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BioNTech Se(NASDAQ: BNTX)
Q2 2024 Earnings Call
Aug 05, 2024, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Welcome to BioNTech second quarter 2024 earnings call. I would like to hand the call over to Dr. Victoria Meissner, vice president of strategy and investor relations. Please go ahead.
Victoria Meissner -- Vice President, Strategy and Investor Relations
Thank you. Good morning, and good afternoon. Thank you for joining BioNTech's second quarter 2024 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website.
On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the 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.
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We undertake no obligation to update or revise any of these statements. 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: Uğur Şahin, 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 Ugur.
Uğur Şahin -- Co-Founder and Chief Executive Officer
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 Comirnaty and our late-stage oncology portfolio. First, I 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. Slide 5. The second quarter of 2024 was marked by a significant execution across our oncology pipeline and our leading COVID-19 franchise. Our progress in the quarter will set us up for an impactful end of 2024 as we continue to progress toward our long-term vision.
I would like to highlight achievements in three areas. First, with regard to our COVID-19 vaccine leadership. On the back of the first regional approvals, we have initiated the launch of our new variant-adapted vaccine and expect additional approvals in the coming weeks and months. Second, in oncology, we shared numerous updates at major medical meetings that highlighted our clinical execution and pipeline progress and provided data on several of our assets across modalities.
Ozlem will discuss some of these updates in more detail, but I would like to highlight two of those specifically. Last week, we announced that our off-the-shelf FixVac mRNA cancer vaccine for melanoma, BNT111, met the primary endpoint in the ongoing randomized Phase 2 trial, evaluating BNT111 in combination with cemiplimab in patients with stage 3 and stage 4 cutaneous melanoma. This preliminary result is a significant milestone for our company and underscores our belief in the transformative potential of this new class of medicines and of our mRNA vaccine technology, which is a key pillar of our oncology strategy. We have exciting news also with regard to another key pillar of our oncology strategy, namely the development of novel IO-ADC combination.
This quarter, we started the first of several preparatory trials for our combination therapy strategy. The trial evaluates the combination of our anti-PD-L1 VEGF bispecific antibody BNT327 and our top two ADC, BNT235. We look forward to reinitiating additional trials, evaluating novel IO-ADC combinations over the next 12 months. The third area in which we made progress is our mission toward the creation of sustainable and resilient end-to-end vaccine ecosystem in Africa by expanding our partnership with CEPI.
CEPI is committed up to $145 million to support us to establish mRNA vaccine 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 threats in Africa in alignment with our corporate purpose of ensuring equitable access to our medicines. Slide 6, starting with our COVID-19 franchise. We continue circulation of SARS-CoV-2 leads to the ongoing evolution and emergence of novel variants of the virus, which we continue to monitor and evaluate for their immune-evasive potential and virulence.
In September 2022, the XBB lineage gradually emerged, dominated globally throughout 2023 with multiple sublineages and was successfully addressed by XBB.1.5-adapted COVID-19 vaccines, including our own. This year, JN.1 lineage, including KP.2, 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 use our real-world effectiveness data to demonstrate that the antigenic shift and the distance of JN.1 lineages from XBB.1.5 has impacted the vaccine effectiveness of the XBB.1.5-adaptive vaccine against the now prevalent JN.1 lineages. Slide 7.
Based on this and additional data, regulatory and public health authorities consequently advised vaccine manufacturers to revise the formulation for their authorized COVID-19 vaccines. The WHO and the EMA recommended the use of JN.1 lineage antigen in a monovalent COVID-19 vaccine for the seasons 2024, 2025. And 70 days later, we were able to submit our application to the European regulator. Based on this recommendation and the consequent EMA approval on July 3rd, we have begun rolling out our updated Comirnaty JN.1 vaccine in Europe.
In the United States, the FDA further recommended the use of KP.2 as the preferred JN.1 lineage antigen for the 2024/2025 COVID-19 mRNA vaccines on June 13th. Less than two weeks later, we initiated our rolling submission with the U.S. FDA. We and our partner, Pfizer, are working hard to enable early availability of variant-adapted vaccines for people around the world with the aim of reducing or preventing severe disease, hospitalization, and COVID-19-related deaths.
We expect the FDA approval of our KP.2-adapted vaccine by mid-September, and we aim to deliver the first vaccine bolus 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. Before I hand over to Ozlem to deep dive into the recent achievements, let me remind you of our overarching oncology strategy.
