down for immunosuppressive medicine candidates.

Speaker 8

Yes. And I would just add one point to that. So in addition to what Jens just said about oncology, I think we're still expecting of course that our COVID business is going to still be for the next couple of years still 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 Pfizer that we think will allow us to keep our overall operating profile quite attractive.

Speaker 12

Thank you.

Operator

Thank you. We will now take the next question from the line of Manu Ereddych from Jefferies. Please go ahead.

Speaker 13

Hi. This is actually Akash. So you recently top line data from your 111 trial in cutaneous melanoma. Our analysis suggests the COMO arm would have a 24% delta versus roughly the 11% historical control rate for APE or PD-one. Is that the ballpark way to think about the ORR delta in this study?

Speaker 13

And what would you have to see on PFS and OS to justify moving this forward into a Phase 3? And maybe just stepping back, what does this trial teach the BioNTech team about the ideal place for cancer vaccines? I feel like one of the lessons from your early INS data was that cancer vaccines were perhaps not well suited for patients with metastatic late stage disease and yet these patients were PD-one refractory. So how should we interpret that? Thank you.

Speaker 2

Okay. Thank you. It's a great question. So the personalized cancer vaccines have a manufacturing turnaround time in the range of 6 to 8 weeks. And therefore, in the metastatic setting, this type of vaccines are are difficult to provide clinical benefit since these patients rapidly progress.

Speaker 2

So the statement of refer us to the personalized vaccines. With regard to FICC VAC, we have seen that FICC VAC has 2 activities. It's on the one side, the direct activity due to the adjuvant function. We are seeing a type 1 interferon response, yes, and have seen now in a number of indications, not only in melanoma, but also in lung cancer, objective responses in patients with advanced cancers. And we expect that the combination, particularly with a treatment that is able to control the disease for a certain time.

Speaker 2

And we are particularly interested in our ADC mRNA vaccine combinations. We will see a number of trials coming up in 2025 for this. Would be an exciting opportunity for our 6 sub approach. And maybe for the other part, I think it's to Aslan.

Speaker 3

Yes. Your question regarding BMD-one hundred and eleven was about the clinical benefit, which we would like to see as compared to standard of care. I cannot preempt our disclosures, which will come when we have mature data. But what I can say is, as you know, standard of care objective response rate for this patient population is around 10% -ish. So what we would like to see is something well above it and this is also what our data shows us.

Speaker 3

We also want to see duration of response. And also, this looks clinically meaningful in the current data set, which we have. And then it's obviously also about safety. And what we see is that BNT-one hundred and eleven as a fixed effect based on RNA lipoplex technology is has a very manageable safety profile. And in combination with cemiplimab, we don't see anything which is surprising.

Speaker 3

So there is no additive toxicity also, which for us means that the clinical profile looks very promising for this patient population.

Operator

Thank you. We will now take the next question from the line of Jessica Fye from JPMorgan Chase. Please go ahead.

Speaker 14

Hey, guys. Good morning. Thanks for taking my question. It looks like the BeyondTech top line guidance reflects a different expectation for 2024 Comirnaty sales than what Pfizer's guidance would imply. What gives you confidence in achieving this result?

Speaker 14

And to the extent that part of the delta is driven by German for pandemic preparedness contract, which I believe falls outside the collaboration, Can you quantify what that is contributing to the guidance? Thank you.

Speaker 5

Yes. Let me start and maybe Ryan want to jump in. So I think we are very much aligned with Pfizer in terms of our Comenity expectations. We should keep in mind that Pfizer has reiterated its guidance. We did the same today.

Speaker 5

You should be aware that and take into account that we have a contract together with the European Union. They have approval 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 in that sense, we feel good about it. And in terms of the pandemic preparedness contract, we have confidentiality with the German government.

Speaker 5

So we are a bit limited in really stating here some numbers. But you should expect that there is a significant amount of money being part of what we have reported in the first half. So we have reported outside of Comenati, if you look into the documents, EUR120 1,000,000. So a big chunk of that in the first half comes from that dynamic preparedness contract.

Speaker 1

Thank you.

Operator

Thank you. We will now take the next question from the line of Cory Kasimov from Evercore ISI. Please go ahead.

