BioNTech SE (NASDAQ:BNTX), a biotechnology company, reported its first-quarter financial results for 2024, emphasizing strategic advancements in its oncology pipeline and preparations to launch a new variant-adapted COVID-19 vaccine.
The company reported a net loss of EUR 315 million, with total revenues of EUR 188 million, a significant decrease from EUR 1.3 billion in the same period last year. Despite the lower revenue, BioNTech reaffirmed its commitment to becoming a multi-product company by 2030, with a focus on developing its oncology and infectious disease portfolios.
Key Takeaways
- BioNTech's first-quarter revenues were EUR 188 million, with a net loss of EUR 315 million.
- The company dosed the first patient in a Phase 3 trial for its breast cancer treatment, BNT323, and presented positive data on its cancer vaccine, Autogene Cevumeran.
- Plans are underway to start global trials for mRNA cancer vaccine candidates and to launch a variant-adapted COVID-19 vaccine.
- BioNTech expects to recognize 90% of its full-year revenues in Q4 2024 and reiterates financial guidance for R&D and SG&A expenses.
- The company is preparing for multiple oncology product launches starting in 2026 and aims to have 10+ pivotal trials by the end of 2024.
Company Outlook
- BioNTech aims to transform into a diversified, multi-product immunotherapy company by 2030.
- The company is working to increase the number of potential pivotal trials across its lead programs to 10 or more by the end of 2024.
- BioNTech plans to introduce a new variant-adapted COVID-19 vaccine and expects regulatory approval in the EU and FDA in late July and August, respectively.
Bearish Highlights
- The company reported a significant decrease in revenue from EUR 1.3 billion in Q1 2023 to EUR 188 million in Q1 2024.
- BioNTech experienced a net loss of EUR 315 million for the quarter.
Bullish Highlights
- BioNTech is preparing to launch multiple oncology therapies starting in 2026.
- The company reported progress in its oncology pipeline, including positive data on its individualized cancer vaccine.
- BioNTech plans to invest in its oncology pipeline while continuing its COVID-19 vaccine business.
Misses
- The company's revenues fell short compared to the previous year's first quarter.
Q&A Highlights
- The CEO explained the increase in patient enrollments is due to multiple trials in Phase 2 and Phase 3.
- BioNTech is open to partnerships and asset acquisitions on an opportunistic basis, with a focus on clinical execution.
- The company is planning investor events throughout the year and will present data on BNT311 at ASCO.
BioNTech is preparing for a future with multiple oncology products on the market, aiming for 10 approvals in the field by 2030. The company's strategic focus remains on long-term growth through product launches and sustained growth in both infectious diseases and oncology. With a variant-adapted COVID-19 vaccine on the horizon and ongoing clinical trials across various cancer types, BioNTech is positioning itself to meet its ambitious targets in the coming years.
InvestingPro Insights
BioNTech SE (BNTX) has been navigating a challenging market environment, as reflected in its first-quarter financial results for 2024. The company's strategic focus on expanding its oncology pipeline while managing the tailwinds from its COVID-19 vaccine business is underscored by several key metrics and insights from InvestingPro.
InvestingPro Data indicates that BioNTech holds a market capitalization of $22.5 billion, with a P/E ratio of 22.28, adjusting to 21.92 for the last twelve months as of Q4 2023. The company's revenue has seen a sharp decline, with a -77.94% change over the last twelve months as of Q4 2023. Despite this, the gross profit margin remains high at 84.29%, suggesting efficient cost management relative to sales.
Two InvestingPro Tips that may be particularly relevant to investors are the company's strong free cash flow yield, which implies a valuation that could attract investors looking for cash-generative businesses. Additionally, BioNTech's balance sheet reflects a healthy financial position, holding more cash than debt, which may provide resilience in a volatile market.
Investors should note that analysts anticipate a sales decline in the current year and do not expect the company to be profitable this year. However, the company's management has been actively buying back shares, a sign that they may believe the stock is undervalued.
For readers looking to delve deeper into BioNTech's financial health and future prospects, InvestingPro offers additional insights and metrics. There are 11 more InvestingPro Tips available for BNTX at https://www.investing.com/pro/BNTX, and users can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription with the coupon code PRONEWS24. These tips include observations on stock price volatility, net income expectations, and the company's profitability over the last twelve months.
BioNTech's commitment to becoming a multi-product company by 2030 and its ongoing investment in its oncology and infectious disease portfolios are central to its long-term strategy. The InvestingPro data and tips provided offer investors additional context to the company's financial performance and market position as they consider the potential of BioNTech's stock.
Full transcript - Biontech Se (BNTX) Q1 2024:
Operator: Welcome to BioNTech’s First 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: Thank you. Good morning, and good afternoon. Thank you for joining BioNTech's first quarter 2024 earnings call. As a reminder, the slides we will be using on this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. 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 Sahin, Chief Executive Officer and Co-Founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; Jens Holstein, Chief Financial Officer; and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand over to Ugur.