MRNA cancer immunotherapies 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 two years, we added platforms to complement the mRNA centerpiece. Today, we have an oncology toolkit featuring multiple modalities, including targeted therapies, such as ADCs and immunomodulators IOs, that open up new combination opportunities to synergistic mechanisms of action.
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 populations 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 improvements in the long-term survival rates of patients. And as you will hear from Ozlem, the last quarter has been about executing toward 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 toward our founding vision. Thank you.
Ozlem Tureci -- Co-Founder and Chief Medical Officer
Thank you, Ugur. 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, two of our modalities, namely mRNA and immunomodulator Ios, are dominantly represented in our pipeline and particularly so in the advanced clinical stages.
Today, I want to focus on priority assets within these modalities which have our special attention, our mRNA vaccines and one of our IO compounds, BNT327. Before I cover these assets, let me just mention that the 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 pipelinewide patient accruals compared to last quarter. Compared to 2022, we and our network of partners are now recruiting six times as many patients per quarter to support enrollment into the clinical trials you saw on the previous slide.
This increase is a testament of our drive toward more and larger mid- to late-stage trials as part of our ambition to achieve multiple product launches in oncology by the year 2030. It also underlines the success of our partnership strategy, which not only gives us 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, iNeST and FixVac, which differ in the type of tumor antigen they target. iNeST targets neoantigens derived from somatic cell mutations in cancer cells that are unique to an individual's tumor.
iNeST vaccines are manufactured on demand and personalized to each individual patient. FixVac vaccines target multiple non-mutated antigens shared by a majority of patients with a given tumor type and are off the shelf. The computational approaches to discover and select these two different types of target antigens are one of our core competencies. INeST and FixVac 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 translational and clinical data over the last couple of years, and future data updates from multiple trials shown on this slide are planned. Aggregate data that we have reported in the past across INeST and FixVac trials indicate that uridine mRNA-LPX-based vaccines have a manageable and largely mild safety profile as single agent, in combination with anti-PD-1/PD-L1 compounds and in combination with chemotherapy. 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-1/PD-L1 treatment. Several of the 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 FixVac program, here on the right, I would like to highlight three vaccine candidates currently being evaluated in multiple trials in both the metastatic and adjuvant settings. First, BNT113 being well under way in first-line HPV16 positive PD-L1 positive head and neck squamous cell carcinoma in a potentially registrational Phase 2 randomized trial.
Second, BNT116 being investigated in two trials as a single agent and in various combinations in different non-small cell lung cancer patient populations and treatment lines. And last but not least, BNTT111 being investigated in anti-PD1 relapsed or refractory melanoma, about which I would like to talk a bit more. BNT111 is a uridine mRNA-LPX-based vaccine that encodes four melanoma-associated antigens that collectively cover more than 90% of melanoma patients and are highly immunogenic. In the randomized three-arm Phase 2 clinical trial conducted in collaboration with our partner, Regeneron, we are evaluating BNT111 in combination with Regeneron's anti-PD-1 compound cemiplimab, and we measure activity of BNT111 alone or cemiplimab alone in a total of 184 enrolled patients with PD-L1 refractory unresectable stage 3 or stage 4 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 BNT111-cemiplimab combination arm as compared to a historical control of anti-PD-1 monotherapy in relapsed/refractory patients. The historic control was based on multiple late-stage clinical trials that established the expected objective response rate for monotherapy checkpoint inhibitors in this setting for this patient population. While the data are further maturing, we do see a trend toward improved overall survival. The BNT111-01 trial is based on the earlier] Lipo-MERIT Phase 1/2 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 BNT111 as single agent and with checkpoint inhibitors approved in this patient population. In that proof-of0concept study, we observed that treatment with BNT111 alone or in combination with anti-PD-1 could induce strong, high-magnitude T-cell responses against at least one targeted tumor-associated antigen in all analyzed patients, most of which were not detectable prior to using the vaccine. As shown here, objective responses by BNT111 were durable with some patients followed up for several years. The safety profile was generally mild and in line with expectations for those patients who were co-treated with checkpoint inhibitors.
The results we are seeing in the Phase 2 BNT111-01 study are consistent with these prior results. We plan to present the full data from the primary analysis at a 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-end continuous increasing incidence and mortality burden. The introduction of checkpoint inhibitor-directed therapies was a breakthrough for patients that led to significant improvements in survival.