Speaker 15

Hi. Thanks for taking the question. So regarding the upcoming data at ESMO for BNT-three twenty seven in EGFR mutated, non small cell lung cancer, There's obviously been a lot of attention, of late on the competitive PD-one VEGF bispecific that's out there. I'm curious, like, 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?

Speaker 15

Thank you.

Speaker 2

Yes. Thank you for the question. I can keep it short. I think the data that we are going to present will be competitive. And as you know, the asset that BNT-three twenty seven is now a molecule that is currently in evaluation of multiple indications.

Speaker 2

At BioNTech and our collaboration partner BioThios. And we will see additional studies to be announced end of this year, beginning next year.

Speaker 5

Okay. Thank you.

Operator

Thank you. We will now take the next question from the line of Chris Shibutani from Goldman Sachs. Please go ahead.

Speaker 4

Yes. Thank you. If I could just follow-up on the BNT-three twenty seven, noting from Slide 10, it appears from the change in your pipeline plans, are some additional trials there, which seem to signal that BioNTech is quite enthusiastic in that regard. 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, SUMR Therapeutics? And in particular, can I ask you, are you looking to do any head to head trial involving KEYTRUDA?

Speaker 4

How are you thinking about sort of clinical development strategy that we can understand to be differentiated? Thank you.

Speaker 3

Thank you for this question, Chris. We cannot comment on the strategy of others, but what we can say is that we think that BNT-three twenty seven and this concept is highly compelling and qualifies as IO backbone for various combinations. With regard to the indications, which we will pursue also in potentially registrational trials. We are well poised for that because our partner, Biophias, has already brought a multi indication program ongoing with a number of signal seeking cohorts in various indications with various standard of care regimens, so that we have a wealth of data already and can pick the indications and expand that as they mature. And another dimension of diversification is that we see BNT-three twenty seven as a backbone for many of our pipeline assets, our wholly owned ones, but also those we have partnered because it has such a permissive synergistic prone mode of action?

Speaker 2

Yes. And regarding Tembo, so we are seeing, of course, data from now a number of indications coming in and continue to mature. And we have seen for data for which, for example, a historical benchmark data are available, for example, in triple negative breast cancer. And the extent of clinical benefit that we have, certain BMT-three twenty seven is really encouraging. And for any indication in which tambour is approved as a backbone, Our plan would be, of course, to compare efficacy of BT3 to 7 plus X against counterpart standard of care.

Speaker 2

And if it's PEMWOL, we would compare against PEMWOL. Thank you.

Operator

Thank you. We will now take the next question from the line of Terence Flynn from Morgan Stanley. Please go ahead.

Speaker 16

Hi, thanks for taking our questions. This is Chris on for Terence. We have a 2 part question on BNT122 in colorectal cancer. You guided data by the end of 2025 or early 2026. But is there a potential for an interim analysis that would allow you to look at the data earlier?

Speaker 16

And then second, what will you and your partner Roche need to see in this trial in order to advance it into Phase 3? Thank you.

Speaker 2

Yes. We have hinted to a potential analysis in end of 2025. As you know, the study is endpoint is disease 2 survival in this indication. And the general principle that we expect from influenza cancer vaccines is that metastatic tumor cells, which are present after surgery, could be removed by inducing a T cell response. The indication that we have chosen is a ctDNA positive indication.

Speaker 2

That means based on published data, we know that this patient population who are ctDNA positive after surgery with the Stage II, Stage III colorectal cancer have a PFS in the range of 10 to 12 months. And after chemotherapy and PFS is more around medium PFS is around 6 to 8 months. So that means at that time point, we would expect that at least part of the data would be matured. And then based on the results, we yes, it will depend how elderly cells are and whether additional studies would be required at that time point or whether the data would be sufficient to continue and request potential regulatory steps.

Speaker 16

Great. Thank you.

Operator

Thank you. We will now take the next question from the line of Simon Baker from Redburn Atlantic. Please go ahead.

Speaker 4

Thank you for taking my question. It's a question on Inest capacity. I wonder if you could give us an idea of the capacity the mines facility will give you in 20 27? And also, you mentioned the ability to reduce the bottlenecks in vein to vein time. I wonder if you could give us an idea of where they stand and where this could currently go to.

Speaker 4

And just related to this, based on your comments on 122, is it right to assume that completion of that facility rather 122 approval is not contingent on completion of that facility? Thanks so much.