Ugur Sahin: Thank you, Victoria. A warm welcome to all those joining us today. We believe that we are entering a transformational period for BioNTech. We have founded BioNTech with the vision to discover and develop scientific great tools that harness the immune system to fight diseases and bring new medicines to patients. In the years following our establishment, we developed various therapeutic platforms demonstrate the safety and clinical effectiveness of various drug candidates in early clinical trials. The period from now to 2030 is about progressing this candidate into late-stage development and registrational trials to become a multi-product company with the first product to be delivered by our late-stage oncology pipeline. We are continuing to execute this vision and our strategic priorities with its intense focus. In the first quarter, we progressed our late-stage oncology pipeline on multiple fronts. We dosed the first patient in the pivotal Phase 3 clinical trial, evaluating our HER2 ADC BNT323 in HR positive HER2-low metastatic breast cancer. At the AACR Annual Meeting, we presented three-year follow-up data from a clinical trial evaluating our individualized cancer vaccine, Autogene Cevumeran in pancreatic cancer. This data showed encouraging relapse-free survival in certain patients with immunogenic response to the vaccine, demonstrating the promise of our vaccine platform to induce persisting de novo neoantigen-specific T-cell responses that correlate with improvements in survival. We have also taken significant steps for our first launches in oncology. Annemarie Hanekamp, an accomplished leader with a remarkable track record is joining our team in July to drive and execute our global commercialization strategy. We appointed a General Manager in the U.S., who has commenced building out our commercial operations in the U.S. and we appointed further expertise in our global commercial team. For our COVID-19 vaccine franchise, we initiated preparations to be on track to introduce a new variant-adapted COVID-19 vaccine for the upcoming season. We have received preliminary sprain selection recommendations from the World Health Organization and European Medicines Agency and plan to submit for regulatory approval later this month. Today, Ozlem and I will focus on our oncology strategy, while Jens and Ryan will provide updates on our financial and corporate progress. Slide 6, our oncology portfolio strategy is driven by understanding the key challenges in cancer. Cancer is genetically diverse and heterogeneous disease driven by the substantial acquisition of mutations. One consequence of this is that many treatments have an initial effect, but are not associated with long-term remission or cure. Our aim is to provide solutions across the continuum of cancer disease and establish new treatment paradigms. We believe our cancer vaccine candidates are particularly suited for early intervention by a thoughtfully designed combination treatments intended for advanced and high-volume tumors. We want to bring our therapies to as many patients as possible and we want to use the potential power of our platforms alone and in combination. Slide 8. Our therapeutics strategy brings together synergistic mechanisms of action across three key categories. The first on novel immune modulators or IO, which are designed to engage the immune system, overcome cancer-mediated immunosuppression and amplify immune responses. Second, targeted therapies, which include CAR-T cell therapies and antibody drug conjugates that can dramatically reduce the tumor burden. The third category are mRNA vaccines, which are the centerpiece of our oncology strategy. Our mRNA cancer vaccines are designed to target multiple cancer antigens in parallel and can be individualized for each patient. BioNTech was built from the very beginning as a technology agnostic company. We do not limit ourselves to any one technology. We are interested in addressing unmet medical need with the best possible solutions. Having a diversity of assets in our pipeline, we are positioned to pursue combination approaches that are proprietary and unique. This strategic advantage allow us to evaluate the activity of each individual compound and enables us to determine those patient population for which monotherapy or synergistic combinations are best suited. T he potential for synergy in this combination is significant, enabling us to design treatment regimens that could lead to improved patient outcomes and broaden the scope of therapeutic options. We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the long-term survival rates for patients. Slide 9. To reiterate, we are entering a transformative period for BioNTech, specifically in the development of our oncology pipeline and the formation of our oncology business, which will continue to evolve over the next few years. In 2024, we are aiming to increase the number of potential pivotal trials across our lead programs to 10 or more by year end. These trials will focus on areas of unmet medical need, clinical indications in which we may achieve an expeditious path-to-market and thereafter the first approval in the initial indication, there is a high potential for expanding the market opportunity to additional indications. Starting in 2025 and continuing into the following years, we expect to enter a period which was pivotal data that if positive could support regulatory submissions for marketing authorization across our pipeline. We have begun building a fully integrated oncology organization to support our transition into a global multi-product company. This process will be accelerated this year as we bring our new Chief Commercial Officer on Board. Ultimately, we are building our organization to support multiple oncology launches beginning in 2026. With that, I would like to thank you all for your ongoing support. I will now turn the call over to Ozlem.
Ozlem Tureci: Thank you, Ugur. Glad to be speaking with everyone today. As Ugur highlighted, we will focus in the next few years on increasing the number of potentially pivotal clinical trials to fuel our transition towards becoming a multi-product company by 2030. In oncology, we have already started to execute against this goal. This is why you can see that the late-stage part of our pipeline on this slide is enriched and populated with multiple trials that feature our priority assets such as our mRNA vaccines and also our most advanced ADCs and IOs, including those which we consider as attractive backbones of unique combination treatments. To highlight recent additions to our pipeline. One is a Phase-3 trial in collaboration with Duality Bio, evaluating BNT323 in patients with hormone receptor positive and HER2 low metastatic breast cancer that have progressed on hormone therapy and/or cyclin dependent kinase 4/6 programs. With BNT323, we are also planning to start a confirmatory Phase-3 trial this year in patients with metastatic endometrial cancer that will complement our ongoing single-arm trial in this indication. In our early-stage pipeline, we have started a Phase 1/2 trial in collaboration with Genmab (NASDAQ:GMAB) evaluating