Nonetheless, in advanced disease stages, only a third of patients achieve a long-term response and long-term survival after failure of checkpoint inhibitors. There is no established standard of care with only limited and short-lived responses to salvage therapy. While a new adapted strategy 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 BNT111 may be of interest to potentially help treat this high medical need population.
Moreover, the BNT111 data is a proof of concept for our computational approaches. Firstly, a proof of concept for our decade-long improved mRNA cancer vaccine technology that uses uridine and mRNA chemistry, a noncoding backbone that is engineered for optimal translational performance and our proprietary lipoplex formulation for systemic delivery. Second, this is a proof of concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication-specific six-leg program candidates. And lastly, it's a proof of concept for our strategy to combine synergistic modalities, in this case BNT111 with an established immune checkpoint inhibitor treatment.
All three of these also applies to BNT122, our individualized mRNA cancer immunotherapy. Based on our iNeST platform and the same delivery technology, we consider individualized cancer vaccines as a medical breakthrough in addressing the high unmet medical need of resectable cancers and in adjuvant or minimal residual disease treatment settings. Here, I want to highlight ongoing randomized Phase 2 trials with our individualized vaccine in pancreatic ductal adenocarcinoma and in colorectal cancer. The five-year survival rate in pancreatic ductal adenocarcinoma after resection alone is 10% and up to 75% of patients with pancreatic ductal carcinoma relapse, even though they appear tumor free within five years after adjuvant treatment.
As for high-risk stage 2 or stage 3 colorectal cancer, about 35% of patients relapse within five years after resection and adjuvant therapy. As discussed in the last earnings call, we demonstrated that our individualized vaccine used in patients with adjuvant pancreatic cancer can induce the 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 three-year follow-up period. At the recent ESMO GI conference, we disclosed findings from the biomarker substudy of our ongoing Phase 2 iNeST trial, BNT122-01, involving patients with stage 2 high-risk or stage 3 colorectal cancer who remain ctDNA positive following the surgical excision 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 patients who were accessible 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 success of vaccination cycles. Notably, in several patients, the T-cell responses were sustained even after two years of follow-up. All 12 patients involved in the immunogenicity analysis remained disease free at the time of data cutoff.
Enrollment for the main part of the Colorado Cancer study is underway to establish the safety and efficacy of BNT122 in patients with ctDNA-positive stage 1 detected cancer as opposed to the standard wait-and-watch strategy. We anticipate presenting the results from this randomized Phase 2 study by late 2025 or early '26. As multiple Phase 2 trials are ongoing and our clinical data on mRNA immunotherapies continues to mature, we are scaling up our manufacturing capabilities and capacities for bulk mRNA drug supply for off-the-shelf FixVac vaccines and also for our individualized vaccine program 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.
We also continue to leverage in study 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 compound, specifically BNT327, which we consider as a key immunomodulatory concept and compelling backbone for novel combination. BNT327 combines two validated mechanisms of action. VEGF-A binding inhibits the VEGF-A with VEGF-R access, blocks tumor angiogenesis, which leads 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-L1/PD-1 access-mediated T-cell exhaustion. The PD-L1 arm also anchors this bispecific antibody to the tumor bed for efficient and localized scavenging of VEGF-A which may contribute to mitigate of tumor on-target side effects. Given that both the anti-VEGF-A and the anti-PD-1 mechanisms are validated across many tumor types, and in some cases, as a combination, we have a clear road map ahead of us where to develop BNT327. Beyond these initial indications in which we may combine with standard-of-care chemotherapy, we plan to evaluate novel BNT327 combination, the first of which were started recently.
These novel BNT327 combinations may open up new areas of activity for our anti-VEGF-A and anti-PD-L1 molecule. We and our partner, Biotheus, have treated over 600 patients across a wide range of clinical indications with BNT327, either as monotherapy or in combination with various standard-of-care protocols. This extensive data collection effort provides a solid foundation for making informed data-driven decisions on potential indications and patient cohorts for future registration studies. Notably, the data demonstrate robust single-agent activity of BNT327 in previously untreated advanced non-small-cell lung cancer and high response rates in combination with standard-of-care chemotherapy in triple-negative breast cancer and small cell lung cancer.