Speaker 2

Yes. So at the moment, we can't comment on the capacity of the facility that is being built because we are still in process further process improvements, increasing the overall capacity. So reliable numbers will be available end of 2025 for the capacity. But the facility has been built with the idea that it could act as a pilot facility if one of the personalized vaccine products is approved at the time pump. So this is ongoing work and parallel for building this facility, which is intended to act as a potential pilot facility.

Speaker 2

We are expanding currently our clinical trial capacity to ensure that we can start additional trials in 2025 and later on. And then I think there's

Speaker 8

a Simon, you asked about bottlenecks in terms of vein to vein time.

Speaker 4

Yes, please.

Speaker 2

Bottlenecks, yes. So this is of course a completely new process, manufacturing a vaccine in real time. And you can imagine and that every step must be validated. So this is we have established personalized manufacturing of mRNA vaccines for the first time in 2014. Since then, we have been 2 additional innovation cycles.

Speaker 2

We have recently implemented additional change in their manufacturing further reducing the turnaround plan. But still manufacturing release of such a vaccine comes with multiple release tests for the individual batches. So we are working on making the steps more robust, reducing the cost and this will become more or less also the value driver of this approach, being able to reduce the cost substantially and thereby allowing that this is an affordable approach, both be available for a large population of patients.

Operator

We will now take the next question from the line of Liana Merle from UBS. Please go ahead.

Speaker 7

Hi, guys. Thanks so much for taking the question. 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 breadth of your portfolio. I guess, what are the programs that you are most excited about for prioritizing for combinations?

Speaker 7

Thanks.

Speaker 3

Thank you for the question, Eliana. We are in principle very excited about IO, ADC combination concept because we expect and also our pre clinical data supports this that this is highly synergistic. And as you pointed out, we have started our first trial, which is the first of the series you will see where we use BNT-three twenty seven as the IO backbone, which in the first trial is combined with our top two ADC from our partnership with Duality in multiple solid cancers, and this will be extended to additional ABCs from our pipeline to be combined with BNT-three twenty seven. We are also very excited about a combination, which is ongoing for quite some time, and namely one of our priority assets BNT-two eleven, which is our Claudine 6 CAR T cells in combination with our vaccine, which is designed in this case in a way that it specifically acts on the adoptively transferred CAR T cells. And our data, which shows that the vaccine in fact adds to the persistence and duration of the adoptive transferred CAR T cells is getting stronger and stronger with data maturing.

Operator

Great. Thank you. Thank you. We will now take the next question from the line of John Newman from Canaccord Genuity. Please go ahead.

Speaker 17

Hi there. Thanks very much for taking my question. You're obviously in the midst very active development for BNT-three twenty seven. I'm wondering specifically for the trials where you're combining with BNT-three twenty five, your TROP-two ADC, do you see the potential down the road for accelerated approval in some of those indications? Thank you.

Speaker 2

Thank you. This is too early to say. Okay. Thanks.

Operator

Thank you. We will now take the next question from the line of Manos Mostarakis from Deutsche Bank. Please go ahead.

Speaker 12

Hello. Thank you for taking my question. Again on BNT twenty seven, just wanted to understand how you're thinking about the clinical trial design. Are you hoping or aiming to study mainly PD L1 positive populations? Or are you keen to keep that open and see what the data looks like after the fact?

Speaker 2

Yes. See, this is a great question. Let me share our view. So the introduction of anti PD-one treatments led to the division of patient population, population in PD L1 high, PD L1 low and PD L1 negative population. And the exciting observation that we made now in 2 indications is that the combination of chemotherapy plus BNP-three twenty seven appears to be effective highly clinically meaningful manner, also in the PD L1 negative population.

Speaker 2

And this really provides the great opportunity. So we believe that BNT-three twenty seven is not only something which could be better than existing PD-one treatment, but we see the chance that we overcome the current classification of the patients into PD L1 negative and PD L1 positive patient population. This is exciting. And by this, of course, the patient populations would dramatically increase and clinical trials could be done in a much easier way and standard of care, yes, could become easier manageable based on treatment combinations that are independent of PD L1 staining.

Operator

Thank you. This is all the time we have for questions today. I would like to hand back over to the speakers.

Speaker 8

Yes. Thank you very much for joining us today.

Operator

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

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BioNTech Q2 2024
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