BNT314, a bispecific antibody product candidate with dependent EpCAM-dependent 4-1BB agonistic activity in multiple solid tumors. Our aim is to continue to progress our oncology pipeline towards pivotal data readouts and submissions for regulatory approvals in the next 18 months. Before highlighting some of the programs and platforms that we consider priority assets to contribute to clinical progress, let me say a couple of words to our execution. The coming years will be about late-stage clinical trial execution, enrolling the patients to participate in clinical trials requires deep coordination across multiple functions within our company and with our partners and collaborators who are integral part of our global trial execution approach. As we and our partners have increased the number of ongoing late-stage trials, we have also drastically increased the number of patients that participate in trials generating data for our fully-owned and partnered product candidates. Comparing the average quarterly number of patients enrolled across the last few years here on this slide, on quarterly average in 2022 through the first quarter of 2024, we have increased the number of patients enrolled by over 400%. On the back of the significant increase in enrollment and thus progress in clinical trial execution, we expect our clinical development pipeline to generate a corresponding increase in the number of datasets in the coming years. Our ultimate goal at BioNTech is to bring our database scientific breakthroughs to patients in need. Moving to our priority assets. Let me start with BNT327 or PM8002, a bispecific antibody consisting of an anti-VEGF-A Fc IgG (ph) fused to a humanized anti-PD-L1 VHH binder being developed in collaboration with our partner Biotheus. BNT327 combines two validated mechanisms of action. VEGF-A binding inhibitor VEGF-A, VEGF-R axis blocks tumor angiogenesis, which leads to reduced tumor cell proliferation and survival. VEGF-A inhibition also counteract formation of the immune suppressive tumor microenvironment as does the PD-L1 arm of this bispecific antibody by reverting PD-L1, PD-1 axis mediated T-cell exhaustion. The PD-L1 arm also anchors this antibody to the tumor [indiscernible] for efficient and localized scavenging of VEGF-A, which may contribute to mitigate off-tumor on-target side effects. Data from ongoing Phase 1/2 clinical trials across several indications in over 600 patients executed by our partner Biotheus have shown a favorable safety profile. Our partner Biotheus presented selected examples of this compound's performance in 2023, showing strong single compound activity and high response rates in combination with chemotherapy in triple-negative breast cancer and small-cell lung cancer. In first-line TNBC in combination with nab-paclitaxel, almost 80% objective response rate as shown on this slide. At ASCO now, there will be more data disclosures in cervical, in ovarian cancer, and in non-small cell lung cancer. An investigational new drug application has been accepted by the FDA for further studies in the United States and we plan to start global trials in several indications this year. One area that we will see increased development activity in the coming years will be our mRNA cancer vaccine candidates. mRNA cancer vaccines are a centerpiece of our pipeline and are pivotal to our goal of developing breakthroughs for cancer patients. The aim is to develop this technology as monotherapy in combination with standard-of-care and in combination with candidates from our proprietary pipeline. Our FixVac vaccines use sets of multiple antigens shared by patients across one tumor type. iNeST, our individualized vaccine program, partnered with Genentech identifies neoantigens derived from cancer mutations that are unique to an individual's tumor. While iNeST and FixVac target different types of cancer cell antigens, they are based on the same mRNA and delivery technology, namely our uridine mRNA-lipoplex platform. Its distinct mechanism of action is that the delivered antigen is presented by professional antigen-preventing cells and lymphoid compartments body-wide in close proximity to T-cells to be induced and that it comes with intrinsic adjuvanticity. These features by design promote the induction of high-magnitude T-cell immune responses that we have been detecting in all our clinical trials across tumor types and for various types of targeted cancer cell antigens as shown on the right-hand side of this slide. On the next slide, you can see exemplary data from different trials in different treatment settings and tumor types in which we are evaluating our neoantigen-based individualized cancer vaccines, including several years of follow-up. Our mRNA-based neoantigen vaccine has demonstrated the ability to induce de novo neoantigen-specific functional polyspecific and persistent T-cell responses at substantial magnitude in high proportions of treated patients. Frequently against tumor antigens that were overlooked by the patient's immune system, so-called de novo immune responses. We have shown that our vaccine-induced T-cells persist over years and build immunological memory. In the two papers quoted on this slide, we have shown that vaccination with neoantigen encoding mRNA is associated with reduction of recurrences in patients. The favorite setting for developing our individualized vaccines are patients that have minimal residual disease or require adjuvant treatment to reduce the probability of recurrence. Today, we have iNeST and FixVac trials in multiple disease settings and indications and data releases from several of the trials shown on this slide are planned. In our FixVac program, we are evaluating four vaccine candidates, which each target tumor-associated antigens specific to melanoma, HPV16 positive head and neck cancer, prostate cancer, and non-small lung cancer as monotherapy and in several combinations. We shared early data for all FixVac candidates in the past years and plan to present additional data this end next year. Further, we plan to start an additional trial with iNeST in the adjuvant setting with our collaborator Genentech. I would like to highlight three of these programs that are on our priority list. Two programs using our individualized cancer vaccine in cancer types that have a low tumor mutational burden and are resistant to immune therapy, namely colorectal cancer and PDAC and our NSCLC FixVac program. Starting with CRC, with colorectal cancer. The majority of patients with early-stage localized and receptor CRC undergo surgery followed by adjuvant chemotherapy. Standard-of-care in Stage 2 high-risk and Stage 3 disease after adjuvant treatment is watchful waiting, 20% to 35% of patients experience recurrences of their disease. ctDNA is a marker for minimal residual disease and identifies patients with high risk of such recurrence. We are running a Phase 2 trial with our individualized vaccine in Stage II high-risk and Stage III resected CRC patients that are ctDNA positive post-surgery. After adjuvant chemotherapy patients are randomized to either receive autogene, cevumeran or individualized vaccine or observation. We