Specifically, in first-line triple-negative breast cancer, we observed an objective response rate approaching 80% with durable responses when combined with nab-paclitaxel. 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-VEGF-A 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-1 checkpoint inhibitor, 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-1 therapies. In metastatic non-small cell lung cancer, while anti-PD-1 inhibitors have significantly changed the treatment landscape, nearly half of these patients, they do not respond to frontline therapy in combination with chemotherapy. We will soon start two global phase 2 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 1/2 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 indications. Most importantly, as Ugur also noted, it is a strategic goal for us to explore BNT327 as part of novel-novel combinations, in particular with our ADC assets and mRNA therapies. We have started to implement this strategy by investigating BNT327 in combination with our TROP2 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 our Annual ESMO Congress in Barcelona, here, we will present an update on our two trials evaluating BNT113, FixVac.
The first update will include patients with anal, head and neck, cervical, and other HPV16-driven carcinomas, and we report mainly safety and immunogenicity findings from the Phase 1/2 trials. The second update from a safety run in cohort of our ongoing Phase 2 trials evaluating BNT113 dosed in combination with pembrolizumab versus pembrolizumab alone will include patients with HPV16-positive head, 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 BNT327 in patients with TNBC, with EGFR-mutated non-small cell lung cancer, and with kidney cancer, together with our partner Biotheus.
These updates will contain either initial or follow-up data on safety and efficacy of BNT327 as a monotherapy and as a combination with different chemotherapeutic regimens. And finally, we will be presenting updated results from our ongoing Phase 1 trial evaluating safety and efficacy of our Claudin 6 CAR-T cells in combination with Claudin 6-encoded mRNA vaccine in patients with relapsed/refractory Claudin 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 cell persistence. We will share additional details on these and further congress publication in the near future.
With that, I will now pass the presentation to our CFO, Jens Holstein.
Jens Holstein -- Chief Financial Officer
Thank you, Ozlem, and a warm welcome to everyone who has dialed in today's call. Let me start by reviewing our financial results for the three months ended June 30, 2024. Our total revenues reported for the second quarter of 2024 reached approximately 129 million euros compared with approximately 168 million euros for the second quarter of 2023. Our second quarter revenues reflect the current demand of a seasonal endemic COVID-19 vaccine market, and I expect it to be the low point in this year's COVID-19 vaccine uptake.
Part of our total revenues are derived from a pandemic preparedness agreement with the German government which is expected to run until early 2027. Moving to cost of sales. Cost of sales amounted to approximately 60 million euros for the second quarter of 2024, compared to approximately 163 million euros for the comparative prior-year period. Research and development expenses were approximately 585 million euros for the second quarter of 2024, compared to approximately 373 million euros for the comparative prior-year period.
Of the total R&D spend in the second 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&D departments to run those clinical trials. Sales, general, and administrative expenses amounted to approximately 184 million euros in the second quarter of 2024, compared to about 138 million euros in the comparative prior-year period. The increase in SG&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 second quarter of 2024, this amounted to approximately 267 million euros in negative operating results, compared to about 57 million euros in negative operating results 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 million euros of tax expenses for the second quarter of 2024, compared to approximately 222 million euros of realized tax income for the comparative prior-year period. The effective income tax rate for the first half of 2024 was approximately 1.3%. For the second quarter of 2024, we reported a net loss of approximately 808 million euros, compared to a net loss of about 190 million euros for the comparative prior-year period.
Our loss per share for the second quarter of 2024 amounted to 3.36 euros, compared to a loss per share of 0.79 euros for the comparative prior-year period. As of June 30, 2024, our cash and cash equivalents, and security investments reached approximately 18.5 billion euros. 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 in the buildout 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 toward potential registration. Turning to the next slide. Today, we are reiterating the company's financial guidance for the current financial year. Consistent with the expectations of approval of our variant-adapted COVID-19 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 also reiterate our R&D and SG&A guidance with 2.4 billion euros to 2.6 billion euros for R&D and 700 million euros to 800 million euros for SG&A expenses. Those expenses are expected to increase in the second half compared to the first half of 2024. Please note that this guidance does not include any M&A transactions, payment for collaboration agreements or licensing deals not yet disclosed, nor any potential payments resulting from the outcomes of ongoing and/or future legal disputes or related activities such as 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 toward potential market authorizations. 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.
Ryan Richardson -- Chief Strategy Officer
Thank you, Jens.Our efforts over the last few months have put us in a strong position to execute our COVID-19 vaccine launches this fall season. In June, the European Medicines Agency recommended marketing authorization for our JN.1-adapted COVID-19 vaccine, followed by European Commission approval on July 3rd. We started distributing vaccine doses to EU member states shortly thereafter. We expect the earlier launch of our updated COVID-19 vaccine in Europe relative to last year will allow vaccination campaigns this year to be more closely aligned with seasonal influenza vaccination campaigns.
In the United States, the FDA has recommended the use of KP.2 as the preferred strain for the '24/'25 season. We and our partner, Pfizer, have initiated a rolling submission with the FDA for our KP.2-adapted COVID-19 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-19 vaccine demand continues to be globally distributed.
We and our partner, Pfizer, are preparing to launch our variant-adapted COVID-19 vaccine in over 40 countries and regions worldwide. We expect approximately two-thirds of demand potential to reside outside the United States. While some regions outside the U.S. continue to be served by government contracts, we anticipate several newly established private markets to open up in regions like the U.K.
and Japan. This could enable broader access to COVID-19 vaccines for individuals who may not qualify under local immunization recommendations, which tend to focus on the higher-risk population segments. In addition, we have increased our supply of 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-19.
Moving to oncology on the next slide. We will continue to invest in our mRNA cancer vaccine platforms based on our belief that personalized mRNA cancer vaccines have potential to establish a new paradigm in cancer treatment. These vaccines employ 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. Neoantigen selection for each patient is today driven by AI algorithms and a fully in-silico process.
We believe this is fundamentally distinct from other pharmaceutical products and that it will allow for iterative improvement over time, powered by data assets. In addition to their ability to be combined with other therapies with complementary mechanisms of action, we believe these therapies have potential to extend beyond the product life cycle of a traditional off-the-shelf pharmaceutical product. The next slide highlights the key pipeline milestones to focus on as we look ahead to '24 and '25. We are entering a catalyst-rich period over the next 18 months with data updates and regulatory submissions expected from multiple product candidates.
This includes, but is not limited to, Phase 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 BNT323, our HER2 ADC, in a variety of solid tumor indications. 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. On the next slide, I would like to remind everyone that we plan to hold our first Artificial Intelligence Innovation Series event via webcast on October 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.
Questions & Answers:
Operator
Thank you. [Operator instructions] We will now take the first question from the line of Daina Graybosch from Leerink Partners. Please go ahead.
Daina Graybosch -- Leerink Partners -- Analyst
Hi. Thank you, guys, and thanks for the question. This one is on the launches as early as 2026. I wonder if you could talk about what specific programs and settings trials you think are most likely to be able to launch in 2026.
And if that's dependent on accelerated approval, 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.
Ryan Richardson -- Chief Strategy Officer
Yeah. Thank you, Daina. 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 BNT323, our HER2 ADC, 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 could be a '26 launch opportunity. In addition, we've highlighted the potential for an accelerated pathway with our BNT122 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 is the potential if the data is strong also for data to be for submission and potentially launch in that sort of timeframe, most likely toward the end of the year or early '27, but it could fall in '26.
Operator
Thank you. We will now take the next question from the line of Yaron Werber from TD Cowen. Please go ahead.
Yaron Werber -- Analyst
Yeah, hi. Thanks for taking my question. Maybe just a quick question. I know you probably can't say a lot, but BNT111 FixVac, 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 are most appropriate, just to kind of help gauge what the efficacy could be? Thank you.
Ozlem Tureci -- Co-Founder and Chief Medical Officer
Yes. This is a very dire indication, CPI refractory resistant melanoma and the controls against which we compare anti-PD-1, PD-L1 treatments, which have been tested in this indication are chemotherapies, which have been tested in this indication. And as compared to those, we see a 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.
Tazeen Ahmad -- Analyst
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? Thanks.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Hi, it's Ugur. Yeah, thanks for your question. So we are expecting that timeframe 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 2025/2026.
Tazeen Ahmad -- Analyst
What would you consider good data though, Ugur, to be an improvement over the regular COVID vaccine?
Uğur Şahin -- Co-Founder and Chief Executive Officer
Can you repeat your question? I didn't get that.