expect the first readout of this trial in the second half of 2025. Secondly, a randomized Phase 2 clinical trial evaluating our individualized vaccine in combination with the anti-PDL-1 agent atezolizumab followed by standard-of-care chemotherapy in patients with resected pancreatic cancer or PDAC compared to chemotherapy alone was started in collaboration with Genentech in 2023 and is recruiting patients. PDAC is a high medical need tumor expected to become the second leading cause in cancer-related death. Up to 85% of patients with localized pancreatic cancer that undergo surgical resection and adjuvant chemotherapy do experience recurrence of disease. This trial was initiated based on data from an investigator-initiated trial that were published last year and updated at AACR a few weeks ago. That Phase-1 trial showed that with our individualized vaccine combined with atezolizumab and standard-of-care adjuvant chemotherapy, half of the 16 treated patients develop high magnitude vaccine-induced immune responses and that these patients have a much lower risk of tumor recurrence at 1.5 years of median follow-up and continue to do so after a three-year follow-up period. Moving to our off-the-shelf tumor-associated antigen-based mRNA cancer vaccine candidate BNT116. BNT116 is an RNA lipoplex cancer vaccine candidate comprising six mRNAs each encoding a tumor-associated antigen, which in Mage-A3, CLDN6, KK-LC-1, PRAME, MAGE-A4, and MAGE-C1. We have selected these tumor-associated antigens by an in silico approach developed for design of FixVac vaccines for different tumor types and based on low or lack of expression in toxicity relevant organs expression and a substantial fraction of lung tumors of various histologies, immunogenicity, and tumor biological role. About 85% of NSCLC specimens express at least one of the six selected tumor-associated antigens, and more than 60% express at least two of them. BNT116 is currently being evaluated with our partner Regeneron (NASDAQ:REGN) in two clinical trials that cover various non-small cell lung cancer patient populations. One is a Phase 1 trial investigating BNT116 in adjuvant first-line and second-line plus (ph) settings and various treatment regimens assisted on the left side of this slide. We plan to introduce novel unique combination cohorts into this multi cohort Phase 1 trial. The second trial is a randomized Phase 2 evaluating BNT116 in combination with cemiplimab in first-line treatment of patients with PD-L1 high expressing non-small cell lung cancer shown on the right side of the slide. At AACR, we presented preliminary results from Cohort 3 of [indiscernible] Phase 1 trial evaluating BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non-small cell lung cancer that progressed on PD-1, PD-L1 inhibitor, and platinum-based chemotherapy. Combination treatment with BNT116 and docetaxel was active with an overall response rate of 30%, a disease control rate of 85%, medium progression-free survival of 4.4 months comparable to other FixVac candidates BNT116 presents a manageable safety profile alone and in combination. We expect further data from these cohorts in the next 12 months and that will inform further development of BNT116 in lung cancer. The ASCO Annual Meeting is right around the corner. At ASCO, we and our partners will present new clinical data for several of our programs, data that is of relevance for making informed decisions about the direction of those project's development. Firstly, we and Genmab plan to present data for BNT311 from our Phase 2 in post-IO non-small cell lung cancer patients. BNT311 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with 4-1BB costimulatory activation. Second, as already mentioned, monotherapy data from Phase 2 trials are planned to be presented for BNT327, the bispecific anti-VEGF-A, anti-PD-L1 antibody we are developing in collaboration with Biotheus. Third, we and our partner MediLink plan to present first-in-human data for our free targeting ADC. Then we will also present epidemiologic data, including post-operative ctDNA prevalence and prognostic value from a non-interventional, observational study in patients with resected high-risk Stage 2, Stage 3 colorectal cancer that supports and informs the development of our individualized vaccine in this patient population. And lastly, for BNT211, our CAR-T cell product candidate, we plan to initiate a potentially registrational trial in patients with germ cell tumors. At ASCO, we will present real-world evidence of overall survival and treatment patterns of this patient population in the U.S. that will inform the trial design for our Phase 2 trial. With that, I will now pass the presentation to our CFO, Jens Holstein.
Jens Holstein: Thank you, Ozlem, and a warm welcome to everyone who has dialed in today's call. Let me begin my section with some key financial figures for Q1 2024. In the first quarter of 2024, we reported total revenues of approximately EUR188 million, driven mostly by commercial revenues from the sales of our COVID-19 vaccine. This revenue figure is consistent with our internal expectations for the period and reflects the seasonality that we expect in an endemic environment for our COVID-19 vaccines. Our group revenues will continue to be driven largely by the uptake of our COVID-19 vaccines until oncology revenues will be recognized. We expect to recognize approximately 90% of our full year revenues in the last month of 2024, mostly in Q4. In terms of our operational spending, we are also in line with our internal plans and ended the first quarter with a loss before tax of EUR332 million. We maintained our strong financial position with EUR16.9 billion in total cash plus security investments at the end of the quarter. As mentioned by my colleagues before, we started the year making real progress across our oncology pipeline. We dosed the first patient in our second pivotal Phase 3 trial and are on track to start multiple additional potentially registrational trials this year. Our focus remains on our late-stage clinical trials and to invest in our mRNA platform approaches that represent the core capability of BioNTech and differentiates us from others in the industry. We also continue to invest in our leading and profitable COVID-19 vaccine business. Alongside our partner Pfizer (NYSE:PFE), we're working on variant-adapted COVID-19 vaccines for the upcoming vaccination season. We also continue to invest in our leading and profitable COVID-19 vaccine business. Alongside our partner Pfizer, we are working on variant-adapted COVID-19 vaccines for the upcoming vaccination season. We are also investing in a COVID-19 flu combination vaccine candidate which we expect to potentially drive additional demand if approved. Bolstered by our strong cash position and stringent cost discipline, we will continue to invest in our pipeline and are well-positioned to achieve future sustainable growth. I'll now be going into a little more detail on our financial results for the first quarter of 2024. As noted earlier, our total revenues reported for the first quarter of 2024 reached EUR188 million compared with approximately EUR1.3 billion for the first quarter of 2023. Moving to cost of sales, these amounted to EUR59.1 million for the first quarter of 2024 compared to EUR96 million for the comparative prior year period. Research and development expenses reached EUR508 million for the first quarter of 2024 compared to EUR334 million for the comparative prior year period. The increase was mainly due to progressing clinical studies for our oncology pipeline and related personal expenses to manage those. Sales and marketing expenses of EUR16 million incurred in the first quarter of 2024 compared to EUR12 million in the comparative prior year period. General and administrative expenses amounted to EUR117 million for the first quarter of 2024 compared to EUR112 million for the comparative prior year period. The increase in SG&A was mainly due to increased expenses for IT services as well as an increase in headcount to support the scaling of our business. Income taxes were realized with an amount of EUR16.7 million for the first quarter of 2024 compared to EUR205.5 million of tax expenses for the comparative prior year period. The derived effective income tax rate for the first quarter of 2024 was approximately 5% applicable on the negative income. For the first quarter of 2024, we reported a net loss of EUR315 million compared to a net profit of approximately EUR502 million for the comparative prior year period. Our loss per share for the first quarter of 2024 amounted to EUR1.31 compared to a diluted profit per share of EUR2.05 for the comparative prior year period. As indicated earlier, this year, 2024 is a year for our company during which we will continue to invest in our long-term growth strategy. We aim to have potentially 10 plus pivotal trials running by year end 2024 which we believe will change the picture of the company going forward. Besides having a strong franchise in infectious diseases, we aim to have multiple oncology products reaching the market by 2026 onwards. Turning to the next slide. I would like to emphasize that we are reiterating the company's financial guidance for the 2024 financial year. As mentioned previously, we expect to recognize approximately 90% of our full-year revenues in the last month of 2024, mostly in Q4. Additionally, we also reiterate our R&D and SG&A guidance from our year end call with EUR2.4 billion to EUR2.6 billion for R&D and EUR700 million to EUR800 million for SG&A expenses. Those expenses are expected to gradually increase quarter-by-quarter until year end. With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson for an update on our strategy, outlook, and concluding remarks.
Ryan Richardson: Thank you, Jens. We are working with Pfizer to be ready to launch our variant-adapted COVID-19 vaccine in the second half of the year upon regulatory approval. Consistent with the WHO's recommendation, we expect that the updated vaccine will encode the JN.1 variant and will be monovalent. As of April 2024, over 90% of SARS-CoV-2 genetic sequences in publicly available databases were derived from the JN.1 variant. In 2023, we received strain inclusion recommendations from the WHO and other advisory committees in May and June and were granted approval in late August and September. This year the timelines for strain selection and those anticipated for approval are expected to come earlier. The WHO and EMA have already received strain recommendations and expect additional regulatory updates in mid-May. We expect approval in the EU and FDA could come in late July and August respectively. If this occurs, it could enable an earlier launch of vaccines relative to last year to support fall vaccination campaigns. We are preparing to launch the variant-adapted COVID-19 vaccine in over 80 geographies worldwide. While most regions outside the U.S. will continue to be served by government contracts, we do expect some new private markets in regions like the U.K. to open in 2024. This could enable individuals who may not qualify under existing immunization recommendations to access updated COVID-19 vaccines should they choose to do so. Turning to the next slide. Our aim is to create value for patients and shareholders by delivering sustained long-term growth, and our strategy is to continue to invest in our technology platforms and diverse pipeline. We believe each of the drug classes we are investing in contain product candidates that aim to address major unmet needs and could unlock significant commercial potential. We are entering a catalyst-rich period over the next 12 to 24 months with data updates expected from one or more product candidates across each of these classes. We look forward to disclosing additional pivotal trials and more details on our go-to-market strategy for selected programs in the months ahead. To conclude on the next slide, our aim is to transform medicine through successive waves of innovation. We remain focused on our near-term goal to have 10 plus potentially registrational trials initiated by year end 2024, and to continue to ramp up our commercial readiness activities. Over the midterm, we aim to enter the commercial stage in oncology by 2026 with our first product candidates while advancing our pipeline of late-stage and novel combination therapies. Longer term, we aim to broaden our portfolio of approved products and transform BioNTech into a diversified, multiproduct immunotherapy company that is in a position to redefine medicine. We are truly excited by the potential our technologies and pipeline hold to make a difference for patients around the world. Before opening the floor for questions, I would like to highlight on the next slide important investor events we will be holding this year. Our Annual General Meeting will take place on May 17, and our inaugural Artificial Intelligence and Machine Learning event will take place on October 1. Our MAINZ 2024 Innovation Series event is planned for November 14. We will share further details on these events in due course. With that, I would like to open the floor for questions.
Operator: Thank you. [Operator Instructions] We will now go to our first question. One moment, please. And your first question comes from the line of Tazeen Ahmad from Bank of America. Please go ahead.
Tazeen Ahmad: Hi. Good morning. Thanks for taking my question. For the data that you're going to be presenting at the upcoming ASCO conference as it relates to the Genmab compound, can you just remind us how many people worth of data to expect? And once that data is presented, can you talk to us about the next steps in the development plan for that program? Thanks.
Ozlem Tureci: Tazeen, the first question was about the number of patients which we will present for the second-line non-small cell lung cancer trial with BNT311. Did I get that right?
Tazeen Ahmad: Yes, that's right. Thanks.
Ozlem Tureci: So that will be -- I cannot tell you the specific number from the top of my head. But these will be around 100 patients. So a substantial number of patients.
Tazeen Ahmad: And also, what level of detail should we expect to see?
Ozlem Tureci: So you will see safety data, the activity data, which we have and then -- and/or ORR data.