Tazeen Ahmad -- Analyst
What would you consider to be good data relative to the COVID-only vaccine in order to --
Uğur Şahin -- Co-Founder and Chief Executive Officer
I think the data is very clear. There is an efficacy trial, yeah. It's about comparability with the COVID-19, plus efficacy in the flu arm, and 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 Darout from BMO Capital Markets. Please go ahead.
Etzer Darout -- BMO Capital Markets -- Analyst
Hi. Thanks for taking the question. Just wondering sort of in the wake of the cemiplimab update and your maintenance of R&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 curious your thoughts around who may be -- what programs may benefit from this internally.
Ryan Richardson -- Chief Strategy Officer
Yeah. Thank you for that question. Ultimately, this does come down to portfolio strategy, as 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 BNT316.
We've just brought out data at ASCO for BNT327, which, albeit early, we do think is quite promising. And we also have a FixVac program that's also in NSCLC. So we've got already critical mass on our portfolio in the non-small cell lung cancer indication, and we are planning a multi-pronged strategy to execute against. So while we found the data encouraging for cemiplimab, 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 an economic stake in the program and a stake in the success, the future success of the program, but we won't fund Phase 3. And we think that's the right balance, given the many shots on goal and exciting data that we're seeing from the portfolio.
Etzer Darout -- BMO Capital Markets -- Analyst
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.
Yifeng Liu -- HSBC -- Analyst
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&D and then SG&A, how should we think about that margin progression, especially as you're launching your oncology for that in the future? Thanks.
Ryan Richardson -- Chief Strategy Officer
Yeah. 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?
Yifeng Liu -- HSBC -- Analyst
Yes, because -- yeah, I think the launches, predominantly we see sort of in oncology space. And yeah, just the question on margin progression. Thank you.
Jens Holstein -- Chief Financial Officer
Maybe I'll start. It's awfully difficult actually to understand you. You're fading away somewhat. But I mean, we're seeing that, of course, the margin that we have with our -- in our partnership with Pfizer is extremely good.
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 internalized 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. We can assure you, we're working very hard to bring the costs down for internalized medicine candidates.
Ryan Richardson -- Chief Strategy Officer
Yeah. 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 vis-a-vis our partner, Pfizer, that we think will allow us to keep our overall operating profile quite attractive.
Yifeng Liu -- HSBC -- Analyst
Thank you.
Operator
Thank you. We will now take the next question from the line of Manoj Eradath from Jefferies. Please go ahead.
Akash Tewari -- Jefferies -- Analyst
Hi. This is actually Akash. So you recently top lined data from your 111 trial in cutaneous melanoma. Our analysis suggests that combo arm would have a 24% delta versus roughly the 11% historical control rate for anti-PD-1 monotherapy in relapsed/refractory patients.
Is that the ballpark way to think about the ORR delta in this study? 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 iNeST data was that cancer vaccines were perhaps not well suited for patients with metastatic late-stage disease, and yet, these patients were PD-1 refractory. So how should we interpret that? Thank you.
Uğur Şahin -- Co-Founder and Chief Executive Officer
OK. Thank you. It's a great question. So the personalized cancer vaccines have a manufacturing turnaround time in the range of six weeks to eight weeks.
And therefore, in the metastatic setting, this type of vaccines are difficult to provide a clinical benefit since these patients rapidly progress. So the statement of -- refers to the personalized vaccines. With regard to FixVac, we have seen that FixVac has two activities on the one side, the direct activity due to the adjuvant function. We are seeing a type1 interferon response 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 and we are particularly interested here in our ADC mRNA vaccine combinations, we will see a number of trials coming up in 2025 for this year [Technical difficulty] would be an exciting opportunity for our FixVac approach. And maybe for the other part, I'll give to Ozlem.
Ozlem Tureci -- Co-Founder and Chief Medical Officer
Yes. Your question regarding BNT111 was about the clinical benefit which we would like to see as compared to standard of care. I cannot pre-empt 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 that, and this is also what our data shows us. We also want to see duration of response. And also, this looks clinically meaningful in the current dataset, which we have, and then it's obviously also about safety. And what we see is that BNT111 as a FixVac-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. So there is no additive toxicity or so, 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 J.P. Morgan Chase. Please go ahead.
Jessica Fye -- Analyst
Hey, guys. Good morning. Thanks for taking my question. It looks like the BioNTech 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? And to the extent that part of the delta is driven by German pandemic preparedness contract, which I believe falls outside the collaboration, can you quantify what that is contributing to the guidance? Thank you.
Jens Holstein -- Chief Financial Officer
Yeah, let me start and maybe Ryan want to jump in. So I think we are very much aligned with Pfizer in terms of our Comirnaty expectations. We should keep in mind that Pfizer has reiterated its guidance. We did the same today.
You should be aware that -- and take into account that we have a contract together with the European Union. They have approval in the U.K. 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, 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 Comirnaty, if you look into the documents, 120 million euros. So a big chunk of that in the first half comes from that pandemic preparedness contract.
Jessica Fye -- Analyst
Thank you.
Operator
Thank you. We will now take the next question from the line of Cory Kasimov from Evercore ISI. Please go ahead.
Cory Kasimov -- Analyst
Hi. Thanks for taking the question. So regarding the upcoming data at ESMO for BNT327 in EGFR-mutated non-small cell lung cancer, there's obviously been a lot of attention of late on the competitive PD-1 VEGF bispecific that's out there. I'm curious like kind of based on what you know about that compound and the data presented to date, how similar or different do you expect your approach to be and how confident are you in having competitive data in this population? Thank you.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Yeah. 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 -- and the asset that BNT327 is now a molecule that is currently in evaluation in multiple indications at BioNTech and our collaboration partner, Biotheus. And we will see additional studies to be announced end of this year, beginning next year.
Cory Kasimov -- Analyst
OK. Thank you.
Operator
Thank you. We will now take the next question from the line of Chris Shibutani from Goldman Sachs. Please go ahead.
Chris Shibutani -- Analyst
Yes. Thank you. If I could just follow up on the BNT327. 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, Summit Therapeutics? And in particular, can I ask you, are you looking to do any head-to-head trial involving Keytruda? How are you thinking about sort of clinical development strategy that we can understand to be differentiated? Thank you.
Ozlem Tureci -- Co-Founder and Chief Medical Officer
Thank you for this question, Chris. We cannot comment on the strategy of others, but what we can say is that we think that BNT327 and this concept is highly compelling and qualifies as IO backbone for various combinations. And our approach here to be -- is to be broad with regard to the indications, which we will pursue also in potentially registrational trials. We are well poised for that because our partner, Biotheus has already a broad multi-indication program ongoing with a number of signal-seeking cohorts in various indications with various standard-of-care regimen 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 BNT327 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.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Yeah. And regarding pembro, so we are seeing, of course, data from now a number of indications coming in and continue to mature. And yes, we have seen for data for which, for example, historical benchmark data are available, for example, in triple-negative breast cancer. And the extent of clinical benefit that we are observing BNT327 is really encouraging.
And for any indication in which pembro is approved as a backbone, our plan would be, of course, to compare efficacy of BNT327 against the counterpart standard of care and pembro, we would compare against pembro.
Chris Shibutani -- Analyst
Thank you.
Operator
Thank you. We will now take the next question from the line of Terence Flynn from Morgan Stanley. Please go ahead.
Unknown speaker -- -- Analyst
Hi. Thanks for taking our questions. This is Chris on for Terence. We have a two-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? 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.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Yeah. We have hinted toward the potential analysis in end of 2025. As you know, the study is -- the endpoint is disease-free survival in this indication. And the general principle that we expect from individual 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. That means, based on the published data, we know that this patient population, who are ctDNA positive after surgery with the stage 2, stage 3 colorectal cancer have a PFS in the range of 10 months to 12 months. And after chemotherapy and PFS, it's more around -- medium PFS is around more six months to eight 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 -- it will depend how the results are, whether additional studies would be required at that time point or whether the data would be sufficient to continue and request potential regulatory steps.
Unknown speaker -- -- Analyst
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.
Simon Baker -- Analyst
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 that Mainz facility will give you in 2027. 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. And just related to this, based on your comments on 122, is it right to assume that completion of that facility is rather 122 approval is not contingent on a completion of that facility? Thanks so much.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Yeah. 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. And so, reliable numbers will be available end of 2025 for the capacity, but 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 that time point. So this is ongoing work.
And parallel for building this facility, which is intended to act as a potential pilot facility, we are expanding currently our clinical trial capacity to ensure that we can start additional trials in 2025 and later on.
Ryan Richardson -- Chief Strategy Officer
And then, I think as -- Simon, you asked about bottlenecks in terms of vein-to-vein time.