Tazeen Ahmad: Okay. And what is the plan moving forward with this program?
Ozlem Tureci: We are in the planning phase with our partner Genmab, so that we cannot disclose any specifics at this time. But you will hear more about this program sometime later this year.
Tazeen Ahmad: Okay. Thank you.
Operator: Thank you. [Operator Instructions] We will now go to the next question. And your next question comes from the line of Daina Graybosch from Leerink Partners. Please go ahead.
Daina Graybosch: Hi. Thank you for the question. I have another one on ASCO. So I wonder if you could talk more about the data we should expect from PM8002 at ASCO? And also, if you could talk about how this molecule compares to the competitor from a Akeso (ph) summit, which also is a bispecific VEGF, but targeting PD-1 rather than your PD-L1. How much readthrough positively can we take from the Akeso data to yours and from yours to the Akeso data for the overall approach? Thank you.
Ugur Sahin: Hi, Daina. So we have at the moment the clinical trial running in multiple indications, including also indications for single arm and combination. What we are going to update is -- on ASCO is on the cervical cancer and platinum-resistant ovarian cancer, and non-small-cell lung cancer trials. And you will see response data and safety data in this cohorts. Just to remind you, we have presented already response data on the combination in triple negative breast cancer and small cell lung cancer which is -- which are very encouraging showing also responses in the PD-L1 or cold tumors. PD-L1 negative are cold tumors and we expect to present similar data now for non-smart cell lung cancer. Of course, we do not have direct comparison -- comparative data with Akeso yet, but I think the data that we are seeing goes into the same direction that this bispecific and that means direct targeting of the PD-L1 access plus VEGF access appears to be associated with a better response rate as well as a better safety profile as compared to anti-VEGF treatment. So we are very excited about using these compounds as combination approach for chemotherapies and in the upcoming future for our ADCs.
Operator: Thank you.
Daina Graybosch: Thank you.
Operator: Thank you. We will now go to the next question. And your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.
Akash Tewari: Hey. This is more high level, but in the past I know the team has tried to position BioNTech as an earnings growth story. With that in mind, what is the best estimate for BioNTech returning to consistent profitability? Is this something that should occur once COVID flu enters the market or is this more tied to your oncology pipeline? And then separately, would you look to work with a large cap partner to launch your ADCs and broader oncology pipeline, or would you look to build that commercial sales force internally? Thanks so much.
Ryan Richardson: Yeah. Thanks, Akash for the question. I'll start with maybe the second part of it. I think strategic partnerships have been one of the hallmarks [Technical Difficulty] in oncology early on, and also with COVID-19. And I think we will continue to evaluate partnerships asset by asset to see if that could help us accelerate certain assets, broaden their reach geographically, or even help us reach profitability sooner for specific assets where there might be a partner that brings infrastructure that's relevant. Generally speaking, though, we do now -- we have a strong balance sheet. We do want to retain more of the economics as a general matter of strategy. So I think that the -- those partnering decisions are going to really be made on an asset by asset basis, while at the same time we do commit to actually build a commercial presence in oncology in the major markets. And so that is going to be a priority over the next couple of years. I'll let Jens speak a little bit to the profitability point, but I'll just say high level at the outset that we do see, as you've alluded, that there's an opportunity here with the pipeline that we're building and advancing now into late stage studies to deliver long term sustained growth driven by successive product launches. We've indicated 2026 as a significant time point in those plans, but really, the plans go beyond that. And that's why we put out the target of having 10 approvals in oncology by 2030 highlighting that we do think that that revenue growth can come from multiple indication approvals in multiple products. And so that -- our priority is to get on that long term growth trajectory. And, of course, being profitable is important, but the focus right now is really getting on that growth trajectory.
Jens Holstein: Yeah. Thanks, Ryan. I think you made the most important statements already. So, I mean, if you look into the revenue development going forward, of course, we see some potential upside when we have a COVID flu combination reaching the market. And how big that upside could be, we are not 100% clear yet. We haven't given any guidance for '25 in the ongoing years for that combination. We got to see how it evolves. In terms of our spend, I think we have shown that we control the cost as good as we can, as sensible as it is. We want to create value in investing in our oncology portfolio and to lift it, I think Ryan made the statement already. We are looking, of course, to have some partners here and there regionally to lift the value going forward, but we are very optimistic in terms of the growth that we have in front of us as a company.
Ryan Richardson: Yeah. And I think so what you're hearing from us, Akash is, in the very short term, we do think that the COVID combination vaccine with flu, if successful, the profitability is going to be dependent in part on COVID vaccination rates. And that's one of the near-term drivers that has the potential to bring those rates up.
Operator: Thank you. We will now go to your next question. And your next question comes from the line Jessica Fye from JP Morgan. Please go ahead.
Jessica Fye: Hey, there. Thanks for taking my questions. Coming back to BNT311 and the ASCO update, which regimen would you focus us on? And what element of the profile do you expect to best showcase the product's efficacy? And related to that, what's the right benchmark to compare that efficacy metric to? Thank you.
Ozlem Tureci: So the regimen we will be presenting will be a combination of BNT311 with pembrolizumab in second line on small cell lung cancers and the post-CPI population to which you would then need to compare this regimen.
Jessica Fye: Okay. Maybe I'll just throw in one more. Can you recap a hypothetical list of what the 10 potentially registrational trials running by year end might be? I imagine you've contemplated a few scenarios here, but maybe you could throw out an example or two.