Simon Baker -- Analyst
Yes, please.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Bottlenecks, yeah. So this is, of course, a completely new process, manufacturing a vaccine in real time, and you can imagine that every step must be validated. So this is -- we are -- we have established personalized manufacturing of mRNA vaccines for the first time in 2014. Since then, we have been to two additional innovation cycles.
We have recently implemented additional change in their manufacturing, further reducing the turnaround plan. But still, a manufacturing release of such a vaccine comes with multiple release tests for the individual batches. So we are working on making these 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.
Simon Baker -- Analyst
Thanks so much.
Operator
Thank you. We will now take the next question from the line of Eliana Merle from UBS. Please go ahead.
Eliana Merle -- UBS -- Analyst
Hi, guys. Thanks so much for taking my question. Your slides mentioned starting the first novel combo trials at 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 or prioritizing for combinations? Thanks.
Ozlem Tureci -- Co-Founder and Chief Medical Officer
We are -- thank you for the question, Eliana. We are, in principle, very excited about the IO-ADC combination concept because we expect and also our preclinical 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 BNT327 as the IO backbone, which in the first trial is combined with our top 2 ADC from our partnership with Duality in multiple solid cancers. And this will be extended to additional ADCs from our pipeline to be combined with BNT327.
We are also very excited about a combination which is ongoing for quite some time, namely one of our priority assets, BNT211, which is our Claudin 6 CAR-T cell in combination with our vaccine, which is designed in this case in a way that it specifically acts on the adaptively transferred CAR-T cells and our data which shows that the vaccine, in fact, adds to the persistence and duration of adaptively transferred CAR-T cells is getting stronger and stronger with data maturing.
Eliana Merle -- UBS -- Analyst
Great. Thank you.
Operator
Thank you. We will now take the next question from the line of John Newman from Canaccord Genuity. Please go ahead.
John Newman -- Analyst
Hi there. Thanks very much for taking my question. You're obviously in the midst of very active development for BNT327. I'm wondering specifically for the trials where you're combining with BNT325 your TROP2 ADC, do you see the potential down the road for accelerated approval in some of those indications? Thank you.
Uğur Şahin -- Co-Founder and Chief Executive Officer
I think this is too early to say.
John Newman -- Analyst
OK. Thanks.
Operator
Thank you. We will now take the next question from the line of Manos Mastorakis from Deutsche Bank. Please go ahead.
Manos Mastorakis -- Deutsche Bank -- Analyst
Hello. Thank you for taking my question. Again, on BNT327, 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? Thank you.
Uğur Şahin -- Co-Founder and Chief Executive Officer
Yes, see, this is a good question. Let me share our view. So the introduction of anti-PD-1 treatments led to the division of patient populations in PD-L1-high, PD-L1-low, and PD-L1-negative population. The exciting observation that we made now in two indications is that the combination of tumor therapy, plus BNT327, appears to be effective in a highly clinically meaningful manner also in the PD-L1-negative population, and this really provides the great opportunity.
So we believe that BNT327 is not only something which is -- which could be better than existing PD-1 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 could become easier manageable based on treatment combinations that are independent of PD-L1 staining.
Manos Mastorakis -- Deutsche Bank -- Analyst
Thank you.
Operator
Thank you. This is all the time we have for questions today. I would like to hand back over to the speakers.
Ryan Richardson -- Chief Strategy Officer
Yes. Thank you very much for joining us today.
Operator
[Operator signoff]
Duration: 0 minutes
Call participants:
Victoria Meissner -- Vice President, Strategy and Investor Relations
Uğur Şahin -- Co-Founder and Chief Executive Officer
Ozlem Tureci -- Co-Founder and Chief Medical Officer
Jens Holstein -- Chief Financial Officer
Ryan Richardson -- Chief Strategy Officer
Daina Graybosch -- Leerink Partners -- Analyst
Yaron Werber -- Analyst
Tazeen Ahmad -- Analyst
Etzer Darout -- BMO Capital Markets -- Analyst
Yifeng Liu -- HSBC -- Analyst
Akash Tewari -- Jefferies -- Analyst
Jessica Fye -- Analyst
Cory Kasimov -- Analyst
Chris Shibutani -- Analyst
Unknown speaker -- -- Analyst
Simon Baker -- Analyst
Eliana Merle -- UBS -- Analyst
John Newman -- Analyst
Manos Mastorakis -- Deutsche Bank -- Analyst
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