Ozlem Tureci: Probably 10 trials we are trying to activate or do you want examples? Is this the question? So we have several of them activated. One example is the BNT316 trial. Our cooperation with OncoC4, an entire CTLA-4 which is in non-small cell lung cancer in PD-1, PDL-1 experienced in Phase 3. Another trial, which is potentially registrational is our breast cancer trial in HER2 low breast cancer with BNT323. Also phase III which has started early this year, then in this priority asset list we have trials with autogene cevumeran, the individualized vaccine we are co-developing with Genentech Roche. One example is our colorectal cancer trial, which will read out in -- around 2026. Another example is our adjuvant pancreatic cancer trial. Additionally, we will activate trials with BNT327. So the PD-L1 VEGF compound, we have talked about earlier. So these are several of the examples of potentially registrational trials we would like to activate by end of this year. One very exciting one I should also list here, which is our trial with our CAR-T cell, Claudin-6 CAR-T cell in testicular cancer.
Operator: Thank you. We will now go to the next question. And your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.
Brendan Smith: Hi, great. This is Brendan on for Yaron. Thanks for taking the questions. Just a quick one from us actually on the infectious disease pipeline. It looks like we're going to have a Phase 1 update from the shingles vaccine sometime this year. But wanted to also see where you're at with enrollment and potential timing to data for maybe malaria HSV and TB programs and kind of if there's any notable updates on how you're prioritizing this part of the pipeline. Thanks very much.
Ugur Sahin: Yeah. We will provide data updates actually on the HSV 2 trial, on the TB trial and the malaria trial, which created safety and immunogenicity data in Phase 1 and are proceeding now into Phase 2 settings. And the data will come at various events until the end of this year.
Operator: Thank you. We will now go to the next question. And your next question comes from the line of Etzer Darout from BMO Capital Markets. Please go ahead.
Etzer Darout: Great. Thanks for taking the question. Just another bigger picture strategy question around oncology. Looks like the early combination approaches rely on external molecules. But just curious about the strategy for moving combinations of internal assets, particularly combinations of immunotherapy and targeted therapy assets, moving those into proof of concept studies, and when we could start maybe seeing some of those sort of emerge. Thank you.
Ugur Sahin: Yeah. Excellent question. This is actually one of the strengths that we would like now to activate. So the first type of combination trails with internal assets is Claudin-6 CAR-T cell therapy with RNA vaccine. And we have recently reported data shown in Dieter (ph) synergy between the two of the combination increasing the persistence of T-cells. We will see start -- end of this year, the first combination trials of our ADC compounds with our IO portfolio. And actually 2025 will be an intense year where we will do multiple combination trails dedicated to contribution of component trails and safety assessments to bring us into the position to go into first registrational trails in our combos in the second half of 2025.
Etzer Darout: Great. Thank you.
Operator: Thank you. We will now go to the next question. And your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.
Terence Flynn: Great. Thanks for taking the question. For BNT122, it sounds like it was on your list of registrational trials. So just wondering for the data next year from that Phase 2 CRC trial what you'd need to show on an efficacy basis to consider filing for an accelerated approval. And then, again, I noticed you had an ASCO presentation on some epidemiologic data here. Again, just what are you expecting to show there at ASCO or what would be the key learnings? Thank you.
Ugur Sahin: Yeah. So this study is a sufficiently powered Phase 2 study. It is in a patient population of colorectal cancer patients who are ctDNA positive. Multiple epidemiological studies have shown that this patient population have a very poor prognosis. Actually -- and PFS in this patient population after surgery is around 12 months, after chemotherapy is around seven months. So this is actually a metastatic -- early metastatic patient population. And the clinical trial compares a standard of care, which is adjuvant chemotherapy, in this patient population versus standard of care, followed by the personalized vaccine. The clinical trial endpoint is disease-free survival. And we expect the endpoint analysis for this trial in the second half of 2025. The trial is enrolling, as expected at the moment. And, of course, this is all what we can say everything else will depend on the totality of the data.
Ryan Richardson: And do you want to say a few words about the epidemiological study at ASCO?
Ozlem Tureci: Yeah, I can do that. So what we will present at ASCO is an epidemiological study. So it's not a treatment study. And we have conducted this epidemiological study in order to better understand the prognosis of those patient populations. We have in our ongoing clinical trial with BNT122 in particular, also of subpopulations which are ctDNA positive because that further informs our ongoing clinical trial. In addition, this epidemiological trial is a pre-screening trial to identify patients to recruit into our investigational trial. So you will get, in particular, epidemiological data of ctDNA positivity rates in high-risk populations in colorectal cancer and the disease-free survivors which are seen in these subpopulations.
Operator: Thank you. Your next question comes from the line of Ellie Merle from UBS. Please go ahead. Hello? Ellie, is your phone on mute? Ellie, is your phone on mute? Okay. Due to no response, I will go to the next question. One moment, please. And your next question comes from the line of Bill Maughan from Canaccord. Please go ahead.
William Maughan: Hi, and thank you. So, as a technology-agnostic oncology company who has not yet gotten into radiotherapy, do you see the excitement recently in that field as warranted? And if so, could we expect BioNTech to potentially get some stake in a radiotherapy combination or technology by partnership, or just bringing it internally? It seems like a lot of the deal sizes recently could be in the range that BioNtech could look at. Thank you.
Ugur Sahin: Yeah. So indeed, value immunotherapy is reaching our maturity. This is one of the aspects that we are following. We are currently not looking for opportunities for in-licensing, but some of the research that we are doing internally could go into that direction. We could talk about this end of this year when we have first validation data.
William Maughan: Thank you.
Operator: Thank you. We will now go to the next question. And your next question comes from the line of Hartaj Singh from Oppenheimer. Please go ahead.
Hartaj Singh: Great. Thank you. Thank you for the question. I just want to ask a question on the slide where you got listed the average quarterly patient enrollments. Over the last couple of years, we've seen actually real difficulty with companies in oncology just because of the vast number of trials going on in oncology and IO recruiting patients. And you've seen a really nice acceleration from 2022 to '23 and the first quarter of '24. So can you just put some color behind that or meat on the bone of what exactly are you doing? Is it just the ability to -- the trials getting IRB approved, more trials actually moving ahead to late stage, maybe spending more patients on recruiting trials at site? Love to hear that. And then how does this change your thinking on potential readouts? I mean, it's nice to see the improvement enrollment but how does that translate to when readouts could actually happen? Thank you.
Ugur Sahin: Yes. Let me take the first part of the question. So, in the timeline of 2020 to 2022, 2023, of course, we dealt with early clinical trials which are typically recruiting a lower number of patients, defining based on those escalations of cohorts, safety assessment, biomarker assessment and so on. And we are now reaching a phase where we have multiple trials in Phase 2 and first clinical trials in Phase 3, which naturally allow us to enroll faster and ensure that we get the statistics. This is also the reason why we now are able to move multiple clinical trials into registration trials end of this year. And for all of the registrational trials, we will provide the timelines, then we expect the readouts. As Ryan alluded, the first readout for our first potential registration trial is in endometrial cancer will be next year -- second half of -- or mid next year with the opportunity to get notarization end of next year. And we will have multiple interim readouts for -- to be presented at ASCO and ESMO and CIPSI this year on the currently running cohorts.
Ozlem Tureci: If I may add to that, you have pointed out quite correctly, that patient recruitment becomes more and more difficult. We are in the fortunate situation that we have a richness of different assets and thereby a design space to choose those assets and combination trials which can give us several hits on our target to become a multi-product oncology company by 2030. But it was very clear to us from the very beginning that this also means that we have to improve our capability to execute these clinical trials. So we have invested, and this is what this bar chart shows, we have invested major efforts to mature our clinical development operations, organization, and also to grow it. And we also have invested into models such as working with partners -- with our partner companies to enroll into our joint trials and public-private partnership. For example, the partnership we have with U.K. in which we are building a cancer vaccine launchpad and thereby mobilizing on a national level large numbers of clinical sites. And this is basically what this numbers reflect.
Operator: Thank you. We will now take the next question. And your next question comes from the line of Ellie Merle of UBS.
Ellie Merle: Hey, guys. Can you hear me now?
Ryan Richardson: We can hear you.
Ellie Merle: Okay. Perfect. Great. Thank you. Just for your HER2 ADC where you got breakthrough designation in endometrial cancer late last year. And I think you just mentioned you expect to have the pivotal data in the second half of next year, if I heard that correctly. Can you tell us a little bit more around the design of this pivotal study and also how you're thinking about the opportunity for this asset in endometrial and where it would fit in the broader landscape there? Thanks.
Ugur Sahin: The currently running trial is a single-arm trial in this population. And it is -- the registration will be based on safety data and response data and durability of response data. And this will be combined with a confirmatory trial for which we still are in the planning phase and we will inform in around three to four months about the design of the confirmatory trial.
Operator: Thank you. Your next question comes from the line of Simon Baker from Redburn Atlantic. Please go ahead.
Simon Baker: Thank you for taking my question. And it's on SG&A, your guidance implies an increase between EUR160 million and EUR260 million this year. I would assume a large part of that is the global commercial footprint build-out. I just wonder if you give us an idea of how that phases over this year and also '24 versus '25, is most of the spend this year, always most of it in 2025? Some idea of the cadence of that build-out would be great. Thanks very much.
Jens Holstein: Yeah. Thanks for the question. You should expect for '24 that we have slight increases quarter-by-quarter in terms of our S&M costs and the G&A costs here in '24. And then for '25, likely to have a further increase in the setup. Of course, you start to hire personnel for the commercialization around C force to only shortly before you launch. And that will -- the timing of that will drive the spend in '25.
Simon Baker: Okay. Thanks so much.
Operator: Thank you. Your next question comes from the line of Yifeng Liu from HSBC. Please go ahead.
Yifeng Liu: Hello. Thanks for taking my question. Just one question on your HER2 ADC in breast cancer. How do you think about the biomarker reflection there when you have HER2 low, and perhaps whether you think about HER2 ultra-low as well in the design of your pivotal study? Thanks.
Ugur Sahin: Yeah. This is a good question, indeed. Indeed, the question is about HER2 low, one plus, two plus or even ultra-low or even negative. So we are considering all patient cohorts in our trial design and will make a decision on the patient population to be enrolled and the patient population to be analyzed later on for the upcoming trials and will most likely report about the clinical trial design end of this year.
Yifeng Liu: Thanks.
Operator: Thank you. We will now take our final question for today. And your final question comes from the line of Suzanne Van Voorthuizen from VLK. Please go ahead.
Suzanne Van Voorthuizen: Hi, there. This is Suzanne from VLK. Thanks for taking my question, which relates to business development and M&A. Last year you were fairly active on the deal making front. So can you give [Technical Difficulty] what we could expect going forward for this and next year? You have a lot of cash on hand, but also a lot of projects to run and many moving parts on the profitability side. So I was wondering if you're continuing to pursue similar deals and assets as previously, or does your appetite change? Thank you.
Ryan Richardson: Yes. Thanks, Suzanne. I think our focus this year is more on clinical execution. That said, we will be opportunistic and if -- we're open to synergistic assets, but I think you can expect the general level of activity in terms of number of deals to be decreased this year.
Suzanne Van Voorthuizen: Got it.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.